ZAPRINEL A 5 mg. / 5 mg. 30 tablets

What is A ZAPRINEL 5 mg/5 mg tablets and what to use
ZAPRINEL 5 mg/5 mg tablets are prescribed to treat high blood pressure (hypertension) and/or the treatment of stable coronary artery disease (a condition in which the blood supply to the heart is reduced or blocked).
Patients who already take perindopril and amlodipine in individual tablets may instead receive a Tablet ZAPRINEL 5 mg/5 mg tablets, which contains both ingredients.
ZAPRINEL 5 mg/5 mg tablets is a combination of two active ingredients, perindopril and amlodipine.
Perindopril is an inhibitor of ACE (angiotensin converting enzyme). Amlodipine is a calcium antagonist (which belongs to a class of medications called dihidropiridini). Together they work to expand and relax the blood vessels so that blood passes through them easier and easier to maintain good blood flow from the heart.

2. What you need to know before you take ZAPRINEL and 5 mg/5 mg tablets
Do not take ZAPRINEL and 5 mg/5 mg tablets:
If you are allergic to perindopril or anyone else of ACE inhibitor, or to amlodipine or any other calcium antagonist or any of the other ingredients of this medication (listed in point 6);
If you have more than 3 months pregnant (is also good to avoid ZAPRINEL and 5 mg/5 mg tablets in early pregnancy-see the pregnancy);
If you have experienced symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rash seen in previous treatment with an ACE inhibitor or someone in your family has had such symptoms in other circumstances (a condition called angioedema);
If you have a narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to send enough blood to the body);
If you have a strong low blood pressure (hypotension);
If you have heart failure after a heart attack;
If you take a drug called aliskiren (used for high blood pressure) and you have diabetes or kidney problems.
Warnings and precautions
If you have any of these problems, talk to your doctor before you take ZAPRINEL and 5 mg/5 mg tablets:
Hypertrophic cardiomyopathy (a disease of the heart muscle) or renal artery stenosis (narrowing of the artery, which supplies blood to the kidneys);
Heart failure;
Strong high blood pressure (hypertensive crisis);
Any other problems with the heart;
Liver problems;
Kidney problems or if you are on dialysis;
Kolagenno vascular disease (disease of the connective tissue) such as systemic lupus erythematosus or Scleroderma;
Diabetes;
If you are on a diet restricting salt or use substitutes that contain potassium (well balanced level of potassium in the blood is essential);
If you are in old age or your dose should be increased.
You must inform your doctor if you think you are pregnant (or may become pregnant).
ZAPRINEL 5 mg/5 mg tablets are not recommended in early pregnancy, and must not be taken after the 3rd month of pregnancy, as it can seriously damage the fetus if it is used at this stage (see pregnancy point).

When taking ZAPRINEL and 5 mg/5 mg tablets, you should inform your doctor or medical staff if:
Will be of general anesthesia and/or will have major surgery;
You recently had diarrhea or vomiting;
Will be put on LDL afereza (removal of cholesterol from the body with sound);
Will be put on desensibiliziraŝo treatment to reduce the effects of allergy to bee stings or axes.
ZAPRINEL 5 mg/5 mg tablets are not recommended for use in children and adolescents.

Other medications and ZAPRINEL and 5 mg/5 mg tablets
Inform your doctor or pharmacist if you are taking, you have recently taken or may take other medications.

You should avoid and ZAPRINEL 5 mg/5 mg tablets for use in:
Lithium (used for the treatment of mania or depression);
Estramustin (used for the treatment of cancer);
Potassium sparing diuretics (spironolactone, triamterene), potassium supplements or potassium-containing salt substitutes;
Aliskiren (used for high blood pressure), if you have diabetes or kidney problems.
Treatment with ZAPRINEL and 5 mg/5 mg tablets can be affected by other medications. Necessarily notify your doctor if you take any of the following medicines as you may need special surveillance:
Other medications for high blood pressure, including aliskiren and diuretics (medications that increase the amount of urine produced by the kidneys);
Nonsteroidal anti-inflammatory drugs (eg ibuprofen) to relieve pain or high dose acetylsalicylic acid;
Drugs for the treatment of diabetes (such as insulin);
Drugs for the treatment of mental illnesses such as depression, anxiety, schizophrenia, etc. (e.g., tricyclic antidepressants, antipsychotics, imipramine-like antidepressants, Neuroleptics);
ZAPRINEL 5 mg/5 mg tablets with food and drinks
Grapefruit and grapefruit juice should not be consumed by people taking ZAPRINEL and 5 mg/5 mg tablets. This is due to the fact that it can lead to increased blood levels of the active ingredient amlodipine, which can cause unforeseeable increase ponižavaŝiâ effect on blood pressure of ZAPRINEL and 5 mg/5 mg tablets.

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.

Pregnancy
You must inform your doctor if you think you are pregnant (or may become pregnant). Usually your doctor will advise you to stop taking ZAPRINEL and 5 mg/5 mg tablets before you become pregnant or as soon as you find out that you are pregnant and will advise you to take other drugs instead of ZAPRINEL and 5 mg/5 mg tablets. ZAPRINEL 5 mg/5 mg tablets are not recommended in early pregnancy, and must not be taken after the 3rd month of pregnancy, as it can seriously damage the fetus if used after the third month of pregnancy.

Breastfeeding
Tell your doctor if breast or plan to start breastfeeding. ZAPRINEL 5 mg/5 mg tablets are not recommended in nursing mothers and your doctor may choose another drug for you, if you want to breastfeed, especially if your baby is a newborn or premature.

Driving and operating machinery
ZAPRINEL 5 mg/5 mg tablets may affect your ability to drive or operate machinery. If your cause nausea, dizziness, weakness or fatigue, or you get a headache, I don't drive and operate machinery, and immediately call your doctor.

ZAPRINEL 5 mg/5 mg tablets contain lactose monohydrate
ZAPRINEL 5 mg/5 mg tablets contain lactose monohydrate (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, talk with him before taking this medicinal product.

3. How to take ZAPRINEL and 5 mg/5 mg tablets
Always take ZAPRINEL and 5 mg/5 mg tablets exactly as your doctor has told you. If you are unsure of something, ask your doctor or pharmacist.
Swallow the Tablet whole with a glass of water, preferably at the same time every day, in the morning before eating. Your doctor will determine the best dose for you. This is usually one tablet daily.
ZAPRINEL 5 mg/5 mg tablets are commonly prescribed for patients who already take perindopril and amlodipine in separate tablets.

If you take more than the required dose ZAPRINEL and 5 mg/5 mg tablets
If you accidentally take too many pills, call immediately to the emergency room of the nearest hospital or your doctor. The most likely effect of overdose is low blood pressure, which can cause dizziness or losing consciousness. If this happens, the recumbent body position with your legs can help.

If you forget to take ZAPRINEL and 5 mg/5 mg tablets
It is important to take your medicine every day, as regular treatment works better. However, if you forget to take a dose of ZAPRINEL and 5 mg/5 mg tablets, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

If you stop taking the ZAPRINEL and 5 mg/5 mg tablets
Because treatment with ZAPRINEL and 5 mg/5 mg tablets is usually prolonged, you should consult with your doctor before you stop taking the tablets.

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 one of the following complaints, stop taking the drug immediately and call your doctor immediately:
Uncommon adverse reactions (may affect up to 1 in 100 people):
Sudden dizziness, chest pain, shortness of breath or difficulty breathing;
Severe dizziness or loss of consciousness;
Swelling of eyelids, face or lips;
Swelling of the tongue or throat, which leads to a lot of difficulty breathing.
Very rare side effects (may affect up to 1 in 10 000 people):
Severe skin reactions, including skin rash, intense urtiki, reddening of the skin all over the body, intense itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson Syndrome) or other allergic reactions;
Heart attacks, unusually fast or other than normal heart activity;
Inflammation of the pancreas, which can cause severe pain in the abdomen and back, accompanied by malaise.
The following common side effects have been reported. If any of them cause you problems or if they continue for more than one week, you should consult with your doctor.
Common side effects (may affect up to 1 in 10 people):
headache, dizziness, drowsiness (especially at the beginning of treatment), dizziness, tingling and pins and needles in extremities, impaired vision (including double vision), ring in the ears (tinnitus sensation), palpitations (feeling the heartbeat), redness, light headedness from low blood pressure, cough, shortness of breath, nausea, vomiting, abdominal pain, altered taste, heartburn or difficulty in digestion, diarrhea, constipation, allergic reactions (such as skin rashes, itching), muscle cramps , fatigue, weakness, swelling of the ankles (edema).
Uncommon adverse reactions (may affect up to 1 in 100 people):
erratic behavior, anxiety, depression, drowsiness, sleep disorders, tremors, loss of sense of pain, rhinitis (nasal congestion or runny nose), altered bowel movements, hair loss, red plaques on the skin, discoloration of the skin, back pain, muscle or joint aches, chest pain, impaired urination, increased need for urination during the night, an increased number of uriniraniâ, pain, malaise, dry mouth, kidney problems , impotence, increased sweating, uncomfortable feeling or breast enlargement in men, increased or reduced weight.
Rare side effects (may affect up to 1 per 1,000 people):
confusion.
Very rare side effects (may affect up to 1 in 10 000 people):
cardiovascular disorders (Angina and stroke), eosinophilic pneumonia (a rare type of pneumonia), multiple Erythema (skin rash that often starts with red spots on the face, arms or legs), sensitivity to light, blood disorders, abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (Icterus), elevated liver enzymes, which can have an effect on some medical studies, abnormal swelling of the abdomen (gastritis) nerve disorders that can cause weakness, tingling or numbness, increased muscle tone, Vasculitis (inflammation of blood vessels), swelling of the gums, increased blood sugar (hyperglycemia).
The following side effects were also observed in patients taking ZAPRINEL and 5 mg/5 mg tablets:
Hypoglycemia (low blood sugar), disorders with a combination of rigidity, tremor and/or impaired movements.
Notification of adverse reactions
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 and 5 mg/5 mg tablets
Keep out of the reach of children.
Do not use this medicine after the expiry date stated on the carton and the bottle after "exp". Refers to the last day of that month.
This medicinal product does not require special temperature conditions of storage. Keep container tightly closed in order to protect from light and moisture.
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/5 mg tablets
The active substances are: perindoprilov tozilat and amlodipine.
Each tablet contains 5 mg perindoprilov tozilat equivalent to 3.4 mg perindopril and 6.935 bezilat amlodipinov mg, equivalent to 5 mg amlodipine.
The other ingredients are: sodium bicarbonate (E500), povidone K30 (E1201), lactose monohydrate, maize starch, cellulose, microcrystalline (E460), sodium starch glycolate (type a), magnesium stearate (E572), and calcium hidrogenfosfat, anhydrous (E341).

Write a review