ZAPRINEL 5 mg. 30 tablets

What is Zaprinel 5 mg film-coated tablets and what to use
Zaprinel is an inhibitor of angiotensin-converting enzyme (ACE). It acts as widens the blood vessels, thus relieving the heart in pumping blood through them.

Zaprinel is used:
to treat high blood pressure (hypertension);
for the treatment of heart failure (a condition in which the heart cannot pump enough blood to meet the needs of the body);
to reduce the risk of cardiac events such as myocardial infarction, in patients with stable coronary artery disease (a condition in which reduces or blocks blood supply to the heart) and who have already received a heart attack and/or have undergone surgery to improve the blood supply through the expansion of the vessels of the heart.
2. What you need to know before you take Zaprinel 5 mg film-coated tablets
Do not take Zaprinel 5 mg film-coated tablets:
If you are allergic (hypersensitive) to perindopril or another ACE-inhibitor or any of the other ingredients of this medication (listed in point 6);
If you have more than 3 months pregnant (it is better to avoid the use of Zaprinel during early pregnancy-see section "pregnancy and breast-feeding");
If during the previous treatment with ACE-inhibitor you had symptoms like wheezing, swelling of the face or tongue, intense itching or severe skin rash, or if you or a member of your family has had these symptoms in any other circumstances (a condition called angionevrotičen edema).
Warnings and precautions
If any of the below listed conditions is valid for you, talk to your doctor or pharmacist before you take Zaprinel:
If you have aortic stenosis (a narrowing of the main blood vessel that comes out of the heart) or hypertrophic cardiomyopathy (a disease of the heart muscle), or renal artery stenosis (narrowing of the artery that's been without circulation for the kidney);
If you have any other heart problems;
If you have liver problems;
If you have kidney problems or are on dialysis;
If you have a kolagenoza (connective tissue disease) such as systemic lupus erythematosus or Scleroderma;
If you have diabetes;
If you're on a diet with limited intake of salt or use salt substitutes that contain potassium;
If you are in the anesthesia and/or major surgery;
If you are on afereza LDL (way to remove cholesterol from your body with the machine);
If you are on desensibiliziraŝo treatment to reduce the effects of the bite of an allergy to bees or wasps;
If you have recently had diarrhea or vomiting, or are dehydrated;
If your doctor has told you that you have an intolerance to some sugars.
If you think you are pregnant (or may become pregnant), you should inform your doctor. Zaprinel is not recommended for use during early pregnancy, and must not be taken if you are pregnant for more than three months, as may be the cause of serious harm to your baby if you use it during this period (see section "pregnancy and lactation").

Children and adolescents
Zaprinel is not recommended for use in children and adolescents.

Other medications and Zaprinel 5 mg film-coated tablets
Inform your doctor or pharmacist if you are taking, you have recently taken or may take other medications, including drugs that are available without a prescription.

Treatment with Zaprinel can be influenced by other medications. Such are:
other medications to treat high blood pressure, including diuretics (medications that increase the amount of urine separated from the kidneys);
potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium supplements or potassium-containing salt substitutes;
lithium for manic or depression;
non-steroidal anti-inflammatory drugs (eg ibuprofen) for pain relief or high-dose aspirin;
drugs for the treatment of diabetes (such as insulin or metformin);
medications to treat mental disorders such as depression, anxiety, schizophrenia, etc. (e.g., tricyclic antidepressants, antipsychotics);
immunosuppressant medications (drugs that weaken the body's defenses), used for the treatment of autoimmune disorders or after transplantation (e.g., Cyclosporine);
Allopurinol (for gout);
procainamide (to treat irregular beating of the heart);
vasodilators, including nitrates (products that dilate the blood vessels);
heparin (blood thinning medicine);
drugs for the treatment of low blood pressure, shock, or asthma (such as ephedrine, noradrenaline or adrenaline).
Zaprinel 5 mg film-coated tablets with food and drinks
It is recommended that Zaprinel to be taken before a meal.

Pregnancy, lactation and fertility
Consult your doctor or pharmacist before taking any medicine.

Pregnancy
You should inform your doctor if you think you have (or may have) pregnant. Usually your doctor will advise you to stop using Zaprinel before you become pregnant or as soon
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Zaprinel not recommended for mothers who breastfeed; Your doctor may choose another treatment for you if you want to breastfeed, especially if your baby is a newborn, or was born prematurely.

Fertility
Effects of perindopril on fertility in humans are unknown.
Driving and operating machinery
Zaprinel usually has no effect on the Chin, but in some patients may experience reactions such as dizziness or weakness associated with lower blood pressure. If they do occur, this may limit Your ability to drive or operate machinery.

Zaprinel 5 mg film-coated tablets contain lactose monohydrate
If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicinal product.

3. How to take Zaprinel 5 mg film-coated tablets
Always take this medicine exactly as you told Your doctor or pharmacist. If you are unsure of something, ask your doctor or pharmacist.
Swallow the tablet with a glass of water, preferably at the same time of day, in the morning, before eating.
Your doctor will determine the exact dose for you.

The recommended doses are as follows:
High blood pressure: the recommended starting and maintenance dose is 5 mg once daily. After one month, if necessary, can be increased to 10 mg once daily. 10 mg/day is the maximum recommended dosage for high blood pressure.
If you are 65 years old or above, the recommended starting dose is 2.5 mg once a day. After one month, if necessary, the dose can be increased to 5 mg once a day, and then to 10 mg once daily.

Heart failure: the recommended starting dose is 2.5 mg once a day. After two weeks, the dose may be increased to 5 mg once a day, which is the maximum recommended dose for heart failure.

Stable coronary artery disease: the recommended starting dose is 5 mg once daily. After two weeks, the dose may be increased to 10 mg once a day, which is the maximum recommended dose for this indication.
If you are 65 years old or above, the recommended starting dose is 2.5 mg once a day. After a week the dose can be increased to 5 mg once a day, and after another week to 10 mg once daily.

If you take more than the required dose Zaprinel 5 mg film-coated tablets
If you take too many pills, call the nearest emergency centre or inform your doctor immediately. The most likely effect of overdose is low blood pressure, which can cause you to feel dizzy or faint. In such cases, into bed and putting her feet up can help.

If you forget to take Zaprinel 5 mg film-coated tablets
It is important to take your medicine every day, as regular treatment is more effective. However, if you forget to take your dose, take Zaprinel next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

If you stop taking the Zaprinel 5 mg film-coated tablets
Because treatment with Zaprinel usually lasts a lifetime, you should consult with your doctor before you stop using this medicinal product. If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all drugs, this medication can cause side effects, although not everybody gets them.

If you receive any of the following reactions, stop taking the product immediately and immediately call your doctor.
swelling of face, lips, mouth, tongue or throat, trouble breathing;
severe dizziness or fainting;
unusually fast or irregular heartbeat.
In descending order depending on the frequency, the side effects can include:
Common (may affect up to 1 in 10 people): headache, lightheadedness, dizziness, numbness and tingling, visual disturbances, tinnitus (ringing in the ears), cornering the world due to low blood pressure, cough, shortness of breath, gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disorders, dyspepsia, or indigestion, diarrhea, constipation), allergic reactions (such as skin rashes, itching), muscle spasms, fatigue;
Uncommon (may affect up to 1 in 100 people): changes in mood, sleep disturbances, bronchospasm (wheezing, chest tightness and shortness of breath), dry mouth, angioedema (symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rashes), kidney problems, impotence, sweating;
Very rare (may affect up to 1 in 10 000 persons): State of confusion, cardiovascular disorders (irregular heartbeat, angina, heart attack or stroke), eosinophilic pneumonia (a rare type of pneumonia), rhinitis (stuffy or runny nose), Erythema Multiforme. Blood, pancreas or liver;
In patients with diabetes may experience hypoglycemia (very low blood sugar);
Vasculitis (inflammation of blood vessels).
If you get any side effects, tell your doctor or pharmacist. This includes all possible other than those described in this leaflet side effects.

5. How to store Zaprinel 5 mg film-coated tablets
Keep out of the reach of children.
Once opened, use within 100 days.
Do not use this medicine after the expiry date stated on the carton and the bottle label, after the "exp". Refers to the last day of that month.
Keep container tightly closed in order to protect from light and moisture. This remedy does not require special storage conditions.
Do not dispose of drugs in wastewater or household waste. Ask your pharmacist how to throw away the medicines that you no longer use. These measures will help protect the environment.

6. Package contents and additional information
What contains Zaprinel 5 mg film-coated tablets
The active substance is perindopril tozilat. One tablet contains filmed 3.408 mg perindopril (corresponding to 5 mg perindopril tozilat).
The other ingredients are lactose monohydrate, corn starch, sodium bicarbonate, pregelatinised starch, povidone K30, magnesium stearate, partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), MACROGOL 3350, talc, Indigo Carmine (e 132), brilliant blue FCF aluminum Polish (133), iron oxide yellow (e 172) and hinolonovo yellow (e 104).

How it looks Zaprinel 5 mg film-coated tablets and what's in the package
Zaprinel 5 mg film-coated tablets are light green, oblong, double convex film-coated tablets with a diameter of approximately 4 mm and 8 mm in length, with a concave embossed image "t" on one side, flat on the other, with a separating slash along both edges.
The tablets are available in packs of 30, 60, 90, 90 (3x30) or 100 film-coated tablets.
Not all pack sizes may be marketed.

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