Perindopril/indapamide Combix 8 mg/2.5 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Perindopril/Indapamide Combix 8 mg/2.5 mg tablets EFG

perindopril tert-butylamine/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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Perindopril/Indapamide Combix is and what it is used for

Perindopril/Indapamide is a combination of two active substances, perindopril and indapamide. This medicine is used for the treatment of high blood pressure (hypertension).

• Perindopril belongs to a group of medicines known as ACE inhibitors. These work by widening the blood vessels, allowing your heart to pump blood through them more easily.
• Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics in that it causes only a slight increase in the amount of urine formed.

Each of the active substances lowers blood pressure, and they act together to control your blood pressure.

2. What you need to know before taking Perindopril/Indapamida Combix

Do not take Perindopril/Indapamida Combix

• if you are allergic to perindopril or any other ACE inhibitor, to indapamide or other sulfonamides, or to any of the other ingredients of this medicine (listed in section 6),
• if you have experienced symptoms such as wheezing, swelling of the face or tongue, severe itching or serious skin rashes during previous treatment with ACE inhibitors, or if you or a family member has ever had these symptoms under any other circumstances (a condition called angioedema),
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren,
• if you have severe liver disease or suffer from a condition known as hepatic encephalopathy (degenerative brain disease),
• if you have severe kidney disease or are undergoing dialysis,
• if you have low or high blood potassium levels,
• if you suspect you may have untreated decompensated heart failure (severe fluid retention, breathing difficulties),
• if you are more than 3 months pregnant (likewise, it is better to avoid perindopril/indapamide at the beginning of pregnancy – see “Pregnancy and breastfeeding”),
• if you are breastfeeding (see breastfeeding).

Children and adolescents: DO NOT give this medicine to children.

Warnings and precautions

Talk to your doctor or pharmacist before taking Perindopril/Indapamida Combix if:

• you have narrowing of the main blood vessel leaving the heart (aortic stenosis),

• you have narrowing of the left heart valve (mitral valve stenosis),

• you have heart muscle disease (hypertrophic cardiomyopathy),

• you have narrowing of the artery supplying blood to the kidney (renal artery stenosis),

• you suffer from any other heart or kidney problems,

• you have liver problems,

• you have a collagen disease (skin disease) such as systemic lupus erythematosus or scleroderma,

• you have atherosclerosis (hardening of the arteries),

• you have hyperparathyroidism (overactive parathyroid gland),

• you have gout,

• you have diabetes,

• you are on a low-salt diet or are using salt substitutes containing potassium,

• you are taking lithium or potassium-sparing diuretics (spironolactone, triamterene), as concomitant use with perindopril/indapamide should be avoided (see “Use with other medicines”),

• 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 Perindopril/Indapamida Combix"

• you are over 70 years old,
• you think you are (or might become) pregnant. Perindopril/indapamide is not recommended in early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to your baby if used during this stage of pregnancy (see pregnancy section).

You should also inform your doctor that you are taking this medicine if:

• you are going to undergo anaesthesia and/or surgery,
• you have recently had diarrhoea, vomiting, or are dehydrated,
• you have noticed increased skin sensitivity to sunlight,
• you have a persistent dry cough,
• you have abdominal pain with or without nausea or vomiting; these could be symptoms of a serious allergic reaction called intestinal angioedema,
• you are going to undergo dialysis or LDL apheresis (removal of cholesterol from the blood by a machine),
• you are going to receive desensitisation treatment to reduce the effects of allergy to bees or wasps,
• you are going to undergo a medical examination requiring injection of an iodinated contrast agent (a substance that makes organs such as the kidney or stomach visible on X-rays).

Perindopril/indapamide may be less effective in people of black race.

Use of Perindopril/Indapamida Combix with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Avoid taking this medicine with:

• lithium (used to treat depression),
• potassium-sparing diuretics (spironolactone, triamterene),
• potassium salts.

In particular, consult your doctor before taking this medicine if you are taking any of the following; your doctor may need to adjust your dose and/or take other precautions:

• other medicines for treating high blood pressure, including angiotensin II receptor antagonists (ARA II), aliskiren (see also information under the headings “Do not take Perindopril/Indapamida Combix” and “Warnings and precautions”),
• other medicines for treating heart rhythm disorders (e.g., procainamide, digoxin, hydroquinidine, disopyramide, quinidine, amiodarone, sotalol, difemethil),
• antihistamines for hay fever or allergies such as terfenadine, astemizole, mizolastine,
• bepridil (for angina pectoris),
• benzamides (for psychotic disorders, e.g., sultopride),
• butyrophenones (for psychiatric disorders, e.g., haloperidol),
• cisapride (intestinal medicine),
• erythromycin for injection (an antibiotic),
• moxifloxacin or sparfloxacin (antibiotics),
• methadone (anti-addiction medicine),
• allopurinol (for gout),
• corticosteroids used to treat various disorders including severe asthma and rheumatoid arthritis,
• immunosuppressants used to treat autoimmune disorders or after transplantation to prevent rejection (e.g., cyclosporine),
• medicines for treating cancer,
• halofantrine (for malaria),
• pentamidine (for pneumonia),
• vincamine (for symptomatic cognitive disorders in elderly patients),
• baclofen (for muscle stiffness occurring in diseases such as multiple sclerosis),
• medicines for diabetes such as insulin, metformin or glimepiride,
• calcium,
• stimulant laxatives (e.g., senna),
• non-steroidal anti-inflammatory drugs (NSAIDs) to relieve pain or high doses of salicylates (e.g., aspirin),
• injectable amphotericin B (for serious fungal infections),
• medicines for treating mental disorders such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants, neuroleptics),
• tetracosactide (for treatment of Crohn's disease),
• injectable gold (sodium aurothiomalate) (medicine for rheumatic disorders).

Consult your doctor if you are unsure whether any of these medicines apply to you.

Taking Perindopril/Indapamida Combix with food, drinks and alcohol

Take the tablets with a glass of water, preferably in the morning and before meals. Exercise particular caution if you are on a salt-restricted diet. Consult your doctor before taking the tablets.

Pregnancy, breastfeeding and fertility

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

Pregnancy

Consult your doctor or pharmacist before using any medicine.

Consult your doctor if you are (or think you may be) pregnant. Generally, your doctor will advise you to stop taking perindopril/indapamide before becoming pregnant or as soon as possible if you become pregnant, and will recommend an alternative medicine. Perindopril/indapamide is not recommended during the first months of pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the baby if used beyond the third month of pregnancy.

Breastfeeding

You must not take perindopril/indapamide while breastfeeding. Consult your doctor immediately if you are breastfeeding or plan to start breastfeeding.

Driving and using machines

This medicine does not affect alertness. However, due to the lowering of blood pressure, you may experience dizziness or weakness, especially at the beginning of treatment or when the dose is increased. If this occurs, your ability to drive or operate machinery may be impaired.

Perindopril/Indapamida Combix contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Perindopril/Indapamide Combix

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is one tablet daily.

Take the tablets with a glass of water, preferably in the morning and before meals.

Adults

The usual dose is one tablet once a day.

Elderly patients

Your doctor will decide the most appropriate dose for you.

Patients with renal impairment

Your doctor may decide to adjust the dosage regimen if you have renal impairment.

Use in children and adolescents

This medicine is not suitable for use in children.

If you take more Perindopril/Indapamide Combix than you should

If you take too many tablets, contact your doctor immediately or go to the nearest hospital emergency department. The most common symptom in case of overdose is low blood pressure. If a significant drop in blood pressure occurs (symptoms such as dizziness or fainting), lying down with your legs raised may help.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Perindopril/Indapamide Combix

It is important to take this medicine every day, as continuous treatment is more effective. However, if you miss a dose of perindopril/indapamide, 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 Perindopril/Indapamide Combix

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

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

4. Possible adverse effects

Like all medicines, Perindopril/Indapamide Combix can produce adverse effects, although not everyone experiences them.

If you experience any of the following symptoms, STOP taking this medicine and contact your doctor immediately. These are symptoms of a severe allergic reaction and must be treated immediately, usually in a hospital.

• swelling of the face, lips, mouth, tongue, eyes or throat,
• difficulty breathing,
• severe dizziness or fainting,
• blistering of the skin, mouth, eyes and genitals.

Also contact your doctor immediately if you experience any of the following adverse effects:

• abnormally fast or irregular heartbeat,
• chest pain.

Other adverse effects

Common (may affect up to 1 in 10 people)

• constipation,
• dry mouth,
• nausea,
• vomiting,
• stomach discomfort after eating (dyspepsia),
• abdominal pain,
• epigastric pain,
• anorexia,
• diarrhoea,
• taste disturbances,
• dry cough,
• difficulty breathing,
• vision disorders,
• ringing or buzzing in the ears,
• muscle cramps,
• feeling of weakness (asthenia),
• low blood pressure and dizziness or fainting upon standing,
• headache,
• dizziness,
• sensation of tingling, itching or prickling without apparent cause (paraesthesia),
• sensation of dizziness (vertigo),
• skin reactions (rash, hives, itching),
• low blood potassium levels.

Uncommon (may affect up to 1 in 100 people)

• red spots on the skin (purpura),
• itchy skin rash (urticaria),
• mood changes and/or sleep disorders,
• difficulty breathing with cough or wheezing (bronchospasm),
• swelling of the face, lips, mouth, tongue, eyes or throat,
• kidney disorders (renal failure),
• impotence (inability to achieve or maintain an erection),
• sweating,
• depression,
• low blood sodium levels, which may cause dehydration and low blood pressure.

If you have systemic lupus erythematosus (a collagen disease), it may worsen.

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

• elevated blood calcium levels,
• intestinal angioedema (presenting with abdominal pain, with or without nausea or vomiting),
• worsening of psoriasis,
• concentrated urine, feeling unwell (nausea) or feeling sick (vomiting), muscle cramps, confusion and seizures. These symptoms may indicate a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion),
• decreased or absent urine output,
• facial flushing,
• acute renal failure,
• low blood chloride levels,
• low blood magnesium levels.

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

• inflammation of the pancreas (pancreatitis),
• reduction in the number of platelets,
• reduction in the number of white blood cells, increasing the likelihood of infections,
• reduction in the number of red blood cells, which may cause paleness of the skin and lead to weakness or shortness of breath (anaemia in patients who have received a kidney transplant or in patients undergoing haemodialysis, aplastic anaemia or haemolytic anaemia),
• inflammation of the liver (hepatitis),
• pneumonia,
• nasal congestion or runny nose,
• cardiac disorders (slow or abnormally fast heartbeat, chest pain or heart attack),
• severe skin reactions (manifested as rash, redness of the skin, swelling of the lips, eyes or mouth, skin peeling with or without fever),
• increased sensitivity of the skin to sunlight,
• confusion.

Not known (frequency cannot be estimated from available data)

• in cases of liver failure (liver problems), there is a possibility of brain disorders (personality changes, confusion, stupor, tremors, seizures, confusion, disturbances of consciousness),
• changes in laboratory parameters assessed in blood tests,
• change in colour, numbness and pain in the fingers or toes (Raynaud's disease).

Reporting of adverse effects:

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

5. Storage of Perindopril/Indapamide Combix

Keep this medicine out of the sight and reach of children. No special storage conditions are required.

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

Do not use this medicine if you notice any visible signs of deterioration.

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

6. Contents of the pack and other information

Composition of Perindopril/Indapamide Combix

• The active substances are perindopril tert-butylamine and indapamide. Each tablet contains 6.676 mg of perindopril, equivalent to 8 mg of perindopril tert-butylamine and 2.5 mg of indapamide.
• The other components (excipients) are lactose monohydrate, microcrystalline cellulose (E460i), anhydrous colloidal silica (E551), and magnesium stearate (E470b).

Appearance of the product and contents of the pack

White to off-white, round, biconvex tablets with bevelled edges and smooth surfaces on both sides.

Blister packs made of OPA/AL/PVC-aluminum, in packs of 30 tablets.

Blister packs made of PVC/PVDC-aluminum, in packs of 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Specialites Pharmaceutiques

ZAC des Suzots

35 Rue de la Chapelle

63450 Saint Amant Tallende

France

Date of latest review of this leaflet: November 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.