TERTENSIF 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for thepatient

Tertensif2.5 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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Tertensif 2.5 mg and what is it used for
2. What you need to know before you take Tertensif 2.5 mg
3. How to take Tertensif 2.5 mg
4. Possible side effects
5. Storage of Tertensif 2.5 mg
6. Pack contents and further information

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

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

Indapamide is a diuretic. Most diuretics increase the amount of urine produced by the kidneys. However, indapamide is different from other diuretics, as it only produces 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 you take 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 disease),
• if you have low blood potassium levels.

Warnings and precautions

Consult 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 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 2.5 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 must 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.

Use in athletes:

This medicine contains an active ingredient that may produce a positive result in doping tests.

Use of Tertensif 2.5 mg withother medicines:

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

Do 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 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., sparfloxacin, 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 medications),
• 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 medications 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

The active ingredient 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 operating machinery. However, when well controlled, these effects are unlikely.

Tertensif 2.5mg contains lactose monohydrate.

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

Tertensif 2.5 mg contains sodium.

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

3. How to take Tertensif 2.5 mg

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again if you have doubts.

The recommended dose is one tablet per day, 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 for life.

If you take more Tertensif 2.5 mgthan you should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 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 the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Tertensif 2.5 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 product, 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 that can 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).
• Liver inflammation (Hepatitis) (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).

Other side effects may occur in decreasing order of frequency:

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 that 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, dizziness, headache, tingling (paresthesia), vertigo.
• 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 bruises 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).
• 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.
• Photosensitivity reactions (change in the appearance of the skin) after sun exposure or artificial UVA radiation have also been described.
• Short-sightedness (myopia).
• Blurred vision.
• Visual disturbance.
• Decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
  • You may observe changes 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 can cause or worsen gout (joint pain, especially in the feet),
• increased glucose levels in the blood in diabetic patients,
• high calcium levels in the blood,
• increased liver enzyme levels.

• Abnormal electrocardiogram

Reporting of side effects

If you experience any side effects, talk to your doctor, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 the sight and reach of children. Do not store above 25°C.

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

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

6. Pack contents and further information

Composition of Tertensif 2.5 mg

• The active ingredient is indapamide. Each tablet contains 2.5 mg of indapamide.
• The other ingredients are:

• tablet core: Lactose monohydrate, corn starch, magnesium stearate (E470B), povidone, talc.
• film coating: Titanium dioxide, white beeswax, glycerol, sodium lauryl sulfate, macrogol 6000, methylhydroxypropylcellulose, magnesium stearate.

Appearance and pack contents

This medicine is a white, lenticular-shaped film-coated tablet.

The tablets are available in blisters of 30 or 500 tablets, packaged in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorios Servier, S.L.

Avenida de los Madroños, 33

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 last revision of this leaflet:

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/.