PONTEA 4 mg. / 1.25 mg. 30 tablets

WHAT PONTEA AND WHAT IT IS USED
PONTEA is a combination of perindopril and indapamide. They belong to the group of antihypertensive drugs designed to treat high blood pressure. Perindopril belongs to the group of ACE inhibitors. These products act as the blood vessels expand, which facilitates the heart to pump blood through them. Indapamide belongs to a group of medicines called diuretics. They act by stimulating the kidneys to excrete more urine than usual. Both drugs together help lower and control blood pressure.

2. BEFORE YOU TAKE PONTEA
Do not take PONTEA:
if you are allergic (hypersensitive) to perindopril and indapamide or any of the other ingredients of PONTEA;
if you are allergic to other ACE inhibitors or diuretics (sulfonamides);
If you have suffered from swelling of the face, lips, mouth, tongue or throat that may cause difficulty in swallowing or breathing in previous ACE inhibitors. This condition is called angioedema (Quincke's edema). Or if you or someone in your family has received such symptoms, tell your doctor as soon as possible;
If you suffer from heart disease or treatment (see "Taking other medicines");
If you are pregnant more than three months. It is advisable to avoid PONTEA in early pregnancy (see Section "Pregnancy");
If you are breastfeeding;
If you have kidney disease or are undergoing dialysis;
If you have serious liver disease or suffer from a condition called hepatic encephalopathy (which is damage to the brain and nervous system caused by severe liver disease);
If your doctor told you that you have low or high levels of potassium.
Take special care with PONTEA
Tell your doctor before you start taking this medicine:
if you have bilateral renal artery stenosis (narrowing of the main blood vessels of the kidneys), or have a single functioning kidney;
if you suffer from diabetes;
if you are on restricted diet salt or salt substitutes containing potassium;
If you are taking lithium or potassium-sparing diuretics (eg, spironolactone, triamterene);
If you are taking medicine that is combined with potassium sparing diuretic;
If you have an operation under general anesthesia may be necessary to stop treatment a few days earlier;
If you are suffering from atherosclerosis (arterial disease, in which the blood vessel walls become thicker and more rigid due to deposition of cholesterol);
If you are undergoing apheresis of LDL-cholesterol (removal of cholesterol from your body by using the apparatus);
If you are undergoing desensitisation treatment to reduce hypersensitivity to the venom of bees and wasps;
If you have to undergo a medical examination, which should you inject a substance which organs such as kidneys and stomach are visible on x-ray (iodinated contrast agents);
If you have anemia (a condition in which red blood cells carry less oxygen, symptoms of anemia are fatigue, headache, dizziness);
If you have gout (a condition in which crystals of uric acid cause swelling of the joints);
If you suffer from connective tissue disease, such as for example lupus erythematosus and scleroderma;
You should tell your doctor if you think you are pregnant or may become pregnant. Your doctor will advise you to stop taking PONTEA before you become pregnant or as soon as you realize you are pregnant and will advise you to take another medicine. PONTEA not recommended in early pregnancy, and must not be taken if you are pregnant more than three months, as it may cause serious harm to your baby if taken after the third month of pregnancy.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

You should not take PONTEA with:
lithium;
Potassium-sparing diuretics (eg. Spironolactone, triamterene, alone or in combination);
Allopurinol (gout);
Procainamide (treatment of abnormal heart rhythm);
Systemic corticosteroids (for treating various conditions including severe asthma and rheumatoid arthritis);
Other drugs for the treatment of high blood pressure;
Immunosuppressants used for the treatment of autoimmune disorders or transplant to prevent rejection (e.g., cyclosporin).
Treatment with PONTEA can be affected by other medicines. Tell your doctor if you are taking any of these medicines because they must be given special attention:
Astemizole or terfenadine (antihistamines for hay fever or allergies);
Bepridil (used to treat angina - chest discomfort);
Erythromycin injectable form, moxifloxacin, sparfloxacin (antibiotics);
Halofantrine (used to treat some forms of malaria);
Pentamidine (used for the treatment of pneumonia, which is a serious lung infection);
Vincamine (used to treat brain diseases in the elderly);
Baclofen (to treat muscle stiffness in diseases such as multiple sclerosis);
Medicines to treat diabetes such as insulin, metformin and sulfonamides;
NSAIDs (eg ibuprofen) or high doses of salicylates (e.g. aspirin);
Potassium-lowering drugs, such as amphotericin B (injectable form for the treatment of severe fungal infections), glucocorticoids and mineralocorticoids (systemic administration), or stimulant laxatives (e.g., senna);
Potassium-sparing diuretics (amiloride, spironolactone, triamterene);
Thiazides or loop diuretics;
Medicines to treat irregular heartbeat, such as quinidine, hydroquinidine, disopyramide, amiodarone, bretylium, ibutilide and sotalol;
Medicines to treat psychiatric disorders such as depression, anxiety, schizophrenia (eg tricyclic antidepressants, neuroleptics such as chlorpromazine, tsiamemazin, levomepromazine, thioridazine, trifluoperazine, Solian, tiapride, droperidol, haloperidol, pimozide);
Cisapride, diphemanil, mizolastine;
methadone;
Sultopride (used for the treatment of psychotic disorders);
Tetrakosaktid (used to treat Crohn's disease);
Calcium salts.
Taking PONTEA with food and drink
Prenorachva intake for POHTEA be in the morning on an empty stomach. Swallow the tablets with a glass of water.

pregnancy
You should tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking PONTEA tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead PONTEA tablets. PONTEA tablets are not recommended in early pregnancy and must not be taken if you are pregnant for more than three months, as it may cause serious harm to your baby if used after the third month of pregnancy.

breastfeeding
Tell your doctor if you are breastfeeding or about to start breast-feeding. PONTEA tablets are not recommended for mothers who are breastfeeding and your doctor may choose another treatment for you if you want to breastfeed, especially if your baby is newborn, or was born prematurely.

Ask your doctor or pharmacist before taking any medicine.

Driving and using machines
PONTEA may have some mild to moderate influence on the ability to drive and use machines. This medicine will not affect alertness but reactions associated with lowering blood pressure can cause dizziness or weakness. If your ability to drive or operate machinery is affected must be given special attention.

Important information about some of the ingredients of PONTEA
The medicinal product contains a small amount of lactose. If your doctor told you that you are intolerant to certain sugars should consult a doctor before you start taking this medicine.

3. HOW TO TAKE PONTEA
Always take PONTEA just as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist. The dose may be increased depending on your condition and if you take other medicines. Take your medicine through the mouth.

The usual dose is:
High blood pressure:
Recommended intake of one tablet PONTEA 2 mg / 0,625 mg once daily in the morning before breakfast. If your blood pressure is not adequately controlled, then your doctor may increase the dose to one tablet PONTEA 4 mg /1.25 mg once daily.

In adult patients with high blood pressure:
PONTEA recommended dose is 2 mg /0.625 mg taken once daily in the morning before breakfast.

If you take more than the amount PONTEA
If you take more than the amount PONTEA or someone else has taken your medicine, immediately contact your doctor or pharmacist. The most common effects of overdose is low blood pressure, symptoms of which are dizziness, insomnia and nausea. Putting in a supine position with raised legs in the air may also help.

If you forget to take PONTEA
Take the tablet as soon as you remember, even if it is time for your next dose. Take your next dose at the usual time. Do not take a double dose to make up for a missed tablet.

If you stop taking PONTEA
If you stop taking pa PONTEA, tell your doctor immediately. Treatment of high blood pressure is usually long.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, PONTEA can cause side effects, although not everybody gets them. They may include:
Common: affects 1 to 100 users in 100:
Dry mouth;
Dry cough;
constipation;
nausea;
Stomach pain or discomfort;
Loss of appetite;
Loss of taste;
Hypokalaemia.
Uncommon: affects 1 to 10 users in 1000:
Low blood pressure;
Headache;
Feelings of dizziness when standing;
Mood swings;
Sleep disturbances;
Hypersensitivity (allergic);
cramps;
Paresthesia (a feeling of numbness in arms and legs).
Rare: affects 1 to 10 users in 10,000:
Increased levels of calcium in the blood.
Very rare: affects less than 1 user in 10,000:
Thrombocytopenia: decreased number of blood platelets. Symptoms can include prolonged bleeding from normal or bruises;
Levkopepiya or agranulocytosis: reduced number of white blood cells. Symptoms may include frequent infections such as fever, feeling cold, sore throat or mouth ulcers;
Aplastic anemia, a rare type of anemia in which there is a reduced number of red blood cells, white blood cells and platelets;
Hemolytic anemia: disease as a result of the destruction of red blood cells;
Anemia in patients after kidney transplant or undergo dialysis;
Pancreatitis: inflammation of the pancreas in the case of hepatic insufficiency;
Hepatic encephalopathy, damage to the brain and nervous system, resulting in a complicated liver disease.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

If you have done blood tests, tell your doctor that you are taking PONTEA, as can be observed the following:
Low or high levels of potassium;
Low levels of sodium;
High levels of uric acid and glucose;
Slightly elevated urea and creatinine.

5. HOW TO STORE PONTEA
Keep out of reach of children.
Store in the original container to protect from moisture. Once laminated bag is printed, blister packs should be stored below 30 ° C. All other tablets should be destroyed two months after opening the laminated pouch.
Do not use PONTEA after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What PONTEA
The active substances are perindopril tert-butylamine and indapamide.
Each tablet PONTEA 2 mg / 0.625 mg contains 2 mg of perindopril tert-butylamine, equivalent to 1,669 mg and 0,625 mg perindopril indapamide.

Each tablet PONTEA 4 mg / 1.25 mg contains 4 mg perindopril tert-butylamine, equivalent to 3.338 mg perindopril and indapamide 1.25 mg.

The other ingredients are lactose monohydrate, magnesium stearate, silica colloidal hydrophobic, microcrystalline cellulose.

PONTEA looks like and contents of the pack
PONTEA 2mg / 0.625 mg tablets:
Oblong, white tablets engraved with "P" and "I" on both sides of the score on one side and scored on the other side.

PONTEA 4 mg / 1.25 mg tablets:
Oblong, white tablets engraved with "Pi" on one side and flat on the other side.