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Package Leaflet: Information for the PatientPreterax 2 mg/0.625 mg Tablets

perindopril terbutilamine/indapamide

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Preterax 2 mg/0.625 mg Tablets are and what they are used for

2. What you need to know before you start taking Preterax 2 mg/0.625 mg Tablets

3. How to take Preterax 2 mg/0.625 mg Tablets

4. Possible side effects

5. Storage of Preterax 2 mg/0.625 mg Tablets

6. Contents of the pack and additional information

Preterax 2 mg/0.625 mg tablets is a combination of two active ingredients, perindopril and indapamida. It is an antihypertensive and is indicated for the treatment of high blood pressure (hypertension) in adults.

Perindopril belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. They work by widening blood vessels, making it easier for your heart to pump blood through them. Indapamida is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamida is different from other diuretics, as it only produces a slight increase in urine production. Each of the active ingredients lowers blood pressure and acts together to control your blood pressure.

Do not take Preterax 2 mg/0.625 mg tablets

• if you are allergic to perindopril or any other angiotensin-converting enzyme (ACE) inhibitor, to indapamide or any other sulfonamide, or to any of the other ingredients of this medicine (listed in section 6),
• if you have experienced symptoms such as wheezing, facial or tongue swelling, intense itching or severe skin rashes with any previous treatment with ACE inhibitors or if you or a family member has had these symptoms in any other circumstance (a condition called angioedema),
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren,
• if you have a severe liver disease or suffer from a condition called hepatic encephalopathy (a degenerative brain disease),
• if you have a severe kidney disease due to which the blood flow to your kidneys is reduced (renal artery stenosis),
• if you are receiving dialysis or any other type of blood filtration.Depending on the machine used, Preterax 2 mg/0.625 mg tablets may not be suitable for you,
• if you have low potassium levels in your blood,
• if you suspect that you may have untreated heart failure (severe fluid retention, difficulty breathing),
• if you are more than 3 months pregnant (It is also best to avoid Preterax 2 mg/0.625 mg tablets at the beginning of pregnancy — see section “Pregnancy”),
• if you have taken or are currently taking sacubitril/valsartan, a heart failure medicine, as this increases the risk of angioedema (rapid swelling under the skin in an area such as the throat) (see “Warnings and precautions” and “Taking Preterax 2 mg/0.625 mg tablets with other medicines”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Preterax 2 mg/0.625 mg tablets:

• if you have aortic stenosis (narrowing of the main blood vessel that leaves the heart) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery that carries blood to the kidney),
• if you have heart failure or any other heart problem,
• if you have kidney problems or if you are on dialysis,
• if you experience a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in your eye and can occur within hours or weeks of taking Preterax 2 mg/0.625 mg tablets. If left untreated, this can lead to permanent vision loss. If you have had a previous allergy to penicillin or sulfonamides, you may be at higher risk of developing this,
• if you have muscle disorders, including muscle pain, sensitivity, weakness, or cramps
• if you have abnormally high levels of a hormone called aldosterone in your blood (primary aldosteronism),
• if you have liver problems,
• if you suffer from a collagen disease (skin disease) such as systemic lupus erythematosus or scleroderma,
• if you have atherosclerosis (hardening of the arteries),
• if you have hyperparathyroidism (overactivity of the parathyroid gland),
• if you have gout,
• if you have diabetes,
• if you are following a low-sodium diet or using salt substitutes that contain potassium,
• if you are taking lithium or potassium-sparing diuretics (e.g. spironolactone, triamterene) or potassium supplements, as simultaneous use with Preterax 2 mg/0.625 mg tablets should be avoided (see “Other medicines and Preterax 2 mg/0.625 mg tablets”),
• if you are an elderly patient,
• if you have had photosensitivity reactions,
• if you have severe allergic reactions with facial, lip, mouth, tongue, or throat swelling that can cause difficulty swallowing or breathing (angioedema). This can occur at any time during treatment.

If you develop these symptoms, stop treatment and contact your doctor immediately.

• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• an angiotensin II receptor antagonist (ARA) (also known as “sartans” — e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium), at regular intervals.

See also the information under the heading “Do not take Preterax 2 mg/0.625 mg tablets”.

• if you are of black ethnicity, as you may be at higher risk of angioedema and this medicine may be less effective in lowering your blood pressure than in patients who are not of black ethnicity,
• if you are a haemodialysis patient with high-flow membranes,
• if you are taking any of the following medicines, the risk of angioedema increases:
• racecadotril (used to treat diarrhea),
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the class called mTor inhibitors (used to prevent organ transplant rejection and for cancer),
• sacubitril (available as a fixed-dose combination with valsartan), used to treat heart failure over a long period,
• linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the class of gliptins (used to treat diabetes).

Angioedema

In patients treated with ACE inhibitors, including Preterax 2 mg/0.625 mg tablets, angioedema (severe allergic reaction with swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing) has been reported. This can occur at any time during treatment. If you develop these symptoms, you should stop treatment with Preterax 2 mg/0.625 mg tablets and seek medical attention immediately. See also Section 4.

You should inform your doctor if you think you are (or could be) pregnant. Preterax 2 mg/0.625 mg tablets are not recommended at the beginning of pregnancy, and you should not take them if you are more than 3 months pregnant, as they can cause serious harm to your baby if used during this period (see “Pregnancy and breastfeeding”).

When taking Preterax 2 mg/0.625 mg tablets, you should inform your doctor or healthcare professional:

• if you are to undergo anaesthesia and/or surgery,
• if you have recently had diarrhoea or vomiting, or are dehydrated,
• if you are to undergo dialysis or LDL apheresis (removal of cholesterol from your blood using a machine),
• if you are to receive a desensitization treatment to reduce the effects of bee or wasp stings,
• if you are to undergo any medical test that requires the injection of a contrast agent containing iodine (a substance that allows organs such as the kidney or stomach to be visible with X-rays),
• if you have vision changes or eye pain while taking Preterax 2 mg/0.625 mg tablets. This may be a sign that you are developing glaucoma, an increase in pressure in your eye(s). You should stop treatment with Preterax 2 mg/0.625 mg tablets and seek medical attention.

Athletes should be aware that Preterax 2 mg/0.625 mg tablets contain an active ingredient (indapamide) that can give a positive result in a doping test.

Children and adolescents

Preterax 2 mg/0.625 mg tablets should not be administered to children or adolescents.

Other medicines and Preterax 2 mg/0.625 mg tablets

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

You should avoid taking Preterax 2 mg/0.625 mg tablets with:

• lithium (used to treat mania or depression),
• aliskiren (a blood pressure-lowering medicine) if you do not have diabetes or kidney problems,
• potassium-sparing diuretics (e.g. triamterene, amiloride…), potassium salts, other medicines that can increase potassium levels in your body (such as heparin, a medicine used to thin the blood and prevent blood clots; trimethoprim and co-trimoxazole also known as trimethoprim/sulfamethoxazole for bacterial infections),
• estramustine (used in cancer treatment),
• other medicines used to treat high blood pressure: ACE inhibitors and angiotensin II receptor antagonists.

The treatment with Preterax 2 mg/0.625 mg tablets may be affected by other medicines.Your doctor may need to modify your dose and/or take other precautions.Make sure to inform your doctor if you are taking any of the following medicines, as you may need special care:

• other medicines for the treatment of high blood pressure (hypertension) including angiotensin II receptor antagonists (ARA), aliskiren (see also the information under the headings “Do not take Preterax 2 mg/0.625 mg tablets” and “Warnings and precautions”), or diuretics (medicines that increase the amount of urine produced by the kidneys),
• potassium-sparing diuretics used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day,
• medicines that are frequently used to treat diarrhea (racecadotril) or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the class called mTor inhibitors). See section “Warnings and precautions”,
• sacubitril/valsartan (used to treat heart failure over a long period). See sections “Do not take Preterax 2 mg/0.625 mg tablets” and “Warnings and precautions”,
• anaesthetics,
• contrast agent containing iodine,
• antibiotics used to treat bacterial infections (e.g.moxifloxacine, esparfloxacine,erythromycin injection),
• metadone (used to treat addiction,
• procainamide (for irregular heart rhythm),
• allopurinol (for gout),

• antihistamines used to treat allergic reactions, such as hay fever (e.g.mizolastine, terfenadine, astemizole),
• corticosteroids used to treat various disorders including severe asthma and rheumatoid arthritis,
• immunosuppressants used to treat autoimmune disorders or after a transplant to prevent rejection (e.g. ciclosporin, tacrolimus),
• halofantrine (used to treat certain types of malaria),
• pentamidine (used to treat pneumonia),
• gold injection (used to treat rheumatoid arthritis),
• vincamine (used to treat cognitive disorders in the elderly including memory loss),
• bepridil (used to treat angina pectoris),
• medicines used to treat heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitals, bretylium),
• cisapride, difemanil (used to treat gastrointestinal problems),
• digoxin or other cardiac glycosides (for heart problems),
• baclofen (for muscle stiffness that occurs in diseases such as multiple sclerosis),
• medicines used to treat diabetes such as insulin, metformin, or gliptins,
• calcium including calcium supplements,
• laxatives (e.g. senna),
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high doses of salicylates (e.g. acetylsalicylic acid (a substance present in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting)),
• amphotericin B injection (for severe fungal infections),
• medicines used to treat mental disorders such as depression, anxiety, schizophrenia… (e.g. tricyclic antidepressants, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol)),
• tetracosactide (for Crohn’s disease),
• trimethoprim (for infections),
• vasodilators including nitrates (medicines that make blood vessels wider),
• medicines used to treat low blood pressure, shock, or asthma (e.g. ephedrine, noradrenaline, or adrenaline).

Preterax 2 mg/0.625 mg tablets with food and drink

It is best to take Preterax 2 mg/0.625 mg tablets before a meal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant,consult your doctor or pharmacist before using any medicine.

Pregnancy

You should inform your doctor if youthink you are (or could be)pregnant.

Normally, your doctor will recommend that you stop taking Preterax 2 mg/0.625 mg tablets before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medicine instead of Preterax 2 mg/0.625 mg tablets. Preterax 2 mg/0.625 mg tablets are not recommended at the beginning of pregnancy, and you should not take them if you are more than three months pregnant, as they can cause serious harm to your baby if taken after the third month of pregnancy.

Breastfeeding

Preterax 2 mg/0.625 mg tablets are not recommended if you are breastfeeding.

Inform your doctor immediately if you are to start or are breastfeeding.

Go to your doctor immediately.

Driving and operating machines

Preterax 2 mg/0.625 mg tablets usually do not affect your alertness, but due to the lowering of blood pressure, some patients may experience different reactions such as dizziness or weakness. If this happens to you, your ability to drive or operate machinery may be impaired.

Preterax 2 mg/0.625 mg tablets contain lactose monohydrate. If your doctor has told you that you are intolerant to certain sugars, consult with him before taking this medicine.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.If in doubt, consult your doctor or pharmacist again.The recommended dose is 1 tablet once a day. Your doctor may decide to increase the dose to 2 tablets a day or modify the dose if you have renal insufficiency.Take your tablet preferably in the morning and before breakfast.Swallow the tablet whole with the help of a glass of water.

If you take more Preterax 2 mg/0.625 mg tablets than you should

If you have ingested too many tablets, contact your doctor immediately or go to the nearest emergency service of your hospital. In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone (91) 562 04 20.

The most frequent symptom in case of overdose is a decrease in blood pressure. If a significant decrease in blood pressure occurs (associated with nausea, vomiting, cramps, dizziness, drowsiness, confusion, and changes in the amount of urine produced by the kidneys), lying down with the legs elevated may help.

If you forgot to take Preterax 2 mg/0.625 mg tablets

It is essential to take this medication every day since continuous treatment is more effective. However, if you forgot to take a dose of Preterax 2 mg/0.625 mg tablets, take the next dose at the usual time. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Preterax 2 mg/0.625 mg tablets

Since hypertension treatment is usually lifelong, you should talk to your doctor before stopping this medication.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking this medicine and seek medical attention immediately if you experience any of the following side effects that may be serious:

• Severe dizziness or fainting due to low blood pressure (Frequent — may affect up to 1 in 10 people),
• Bronchospasm (chest tightness, shortness of breath, or difficulty breathing) (Infrequent) (may affect up to 1 in 100 people),
• Swelling of the face, lips, mouth, tongue, or throat, which causes severe difficulty breathing (angioedema) (See Section 2 «Warnings and Precautions») (Infrequent) (may affect up to 1 in 100 people),
• Severe skin reactions, including erythema multiforme (skin rash that often starts with red, itchy patches on the face, arms, or legs), or intense skin rash, blisters, widespread skin redness, intense itching, blistering, peeling, and inflammation of the skin and mucous membranes (Stevens-Johnson syndrome, or other allergic reactions) (Very rare — may affect up to 1 in 10,000 people),
• Cardiovascular problems (irregular heartbeat, angina (chest pain, jaw pain, and back pain, caused by physical exertion), myocardial infarction (Very rare) (may affect up to 1 in 10,000 people),
• Weakness in arms or legs, or speech problems that may indicate a possible stroke (Very rare — may affect up to 1 in 10,000 people),
• Pancreatitis, which can cause severe abdominal and back pain, accompanied by a feeling of great discomfort (Very rare) (may affect up to 1 in 10,000 people),
• Yellowing of the skin or eyes (jaundice) that may indicate hepatitis (Very rare — may affect up to 1 in 10,000 people),
• Irregular heartbeat with life-threatening implications. (Unknown frequency),
• Brain disease caused by liver disease (Hepatic encephalopathy) (Unknown frequency),
• Muscle weakness, cramps, muscle sensitivity or pain, and especially if you feel unwell or have a high temperature, as they may be caused by abnormal muscle breakdown. (Unknown frequency).

In decreasing order of frequency, side effects may include:

• Frequent (may affect up to 1 in 10 people): skin reactions in people prone to allergic and asthmatic reactions, headache, dizziness, vertigo, tingling, visual disturbances, tinnitus (sensation of noise in the ears), cough, shortness of breath (dyspnea), gastrointestinal disturbances (nausea, vomiting, abdominal pain, taste disturbances, indigestion, or difficulty digesting, diarrhea, constipation), allergic reactions (such as skin rashes, itching), muscle cramps, feeling tired, low potassium levels in the blood.,low blood potassium levels.

• Infrequent (may affect up to 1 in 100 people): mood changes, depression, sleep disturbances, urticaria, purpura (red spots on the skin), blistering, kidney problems, impotence (inability to achieve or maintain an erection), sweating, an excess of eosinophils (a type of white blood cell), changes in laboratory parameters: reversible increase in blood potassium levels, decrease in blood sodium levels that may cause dehydration and low blood pressure, somnolence, fainting, palpitations (feeling the heartbeat), tachycardia (rapid heartbeat), hypoglycemia (very low blood sugar) in diabetic patients, vasculitis (inflammation of blood vessels), dry mouth, photosensitivity reactions (increased skin sensitivity to the sun), arthralgia (joint pain), myalgia (muscle pain), chest pain, feeling unwell, peripheral edema, fever, elevated urea levels in the blood, and elevated creatinine levels in the blood, fall.

• Rare (may affect up to 1 in 1,000 people):Worsening of psoriasis, changes in analytical results: low chloride levels in the blood, low magnesium levels in the blood, increased levels of liver enzymes, high bilirubin levels in the blood, fatigue,facial flushing, decreased or absent diuresis, acute renal failure.

Concentrated urine, feeling unwell (nausea) or vomiting, muscle cramps, confusion, and convulsions. These symptoms may be a sign of a disease called SIADH (inadequate secretion of antidiuretic hormone).

• Very rare (may affect up to 1 in 10,000 people): confusion, eosinophilic pneumonia (a rare type of pneumonia), rhinitis (stuffy or runny nose), severe kidney problems, changes in blood values such as decreased white and red blood cell counts, decreased hemoglobin, decreased platelet count, increased calcium levels in the blood, abnormal liver function.

• Unknown frequency (cannot be estimated from available data):Abnormal ECG tracing,changes in blood parameters: high uric acid and blood sugar levels,myopia (nearsightedness), blurred vision, visual disturbances, decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma),change in color, numbness, and pain in the fingers of the hands or feet (Raynaud’s disease).If you have systemic lupus erythematosus (a type of collagen disease), it may worsen.

You may experience blood, kidney, liver, or pancreas problems, and changes in analytical results (blood tests). Your doctor may need to prescribe blood tests to monitor your condition.

If you experience these symptoms, contact your doctor as soon as possible.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store above 30°C. Dispose of the blister 2 months after opening the outer packaging.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at your local SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Preterax 2 mg/0.625 mg tablets

• The active ingredients are perindopril terbutilamine and indapamide. Each tablet contains 2 mg of perindopril terbutilamine (which corresponds to 1.669 mg of perindopril) and 0.625 mg of indapamide.
• The other components of the tablet are: lactose monohydrate, magnesium stearate (E470B), hydrophobic colloidal silica, and microcrystalline cellulose.

Appearance of the product and contents of the packaging

Preterax 2 mg/0.625 mg tablets are white, rod-shaped, scored on each side. A tablet contains 2 mg of perindopril terbutilamine and 0.625 mg of indapamide.

The tablets are available in blister-type packaging within a box containing 14, 20, 28, 30, 50, 56, 60, 90, 100, or 500 tablets.

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex – France

Responsible manufacturer:

Les Laboratoires Servier Industrie

905 route de Saran

45520 Gidy – France

or

Servier (Ireland) Industries Ltd

Gorey Road

Arklow – Co. Wicklow – Ireland

This medicine is authorized in the member states of the European Economic Area with the following names:

SloveniaNOLIPREL 2mg/0.625 mg tablets

SpainPreterax 2mg/0.625mg tablets

FrancePERINDOPRIL/INDAPAMIDE ARROW LAB 2mg/0.625 mg

MaltaPRETERAX

Last review date of this leaflet: May 2022.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.