Label: Information for the User

Indapamida Retard Tevagen 1.5 mg prolonged-release tablets EFG

indapamida

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

-Keep this label, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to others, 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 label. See section 4.

Indapamida Retard Tevagen is a prolonged-release tablet containing the active ingredient indapamida.

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 widens blood vessels so that blood passes through them more easily. This helps to reduce blood pressure.

Do not take Indapamida Retard Tevagen:

• if you are allergic to indapamide or any other sulfonamide, or to any of the other components of this medication (listed in section 6)
• if you have severe kidney disease.
• if you have severe liver disease or suffer from a condition called hepatic encephalopathy (degenerative brain disease).
• if you have low levels of potassium in your blood.

Warnings and precautions

Consult your doctor or pharmacist before taking Indapamida Retard Tevagen:

• 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 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 eye pressure, which can occur within hours to weeks after taking indapamide 2.5 mg. 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 higher risk of developing this,

- if you have muscle disorders, including muscle pain, sensitivity, weakness, or cramps,

- if you need to undergo a test to check if your parathyroid gland is functioning correctly.

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 think any of these situations apply to you or have any doubts or questions about taking your medication, you should consult your doctor or pharmacist.

Athletes should be aware that this medication contains an active ingredient that can produce a positive result in doping control tests.

Taking Indapamida Retard Tevagen with other medications

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

Do not take Indapamida Retard Tevagen in combination with:

• Lithium (used to treat depression): due to the risk of increased lithium levels in the blood.

Ensure you inform your doctor if you are using any of the following medications, as special care may be required:

- medications for heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitals, bretylium),

- medications 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),

- intravenous vincamine (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),

- nonsteroidal 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),

- intravenous amphotericin B (antifungal medications),

- 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),

- potassium-sparing diuretics (e.g. amiloride, spironolactone, triamterene),

- metformin (for the treatment of diabetes),

- iodinated contrast agents (used for X-ray tests),

- calcium tablets or other calcium supplements,

- ciclosporin, tacrolimus, or other immunosuppressive medications used after transplantation, 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, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

This medication is not recommended during pregnancy. When pregnancy is planned or confirmed, switching to an alternative treatment as soon as possible is recommended. Inform your doctor if you are pregnant or plan to become pregnant.

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

Driving and operating machinery

This medication may cause adverse effects due to decreased blood pressure, causing dizziness or fatigue (see section 4). These adverse effects are more likely to occur after starting treatment and after increasing the dose. If this happens, you should refrain from driving and performing activities that require alertness. However, with good control, these adverse effects are unlikely to occur.

Indapamida Retard Tevagen contains Lactose

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 1.5 mg (one tablet) per day, preferably in the morning.

Tablets can be taken regardless of meals. They should be swallowed whole with water. Do not break or chew them.

The treatment for high blood pressure is usually lifelong.

Patients with kidney problems

Indapamida Retard Tevagen is not recommended for patients with kidney problems.

Patients with liver problems

Indapamida Retard Tevagen is not recommended for patients with liver problems.

Older adults

Older adults can be treated with Indapamida Retard Tevagen as long as they do not have kidney problems.

Children and adolescents

Indapamida Retard Tevagen is not recommended for use in children and adolescents.

If you take more Indapamida Retard Tevagen 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 Tevagen

If you forget to take a dose of this medication, 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 Tevagen

Since the 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, mucous membrane inflammation (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)

- Inflammation of the liver (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 patients)

• Skin rash with redness
• 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 patients)

• Vomiting.
• Purple spots or patches on the skin (Purpura).
• Low sodium levels in the blood that may cause dehydration and low blood pressure
• Impotence (inability to have or maintain an erection)

Rare: (may affect up to 1 in 1,000 patients)

• Feeling tired, dizziness, headache, tingling (paresthesia), vertigo;
• 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 patients)

• Changes in blood cells, such as thrombocytopenia (decreased platelet count, which may cause bruising and nosebleeds), leucopenia (decreased white blood cell count, which may 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).
• Irregular heart rhythm, low blood pressure;
• Kidney disease;
• Abnormal liver function.

Unknown: (cannot be estimated from available data)

• Loss of consciousness.
• 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 tests), so your doctor may prescribe blood tests to monitor your condition. The following changes may be observed in your laboratory tests:

• Low potassium levels in the blood,
• Low sodium levels in the blood that may cause dehydration and low blood pressure,
• Increased uric acid, a substance that may cause or worsen gout (joint pain, especially in the feet),
• Increased blood glucose levels in diabetic patients,
• High calcium levels in the blood,
• Increased 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 theSpanish System for the Pharmacovigilance of Medicines for Human Use:https://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.

Do not usethis medicationafter the expiration date that appears on the packaging and the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Composition of Indapamida Retard Tevagen

• The active ingredient is indapamida. Each tablet contains 1.5 mg of indapamida.
• The other components are: lactose monohydrate, hypromellose (Methocel K4M Premium), anhydrous colloidal silica, and magnesium stearate.
• The coating (Opadry II white 33G28707) contains: hypromellose 6cP (E-464), titanium dioxide (E-171), lactose monohydrate, macrogol 3000, and triacetin.

Aspect of the product and content of the packaging

Indapamida Retard Tevagen are white, round, biconvex tablets, marked with “1,5” on one face and smooth on the other.

Indapamida Retard Tevagen are packaged in blisters of 10, 14, 15, 20, 28, 30, 50, 60, 90, 98, and 100 tablets.

Only some packaging sizes may be commercially marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B, 1st floor.

28108 Alcobendas.Madrid.

Responsible for manufacturing

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Denmark:Indapamid Teva

Estonia:Indamax

France:Indapamide TEVA Santé LP 1.5 mg, prolonged-release coated tablet

Lithuania:Indamax 1.5 mg prolonged-release tablets

Portugal:Indapamida Teva

Spain:Indapamida Retard Tevagen 1.5mg prolonged-release tablets EFG

United Kingdom (NI):CARDIDE SR 1.5 mg Prolonged Release Tablets

Last review date of this leaflet: February 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/74633/P_74633.html

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