PERINDOPRIL/INDAPAMIDE VISO FARMACEUTICA 2 mg/0.625 mg TABLETS

Introduction

Patient Information Leaflet

Perindopril / Indapamide Viso Farmacéutica 2 mg/0.625 mg film-coated tablets EFG

perindopril tert-butylamine / indapamide

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Perindopril / Indapamide Viso Farmacéutica and what is it 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. Storage of Perindopril / Indapamide Viso Farmacéutica
6. Package contents and additional information

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

Perindopril / Indapamide Viso Farmacéutica is a combination of two active substances, perindopril and indapamide. It is an antihypertensive, and it is used to treat high blood pressure in adults.

Perindopril belongs to a group of medications called ACE inhibitors. They work by widening the blood vessels, making it easier for your heart to pump blood through them.

Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics in that it only causes a slight increase in urine production.

Each of the active substances reduces blood pressure and works together 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 medication (listed in section 6).
• if you have experienced symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rash with previous treatments with ACE inhibitors, or if you or a family member have had these symptoms in any other circumstance (a disorder called angioedema).
• if you have diabetes or kidney problems and are being treated with a blood pressure medication that contains aliskiren
• if you have severe liver problems or a disease called hepatic encephalopathy (degenerative brain disease).
• if you have severe kidney problems, where blood flow to the kidneys is reduced (renal artery stenosis),
• if you are undergoing dialysis, or any other type of blood filtration. Depending on the machine used, Perindopril/Indapamida Viso Farmacéutica may not be suitable for you,
• if you have low potassium levels in your blood,
• if you suspect you have untreated, decompensated heart failure (severe fluid retention, difficulty breathing).
• if you are pregnant for more than 3 months. (It is also preferable to avoid Perindopril/Indapamida Viso Farmacéutica in the first months of pregnancy, see "Pregnancy and breastfeeding").
• if you have taken or are currently taking sacubitril/valsartan, a medication for heart failure, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Perindopril / Indapamide Viso Farmacéutica:

• if you have aortic stenosis (narrowing of the main blood vessel that comes out of the heart), hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery that carries blood to the kidneys),
• if you have heart failure and other heart problems
• if you have kidney problems or are undergoing dialysis

• if you experience a decrease in vision or eye pain. These could 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 to weeks after taking Perindopril / Indapamide Viso Farmacéutica. If left untreated, this can lead to permanent vision loss. If you have previously had an 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 have a connective tissue disease (skin disease) such as systemic lupus erythematosus or scleroderma,
• if you have atherosclerosis (hardening of the arteries),
• if you have hyperparathyroidism (overactive parathyroid gland),
• if you have gout,
• if you are diabetic,
• if you follow a low-salt diet or are using salt substitutes that contain potassium,
• if you take lithium or potassium-sparing medications (such as spironolactone or triamterene) or potassium supplements, as concurrent use with Perindopril / Indapamida Viso Farmacéutica should be avoided (see section "Using Perindopril / Indapamida Viso Farmacéutica with other medications").
• if you are elderly,
• if you have had photosensitivity reactions
• if you have a severe allergic reaction with inflammation of the face, lips, mouth, tongue, or throat that can cause difficulty swallowing or breathing (angioedema). This can occur at any time during treatment. If you develop these symptoms, discontinue treatment and contact your doctor immediately.
• if you are taking any of the following medications used to treat high blood pressure:
• • an "angiotensin II receptor antagonist" (ARA) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), particularly if you have diabetic kidney problems.
  • Aliskiren.

May need to have your kidney function, blood pressure, and blood electrolyte levels (such as potassium) checked regularly by your doctor. See also the information under the heading "Do not take Perindopril / Indapamida Viso Farmacéutica"

• if you are of black origin, as you may be at higher risk of angioedema and this medication may be less effective in lowering your blood pressure than in non-black patients
• if you are a hemodialysis patient dialyzed with high-flux membranes

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

• racecadotril (a medication used to treat diarrhea)

-sirolimus, everolimus, temsirolimus, and other medications 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 long-term heart failure
  • linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medications belonging to the class of gliptins (used to treat diabetes).

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

You should inform your doctor if you think you are (or might become) pregnant. Perindopril/Indapamida Viso Farmacéutica is not recommended at the start of pregnancy, and you should not take it if you are pregnant for more than 3 months, as it may cause serious harm to your baby if used during this period (see "Pregnancy and breastfeeding").

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

• if you need to receive anesthesia and/or undergo surgery.
• if you have recently had diarrhea, vomiting, or dehydration.
• if you need to undergo dialysis or LDL apheresis (which is the removal of 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 to undergo a medical test that requires the injection of an iodinated contrast medium (a substance that makes organs, such as the kidneys or stomach, visible on X-rays).
• if you experience changes in your vision or pain in one or both eyes while taking Perindopril/Indapamida Viso Farmacéutica, this could be a sign that you are developing glaucoma, an increase in pressure in your eye(s). You should discontinue treatment with Perindopril/Indapamida Viso Farmacéutica and seek medical attention.

Athletes should be aware that Perindopril / Indapamida Viso Farmacéutica contains an active ingredient (indapamide) that may give a positive result in doping tests.

Children and adolescents

Perindopril / Indapamida Viso Farmacéutica should not be administered to children and adolescents.

Other medications and Perindopril / Indapamida Viso FarmacéuticaInform your doctor or pharmacist if you are using, have recently used, or might need to use any other medication.

You should avoid taking Perindopril / Indapamida Viso Farmacéutica with:

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

Treatment with Perindopril / Indapamida Viso Farmacéutica may be affected by other medications. Your doctor may need to adjust your dose and/or take other precautions. If you are taking any of the following medications, make sure to inform your doctor, as you may need special attention:

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

Taking Perindopril / Indapamida Viso Farmacéutica with food and drinks

It is preferable to take Perindopril / Indapamida 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 medication.

Pregnancy

You should inform your doctor if you think you are (or might become) pregnant. Your doctor will advise you to stop taking Perindopril / Indapamida Viso Farmacéutica before becoming pregnant or as soon as you know you are pregnant and will recommend taking another medication instead. Perindopril / Indapamida Viso Farmacéutica is not recommended at the start of pregnancy and should not be taken when pregnant for more than three months, as it may cause serious harm to your baby if taken after the third month of pregnancy.

Breastfeeding

Perindopril / Indapamida Viso Farmacéutica is not recommended if you are breastfeeding.

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

Go to your doctor immediately

Driving and using machines

Perindopril / Indapamida Viso Farmacéutica generally does not affect alertness, however, in certain patients, different reactions such as dizziness or weakness may occur due to the decrease in blood pressure. As a result, the ability to drive or operate machines may be impaired.

Perindopril / Indapamida Viso Farmacéutica contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Perindopril / Indapamida Viso Farmacéutica

Follow the instructions for administration of this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet once a day. 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 / Indapamida Viso Farmacéutica than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 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 significant drop in blood pressure occurs (associated with nausea, vomiting, cramps, dizziness, drowsiness, mental 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 / Indapamida Viso Farmacéutica

It is important that you take your medication every day, as regular treatment is more effective. However, if you forget to take a tablet 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 treatment with Perindopril / Indapamida Viso Farmacéutica

Since treatment for high blood pressure is generally for life, you should consult your doctor before stopping treatment with this medication.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

• Severe dizziness or fainting due to low blood pressure (Common: may affect up to 1 in 10 people),
• Bronchospasm (chest tightness, 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 intense skin rash, hives, redness of the skin all over the body, severe itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome) or other allergic reactions (very rare) (may affect up to 1 in 10,000 people),
• Cardiovascular disorders (irregular heartbeat, chest pain (pain in the chest, jaw, and back caused by physical exertion), heart attack) (Very rare) (may affect up to 1 in 10,000 people),
• Weakness in the arms or legs, or problems speaking, which could be a sign of a possible stroke (very rare) (may affect up to 1 in 10,000 people),
• Inflamed pancreas that can 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, sensitivity, or muscle pain, especially if you feel unwell or have a high temperature, as they may be caused by abnormal muscle breakdown (not known).

In decreasing order of frequency, other adverse effects are the following:

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

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

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

• Mood changes, sleep disorders, hives, purpura (red spots on the skin), blisters, kidney problems, impotence (inability to have or maintain an erection), sweating, high levels of eosinophils (a type of white blood cell), changes in laboratory parameters: high blood potassium levels reversible upon interruption, low sodium levels in the blood that can cause dehydration and low blood pressure, drowsiness, fainting, palpitations (awareness of heartbeats), 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 the sun), 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 bilirubin levels, fatigue, low chloride levels in the blood,

• low magnesium levels in the blood,
• dark urine, discomfort (nausea) or vomiting, muscle cramps, confusion, and convulsions. These may be symptoms of a condition called SIADH (inadequate secretion of antidiuretic hormone), decreased or absent urine production, shortness of breath, acute kidney 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 a lower number of white and red blood cells, lower hemoglobin, lower platelet count, high calcium levels in the blood, abnormal liver function.

Frequency Not Known(frequency cannot be estimated from available data)

• Abnormal ECG heart tracing, changes in laboratory parameters: high uric acid levels and high blood sugar levels, short-sightedness (myopia), 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 effusion) or acute angle-closure glaucoma], discoloration, 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), this may worsen.
• Blood, kidney, liver, or pancreas disorders and changes in analytical results (blood tests) may appear. 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 Adverse Effects

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

5. Storage of Perindopril / Indapamida Viso Farmacéutica

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

Store in the original package to protect it from moisture.

This medicine does not require any special storage conditions as long as the protective bag remains unopened. Once opened, the blisters should 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 expiration date stated on the label, blister, bag, or packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

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

• The active ingredients 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:

Lactose monohydrate

Magnesium stearate

Hydrophobic colloidal silica

Microcrystalline cellulose

Product Appearance and Package Contents

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

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

Package Sizes

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

*Some package sizes may only be marketed.

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

You can request more information about this medicine by contacting the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This pharmaceutical 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 Last Revision of this Prospectus:October 2022.

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