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BETADORM D, diphenhydramine hydrochloride UK
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BETADORM D, diphenhydramine hydrochloride

Recordati Pharma GmbH

£39.79 £50.00

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Betadorm ® -D 50 mg diphenhydramine hydrochloride tablets

Active substance:
diphenhydramine hydrochloride.

Area of ​​application:
Betadorm-D is used for the short-term treatment of sleep disorders in adults.

For risks and side effects, read the leaflet and ask your doctor or pharmacist.
Recordati Pharma GmbH, 89075 Ulm.

Sleeping aids

Active ingredients

  • 50 mg diphenhydramine hydrochloride

Excipients

  • Silicon dioxide, highly dispersed
  • Cellulose powder
  • Cellulose, microcrystalline
  • Potato starch, pregelatinized
  • Magnesium stearate (vegetable)
  • talc
Indication :
  • The tablets are a sleeping pill from the group of antihistamines.
  • They are used for the short-term treatment of sleep disorders.
  • Sedatives/hypnotics should only be used for sleep disorders of clinically significant severity.
Dosage :
  • Use in adults
    • Always take this medicine exactly as described or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
    • The recommended dose for adults is 1 tablet (equivalent to 50 mg diphenhydramine hydrochloride). 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.
  • If sleep problems persist, please consult a doctor!
  • Patients with impaired liver or kidney function
    • Patients with impaired liver or kidney function should receive lower doses. It is also recommended that the dose be adjusted if necessary in elderly or weakened patients, who may be particularly sensitive.
  • Use in children and adolescents
    • Children and adolescents under 18 years of age must not be treated with these tablets.

 

  • If you take more than you should
    • Overdoses with diphenhydramine can be dangerous - especially for children and infants. For this reason, if an overdose or poisoning is suspected, a doctor should be informed immediately (e.g. poison control center)!
    • Overdoses with diphenhydramine primarily manifest themselves, depending on the amount ingested, through disturbances of the central nervous system (confusion, states of excitement up to seizures, clouding of consciousness up to coma, respiratory disorders up to respiratory arrest) and the cardiovascular system.
    • In addition, increased muscle reflexes, fever, dry mucous membranes, visual disturbances, constipation and urinary disorders may occur.
    • Rhabdomyolysis (severe muscle damage) has also been observed.

 

  • If you forget to take it
    • Do not take a double dose to make up for a forgotten dose.

 

  • If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Manner :
  • The tablets are taken in the evening 30 minutes before going to bed with some liquid (water).
  • Afterwards, sufficient sleep (7 - 8 hours) should be ensured.
Side effects :
  • Like all medicines, this medicine can cause side effects, although not everybody gets them.
    • Very common (may affect more than 1 in 10 people):
    • Common (may affect up to 1 in 10 people)
    • Uncommon (may affect up to 1 in 100 people)
    • Rare (may affect up to 1 in 1,000 people)
    • Very rare (may affect up to 1 in 10,000 people)
    • Not known (frequency cannot be estimated from the available data)
  • If you notice the following side effects, please discuss this with your doctor, who will then determine how to proceed.
  • The following side effects are to be expected, especially at the beginning of treatment:
    • The most commonly reported side effects are drowsiness, dizziness and difficulty concentrating during the following day, especially after insufficient sleep, as well as dizziness and muscle weakness.
    • Other common side effects include headaches, gastrointestinal complaints such as nausea, vomiting or diarrhea and so-called "anticholinergic effects" such as dry mouth, constipation, heartburn, visual disturbances or difficulty urinating.
    • During treatment, certain cardiac arrhythmias may occur (prolongation of the QT interval in the ECG).
    • In addition, hypersensitivity reactions, increased photosensitivity of the skin, changes in blood count, increased intraocular pressure, jaundice (cholestatic jaundice) and so-called "paradoxical reactions" such as restlessness, nervousness, excitement, anxiety, tremors or sleep disorders have been reported.
  • If you notice any side effects, talk to your doctor or pharmacist. This includes any side effects not listed.
Interactions :
  • Taking with other medicines
    • Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines
      .
    • Diphenhydramine hydrochloride must not be given together with so-called "MAO inhibitors" (certain drugs used to treat depression).
    • The so-called "anticholinergic" effect of diphenhydramine can be potentiated by drugs with similar effects such as atropine, biperiden, tricyclic antidepressants or monoamine oxidase inhibitors.
    • Increased intraocular pressure, urinary retention or potentially life-threatening intestinal paralysis may occur.
    • The tablets should be avoided at the same time as other medicines that also contain diphenhydramine, including those used externally.
    • The simultaneous use with other centrally depressant drugs such as sleeping pills, sedatives, painkillers or anesthetics, anti-anxiety drugs (anxiolytics), drugs for treating depression or drugs for treating seizure disorders (antiepileptics) can lead to mutual reinforcement.
    • The use of diphenhydramine together with antihypertensive medicines may lead to increased fatigue.
    • The simultaneous use with medicines that also prolong the so-called QT interval in the ECG, e.g. medicines for cardiac arrhythmias (class IA or III antiarrhythmics), certain antibiotics (e.g. erythromycin), antimalarials, medicines for allergies or stomach/intestinal ulcers (antihistamines) or medicines for the treatment of specific mental illnesses (neuroleptics) or which can lead to a potassium deficiency (e.g. certain diuretics) should be avoided.
    • Diphenhydramine may potentially distort test results in allergy tests and should therefore not be used at least 3 days beforehand.
  • Taking with alcohol
    • Alcohol must not be consumed during treatment with the tablets, as this will alter and intensify the effect of diphenhydramine in an unpredictable way.
Contraindications :
  • The medicine must not be taken
    • if you are allergic to diphenhydramine hydrochloride, to other antihistamines or to any of the other ingredients of this medicine.
    • in acute asthma.
    • in the case of glaucoma (narrow-angle glaucoma).
    • in certain tumors of the adrenal medulla (pheochromocytoma).
    • in case of enlargement of the prostate gland with residual urine formation.
    • in epilepsy.
    • in case of potassium or magnesium deficiency.
    • with a slow heartbeat (bradycardia).
    • in certain heart diseases (congenital QT syndrome or other clinically significant heart damage, in particular circulatory disorders of the coronary arteries, conduction disorders, arrhythmias).
    • when used simultaneously with medicines that also prolong the so-called QT interval in the ECG or lead to hypokalaemia.
    • when taking alcohol or so-called "MAO inhibitors" (medicines for treating depression).
    • during pregnancy or breastfeeding.
    • by children and young people under 18 years of age.
Pregnancy and breastfeeding :
  • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
  • The tablets must not be taken during pregnancy or breastfeeding.
Patient information :
  • Warnings and precautions
    • Please talk to your doctor or pharmacist before taking this medicine.
    • Special care is required if you suffer from any of the following conditions:
      • impaired liver function
      • chronic lung disease or asthma
      • certain gastric dysfunctions (pyloric stenosis or achalasia of the cardia).
    • After repeated use of sleeping pills over a long period of time, a loss of effectiveness (tolerance) may occur.
    • As with other sleeping pills, taking the tablets can lead to the development of physical and psychological dependence. The risk of dependence increases with the dose and duration of treatment. This risk is also increased in patients with a history of alcohol, medication or drug dependence.
    • When stopping treatment with the tablets, sleep disorders may temporarily recur if the tablets are stopped suddenly. It is therefore recommended that treatment be stopped by gradually reducing the dose if necessary.
    • Children and young people
      • Children and adolescents must not take these tablets.

 

  • Ability to drive and use machines
    • After taking the tablets, you must not drive or operate dangerous machinery. Even the following day, residual tiredness and impaired reaction time may still have a negative effect on your ability to drive or work with machinery, especially after insufficient sleep.