INDAPAMIDE RETARD TEVAGEN 1.5 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Indapamide Retard Tevagen 1.5 mg prolonged-release tablets EFG

indapamide

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

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

-This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

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

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

Indapamide Retard Tevagen is a prolonged-release tablet containing the active substance indapamide.

This medication 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 widens blood vessels so that blood can pass through them more easily. This helps to reduce blood pressure.

2. What you need to know before taking Indapamide Retard Tevagen

Do not take Indapamide Retard Tevagen:

• if you are allergic to indapamide or any other sulfonamide, or to any of the other ingredients 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 (a degenerative brain disease).
• if you have low potassium levels in your blood.

Warnings and precautions

Consult your doctor or pharmacist before taking Indapamide 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 pressure in your eye, and 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 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, sensitivity, weakness, or cramps,
• if you need to undergo any tests 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 think any of these situations apply to you or if you 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 substance that can produce a positive result in doping tests.

Taking Indapamide Retard Tevagen with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.

Do not take Indapamide Retard Tevagen in combination 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 medications, as special care may be required:

• medications for heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis, bretylium),
• medications 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 condition that causes chest pain),
• cisapride, difemanil (used to treat gastrointestinal problems),
• antibiotics used to treat bacterial infections (e.g., esparfloxacin, moxifloxacin, intravenous erythromycin),
• vincamine intravenously (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 acetylsalicylic acid,
• 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,
• 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 medications 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).

Pregnancy, breastfeeding, and fertility

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

This medication is not recommended during pregnancy. When pregnancy is planned or confirmed, alternative treatment should be initiated as soon as possible. Inform your doctor if you are pregnant or wish to become pregnant.

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

Driving and using machines

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

Indapamide 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.

3. How to take Indapamide Retard Tevagen

Follow the administration instructions of this medication exactly 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.

The tablets can be taken independently of meals. They should be swallowed whole with water. Do not break or chew them.

Treatment for high blood pressure is usually for life.

Patients with kidney problems

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

Patients with liver problems

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

Elderly patients

Elderly patients can be treated with Indapamide Retard Tevagen as long as they do not have kidney problems.

Children and adolescents

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

If you take more Indapamide Retard Tevagen 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 medication 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 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 make up for forgotten doses.

If you stop taking Indapamide Retard Tevagen

Since treatment for high blood pressure is usually for life, 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.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Stop treatment with this medication 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 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, which 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) (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 fever, as these can be caused by abnormal muscle breakdown. (Frequency not known)

Other side effects may occur, in decreasing order of frequency:

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
• Purpura (purple spots or patches on the skin)
• 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 patients)

• Feeling tired, dizzy, 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 (decrease in platelet count, which can cause bruising and bleeding), leucopenia (decrease in white blood cells, which can cause fever without apparent cause, sore throat, or other flu-like symptoms – if this happens, contact your doctor) and anemia (decrease in red blood cells).
• Irregular heartbeat, low blood pressure;
• Kidney disease;
• Abnormal liver function.

Not known (cannot be estimated from available data)

• Fainting
• If you have systemic lupus erythematosus (a type of collagen disease), it may worsen.
• Photosensitivity reactions (change in skin appearance) have also been reported 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).
• You may notice changes 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:

• low potassium levels in the blood,
• low sodium levels in the blood, which can cause dehydration and low blood pressure,
• 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,
• high calcium levels in the blood,
• increased liver enzyme levels.

• Abnormal electrocardiogram

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Indapamide Retard Tevagen

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

Do not use this medication after the expiration date stated on the packaging and blister after EXP. 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 wastewater or household waste. Return the packaging and any unused medication to the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medication you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Indapamide Retard Tevagen

• The active substance is indapamide. Each tablet contains 1.5 mg of indapamide.
• The other ingredients are: lactose monohydrate, hypromellose (Methocel K4M Premium), colloidal anhydrous 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.

Appearance of the product and packaging contents

Indapamide Retard Tevagen are white, round, biconvex tablets, marked with "1.5" on one side and smooth on the other.

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

Not all pack sizes may be marketed.

Marketing authorization holder

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid.

Manufacturer

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

This medication is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Denmark: Indapamid Teva

Estonia: Indamax

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

Latvia: Indamax 1.5 mg prolonged-release tablets

Lithuania: Indamax 1.5 mg prolonged-release tablets

Portugal: Indapamida Teva

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

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

Date of last revision of this package leaflet: February 2023

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

You can access detailed and updated information about this medication 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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