Anadin Ultra

Anadin Ultra Double Strength 400 mg Capsules

Anadin LiquiFast 400 mg Capsules

Each capsule contains 400mg Ibuprofen

For excipients, see 6.1

Soft capsule

A 14 oval capsule with a dye free, translucent gelatin shell, printed with '400' in black ink, and containing a clear liquid fill.

For relief of rheumatic or muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza.

For oral administration and short term use only. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

Adults, the elderly, and children and adolescents over 12 years of age:

If in children and adolescents, between the age of 12 and 18 years, this medicinal product is required for more than 3 days, or if symptoms worsen, a doctor should be consulted.

For adults aged 18 years or older the minimum effective dose should be used for the shortest time necessary to relieve symptoms. If the product is required for more than 10 days or if the symptoms worsen, or persist, the patient should consult a pharmacist or a doctor.

1 capsule up to 3 times a day, as required.

The capsules should be taken with water.

Leave at least 4 hours between doses and do not take more than 1200 mg (3 capsules) in any 24 hour period.

Not to be used for children under 12 years of age.

Hypersensitivity to ibuprofen or any of the constituents in the product.

Ibuprofen is contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angiodema or urticaria) in response to aspirin or other non steroidal anti-inflammatory drugs.

Active or previous peptic ulcer (two or more distinct episodes of proven ulceration or bleeding).

History of upper gastrointestinal bleeding or perforation, related to previous NSAID therapy.

Patients with severe hepatic failure, severe renal failure or severe heart failure (NYHA Class IV).

Use in third trimester of pregnancy.

Caution is required in patients with certain conditions:

- systemic lupus erythematosus as well as those with mixed connective tissue disease due to increased risk of aseptic meningitis.

- gastrointestinal disorders and chronic inflammatory intestinal disease as these conditions may be exacerbated (ulcerative colitis, Crohn's disease).

- caution is required prior to starting treatment in patients with a history of hypertension and/or heart failure. Oedema, hypertension and/or cardiac impairment as renal function may deteriorate and/or fluid retention occur.

- renal impairment as renal function may deteriorate.

- hepatic dysfunction.

Undesirable effects may be minimised by using the minimum effective dose for the shortest possible duration (see GI and cardiovascular risks below).

The elderly are at increased risk of the serious consequences of adverse reactions.

Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease.

Use with concomitant NSAIDs including cyclo-oxygenase-2 specific inhibitors.

Cardiovascular and cerebrovascular effects

Clinical studies suggest that use of ibuprofen, particularly at high doses (2400mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤ 1200 mg daily) is associated with an increased risk of arterial thrombotic events.

Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided.

Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required.

There is some evidence that drugs which inhibit cyclo-oxygenase/prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment.

GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events (including ulcerative colitis, Crohn's disease).

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation , and in the elderly. These patients should commence treatment on the lowest dose available.

Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications, which could increase the risk of gastrotoxicity or bleeding, such as corticosteroids, or anticoagulants such as warfarin, selective serotonin re-uptake inhibitors or anti-platelet agents such as aspirin.

Where GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn immediately.

Dermatological:

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDSs. Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Ibuprofen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

There is a risk of renal impairment in dehydrated children and adolescents, between the ages of 12-18 year olds.

The label will include:

12-18 years: if symptoms worsen, or persist for more than 3 days, or you get new symptoms consult your doctor.

Adults: if symptoms worsen, or persist for more than 10 days, or you get new symptoms consult your pharmacist or doctor.

Read the enclosed leaflet before taking this product.

Do not take if you:

- have ever had a stomach ulcer, perforation or bleeding

- are allergic to ibuprofen (or anything else in this medicine), aspirin or other related painkillers

- are taking other NSAID painkillers, or aspirin with a daily dose above 75mg

- are in the last 3 months of pregnancy.

Speak to a pharmacist or your doctor before taking if you:

- have asthma, diabetes, high cholesterol, high blood pressure, had a stroke, heart, liver, kidney or bowel problems

- are a smoker

- are pregnant

None.

Hypersensitivity reactions have been reported and these may consist of:

a) Non-specific allergic reactions and anaphylaxis,

b) Respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea,

c) Various skin reactions, e.g. pruritus, urticaria, angioedema and more rarely, exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).

The list of the following adverse effects relates to those experienced with ibuprofen at OTC doses, from short-term use. In chronic conditions, under long-term treatment, additional adverse effects may occur. The most commonly-observed adverse events are gastrointestinal in nature.

Clinical studies suggest that use of ibuprofen, particularly at a high dose 2400mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

In children ingestion of more than 400mg/kg may cause symptoms. In adults the dose response effect is less clear cut. The half-life in overdose is 1.5-3 hours.

Symptoms - Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as vertigo, headache, respiratory depression, dyspnoea, drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning, hypotension, hyperkalaemia, and metabolic acidosis may occur and the prothrombin time / INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.

Management - should be symptomatic and supportive and include maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.

Pharmacotherapeutic group: Propionic acid derivatives

ATC code: M01AE

Ibuprofen is a phenylpropionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans, ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation.

Single-dose clinical studies demonstrate that the pain relieving effects of ibuprofen liquigels are evident within around 30 minutes of dosing. The effects of a 400mg dose of ibuprofen liquigels are statistically superior to 1000mg paracetamol tablets both in the speed of onset and extent of analgesia. The differences in onset (see table below) are between 0.6 and 14 min. Ibuprofen 400mg pain relieving effects can last for up to 8 hours.

Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose aspirin (acetylsalicylic acid) on platelet aggregation when they are dosed concomitantly. Some pharmacodynamics studies show that when single doses of ibuprofen 400mg were taken within 8 h before or within 30 min after immediate release aspirin (acetylsalicylic acid) dosing (81 mg), a decreased effect of aspirin (acetylsalicylic acid) on the formation of thromboxane or platelet aggregation occurred. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose aspirin (acetylsalicylic acid) cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use.

Ibuprofen is rapidly absorbed following administration and is rapidly distributed throughout the whole body. The excretion is rapid and complete via the kidneys. Compared to standard tablet formulations, ibuprofen administered in liquid-filled capsules reaches maximum plasma concentrations significantly faster. Peak plasma concentrations were achieved in around 35 minutes for liquigels compared to around 90 minutes for standard ibuprofen tablets.

The half life of ibuprofen is about 2 hours. In limited studies, ibuprofen appears in breast milk in very low concentrations.

No relevant information additional to that already contained elsewhere in the SPC.

Capsule Contents:

Macrogol 600

Potassium hydroxide

Capsule shell:

Sorbitol liquid, partially dehydrated (containing sorbitan and mannitol)

Gelatin

Purified water

Processing Aids:

Lecithin

Triglycerides (medium chain)

Glyceryl stearate

Oleic acid

Ascorbyl palmitate

Printing Ink:

Opacode black ink [iron oxide black (E172), propylene glycol, polyvinyl acetate phthalate (PVAP), macrogol 400].

None known.

3 years

Do not store above 25°C.

Anadin Ultra Double Strength 400 mg Capsules/Anadin LiquiFast 400mg Capsules are packed into blister strips in a cardboard box.

Pack A: Blister: White opaque thermoformed unplasticised PVC (250 μm) / Polyethylene extrusion coating (30 μm) / PVdC (90 gsm) heat sealed to the foil.

Pack B: Blister: White opaque thermoformed unplasticised PVC (250 μm) / PVdC coating (60 gsm) heat sealed to the foil.

Foil: Glassine (35 gsm) / Lamination adhesive / Aluminium foil (9 μm) / Heat seal lacquer (7 gsm).

No special instructions.

Pfizer Consumer Healthcare Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

PL 00165/0148

11/05/2006 / 03/06/2011

February 2018