TERTENSIF RETARD 1.5 mg PROLONGED-RELEASE FILM-COATED TABLETS

2. What you need to know before you take Tertensif retard 1.5 mg

Do not take Tertensif retard 1.5 mg:

• if you are allergic to indapamide or to any other sulfonamide, or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe kidney disease,
• if you have severe liver disease or suffer from a disorder called hepatic encephalopathy (a degenerative brain disease),
• if you have low blood potassium levels.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Tertensif retard 1.5 mg:

• if you have liver problems,
• if you have diabetes,
• if you have gout,
• if you have any heart rhythm problems or kidney problems,
• if you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in your eye and can occur within hours to weeks after taking Tertensif retard 1.5 mg. If left untreated, this can lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamides, you may be at greater risk of developing this,
• if you have muscle disorders, including muscle pain, sensitivity, weakness, or cramps,
• if you need to undergo any tests to check if your parathyroid gland is working properly.

You should inform your doctor if you have had photosensitivity reactions.

Your doctor may prescribe blood tests to check if you have low sodium or potassium levels, or high calcium levels.

If you think any of the above situations may apply to you, or if you have any doubts about taking this medicine, consult your doctor or pharmacist.

Use in athletes:

This medicine contains indapamide, which may produce a positive result in doping tests.

Using Tertensif retard 1.5 mg with other medicines:

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

Do not take Tertensif retard 1.5 mg with lithium (used to treat depression) due to the risk of increased lithium levels in the blood.

Make sure to inform your doctor if you are using any of the following medicines, as special care may be required:

• medicines for heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis, bretylium),
• medicines used to treat mental disorders such as depression, anxiety, schizophrenia... (e.g., tricyclic antidepressants, antipsychotics, neuroleptics (such as amisulpride, sulpiride, sultoprida, tiaprida, haloperidol, droperidol)),
• bepridil (used to treat angina pectoris, a disorder that causes chest pain),
• cisapride, difemanil (used to treat gastrointestinal problems),
• antibiotics used to treat bacterial infections (e.g., esparfloxacin, moxifloxacin, intravenous erythromycin,
• vincamine intravenously (used to treat symptomatic cognitive disorders in elderly patients, including memory loss),
• halofantrine (antiparasitic used to treat certain types of malaria),
• pentamidine (used to treat certain types of pneumonia),
• antihistamines used to treat allergic reactions, such as hay fever (e.g., mizolastine, astemizole, terfenadine)
• non-steroidal anti-inflammatory drugs for pain relief (e.g., ibuprofen) or high doses of acetylsalicylic acid,
• angiotensin-converting enzyme inhibitors (ACE inhibitors) (used to treat high blood pressure and heart failure),
• intravenous amphotericin B (antifungal medicines),
• oral corticosteroids used in various treatments, including severe asthma and rheumatoid arthritis,
• stimulant laxatives,
• baclofen (for the treatment of muscle stiffness that occurs in diseases such as multiple sclerosis),
• allopurinol (for the treatment of gout), potassium-sparing diuretics (e.g., amiloride, spironolactone, triamterene),
• metformin (for the treatment of diabetes),
• iodinated contrast agent (used for X-ray tests),
• calcium tablets or other calcium supplements,
• cyclosporin, tacrolimus, or other immunosuppressive medicines used after a transplant, for the treatment of autoimmune diseases, or severe dermatological or rheumatological diseases,
• tetracosactide (for the treatment of Crohn's disease)
• methadone (used to treat addiction).

Pregnancy and breastfeeding:

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.

This medicine is not recommended during pregnancy. When pregnancy is planned or confirmed, a switch to an alternative treatment should be made as soon as possible. Inform your doctor if you are pregnant or wish to become pregnant.

The active substance is excreted in breast milk. If you are taking this medicine, breastfeeding is not recommended.

Driving and using machines:

This medicine may cause side effects due to the lowering of blood pressure, such as dizziness or fatigue (see section 4). The occurrence of these side effects is more likely after starting treatment and after dose increases. If this happens, you should avoid driving or performing other activities that require a state of alertness. However, when there is good control, these effects are unlikely.

Tertensif retard 1.5 mg contains lactose monohydrate.

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

3. How to take Tertensif retard 1.5 mg

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

The recommended dose is one tablet per day, preferably in the morning. The tablets can be taken with or without food.

The tablets should be swallowed whole with a glass of water. Do not break or chew them.

Treatment for high blood pressure is usually for life.

If you take more Tertensif retard 1.5 mg than you should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

A very high dose of Tertensif retard 1.5 mg could cause nausea, vomiting, low blood pressure, cramps, dizziness, drowsiness, confusion, and changes in the amount of urine produced by the kidneys.

If you forget to take Tertensif retard 1.5 mg:

If you forget to take a dose of Tertensif retard 1.5 mg, take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Tertensif retard 1.5 mg:

Since treatment for high blood pressure is usually for life, you should talk to your doctor before stopping this medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking this medicine and contact your doctor immediately if you experience any of the following serious side effects:

• Angioedema and/or urticaria. Angioedema is characterized by swelling of the skin of the extremities or face, swelling of the lips or tongue, swelling of the mucous membranes of the throat or respiratory tract, causing difficulty breathing or difficulty swallowing. If this happens, contact your doctor immediately. (Very rare) (may affect up to 1 in 10,000 people).
• Severe skin reactions, including intense skin rash, redness of the skin all over the body, intense itching, blisters, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome) or other allergic reactions, (Very rare) (may affect up to 1 in 10,000 people).
• Life-threatening irregular heartbeat (Frequency not known).
• Pancreatitis, which can cause severe abdominal and back pain, accompanied by severe discomfort (Very rare) (may affect up to 1 in 10,000 people).
• Brain disease caused by liver disease (Hepatic Encephalopathy) (Frequency not known).
• Hepatitis (inflammation of the liver) (Frequency not known).
• Muscle weakness, cramps, sensitivity, or muscle pain, and especially if you feel unwell or have a fever, as they can be caused by abnormal muscle breakdown. (Frequency not known).

In decreasing order of frequency, other side effects may be:

Frequent (may affect up to 1 in 10 people):

• Redness of the skin
• Allergic reactions, mainly dermatological in individuals with a predisposition to allergic and asthmatic reactions.
• Low potassium levels in the blood.

Uncommon (may affect up to 1 in 100 people):

• Vomiting.
• Red spots on the skin (Purpura).

• Low sodium levels in the blood, which can cause dehydration and low blood pressure.
• Impotence (inability to have or maintain an erection).

Rare (may affect up to 1 in 1,000 people):

• Feeling tired, headache, tingling (paresthesia), dizziness
• Gastrointestinal disorders (such as nausea, constipation), dry mouth.

• Low chloride levels in the blood.
• Low magnesium levels in the blood.

Very rare (may affect up to 1 in 10,000 people):

• Changes in blood cells, such as thrombocytopenia (decrease in platelet count, which favors the appearance of hematomas and nosebleeds), leucopenia (decrease in white blood cells, which can produce fever without apparent cause, sore throat, or other flu-like symptoms - if this happens, contact your doctor) and anemia (decrease in red blood cells).
• High calcium levels in the blood.
• Irregular heartbeat, low blood pressure.
• Kidney disease.
• Abnormal liver function.

Frequency not known (cannot be estimated from the available data):

• Fainting.
• If you suffer from systemic lupus erythematosus (a type of collagen disease), it may worsen.
• There have also been reports of photosensitivity reactions (change in the appearance of the skin) after sun exposure or artificial UVA radiation.
• Short-sightedness (myopia).
• Blurred vision.
• Visual disturbance.
• 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).
• Changes may be observed in your blood tests (blood analysis), so your doctor may prescribe blood tests to monitor your condition. The following changes may be observed in your blood tests:
• increased uric acid, a substance that can cause or worsen gout (joint pain, especially in the feet),
• increased glucose levels in the blood in diabetic patients,
• increased liver enzyme levels.
• Abnormal electrocardiogram

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system included in Appendix V*. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tertensif retard 1.5 mg

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

Do not use this medicine after the expiry date, EXP.: that appears on the packaging and on the blister. The expiry date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Tertensif retard 1.5 mg

The active substance is indapamide. Each tablet contains 1.5 mg of indapamide.

The other ingredients are:

• tablet core: anhydrous colloidal silica (E551), hypromellose (E464), lactose monohydrate, magnesium stearate (E470B), povidone.
• film coating: glycerol (E422), hypromellose (E464), macrogol 6000, magnesium stearate (E470B), titanium dioxide (E171).

Appearance of the product and pack contents

This medicine is a white, round, prolonged-release tablet.

The tablets are available in blisters of 10, 14, 15, 20, 30, 50, 60, 90, or 100 tablets, packaged in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex - France

Manufacturers:

Les Laboratoires Servier Industrie

905 route de Saran

45520 Gidy

FRANCE

and

Servier (Ireland) Industries Ltd

Gorey Road

Co. Wicklow - Arklow

IRELAND

and

ANPHARM Przedsiebiorstwo Farmaceutyczne S.A.

Ul. Annopol 6B - 03-236 Warszawa

POLAND

Manufacturer responsible for batch release (only for the Spanish market):

Laboratorios Servier, S.L.

Avda. de los Madroños 33

28043 – Madrid

SPAIN

Manufacturer responsible for batch release:

Delpharm Bretigny

Usine du Petit Paris

91220 Bretigny sur Orge

FRANCE

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria FLUDEX RETARD 1.5 mg

Belgium FLUDEX 1.5 mg

Cyprus FLUDEX 1.5 mg

Denmark NATRILIX RETARD

Estonia TERTENSIF SR

Finland NATRILIX RETARD 1.5 mg

France FLUDEX 1.5 mg

Germany NATRILIX SR 1.5 mg

Greece FLUDEX 1.5 mg

Hungary PRETANIX

Ireland NATRILIX SR

Italy NATRILIX LP 1.5 mg

Latvia TERTENSIF SR

Lithuania TERTENSIF SR

Luxembourg FLUDEX 1.5 mg

Malta NATRILIX SR

Netherlands FLUDEX SR 1.5 mg

Portugal FLUDEX LP

Slovakia TERTENSIF SR

Slovenia TERTENSIF SR

Spain TERTENSIF RETARD 1.5 mg

United Kingdom NATRILIX SR

(Northern Ireland)

Date of last revision of this leaflet: October 2021

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/.