PERINDOPRIL/INDAPAMIDE TECNIGEN 8mg/2.5mg TABLETS

2. What you need to know before you take Perindopril/Indapamide TecniGen

Do not take Perindopril/Indapamide TecniGen

• if you are allergic to perindopril or any other ACE inhibitor, to indapamide, or to any of the other ingredients of this medicine (listed in section 6),
• if you have experienced symptoms such as wheezing, facial swelling, or intense itching with previous treatment with ACE inhibitors, or if you or a member of your family has 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-lowering medicine that contains aliskiren,
• if you have severe liver disease or suffer from a condition called hepatic encephalopathy (degenerative brain disease),
• if you have severe kidney disease or are on dialysis,
• if you have low or high potassium levels in your blood,
• if you suspect you may have untreated heart failure (severe fluid retention, difficulty breathing),
• if you are pregnant more than 3 months. (It is also recommended to avoid ACE inhibitors during the first months of pregnancy, see pregnancy section)
• if you are breastfeeding.

Warnings and precautions

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

• if you have aortic stenosis (narrowing of the main blood vessel that comes out of the heart) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery that carries blood to the kidney),
• if you have any other heart or kidney problems,
• if you have liver problems,
• if you suffer from a collagen disease (skin disease) 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 have diabetes,
• if you are on a low-salt diet or are using salt substitutes that contain potassium,
• if you are taking lithium or potassium-sparing diuretics (spironolactone, triamterene), as concurrent use with Perindopril/Indapamida should be avoided (see "Use of other medicines").
• if 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), especially if you have kidney problems related to diabetes.
• aliskiren

If you experience a decrease in vision or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and can occur within a few hours to a week after taking perindopril/indapamide.

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/Indapamide TecniGen".

• tell your doctor if you are pregnant (or think you may be). Perindopril/Indapamida TecniGen is not recommended during the first trimester of pregnancy, and in no case should it be administered if you are pregnant more than three months, as it may cause serious harm to your baby when administered from that time on (see pregnancy section)

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

• if you are going to undergo anesthesia and/or surgery,
• if you have recently had diarrhea or vomiting, or are dehydrated,
• if you are going to undergo dialysis or LDL apheresis (removal of cholesterol from your blood by a machine),
• if you are going to receive desensitization treatment to reduce allergic effects to bee or wasp stings,
• if you are going to undergo any medical test that requires the injection of an iodinated contrast agent (a substance that allows organs such as the kidney or stomach to be visible with X-rays).

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

Children and adolescents

Perindopril/Indapamida should not be administered to children.

If you are taking any of the following medicines, the risk of angioedema increases:

• racecadotril (used to treat diarrhea)
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the class called mTOR inhibitors (used to prevent organ rejection in transplants)

Taking Perindopril/Indapamida with other medicines

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

You should avoid taking Perindopril/Indapamida with:

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

Treatment with Perindopril/Indapamida may be affected by other medicines. Your doctor may need to change your dose and/or take other precautions. Make sure to tell your doctor if you are taking any of the following medicines, as you may need special care:

• other medicines for the treatment of high blood pressure, including angiotensin II receptor antagonists (ARA) or aliskiren. (See also the information under the headings "Do not take Perindopril/Indapamida TecniGen" and "Warnings and precautions".
• procainamide (for the treatment of irregular heartbeat),
• allopurinol (for the treatment of gout),
• terfenadine or astemizole (antihistamines for allergic rhinitis or allergies)
• corticosteroids used to treat various disorders including severe asthma and rheumatoid arthritis,
• immunosuppressants used to treat autoimmune disorders or after a transplant to prevent rejection (e.g., cyclosporine),
• cancer treatments,
• erythromycin injection (an antibiotic),
• halofantrine (used to treat some types of malaria),
• pentamidine (used to treat pneumonia),
• vincamine (used to treat cognitive disorders in elderly patients, including memory loss),
• bepridil (used to treat angina pectoris),
• sultopride (for the treatment of psychoses).
• medicines for heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol),
• digoxin or other cardiac glycosides (for the treatment of heart problems),
• baclofen (for the treatment of muscle stiffness that occurs in diseases such as multiple sclerosis),
• medicines for the treatment of diabetes, such as insulin or metformin,
• calcium, including calcium supplements,
• stimulant laxatives (e.g., senna),
• non-steroidal anti-inflammatory drugs (e.g., ibuprofen) or high doses of salicylates (e.g., acetylsalicylic acid),
• amphotericin B injection (for the treatment of severe fungal infections),
• medicines used to treat mental problems such as depression, anxiety, schizophrenia... (e.g., tricyclic antidepressants, neuroleptics),
• tetracosactide (for the treatment of Crohn's disease).
• medicines that are commonly used to treat diarrhea (racecadotril) or to prevent organ rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of mTOR inhibitors). See section "Warnings and precautions".

Taking Perindopril/Indapamida TecniGen with food, drinks, and alcohol

It is preferable to take Perindopril/Indapamida before a meal.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should tell your doctor if you are pregnant or think you may be pregnant.

Your doctor will normally advise you to stop taking Perindopril/Indapamida before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Perindopril/Indapamida.

Perindopril/Indapamida is not recommended during the first trimester of pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken after the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or are planning to breastfeed. Perindopril/Indapamida is contraindicated in breastfeeding mothers, and your doctor may choose another treatment for you if you wish to breastfeed your baby, especially if your baby is newborn or premature.

Consult your doctor immediately.

Driving and using machines

Perindopril/Indapamida usually does not affect alertness, but due to the blood pressure-lowering effect, some patients may notice different reactions such as dizziness or weakness. If this happens to you, your ability to drive or use machines may be impaired.

Perindopril/Indapamida TecniGen contains lactose monohydrate

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

3. How to take Perindopril/Indapamida TecniGen

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. The normal dose is one tablet per day. Your doctor may decide to change the dose if you have kidney problems. Take your tablet preferably in the morning and before breakfast. Swallow the tablet whole with the help of a glass of water.

If you take more Perindopril/Indapamida than you should

If you ingest too many tablets, consult your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. In case of overdose or accidental ingestion, call the Toxicology Information Service, telephone 91 562 04 20, indicating the amount taken.

The most frequent symptom in case of overdose is a decrease in blood pressure. If a significant decrease in blood pressure occurs (symptoms such as dizziness or fainting), it may help to lie down with your legs raised.

If you forget to take Perindopril/Indapamida

It is important to take this medicine every day, as continuous treatment is more effective. However, if you forget to take a dose of Perindopril/Indapamida, take the next dose at the usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Perindopril/Indapamida

Since treatment for high blood pressure is usually for life, you should talk to your doctor before stopping this medicine.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following symptoms, stop taking this medicine immediately and inform your doctor:

• swelling of the face, lips, mouth, tongue, or throat, difficulty breathing,
• severe dizziness or fainting,
• abnormally fast or irregular heartbeats.

In decreasing order of frequency, side effects may include:

• Frequent (affect 1 to 10 users in 100): headache, dizziness, vertigo, tingling, vision changes, tinnitus (ringing in the ears), mild dizziness due to low blood pressure, cough, difficulty breathing, digestive disorders (nausea, vomiting, abdominal pain, taste changes, dry mouth, dyspepsia or difficulty digesting, diarrhea, constipation), allergic reactions (such as skin rash, itching), muscle cramps, feeling tired, low potassium levels in the blood.
• Uncommon (affect 1 to 10 users in 1,000): mood changes, sleep disorders, bronchospasm (chest tightness, wheezing, and difficulty breathing), angioedema (symptoms such as wheezing, facial swelling, or tongue swelling), urticaria, purpura (red spots on the skin), kidney problems, impotence, sweating, depression, low sodium levels in the blood that can cause dehydration and low blood pressure, impotence (inability to have or maintain an erection).

Rare (may affect up to 1 in 1,000 people): worsening of psoriasis, decreased or absent diuresis, facial flushing, acute kidney failure, low chloride levels in the blood, low magnesium levels in the blood.

Concentrated urine, feeling unwell (nausea) or sick (vomiting), muscle cramps, confusion, and convulsions. These symptoms may be due to a condition called SIADH (inappropriate secretion of antidiuretic hormone).

• Very rare (affect less than 1 in 10,000 users): confusion, cardiovascular disorders (irregular heartbeat, angina pectoris, myocardial infarction), eosinophilic pneumonia (a rare type of pneumonia), rhinitis (stuffy or runny nose), severe skin disorders such as erythema multiforme. If you have systemic lupus erythematosus (a type of collagen disease), it may worsen. There have also been reports of photosensitivity reactions (changes in skin appearance) after sun exposure or artificial UVA radiation.
• Frequency not known (cannot be estimated from the available data): fainting, life-threatening irregular heartbeat (Torsade de Pointes), abnormal electrocardiogram, increased liver enzyme levels. Change in color, numbness, and pain in the fingers of the hands or feet (Raynaud's disease). Decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].

Blood, kidney, liver, or pancreas disorders and changes in laboratory test results (blood tests) may occur. Your doctor may need to prescribe blood tests to monitor your condition.

In cases of liver failure (liver problems), there is a possibility of hepatic encephalopathy (degenerative brain disease).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines. Website: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Perindopril/Indapamide TecniGen

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the container after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

6. Container contents and additional information

Composition of Perindopril/Indapamide TecniGen

The active ingredients are perindopril and indapamide. Each tablet contains 8 mg of perindopril terbutylamine (which corresponds to 6.676 mg of perindopril) and 2.5 mg of indapamide.

The other components (excipients) are:

Monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and container contents

Perindopril/Indapamide TecniGen is presented in the form of white, round tablets with a notch on one of their faces.

Each container contains 30 tablets in OPA-ALU blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América.

Polígono Arroyo de la Vega

28108 Alcobendas (Madrid) SPAIN

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande, 2, Abrunheira, 2710 – 089 Sintra

Portugal

or

MEDINFAR MANUFACTURING, S.A.

Parque Industrial Armando Martins Tavares

Rua Outeiro Da Armada, nº 5.

Condeixa-a-Nova, 3150-194. Portugal

Date of the last revision of this prospectus:May 2020.

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