Perindopril/indapamide Tecnigen 4 mg/1.25 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Perindopril/Indapamide TecniGen 4 mg/1.25 mg tablets EFG

perindopril/indapamide

Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further 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, since it could 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.

Leaflet Contents:

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 and is indicated for the treatment of high blood pressure (hypertension). Perindopril/Indapamide TecniGen is prescribed for patients who are already receiving perindopril and indapamide as 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 ACE inhibitors (angiotensin-converting enzyme inhibitors). They work by widening the 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 Perindopril/Indapamide TecniGen

Do not take Perindopril/Indapamide TecniGen

• if you are allergic to perindopril, to any other ACE inhibitor, to indapamide, to any other sulfonamide, or to any of the other components of this medicine (listed in section 6)
• if you have experienced symptoms such as wheezing, facial or tongue swelling, severe itching, or serious skin rashes during previous 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 impairment 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, breathing difficulty)
• 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 to take Perindopril/Indapamide 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 vascular disease (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/Indapamide must 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 hours to one 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”.

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

When taking Perindopril/Indapamide, inform your doctor or healthcare provider:

• if you are undergoing 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 undergoing any medical test requiring injection of an iodinated contrast agent (a substance that makes organs such as the kidney or stomach visible on X-ray)

Athletes should be aware that Perindopril/Indapamide contains an active substance (indapamide) that may lead to a positive doping test.

Children and adolescents

Perindopril/Indapamide 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 called mTOR inhibitors (used to prevent organ transplant rejection)

Taking Perindopril/Indapamide 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/Indapamide with:

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

Treatment with Perindopril/Indapamide may be affected by other medicines. Your doctor may need to adjust your dose and/or take other precautions. Be sure to inform your doctor if you are taking any of the following medicines, as you may require special monitoring:

• other medicines for treating high blood pressure, including angiotensin II receptor antagonists (ARA) or aliskiren. (See also information under the headings “Do not take Perindopril/Indapamide TecniGen” and “Warnings and precautions”)
• procainamide (for treating irregular heart rhythm)
• allopurinol (for treating 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)
• cancer treatment medicines
• 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 treating psychosis)
• medicines for heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol)
• digoxin or other cardiac glycosides (for treating heart problems)
• baclofen (for treating muscle stiffness occurring in diseases such as multiple sclerosis)
• medicines for treating 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 treating serious fungal infections)
• medicines for treating mental disorders such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants, neuroleptics)
• tetracosactide (for treating 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/Indapamide TecniGen with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

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

Perindopril/Indapamide 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 plan to breastfeed. Perindopril/Indapamide 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.

Consult your doctor immediately.

Driving and using machines

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

Perindopril/Indapamide 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 administration instructions for 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 decrease in blood pressure. If a significant drop in blood pressure occurs (symptoms such as dizziness or fainting), lying down with your legs elevated 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 your next dose at the usual time. Do not take a double dose to make up for the missed 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, breathing difficulty,
• severe dizziness or fainting,
• abnormally rapid or irregular heartbeats.

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 (sensation of 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 every 1,000 people): worsening of psoriasis, decreased 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 (inappropriate antidiuretic hormone secretion).

• Very rare (affects fewer than 1 in every 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 liver enzyme levels. Change in color, numbness and pain in fingers or toes (Raynaud's disease). Decreased vision or eye pain due to elevated 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 type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through 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 TecniGen

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and outer 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 or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Perindopril/Indapamide TecniGen tablets

The active substances are perindopril and indapamide. Each tablet contains 4 mg of perindopril tert-butylamine salt, equivalent to 3.338 mg of perindopril, and 1.25 mg of indapamide.

The other components (excipients) are:

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

Appearance of the product and contents of the pack

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 FARMACÉUTICA, S.A.
Avda. de Bruselas, 13, 3º D.Edificio América. Polígono Arroyo de la Vega,
28108 Alcobendas, Spain

Manufacturer:

ATLANTIC PHARMA PRODUÇOES FARMACÊUTICAS, 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 revision 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/