Leaflet: Information for the User

indapamida retard cinfa 1.5 mg prolonged-release tablets

Read this leaflet carefully before you start taking this medicine, as 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.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is indapamida retard cinfa and what is it used for

2. What you need to know before you start taking indapamida retard cinfa

3. How to take indapamida retard cinfa

4. Possible side effects

5. Storage of indapamida retard cinfa

6. Contents of the pack and additional information

indapamida retard cinfa is presented in the form of a prolonged-release tablet 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.

Do not take indapamida retard cinfa:

• if you areallergicto indapamida or to any other sulfonamide or to any of the other components of this medication (listed in section 6),
• if you have aserious kidney disease,
• if you have a serious liver disease or suffer from a condition calledhepatic encephalopathy(degenerative brain disease),
• if you have low levels ofpotassium in the blood(hypokalemia).

Warnings and precautions

Consult your doctor or pharmacist before starting to take indapamida retard cinfa:

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 consider that any of the above situations may affect you or have any doubts about how to take this medication, consult your doctor or pharmacist.

Athletes should be aware that this medication contains an active ingredient that can produce positive results in doping tests.

Use of indapamida retard cinfa with other medications

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

You should not take indapamida retard cinfa 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 problems (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitals, bretylium)
• medications used to treat mental disorders such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotics, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol))
• bepridil (used to treat angina pectoris, a condition that causes chest pain)
• cisapride
• difenamilo (used to treat gastrointestinal problems)
• antibiotics used to treat bacterial infections (e.g. esparfloxacino, moxifloxacino, eritromicina intravenosa)
• vincamina intravenosa (used to treat cognitive disorders in elderly patients, including memory loss)
• halofantrina (antiparasitic used to treat some types of malaria)
• pentamidine (used to treat certain types of pneumonia)
• antihistamines used to treat allergic reactions, such as pollen allergy (e.g. Mizolastina, astemizol, terfenadine)
• non-steroidal anti-inflammatory drugs for pain relief (e.g. ibuprofen) or high doses of aspirin
• angiotensin-converting enzyme inhibitors (used to treat high blood pressure and heart failure)
• anfotericina B intravenosa (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)
• alopurinol (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
• ciclosporina, tacrolimus, or other immunosuppressive medications used after a transplant, for the treatment of autoimmune diseases, or severe dermatological 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 if you 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:

It is unlikely that indapamida retard cinfa will affect your ability to drive or operate machinery. However, like other medications used to treat high blood pressure, indapamida retard cinfa may cause dizziness or drowsiness in some people, especially at the beginning of treatment, when changing doses, or if alcohol is consumed. If you experience dizziness or drowsiness, consult your doctor before engaging in these activities.

indapamida retard cinfa contains lactose.

If your doctor has told you that you have anintoleranceto certain sugars, consult with them before taking this medication.

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

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

Tablets can be taken with or without food. Tablets must be swallowed whole with water. Do not break or chew them. Treatment for high blood pressure is normally lifelong.

If you take more indapamida retard cinfa 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 indapamida retard cinfa could cause nausea, vomiting, low blood pressure, cramps, dizziness, drowsiness, confusion, and changes in the amount of urine produced by the kidneys.

If you forgot to take indapamida retard cinfa

If you forgot to take a dose of your 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 indapamida retard cinfa

Since treatment for high blood pressure is normally 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, sensitivity, or pain, and particularly if you feel unwell or have high fever, may be caused by an abnormal muscle rupture (Unknown)

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

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 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 may 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, 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 nosebleeds), leucopenia (decreased white blood cell count, which may 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 (causing palpitations, feeling the heartbeat), low blood pressure
• Kidney disease (which may cause symptoms of fatigue, increased need to urinate, skin itching, discomfort, swollen extremities)

• Abnormal liver function.

Unknown frequency(cannot be estimated from available data):

• Loss of consciousness.
• If you have systemic lupus erythematosus (a disorder of the immune system that causes inflammation and damage to joints, tendons, and organs with symptoms such as skin rashes, fatigue, loss of appetite, weight gain, and joint pain) it may worsen.
• Phototoxicity reactions (change in skin appearance) have also been described after exposure to sunlight or artificial UVA radiation.
• Short-sightedness (myopia).
• Blurred vision.
• Visual impairment
• Decreased vision or eye pain due to increased 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 blood test, so your doctor may prescribe blood tests to monitor your condition. The following changes may be observed in your analytical 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
  • 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 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 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 that appears on the carton and on the blister pack. The expiration date is the last day of the month indicated.

Store in the original packaging.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and themedicines that you no longer need at the SIGREcollection point at the pharmacy. If in doubt, ask yourpharmacist how to dispose of the packaging and the medicines that you no longer need. By doing so, you will help protect the environment.

Composition of indapamida retard cinfa

The active ingredient is: indapamida

Each prolonged-release tablet contains 1.5 mg of indapamida.

The other components are:

Lactose monohydrate, cornstarch pregelatinized without gluten, hypromellose, anhydrous colloidal silica, magnesium stearate (Ph. Eur.) (vegetal), macrogol 6000, titanium dioxide.

Appearance of the product and contents of the package

White and round tablets with prolonged release of the active ingredient.

10, 14, 15, 20, 30, 50, 60, 90, 100 prolonged-release tablets in blister packaging (PVC/aluminum).

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

or

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50. Gebersdof

90449 Nürnberg

Germany

or

Torrent Pharma (Malta) Ltd

Central Business Centre, Level 2, Triq Hal Tarxien

I1-Gudja, GDJ 1907, Malta

or

Labesfal – Laboratórios Almiro, S.A.

Lagedo, Santiago de Besteiros

3465-157 Santiago de Besteiros

Portugal

This medicine is authorized in the Member States of the European Economic Area with the following names:

Spain: indapamida retard cinfa 1.5 mg prolonged-release tablets EFG

Germany: Indapamid Heumann 1.5 mg Retardtabletten

Last review date of this leaflet:December 2023

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/70059/P_70059.html

QR code to:https://cima.aemps.es/cima/dochtml/p/70059/P_70059.html