Leaflet: information for thepatient

Tertensif2.5 mg film-coated tablets

Indapamida

Read this leaflet carefully before you start taking this medicinebecause 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• Ifyou experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Tertensif2.5 mg and what it is used for

2.What you need to knowbefore taking Tertensif2.5 mg

3.How to take Tertensif2.5 mg

4.Possible side effects

5.Storage of Tertensif2.5 mg

6.Contents of the packadditional information

Tertensif 2.5mgis presented in the form of a coated tablet containing indapamida as the active ingredient.

Indapamida is a diuretic. Most diuretics increase the amount of urine produced by the kidneys. However, indapamida is different from other diuretics, as it only produces a slight increase in the amount of urine formed.

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

Do not take Tertensif 2.5 mg:

• if you are allergic to indapamide or any other sulfonamide, or to any of the other components of this medication (listed in section 6)
• if you have a severe kidney disease
• if you have a severe liver disease or suffer from a condition called hepatic encephalopathy (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 blood vessel layer of the eye (choroidal effusion) or increased eye pressure, which can occur within hours or weeks of taking Tertensif 2.5 mg. If left untreated, this can lead to permanent vision loss. If you have had a previous allergy to penicillin or sulfonamides, you may be at higher risk of developing this
• if you have muscle disorders, including muscle pain, sensitivity, weakness, or cramps
• if you are undergoing a test to check if your parathyroid gland is functioning correctly

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 medication contains an active ingredient that can produce a positive result in doping control tests

Use of Tertensif 2.5 mg with other medications:

Inform your doctor or pharmacist if you are using or have recently used or may need to use any other medication

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 medications, as special care may be required:

• medications for heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitals, bretylium)
• medications 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 that causes chest pain)
• cisapride, difemanil (used to treat gastrointestinal problems)
• antibiotics used to treat bacterial infections (e.g. enoxacin, moxifloxacin, intravenous erythromycin)
• vincamine intravenous (used to treat 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)
• nonsteroidal anti-inflammatory drugs for pain relief (e.g. ibuprofen) or high doses of aspirin
• angiotensin-converting enzyme inhibitors (ACE inhibitors) (used to treat high blood pressure and heart failure)
• amphotericin B intravenous (antifungal medications)
• oral corticosteroids used in various treatments, including severe asthma and rheumatoid arthritis
• stimulant laxatives
• baclofen (used to treat muscle stiffness that occurs in diseases such as multiple sclerosis)
• allopurinol (used to treat gout)
• potassium-sparing diuretics (e.g. amiloride, spironolactone, triamterene)
• metformin (used to treat diabetes)
• iodinated contrast agents (used in X-ray tests)
• calcium tablets or other calcium supplements
• ciclosporin, tacrolimus, or other immunosuppressive medications used after transplantation, to treat autoimmune diseases, or severe skin or rheumatological diseases
• tetracosactide (used to treat Crohn's disease)
• methadone (used to treat addiction)

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication

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

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

Driving and operating machinery:

This medication can cause side effects due to low blood pressure, such as dizziness or fatigue (see section 4). These side effects are more likely to occur after starting treatment and after dose increases. If this happens, you should avoid driving or performing other activities that require alertness. However, when control is good, these side effects are unlikely

Tertensif 2.5 mg contains lactose monohydrate

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication

Tertensif 2.5 mg contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult again with your doctor or pharmacist if you have any questions.

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.

The 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

A very high dose of Tertensif could cause nausea, vomiting, low blood pressure, muscle cramps, dizziness, drowsiness, confusion, and changes in urine production by the kidneys.

If you forget to take Tertensif 2.5 mg:

If you forget to take a dose of this medication, take the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Tertensif 2.5 mg:

Since the treatment for high blood pressure is usually lifelong, you should talk to your doctor before stopping this medication.

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

Like all medications,this medicationcan cause side effects, although not everyone will experience them.

Stop taking this medication and seek immediate medical attentionif you experience any of the following serious side effects:.

• Angioedema and/or urticaria. Angioedema is characterized by swelling of the skin on 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 occurs, contact your doctor immediately. (Very rare) (may affect up to 1 in 10,000 people).
• Severe skin reactions, including intense skin rash, body-wide skin redness, intense itching, blisters, peeling, and skin swelling, Stevens-Johnson syndrome, or other allergic reactions, (Very rare) (may affect up to 1 in 10,000 people).
• Irregular heartbeat with life-threatening risk (Unknown frequency).
• 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) (Unknown frequency).
• Liver inflammation (Hepatitis) (Unknown frequency).
• Muscle weakness, cramps, muscle sensitivity or pain, and especially if you feel unwell or have a high temperature, as they may be caused by abnormal muscle breakdown. (Unknown frequency).

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

Frequent (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 potassium levels in the blood.

Infrequent (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 (decreased platelet count, which can cause bruising and nosebleeds), leucopenia (decreased white blood cell count, which can cause fever without apparent cause, sore throat, or other symptoms similar to the flu – if this occurs, contact your doctor), and anemia (decreased red blood cell count).
• Irregular heart rhythm, low blood pressure.
• Kidney disease.
• Abnormal liver function.

Unknown frequency (cannot be estimated from available data):

-Fainting.

-If you have systemic lupus erythematosus (a type of collagen disease), it may worsen.

-Phototoxicity reactions (skin changes) have also been described after exposure to sunlight or artificial UVA radiation.

-Short-sightedness (myopia).

-Blurred vision.

-Visual disturbances.

-Decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma).

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

• Increased uric acid levels, a substance that can cause or worsen gout (joint pain, especially in the feet),
• High blood glucose levels in diabetic patients,
• High calcium levels in the blood,
• Increased liver enzyme levels.

• Abnormal electrocardiogram.

Reporting side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of sight and reach of children. Do not store at a temperature above 25°C.

Do not usethis medicationafter the expiration date that appears on the box and on the blister pack. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tertensif 2.5 mg

• The active ingredient is indapamida. Each tablet contains 2.5 mg of indapamida.
• The other components are:

• tablet core: Lactose monohydrate, cornstarch, magnesium stearate (E470B), polyvidone, talc.
• coating film: Titanium dioxide, beeswax, glycerol, sodium lauryl sulfate, macrogol 6000, methycellulose, magnesium stearate.

Appearance of the product and contents of the packaging

This medication is a white, lenticular-coated tablet.

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

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Servier Laboratories, S.L.

Avenida de los Madroños, 33

28043 – Madrid

Spain

Responsible manufacturers:

Servier Laboratories, S.L.

Avenida de los Madroños, 33

28043 – Madrid

Spain

Servier Industrie Laboratories

905 Route de Saran

45520 Gidy

France

Last review date of this prospectus:

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.