Indapamide Kern Pharma 1.5 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Indapamide Retard Kern Pharma 1.5 mg prolonged-release tablets EFG

Read all of this 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 others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Indapamida Retard Kern Pharma is and what it is used for

Indapamida Retard Kern Pharma 1.5 mg is presented in the form of prolonged-release film-coated tablets containing indapamide as the active substance.

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

Indapamide is a diuretic. Most diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics in that it produces only a slight increase in the amount of urine formed.

In addition, indapamide dilates blood vessels, allowing blood to flow more easily. This helps reduce blood pressure.

2. What you need to know before taking Indapamide Retard Kern Pharma

Do not take indapamide retard kern pharma:

• 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 blood potassium levels.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Indapamide Retard Pharma:

• 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 need to undergo any test to check whether your parathyroid gland is functioning properly,
• 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, which may occur within hours to weeks after taking Indapamide Retard Kern Pharma. If left untreated, this may lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this,
• if you have muscle disorders, including muscle pain, tenderness, weakness, or 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 previously 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 conditions may apply to you, or if you have any doubts about how to take this medicine, consult your doctor or pharmacist.

Use in athletes:

This medicine contains indapamide, which may result in a positive doping test.

Other medicines and Indapamide Retard Kern Pharma

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to take any other medicines.

You must not take indapamide 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 (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, difenamizole (used to treat gastrointestinal problems),
• 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 inhibitors (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 the treatment of muscle stiffness occurring 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 in X-ray procedures),
• calcium tablets or other calcium supplements,
• cyclosporine, tacrolimus, or other immunosuppressive medicines used after organ transplantation, or for the treatment of autoimmune diseases, or severe dermatological or rheumatological conditions,
• tetracosactide (for the treatment of Crohn's disease),
• methadone (used for the treatment of 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.

The use of 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.

Indapamide is excreted in breast milk. Breastfeeding is not recommended if you are taking this medicine.

Driving and use of machines

This medicine may cause adverse effects due to lowered blood pressure, such as dizziness or fatigue (see section 4). The occurrence of these adverse effects is more likely at the beginning of treatment and after dose increases. If this happens, you must refrain from driving or performing other activities requiring alertness. However, once good control is achieved, these effects are unlikely.

Indapamida Retard Kern Pharma contains lactose

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

3. How to take Indapamide Retard Kern Pharma

Follow exactly the instructions for use of this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again. The recommended dose is one tablet per day, preferably in the morning. The tablets may be taken with or without food.

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

Treatment for high blood pressure is usually lifelong.

If you take more Indapamida Retard Kern Pharma than you should

In case of overdose or accidental ingestion, consult 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 may 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 Indapamida Retard Kern Pharma

If you forget to take your dose of indapamide, take the next dose at your usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Indapamida Retard Kern Pharma

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 everyone 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 characterized by swelling of the skin in the limbs or face, swelling of the lips or tongue, or swelling of the mucous membranes in 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 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 intense discomfort. (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, sensitivity or muscle pain, especially if you also feel unwell or have a high temperature, as these may be caused by abnormal muscle breakdown. (Frequency not known).

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

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

• Skin rash with redness.
• Allergic reactions, mainly dermatological, in individuals predisposed to allergic and asthmatic reactions.
• Low blood potassium levels.

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

• Vomiting.
• Small 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 tired, headache, tingling (paraesthesia), 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):

• High levels of calcium in the blood.
• Irregular heart rhythm, low blood pressure.
• Kidney disease.
• Abnormal liver function.
• Changes in blood cells, such as thrombocytopenia (reduced platelet count, which may lead to bruising and nosebleeds), leucopenia (reduced white blood cell count, which may cause fever without apparent cause, sore throat, or flu-like symptoms – if this occurs, contact your doctor), and anaemia (reduced red blood cell count).

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

• Fainting.

• If you have systemic lupus erythematosus (a type of collagen disease), it 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 disturbances.

• 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 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 may cause or worsen gout (joint pain, especially in the feet),

• increased blood glucose levels in diabetic patients,

• elevated liver enzyme levels.

• Abnormal electrocardiogram.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Indapamide Retard Kern Pharma

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Indapamide Retard Kern Pharma

The active substance is indapamide. Each tablet contains 1.5 mg of indapamide.

The other components are:

• tablet core: monohydrate lactose, pregelatinized corn starch, hypromellose, colloidal silicon dioxide, magnesium stearate.
• coating film: hypromelose, macrogol 6000, titanium dioxide.

Appearance of the product and contents of the pack

Prolonged-release film-coated tablets, white, round and biconvex.

The tablets are packaged in PVC/aluminum blisters.

Packages containing 30 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent review of this leaflet: June 2024

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