INDAPAMIDE RETARD KERN PHARMA 1.5 mg PROLONGED RELEASE TABLETS

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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

Indapamide Retard Kern Pharma 1.5 mg is presented in the form of a film-coated tablet with prolonged release that contains indapamide as the active ingredient.

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 is different from other diuretics, as it only produces a slight increase in the amount of urine formed.

In addition, indapamide dilates blood vessels so that blood can circulate more easily. This helps to reduce blood pressure.

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

N:

• if you are allergic to indapamide or 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 problems or kidney problems,
• if you need to undergo any test to check if your parathyroid gland is working 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 and can occur within hours to weeks after taking Indapamia Retard Kern Pharma. If left untreated, this can lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamides, you may be at greater risk of developing this,
• if you have muscle disorders, including muscle pain, sensitivity, weakness, or cramps,
  • if you need to undergo any test to check if your parathyroid gland is working properly.

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.

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

Use in athletes:

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

Other medicines and Indapamide Retard Kern Pharma

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

Do 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 using 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, bretylium),
• medicines used to treat mental disorders such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants, antipsychotics, neuroleptics (such as amisulpride, sulpiride, sultoprida, tiaprida, 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., sparfloxacin, moxifloxacin, intravenous erythromycin),
• vincamine intravenously (used to treat symptomatic 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),
• non-steroidal anti-inflammatory drugs 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 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 agent (used for X-ray tests),
• calcium tablets or other calcium supplements,
• cyclosporin, tacrolimus, or other immunosuppressive medicines used after a transplant, 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).

Embarazo y lactancia

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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.

Indapamide is excreted in breast milk. If you are taking this medicine, breastfeeding is not recommended.

Driving and using machines

This medicine may cause side effects due to the lowering of blood pressure, such as dizziness or fatigue (see section 4). The occurrence of these side effects is more likely after starting treatment and after dose increases. If this happens, you should avoid driving or performing other activities that require alertness. However, when there is good control, these effects are unlikely.

Indapamida Retard Kern Pharma contains lactose

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

3. How to take Indapamide Retard Kern Pharma

Follow exactly the administration instructions of this medicine 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 morning. The tablets can 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 for life.

If you take more Indapamide 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, phone: 91 562 04 20, indicating the medicine and the amount ingested.

A very high dose of indapamide 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 Kern Pharma

If you forget to take your dose of indapamide, 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 Kern Pharma

Since treatment for high blood pressure is usually for life, you should talk to your doctor before stopping this medicine.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking this medicine and contact your doctor immediately if you experience any of the following serious side effects:

• Angioedema and/or urticaria. Angioedema is characterized by swelling of the skin of 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 happens, 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, intense itching, blisters, peeling, and swelling of the skin, inflammation of the 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).
• Pancreatitis that can cause severe abdominal and back pain accompanied by severe discomfort (Very rare) (may affect up to 1 in 10,000 people).
• Brain disease caused by liver disease (Hepatic Encephalopathy) (Frequency not known).
• Hepatitis (inflammation of the liver) (Frequency not known).
• Muscle weakness, cramps, sensitivity, or muscle pain, and especially if you feel unwell or have a high temperature, as they can be caused by abnormal muscle breakdown. (Frequency not known).

Other side effects may be:

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

• Redness of the skin.
• 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, which 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, 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):

• High calcium levels in the blood.
• Irregular heart rhythm, low blood pressure.
• Kidney disease.
• Abnormal liver function.
• Changes in blood cells, such as thrombocytopenia (decrease in the number of platelets, which favors the appearance of hematomas and nosebleeds), leucopenia (decrease in white blood cells, which can produce fever without apparent cause, sore throat, or other flu-like symptoms - if this happens, contact your doctor) and anemia (decrease in red blood cells).

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

• Fainting.
• If you suffer from systemic lupus erythematosus (a type of collagen disease), it may worsen.
• There have also been reports of photosensitivity reactions (change in the appearance of the skin) after sun exposure or artificial UVA radiation.
• Short-sightedness (myopia).
• Blurred vision.
• Visual disturbance.
• 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 (blood analysis), so your doctor may prescribe blood tests to monitor your condition. The following changes may be observed in your blood tests:

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

• Abnormal electrocardiogram.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 which is stated on the packaging after “EXP”. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicine to a pharmacy for disposal. By doing this, you will help protect the environment.

6. Contents of the pack and other information

Composition of Indapamide Retard Kern Pharma

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

The other ingredients are:

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

Appearance of the product and packaging contents

White, round, biconvex film-coated tablets with prolonged release.

The tablets are packaged in PVC/Aluminum blisters.

Packaging 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 last revision of this leaflet:June 2024

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