Таблетки Enaladex

ENALADEX - TABLETS

Patient package insert according to Pharmacists' Regulations (Preparations), 1986.

This medicine is to be dispensed upon physician's prescription only. Carefully read the entire package insert before using this medication. Composition: Each tablet contains:

Enaladex 5 mg Enaladex 10 mg Enaladex 20 mg

Enalapril Maieate 5 mg Enalapril Maleate 10 mg Enalapril Maleate 20 mg

Inactive ingredients: Lactose monohydrate, starch pregelatinized, maize starch, sodium hydrogen carbonate, magnesium stearate.

Enaladex 10 mg and Enaladex 20 mg also contain red oxide (E172).

Therapeutic group: Vasodilator belonging to the angiotensin converting enzyme (ACE) inhibitor

group.

Терапевтическое действие: Таблетки Enaladex расширяют кровеносные сосуды, тем самым способствуя снижению артериального давления. Enaladex также предназначен для лечения сердечной недостаточности (снижение функции сердца).

Therapeutic action: This medicine dilates the blood vessels, thus helping to lower blood pressure. It is also intended for the treatment of heart failure (reduced heart function).

When should this medicine not be used?

Do not use this medicine if you are pregnant in the third month and further.

Do not use this medicine if you are aware of any hypersensitivity to one of its ingredients or to

other medicines of the ACE inhibitor group.

Do not use in infants and children with impaired kidney function.

Do not use this medicine without consulting your physician before commencing treatment:

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If you are pregnant or think you may be pregnant, or if you are breastfeeding, if you suffer or have suffered in the past from a disease or impaired function of: the heart and/or vascular system, the kidney (including patients on dialysis or after a kidney transplantation), from diabetes
or edema (angioedema, a disease whose characteristics include: swelling of the face, eyelids, mouth, throat, hands or feet; difficulty swallowing, hoarseness, wheezing or difficulty breathing). Before taking this medicine, notify your physician if you are on a sodium or salt restricted diet, if you suffered from excessive vomiting or diarrhea, if you notice signs of infection such as fever. If a physician told you in the past that you have intolerance to certain sugars, refer to your physician before starting treatment with this medicine.

How will this medicine influence your daily schedule?

Use of this medicine may impair alertness and/or cause dizziness, light-headedness or blurred vision. It is therefore advisable to take special care when driving, operating dangerous machinery or when engaging in any other activity which requires alertness and/or clear vision. Children should be cautioned against bicycle riding or playing near traffic, etc.

Avoid excessive consumption of alcoholic beverages during the period of treatment with this medicine. Be alert to situations involving increased sweating (e.g. during hot weather or physical training), since increased sweating while under treatment with this medicine may cause dizziness, light¬headedness or fainting.

Warnings: During treatment with this medicine, the following tests should be performed: blood, liver and kidney function. If you are aware of any sensitivities to foods or drugs inform your physician before taking this medicine. You should hot become pregnant while under treatment with this medicine. If you do become pregnant while under treatment with Enaladex, refer to a physician immediately. Before starting treatment or in the course of treatment notify your physician if you are pregnant, breastfeeding, or planning to become pregnant, so that alterative treatment can be considered. Use of Enaladex is not recommended for pregnant or breastfeeding women. Inform the attending physician that you are taking this medicine before undergoing: surgery (including dental), emergency treatment, any procedure involving anesthesia (including local), mechanical treatment for removal of cholesterol from the blood or treatment for reducing allergic reaction to bee or wasp stings.

Drug interactions: If you are taking other medicines concurrently, ihcluding non-prescription and/or herbal medicines, or nave just completed treatment with another medicine, inform your physician in order to prevent hazards or inefficacy arising from drug interactions, especially in regard to: antihypertensives, diuretics, medicines for treatment of the heart, low blood pressure, asthma, allergies, cold, anti-cough medicines, antidiabetics, non-steroidal anti-inflammatory drugs (NSAIDs) (for instance, for pain relief, reducing fever), gold salts, tricyclic antidepressants, antipsychotics, narcotic substances (for instance, for relief of severe pain), immunosuppressants (for instance, for preventing rejection of transplants, for treatment of rheumatoid arthritis, for treatment of psoriasis), allopurinol (for instance, for treatment of gout), nitrates, vasodilators or procainamide (for instance, for heart treatment), anesthetics, lithium, medicines that cause a rise in blood potassium levels (e.g. potassium containing medicines), food supplements containing potassium, salt substitutes containing potassium or foods containing potassium as a substitute for salt (e.g. low-salt milk). Side effects: in addition to the desired effect of the medicine, some side effects may appear during treatment, such as: blurred vision, diarrhea, feeling unwell, nausea, changes in taste, fatigue, weakness, coughing or headache, depression, low blood pressure, fainting, changes in heart rate, pain or tightness in the chest, shortness of breath, abdominal pain or bloating, accumulation of fluids, edema of the face, throat or tongue. Rarely, the following may also occur: anemia, changes in behavior or mood, anxiety, confusion, nervousness, drowsiness, difficulty sleeping, numbness or tingling, dizziness, heart attack or stroke in patients at high risk, cold, sore throat or hoarseness, digestive tract disturbances such as: intestinal obstruction, constipation, vomiting, lack of appetite and dryness of the mouth. In addition, there may be a burning sensation in the stomach due to ulcer, increased sweating, hair loss, impotence, muscle cramps, flushing, ringing in the ears, apathy, fever, fluid in the lungs. Kidney problems manifested by lower back pain and reduction in volume of urine, liver problems manifested by yellowing of the skin, breast development in men, joint and muscle pain, increased sensitivity to sunlight, and changes in blood tests. Contact your physician if these effects persist and/or are bothersome.

Side effects requiring special attention:

Signs of allergy such as: skin rash or irritation, swelling (of the hands, around the face, the eyes, mouth or throat), wheezing or difficulty breathing, severe dizziness (especially at the beginning of treatment, when increasing the dosage, or when you stand up), flushing of tne skin, blistering or peeling of the skin (rare): stop treatment and contact your physician immediately. Also contact your doctor immediately if you develop jaundice or a persistent dry cough.

If you experience side effects not mentioned in this insert, or if you feel any change in your general health, contact your physician immediately.

Side effects and drug interactions in children and infants:

Parents should report to the attending physician any side effects as well as any additional medicines taken by the child! See "Side effects" and "Drug interactions" above. Please note that some of the side effects require discontinuation of treatment and immediate referral to the physician, see the list under "Side effects requiring special attention".

Dosage: Dosage according to physician's instructions only. Do not exceed the recommended dosage. This medicine is to be taken at regular intervals as determined by the attending physician. If you have forgotten to take a dose at the specified time, take it as soon as you remember; however, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Never take two doses together!

Directions for use: Swallow the medicine with a small amount of water. The tablet may be halved, chewed or crushed. How can you help this treatment succeed? Complete the entire course of treatment as directed by your physician. Even if there is an improvement in your health, do not discontinue treatment with this medicine without consulting the physician.

Avoid poisoning! This medicine, and any other medicine should be kept in a closed place out of the reach of children and/or infants to avoid poisoning. If you took an overdose, or if a child accidentally swallowed this medicine, proceed immediately to a hospital emergency room and bring the medicine package with you. Do not induce vomiting without explicit instructions from a physician! This medicine has been prescribed for the treatment of your ailment. In another patient it may cause harm. Do not give this medicine to relatives, neighbours or friends. Medicines should not be taken in the darkl Check the label and the dose every time you take this medicine. Wear glasses if you need them. Storage: Store in a cool and dry place. Even if kept in their recommended storage conditions, drugs retain their potency for a limited period only. Please note the expiry date of this medicine. If in doubt, consult with the dispensing pharmacist. Do not store different medicines in the same container.

Registration number of the drug: Enaladex 5 mg: 1T5 84 29809 00

Enaladex 10 mg: 115 85 29810 00 Enaladex 20 mg: 115 86 29811 00 The format of this leaflet was determined by the Ministry of Health (MOH) and its content was checked and approved by the MOH.

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