Perindopril/indapamide Viatris 4 mg/1.25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Perindopril / Indapamide Viatris 4 mg/1.25 mg tablets EFG

perindopril tert-butylamine and indapamide

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not effects listed in this leaflet. See section 4.

Leaflet contents

1. What Perindopril / Indapamide Viatris is and what it is used for
2. What you need to know before taking Perindopril / Indapamide Viatris
3. How to take Perindopril / Indapamide Viatris
4. Possible side effects
5. How to store Perindopril / Indapamide Viatris
6. Contents of the pack and other information

1. What Perindopril / Indapamida Viatris is and what it is used for

Perindopril / Indapamida Viatris is a combination of two active substances, perindopril and indapamida. It is an antihypertensive medicine used for the treatment of hypertension (high blood pressure).

It belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. These medicines dilate blood vessels, allowing the heart to pump blood through them more easily. Indapamida is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamida differs from other diuretics in that it produces only a slight increase in urine production. Both active substances reduce blood pressure and act together to control blood pressure effectively.

2. What you need to know before taking Perindopril / Indapamide Viatris

Do not take Perindopril / Indapamide Viatris:

• If you are allergic to perindopril, other ACE inhibitors, indapamide, other sulfonamides (including other diuretics or antibiotics such as cotrimoxazole), or any of the other ingredients of this medicine (listed in section 6).

• If you have experienced symptoms such as wheezing, facial or tongue swelling, severe itching, or widespread skin rash during previous treatment with ACE inhibitors, or if you or a family member has had these symptoms under other circumstances (a condition called angioedema).

• If you have severe liver problems or a condition called hepatic encephalopathy (degenerative brain disease).

• If you have severe renal failure with reduced blood flow to your kidneys (renal artery stenosis).

• If you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, perindopril/indapamide may not be suitable for you.

• If you have low levels of potassium in your blood.

• If you are taking other medicines that may affect your heart rhythm (see section “Other medicines and Perindopril / Indapamide Viatris”).

• If untreated decompensated heart failure (severe fluid retention, breathing difficulty) is suspected.

• If you are more than 3 months pregnant (you should avoid taking this medicine during the first months of pregnancy) (see section "Pregnancy and breastfeeding").

• If you are breastfeeding.

• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, e.g., in the throat).

Warnings and precautions

Talk to your doctor or pharmacist before taking Perindopril / Indapamide Viatris:

• If you have aortic stenosis (narrowing of the main blood vessel leaving the heart), hypertrophic cardiomyopathy (heart muscle disease), or renal artery sten游戏副本

3. How to take Perindopril / Indapamide Viatris

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again. The recommended dose is one tablet once daily. Your doctor may decide to adjust the dose if you have kidney problems. Take the tablet preferably in the morning before eating. Swallow the tablet with a glass of water.

If you take more Perindopril / Indapamide Viatris than you should

If you accidentally take too many tablets, contact your doctor or pharmacist immediately, call the Poison Information Service (Tel. 91 562 04 20), stating the name of the medicine and the amount taken, or go to the nearest hospital emergency department. The most likely effect in case of overdose is a drop in blood pressure, sometimes accompanied by feelings of discomfort, cramps, dizziness, drowsiness, confusion, and problems with urination. If a significant drop in blood pressure occurs (symptoms such as dizziness or fainting), lie down with your legs raised.

If you forget to take Perindopril / Indapamide Viatris

It is important that you take your medicine every day, as regular treatment is more effective. However, if you forget to take a dose, take your next dose at the usual time. Do not take a double dose to make up for missed doses.

If you stop taking Perindopril / Indapamide Viatris

Since treatment for high blood pressure is usually lifelong, you must consult your doctor before stopping treatment with this medicine.

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

4. Possible adverse effects

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

The following adverse effects have been reported in patients taking perindopril and/or indapamide.

If you experience any of the following adverse effects, stop taking the medicine immediately and contact your doctor right away, or go to the nearest hospital emergency department:

Common (may affect up to 1 in 10 people)

• Any change in vision or pain in one or both eyes. This may be a sign of high eye pressure (glaucoma).
• Allergic skin reactions such as redness, itching, and rash with spots, in patients with known history of respiratory and allergic disorders (such as asthma).
• Headache, dizziness, vertigo, or lightheadedness due to low blood pressure, especially when standing.

Uncommon (may affect up to 1 in 100 people)

• Swelling of the face, lips, tongue, or throat, or difficulty breathing (more likely in black patients).

Rare (may affect up to 1 in 1,000 people)

• Production of little or no urine, cloudy urine or blood in the urine, pain when urinating, or lower back pain (these may be signs of serious kidney problems (acute renal failure)).

Very rare (may affect up to 1 in 10,000 people)

• Severe skin problems such as a widespread rash with spots and itching on the face, arms, or legs (erythema multiforme). You may develop blisters or bleeding on the lips, eyes, nose, mouth, and genitals (Stevens-Johnson syndrome) and widespread skin peeling (toxic epidermal necrolysis).
• Increase in the number of infections you may experience, such as fever, severe chills, sore throat, or mouth ulcers. These symptoms could indicate low white blood cell count.
• Unusual bruising or prolonged bleeding. These symptoms could indicate low platelet count in the blood.
• Weakness, fatigue, headaches, shortness of breath during exercise, dizziness, paleness, or yellowing of the skin and whites of the eyes. These symptoms could indicate low red blood cell levels.
• Low blood cell counts, which you may notice as increased infections, unusual or prolonged bruising or bleeding, and fatigue, weakness, or shortness of breath.
• Collapse, numbness or weakness in arms or legs, confusion, difficulty speaking, or vision problems. These may be signs of stroke and may occur after signs of low blood pressure.
• Irregular or unusually fast heartbeat, which may be seen on an electrocardiogram (ECG).
• If you feel a strong pressure in your chest with abdominal pain and increased shortness of breath after exercise (this may be due to heart problems such as angina).
• Sudden chest pain that may spread to the neck or arm, with difficulty breathing and a feeling of warmth. These may be signs of a heart attack and may occur after signs of low blood pressure.
• Hepatitis, possibly due to liver problems, characterized by feeling unwell (nausea) or dizzy (vomiting), loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, light-colored stools, and dark-colored urine.
• Severe stomach pain that may radiate to the back (this may be due to inflammation of the pancreas).
• You suffer from cough, fever, increased shortness of breath, and night sweats, which may be caused by lung problems called eosinophilic pneumonia (a rare type of pneumonia).

Frequency not known (cannot be estimated from available data)

• You feel weak or your heartbeat is faster and/or irregular. This may be due to low potassium levels in the blood (this is more common in elderly, undernourished patients, or those with heart, liver, or kidney problems).

• Hepatic encephalopathy, characterized by feeling tired, irritable, forgetful, and confused, with tremors, seizures, unconsciousness, and coma due to brain inflammation (this is common if you have liver problems).

• Decreased vision or eye pain, possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion).

• Muscle weakness, cramps, tenderness, or muscle pain, especially if you also feel unwell or have a high temperature, as these may be caused by abnormal muscle breakdown.

Other possible adverse effects:

Common (may affect up to 1 in 10 people)

• Vision problems.
• Dizziness, headaches.
• A sensation of spinning when still (vertigo).
• Unpleasant or metallic taste in the mouth.
• Ringing, buzzing, whistling, or other persistent noises in the ears (tinnitus).
• Cough (if the cough is persistent (more than several days), consult your doctor), difficulty breathing.
• Feeling unwell (nausea), stomach pain, discomfort (vomiting), disturbances in taste, indigestion (dyspepsia or difficulty digesting), diarrhea, constipation.
• Skin rashes, itching.
• Muscle cramps, tingling.
• Feeling of weakness.
• Low potassium levels in blood, which improves upon discontinuation of treatment.

Uncommon (may affect up to 1 in 100 people)

• Increase in white blood cells (eosinophilia).
• Low blood sugar levels.
• Low sodium levels in blood, which may cause dehydration and low blood pressure.
• Depression, mood changes, sleep disturbances.
• Drowsiness.
• Fainting.
• Fast heartbeat (tachycardia), rapid heartbeats that may be felt as pounding in the chest (palpitations).
• Inflammation of blood vessels (vasculitis).
• Feeling of tightness in the chest, wheezing, and difficulty breathing (bronchospasm).
• Dry mouth.
• Red spots on the skin (purpura), hives, increased skin sensitivity to sunlight.
• Muscle or joint pain.
• Kidney problems.
• Inability to achieve or maintain an erection (impotence).
• Excessive sweating.
• Pain in the middle or upper back (thoracic pain).
• General feeling of discomfort, fever.
• Swelling of the hands, ankles, or feet (fluid retention).
• Increases in blood urea and creatinine levels, which may be seen in a blood test.
• Falls.

Rare (may affect up to 1 in 1,000 people)

• Fatigue.

• Elevated levels of bilirubin or liver enzymes in blood, which may be seen in a blood test.

• Low chloride levels in blood.

• Low magnesium levels in blood.

• Concentrated urine (dark-colored), nausea or vomiting, muscle cramps, confusion, and seizures that may be due to inappropriate ADH (antidiuretic hormone) secretion.

• Decreased or absent urine output.

• Facial flushing.

• Worsening of psoriasis.

Very rare (may affect up to 1 in 10,000 people)

• Confusion.
• Stuffy or runny nose (rhinitis).
• Increased calcium levels in blood (which will show in blood tests). This may cause you to urinate more than usual, feel unwell, and have nausea with stomach pain.
• Abnormal liver function.
• Decreased hemoglobin and hematocrit levels, which may be seen in a blood test.

Frequency not known (cannot be estimated from available data)

• If you suffer from systemic lupus erythematosus (a type of connective tissue disease), as symptoms may worsen.

• Increased levels of urea and blood glucose, which may be seen in a blood test.

• Change in color, numbness, and pain in fingers and toes (Raynaud's phenomenon).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Perindopril / Indapamide Viatris

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

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the packaging, after CAD or EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Perindopril / Indapamide Viatris

The active substances are perindopril tert-butylamine and indapamide.

One tablet contains 4 mg of perindopril tert-butylamine (equivalent to 3.338 mg of perindopril) and 1.25 mg of indapamide.

The other components are: colloidal anhydrous silica (E-551), lactose, magnesium stearate (E-572), microcrystalline cellulose (E-460) and sodium bicarbonate (E-500).

Appearance of the product and contents of the pack

Perindopril / Indapamide Viatris are white, capsule-shaped tablets, convex on both sides, marked with 'PTI' on one side and 'M2' on the other.

It is available in blisters of 14, 30, 90 and 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland

or

Mylan Hungary Ltd
H-2900 Komarom,
Mylan utca 1
Hungary

Further information on this medicinal product is available from the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Spain: Perindopril / Indapamide Viatris 4 mg/1.25 mg tablets EFG
Netherlands: Perindopril tert-butylamine/Indapamide Mylan 4 mg/1.25 mg tabletten
Portugal: Perindopril + Indapamide Mylan 4 mg/1.25 mg tablets

Date of the most recent review of this leaflet: November 2024

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): https://www.aemps.gob.es/