Tertensif Retard 1.5 mg prolonged-release film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tertensif retard 1.5 mg prolonged-release film-coated tablets

Indapamide

Read the entire 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 or pharmacist.
• This medicine has been prescribed for you and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Tertensif retard 1.5 mg is and what it is used for
2. What you need to know before taking Tertensif retard 1.5 mg
3. How to take Tertensif retard 1.5 mg
4. Possible side effects
5. How to store Tertensif retard 1.5 mg
6. Contents of the pack and other information

1. What Tertensif retard 1.5 mg is and what it is used for

Tertensif retard 1.5 mg is presented as a prolonged-release film-coated tablet containing indapamide as the active substance.

This medicine is used to lower high blood pressure (hypertension) in adults.

Indapamide is a diuretic. Most 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.

In addition, indapamide dilates blood vessels so that blood flows more easily. This helps reduce blood pressure.

2. What you need to know before taking 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 (degenerative brain disease),
• if you have low blood potassium levels.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Tertensif retard 1.5 mg:

• if you have liver problems,
• if you have diabetes,
• if you have gout,
• if you have any heart rhythm disorders 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, which may occur within hours to weeks after taking Tertensif retard 1.5 mg. If untreated, this may lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamides, you may have a higher risk of developing this,
• if you have muscle disorders, including muscle pain, tenderness, weakness, or cramps,
• if you need to undergo any test to check whether your parathyroid gland is functioning properly.

You should inform your doctor if you have previously experienced photosensitivity reactions.

Your doctor may prescribe blood tests to check for low levels of sodium or potassium, or high levels of calcium.

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

Use in athletes:

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

Use of Tertensif retard 1.5 mg with other medicines:

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

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

Make sure to inform your doctor if you are taking 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 glycosides, bretylium),
• medicines used to treat mental disorders such as depression, anxiety, schizophrenia... (e.g. tricyclic antidepressants, antipsychotics, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol)),
• bepridil (used to treat angina pectoris, a disorder causing chest pain),
• cisapride, difemanil (used to treat gastrointestinal problems),
• antibiotics used to treat bacterial infections (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin),
• intravenous vincamine (used to treat symptomatic cognitive disorders in elderly patients including memory loss),
• halofantrine (an 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 (NSAIDs) 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 occurring 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 agents (used in X-ray examinations),
• calcium tablets or other calcium supplements,
• cyclosporine, tacrolimus or other immunosuppressant medicines used after transplantation, or for the treatment of autoimmune diseases, or severe dermatological or rheumatological conditions,
• 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 intend to become pregnant.

The active substance is excreted in breast milk. Breastfeeding is not recommended if you are taking this medicine.

Driving and use of machines:

This medicine may cause adverse effects due to lowering of blood pressure, such as dizziness or fatigue (see section 4). These adverse effects are more likely to occur at the beginning of treatment or after dose increases. If this happens, you should refrain from driving or performing other activities requiring alertness. However, once good control is achieved, these effects are unlikely.

Tertensif retard 1.5 mg contains lactose monohydrate.

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

3. How to take Tertensif retard 1.5 mg

Follow exactly the instructions for use provided by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet daily, preferably in the morning. The tablets may be taken with or without food.

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

Treatment for high blood pressure is usually lifelong.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication 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 treatment with Tertensif retard 1.5 mg:

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

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

4. Possible adverse effects

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

Stop taking this medicine and contact your doctor immediately if you experience any of the following adverse effects, which may be serious:

• Angioedema and/or urticaria. Angioedema is characterized by swelling of the skin in the limbs or face, swelling of the lips or tongue, swelling of the mucous membranes of the throat or airways causing difficulty breathing or difficulty swallowing. If this occurs, contact your doctor immediately. (Very rare) (may affect up to 1 in 10,000 people).
• Severe skin reactions including intense rash, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of 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).
• Inflammation of the pancreas which may cause severe abdominal and back pain accompanied by intense discomfort (Very rare) (may affect up to 1 in 10,000 people).
• Brain disease caused by liver disease (Hepatic Encephalopathy) (Frequency not known).
• Inflammation of the liver (Hepatitis) (Frequency not known).
• Muscle weakness, cramps, tenderness or muscle pain, especially if accompanied by feeling unwell or having a high temperature, as these may be caused by abnormal muscle breakdown. (Frequency not known).

In decreasing order of frequency, other adverse effects may include:

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

• Skin rash with redness
• Allergic reactions, mainly dermatological, in individuals with a predisposition to allergic and asthmatic reactions.
• Low blood potassium levels.

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

• Vomiting

• Red spots on the skin (Purpura)

• 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):

• Feeling tired, headache, tingling (paresthesia), dizziness

• Gastrointestinal disorders (such as nausea, constipation), dry mouth

• Low blood chloride levels.

• Low blood magnesium levels.

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

• Changes in blood cells, such as thrombocytopenia (decrease in the number of platelets, which increases the risk of bruising and nosebleeds), leucopenia (decrease in white blood cells, which may cause fever without apparent cause, sore throat or other flu-like symptoms – if this occurs, contact your doctor), and anemia (decrease in red blood cells).
• High levels of calcium in the blood.
• Irregular heart rhythm, low blood pressure.
• Kidney disease.
• Abnormal liver function.

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

• Fainting
• If you have systemic lupus erythematosus (a type of collagen disease), it may worsen.
• Cases of photosensitivity reactions (skin changes) after exposure to sunlight or artificial UVA radiation have also been reported.
• Shortness of vision (myopia).
• Blurred vision.
• Visual disturbances.
• 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).
• Changes may be observed in your laboratory tests (blood tests), so your doctor may prescribe blood tests to monitor your condition. The following changes may be observed in your laboratory tests:
• increased uric acid, a substance that may cause or worsen gout (joint pain, especially in the feet),
• increased blood glucose levels in diabetic patients,
• elevated liver enzyme levels.
• Abnormal electrocardiogram

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V*. By reporting adverse 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., stated on the packaging and on the blister. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tertensif retard 1.5 mg

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

The other components are:

• tablet core: colloidal anhydrous 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 medicine and contents of the pack

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

The tablets are available in blisters of 10, 14, 15, 20, 30, 50, 60, 90 or 100 tablets, packed in a cardboard box. Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 packaging and batch release (only for the Spanish market):

Laboratorios Servier, S.L.
Avda. de los Madroños 33
28043 – Madrid
SPAIN

Manufacturer responsible for packaging and batch release:

Delpharm Bretigny
Usine du Petit Paris
91220 Bretigny sur Orge
FRANCE

This medicine is authorised 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 the most recent review of this leaflet: October 2021

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