• 50 mg diphenhydramine hydrochloride

• Silica, colloidal
• cellulose powder
• cellulose, microcrystalline
• cellulose granules
• Magnesium stearate (vegetable)
• potato starch
• 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 disturbances of clinically significant severity.

dosage

• Use in adults
  • Always take this medicine exactly as described or as your doctor or pharmacist has told you. 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 be a few days and not exceed 2 weeks.
• If you continue to have trouble sleeping, please see 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 debilitated 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
  • Diphenhydramine overdoses can be dangerous—especially for children and young children. For this reason, a doctor must be informed immediately if an overdose or poisoning is suspected (e.g. poison emergency call)!
  • Overdoses with diphenhydramine primarily manifest themselves, depending on the amount ingested, as disturbances in the central nervous system (confusion, states of excitement through to seizures, clouding of consciousness through to coma, respiratory disorders through to respiratory arrest) and the cardiovascular system.
  • In addition, increased muscle reflexes, fever, dry mucous membranes, visual disturbances, constipation and urination disorders 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 bedtime with some liquid (water).
• Afterwards, a sufficient sleep duration (7 - 8 hours) should be guaranteed.

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 (cannot be estimated from the available data)
• If you notice any of 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 frequently 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 side effects that occur more frequently are headaches, gastrointestinal symptoms such as nausea, vomiting or diarrhea and so-called "anticholinergic effects" such as dry mouth, constipation, heartburn, blurred vision or problems with urination.
  • Certain cardiac arrhythmias may occur during treatment (prolongation of the QT interval on the ECG).
  • In addition, hypersensitivity reactions, increased skin sensitivity to light, changes in the blood picture, 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 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 might 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 enhanced by drugs with similar effects such as atropine, biperiden, tricyclic antidepressants or monoamine oxidase inhibitors.
  • An increase in intraocular pressure, urinary retention or potentially life-threatening intestinal paralysis may occur.
  • Avoid taking the tablets at the same time as other medications that also contain diphenhydramine, including those used externally.
  • Simultaneous use with other centrally depressant drugs such as sleeping pills, sedatives, painkillers or anaesthetics, anxiolytics, drugs to treat depression or drugs to treat seizure disorders (antiepileptics) can lead to mutual reinforcement.
  • Using diphenhydramine with antihypertensive medicines can lead to increased tiredness.
  • Simultaneous use with drugs that also prolong the so-called QT interval in the ECG, e.g. B. Medicines for cardiac arrhythmias (class IA or III antiarrhythmics), certain antibiotics (e.g. erythromycin), antimalarial medicines, medicines for allergies or gastric/intestinal ulcers (antihistamines) or medicines for the treatment of specific mental disorders (neuroleptics). ) or can lead to potassium deficiency (e.g. certain diuretics) should be avoided.
  • Diphenhydramine can possibly falsify the test results in allergy tests and should therefore no longer be used at least 3 days beforehand.
• Consumed with alcohol
  • Alcohol must not be drunk during treatment with the tablets, as this changes and intensifies the effect of diphenhydramine in an unpredictable manner.

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.
  • with glaucoma (narrow-angle glaucoma).
  • in certain tumors of the adrenal medulla (pheochromocytoma).
  • with enlargement of the prostate gland with residual urine.
  • in epilepsy.
  • with potassium or magnesium deficiency.
  • if you have a slow heartbeat (bradycardia).
  • in certain heart diseases (congenital QT syndrome or other clinically significant heart damage, in particular circulatory disorders of the coronary vessels, conduction disorders, arrhythmias).
  • with simultaneous use of drugs that also prolong the so-called QT interval in the ECG or lead to hypokalemia.
  • if you are taking alcohol or so-called "MAO inhibitors" (medicines used to treat depression) at the same time.
  • during pregnancy or lactation.
  • of children and young people under the age of 18.

pregnancy and breast feeding period

• 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 should not be taken during pregnancy and lactation.

patient notes

• Warnings and Precautions
  • Please talk to your doctor or pharmacist before taking this medicine.
  • 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 long 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 mental dependence. The risk of dependence increases with dose and duration of treatment. This risk is also increased in patients with a history of alcohol, drug or drug dependence.
  • When stopping treatment with the tablets, sleep disturbances may temporarily recur if you stop suddenly. Therefore it is recommended to stop the treatment by gradually reducing the dose if necessary.
  • children and young people
    • Children and adolescents should not take these tablets.

• Ability to drive and use machines
  • Do not drive or operate dangerous machinery after taking the tablets. Residual tiredness and impaired responsiveness can also have a negative effect on the ability to drive or work with machines the following day, especially after insufficient sleep.