Patient Leaflet According to the Pharmacists' Regulations (Preparations), 1986 This medicine requires a physician's prescription. Please read the entire leaflet carefully before using your medication.
MODAL Capsules MODAL Forte Tablets
Composition: Each capsule contains: Sulpiride 50 mg Each tablet contains: Sulpiride 200 mg Inactive ingredients include: Cellulose, magnesium stearate. In addition the tablets contain: Lactose (27 mg), potato starch, talc, silicon dioxide
Therapeutic Activity: Modal is an anti-dopaminergic drug used for vertigo, varied gastro-intestinal disturbances, psychotic disturbances and more.
Therapertic group: Substituted benzamide.
Терапевтическая активность: Модал является анти-дофаминергических препаратом, используемым для лечения головокружения, разнообразных желудочно-кишечных расстройств, психотических расстройств и т.п.
Терапевтическая группа: заменители бензамида.
When should this medicine not be used:
Do not use this medicine if you are hypersensitive to sulpiride. Do not use this medicine in patients with pre-existing CNS depression or coma. Do not use this medicine if you are taking high doses of CNS depressants eg, Alcohol, barbiturates, opioids. Do not use this medicine if you suffer from pheochromocytoma, acute agitation or mania, or high blood pressure.
Do not start to use this medicine without first consulting your physician: if you are pregnant, or breastfeeding; or if you suffer or have suffered in the past from impaired function of: the respiratory tract (e.g. asthma), heart or vascular system, eyes (e.g. glaucoma), liver, kidneys/urinary tract, digestive system (e.g. gastro¬intestinal obstruction), prostate gland, or if you suffer or have suffered in the past from seizures, Parkinson's disease or alcoholism.
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How might this medicine affect your daily life?
Use of this drug may reduce alertness. Caution should be exercised when driving a vehicle, operating dangerous machinery, or performing any other activity that requires special vigilance. Children should be warned against riding a bicycle or playing near roads or engaging in other potentially hazardous activities.
Do not drink wines and other alcoholic beverages while under treatment with this medicine.
Warnings: If you are sensitive to any foods or medications notify your physician before starting treatment.
Consult your physician if you are pregnant or breastfeeding, use with caution especially in the first weeks of pregnancy.
Use of this medicine can cause blurred vision. During prolonged treatment eye examinations must be performed.
If you are scheduled to undergo surgery (including dental surgery) or any other procedure requiring anesthesia, please inform the anesthesiologist that you are taking this medicine.
While taking this medicine avoid becoming overheated during exercise, in hot weather or while taking a hot shower (may cause heatstroke). In addition, avoid prolonged exposure to cold temperatures (may cause hypothermia).
Drug Interactions: If you are taking any other medications or if you have recently finished treatment with another drug, please notify your physician in order to prevent any potential risks or a potential reduction in efficacy that may result from drug interactions. In particular, the following therapeutic groups may interact with your medicine: drugs that affect the central nervous system (e.g., anti-anxiety drugs, sleeping tablets, drugs to treat Parkinson's disease or epilepsy, anesthetics, opioid analgesics), anti-depressants, barbiturates, thyroid medications, drugs for the heart or that lower blood presure, and drugs that contain: alcohol, antihistamines, antacids (containing aluminium or magnesium), sucralfate (for peptic or doudenal ulcer), adsorbent antidiarrheals, and amphetamines.
Side Effects: In addition to the desired effect of the drug, unwanted side effects may also appear. These may include: dry mouth, constipation, nausea/vomiting, drowsiness, dizziness, restlessness, leakage of milk from the breast or amenorrhea.
The following side effects require special attention:
skin rash or irritation, feeling unstable, restlessness, seizures, extreme fatigue or weakness, yellowish tinge of the eyes or skin, visual disturbances, unwanted movements or difficulty in speaking (rare effects): Stop the treatment and consult your physician immediately!
If at any time you experience side effects that are not mentioned in this leaflet or if you feel an adverse change in your general wellbeing, consult your physician immediately.
Side effects associated with the discontinuation of the drug: unwanted movements (especially of the face) - consult your physician immediately.
Side effects and drug interactions in children and infants:
Parents must consult the physician if side effects occur or if any other medications are being taken by the child/infant.
Dosage: Administer according to the physician's instructions. Do not exceed the recommended dose.
This medication should be administered at set intervals according to your physician's instructions. If you forgot to take your medicine at the proper time, take the missed dose as soon as you remember; but, on no account should you take two doses at the same time.
Directions for use: Do not chew! Swallow the medicine with a cup of water.
Do not retain the medicine in your mouth beyond the time necessary to swallow it.
This medicine may be taken with food.
Modal Forte tablet may be cut in half using the scored line.
How can you help ensure that your treatment is successful?
You must complete the course of treatment according to your physician's instructions. Even if your condition improves do not stop taking this drug without consulting your physician.
Help prevent poisoning!!
This medicine, like all medicines, should be kept in a closed cupboard, out of the reach of children/infants in order to prevent accidental poisoning. If you or a child took an overdose of the medicine, go immediately to the emergency room of the hospital and bring with you any remaining drug and the original packaging. Do not induce vomiting without explicit instructions from the physician. This medicine was prescribed to treat your ailment; in another patient, it may be harmful. Do not give this medicine to your relatives, neighbors, or acquaintances. Do not take any medicine in the dark! Carefully check the label and dose each time you take the medicine. Wear your glasses if you normally use them for reading.
Storage: Below 25°C. Even if stored properly according to the manufacturer's recommendations, all medicines have a limited shelf life. Please pay attention to the expiry date of your medicine! If you have any doubts, please consult the dispensing pharmacist. Do not store different medicines in the same container.
Drug Registration License No.: Capsules: 292721906
Tablets: 292921895

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