Sleep Tabs-ratiopharm, 20 tablets

active ingredients

• 25 mg of doxylamine hydrogen succinate

ingredients

• magnesium stearate
• ethyl cellulose
• silica
• cellulose, microcrystalline
• cornstarch
• lactose

Indication :

• The preparation is a drug against allergic reactions with drowsy properties (antihistamine, sedative).
• It is applied to
  • Disorders of falling asleep and staying asleep that require medication.
• A notice:
  • Not all sleep disorders require drug therapy. They are often an expression of physical or mental illnesses and can be influenced by other measures or therapy for the underlying disease. Therefore, long-term insomnia should not be treated with the preparation, but the doctor treating you should be consulted.

Dosage :

• Always take the medicine exactly as directed. Please check with your doctor or pharmacist if you are not sure.
• Unless otherwise prescribed, adults take 1 tablet (equivalent to 25 mg doxylamine succinate) about ½-1 hour before bedtime. In the case of severe sleep disorders, the maximum dose is 2 tablets (equivalent to 50 mg doxylamine succinate).
• How long should you take the medicine?
  • In the case of acute sleep disorders, treatment should be limited to single doses if possible. In order to check the need for continued use in the case of chronic sleep disorders, the dose should be gradually reduced or discontinued after two weeks of daily use.
  • Please talk to your doctor or pharmacist if you have the impression that the effect of the medicine is too strong or too weak.
• If you take more than you should
  • An overdose can be recognized by the fact that central symptoms such as restlessness, increased muscle reflexes, unconsciousness, respiratory depression and cardiac arrest can initially occur. Other signs of an overdose are dilation of the pupils, increased heart rate (tachycardia), fever, hot, red skin, dry mucous membranes, muscle weakness and muscle pain. If these symptoms occur, a doctor should be contacted immediately.
  • In the event of an overdose, gastric lavage with activated charcoal is recommended as an immediate measure. If gastrointestinal complaints, central nervous disorders, dry mouth, problems with emptying the bladder (urinary problems) and visual disturbances occur, the appropriate measures must be taken depending on the appearance.
• 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 the medicine, ask your doctor or pharmacist.

way :

• The tablets are taken with sufficient liquid (e.g. 1 glass of water) without chewing, about 1/2 - 1 hour before going to bed.
• It is important to ensure that after taking the preparation you have enough sleep to avoid impairing your ability to react the following morning.

Side effects :

• Like all medicines, this can cause side effects, although not everyone gets them. Depending on the sensitivity of the individual patient and the dose taken, the following side effects may occur:
• Tiredness, drowsiness, fatigue, dizziness, lightheadedness, increased reaction time, difficulty concentrating, headache, depression, muscle weakness, ringing in the ears and tiredness the following day.
• There is also the possibility of the occurrence of so-called "paradoxical" reactions such as restlessness, excitement, tension, insomnia, nightmares, confusion, tremors. In rare cases, seizures of the brain can occur.
• Concomitant effects on the vegetative nervous system such as blurred vision, dry mouth, feeling of stuffy nose, increase in intraocular pressure, constipation and urinary disorders can occur, as well as nausea, vomiting, diarrhea, loss of appetite or increased appetite, and pain in the stomach area. Life-threatening intestinal paralysis can occur very rarely.
• Accelerated heartbeat, irregular heartbeat, fall or rise in blood pressure and worsening of an existing heart failure can occur. ECG changes were observed.
• The respiratory function can be impaired by thickening of mucus and obstruction or constriction of the bronchi.
• Allergic skin reactions and photosensitivity of the skin (avoid direct sunlight) during therapy with antihistamines have been reported, as well as liver dysfunction (cholestatic jaundice) and disturbances in body temperature regulation.
• Blood cell damage can occur in exceptional cases.
• In patients with an adrenal gland tumor (pheochromocytoma), the administration of antihistamines, to which this medicine belongs, can lead to the release of substances from the tumor that have a very strong effect on the cardiovascular system.
• After long-term daily use, sudden discontinuation of therapy can lead to increased sleep disturbances.
• Hints:
  • The frequency and extent of side effects can be reduced by careful and individual adjustment of the daily doses.
  • The risk of side effects occurring is greater in elderly patients, and this can also increase the risk of falls in this group of people.
• Countermeasures:
  • If you notice the side effects mentioned above, you should not take the drug again.
  • Please notify your doctor so that he can decide on the severity and any further action that may be necessary.
• Please tell your doctor or pharmacist if any of the side effects gets serious, or if you notice any side effects that are not listed.

Interactions :

• Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines.
• Simultaneous use of other centrally acting drugs (such as psychotropic drugs, sleeping pills, painkillers, anesthetics, drugs for the treatment of seizure disorders) can lead to a mutual intensification of the effect. This applies in particular to the simultaneous consumption of alcohol, which can change and intensify the effects of the preparation in an unforeseeable manner.
• If the preparation is given at the same time as phenytoin, a drug used to treat seizure disorders, the effect of phenytoin is weakened.
• The anticholinergic effect of the preparation can be enhanced in an unforeseeable manner by the simultaneous administration of other substances with anticholinergic effects (e.g. Biperiden, a drug used to treat Parkinson's disease; tricyclic antidepressants). Simultaneously taking monoamine oxidase inhibitors, which are used to treat depression, can also increase the anticholinergic effect of the drug, which can manifest itself in life-threatening intestinal paralysis, urinary retention or an acute increase in intraocular pressure. Simultaneous use with monoamine oxidase inhibitors can also lead to a drop in blood pressure and increased functional impairment of the central nervous system and breathing.
• Using medicines for high blood pressure that act on the central nervous system (such as guanabenz, clonidine, alpha-methyldopa) together with the preparation may lead to increased tiredness and fatigue.
• The effect of neuroleptics may be weakened when used simultaneously with the drug.
• Symptoms of incipient damage to the inner ear caused by other drugs (e.g. aminoglycoside antibiotics, some painkillers, some diuretics) may be reduced under treatment with the preparation or other antihistamines.
• The result of skin tests can be falsified (false negative) under therapy with the drug.
• Epinephrine should not be administered together with the preparation (vasodilatation, drop in blood pressure, accelerated heart rate).
• Please note that this information may also apply to recently used medicines.
• Taking the preparation with food and drink
  • Alcohol consumption should be avoided while using the drug.

Contraindications :

• The medicine must not be taken
  • if you are allergic (hypersensitive) to doxylamine or other antihistamines or any of the other ingredients
  • in an acute asthma attack
  • glaucoma (narrow-angle glaucoma)
  • with adrenal tumor (pheochromocytoma)
  • with enlargement of the prostate gland (prostate hypertrophy) with residual urine
  • in acute poisoning from alcohol, sleeping pills or painkillers and psychotropic drugs (neuroleptics, tranquilizers, antidepressants, lithium)
  • for seizure disorders
  • with simultaneous treatment with inhibitors of monoamine oxidase

Pregnancy and lactation :

• pregnancy
  • The drug should only be taken during pregnancy if your doctor has specifically told you to.
• lactation
  • Since the active ingredient is excreted in breast milk, breastfeeding should be discontinued for the duration of treatment.

Patient Notes :

• Special care is required when ingesting
  • impaired liver function
  • Previous damage to the heart and high blood pressure
  • chronic breathing problems and asthma
  • insufficient closure of the entrance to the stomach with reflux of food into the esophagus (gastro-oesophageal reflux)
• Particular caution is required in patients with neurologically evident brain damage in the cerebral cortex and a history of seizures, since administration of even small doses can trigger large seizures.
• Children:
  • Children and adolescents should not be treated with the drug.
• Elderly people:
  • The risk of side effects is greater in elderly patients; this can also increase the risk of falling for this group of people.
• Driving and using machines:
  • Even when used as directed, this medicinal product can change the ability to react to such an extent that the ability to drive or operate machines is impaired. This applies even more in combination with alcohol.
  • You can then no longer react quickly and specifically enough to unexpected and sudden events. Do not drive a car or other vehicles. Do not operate any electrical tools or machinery. Do not work without a safe grip.
  • Be especially aware that alcohol will make your ability to drive even worse.

Manufacturer: ratiopharm GmbH