Prospecto: information for the user

Perindopril/Indapamida TecniGen 4 mg/1.25 mg tablets EFG

perindopril/indapamida

Read this prospect carefully before starting to take the medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed only for you and should not be given 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 or nurse, even if they are not listed in this prospect. See section 4.

1. What is Perindopril/Indapamida TecniGen and how it is used

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

3. How to take Perindopril/Indapamida TecniGen

4. Possible adverse effects

5. Storage of Perindopril/Indapamida TecniGen

6. Contents of the package and additional information

Perindopril/Indapamida TecniGen is an association of two active principles, perindopril and indapamida. It is an antihypertensive and is indicated for the treatment of high blood pressure (hypertension). Perindopril/Indapamida TecniGen is prescribed to patients who are already receiving perindopril and indapamida in separate tablets. Instead, these patients can receive a tablet of Perindopril/Indapamida TecniGen that contains both ingredients.

Perindopril/Indapamida belongs to the group of medications called angiotensin-converting enzyme (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 is different from other diuretics, as it only produces a slight increase in the amount of urine formed.

Each of the active principles reduces blood pressure and acts in conjunction to control blood pressure.

Do not take Perindopril/IndapamidaTecniGen

- if you are allergic to perindopril, any other ACE inhibitor, indapamide, or any other sulfonamide, or any of the other ingredients of this medication (listed in section 6).

- if you have experienced symptoms such as wheezing, facial or tongue swelling, intense itching, or severe skin rashes with previous treatment 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 blood pressure medication that contains aliskiren.

- if you have a severe liver disease or suffer from a condition called hepatic encephalopathy (degenerative brain disease),

- if you have a severe kidney disease or are receiving dialysis,

- if you have low or high levels of potassium in your blood,

- if you suspect that you may have untreated heart failure (severe fluid retention, difficulty breathing),

-if you are more than 3 months pregnant. (It is also recommended to avoid ACE inhibitors during the first months of pregnancy, see the pregnancy section)

- if you are breastfeeding.

Warnings and precautions

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

- if you have aortic stenosis (narrowing of the main blood vessel that leaves 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 following a low-sodium diet or using salt substitutes that contain potassium,

- if you are taking lithium or potassium-sparing diuretics (espironolactone, triamterene), as simultaneous use with Perindopril/Indapamida should be avoided (see "Use of other medications").

-if you are taking any of the following medications used to treat high blood pressure (hypertension):

-an angiotensin II receptor antagonist (ARA) (also known as "sartanes" - for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.

-aliskirén

If you experience a decrease in vision or eye pain, it may be a symptom of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or an increase in eye pressure, which can occur within a few hours to a week after taking perindopril/indapamida.

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 TecniGen".

-Inform your doctor if you are pregnant (or if you suspect that you may be). Perindopril/Indapamida TecniGen is not recommended for use at the beginning of pregnancy, and in no case should it be administered if you are more than three months pregnant, as it may cause serious harm to your baby when administered from that point on (see the pregnancy section)

When taking Perindopril/Indapamida, inform your doctor or healthcare staff:

- if you are about to undergo anesthesia and/or surgery,

- if you have recently experienced diarrhea or vomiting, or are dehydrated,

- if you are about to undergo dialysis or LDL apheresis (removal of cholesterol from your blood using a machine),

- if you are about to receive a desensitization treatment to reduce the effects of bee or wasp stings,

- if you are about 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 cause 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 medications, the risk of angioedema increases:

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

Perindopril/Indapamida with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

You should avoid taking Perindopril/Indapamida with:

- lithium (used to treat depression),

- potassium-sparing diuretics (espironolactone, triamterene), potassium salts.

The treatment with Perindopril/Indapamida may be affected by other medications. Your doctor may need to modify your dose and/or take other precautions. Make sure to inform your doctor if you are taking any of the following medications, as you may require special care:

- other medications for the treatment of high blood pressure, including angiotensin II receptor antagonists (ARA) or aliskirén. (See also the information under the headings "Do not take Perindopril/Indapamida TecniGen" and "Warnings and precautions".

- procainamide (for the treatment of irregular heart rhythm),

- allopurinol (for the treatment of gout),

- terfenadine or astemizol (antihistamines for seasonal allergic rhinitis or allergies)

- corticosteroids used to treat various conditions, including severe asthma and rheumatoid arthritis,

- immunosuppressants used to treat autoimmune disorders or after an organ transplant to prevent rejection (e.g., ciclosporin),

- medications for the treatment of cancer,

- injectable erythromycin (an antibiotic),

- halofantrine (used to treat certain types of malaria),

- pentamidine (used to treat pneumonia),

- vincamine (used to treat cognitive symptoms in elderly patients, including memory loss),

- bepridil (used to treat angina pectoris),

- sultoprida (for the treatment of psychosis).

- medications for arrhythmia 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),

- medications for the treatment of diabetes, such as insulin or metformin,

- calcium, including calcium supplements,

- laxatives (e.g., sena),

- nonsteroidal anti-inflammatory drugs (e.g., ibuprofen) or high doses of salicylates (e.g., acetylsalicylic acid),

- injectable amphotericin B (for the treatment of severe fungal diseases),

- medications for mental disorders, such as depression, anxiety, or schizophrenia (e.g., tricyclic antidepressants, neuroleptics),

- tetracosactide (for the treatment of Crohn's disease).

- medications that are frequently 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 the section "Warnings and precautions"

Perindopril/Indapamida TecniGen with food, drinks, and alcohol

It is recommended to take Perindopril/Indapamida before a meal

Perindopril/Indapamida TecniGen contains lactose monohydrate

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

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

If you take more Perindopril/Indapamida than you should

If you ingest too many tablets, consult immediately with your doctor or pharmacist or go to the emergency department of your nearest hospital. In case of overdose or accidental ingestion, call the Toxicological Information Service, phone 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 elevated.

If you forgot to take Perindopril/Indapamida

It is essential to take this medication every day since continuous treatment is more effective. However, if you forgot to take a dose of Perindopril/Indapamida, take the next dose at the usual time. Do not take a double dose to compensate for the missed dose.

If you interrupt the treatment with Perindopril/Indapamida

Since hypertension treatment is usually lifelong, you should talk to your doctor before stopping this medication.

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

Like all medicines, thismedicinecan cause side effects, although not everyone will experience them.

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

- facial swelling, lip, mouth, tongue, or throat inflammation, difficulty breathing,

-severe dizziness or fainting,

-abnormally fast or irregular heartbeats.

In decreasing order of frequency, side effects may include:

-Frequent (affecting between 1 and 10 out of every 100 patients treated): headache, dizziness, vertigo, numbness, visual disturbances, tinnitus (sensation of noise in the ears), mild dizziness due to low blood pressure, cough, difficulty breathing, gastrointestinal disturbances (nausea, vomiting, abdominal pain, altered taste, dry mouth, dyspepsia or difficulty digesting, diarrhea, constipation), allergic reactions (such as skin rashes, itching), muscle cramps, feeling tired, low potassium levels in the blood.

-Less frequent (affecting between 1 and 10 out of every 1,000 patients treated): mood changes, sleep disturbances, bronchospasm (chest tightness, wheezing, and difficulty breathing), angioedema (symptoms such as wheezing, facial or tongue inflammation), urticaria, purpura (red spots on the skin), kidney problems, impotence, sweating, depression, low sodium levels in the blood that may cause dehydration and low blood pressure, impotence (inability to achieve or maintain an erection).

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

Concentrated urine, feeling unwell (nausea) or vomiting, muscle cramps, confusion, and seizures. These symptoms may be a condition called SIADH (inadequate secretion of antidiuretic hormone).

-Very rare (affecting fewer than 1 in 10,000 patients treated): confusion, cardiovascular disorders (irregular heartbeat, angina, myocardial infarction), eosinophilic pneumonia (a rare type of pneumonia), rhinitis (stuffy or runny nose), severe skin changes such as erythema multiforme. If you have systemic lupus erythematosus (a type of collagen disease), it may worsen. Cases of photosensitivity reactions (skin changes) after exposure to sunlight or artificial UVA radiation have also been described.
-Frequency not known (cannot be estimated from available data):fainting, irregular heartbeat with life-threatening risk (Torsade de Pointes),abnormal electrocardiogram, elevated liver enzymes.Change in color, numbness, and pain in the fingers or toes (Raynaud's disease).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].

Abnormal blood test results, kidney, liver, or pancreas problems, and changes in blood test results 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 developing hepatic encephalopathy (degenerative brain disease).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use. Website:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Perindopril/Indapamida TecniGen tablets

The active principles are perindopril and indapamida. Each tablet contains 4 mg of perindopril terbutilaminate salt, equivalent to 3,338 mg of perindopril; and 1.25 mg of indapamida.

The other components (excipients) are:

Lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and content of the packaging

Perindopril/Indapamida TECNIGEN is presented in the form of white tablets, in capsule shape, with a groove on both sides; engraved with a “-”on both sides of the groove, on one of the faces and smooth on the back.

Each package contains 30 tablets in PA-ALU-PVC/ALU blisters.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

TECNIMEDE ESPAÑA INDUSTRIA FARMACEUTICA, S.A.

Avda. de Bruselas, 13, 3rd D.Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas, Spain

Responsible for manufacturing:

ATLANTIC PHARMA PRODUÇOES FARMACEUTICAS, S.A.

Rua da Tapada Grande 2

Abrunheira, Sintra - Portugal

or

MEDINFAR MANUFACTURING, S.A.

Parque Industrial Armando Martins Tavares

Rua Outeiro Da Armada, nº 5.

Condeixa-a-Nova, 3150-194. Portugal

Last review date of this leaflet: May 2020

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