SCHLAF TABS-

SLEEP TABS-ratiopharm 25 mg tablets

Important notes (mandatory information)

SchlafTabs-ratiopharm 25 mg Tablets. Active ingredient: Doxylamine succinate. Areas of application: for medication-requiring treatment of sleep onset and maintenance disorders.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist!


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

SchlafTabs-ratiopharm 25 mg Tablets for use in adults
Active ingredient: Doxylamine succinate

Read the entire package leaflet carefully, as it contains important information for you. This medicine is available without a prescription. However, to achieve the best possible treatment results, SchlafTabs-ratiopharm must be taken as directed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If your symptoms worsen or do not improve, you must see a doctor in any case.

This package leaflet contains

1. WHAT IS SCHLAFTABS-RATIOPHARM AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING SCHLAFTABS-RATIOPHARM?
3. HOW SHOULD SCHLAFTABS-RATIOPHARM BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD SCHLAFTABS-RATIOPHARM BE STORED?
6. FURTHER INFORMATION

1. WHAT IS SCHLAFTABS-RATIOPHARM AND WHAT IS IT USED FOR?

SchlafTabs-ratiopharm is a medicine for allergic reactions with sedative properties (antihistamine, sedative). SchlafTabs-ratiopharm is used for medication-requiring treatment of sleep onset and maintenance disorders.

Note

Not all sleep disorders require drug therapy. They are often an expression of physical or mental illness and can be influenced by other measures or treatment of the underlying disease. Therefore, in the case of persistent sleep disorders, SchlafTabs-ratiopharm should not be taken for a long period of time, but a doctor should be consulted.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING SCHLAFTABS-RATIOPHARM?

SchlafTabs-ratiopharm must not be taken:

• if you are hypersensitive (allergic) to doxylamine or other antihistamines or any of the other ingredients of SchlafTabs-ratiopharm.
• in the case of an acute asthma attack.
• in the case of narrow-angle glaucoma.
• in the case of an adrenal gland tumor (pheochromocytoma).
• in the case of an enlarged prostate gland (prostate hypertrophy) with residual urine.
• in the case of acute poisoning by alcohol, sleeping pills or painkillers as well as psychotropic drugs (neuroleptics, tranquilizers, antidepressants, lithium).
• in the case of epilepsy.
• in the case of concomitant treatment with monoamine oxidase inhibitors.

Special care should be taken when taking SchlafTabs-ratiopharm in the case of:

• impaired liver function.
• pre-existing heart damage and high blood pressure.
• chronic respiratory problems and asthma.
• insufficient closure of the stomach entrance with reflux of food into the esophagus (gastro-esophageal reflux).

Special care should be taken in patients with neurologically recognizable brain damage in the cerebral cortex and a history of seizures, as even small doses can trigger major seizures.

Children

Children and adolescents should not be treated with SchlafTabs-ratiopharm.

Elderly people

The risk of side effects is greater in elderly patients; in this group of people, this can also increase the risk of falling.

When taking SchlafTabs-ratiopharm with other medicines

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.

When used concomitantly with other centrally acting medicines (such as psychotropic drugs, sleeping pills, painkillers, anesthetics, medicines for the treatment of epilepsy), the effects may be mutually verstärken. This applies in particular to the simultaneous consumption of alcohol, which can alter and intensify the effects of SchlafTabs-ratiopharm in an unpredictable manner. When SchlafTabs-ratiopharm and phenytoin, a medicine for the treatment of epilepsy, are taken at the same time, the phenytoin effect is weakened. The anticholinergic effect of SchlafTabs-ratiopharm can be unpredictably intensified by the simultaneous administration of other substances with anticholinergic effects (e.g. biperiden, a medicine for the treatment of Parkinson's disease; tricyclic antidepressants).

The anticholinergic effect of SchlafTabs-ratiopharm can also be intensified by the simultaneous administration of monoamine oxidase inhibitors, which are used to treat depression; this can manifest itself in life-threatening intestinal paralysis, urinary retention or an acute increase in intraocular pressure. The simultaneous use of monoamine oxidase inhibitors can also lead to a drop in blood pressure and an increased functional impairment of the central nervous system and respiration. For these reasons, both substances must not be used simultaneously for therapy. The use of medicines for high blood pressure that act on the central nervous system (such as guanabenz, clonidine, alpha-methyldopa) together with SchlafTabs-ratiopharm can lead to increased tiredness and fatigue.

The effect of neuroleptics can be weakened when used concomitantly with SchlafTabs-ratiopharm. Symptoms of incipient damage to the inner ear, which were triggered by other medicines (e.g. aminoglycoside antibiotics, some painkillers, some diuretics), can be attenuated under treatment with SchlafTabs-ratiopharm. The result of skin tests can be falsified under therapy with SchlafTabs-ratiopharm (false negative). Epinephrine should not be administered together with SchlafTabs-ratiopharm (vasodilation, drop in blood pressure, accelerated heart rate).

Please note that this information may also apply to medicines that have been used recently.

When taking SchlafTabs-ratiopharm with food and drink

Alcohol consumption should be avoided during the use of SchlafTabs-ratiopharm.

Pregnancy and breast-feeding

SchlafTabs-ratiopharm should only be taken during pregnancy on the express instructions of a doctor. Since the active ingredient passes into breast milk, breast-feeding should be discontinued for the duration of treatment.

Driving and operating machinery

Even when used as intended, this medicine can alter reactions to such an extent that the ability to actively participate in road traffic or to operate machinery is impaired. This applies to an even greater extent in conjunction with alcohol. You will then no longer be able to react quickly and purposefully enough to unexpected and sudden events. Do not drive a car or other vehicles! Do not operate electrical tools or machinery! Do not work without a secure hold! Pay particular attention to the fact that alcohol further impairs your ability to drive!

Important information about certain other ingredients of SchlafTabs-ratiopharm

This medicine contains lactose. Therefore, please only take SchlafTabs-ratiopharm after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW SHOULD SCHLAFTABS-RATIOPHARM BE TAKEN?

Always take SchlafTabs-ratiopharm exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure.

How much SchlafTabs-ratiopharm and how often should you take SchlafTabs-ratiopharm?
Unless otherwise prescribed, adults take 1 tablet of SchlafTabs-ratiopharm (equivalent to 25 mg doxylamine succinate) about 1/2 - 1 hour before going to bed. In the case of more severe sleep disorders, 2 tablets of SchlafTabs-ratiopharm (equivalent to 50 mg doxylamine succinate) can be taken as the maximum dose.

How and when should you take SchlafTabs-ratiopharm?
The tablets are taken unchewed with sufficient liquid (e.g. 1 glass of water) about 1/2 - 1 hour before going to bed. It is important to ensure that there is sufficient sleep after taking SchlafTabs-ratiopharm in order to avoid impaired reactions the following morning.

How long should you take SchlafTabs-ratiopharm?
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 SchlafTabs-ratiopharm is too strong or too weak.

If you have taken more SchlafTabs-ratiopharm than you should

An overdose can be recognized by the fact that it can initially lead to central symptoms such as restlessness, increased muscle reflexes, unconsciousness, depression of respiration and cardiovascular arrest. Other signs of an overdose are dilated pupils, accelerated heart rate (tachycardia), fever, hot, red skin, dry mucous membranes, muscle weakness and muscle pain. If these symptoms occur, a doctor should be consulted immediately. In the event of an overdose, gastric lavage with activated charcoal is recommended as an immediate measure. Depending on the clinical picture, appropriate measures should be taken in the event of gastrointestinal complaints, central nervous disorders, dry mouth, voiding disorders (micturition problems) and visual disturbances.

If you forget to take SchlafTabs-ratiopharm

Do not take a double dose if you have forgotten to take the previous dose.

If you have any further questions about the use of the medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, SchlafTabs-ratiopharm can have side effects, although not everybody gets them.

Depending on the sensitivity of the individual patient and the dose taken, the following side effects may occur:

• Tiredness, drowsiness, fatigue, dizziness, light-headedness, prolonged reaction time, difficulty concentrating, headaches, depression, muscle weakness, tinnitus and tiredness the following day.
• In addition, there is the possibility of so-called "paradoxical" reactions such as restlessness, agitation, tension, insomnia, nightmares, confusion, trembling.
• In rare cases, seizures of the brain can occur.
• Accompanying effects on the autonomic nervous system such as blurred vision, dry mouth, feeling of a blocked nose, increased intraocular pressure, constipation and difficulty urinating can occur, as well as nausea, vomiting, diarrhea, loss of appetite or increased appetite, pain in the stomach area.
• Very rarely, life-threatening intestinal paralysis can occur.
• Acceleration of the heartbeat, irregularity of the heartbeat, drop or rise in blood pressure and increase in existing heart failure can occur. ECG changes have been observed.
• Impairment of respiratory function can occur due to thickening of mucus and obstruction or narrowing of the bronchi.
• Allergic skin reactions and photosensitivity of the skin (avoid direct sunlight!) have been reported during therapy with antihistamines, as well as liver function disorders (cholestatic jaundice) and disorders of body temperature regulation.
• Blood cell damage can occur in exceptional cases.
• In patients with an adrenal gland tumor (pheochromocytoma), the administration of antihistamines, which include the present medicine, can lead to the release of substances from the tumor that have a very strong effect on the cardiovascular system.
• After prolonged daily use, sleep disorders can be exacerbated again by sudden discontinuation of therapy.

Notes

By carefully and individually adjusting the daily doses, the frequency and extent of side effects can be reduced. The risk of side effects is greater in elderly patients; in this group of people, this can also increase the risk of falling.

Countermeasures

If you observe the above side effects, SchlafTabs-ratiopharm should not be taken again. Please inform your doctor so that he/she can decide on the severity and any further measures that may be necessary.

Reporting of side effects

If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Department of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information about the safety of this medicine.

5. HOW SHOULD SCHLAFTABS-RATIOPHARM BE STORED?

Keep medicines out of the reach of children. Do not use the medicine after the expiry date stated on the carton and blister packs. The expiry date refers to the last day of the month. Do not store above 30°C.

6. FURTHER INFORMATION

What SchlafTabs-ratiopharm contains

The active ingredient is doxylamine succinate. Each tablet contains 25 mg doxylamine succinate. The other ingredients are: corn starch, lactose, microcrystalline cellulose, silicon dioxide, magnesium stearate, ethylcellulose.

What SchlafTabs-ratiopharm looks like and contents of the pack

White, round tablet. SchlafTabs-ratiopharm is available in packs of 20 tablets.

Pharmaceutical entrepreneur

ratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren

This leaflet was last revised in September 2017.

Source: Information from the package leaflet
Status: 08/2020
Active ingredient: Doxylamine succinate. Areas of application: for medication-requiring treatment of sleep onset and maintenance disorders.