Tertensif 2.5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tertensif 2.5 mg film-coated tablets

Indapamide

Read all of 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, ask your doctor or pharmacist.
• 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, because it could 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.

Contents of the leaflet

1. What Tertensif 2.5 mg is and what it is used for
2. What you need to know before taking Tertensif 2.5 mg
3. How to take Tertensif 2.5 mg
4. Possible adverse effects
5. How to store Tertensif 2.5 mg
6. Contents of the pack and other information

1. What Tertensif 2.5 mg is and what it is used for

Tertensif 2.5 mg is presented as a film-coated tablet containing indapamide as the active substance.

Indapamide is a diuretic. Most diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics in that it produces only a slight increase in the amount of urine formed.

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

2. What you need to know before taking Tertensif 2.5 mg

Do not take Tertensif 2.5 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 condition),
• if you have low blood potassium levels.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tertensif 2.5 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 2.5 mg. If untreated, this may lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamides, you may be at 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 must inform your doctor if you have experienced photosensitivity reactions.

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

Use in athletes:

This medicine contains an active substance that may result in a positive doping test.

Use of Tertensif 2.5 mg 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 not take Tertensif 2.5 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 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, 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 for X-ray tests),
• calcium tablets or other calcium supplements,
• ciclosporin, tacrolimus, or other immunosuppressants used after transplantation, for the treatment of autoimmune diseases, or serious 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 wish to become pregnant.

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

Driving and using 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 and 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 2.5 mg contains lactose monohydrate.

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

Tertensif 2.5 mg contains sodium.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially "sodium-free".

3. How to take Tertensif 2.5 mg

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet daily, preferably in the morning.

The tablets should 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 2.5 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 medicine and the amount ingested.

A very high dose of Tertensif 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 2.5 mg:

If you forget to take a dose of this medicine, take the next dose at your usual time. Do not take a double dose to make up for missed doses.

If you stop taking Tertensif 2.5 mg:

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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 of 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 skin rash, redness of the skin over the entire 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 malaise (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, at the same time, you feel unwell or have a high temperature, as these may be caused by abnormal muscle breakdown. (Frequency not known).

Other adverse effects, listed in decreasing order of frequency, may include:

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

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

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

• Vomiting.
• Small 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, dizziness, headache, tingling (paraesthesia), vertigo.
• 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 (reduced platelet count, which increases the risk of bruising and nosebleeds), leucopenia (reduced white blood cell count, which may cause fever without apparent cause, sore throat or other flu-like symptoms – if this occurs, contact your doctor), and anaemia (reduced red blood cells).
• Irregular heart rhythm, low blood pressure.
• Kidney disease.
• Abnormal liver function.

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

• Fainting.
• If you suffer from 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.
• Shortness of vision (myopia).
• Blurred vision.
• Visual disturbances.
• 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).

• You may notice changes in your laboratory test results (blood tests), so your doctor may prescribe blood tests to monitor your condition. The following changes may be observed in your test results:

• increased uric acid, a substance that may cause or worsen gout (joint pain, especially in the feet),

• increased blood glucose levels in diabetic patients,

• high blood calcium levels,

• elevated liver enzyme levels.

• Abnormal electrocardiogram

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tertensif 2.5 mg

Keep this medicine out of sight and reach of children. Do not store above 25°C.

Do not use this medicine after the expiry date stated on the carton and on the blister. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tertensif 2.5 mg

• The active substance is indapamide. Each tablet contains 2.5 mg of indapamide.

• The other components are:

• tablet core: Monohydrate lactose, corn starch, magnesium stearate (E470B), povidone, talc.

• film coating: Titanium dioxide, white beeswax, glycerol, sodium lauryl sulfate, macrogol 6000, methylhydroxypropylcellulose, magnesium stearate.

Appearance of the medicine and contents of the pack

This medicine is a white, film-coated, biconvex tablet.

Tablets are available in blisters of 30 tablets, packed in a cardboard box.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Servier, S.L.

Glorieta Mar Caribe, 1

28043 – Madrid

Spain

Manufacturers:

Laboratorios Servier, S.L.

Avenida de los Madroños, 33

28043 – Madrid

Spain

Les Laboratoires Servier Industrie

905 Route de Saran

45520 Gidy

France

Date of the most recent revision 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 Medical Devices (AEMPS) http://www.aemps.gob.es/.