Package Insert: Information for the Patient

Perindopril /Indapamida Viso Pharmaceutical4 mg/1,25mgTablets EFG

perindopril tertbutilamine/indapamide

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

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

Indapamida is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamida differs from other diuretics by only causing a slight increase in urine production.

Each of the active principles reduces blood pressure and acts together with the other to control blood pressure.

No take Perindopril / Indapamida Viso Farmacéutica

• If you are allergic to perindopril or any other ACE inhibitor, to indapamida, 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 sneezing, facial or tongue swelling, intense itching or severe skin eruptions with previous treatments 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 insufficiency and are being treated with a medication to lower blood pressure that contains aliskireno.
• If you have severe liver problems or a condition called hepatic encephalopathy (degenerative brain disease).
• If you have severe kidney insufficiency, where blood supply to the kidneys is reduced (renal artery stenosis).
• If you are receiving 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 heart failure (intense fluid retention, difficulty breathing).
• If you are more than 3 months pregnant. (It is also recommended to avoid Perindopril/Indapamida Viso Farmacéutica in the early 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 / Indapamida Viso Farmacéutica:

• If you have aortic stenosis (narrowing of the main blood vessel that leaves 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 receiving 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 hemorrhage) or increased pressure in your eye, which can occur within hours or weeks of taking Perindopril / Indapamida 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 disease of the connective tissue (skin disease) such as systemic lupus erythematosus or scleroderma.
• If you have atherosclerosis (hardening of the arteries).
• If you have hyperparathyroidism (overfunctioning of the parathyroid gland).
• If you have gout.
• If you are diabetic.
• If you are following a low-sodium diet or using salt substitutes that contain potassium.
• If you are taking lithium or potassium-sparing medications (such as spironolactone or triamterene) or potassium supplements, as simultaneous use with Perindopril / Indapamida Viso Farmacéutica should be avoided (see section "Use of Perindopril / Indapamida Viso Farmacéutica with other medications").
• If you are an elderly person.

• If you have had photosensitivity reactions.
• If you have a severe allergic reaction with facial, lip, mouth, tongue, or throat inflammation 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 - for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
  • Aliskireno.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels (such as potassium) at regular intervals.

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 with high-flow membranes.

• If you are takingany of the following medications, the risk of angioedema may increase:

- Racecadotril (a medication used to treat diarrhea)

-Sacubitrilo (available as a fixed-dose combination with valsartan), used to treat heart failure over a long period

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

You should inform your doctor if you think you are (or could become) pregnant. Perindopril/Indapamida Viso Farmacéutica is not recommended in the early months of pregnancy, and you should not take it if you are more than 3 months pregnant, as it can cause severe harm to your baby if used during that period (see "Pregnancy and breastfeeding").

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

• If you are to receive anesthesia and/or undergo a surgical procedure.
• If you have recently had diarrhea, vomiting, or dehydration.
• If you are to receive 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 bee or wasp stings.
• If you are to undergo a medical test that requires the injection of a contrast medium containing iodine (a substance that makes organs, such as the kidneys or stomach, visible in X-rays).
• If you experience changes in vision or eye pain while taking Perindopril/Indapamida Viso Farmacéutica. This could be a sign of developing glaucoma, increased pressure in your eye(s). You should discontinue treatment with Perindopril/Indapamida Viso Farmacéutica and seek medical attention.

Patients should be aware that Perindopril / Indapamida Viso Farmacéutica contains an active ingredient (indapamida) that can cause 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 Farmacéutica

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

You should avoid taking Perindopril / Indapamida Viso Farmacéutica with:

• Lithium (used to treat mania or depression).
• Aliskireno (a medication used to treat hypertension) if you do not have diabetes mellitus or kidney problems.
• Potassium-sparing diuretics (such as triamtereno, amilorida) or 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; trimetoprima and cotrimoxazol, also known as trimetoprim/sulfametoxazol for bacterial infections),
• Estramustina (used in cancer therapy).
• Other medications used to treat high blood pressure: ACE inhibitors and angiotensin receptor blockers.

The treatment with Perindopril / Indapamida Viso Farmacéutica may be affected by other medications. Your doctor may need to modify 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 require special attention:

• Other medications for the treatment of high blood pressure, including angiotensin II receptor antagonists (ARAs), aliskireno (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).
• Medications that are used frequently to treat diarrhea (racecadotril) or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other medications belonging to the class called mTor inhibitors). See section "Warnings and precautions",
• Sacubitrilo / valsartan (used to treat heart failure over a long period). See sections "Do not take Perindopril/Indapamida Viso Farmacéutica" and "Warnings and precautions".
• Anesthetics,
• Contrast medium containing iodine,
• Antibiotics used to treat bacterial infections (such as moxifloxacina, esparfloxacina, eritromicina inyectable),
• Metadona (used to treat addiction),
• Procainamida (to treat arrhythmia).
• Alopurinol (to treat gout).
• Antihistamines used to treat allergic reactions, such as hay fever (for example, mizolastina, terfenadina, astemizol). Corticosteroids to treat various conditions, such as severe asthma or rheumatoid arthritis.
• Immunosuppressants to treat autoimmune diseases or after a transplant to prevent rejection (e.g., ciclosporina, tacrolimus).
• Halofantrina (to treat certain types of malaria).
• Pentamidina (to treat pneumonia).
• Oro inyectable (to treat rheumatoid arthritis).
• Vincamina (used to treat cognitive symptoms, such as memory loss, in elderly patients).
• Bepridil (to treat angina pectoris).
• Medications used to correct heart rhythm problems (e.g., quinidina, hidroquinidina, disopiramida, amiodarona, sotalol, ibutilida, dofetilida, digitálicos, bretilio).
• Cisaprida, difemanilo (used to treat gastrointestinal and digestive problems)
• Digoxina or other cardiac glycosides (to treat heart problems).
• Baclofeno (to treat muscle stiffness caused by diseases such as multiple sclerosis).
• Medications to treat diabetes, such as insulin, metformina or gliptinas.
• Calcium, such as calcium supplements.
• Laxatives (e.g., sen).

• Nonsteroidal anti-inflammatory drugs (e.g., ibuprofeno) or salicylates in high doses (e.g.,ácido acetilsalicílico (a substance present in many medications used to relieve pain and reduce fever, as well as to prevent blood clotting).

• Amfotericina B in injection (to treat severe fungal infections).
• Medications used to treat psychiatric disorders such as depression, anxiety, or schizophrenia (e.g., tricyclic antidepressants or neuroleptics) (such as amisulpirida, sulpirida, sultoprida, tiaprida, haloperidol, droperidol)).
• Tetracosactida (to treat Crohn's disease).
• Trimetoprim (to treat infections),
• Vasodilators, including nitrates (substances that cause blood vessels to dilate)
• Medications used to treat low blood pressure, shock, or asthma (e.g., efedrina, noradrenalina or adrenalina)

Perindopril / Indapamida Viso Farmacéutica with food and drinks

It is recommended to take Perindopril / Indapamida Viso Farmacéutica before a meal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using any medication.

Pregnancy

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

Your doctor will recommend that you stop taking Perindopril / Indapamida Viso Farmacéutica before becoming pregnant or as soon as you know you are pregnant and will advise you to take another medication instead. Perindopril / Indapamida Viso Farmacéutica is not recommended in the early months of pregnancy and should not be taken when more than three months pregnant, as it can cause severe harm to your baby if taken after the third month of pregnancy.

Breastfeeding

Perindopril / Indapamida Viso Farmacéutica is not recommendedif you are breastfeeding.

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

Go to your doctor immediately

Driving and operating 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 decreased 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 indicated that you have a lactose intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication 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 modify the dose if you have kidney insufficiency. Take the tablet as possible 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. The most probable 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 legs elevated may help.

If you forgot to take Perindopril / Indapamida Viso Farmacéutica

It is essential to take your medication every day, as regular treatment is more effective. However, if you forget to take one tablet of perindopril / indapamida, take the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Perindopril / Indapamida Viso Farmacéutica

Since high blood pressure treatment is generally lifelong, you should consult your doctor before interrupting treatment with this medication.

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

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

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

• Intense 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, angina pectoris (chest pain, jaw pain, and back pain caused by physical exertion), heart attack) (Very rare) (may affect up to 1 in 10,000 people),
• Weakness in the 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 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 (Unknown),
• Brain disease caused by liver disease (hepatic encephalopathy) (Unknown).
• 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).

In decreasing order of frequency, other side 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 difficulty digesting, diarrhea, constipation), allergic reactions (such as skin rashes, itching), muscle cramps, feeling tired, low potassium levels in the blood.

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 have or maintain an erection), sweating, eosinophilia (a type of white blood cell), changes in laboratory parameters: reversible high potassium levels in the blood, low sodium levels in the blood that may cause dehydration and low blood pressure, somnolence, fainting, palpitations (awareness of heartbeats), tachycardia (rapid heart rate), 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, general discomfort, peripheral edema, fever, increased urea in the blood, increased creatinine in the blood, fall, depression.

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

• Worsening of psoriasis,changes in laboratory parameters: increased levels of liver enzymes, high serum bilirubin levels,fatigue.
  low chloride levels in the blood,
• low magnesium levels in the blood,

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(the frequency cannot be estimated from the available data)

• Abnormal ECG tracing, changes in laboratory parameters: high uric acid levels and high blood sugar levels, nearsightedness, blurred vision, 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],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 could worsen.
• Blood, kidney, liver, or pancreas disorders 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 adverse reactions

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

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

For2 mg/0.625 mg and 4 mg/1.25 mg tablets: PVC / PVdC-Aluminum blisters:

Store in the original packaging to protect it from moisture.

This medication does not require special storage conditions as long as the protective bag remains unopened. Once opened, the blisters must be stored in the outer packaging below 30°C. Unused tablets must be discarded 2 months after opening the protective bag.

For4 mg/1.25 mg tablets: Aluminum-Aluminum blisters:

Store in the original packaging to protect it from moisture. Store below 30°C.

Do not use this medication after the expiration date that appears on the label, blister, bag, or packaging, after CAD. The expiration date is the last day of the month indicated.

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

Composition of Perindopril / Indapamida Viso Pharmaceutical 4 mg/1.25 mg tablets

Appearance of the product and contents of the package

Perindopril / Indapamida Viso Pharmaceutical 4 mg/1.25 mg are white tablets, in capsule shape, marked with “PI” on one face and smooth on the other.

For 2 mg/0.625 mg and 4 mg/1.25 mg tablets: PVC / PVdC-Aluminum blisters:

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.

For 4 mg/1.25 mg tablets: Aluminum-Aluminum blisters:

The tablets are presented in Aluminum-Aluminum blisters in a cardboard box.

Package sizes

4 mg/1.25 mg: 30, 90, and 100 tablets.

*Some package sizes may only be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Responsible 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 medication by contacting the local representative of the marketing authorization holder:

Viso 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 with the following names:

ItalyPerindopril E Indapamide EG 4/1.25mg

NetherlandsPerindopril tert-butylamine /Indapamide Glenmark 4/1.25mg Tabletten

SpainPerindopril/Indapamida Viso Farmaceutica 4/1,25 mg tablets EFG

Last review date of this leaflet:May 2024

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