Dolestan

"Diphenhydramin? enthält den Wirkstoff Diphenhydramin, ein Arzneimittel aus der Gruppe der sogenannten H1-Antihistaminika.

Aufgrund der Blockade zentraler H1-Rezeptoren haben diese Mittel einen sedierenden und antiemetischen Effekt und werden hauptsächlich als Sedativa (Schlaf- und Beruhigungsmittel) oder Antiemetika (Mittel gegen Übelkeit und Erbrechen) eingesetzt.

Diphenhydramin wird üblicherweise in Salzform als Diphenhydraminhydrochlorid angewendet.

Diphenhydramin zum Einnehmen oder zur rektalen Anwendung ist apothekenpflichtig und rezeptfrei in der Apotheke erhältlich.

for short-term treatment of sleep?or dizziness, ?nausea, vomiting, kinetoses (e.g. motion sickness).

for the treatment of ?nausea and vomiting from a K?weight of 8 kg.

When used with S?infants and young children under 3 years of age: Studies have shown that the administration of diphenhydramine to S?ugling and toddlers for the treatment of banal gastroenteritis have no advantage compared to a sole substitution with fl?shows speed and electrolytes. Against the background of a go?If serious side effects occur in children up to 3 years of age in this indication, diphenhydramine should not be used to treat banal gastroenteritis. Because diphenhydramine is a seizure, especially in young children?and this patient group also to fever?prone to diphenhydramine should not be given in febrile infections. The indication must be strict in children up to 3 years of age. The recommended H?Chst dose should not be given in this age group ?be exceeded.

Apply "diphenhydramine? always exactly according to the doctor's instructions or according to the package leaflet. Please ask your doctor or pharmacist if you are not completely sure.

The tablets / film-coated tablets as sleeping pills are taken whole with a little liquid (water) in the evening 30 minutes before bed. A sufficient sleep duration (7 to 8 hours) should then be guaranteed.

The rectal capsules / suppositories must be inserted into the rectum with the thick end in advance (possibly. after light moistening with a little water). This makes it easier for the rectal capsules to slide into the intestine and prevents unwanted sliding out.

To prevent motion sickness, use should be made at least 30 minutes before the start of the trip.

There should be at least a interval of 4 to 6 hours between the administration of two single doses.

The duration of treatment should be as short as possible. It should generally be only a few days and not exceed 2 weeks. If the symptoms persist, please see a doctor immediately.

When you stop treatment with tablets, sleep disorders due to sudden discontinuation can temporarily recur. Therefore, you should stop treatment by gradually reducing the dose.

3.2.a.1. Short-term treatment of sleep disorders

Adults take 50 mg diphenhydramine hydrochloride 30 minutes before bed. This dose should not be exceeded. The duration of treatment should be as short as possible. It should generally be only a few days and not exceed 2 weeks.

3.2.a.2.Prevention and treatment of nausea and vomiting

50 mg 1 to 3 times a day (corresponding to 50 to 150 mg diphenhydramine hydrochloride per day) as tablets or suppositories. There should be at least a interval of 4 to 6 hours between the administration of two single doses.

To prevent nausea and vomiting, one dose per day should first be used. If acute symptoms occur, the dose can be increased to the maximum daily dose according to age, with a interval of at least 4 to 6 hours between the individual doses.

To prevent motion sickness, use should be made at least 30 minutes before the start of the trip.

should get lower doses.

3.2.c.1.Bags in children from 8 kg body weight

Overdose with the active ingredient diphenhydramine hydrochloride can be life-threatening, especially in children under 3 years of age, and must therefore be avoided under all circumstances, especially in this age group. Therefore, never give your toddler more than 3 mg / kg body weight in 24 hours.

The recommended dosage should never be increased arbitrarily! There should be at least a interval of 4 to 6 hours between the administration of two single doses. The following recommendations apply:

- Infants with 8 to 16 kg body weight: 1 x 1 rectal capsule with 20 mg daily (corresponding to max. 20 mg diphenhydramine hydrochloride per day)

- Infants with a body weight of 16 to 21 kg: 1 to 2 times 1 rectal capsule with 20 mg daily (corresponding to max. 40 mg diphenhydramine hydrochloride per day)

- Children from 6 years with and over 21 kg body weight: 1 to 3 times 1 rectal capsule with 20 mg daily (corresponding to max. 60 mg diphenhydramine hydrochloride per day)

To prevent motion sickness, use should be made at least 30 minutes before the start of the trip.

Weak children and children with hepatic or renal impairment should be given lower doses than indicated above.

To prevent nausea and vomiting, a rectal capsule / suppositories should be used per day. If acute symptoms occur, the dose can be reduced to a maximum of 2 rectal capsules per day (children 3 to 6 years) or. up to a maximum of 3 rectal capsules per day (children from 6 years) should be increased, with a time interval of at least 4-6 hours between the individual doses.

3.2.c.2.Tablets in children from 6 years

- Children from 6 to 12 years receive 25 mg diphenhydramin hydrochloride (corresponding to. ½ tablet) a maximum of 2 times a day.

- Children over 12 years and adolescents receive 50 mg diphenhydramin hydrochloride (corresponding to. 1 tablet) a maximum of 2 times a day.

To prevent nausea and vomiting, the lowest single dose per day should be taken according to age. If acute symptoms occur, the dose can be increased to the maximum daily dose according to age, with a interval of at least 4-6 hours between the individual doses.

Overdoses with diphenhydramine can be dangerous, especially for children and toddlers. For this reason, a doctor must be informed immediately if an overdose or poisoning is suspected (e.g. emergency poisoning call)!

Overdoses with diphenhydramine primarily express themselves depending on the amount absorbed by disturbances in the central nervous system (confusion, excitation conditions up to seizures, deterioration of consciousness up to coma, breathing disorders up to respiratory arrest) and the cardiovascular system. Increased muscle reflexes, fever, dry mucous membranes, vision problems, constipation and urinary disorders can also occur.

Rhabdomyolysis (severe muscle damage) have also been observed.

- in case of hypersensitivity to the active substance diphenhydramine hydrochloride, to other antihistamines or to any of the other components of the medicinal product,

- with acute asthma ,

- with green star (narrow-angle glaucoma) ,

- for certain tumors of the adrenal medulla (phaeochromocytoma),

- when the prostate gland is enlarged with residual urine formation,

- with epilepsy,

- with potassium or magnesium deficiency ,

- with a slow heartbeat (bradycardia) ,

- for certain heart diseases (congenital QT syndrome or other clinically significant heart damage, in particular circulatory disorders of the coronary arteries, conduction disorders, arrhythmias),

- with simultaneous use of medicinal products that also extend the so-called QT interval in the ECG or lead to hypokalaemia (see under "Interaction with other medicinal products"),

- with simultaneous use of alcohol or so-called "MAO inhibitors" (medicines for the treatment of depression),

- during breastfeeding.

if you have any of the following:

- impaired liver function

- impaired kidney function

- chronic lung diseases or asthma

- certain stomach disorders (pyloric stenosis or achalasia of the cardia).

Before starting treatment with diphenhydramine hydrochloride, specific causes of the present disease should be clarified (see also note under areas of application).

Repeated use over a longer period of time can lead to a loss of effectiveness (tolerance).

The use of the active substance diphenhydramine hydrochloride can lead to the development of physical and mental addiction. The risk of addiction increases with the dose and the duration of treatment. This risk is also increased in patients with a history of alcohol, drug or drug addiction.

Notes on other components: suppositories can contain soy proteins. Do not use this medicine or. not with your child if allergies are peanuts or soy. Macrogol glycerol ricinoleate (Ph. Eur.) can cause irritation of the mucous membrane.

In infants and young children up to 3 years of age in particular, the active ingredient diphenhydramine can lead to serious side effects such as seizures. The indication for treatment should therefore be strict in this patient group. Infants with simple gastrointestinal flu or feverish infections should not be treated with diphenhydramine. In these cases, however, care should be taken to ensure that liquids and electrolytes are adequately supplied.

In infants in particular, so-called "paradox reactions" can be used when treating with diphenhydramine? (Restlessness, excitement, anxiety) occur. Therefore, special caution is required and reserved to dose in this age group. Weak children and children with hepatic or renal impairment should also be given reduced doses. Overdoses must be avoided in small children and these patient groups under all circumstances.

The recommended dosage should never be increased arbitrarily. Infants weighing less than 8 kg should not be treated with children's suppositories (20 mg).

There is insufficient experience with the effectiveness and tolerability of diphenhydramine as a sleeping pill in children and adolescents.

In elderly or weakened patients who may be particularly sensitive, it is recommended to adjust the dose if necessary.

"Diphenhydramine? should not be used during pregnancy, especially not in the last weeks of pregnancy due to the risk of premature labor. If necessary, ask. Your doctor or pharmacist if you want to use diphenhydramine for nausea and vomiting during pregnancy.

"Diphenhydramine? must not be used during breastfeeding.

The active ingredient diphenhydramine hydrochloride can change the reactivity even when used as intended to such an extent that the ability to actively participate in road traffic or to operate machines is impaired. Therefore, no vehicles may be operated or dangerous machines operated. The following day, residual fatigue and impaired responsiveness or. reduced ability to concentrate still adversely affects the ability to drive or work with machines, especially after insufficient sleep or. in interaction with alcohol.

Like all medicines, "diphenhydramine? Have side effects, but not everyone has to experience them.

The following frequency information is used to assess side effects:

- very common: more than 1 in 10 people treated

- common: less than 1 in 10 but more than 1 in 100 people

- uncommon: less than 1 in 100 but more than 1 in 1,000 people

- rare: less than 1 in 1,000 but more than 1 in 10,000 people

- very rare: less than 1 in 10,000 people, including isolated cases

- Frequency not known: Frequency cannot be calculated from the available data

Overdoses with diphenhydramine can be dangerous, especially for children and toddlers. For this reason, a doctor must be informed immediately if an overdose or poisoning is suspected (e.g. emergency poisoning call)!

Overdoses with diphenhydramine primarily express themselves depending on the amount absorbed by disturbances in the central nervous system (confusion, excitation conditions up to seizures, deterioration of consciousness up to coma, breathing disorders up to respiratory arrest) and the cardiovascular system. Increased muscle reflexes, fever, dry mucous membranes, vision problems, constipation and urinary disorders can also occur.

Rhabdomyolysis (severe muscle damage) have also been observed.

Like all medicines, "diphenhydramine? Have side effects, but not everyone has to experience them.

The following frequency information is used to assess side effects:

- very common: more than 1 in 10 people treated

- common: less than 1 in 10 but more than 1 in 100 people

- uncommon: less than 1 in 100 but more than 1 in 1,000 people

- rare: less than 1 in 1,000 but more than 1 in 10,000 people

- very rare: less than 1 in 10,000 people, including isolated cases

- Frequency not known: Frequency cannot be calculated from the available data