Package Leaflet: Information for the User

Tertensif retard 1.5 mg prolonged-release coated tablets

Indapamida

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package 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. Do not pass it on to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4

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

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

3. How to take Tertensif retard 1.5 mg

4. Possible side effects

5. Storage of Tertensif retard 1.5 mg

6. Contents of the pack and additional information

Tertensif retard 1,5 mg is presented in the form of a coated tablet with prolonged release film that contains indapamida as the active ingredient.

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

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.

In addition, indapamida dilates blood vessels so that blood circulates more easily. This helps to reduce blood pressure.

Do not take Tertensif retard 1.5 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 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 blood vessel layer of the eye (choroidal effusion) or increased eye pressure, which 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 had a previous allergy to penicillin or sulfonamides, you may be at a 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 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 affect you or have any doubts about how to take this medication, consult your doctor or pharmacist.

Use in athletes:

This medication contains indapamide, which can produce a positive result in doping control tests.

Use of Tertensif retard 1.5 mg with other medications:

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

You should 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 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,
• intravenous vincamine (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),
• 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 agents (used for X-ray tests),
• calcium tablets or other calcium supplements,
• ciclosporin, tacrolimus, or other immunosuppressive medications used after transplantation, 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, or think you may be 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 retard 1.5 mg contains lactose monohydrate.

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

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

Typically, treatment for high blood pressure is lifelong.

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 Toxicological Information Service, phone: 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, muscle cramps, dizziness, drowsiness, confusion, and changes in urine production 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 compensate for the missed doses.

If you interrupt treatment with Tertensif retard 1.5 mg:

Since treatment for high blood pressure is typically 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 medicines, this medicine may cause side effects, although not everyone will experience them.

Stop taking this medicine and seek immediate medical attention if 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, mucous membrane inflammation (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 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 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 favors the appearance of bruises and nasal bleeding), 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).
• High calcium levels in the blood.
• Irregular heart rhythm, low blood pressure.
• Kidney disease.
• Abnormal liver function.

Unknown frequency (cannot be estimated from available data):

• Loss of consciousness.
• If you have systemic lupus erythematosus (a type of collagen disease) it may worsen.
• Also, cases of photosensitivity reactions (skin changes) have been described after exposure to sunlight or artificial UVA radiation.
• Short-sightedness (myopia).
• Blurred vision.
• Visual alteration.
• 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 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, a substance that can cause or worsen gout (joint pain, especially in the feet),
• Increased blood glucose levels in diabetic patients,
• Increased levels of liver enzymes.
• Abnormal electrocardiogram

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in Appendix V*. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date, CAD.: which appears on the packaging and on the blister. The expiration date is the last day of the month indicated.

Store below 30°C.

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

Composition of Tertensif retard 1.5 mg

The active ingredient is indapamida. Each tablet contains 1.5 mg of indapamida.

The other components are:

- tablet core: anhydrous colloidal silica (E551), hypromellose (E464), lactose monohydrate, magnesium stearate (E470B), povidone.

- coating film: glycerol (E422), hypromellose (E464), macrogol 6000, magnesium stearate (E470B), titanium dioxide (E171).

Appearance of the product and contents of the package

This medicine is a prolonged-release coated tablet of white color and round shape.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex - France

Responsible for manufacturing:

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

Responsible manufacturer for packaging and release of the batch (only for the Spanish market):

Laboratorios Servier, S.L.

Avda. de los Madroños 33

28043 – Madrid

SPAIN

Responsible manufacturer for packaging and release of the batch:

Delpharm Bretigny

Usine du Petit Paris

91220 Bretigny sur Orge

FRANCE

This medicine is authorized in the member states of the European Economic Area with the following names:

AustriaFLUDEX RETARD 1.5 mg

BelgiumFLUDEX 1.5 mg

CyprusFLUDEX 1.5 mg

DenmarkNATRILIX RETARD

EstoniaTERTENSIF SR

FinlandNATRILIX RETARD 1.5 mg

FranceFLUDEX 1.5 mg

GermanyNATRILIX SR 1.5 mg

GreeceFLUDEX 1.5 mg

HungaryPRETANIX

IrelandNATRILIX SR

ItalyNATRILIX LP 1.5 mg

LatviaTERTENSIF SR

LithuaniaTERTENSIF SR

LuxembourgFLUDEX 1.5 mg

MaltaNATRILIX SR

NetherlandsFLUDEX SR 1.5 mg

PortugalFLUDEX LP

SlovakiaTERTENSIF SR

SloveniaTERTENSIF SR

SpainTERTENSIF RETARD 1.5 mg

United KingdomNATRILIX SR

(Northern Ireland)

Last review date of this leaflet: October 2021

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