Perindopril/indapamide Tecnigen 2 mg/0.625 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Perindopril/Indapamide Tecnigen 2 mg/0.625 mg tablets EFG

perindopril/indapamide

Read all of this leaflet carefully before you start taking this medicine, because 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, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

Perindopril/Indapamide TecniGen is a combination of two active substances, perindopril and indapamide. It is an antihypertensive medicine indicated for the treatment of high blood pressure (hypertension). Perindopril/Indapamide TecniGen is prescribed for patients who are already receiving perindopril and indapamide in separate tablets. Instead, these patients may receive a single tablet of Perindopril/Indapamide TecniGen containing both ingredients.

Perindopril/Indapamide belongs to a group of medicines known as angiotensin-converting enzyme (ACE) inhibitors. They work by widening 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 the amount of urine formed.

Each of the active substances lowers blood pressure, and together they work in combination to control your blood pressure.

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

Do not take Perindopril/Indapamida TecniGen

• if you are allergic to perindopril, to 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 kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren
• if you have severe liver disease or a condition called hepatic encephalopathy (a degenerative brain disorder)
• if you have severe kidney disease or are undergoing dialysis
• if you have low or high levels of potassium in your blood
• if you suspect you may have untreated decompensated heart failure (severe fluid retention, difficulty breathing)
• if you are more than 3 months pregnant. (It is also advisable to avoid ACE inhibitors during the first months of pregnancy; see pregnancy section)
• if you are breastfeeding

Warnings and precautions

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

• 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 kidney)
• if you have any other heart or kidney problems
• if you have liver problems
• if you have a collagen disease (a 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 have diabetes
• if you are on a low-salt diet or using salt substitutes containing potassium
• if you are taking lithium or potassium-sparing diuretics (spironolactone, triamterene), as concomitant use with Perindopril/Indapamida should be avoided (see "Use with 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), particularly if you have kidney problems related to diabetes
• aliskiren

If you experience a decrease in vision or eye pain, these may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within a few hours to one week after taking perindopril/indapamida.

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/Indapamida TecniGen”.

• inform your doctor if you are pregnant (or suspect you might be). Perindopril/Indapamida TecniGen is not recommended during early pregnancy, and must not be used after the third month of pregnancy, as it may cause severe harm to your baby when used from that stage onward (see pregnancy section)

While taking Perindopril/Indapamida, inform your doctor or healthcare provider:

• if you are scheduled for anesthesia and/or surgery
• if you have recently had diarrhea or vomiting, or are dehydrated
• if you are undergoing dialysis or LDL apheresis (removal of cholesterol from your blood using a machine)
• if you are receiving desensitization treatment to reduce allergic reactions to bee or wasp stings
• if you are scheduled for a medical test requiring injection of an iodinated contrast agent (a substance that makes organs such as the kidney or stomach visible on X-rays)

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

Children and adolescents

Perindopril/Indapamida must not be given 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 known as mTOR inhibitors (used to prevent organ transplant rejection)

Taking Perindopril/Indapamida with other medicines

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

You must 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 adjust your dose and/or take other precautions. Make sure to inform your doctor if you are taking any of the following medicines, as you may require special monitoring:

• other medicines for high blood pressure, including angiotensin II receptor antagonists (ARA) or aliskiren. (See also information under “Do not take Perindopril/Indapamida TecniGen” and “Warnings and precautions”)
• procainamide (for treatment of irregular heart rhythm)
• allopurinol (for treatment of gout)
• terfenadine or astemizole (antihistamines for seasonal allergic rhinitis or allergies)
• corticosteroids used to treat various disorders including severe asthma and rheumatoid arthritis
• immunosuppressants used to treat autoimmune disorders or to prevent transplant rejection (e.g., cyclosporine)
• medicines for cancer treatment
• injectable erythromycin (an antibiotic)
• halofantrine (used to treat certain types of malaria)
• pentamidine (used to treat pneumonia)
• vincamine (used to treat symptomatic cognitive disorders in elderly patients including memory loss)
• bepridil (used to treat angina pectoris)
• sultopride (for treatment of psychoses)
• medicines for heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol)
• digoxin or other cardiac glycosides (for treatment of heart problems)
• baclofen (for treatment of muscle stiffness occurring in diseases such as multiple sclerosis)
• medicines for 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)
• injectable amphotericin B (for treatment of serious fungal infections)
• medicines for mental disorders such as depression, anxiety, schizophrenia... (e.g., tricyclic antidepressants, neuroleptics)
• tetracosactide (for treatment of Crohn's disease)
• medicines frequently used to treat diarrhea (racecadotril) or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you think you are or could become pregnant.

Your doctor will usually advise you to stop taking Perindopril/Indapamida before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.

Perindopril/Indapamida 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 this point.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Perindopril/Indapamida is contraindicated in breastfeeding mothers. Your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

Contact your doctor immediately.

Driving and using machines

Perindopril/Indapamida generally does not affect alertness. However, due to blood pressure lowering, some patients may experience side effects such as dizziness or weakness. If this occurs, your ability to drive or operate machinery may be impaired.

Perindopril/Indapamida TecniGen contains lactose monohydrate

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

3. How to take Perindopril/Indapamide TecniGen

Follow exactly the instructions for using this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. The usual dose is 1 tablet daily. Your doctor may decide to adjust the dose if you have renal impairment. Take your tablet preferably in the morning and before breakfast. Swallow the tablet whole with a glass of water.

If you take more Perindopril/Indapamide than you should

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

The most common symptom in case of overdose is a drop in blood pressure. If a significant decrease in blood pressure occurs (symptoms such as dizziness or fainting), lying down with legs raised may help.

If you forget to take Perindopril/Indapamide

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/Indapamide, 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/Indapamide

Since treatment for high blood pressure is usually lifelong, you must speak with your doctor before stopping this medicine.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

If you experience any of the following symptoms, stop treatment with this medicine immediately and inform your doctor without delay:

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

In decreasing order of frequency, adverse effects may include:

• Frequent (affects between 1 and 10 out of every 100 patients treated): headache, dizziness, vertigo, tingling, visual disturbances, tinnitus (ringing in the ears), mild dizziness due to low blood pressure, cough, difficulty breathing, gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, dry mouth, dyspepsia or difficulty digesting, diarrhea, constipation), allergic reactions (such as skin rashes, itching), muscle cramps, feeling of fatigue, low blood potassium levels.
• Uncommon (affects between 1 and 10 out of every 1,000 patients treated): mood changes, sleep disorders, bronchospasm (chest tightness, wheezing and difficulty breathing), angioedema (symptoms such as wheezing, swelling of the face or tongue), urticaria, purpura (red spots on the skin), kidney problems, impotence, sweating, depression, low blood sodium levels which 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, reduced or absent urine output, facial flushing, acute renal failure, low blood chloride levels, low blood magnesium levels.

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

• Very rare (affects 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 reactions such as erythema multiforme. If you have systemic lupus erythematosus (a type of collagen disease), it may worsen. Cases of photosensitivity reactions (skin changes) following exposure to sunlight or artificial UVA radiation have also been reported.
• Frequency not known (cannot be estimated from available data): collapse, life-threatening irregular heartbeat (Torsade de Pointes), abnormal electrocardiogram, increased levels of liver enzymes. Change in color, numbness and pain in the fingers or toes (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 order blood tests to monitor your condition.

In cases of hepatic impairment (liver problems), there is a possibility of developing hepatic encephalopathy (a degenerative brain disorder).

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines. Website: www.notificaRAM.es.

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

5. Storage of Perindopril/Indapamide TecniGenTECNIGEN

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

Do not use this medicine after the expiry date stated on the blister and packaging following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and additional information

Composition of Perindopril/Indapamide TecniGen tablets

The active substances are perindopril and indapamide. Each tablet contains 2 mg of perindopril tert-butylamine salt, equivalent to 1.669 mg of perindopril; and 0.625 mg of indapamide.

The other components (excipients) are:

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

Appearance of the product and contents of the container

Perindopril/Indapamide TecniGen is presented as white, capsule-shaped tablets, with a groove on both sides; marked with a "-" on both sides of the groove on one face, and smooth on the reverse.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

TECNIMEDE ESPAÑA INDUSTRIA FARMACEUTICA, S.A.

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

28108 Alcobendas, Spain

Manufacturer

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

Date of the most recent review of this leaflet: May 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/