Leaflet: information for the user

Perindopril TecniGen 4 mg tablets EFG

Perindopril

Read 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, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Perindopril TecniGen

3. How to take Perindopril TecniGen

4. Possible side effects

5. Storage of Perindopril TecniGen

6. Contents of the pack and additional information

Perindopril TecniGenis an angiotensin-converting enzyme inhibitor (ACE inhibitor). It works by widening blood vessels, making it easier for the heart to pump blood through them.

Perindopril TecniGenis used for:

• treat high blood pressure (hypertension),
• reduce the risk of cardiac events, such as heart attacks, in patients withstable coronary artery disease(a disease in which blood supply to the heart is reduced or blocked) who have already had a heart attack and/or a procedure to improve blood supply to the heart by widening the blood vessels that supply it.

Do not take Perindopril TecniGen:

- if you are allergic to the active ingredient or to any other ACE inhibitor, or to any of the other components of this medication included in section 6.

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

- if you have experienced symptoms such as wheezing, facial, tongue or throat inflammation, intense itching or severe skin eruptions with any 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 failure and are being treated with a blood pressure medication that contains aliskiren.

Warnings and precautions:

Consult your doctor, pharmacist or nurse before starting to take Perindopril 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 kidneys),
• if you have any other heart problems,
• if you have liver problems,
• if you have kidney failure or if you are on dialysis,
• if you have a vascular disease of the collagen (connective tissue disease) such as systemic lupus erythematosus or scleroderma,
• if you have diabetes,
• if you are on a low-sodium diet or use salt substitutes that contain potassium,
• if you are about to undergo anesthesia and/or major surgery,
• if you are about to undergo LDL apheresis (a procedure that removes cholesterol from your blood using a machine),
• if you are about to receive desensitization treatment to reduce the effects of an allergy to bee or wasp stings,
• if you have recently had diarrhea or vomiting, or are dehydrated,
• if your doctor has told you that you have intolerance to some sugars,
• inform your doctor if you are pregnant (or if you suspect you may be). Perindopril is not recommended to be used at the beginning of pregnancy, and in any case, should not be administered if you are more than three months pregnant, as it may cause serious harm to your baby when administered from that point onwards (see pregnancy section)

• 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.
• aliskiren

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

See also the information under the heading “Do not take Perindopril TecniGen”.

Perindopril TecniGen is not recommended for use in children and adolescents.

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 called mTOR inhibitors (used to prevent rejection in organ transplant)

Use of Perindopril TecniGen with other medications

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

The treatment with Perindopril TecniGen may be affected by other medications. Your doctor may need to modify your dose and/or take other precautions. These include:

• other medications for high blood pressure, includingangiotensin II receptor antagonists (ARA) or aliskirén. (See also the information under the headings “Do not take Perindopril TecniGen” and “Warnings and precautions”, ordiuretics (medications that increase the amount of urine produced by the kidneys),
• diuretics that spare potassium (espironolactona, triamtereno, amilorida), potassium supplements or salt substitutes that contain potassium,
• lithium for mania or depression,
• non-steroidal anti-inflammatory medications (e.g. ibuprofen) for pain treatment or high doses of acetylsalicylic acid,
• medications to treat diabetes (such as insulin or metformin),
• medications to treat mental disorders such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotics),
• immunosuppressants (medications that reduce the body's defense mechanism) used to treat autoimmune disorders or after a transplant (e.g. ciclosporina),
• alopurinol (for gout treatment),
• procainamide (for irregular heartbeats treatment),
• vasodilators including nitrates (medications that produce the widening of blood vessels),
• heparin (medications used to thin the blood),
• medications used to treat low blood pressure, shock or asthma (e.g. efedrina, noradrenalina or adrenalina).
• medicationsthat are frequently used to treat diarrhea (racecadotril) or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus and other medications belonging to the group of mTOR inhibitors). See section “Warnings and precautions”

Perindopril TecniGen with food, drinks and alcohol

It is recommended to take Perindopril TecniGen before a meal.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you suspect you may be pregnant, consult your doctor or pharmacist before using this medication..

Pregnancy

You should inform your doctor if you are pregnant (or if you suspect you may be). Your doctor will usually recommend that you stop takingperindoprilbefore becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead ofperindopril. Perindopril is not recommended to be used at the beginning of pregnancy, and in any case, should not be administered from the third month of pregnancy onwards as it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or are about to start. Perindopril is not recommended to be used during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and operating machinery

perindoprildoes not affect alertness, but due to the lowering of blood pressure, some patients may experience different reactions such as dizziness or weakness. If this occurs, your ability to drive or operate machinery may be impaired.

Perindopril TecniGen contains lactose

If your doctor has told you that you have 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 doubt, consult your doctor or pharmacist again. Swallow the tablet with the help of a glass of water, preferably at the same time every day, in the morning, before breakfast. Your doctor will decide on the correct dose for you.

The usual doses are as follows:

Hypertension The initial and maintenance dose is usually 4 mg per day. If necessary, after one month of treatment, your doctor may increase the dose to 8 mg per day. The maximum recommended dose for hypertension is 8 mg per day.

If you are 65 years or older, the initial dose is usually 2 mg per day. If necessary, after one month of treatment, your doctor may increase the dose to 4 mg per day, and if necessary up to 8 mg per day.

Stable coronary disease The initial dose is usually 4 mg per day. If necessary, after two weeks of treatment, your doctor may increase the dose to 8 mg per day, which is the maximum recommended dose for this indication.

If you are 65 years or older, the initial dose is usually 2 mg per day. If necessary, after one week of treatment, your doctor may increase the dose to 5 mg per day, and if necessary, one week later, it may be increased up to 8 mg per day.

If you take more Perindopril TecniGen than you should

If you have taken more tablets of Perindopril TecniGen than you should, contact your doctor immediately or call the Toxicological Information Service, phone 91-562 04 20.

The most common symptom in case of overdose is a decrease in blood pressure with possible symptoms of dizziness or fainting. If this occurs, you can help by lying down with your legs elevated.

If you forget to take Perindopril TecniGen

It is essential to take this medication every day since continuous treatment is more effective. However, if you forget to take a dose of Perindopril TecniGen , 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 TecniGen

Since treatment with Perindopril TecniGen will usually be 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, this medicine can have side effects, although not everyone will experience them.

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

• inflammation of the face, lips, mouth, tongue, or throat, difficulty breathing,
• intense dizziness or fainting,
• abnormally fast or irregular heartbeat.

In decreasing order of frequency, these side effects may include:

• Frequent (occur in fewer than 1 in 10 patients but more than 1 in 100 patients): 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, dyspepsia or difficulty digesting, diarrhea, constipation), allergic reactions (such as skin rashes, itching), muscle cramps, feeling of fatigue,
• Infrequent (occur in fewer than 1 in 100 patients but more than 1 in 1,000 patients): mood changes, sleep disturbances, bronchospasm (chest tightness, wheezing, and difficulty breathing), dry mouth, angioedema (symptoms such as wheezing, inflammation of the face, tongue, or throat, intense itching, or severe skin rashes), kidney problems, impotence, sweating, depression
• Rare (may affect up to 1 in 1,000 people): worsening of psoriasis, decreased or absent urine production, facial flushing, acute renal insufficiency.

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

• Very rare (occur in fewer than 1 in 10,000 patients): confusion, cardiovascular disturbances (irregular heartbeat, angina, heart attack, or stroke), eosinophilic pneumonia (a rare type of pneumonia), rhinitis (congestion or nasal discharge), polymorphic erythema, blood, pancreas, or liver disorders.
• Unknown frequency (cannot be estimated from available data): Change in color, numbness, and pain in the fingers of the hands or feet (Raynaud's disease).
• In diabetic patients, it may cause hypoglycemia (very low blood sugar level).
• Vasculitis (inflammation of blood vessels) has been reported.

Reporting of 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 prospectus. You can also report them directly through the Spanish System for the 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 Perindopril TecniGen after the expiration date that appears on the box and on the packaging behind CAD. The expiration date is the last day of the month indicated.

Keep the packaging perfectly closed to protect it from moisture.

Store below 30°C.

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

Composition of Perindopril TecniGen:

The active ingredient is perindopril. Each tablet contains 4 mg of perindopril terbutilamine salt, equivalent to 3,338 mg of perindopril

The other components (excipients) are:

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

Appearance of the product and contents of the packaging

Perindopril TecniGen 4 mg tablets EFG are presented in the form of white, capsule-shaped tablets with a groove on both sides.

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, 3º 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,2710 – 089Sintra – Portugal

or

MEDINFAR MANUFACTURING, S.A.

Parque Industrial Armando Martins Tavares

Rua Outeiro Da Armada, nº 5.

Condeixa-a-Nova, 3150-194. Portugal

Revision date of this leaflet: January 2019

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/