Calmaben 50 mg x10 tablets Montavit

 
KALMABEN tablets 50 mg * 10 MONTAVIT
PATIENT INFORMATION Calmaben 50 mg Coated tablets Calmaben 50 mg Coated tablets Active ingredient: diphenhydramine hydrochloride
Read all of this leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, to get the best results from your treatment, you should carefully follow the instructions for use of the medicinal product. Keep this leaflet. You may need to read it again. If you need further information or advice, ask your pharmacist. You should seek medical advice if your symptoms worsen or do not improve after 14 days. If any of the side effects become serious, or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet: 1. What Calmaben is and what it is used for 2. Before you take Calmaben 3. How to take Calmaben 4. Possible side effects 5. How to store Calmaben 6. Further information 1. WHAT CALMABEN IS AND WHAT IT IS USED FOR Action: Diphenhydramine hydrochloride, the active ingredient of Calmaben, acts against allergies and pruritus, and is also a hypnotic for the treatment of difficulty falling asleep and sleep disturbances. Indications: Calmaben is a hypnotic medicinal product for the short-term treatment of sleep disorders, such as difficulty falling asleep or staying asleep. Note: Not all sleep disorders require the use of hypnotics. These disorders are often a reflection of physical or mental illnesses and may respond to other measures or treatment of the primary illness. 2. BEFORE YOU TAKE CALMABEN Do not take Calmaben:

if you are allergic (hypersensitive) to diphenhydramine hydrochloride, to other antihistamines (medicines for treating allergies) or to any of the other ingredients of Calmaben;
acute asthma attack;
increased intraocular pressure, glaucoma;
adrenal gland tumor;
prostate enlargement with residual urine;
epilepsy;
congenital long QT syndrome (ECG change);
irregular or slow heartbeat;
concomitant administration of medicinal products that may prolong the QT interval in the ECG, such as antiarrhythmic cardiac medicinal products;
potassium and magnesium deficiency;
after consuming alcohol or taking medication to treat depression;
pregnancy and breastfeeding;
children under 12 years old.

Take special care when using Calmaben if you suffer from:

chronic lung disease, narrowed airways, and asthma;
narrowed pylorus or functional disorders of the stomach inlet;
functional liver failure.

Calmaben should not be taken after midnight if full concentration is required the next morning. If the sleep period after taking Calmaben is insufficient, morning fatigue can be expected. Calmaben may cause false negative results in allergy tests, so its use should be discontinued at least 72 hours before such a test. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. Calmaben should not be used together with other medicinal products containing diphenhydramine hydrochloride, including products for topical application. The simultaneous use of Calmaben and alcoholic beverages should be avoided. In addition, it should not be taken together with MAO inhibitors (drugs for the treatment of depression), as it may lower blood pressure, cause CNS disturbances and difficulty breathing. The additional use of drugs that can prolong the QT interval in the ECG (e.g. those against cardiac arrhythmia) should also be avoided. Drugs that lower blood pressure when taken simultaneously with Calmaben may cause increased fatigue. The simultaneous use of Calmaben and drugs containing atropine, or drugs used to treat Parkinson's syndrome (biperiden) or to treat depression may cause life-threatening intestinal paralysis, urinary retention or increased intraocular pressure; CNS depressants such as hypnotics, narcotics, opioid analgesics, psychotropic drugs and alcohol may cause unpredictable mutual enhancement of effects. This particularly affects the ability to react, drive and operate machinery. Taking Calmaben with food and drink The simultaneous use of Calmaben and alcohol is strictly prohibited because it can cause unpredictable mutual intensification of the effects. Pregnancy and breastfeeding Ask your doctor or pharmacist before using any medicine. Calmaben should not be taken by pregnant or breastfeeding women. Calmaben should not be used by women who are planning to become pregnant or are already pregnant. Please inform your doctor if you become pregnant. Driving and operating machinery Calmaben causes drowsiness, reduces your ability to react, as well as to drive and operate machinery. This effect is enhanced when combined with alcohol. In case of insufficient sleep duration after taking Calmaben, the ability to concentrate is reduced and fatigue and weakening (slowing down) of reactions in the morning are possible. Important information about some of the ingredients of Calmaben This medicine contains sucrose. If you have an intolerance to some sugars, please tell your doctor before taking Calmaben. 3. HOW TO TAKE CALMABEN Always take Calmaben exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The usual dose for adults and children over 12 years of age is 1 tablet 30 minutes before bedtime, with a sufficient amount of non-alcoholic liquid (e.g. 1 glass of water). Calmaben tablets are contraindicated for children under 12 years of age. Ensure an adequate sleep period of 7-8 hours to reduce the risk of a negative effect on your reactivity and in particular on your ability to drive and use machines the next morning. Do not take more than 1 tablet. The duration of treatment should be as short as possible. In case of more persistent sleep disturbances, use of the product should be discontinued after 2 weeks at the latest and the need for its use should be re-examined. Consult your doctor or pharmacist. If you have taken more than the required dose of CalmabenIf you observe signs of overdose, please contact a doctor or hospital immediately. Impairment of consciousness is a sign of overdose. Other symptoms that may occur are altered states of consciousness, anxiety, agitation, convulsions, fever, redness of the skin, drying of the mucous membranes, dilated pupils, irregular heartbeat and rapid pulse. Information for the doctor: Symptoms: Overdose reactions range from CNS depression (sedation, drowsiness, low blood pressure, respiratory depression) to CNS stimulation (excitement, restlessness, hand tremor, muscle spasms, hallucinations), to poisoning with symptoms similar to atropine poisoning (dry mouth, dilated pupils, rapid heartbeat, irregular heartbeat and circulatory and respiratory arrest). In rare cases, striated muscle fibers have been described after an overdose of diphenhydramine hydrochloride. Treatment: Poisoning is treated symptomatically by supportive measures: ventilation, intravenous fluids and cooling the body in cases of overheating. The stomach contents should be emptied and the stomach should be washed, which has a beneficial effect even hours after the overdose due to the anticholinergic properties of diphenhydramine hydrochloride. In case of a decrease in blood pressure, vasopressors such as noradrenaline or phenylephrine can be used, but not adrenaline, as it can further lower blood pressure. Convulsions can be controlled by intravenous diazepam. Stimulants should not be given! As an antidote for diphenhydramine hydrochloride overdose, physostigmine (0.02 - 0.06 mg/kg body weight) can be administered intravenously several times to cause a decrease in anticholinergic symptoms. In case of physostigmine overdose, atropine is recommended. If you forget to take Calmaben: Do not take a double dose to make up for the missed dose. If you stop taking Calmaben: If you have any further questions on the use of this product, please ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Calmaben can cause side effects, although not everybody gets them. If any of the side effects become serious, or you notice other side effects not listed in this leaflet, please tell your doctor or pharmacist. Nervous system disorders Uncommon (>=1/1,000, =1/10,000, <1/1,000): headache. Very rare (=1/10,000, <1/1,000): dry mouth, nose and throat. Very rare (=1/10,000, =1/10,000, <1/1,000): visual disturbances. Very rare (<1/10,000): increased intraocular pressure. Blood and lymphatic system disordersVery rare (<1/10,000): changes in the blood count (hemolytic anemia, thrombocytopenia, agranulocytosis). Hepatobiliary disordersVery rare (<1/10,000): functional liver disorders. In case of sudden discontinuation after prolonged use of diphenhydramine hydrochloride, transient sleep disturbances may occur. Therefore, gradual discontinuation of use is recommended. As with other hypnotic medicinal products, dependence is possible with prolonged improper use.5. HOW TO STORE CALMABEND Store in the original packaging to protect from light and moisture. Keep out of the reach of children. Do not use Calmaben after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Medicines should not be thrown away via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures will help protect the environment. 6. FURTHER INFORMATION What Calmaben contains The active substance is: diphenhydramine hydrochloride. Each tablet contains 50 mg of diphenhydramine hydrochloride. The other ingredients are: 53.9 mg Sucrose, Silicon dioxide, Maltodextrin, Microcrystalline cellulose, Copovidone, Crospovidone, Magnesium stearate, Gum Arabic, Talc, Methylcellulose, Calcium carbonate, Povidone, Titanium dioxide (E171), Glycerol 85%, Wax. What Calmaben looks like and contents of the pack White coated tablets. Pack of 10, 20 and 30 tablets. Marketing authorisation holder and manufacturer: Pharmazeutishe Fabrik Montavit Ges.mbH, Austria. Marketing authorisation number: 20040458. Date of last approval of the leaflet: 08/2010.