Zaprinel plus 5 mg. / 1,25 mg. 30 tablets

WHAT IS ZAPRINEL PLUS AND WHAT TO USE
What is Zaprinel plus
Zaprinel plus is a combination of two active ingredients, perindopril and indapamide. They are the antihypertensive and are used to treat high blood pressure (hypertension).

What it's used for Zaprinel plus
Perindopril belongs to a class of medications called ACE inhibitors. It acts as dilates blood vessels and thus relieves the heart in pumping blood through them.
Indapamide is a diuretic. Diuretics increase the amount of urine from the kidneys of the separated. However, indapamide differs from other diuretics, as only slightly increases the amount of the separated urine. Each of the active ingredients lowers blood pressure and the two act simultaneously to control your blood pressure.

2. What YOU NEED to KNOW before taking ZAPRINEL PLUS
Do not take Zaprinel plus:
If you are allergic to perindopril or other ACE inhibitors, or to indapamide or other sulfonamides, or any of the other ingredients of this medication (listed in point 6);
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);
If you have severe liver disease or suffer from a condition called hepatic encephalopathy (a degenerative disease of the brain);
If you have severe kidney disease or are on dialysis;
If you have a low level of potassium in the blood;
If you are in doubt or have decompensated heart failure (severe fluid retention, shortness of breath);
If you have more than 3 months pregnant (it is better to avoid the use of Zaprinel plus during early pregnancy-see "pregnancy and lactation");
If you are breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Zaprinel plus:
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 cardiac problems or kidney problems;
If you have liver problems;
If you have a kolagenoza (skin disease), such as systemic lupus erythematosus or Scleroderma;
If you have arteriosclerosis (hardening of the arteries);
If you suffer from hyperparathyroidism (overactive parathyroid glands);
If you have gout;
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 taking lithium or potassium-sparing diuretics (spironolactone, triamterene), since their use along with Zaprinel plus should be avoided (see "intake of other drugs").
If you think you are pregnant (or may become pregnant), you must inform your doctor. Zaprinel plus 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 "pregnancy and lactation").

When taking Zaprinel plus, you should inform your doctor or medical team:
If you are in the anesthesia and/or surgery;
If you have recently had diarrhea or vomiting, or are dehydrated;
If you are on dialysis or LDL-afereza (method of removing cholesterol from your blood by means of apparatus);
If you are on hiposensibiliziraŝo treatment to reduce the effect of an allergy to bees or wasps bite;
If you are in a medical study that requires an injection of iodine-containing contrast agents (a substance that makes visible the internal organs during x-ray examination).
Athletes need to know that the Zaprinel plus contains the active ingredient (indapamide), which may be the reason for a positive reaction to doping.
Zaprinel plus should not be given to children.

Other medications and Zaprinel plus
Inform your doctor or pharmacist if you are taking, you have recently taken or may take other medications.
You should avoid the use of Zaprinel plus:
Lithium (used to treat depression);
potassium-sparing diuretics (spironolactone, triamterene), potassium salts.
Treatment with Zaprinel plus can be influenced by other medications. Make sure you tell your doctor if you are taking any of the following medications, particular attention is needed for:
other medications to treat high blood pressure;
procainamide (to treat irregular beating of the heart);
Allopurinol (for gout);
terfenadin or astemizol (antihistamines for hives or allergies);
corticosteroids used to treat a variety of conditions, including severe asthma and rheumatoid arthritis;
immunosuppressant medications used for the treatment of autoimmune diseases or following an organ transplant, for prevention of graft rejection (such as Cyclosporine);
drugs for the treatment of cancer;
erythromycin administered intravenous (antibiotic);
halofantrin (used for the treatment of certain types of malaria);
pentamidin (for the treatment of pneumonia);
injection gold (used for the treatment of rheumatoid polyarthritis);
vincamine (used for symptomatic treatment of cognitive disorders in patients in old age, including memory loss);
bepridil (used to treat angina pectoris);
sultoprid (for the treatment of psychoses);
drugs used to treat heart rhythm disturbances (e.g. quinidine, dizopiramid, hidrohinidin, amiodarone, sotalol);
digoxin or other cardiac glycosides (for treatment of heart problems);
baclofen (muscle cramp treatment observed in diseases such as multiple sclerosis);
medicines for diabetes such as insulin or metformin;
calcium, including calcium supplements;
stimulant laxatives (e.g. Senna);
non-steroidal anti-inflammatory drugs (eg ibuprofen) or high doses of Salicylates (e.g. aspirin);
amphotericin in applied injection (for the treatment of severe fungal infections);
drugs for the treatment of mental illnesses such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants, Neuroleptics);
tetrakozaktid (for treatment of Crohn's disease).
Zaprinel plus with food and drinks
It is recommended Zaprinel plus should be taken before meals.

Pregnancy and lactation
If you are pregnant or breastfeeding, you think you may be pregnant or planning pregnancy, ask your doctor or pharmacist before taking this medication. You must inform your doctor if you think you have (or may have) pregnant.

Pregnancy
Usually your doctor will advise you to stop using Zaprinel plus before you become pregnant or as soon as you became pregnant and would recommend you to take another medicine instead of Zaprinel plus. The use of Zaprinel plus is not recommended during early pregnancy, and must not be taken if you are pregnant for more than three months, as it can cause serious harm to your baby if used after the third month of pregnancy.
Breastfeeding
Inform your doctor immediately if you are breastfeeding or planning to breastfeed.
You should not take Zaprinel plus if you are breastfeeding.
Visit your doctor immediately.

Fertility
Effects of perindopril and indapamin on fertility in humans are unknown.

Driving and operating machinery
Zaprinel plus 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 plus contains 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 PLUS
Always take this medicine exactly as you told Your doctor or pharmacist. If you are unsure of something, ask your doctor or pharmacist. The recommended dosage is one tablet once a day. Your doctor may change the dosage regimen if you have kidney damage. Take the Tablet, preferably in the morning before eating. Swallow the tablet with a glass of water.

If you take more than the required dose plus Zaprinel
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 the Zaprinel plus
It is important to take your medicine every day, as regular treatment is more effective. However, if you forget to take your dose Zaprinel plus, take the 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 plus
Because the treatment of high blood pressure still life, 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, a feeling of dizziness, Vertigo, 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, epigastric pain, anorexia, vomiting, abdominal pain, taste disorders, dry mouth, dyspepsia, or indigestion, diarrhea, constipation), allergic reactions (such as skin rashes, itching), cramps, fatigue;
Uncommon (may affect up to 1 in 100 people): changes in mood, sleep disturbances, bronchospasm (wheezing, chest tightness and shortness of breath), angioedema (symptoms such as wheezing, swelling of the face or tongue), urticaria, Purpura (Red flecks as a prick of a PIN on the skin), 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), eosinophilic pneumonia (a rare type of pneumonia), rhinitis (stuffy nose), severe skin manifest as Erythema Multiforme. If you have a Systemic Lupus Erythematosus (kolagenoza type), it can get worse. After exposure to the Sun or artificial light are UVA reported cases of photosensitivity reactions (changes in the types of skin);
With unknown frequency (frequency cannot be made from the available data): fit, life-threatening cardiac arrhythmia (Torsade de Pointes), changes in the electrocardiogram, elevated levels of liver enzymes.
Can show blood, kidney, liver or pancreas, and changes in laboratory parameters (blood tests). Your doctor may request more often conduct blood tests to monitor your condition. In cases of hepatic failure (liver problems), there is a likelihood for the development of hepatic encephalopathy (a degenerative disease of the brain).

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 PLUS
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 label of the immediate container after ' exp '. Refers to the last day of that month.
Keep tightly closed packaging, to protect from 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 the Zaprinel plus
The active substances are tozilat perindopril and indapamide. A filmed 5 mg perindopril Tablet contains tozilat (corresponding to 3.408 mg perindopril) and 1.25 mg indapamide.

The other ingredients are lactose monohydrate, corn starch, sodium hydrogen carbonate, pregelatinised starch (corn), povidone, magnesium stearate, partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), MACROGOL/PEG 3350 and talc.

How it looks and what Zaprinel plus contains the package
Zaprinel plus 5 mg/1.25 mg film-coated tablets are white, oblong, film-coated tablets double convex, concave embossed "r", "1", with a separating black on one side and plain on the other.
The tablets are available in packs of 30, 60, 90, 90 (3x30) or 100 tablets.
Not all pack sizes may be marketed.

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