Prospect: information for the user

Indapamida Retard Kern Pharma 1.5 mg prolonged-release tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

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

3.How to take Indapamida Retard Kern Pharma

4.Possible adverse effects

5.Storage of Indapamida Retard Kern Pharma

6.Contents of the package and additional information

IndapamidaRetard Kern Pharma 1.5 mg is presented in the form of a coated tablet with prolonged release filmcontaining 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 indapamida retard kern pharma:

• 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 a severe kidney disease,
• If you have a severe liver disease or suffer from a condition called hepatic encephalopathy (a 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 are undergoing a test to check if your parathyroid gland is working properly,

-If you experience a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which can occur within hours or weeks of taking Indapamia Retard Kern Pharma. 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 working properly.

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 medicine, consult your doctor or pharmacist.

Use in athletes:

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

Other medicines and Indapamide Retard Kern Pharma

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

You should 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, digitals, 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 that causes chest pain),

-Cisapride, difemanil (used to treat gastrointestinal problems),

-Antibiotics used to treat bacterial infections (e.g. enoxacin, moxifloxacin, intravenous erythromycin),

-Vincamine intravenous (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),

-Non-steroidal 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),

-Anfotericin B intravenous (antifungal medicines),

-Oral corticosteroids used in various treatments, including severe asthma and rheumatoid arthritis,

-Laxatives,

-Baclofen (for the treatment of muscle stiffness that occurs in diseases such as multiple sclerosis),

-Allopurinol (for the treatment of gout),

-Diuretics that spare potassium (e.g. amiloride, spironolactone, triamterene),

-Metformin (for the treatment of diabetes),

-Contrast agents (used for X-ray tests),

-Calcium tablets or other calcium supplements,

-Ciclosporin, tacrolimus, or other immunosuppressive medicines used after a transplant, for the treatment of autoimmune diseases, or severe skin 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, 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 change to an alternative treatment should be made as soon as possible. Inform your doctor if you are pregnant or plan to become pregnant.

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

Driving and operating machinery

This medicine may cause side effects due to low 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 occurs, you should refrain from driving or performing other activities that require alertness. However, when control is good, these side effects are unlikely.

Indapamide Retard Kern Pharma contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

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 must 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

A very high dose of indapamida 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 Indapamida Retard Kern Pharma

If you forget to take your indapamida dose, 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 Kern Pharma

Since treatment for high blood pressure is usually 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, 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.

Rare (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):

• High calcium levels in the blood.
• Irregular heart rhythm, low blood pressure.
• Kidney disease.
• Abnormal liver function.
• Changes in blood cells, such as thrombocytopenia (decreased platelet count, which can cause bruising and nosebleeds), 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).

Unknown frequency(cannot be estimated from available data):

• Fainting.
• If you have systemic lupus erythematosus (a type of collagen disease), it may worsen.
• Phototoxicity reactions (skin changes) have also been described after exposure to sunlight or artificial UVA radiation.
• Short-sightedness (myopia).
• Blurred vision.
• Visual disturbance.
• 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)(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 levels, 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 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 Spanish System for the Pharmacovigilance of Medicines for Human Use: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.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

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

Composition of Indapamida RetardKern Pharma

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

The other components are:

• tablet core: lactose monohydrate, cornstarch, hypromellose, colloidal silicon dioxide, magnesium stearate.
• coating film: hypromellose, macrogol 6000, titanium dioxide.

Appearance of the product and content of the packaging

Coated tablets with prolonged release film, white in color, round, and biconvex.

The tablets are packaged in PVC/Aluminum blisters.

Packaging containing 30 tablets.

Holder of the marketing authorization and responsible manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet:June 2024

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