Perindopril/indapamide Viso Farmaceutica 2 mg/0.625 mg tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Perindopril / Indapamide Viso Farmacéutica 2 mg/0.625 mg Tablets EFG

perindopril tert-butylamine / indapamide

Read the entire leaflet carefully before you start taking this medicine, as 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 you should not give it to others, even if they have the same symptoms as you, since it could harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents:

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

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

Perindopril / Indapamide Viso Farmacéutica is a combination of two active substances, perindopril and indapamide. It is an antihypertensive agent used for the treatment of high blood pressure (hypertension) in adults.

Perindopril belongs to a group of medicines known as ACE inhibitors. It works 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 urine production.

Each of the active substances lowers blood pressure and works together with the other to control blood pressure.

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

Do not take Perindopril / Indapamide Viso Farmacéutica

• if you are allergic to perindopril or any other ACE inhibitor, to indapamide, or to any other sulfonamide, or to any of the other components of this medicine (listed in section 6).
• if you have previously experienced symptoms such as wheezing, facial or tongue swelling, severe itching, or serious skin rashes during prior treatment with ACE inhibitors, or if you or a family member has ever had these symptoms under any circumstances (a condition called angioedema).
• if you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.
• if you have severe liver problems or a condition called hepatic encephalopathy (a degenerative brain disease).
• if you have severe renal failure, especially when blood supply to the kidneys is reduced (renal artery stenosis).
• if you are undergoing dialysis or any other type of blood filtration. Depending on the equipment used, Perindopril/Indapamide Viso Farmacéutica may not be suitable for you.
• if you have low levels of potassium in your blood.
• if you suspect you have untreated decompensated heart failure (severe fluid retention, breathing difficulty).
• if you are more than 3 months pregnant. (It is also advisable to avoid Perindopril/Indapamide Viso Farmacéutica during early pregnancy; see "Pregnancy and breastfeeding".)
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat heart failure, as the risk of angioedema (rapid swelling beneath the skin, for example in the throat) is increased.

Warnings and precautions

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

• if you have aortic stenosis (narrowing of the main blood vessel leaving the heart), hypertrophic cardiomyopathy (a heart muscle disorder), or renal artery stenosis (narrowing of the artery supplying blood to the kidneys).
• if you have heart failure or other heart problems.
• if you have kidney problems or are undergoing dialysis.
• if you experience vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to weeks after taking Perindopril / Indapamide Viso Farmacéutica. If untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk. Also, if you have muscle disorders, including muscle pain, tenderness, weakness, or cramps.
• if you have abnormally high levels of a hormone called aldosterone in your blood (primary hyperaldosteronism).
• if you have liver problems.
• if you have a connective tissue disease (skin disorder) 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 are diabetic.
• if you are on a low-salt diet or using salt substitutes containing potassium.
• if you are taking lithium or potassium-sparing medicines (e.g., spironolactone or triamterene) or potassium supplements, as concomitant use with Perindopril / Indapamide Viso Farmacéutica should be avoided (see section "Use of Perindopril / Indapamide Viso Farmacéutica with other medicines").
• if you are elderly.
• if you have previously experienced photosensitivity reactions.
• if you develop a severe allergic reaction with swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema). This may occur at any time during treatment. If you experience these symptoms, stop treatment immediately and contact your doctor without delay.
• if you are taking any of the following medicines for high blood pressure:
  • an “angiotensin II receptor antagonist” (ARB) (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 information under the heading “Do not take Perindopril / Indapamide Viso Farmacéutica”.

• if you are of Black origin, as you may have a higher risk of angioedema and this medicine may be less effective in lowering your blood pressure compared to non-Black patients.

• if you are a hemodialysis patient dialyzed with high-flux membranes.

• if you are taking any of the following medicines, the risk of angioedema may increase:

• racecadotril (a medicine used to treat diarrhea).

• sirolimus, everolimus, temsirolimus, and other medicines belonging to the class known as mTor inhibitors (used to prevent organ transplant rejection and in cancer treatment).

• sacubitril (available as a fixed-dose combination with valsartan), used for long-term treatment of heart failure.

  • linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the class known as gliptins (used to treat diabetes).

Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat, causing difficulty in swallowing or breathing) has been reported in patients treated with ACE inhibitors, including perindopril. This may occur at any time during treatment. If you develop these symptoms, you must stop taking Perindopril/Indapamide Viso Farmacéutica and consult a doctor immediately. See also section 4.

You must inform your doctor if you think you are (or could become) pregnant. Perindopril/Indapamide Viso Farmacéutica is not recommended during early pregnancy, and you must not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period (see “Pregnancy and breastfeeding”).

While taking Perindopril / Indapamide Viso Farmacéutica, you should also inform your doctor or healthcare professional:

• if you are due to receive anesthesia and/or undergo surgery.
• if you have recently had diarrhea, vomiting, or dehydration.
• if you are due to undergo dialysis or LDL apheresis (a procedure to remove cholesterol from your blood using a machine).
• if you are receiving desensitization treatment to reduce the effects of an allergy to wasp or bee stings.
• if you are scheduled for a medical test requiring injection of an iodinated contrast agent (a substance that makes organs such as kidneys or stomach visible on X-rays).
• if you experience changes in vision or eye pain in one or both eyes while taking Perindopril/Indapamide Viso Farmacéutica, as this could indicate the development of glaucoma, an increase in eye pressure. You should stop treatment with Perindopril/Indapamide Viso Farmacéutica and seek medical attention.

Athletes should be aware that Perindopril / Indapamide Viso Farmacéutica contains an active substance (indapamide) that may lead to a positive result in doping tests.

Children and adolescents

Perindopril / Indapamide Viso Farmacéutica must not be given to children or adolescents.

Other medicines and Perindopril / Indapamide Viso Farmacéutica
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

You must avoid taking Perindopril / Indapamide Viso Farmacéutica with:

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

Treatment with Perindopril / Indapamide Viso Farmacéutica may be affected by other medicines. Your doctor may need to adjust your dose and/or take other precautions. If you are taking any of the following medicines, ensure you inform your doctor, as you may require special monitoring:

• other medicines for treating hypertension, including angiotensin II receptor antagonists (ARBs), aliskiren (see also information under the headings “Do not take Perindopril / Indapamide Viso Farmacéutica” and “Warnings and precautions”), or diuretics (medicines that increase urine production by the kidneys).
• potassium-sparing medicines used in heart failure treatment: eplerenone and spironolactone at doses of 12.5 mg to 50 mg per day.
• medicines frequently used to treat diarrhea (racecadotril) or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the mTor inhibitor class). See section “Warnings and precautions”.
• sacubitril/valsartan (used for long-term treatment of heart failure). See sections "Do not take Perindopril/Indapamide Viso Farmacéutica" and "Warnings and precautions".
• anesthetic agents.
• iodinated contrast agents.
• antibiotics used to treat bacterial infections (e.g., moxifloxacin, sparfloxacin, injectable erythromycin).
• methadone (used to treat addiction).
• procainamide (used to treat arrhythmia).
• allopurinol (used to treat gout).
• antihistamines used to treat allergic reactions such as hay fever (e.g., mizolastine, terfenadine, astemizole).
• corticosteroids used to treat various conditions such as severe asthma or rheumatoid arthritis.
• immunosuppressants used to treat autoimmune diseases or to prevent transplant rejection (e.g., cyclosporine, tacrolimus).
• halofantrine (used to treat certain types of malaria).
• pentamidine (used for pneumonia).
• injectable gold (used for rheumatoid polyarthritis).
• vincamine (used to treat symptomatic cognitive disorders, e.g., memory loss, in elderly patients).
• bepridil (used for angina pectoris).
• medicines used to correct heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis, bretylium).
• cisapride, difemanil (used to treat gastric and digestive problems).
• digoxin or other cardiac glycosides (used to treat heart problems).
• baclofen (used to treat muscle stiffness caused by conditions such as multiple sclerosis).
• medicines used to treat diabetes, such as insulin, metformin, or gliptins.
• calcium, such as calcium supplements.
• stimulant laxatives (e.g., senna).
• non-steroidal anti-inflammatory drugs (e.g., ibuprofen) or high-dose salicylates (e.g., acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, and to prevent blood clotting)).
• intravenous amphotericin B (used to treat serious fungal infections).
• medicines used to treat psychiatric disorders such as depression, anxiety, or schizophrenia (e.g., tricyclic antidepressants or neuroleptics) (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol).
• tetracosactide (used to treat Crohn's disease).
• trimethoprim (used to treat infections).
• vasodilators, including nitrates (substances that cause blood vessels to widen).
• medicines used to treat low blood pressure, shock, or asthma (e.g., ephedrine, noradrenaline, or adrenaline).

Taking Perindopril / Indapamide Viso Farmacéutica with food and drink

It is preferable to take Perindopril / Indapamide Viso Farmacéutica before a meal.

Pregnancy and breastfeeding

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

Pregnancy

Inform your doctor if you think you are (or could become) pregnant. Your doctor will advise you to stop taking Perindopril / Indapamide Viso Farmacéutica before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Perindopril / Indapamide Viso Farmacéutica is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used beyond the third month of pregnancy.

Breastfeeding

Perindopril / Indapamide Viso Farmacéutica is not recommended during breastfeeding.

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

Seek medical advice immediately.

Driving and using machines

Perindopril / Indapamide Viso Farmacéutica generally does not affect alertness. However, in some patients, side effects such as dizziness or weakness due to lowered blood pressure may occur. As a result, your ability to drive or operate machinery may be impaired.

Perindopril / Indapamide Viso Farmacéutica contains lactose

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

3. How to take Perindopril / Indapamide Viso Farmacéutica

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 renal impairment. Take the tablet preferably in the morning before eating. Swallow the tablet with a glass of water.

If you take more Perindopril / Indapamide Viso Farmacéutica than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested. The most likely effect in case of overdose is a drop in blood pressure. If a substantial decrease in blood pressure occurs (associated with nausea, vomiting, cramps, dizziness, drowsiness, confusion, changes in the amount of urine produced by the kidneys), lying down with your legs raised may help.

If you forget to take Perindopril / Indapamide Viso Farmacéutica

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

If you stop taking Perindopril / Indapamide Viso Farmacéutica

Since treatment for high blood pressure is usually lifelong, you should 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.

Stop taking the medicine and contact your doctor immediately if you experience any of the following side effects, which may be serious:

• Severe dizziness or fainting due to low blood pressure (Common: may affect up to 1 in 10 people),
• Bronchospasm (tightness in the chest, wheezing, and shortness of breath) (Uncommon) (may affect up to 1 in 100 people),
• Swelling of the face, lips, tongue, or throat, or difficulty breathing (angioedema) (see section 2 “Warnings and precautions”) (Uncommon) (may affect up to 1 in 100 people),
• Severe skin reactions, such as erythema multiforme (a skin rash that often starts with red patches on the face, arms, or legs) or severe rash, hives, widespread redness of the skin, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome), or other allergic reactions (very rare) (may affect up to 1 in 10,000 people),
• Cardiovascular disorders (irregular heartbeat, angina (chest, jaw, and back pain caused by physical exertion), heart attack) (Very rare) (may affect up to 1 in 10,000 people),
• Weakness in arms or legs, or difficulty speaking, which could be a sign of a possible stroke (very rare) (may affect up to 1 in 10,000 people),
• Inflamed pancreas that may cause severe abdominal and back pain accompanied by feeling very unwell (very rare) (may affect up to 1 in 10,000 people),
• Yellowing of the skin or eyes (jaundice), which could be a sign of hepatitis (very rare) (may affect up to 1 in 10,000 people),
• Life-threatening irregular heartbeat (not known), brain disease caused by liver disease (hepatic encephalopathy) (not known).
• 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 (not known).

In decreasing order of frequency, other adverse effects are as follows:

Common (may affect up to 1 in 10 patients):

• Skin reactions in subjects predisposed to allergic and asthmatic reactions, headache, dizziness, vertigo, tingling, tinnitus (sensation of noise in the ears), cough, difficulty breathing (dyspnea), gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or indigestion, diarrhea, constipation), allergic reactions (such as skin rashes, itching), cramps, feeling of fatigue, low blood potassium levels.

Uncommon (may affect up to 1 in 100 patients):

• Mood changes, sleep disorders, urticaria, purpura (red spots on the skin), blisters, kidney problems, impotence (inability to achieve or maintain an erection), sweating, eosinophilia (an increased number of a type of white blood cells), changes in laboratory parameters: high blood potassium levels (reversible upon discontinuation), low blood sodium levels that may cause dehydration and low blood pressure, drowsiness, fainting, palpitations (awareness of heartbeat), tachycardia (rapid heart rate), hypoglycemia (very low blood sugar levels) in diabetic patients, vasculitis (inflammation of blood vessels), dry mouth, photosensitivity reactions (increased skin sensitivity to sunlight), arthralgia (joint pain), myalgia (muscle pain), chest pain, general malaise, peripheral edema, fever, increased blood urea, increased blood creatinine, falls, depression.

Rare (may affect up to 1 in 1,000 patients):

• Worsening of psoriasis, changes in laboratory parameters: increased liver enzyme levels, high serum bilirubin levels, fatigue, low blood chloride levels,
• Low blood magnesium levels,
• Dark urine, malaise (nausea) or vomiting, muscle cramps, confusion, and seizures. These may be symptoms of a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion), decreased or absent urine production, hot flushes, acute renal failure.

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

• Confusion, eosinophilic pneumonia (a rare type of pneumonia), rhinitis (nasal congestion or runny nose), severe kidney problems, changes in blood values such as reduced numbers of white and red blood cells, reduced hemoglobin, reduced platelet count, high blood calcium levels, abnormal liver function.

Frequency not known (frequency cannot be estimated from available data):

• Abnormal ECG heart tracing, changes in laboratory parameters: high levels of uric acid and high blood sugar levels, short-sightedness (myopia), blurred vision, visual disturbances, decreased vision or eye pain due to elevated pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma], discoloration, numbness, and pain in fingers or toes (Raynaud's disease). If you have systemic lupus erythematosus (a type of collagen disease), this could worsen.
• Blood, kidney, liver, or pancreas disorders may occur, along with changes in laboratory test results (blood tests). Your doctor may need to order blood tests to monitor your condition.

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

Reporting of adverse effects

If you experience any type of 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Perindopril / Indapamide Viso Farmacéutica

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

Store in the original container to protect it from moisture.

This medicine does not require any special storage conditions as long as the protective bag remains unopened. After opening, the blisters must be stored in the outer packaging at a temperature below 30 °C. Unused tablets should be discarded 2 months after opening the protective bag.

Do not use this medicine after the expiry date stated on the label, blister, bag, or container, after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Perindopril / Indapamida Viso Farmacéutica 2 mg/0.625 mg tablets

• The active substances are perindopril tert-butylamine and indapamide.

• Each tablet contains 2 mg of perindopril tert-butylamine, equivalent to 1.669 mg of perindopril, and 0.625 mg of indapamide.

• The other components are:

Monohydrate lactose
Magnesium stearate
Colloidal anhydrous silica
Microcrystalline cellulose

Appearance of the medicine and contents of the pack

Perindopril / Indapamida Viso Farmacéutica 2 mg/0.625 mg are capsule-shaped, white tablets, marked with a 'P' to the left and an 'I' to the right of the breakline on one side, and scored on the other side. The tablet can be divided into two equal parts.

The tablets are presented in PVC/PVDC-Aluminum blisters with an aluminum protective pouch, including a desiccant to protect the tablets from moisture. Do not ingest the desiccant.

Pack sizes

2 mg/0.625 mg: 20, 30, 90 and 100 tablets.

*Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH
Industriestr. 31
82194 Gröbenzell
Germany

Manufacturer:

Glenmark Pharmaceuticals S.R.O.
Fibichova 143
56617 Vysoke Myto
Czech Republic

Glenmark Pharmaceuticals Europe Limited
Building 2, Croxley Green Business Park
Croxley Green
Hertfordshire, WD18 8YA
United Kingdom

Further information about this medicine can be requested from the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.
C/ Retama 7, 7th floor
28045 Madrid
Spain

This medicinal product is authorized in the member states of the European Economic Area under the following names:

Italy Perindopril E Indapamide EG 2/0.625mg
Netherlands Perindopril tert-butylamine /Indapamide Glenmark 2/0.625mg Tabletten
Spain Perindopril/Indapamida Viso Farmaceutica 2/0,625 mg comprimidos EFG

Date of the most recent review of this leaflet: October 2022.

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