Adcom-H

Adcom-H is a white to slightly yellowish solid. It is chemically described as 4'-[(1,4'-dimethyl-2'-propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C₃₃H₃₀N₄O₂, its molecular weight is 514.63.

Hydrocholorothiazide is a white or almost white, crystalline powder. It is chemically described as [6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide]. Its empirical formula is C₇H₈CIN₃O₄S₂. Its molecular weight is 297.74.

Adcom-H/Adcom-H Plus also contains the following inactive ingredients: Microcrystalline cellulose PH 101, croscarmellose sodium, meglumine, poloxamer 188, povidone K-30, microcrystalline cellulose PH 102, magnesium stearate, isopropyl alcohol.

Adcom-H Plus also contains the following inactive ingredients: Anhydrous lactose (DC grade), sodium starch glycollate, lake sunset yellow.

1. What Actelsar HCT is and what it is used for

Actelsar HCT is a combination of two active substances, Telmisartan and hydrochlorothiazide in one tablet. Both active substances help control high blood pressure.
- Telmisartan belongs to a group of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body that causes your blood vessels to narrow, thereby increasing your blood pressure. Telmisartan blocks the effect of angiotensin II, so that blood vessels relax and your blood pressure is lowered.
- Hydrochlorothiazide belongs to a group of drugs known as thiazide diuretics, which increase your urine output producing a decrease in your blood pressure.
High blood pressure, if left untreated, can damage blood vessels in various organs, which can sometimes lead to a heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before the damage occurs. Therefore, it is important to periodically monitor blood pressure to check that it is within the normal range.

- if you are allergic to Telmisartan or any of the other ingredients of this medicine
(included in Section 6).
- if you are allergic to hydrochlorothiazide or other medicines derived from sulphonamide.
- if you are more than 3 months pregnant. (In any case, it is better to avoid taking ACTELSAR HCT
also at the beginning of your pregnancy - see Section pregnancy).
- if you have serious liver problems such as cholestasis or biliary obstruction (problems draining bile from the liver and gallbladder) or any other serious liver disease.
- if you have any serious kidney disease.
- if your doctor determines that you have low potassium or high blood calcium levels, which do not improve with treatment.
- if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
If any of the above happens to you, tell your doctor or pharmacist before taking Actelsar HCT.

Consult your doctor before you start taking Actelsar HCT if you have or have ever had any of the following conditions:
- Low blood pressure (hypotension), which may occur if you are dehydrated (excessive loss of body water) or deficient in salts due to treatment with diuretics, low sodium diet, diarrhoea, vomiting or haemodialysis.
- Kidney disease or transplant.
- Stenosis of the renal artery (narrowing of the blood vessels of one or both kidneys).
- Liver disease.
- Heart problems.
- Diabetes.
- Drop.
- Elevated levels of aldosterone (retention of water and salt in the body along with imbalance of various blood minerals)
- Systemic Lupus erythematosus (also called “lupus " or "SLE"”, a disease in which the body's immune system attacks the body itself
- The active substance hydrochlorothiazide may cause a rare reaction, resulting in decreased vision and pain in the eyes. These symptoms may be indicative of a
increased pressure in your eye and may appear between hours and weeks after taking
Actelsar HCT. If left untreated, it can lead to a permanent decrease in vision.
- if you have had skin cancer or if you have an unexpected skin injury during treatment.
Treatment with hydrochlorothiazide, particularly its long-term use at high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Actelsar HCT
Consult your doctor before you start taking Actelsar HCT if you are taking:
- any of the following medicines used to treat high blood pressure
(hypertension):
- an angiotensin converting enzyme (ACE) inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you suffer from kidney problems related to diabetes.
- aliskiren.
Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (for example, potassium) at regular intervals. See also the information under the heading”do not take Actelsar HCT".
- digoxin
If you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant, you should tell your doctor. The use of Actelsar HCT in early pregnancy (first 3 months) is not recommended and in no case should it be given from the third month of pregnancy because it can cause serious harm to your baby (see Pregnancy section).
Treatment with hydrochlorothiazide may cause electrolyte imbalance in your body. Typical symptoms of a fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea, vomiting, fatigue of the
muscles and an abnormally fast rhythm of the heart (more than 100 beats per minute). If you experience any of these symptoms tell your doctor.
You should also inform your doctor if you experience increased sensitivity of the skin to the sun with symptoms
symptoms of sunburn (such as redness, itching, swelling, the appearance of blisters) appear more quickly than usual.
If you are going to have a surgical operation (surgery) or anesthesia, you should tell your doctor that you are taking Actelsar HCT.
Actelsar HCT may be less effective in lowering blood pressure in black patients.

The use of Actelsar HCT in children and adolescents up to 18 years is not recommended.

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicines. Your doctor may need to change the dose of these other medicines or take other precautions. In some cases, you may need to stop using any of these medicines, especially if you are using any of the medicines listed below together with Actelsar HCT.
- Lithium-containing drugs for the treatment of some types of depression.
- Medicines associated with low blood potassium levels (hypokalaemia) such as other diuretics, laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), ACTH (adrenocorticotropic hormone), amphotericin (antifungal medicine), carbenoxolone (used to treat mouth ulcers), penicillin g Sodium (an antibiotic) and acetylsalicylic acid and derivatives.
- Medicines that may increase blood potassium levels as diuretics
potassium-sparing, potassium supplements, salt substitutes containing potassium, ACE inhibitors, cyclosporine (immunosuppressive drug) and other drugs such as Heparin Sodium (anticoagulant).
- Drugs that affect the changes in the levels of potassium in the blood such as heart medicines (e.g. digoxin) or medicines to control the rhythm of your heart (e.g. quinidine, disopyramide, amiodarone, sotalol), drugs used in the treatment of mental disorders (e.g. thioridazine, chlorpromazine, levomepromazina) and other drugs such as some antibiotics (e.g. esparfloxacino, pentamidine) or some medicines to treat allergic reactions (e.g. terfenadine).
- Medicines for the treatment of diabetes (insulins or oral agents such as metformin).
- Cholestyramine and colestipol, drugs to reduce blood fat levels.
- Drugs to increase blood pressure, such as norepinephrine.
- Muscle relaxant drugs, such as tubocurarin.
- Calcium supplements and / or vitamin D supplements.
- Anticholinergic medicines (medicines used to treat a variety of disorders such as gastrointestinal spasms, urinary spasms, asthma, motion sickness, muscle spasms, Parkinson's disease and as an aid to anesthesia) such as atropine and biperiden.
- Amantadine (medicine used to treat Parkinson's disease and also to treat or prevent certain diseases caused by viruses).
- Other medicines used to treat high blood pressure, corticosteroids, pain relievers (such as nonsteroidal anti-inflammatory drugs [NSAIDs]), medicines to treat cancer, gout or arthritis.
- If you are taking an angiotensin converting enzyme (ACE) inhibitor or aliskiren (See also information under the headings “do not take Actelsar HCT” and “warnings and precautions”).
- Digoxin.
Actelsar HCT may increase the ability of other medicines used to lower blood pressure or medicines with the potential to lower blood pressure (e.g. baclofen, amifostine). In addition, low blood pressure can be aggravated by alcohol, barbiturates, narcotics or antidepressants. You can notice it as dizziness when standing. You should tell your doctor about the need to adjust the dose of your other medicines while you are using Actelsar HCT.
The effect of Actelsar HCT may be diminished when using NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid or ibuprofen).

You can take Actelsar HCT with or without food.
Avoid taking alcohol until you have spoken to your doctor. Alcohol can further lower your blood pressure and / or increase the risk of feeling dizzy or weak.

Pregnancy

You should tell your doctor if you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant. Your doctor will usually advise you to stop taking Actelsar HCT before you become pregnant or as soon as you become pregnant, and will recommend taking another antihypertensive medicine instead. It is not recommended to use Actelsar HCT during pregnancy and in no case should it be administered from the third month of pregnancy as it can cause serious harm to your baby when administered from that time.

Lactation

Tell your doctor if you are going to start or are breast-feeding as it is not recommended to give actelsar HCT to women during this period. Your doctor may decide to give you a treatment that is more appropriate if you want to breastfeed.

Some people feel dizzy or tired when taking ACTELSAR HCT. If you feel dizzy or tired do not drive or use machines.

Follow exactly the instructions for taking this medicine as directed by your doctor. If in doubt, consult your doctor or pharmacist again.
The recommended dose is one tablet a day. Try taking the tablet at the same time each day. You can take Actelsar HCT with or without food. Tablets should be swallowed with a little water or other non-alcoholic beverage. It is important that you take Actelsar HCT every day until your doctor tells you otherwise.
If your liver is not working properly, the usual dose should not exceed 40 mg / 12.5 mg once a day.

If you accidentally take too many tablets you may experience symptoms such as low blood pressure and rapid heartbeat. Slow heartbeat, dizziness have also been described,
vomiting and reduced kidney function including kidney failure. Due to the hydrochlorothiazide component,
noticeably low blood pressure and low blood potassium levels can also occur, which can lead to nausea, drowsiness and muscle cramps and/or irregular heartbeat associated with the concomitant use of medications such as digitalis or certain antiarrhythmic treatments. Immediately contact your doctor or pharmacist or the emergency department of the nearest hospital.

If you forget to take the medicine, do not worry. Take the dose as soon as you remember and continue as before. If you do not take your tablet one day, take your normal dose the next day. Do not take a double dose to make up for forgotten doses.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone suffers from them.

If you experience any of the following symptoms, you should visit your doctor immediately:
Sepsis* (often called “blood infection”), is a serious infection that involves an inflammatory reaction throughout the body, swelling, rapid of the skin and mucous membranes (angioedema), formation of blisters and flakes in the surface layer of the skin (necrolisis epidermal toxic), these adverse effects are rare (may affect up to 1 in 1,000 people) or frequency not known (necrolisis epidermal toxic) but are extremely serious and patients should stop
to take the drug and visit your doctor immediately. If these side effects are not treated, they can be fatal. An increased incidence of sepsis has been observed with Telmisartan alone, however, it cannot be ruled out for Actelsar HCT.

Common (may affect up to 1 in 10 people): dizziness

Uncommon (may affect up to 1 in 100 people):

Decreased levels of potassium in the blood, anxiety, fainting (syncope), feeling of tingling, tingling (paresthesia), dizziness (vertigo), rapid heartbeat (tachycardia), disturbances of the heart rhythm, low blood pressure, sudden drop in blood pressure when standing, shortness of breath (dyspnea), diarrhea, dry mouth, flatulence, back pain, muscle spasms, muscle pain, erectile dysfunction (inability to have or keep an erection), chest pain and increase the levels of uric acid in the blood.

Rare (may affect up to 1 in 1,000 people):

Inflammation of the lungs (bronchitis), activation or worsening of systemic lupus erythematosus (a disease in which the body's immune system attacks the body, causing joint pain, skin rashes and fever), sore throat, inflammation of the
sinuses, feeling sad (depression), trouble sleeping (insomnia), altered vision, difficulty breathing, abdominal pain, constipation, bloating (dyspepsia), general discomfort (vomiting), inflammation of the stomach (gastritis), alteration in liver function (japanese patients show a greater tendency to experience this adverse effect), redness of the skin (erythema), allergic reactions such as itching or rash, increased
sweating, hives (hives), joint pain (arthralgia) and limb pain, muscle cramps, flu-like illness, pain, low sodium levels, increased levels of creatinine, liver enzymes or creatine phosphokinase in the blood.
Adverse reactions reported for one of the individual components may be potential adverse reactions of Actelsar HCT, although they have not been observed in clinical trials with this product.

Telmisartan

The following side effects have also been described in patients taking Telmisartan alone:

Uncommon (may affect up to 1 in 100 people):

Upper respiratory tract infection (e.g. sore throat, sinus inflammation, common cold), urinary tract infections, red blood cell deficiency (anaemia), high potassium levels, slow heart rate (bradycardia), impaired kidney function including acute kidney failure, weakness, cough.

Rare (may affect up to 1 in 1,000 people):

Low platelet count (thrombocytopenia), increase in certain white blood cells (eosinophilia), serious allergic reactions (e.g. hypersensitivity, anaphylactic reactions, drug eruption), blood sugar levels low (in diabetic patients), upset stomach, eczema (a skin disorder), osteoarthritis, inflammation of the tendons, decreased haemoglobin (a blood protein), drowsiness.

Very rare (may affect up to 1 in 10,000 people):

Progressive Fibrosis of lung tissue (interstitial lung disease)**
*This may have been a casual finding or be related to a currently unknown mechanism.
** Cases of progressive fibrosis of lung tissue have been reported with Telmisartan. However, it is unknown whether Telmisartan was the cause.

Hydrochlorothiazide

The following side effects have also been described in patients taking hydrochlorothiazide alone:

Common (may affect up to 1 in 10 people): nausea, low blood magnesium.

Rare (may affect up to 1 in 1,000 people):

Decreased platelets in the blood, which increases the risk of bleeding and hematoma formation (small purple-red marks on the skin or other tissues caused by bleeding), high calcium level in the blood, headache.

Very rare (may affect up to 1 in 10,000 people):

Increased pH (disturbance of acid-base balance) due to a low level of chloride in the blood.

Side effects of unknown frequency( cannot be estimated from available data): inflammation of the salivary gland, skin and lip cancer (non-melanoma skin cancer), decreased number (or even absence) of cells in the blood, including a low red and white blood cell count, severe allergic reactions (p. ej. loss of appetite, restlessness, dizziness, blurred or yellowed vision, decreased vision and pain in the eyes (possible signs of acute myopia or acute angle-closure glaucoma), inflammation of the blood vessels (necrotizing vasculitis), inflammation of the pancreas, stomach upset, yellowing of the skin or eyes (jaundice), pseudolupic syndrome (a condition known as pseudolupic syndrome).

that mimics a disease called systemic lupus erythematosus in which the body's immune system attacks the body), skin disorders such as inflammation of the blood vessels of the skin, increased sensitivity to sunlight, rash, redness of
skin, blistering of the lips, eyes or mouth, peeling of the skin, fever (possible signs of erythema multiforme), weakness, inflammation of the kidney or impaired function, glucose in the urine (glucosuria), fever, impaired electrolyte balance, high blood cholesterol levels, decreased blood volume, increased blood sugar levels, difficulty in controlling blood/urine glucose levels in patients diagnosed with diabetes mellitus, or fat in the blood.

If you experience any side effects, consult your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also communicate them directly through the National notification system included in Appendix V.
reporting side effects you can help provide more information about the
safety of this drug.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister or bottle label after “EXP”/“CAD”. The expiration date is the last day of the month indicated. 'Lot', which is printed on the carton, refers to the lot number.
For Al/Al blisters and HDPE tablet packaging
This medicine does not require special storage conditions.

For Al/PVC/PVDC blisters
Do not store above 30ºC.

Medicines should not be thrown down drains or into the trash. Ask your pharmacist how to dispose of containers and medicines you no longer need. In this way, it will help protect the environment.

- The active substances are Telmisartan and hydrochlorothiazide. Each tablet contains 40 mg Telmisartan and 12.5 mg hydrochlorothiazide.
- The other ingredients are magnesium stearate (E470b), potassium hydroxide, meglumine, povidone, sodium starch glycolate (Type A), microcrystalline cellulose, mannitol (E421).

Actelsar HCT 40 mg/12.5 mg tablets are white or almost white, oval and biconvex tablets, 6.55 x 13.6 mm, with” TH " engraved on one side.

Package sizes

Al/Al blister: 14, 28, 30, 56, 84, 90 and 98 tablets
Al/PVC/PVDC blister: 28, 56, 84, 90 and 98 tablets
Pack size for tablets: 30, 90 and 250 tablets
Only some pack sizes may be available.

Marketing authorisation holder

Actavis Group PTC ehf.
Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

Responsible for manufacturing

Actavis hf.
Reykjavíkurvegur 78, 220 Hafnarfjörður, Iceland
Actavis Ltd.
BLB016, Bulebel Industrial Estate, Zejtun ZTN 3000, Malta
You can request more information about this medicinal product by contacting the local representative of the marketing authorisation holder:

UAB Sicor Biotech Tel: 370 5 266 0203

????????? ????
You?.: 359 2 489 95 85

Teva Pharmaceuticals CR, s.R. O. Tel: 420 251 007 111

Teva Gyógyszergyár Zrt. Tel.: 36 1 288 6400

Teva Denmark A / S Tlf: 45 44 98 55 11

Actavis Ltd.
Tel: 35621693533

PUREN Pharma GmbH

Aurobindo Pharma B. V. Tel: 31 (0)35 542 99 33

UAB Sicor Biotech Eesti Filiaal
Tel: 372 661 0801

Teva Norway as Tlf: 47 66 77 55 90

Specifar ABEE
Τηλ: 30 210 5401500

ratiopharm Arzneimittel Vertriebs-GmbH Tel: 43 (0)1 97007 0

Aurovitas Spain, S. A. U. Tfno.: 34 91 630 86 45

Teva Pharmaceuticals Polska Sp. z O. O. Tel: 48 22 345 93 00

Actavis Group PTC ehf. Iceland

Aurovitas, Unipessoal, Lda
Tel: 351 214 185 104

Pliva Hrvatska D. O. O. Tel: 385 1 37 20 000

Teva Pharmaceuticals S. R. L Tel: 4021 230 65 24

Actavis Ireland Limited
Tel: 353 (0)21 4619040

Pliva Ljubljana D. O. O. Tel: 386 1 58 90 390

Actavis Group PTC ehf. Sími: 354 550 3300

TEVA Pharmaceuticals Slovakia s.r. O. Tel: 421 2 57 26 79 11

Aurobindo Pharma (Italy) S. r.L. Tel: 39 0296392601

ratiopharm Oy
Puh/Tel: 358 (0) 20 180 5900

Specifar ABEE
Τηλ: 30 210 5401500
Ελλ?δα

Teva Sweden AB Tel: 46 42 12 11 00

UAB Sicor Biotech fili??the Latvij??
Tel: 371 673 23 666

Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.

Telmisartan / hydrochlorothiazide

- Keep this leaflet as you may have to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if these are any side effects not listed in this leaflet. See Section 4.

1. What Actelsar HCT is and what it is used for
2. What you need to know before you start taking Actelsar HCT
3. How to take Actelsar HCT
4. Possible side effects
5. How to store Actelsar HCT
6. Contents of the pack and additional information

Actelsar HCT is a combination of two active substances, Telmisartan and hydrochlorothiazide in one tablet. Both active substances help control high blood pressure.
- Telmisartan belongs to a group of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body that causes your blood vessels to narrow, thereby increasing your blood pressure. Telmisartan blocks the effect of angiotensin II, so that blood vessels relax and your blood pressure is lowered.
- Hydrochlorothiazide belongs to a group of drugs known as thiazide diuretics, which increase your urine output producing a decrease in your blood pressure.
High blood pressure, if left untreated, can damage blood vessels in various organs, which can sometimes lead to a heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before the damage occurs. Therefore, it is important to periodically monitor blood pressure to check that it is within the normal range.

- if you are allergic to Telmisartan or any of the other ingredients of this medicine
(included in Section 6).
- if you are allergic to hydrochlorothiazide or other medicines derived from sulphonamide.
- if you are more than 3 months pregnant. (In any case, it is better to avoid taking ACTELSAR HCT
also at the beginning of your pregnancy - see Section pregnancy).
- if you have serious liver problems such as cholestasis or biliary obstruction (problems draining bile from the liver and gallbladder) or any other serious liver disease.
- if you have any serious kidney disease.
- if your doctor determines that you have low potassium or high blood calcium levels, which do not improve with treatment.
- if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
If any of the above happens to you, tell your doctor or pharmacist before taking Actelsar HCT.

Consult your doctor before you start taking Actelsar HCT if you have or have ever had any of the following conditions:
- Low blood pressure (hypotension), which may occur if you are dehydrated (excessive loss of body water) or deficient in salts due to treatment with diuretics, low sodium diet, diarrhoea, vomiting or haemodialysis.
- Kidney disease or transplant.
- Stenosis of the renal artery (narrowing of the blood vessels of one or both kidneys).
- Liver disease.
- Heart problems.
- Diabetes.
- Drop.
- Elevated levels of aldosterone (retention of water and salt in the body along with imbalance of various blood minerals)
- Systemic Lupus erythematosus (also called “lupus " or "SLE"”, a disease in which the body's immune system attacks the body itself
- The active substance hydrochlorothiazide may cause a rare reaction, resulting in decreased vision and pain in the eyes. These symptoms may be indicative of a
increased pressure in your eye and may appear between hours and weeks after taking
Actelsar HCT. If left untreated, it can lead to a permanent decrease in vision.
- if you have had skin cancer or if you have an unexpected skin injury during treatment.
Treatment with hydrochlorothiazide, particularly its long-term use at high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Actelsar HCT
Consult your doctor before you start taking Actelsar HCT if you are taking:
- any of the following medicines used to treat high blood pressure
(hypertension):
- an angiotensin converting enzyme (ACE) inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you suffer from kidney problems related to diabetes.
- aliskiren.
Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (for example, potassium) at regular intervals. See also the information under the heading”do not take Actelsar HCT".
- digoxin
If you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant, you should tell your doctor. The use of Actelsar HCT in early pregnancy (first 3 months) is not recommended and in no case should it be given from the third month of pregnancy because it can cause serious harm to your baby (see Pregnancy section).
Treatment with hydrochlorothiazide may cause electrolyte imbalance in your body. Typical symptoms of a fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea, vomiting, fatigue of the
muscles and an abnormally fast rhythm of the heart (more than 100 beats per minute). If you experience any of these symptoms tell your doctor.
You should also inform your doctor if you experience major

Adults: Adcom-H should be taken once daily. The dose of Adcom-H could be up-titrated before switching to Adcom-H. Direct change from monotherapy to the fixed combinations may be considered.

Adcom-H 40/12.5 mg may be administered in patients whose blood pressure is not adequately controlled by MICARDIS 40 mg or Hydrochlorothiazide (Adcom-H).

Adcom-H 80/12.5 mg may be administered in patients whose blood pressure is not adequately controlled by MICARDIS 80 mg or by Adcom-H 40/12.5 mg.

Adcom-H 80/25 mg may be administered in patients whose blood pressure is not adequately controlled by Adcom-H 80/12.5 mg or patients who have been previously stabilised on Adcom-H and Hydrochlorothiazide (Adcom-H) given separately.

The maximum antihypertensive effect is generally attained with Adcom-H 4-8 weeks after the start of treatment.

When necessary, Adcom-H may be administered with another antihypertensive drug.

In patients with severe hypertension treatment with Adcom-H at doses up to 160 mg alone and in combination with Hydrochlorothiazide (Adcom-H) 12.5-25 mg daily was well tolerated and effective.

Renal Impairment: Due to the Hydrochlorothiazide (Adcom-H) component, Adcom-H should not be used in patients with severe renal dysfunction (creatinine clearance <30 ml/min). Loop diuretics are preferred to thiazides in this population. Experience in patients with mild to moderate renal impairment is modest but has not suggested adverse renal effects and dose adjustment is not considered necessary. Periodic monitoring of renal function is advised.

Hepatic Impairment: In patients with mild to moderate hepatic impairment the posology should not exceed Adcom-H 40/12.5 mg once daily. Adcom-H is not indicated in patients with severe hepatic impairment. Thiazides should be used with caution in patients with impaired hepatic function.

Elderly: No dosage adjustment is necessary.

Children and Adolescents: Safety and efficacy of Adcom-H have not been established in children and in adolescents up to 18 years.

Administration: Adcom-H may be taken with or without food.

See also:
What is the most important information I should know about Adcom-H?

Hypersensitivity to Adcom-H or any of the excipients of Adcom-H or to other sulfonamide-derived substances (Hydrochlorothiazide (Adcom-H) is a sulfonamide-derived substance).

Refractory hypokalemia, hypercalcemia. Concomitant use of Adcom-H with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m²).

In case of rare hereditary conditions that may be incompatible with an excipient of Adcom-H, its use is contraindicated.

Hepatic Impairment: Adcom-H should not be given to patients with cholestasis, biliary obstructive disorders or severe hepatic insufficiency since Adcom-H is mostly eliminated with the bile. These patients can be expected to have reduced hepatic clearance for Adcom-H.

Renal Impairment and Kidney Transplant: Adcom-H should not be used in patients with severe renal impairment (CrCl <30 mL/min).

There is no experience regarding the administration of Adcom-H in patients with severe renal impairment or with a recent kidney transplant. Experience with Adcom-H is modest in the patients with mild to moderate renal impairment, therefore periodic monitoring of potassium, creatinine and uric acid serum levels is recommended. Thiazide diuretic-associated azotaemia may occur in patients with impaired renal function.

Use in pregnancy & lactation: Adcom-H: The use of angiotensin II receptor antagonists is not recommended during the 1st trimester of pregnancy and should not be initiated during pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be discontinued immediately, and, if appropriate, alternative therapy should be started. The use of angiotensin II receptor antagonists is contraindicated during the 2nd and 3rd trimester of pregnancy.

Preclinical studies with Adcom-H do not indicate teratogenic effect, but have shown fetotoxicity. Angiotensin II receptor antagonists exposure during the 2nd and 3rd trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalemia).

Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.

Should exposure to angiotensin II receptor antagonists have occurred from the 2nd trimester of pregnancy, ultrasound check of renal function and skull is recommended.

Infants whose mothers have taken angiotensin II receptor antagonists should be closely observed for hypotension.

Hydrochlorothiazide (Adcom-H): There is limited experience with Hydrochlorothiazide (Adcom-H) during pregnancy, especially during the 1st trimester. Hydrochlorothiazide (Adcom-H) crosses the placenta. Based on the pharmacological mechanism of action of Hydrochlorothiazide (Adcom-H) its use during the 2nd and 3rd trimester may compromise feto-placental perfusion and may cause fetal and neonatal effects eg, icterus, disturbance of electrolyte balance and thrombocytopenia.

Hydrochlorothiazide (Adcom-H) should not be used for gestational edema, gestational hypertension or preeclampsia due to the risk of decreased plasma volume and placental hypoperfusion, without a beneficial effect on the course of the disease.

Hydrochlorothiazide (Adcom-H) should not be used for essential hypertension in pregnant women except in rare situations where no other treatment could be used.

Adcom-H is contraindicated during lactation. It is not known whether Adcom-H is excreted in human milk. Animal studies have shown excretion of Adcom-H in breast milk.

Thiazides appear in human milk and may inhibit lactation.

Use Adcom-H as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Adcom-H by mouth with or without food.
• Do not remove Adcom-H from the blister until you are ready to take it.
• Drinking extra fluids while you are taking Adcom-H is recommended. Check with your doctor for instructions.
• Adcom-H may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.
• If you take cholestyramine or colestipol, ask your doctor or pharmacist how to take it with Adcom-H.
• Continue to take Adcom-H even if you feel well. Do not miss any doses.
• If you miss a dose of Adcom-H, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Adcom-H.

Use: Labeled Indications

Hypertension: Treatment of hypertension; Note: A fixed-dose combination product should not be used for initial therapy

See also:
What other drugs will affect Adcom-H?

Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors. Cases have also been reported with angiotensin II receptor antagonists, including Adcom-H. Furthermore, renal clearance of lithium is reduced by thiazides so the risk of lithium toxicity could be increased with Adcom-H. Lithium and Adcom-H should only be co-administered under medical supervision and serum lithium level monitoring is advisable during concomitant use.

The potassium-depleting effect of Hydrochlorothiazide (Adcom-H) is attenuated by the potassium-sparing effect of Adcom-H. However, this effect of Hydrochlorothiazide (Adcom-H) on serum potassium would be expected to be potentiated by other drugs associated with potassium loss and hypokalemia (eg, other kaliuretic diuretics, laxatives, corticosteroids, adrenocorticotropic hormone, amphotericin, carbenoxolone, penicillin G sodium, salicylic acid and derivatives).

If these drugs are to be prescribed with Adcom-H, monitoring of potassium plasma level is advised.

Conversely, based on the experience with the use of other drugs that blunt the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other drugs that may increase serum potassium levels (eg, heparin sodium) may lead to increases in serum potassium.

If these drugs are to be prescribed with Adcom-H, monitoring of potassium plasma levels is advised.

Periodic monitoring of serum potassium is recommended when Adcom-H is administered with drugs affected by serum potassium disturbances eg, digitalis glycosides, antiarrhythmic agents and drugs known to induce Torsade de pointes.

Treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) including acetylsalicylic acid (ASA) at anti-inflammatory dosage regimens, COX-2 inhibitors and nonselective NSAIDs is associated with the potential for acute renal insufficiency in patients who are dehydrated. Compounds acting on the renin-angiotensin-system eg, Adcom-H may have synergistic effects. Patients receiving NSAIDs and Adcom-H should be adequately hydrated and be monitored for renal function at the beginning of combined treatment.

The co-administration of NSAIDs may reduce the diuretic, natriuretic and antihypertensive effects of thiazide diuretics in some patients.

Adcom-H may increase the hypotensive effect of other antihypertensive agents. Other interactions of clinical significance have not been identified.

Co-administration of Adcom-H did not result in a clinically significant interaction with digoxin, warfarin, Hydrochlorothiazide (Adcom-H), glibenclamide, ibuprofen, paracetamol, simvastatin and amlodipine. For digoxin, a 20% increase in median plasma digoxin trough concentration has been observed (39% in a single case), monitoring of plasma digoxin levels should be considered.

In 1 study, the co-administration of Adcom-H and ramipril led to an increase of up to 2.5-fold in the AUC_0-24 and C_max of ramipril and ramiprilat. The clinical relevance of this observation is not known.

When administered concurrently, the following drugs may interact with thiazide diuretics: Alcohol, Barbiturates or Narcotics: Potentiation of orthostatic hypotension may occur.

Antidiabetic Drugs (Oral Agents and Insulins): Dosage adjustment of the antidiabetic drug may be required.

Metformin: There is a risk of lactic acidosis when co-administered with Hydrochlorothiazide (Adcom-H).

Cholestyramine and Colestipol Resins: Absorption of Hydrochlorothiazide (Adcom-H) is impaired in the presence of anionic exchange resins.

Digitalis Glycosides: Thiazide-induced hypokalemia or hypomagnesemia favor the onset of digitalis-induced cardiac arrhythmias.

Pressor Amines (eg, Noradrenaline): The effect of pressor amines may be decreased.

Nondepolarizing Skeletal Muscle Relaxants (eg, Tubocurarine): The effect of nondepolarizing skeletal muscle relaxants may be potentiated by Hydrochlorothiazide (Adcom-H).

Treatment for Gout: Dosage adjustment of uricosuric medications may be necessary as Hydrochlorothiazide (Adcom-H) may raise the level of serum uric acid. Co-administration of thiazide may increase the incidence of hypersensitivity reactions of allopurinol.

Calcium Salts: Thiazide diuretics may increase serum calcium levels due to the decreased excretion. If calcium supplements must be prescribed, serum calcium levels should be monitored and calcium dosage adjusted accordingly.

Other Interactions: The hyperglycemic effect of β-blockers and diazoxide may be enhanced by thiazides. Anticholinergic agents (eg, atropine, biperiden) may increase the bioavailability of thiazide-type diuretics by decreasing gastrointetstinal motility and stomach emptying rate.

Thiazides may increase the risk of adverse effects caused by amantadine. Thiazides may reduce the renal excretion of cytotoxic drugs (eg, cyclophosphamide, methotrexate) and potentiate their myelosuppressive effects.

See also:
What are the possible side effects of Adcom-H?

The overall incidence of adverse events reported with Adcom-H was comparable to those reported with Adcom-H alone in randomized, controlled trials involving 1,471 patients receiving Adcom-H plus Hydrochlorothiazide (Adcom-H) or Adcom-H alone. There was no dose-relationship to adverse effects and there was no correlation with gender, age or race of the patients.

Adverse reactions reported in clinical trials with Adcom-H are listed as follows according to system organ class. Adverse reactions not observed in clinical trials with Adcom-H but expected during treatment with Adcom-H based on the experience with Adcom-H or Hydrochlorothiazide (Adcom-H) alone have been included and are detailed in separate sections as follows.

Infections and Infestations: Bronchitis, pharyngitis, sinusitis.

Immune System Disorders: Exacerbation or activation of systemic lupus erythematosus.

Metabolism and Nutrition Disorders: Hypokalemia, hyponatremia, hyperuricemia.

Psychiatric Disorders: Anxiety, depression.

Nervous System Disorders: Dizziness, syncope/faint, paresthesia, sleep disturbances, insomnia.

Eye Disorders: Abnormal vision, transient blurred vision.

Ear and Labyrinth Disorders: Vertigo.

Cardiac Disorders: Cardiac arrhythmias, tachycardia.

Vascular Disorders: Hypotension (including orthostatic hypotension).

Respiratory, Thoracic and Mediastinal Disorders: Respiratory distress (including pneumonitis and pulmonary edema), dyspnea.

Gastrointestinal Disorders: Diarrhea, dry mouth, flatulence, abdominal pain, constipation, dyspepsia, vomiting, gastritis.

Hepatobiliary Disorders: Abnormal hepatic function/liver disorder.

Skin and Subcutaneous Tissue Disorders: Angioedema, erythema, pruritus, rash, increased sweating, urticaria.

Musculoskeletal, Connective Tissue and Bone Disorders: Back pain, muscle spasm, myalgia, arthralgia, leg pain, leg cramps.

Reproductive System and Breast Disorders: Impotence.

General Disorder and Administration Site Conditions: Chest pain, influenza-like symptoms, pain.

Investigations: Increase in creatinine, liver enzymes, blood creatinine phosphokinase and uric acid.

Adcom-H: Additional adverse effects reported in clinical trials with Adcom-H monotherapy in the indication hypertension or in patients ≥50 years at high risk of cardiovascular events are as follows: Infections and Infestations: Upper respiratory tract infections, urinary tract infection (including cystitis), sepsis including fatal outcome.

Blood and Lymphatic System Disorders: Anemia, thrombocytopenia, eosinophilia.

Immune System Disorders: Anaphylactic reaction, hypersensitivity.

Metabolism and Nutrition Disorders: Hyperkalemia, hypoglycemia (in diabetic patients).

Cardiac Disorders: Bradycardia.

Gastrointestinal Disorders: Stomach upset.

Skin and Subcutaneous Tissue Disorders: Eczema, drug eruption, toxic skin eruption.

Musculoskeletal, Connective Tissue and Bone Disorders: Arthrosis, tendon pain (tendonitis-like symptoms).

Renal and Urinary Disorders: Renal impairment including acute renal failure.

General Disorders and Administration Site Conditions: Asthenia (weakness).

Investigations: Decreased hemoglobin.

Hydrochlorothiazide (Adcom-H): Additional adverse effects reported with Hydrochlorothiazide (Adcom-H) monotherapy were as follows: Infections and Infestations: Sialadenitis.

Blood and Lymphatic System Disorders: Thrombocytopenia, aplastic and hemolytic anemia, bone marrow depression, leukopenia, neutropenia/agranulocytosis.

Immune System Disorders: Anaphylactic reactions, allergy.

Endocrine Disorders: Loss of diabetic control.

Metabolism and Nutrition Disorders: May cause or exacerbate volume depletion, electrolyte imbalance, anorexia, loss of appetite, hyperglycemia, hypercholesterolemia.

Psychiatric Disorders: Restlessness.

Nervous System Disorders: Lightheadedness.

Eye Disorders: Xanthopsia, acute myopia, acute angle-closure glaucoma.

Vascular Disorders: Necrotizing angitis (vasculitis).

Gastrointestinal Disorders: Pancreatitis, stomach upset.

Hepatobiliary Disorders: Jaundice (hepatocellular or cholestatic jaundice).

Skin and Subcutaneous Tissue Disorders: Toxic epidermal necrolysis, cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, cutaneous vasculitis, photosensitivity reactions.

Musculoskeletal, Connective Tissue and Bone Disorders: Weakness.

Renal and Urinary Disorders: Intestinal nephritis, renal dysfunction, glycosuria.

General Disorders and Administration Site Conditions: Fever.

Investigations: Increased triglycerides.