INDAPAMIDE RETARD PENSA 1.5 mg PROLONGED-RELEASE FILM-COATED TABLETS

Introduction

Leaflet: information for the user

Indapamide Retard Pensa 1.5 mg prolonged-release film-coated tablets EFG

Read the entire leaflet carefully before starting to take the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet

1. What is Indapamide Retard Pensa and what is it used for
2. Before taking Indapamide Retard Pensa
3. How to take Indapamide Retard Pensa
4. Possible side effects
5. Storage of Indapamide Retard Pensa
6. Additional information

1. What is Indapamide Retard Pensa and what is it used for

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.

This medicine is indicated for the treatment of high blood pressure (hypertension).

2. Before taking Indapamide Retard Pensa

Do not take Indapamide Retard Pensa

-if you are allergic (hypersensitive) to indapamide, sulfamides, or any of the other components of Indapamide Retard Pensa.

• if you have severe kidney disease.
• if you have severe liver disease or suffer from a disorder called hepatic encephalopathy (a brain function disorder that occurs when the liver is no longer able to remove toxic substances from the blood).
• if you have abnormally low potassium levels in your blood.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Indapamide Retard Pensa

• if you have liver problems
• if you have diabetes
• if you have gout
• if you have any heart problems or kidney problems
• if you need to undergo a test to check if your parathyroid gland is working properly
• if you experience a decrease in vision or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within a few hours to a week after taking Indapamide Retard Pensa.

You should inform your doctor if you have had photosensitivity reactions. Avoid exposure to the sun (even on cloudy days) and UVA lamps while using this medicine.

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 affect you or have any doubts about how to take this medicine, consult your doctor or pharmacist.

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those purchased without a prescription.

Do not take Indapamide Retard Pensa 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 (such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis),
• medicines used to treat mental disorders such as depression, anxiety, schizophrenia (such as tricyclic antihypertensives, antipsychotics, neuroleptics),
• bepridil (used to treat angina pectoris, a disorder that causes chest pain),
• cisapride, difemanil (used to treat gastrointestinal problems),
• esparfloxacino, moxifloxacino (antibiotics used to treat infections),
• halofantrine (antiparasitic used to treat certain types of malaria),
• pentamidine (used to treat certain types of pneumonia),
• mizolastine (used to treat allergic reactions, such as pollen allergy),
• non-steroidal anti-inflammatory drugs for pain relief (such as ibuprofen) or high doses of acetylsalicylic acid.
• angiotensin-converting enzyme inhibitors (ACE inhibitors) (used to treat high blood pressure and heart failure),
• 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),
• potassium-sparing diuretics (amiloride, spironolactone, triamterene),
• metformin (for the treatment of diabetes)
• iodinated contrast agent (used for X-ray tests)
• calcium tablets or other calcium supplements,
• cyclosporine, tacrolimus, or other immunosuppressive drugs used after transplantation, for the treatment of autoimmune diseases, or severe dermatological or rheumatological diseases,
• tetracosactide (for the treatment of Crohn's disease).

Taking Indapamide Retard Pensa with food and drinks

Indapamide Retard Pensa can be taken with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

It is not recommended to take this medicine 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 wish to become pregnant.

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

Use in athletes

Athletes are informed that this medicine contains a component that may produce a positive result in doping tests.

Driving and using machines

It is unlikely that Indapamide Retard Pensa will affect your ability to drive or use machines. However, like other medicines used to treat high blood pressure, Indapamide Retard Pensa may cause dizziness or drowsiness in some people, especially at the start of treatment, when changing doses, or when consuming alcohol. If you experience dizziness or drowsiness, consult your doctor before performing these activities.

Important information about some of the components of Indapamide Retard Pensa

This medicine 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 Pensa

Follow the administration instructions of Indapamide Retard Pensa indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Remember to take your medicine.

Dosage

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

Treatment for high blood pressure is usually for life.

Your doctor will indicate the duration of your treatment with Indapamide Retard Pensa.

Method of administration

This medicine is administered orally.

The tablets can be taken with or without food. They should be swallowed whole with a glass of water and not chewed.

If you take more Indapamide Retard Pensa 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 Retard Pensa could cause nausea, vomiting, low blood pressure, cramps, dizziness, drowsiness, confusion, changes in the amount of urine produced by the kidneys.

If you forget to take Indapamide Retard Pensa

If you forgot to take your dose of Indapamide Retard Pensa 1.5 mg tablets, take the next dose at the usual time. Do not take a double dose to make up for the forgotten doses.

If you stop treatment with Indapamide Retard Pensa

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

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

4. Possible side effects

Like all medicines, Indapamide Retard Pensa can cause side effects, although not everyone gets them.

These may include:

Frequent (affecting 1 to 10 in every 100 patients):

• low potassium levels in the blood, which can cause muscle weakness.

Uncommon (affecting 1 to 10 in every 1,000 patients):

• vomiting,
• allergic reactions, mainly skin-related, such as skin rashes, purpura (red spots on the skin) in people with a predisposition to allergic and asthmatic reactions.
• Low sodium levels in the blood that can cause dehydration and low blood pressure.
• Impotence (inability to have or maintain an erection).

Rare (affecting 1 to 10 in every 10,000 patients):

• Fatigue, dizziness, headache, tingling (paresthesia);
• Gastrointestinal disorders (such as nausea, constipation), dry mouth;
• Increased risk of dehydration in the elderly and in patients with heart failure.
• Low chloride levels in the blood.
• Low magnesium levels in the blood.

Very rare (affecting less than 1 in every 10,000 patients):

• Heart rhythm irregularities, low blood pressure;
• Kidney disease;
• Pancreatitis (inflammation of the pancreas that causes pain in the upper abdomen), liver function changes. In cases of liver failure, there is a possibility of developing hepatic encephalopathy (a degenerative brain disease).
• 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 cause fever without apparent cause, sore throat, or other flu-like symptoms - if this occurs, contact your doctor) and anemia (decrease in red blood cells).
• Angioedema and/or urticaria, severe skin manifestations. Angioedema is characterized by inflammation of the skin of the extremities or face, inflammation of the lips or tongue, inflammation of the mucous membranes of the throat or respiratory tract that causes difficulty breathing or swallowing. If this occurs, contact your doctor immediately. If you have systemic lupus erythematosus (a type of collagen disease), it may worsen. There have also been reports of photosensitivity reactions (change in skin appearance) after exposure to the sun or artificial UVA rays.

Some changes may be observed in your analytical tests, 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 can cause or worsen gout (joint pain, especially in the feet),
• increased glucose levels in the blood in diabetic patients,
• increased calcium levels in the blood.

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]

If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Indapamide Retard Pensa

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Indapamide Retard Pensa after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines that you no longer need in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

6. Additional information

Composition of Indapamide Retard Pensa

• The active ingredient is indapamide. Each tablet contains 1.5 mg of indapamide.
• The other components (excipients) are: lactose monohydrate, pregelatinized corn starch, hypromellose, colloidal silicon dioxide, magnesium stearate. Coating components: hypromellose, macrogol 6000, and titanium dioxide.

Appearance of the product and packaging content

Indapamide Retard Pensa are prolonged-release film-coated tablets, round, biconvex, white or almost white.

The tablets of Indapamide Retard Pensa are packaged in PVC/Aluminum blisters. Each package contains 30 tablets.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50, 90449 Nürnberg (Germany)

or

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19,

Venda Nova 2700-487 Amadora

Portugal

Date of the last revision of this leaflet: September 2021

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