• 50 mg diphenhydramine hydrochloride

• Cellulose, microcrystalline
• Hypromellose
• Magnesium stearate (vegetable)
• Crospovidone
• Silicon dioxide, finely divided

Indication / application

• The tablets are a sleeping aid from the group of antihistamines.
• They are used for the short-term treatment of sleep disorders.
• Sedatives / sleeping pills 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 discussed. Check with your doctor or pharmacist if you are not sure.
  • 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. In general, it should only last a few days and not exceed 2 weeks.
• If you have persistent sleep disorders, please consult a doctor!
• Patients with impaired liver or kidney function
  • Lower doses should be given to patients with impaired liver or kidney function. It is also recommended that the dose be adjusted if necessary in elderly or debilitated patients who may be particularly sensitive.
• Use in children and adolescents
  • Children and adolescents under 18 years of age should not be treated with these tablets.

• If you take more than you should
  • Diphenhydramine overdoses can be dangerous - especially for children and toddlers. For this reason, if you suspect an overdose or poisoning, a doctor should be informed immediately (e.g. poisoning emergency number)!
  • Overdoses with diphenhydramine are primarily expressed, depending on the amount consumed, by disorders of the central nervous system (confusion, states of excitement up to seizures, clouded consciousness up to coma, breathing disorders up to respiratory arrest) and the cardiovascular system.
  • In addition, increased muscle reflexes, fever, dry mucous membranes, visual disturbances, constipation and disorders of urinary excretion can occur.
  • Rhabdomyolysis (severe muscle damage) has also been observed.

• If you forget to take a dose
  • 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.

way

• The tablets are taken in the evening 30 minutes before going to bed with a little liquid (water).
• Subsequently, sufficient sleep time (7 - 8 hours) should be guaranteed.

Side effects

• Like all medicines, this medicine can have 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 observe 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, drowsiness and difficulty concentrating during the following day, especially after insufficient sleep, as well as dizziness and muscle weakness.
  • Other more common side effects are headaches, gastrointestinal complaints such as nausea, vomiting or diarrhea and so-called "anticholinergic effects" such as dry mouth, constipation, heartburn, visual disturbances or urination problems.
  • Certain cardiac arrhythmias may occur during treatment (prolongation of the QT interval in the ECG).
  • Hypersensitivity reactions, increased sensitivity of the skin to light, changes in the blood count, increased intraocular pressure, jaundice (cholestatic jaundice) and so-called "paradoxical reactions" such as restlessness, nervousness, agitation, anxiety, tremors or sleep disorders have been reported.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

Interactions

• Taking with other medicines
  • Tell your doctor or pharmacist if you are taking / using, have recently taken / used or may
    take / use any other medicines .
  • Diphenhydramine hydrochloride must not be given together with so-called "MAOIs" (certain medicines used to treat depression).
  • The so-called "anticholinergic" effect of diphenhydramine can be increased by drugs with a similar effect such as atropine, biperiden, tricyclic antidepressants or monoamine oxidase inhibitors.
  • An increase in intraocular pressure, urinary retention or possibly life-threatening intestinal paralysis can occur.
  • Avoid taking the tablets at the same time as other medications that contain diphenhydramine, including those that are used externally.
  • Simultaneous use with other central depressant drugs such as sleeping pills, sedatives, painkillers or anesthetics, anti-anxiety drugs (anxiolytics), drugs for the treatment of depression or drugs for the treatment of seizure disorders (antiepileptics) can lead to mutual reinforcement.
  • Taking diphenhydramine with medicines to lower blood pressure can make you feel more tired.
  • Simultaneous use with drugs that also prolong the so-called QT interval in the ECG, e.g. B. Agents against cardiac arrhythmias (antiarrhythmics class IA or III), certain antibiotics (e.g. erythromycin), antimalarials, agents against allergies or gastrointestinal ulcers (antihistamines) or agents for the treatment of special mental and emotional diseases (neuroleptics ) or lead to a potassium deficiency (e.g. certain diuretics) should be avoided.
  • Diphenhydramine can possibly falsify the test results in allergy tests and should therefore not be used at least 3 days beforehand.
• Consumption with alcohol
  • Do not drink alcohol during treatment with the tablets, as this changes and increases the effect of diphenhydramine in an unforeseeable 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 glaucoma (narrow-angle glaucoma).
  • in certain tumors of the adrenal medulla (pheochromocytoma).
  • with enlargement of the prostate gland with residual urine formation.
  • in epilepsy.
  • if you have a potassium or magnesium deficiency.
  • if the heartbeat is slow (bradycardia).
  • with 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 drugs that also prolong the so-called QT interval in the ECG or lead to hypokalaemia.
  • if you are also taking alcohol or so-called "MAO inhibitors" (agents used to treat depression).
  • during pregnancy or breastfeeding.
  • by children and adolescents under 18 years of age.

pregnancy and breast feeding period

• Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or breast-feeding, if you suspect you may be pregnant or planning to become pregnant.
• The tablets must not be taken during pregnancy and breastfeeding.

Patient information

• Warnings and Precautions
  • Please talk to your doctor or pharmacist before taking the preparation.
  • Take special care if you suffer from any of the following diseases:
    • impaired liver function
    • chronic lung disease or asthma
    • certain gastric disorders (pyloric stenosis or achalasia of the cardia).
  • Repeated use of sleeping pills over a longer period of time can lead to a loss of effectiveness (tolerance).
  • As with other sleeping pills, taking the tablets can lead to the development of physical and emotional dependence. The risk of addiction increases with dose and duration of treatment. This risk is also increased in patients with a history of alcohol, drug, or drug addiction.
  • When you stop taking the tablets, suddenly stopping your sleep may temporarily return. It is therefore recommended that treatment be stopped by gradually reducing the dose if necessary.
  • Children and adolescents
    • Children and adolescents should not take these tablets.

• Driving and using machines
  • No vehicles may be driven or dangerous machines operated after taking the tablets. Even on the following day, residual tiredness and impaired reactions can still have a negative effect on the ability to drive or work with machines, especially after insufficient sleep.