PERINDOPRIL TECNIGEN 4 mg TABLETS

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

Do not take Perindopril TecniGen:

• if you are allergic to the active substance or to any other ACE inhibitor, or to any of the other ingredients of this medicine listed in section 6.
• if you are more than 3 months pregnant. (It is also better to avoid ACE inhibitors during the first months of pregnancy, see pregnancy section)
• if you have experienced symptoms such as wheezing, swelling of the face, tongue, or throat, intense itching, or severe skin rashes 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 known as angioedema).
• If you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine 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 (a disease of the heart muscle) or renal artery stenosis (narrowing of the artery that supplies blood to the kidneys),
• if you have any other heart problems,
• if you have liver problems,
• if you have kidney problems or if you are on dialysis,
• if you suffer from a collagen vascular disease (a disease of the connective tissue) such as systemic lupus erythematosus or scleroderma,
• if you have diabetes,
• if you follow a salt-free diet or use salt substitutes that contain potassium,
• if you are going to undergo anesthesia and/or major surgery,
• if you are going to undergo LDL apheresis (which involves removing cholesterol from your blood through a machine),
• if you are going 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 an intolerance to some sugars,
• inform your doctor if you are pregnant (or if you think you might be). Your doctor will generally advise you to stop taking perindopril before you become pregnant or as soon as you know you are pregnant and will recommend that you take another medicine instead of perindopril. It is not recommended to use perindopril at the start of pregnancy, and in no case should it be administered after the third month of pregnancy, as it can cause serious harm to your baby when administered from that time on.

• 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

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 TecniGen".

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

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)

Use of Perindopril TecniGen with other medicines

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

Treatment with Perindopril TecniGen may be affected by other medicines. Your doctor may need to change your dose and/or take other precautions. These include:

• other medicines for high blood pressure, including angiotensin II receptor antagonists (ARAs) or aliskiren. (See also the information under the headings "Do not take Perindopril TecniGen" and "Warnings and precautions", or diuretics (medicines that increase the amount of urine produced by the kidneys),
• potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes that contain potassium,
• lithium for mania or depression,
• non-steroidal anti-inflammatory medicines (e.g., ibuprofen) for pain relief or high doses of acetylsalicylic acid,
• medicines to treat diabetes (such as insulin or metformin),
• medicines to treat mental disorders such as depression, anxiety, schizophrenia, etc. (e.g., tricyclic antidepressants, antipsychotics),
• immunosuppressants (medicines that reduce the body's defense mechanism) used to treat autoimmune disorders or after a transplant (e.g., cyclosporine),
• allopurinol (for the treatment of gout),
• procainamide (for the treatment of irregular heartbeats),
• vasodilators, including nitrates (medicines that cause blood vessels to widen),
• heparin (medicines used to thin the blood),
• medicines used to treat low blood pressure, shock, or asthma (e.g., ephedrine, noradrenaline, or adrenaline).
• medicines that are commonly used to treat diarrhea (racecadotril) or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of mTOR inhibitors). See section "Warnings and precautions"

Taking Perindopril TecniGen with food, drinks, and alcohol

It is preferable to take Perindopril TecniGen 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 inform your doctor if you are pregnant (or if you think you might be). Your doctor will generally advise you to stop taking perindopril before you become pregnant or as soon as you know you are pregnant and will recommend that you take another medicine instead of perindopril. It is not recommended to use perindopril at the start of pregnancy, and in no case should it be administered after the third month of pregnancy, as it can cause serious harm to your baby when administered from that time on.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to start breastfeeding. It is not recommended to use perindopril during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

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

Perindopril TecniGen contains lactose

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

3. How to take Perindopril TecniGen

Follow exactly the instructions of administration of this medicine 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 each day, in the morning, before breakfast. Your doctor will decide 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 a 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 a 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 artery 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 4 mg per day, and if necessary, one week later, up to 8 mg per day.

If you take more Perindopril TecniGen than you should

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

The most frequent symptom in case of overdose is a decrease in blood pressure with possible symptoms of dizziness or fainting. If this happens, it may help to lie down with your legs raised.

If you forget to take Perindopril TecniGen

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 TecniGen, take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Perindopril TecniGen

As treatment with Perindopril TecniGen will usually be lifelong, 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, stop taking this medicine and tell your doctor immediately:

• 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, these side effects may include:

• Frequent (occurring in less than 1 in 10 patients but in more than 1 in 100 patients): headache, dizziness, vertigo, tingling, visual disturbances, tinnitus (ringing in the ears), mild dizziness due to low blood pressure, cough, difficulty breathing, digestive disorders (nausea, vomiting, abdominal pain, altered taste, dyspepsia, or difficulty digesting, diarrhea, constipation), allergic reactions (such as skin rashes, itching), muscle cramps, feeling of fatigue,
• Uncommon (occurring in less than 1 in 100 patients but in more than 1 in 1,000 patients): mood changes, sleep disorders, bronchospasm (chest tightness, wheezing, and difficulty breathing), dry mouth, angioedema (symptoms such as wheezing, swelling 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 diuresis, facial flushing, acute kidney failure.

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

• Very rare (occurring in less than 1 in 10,000 patients): confusion, cardiovascular disorders (irregular heartbeat, chest pain, heart attack, and stroke), eosinophilic pneumonia (a rare type of pneumonia), rhinitis (nasal congestion or runny nose), erythema multiforme, blood, pancreas, or liver disorders.
• Frequency not known (cannot be estimated from the available data): change in color, numbness, and pain in the fingers of the hands or feet (Raynaud's disease).
• In the case of diabetic patients, hypoglycemia (very low blood sugar level) may occur.
• Vasculitis (inflammation of blood vessels) has been reported.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any 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 TecniGen

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

Do not use Perindopril TecniGen after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month shown.

Keep the container tightly closed to protect from moisture.

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Perindopril TecniGen:

The active substance is perindopril. Each tablet contains 4 mg of perindopril tert-butylamine salt, equivalent to 3.338 mg of perindopril.

The other ingredients (excipients) are:

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

Appearance of the product and contents of the pack

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

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, España

Manufacturer:

ATLANTIC PHARMA PRODUÇOES FARMACEUTICAS, S.A.

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 last revision of this leaflet: January 2019

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