Indapamide retard Cinfa 1.5 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

indapamide retard cinfa 1.5 mg prolonged-release tablets EFG

Read the entire 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 you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What indapamide retard cinfa is and what it is used for
2. What you need to know before taking indapamide retard cinfa
3. How to take indapamide retard cinfa
4. Possible side effects
5. How to store indapamide retard cinfa
6. Contents of the pack and other information

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

indapamida retard cinfa is available in the form of a prolonged-release tablet containing Indapamida as the active substance. This medicine 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 differs from other diuretics in that it causes only a slight increase in the amount of urine formed.

In addition, indapamida dilates blood vessels, allowing blood to flow more easily.

2. What you need to know before taking indapamide retard cinfa

Do not take indapamide retard cinfa:

• 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 (degenerative brain disease),
• if you have low potassium levels in the blood (hypokalaemia).

Warnings and precautions

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

• 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, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, and may occur within a few hours to one week after taking indapamide retard cinfa. This may lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this reaction,
• if you have muscle disorders including pain, tenderness, weakness, or muscle cramps,
• if you need to undergo any test to check whether your parathyroid gland is functioning properly.

You should 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.

If you think any of the above situations may apply to you, or if you have any doubts about how to take this medicine, consult your doctor or pharmacist.

Athletes should be aware that this medicine contains an active substance that may result in positive findings in doping tests.

Taking indapamide retard cinfa with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

You must not take indapamide 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 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 glycosides, bretylium),
• medicines 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 disorder causing chest pain),
• cisapride,
• difemethil (used to treat gastrointestinal disorders),
• 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 (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 treatment of muscle stiffness occurring in diseases such as multiple sclerosis),
• allopurinol (for treating gout),
• potassium-sparing diuretics (e.g. amiloride, spironolactone, triamterene),
• metformin (for treatment of diabetes),
• iodinated contrast agents (used in X-ray tests),
• calcium tablets or other calcium supplements,
• cyclosporine, tacrolimus, or other immunosuppressants used after transplantation, for treatment of autoimmune diseases, or severe dermatological or rheumatological conditions,
• tetracosactide (for 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 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. If you are taking this medicine, breastfeeding is not recommended.

Driving and use of machines:

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

indapamide retard cinfa contains lactose.

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

3. How to take indapamide retard cinfa

Follow exactly the instructions for administering 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 may be taken with or without food. The tablets must be swallowed whole with water. Do not break or chew them. Treatment for high blood pressure is usually lifelong.

If you take more indapamide retard cinfa 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 medication and the amount ingested.

A very high dose of indapamide 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 forget to take indapamide retard cinfa

If you forget to take a dose of your 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 indapamide retard cinfa

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 everybody 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 characterised by swelling of the skin in the limbs or face, swelling of the lips or tongue, or 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 all over the 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 severe 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 pain, particularly if you also feel unwell or have a high fever, which may be caused by abnormal muscle breakdown (Frequency not known).

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

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

• Skin rash with redness
• Allergic reactions, mainly skin-related, in individuals with a predisposition to allergic and asthmatic reactions
• Low blood potassium levels

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

• Vomiting
• 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 of tiredness, headache, tingling (paresthesia), dizziness
• 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 number of platelets, which increases the risk of bruising and nosebleeds), leucopenia (reduced white blood cells, 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)
• High levels of calcium in the blood
• Irregular heart rhythm (causing palpitations, awareness of heartbeat), low blood pressure
• Kidney disease (which may cause symptoms such as fatigue, increased need to urinate, skin itching, malaise, swollen limbs)
• Abnormal liver function

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

• Fainting
• If you have systemic lupus erythematosus (an immune system disorder causing inflammation and damage to joints, tendons and organs, with symptoms such as skin rashes, fatigue, loss of appetite, weight gain and joint pain), your condition may worsen.
• Cases of photosensitivity reactions (skin changes) after exposure to sunlight or artificial UVA radiation have also been reported.
• Shortness of vision (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 effusion) or acute angle-closure glaucoma]
• Changes may be observed in your 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 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 adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, 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. Indapamide Retard CINFA Storage

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

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

Store in the original packaging.

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

6. Contents of the pack and other information

Composition of indapamida retard cinfa

The active substance is: indapamida

Each prolonged-release tablet contains 1.5 mg of indapamida.

The other components are:

Lactose monohydrate, pregelatinized maize starch gluten-free, hypromellose, anhydrous colloidal silica, magnesium stearate (Ph. Eur.) (vegetable), macrogol 6000, titanium dioxide.

Appearance of the medicine and contents of the pack

White, round prolonged-release tablets.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain

Manufacturer

Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain

or

Heumann Pharma GmbH & Co. Generica KG
Südwestpark 50. Gebersdof
90449 Nürnberg
Germany

or

Torrent Pharma (Malta) Limited
HHF 028 Hal Far Industrial Estate, Birzebbuga, BBG, 3000, Malta

This medicinal product is authorized in the European Economic Area Member States under the following names:

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

Germany: Indapamid Heumann 1.5 mg Retardtabletten

Date of the most recent revision of this leaflet: December 2023

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. 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