Indapamide Tevagen 1.5 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Indapamida Retard Tevagen 1.5 mg prolonged-release tablets EFG

indapamide

Read the entire 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 questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

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 causes only a slight increase in the amount of urine formed.

In addition, indapamide widens the blood vessels, allowing blood to flow through them more easily. This helps reduce blood pressure.

2. What you need to know before starting to take Indapamide Retard Tevagen

Do not take Indapamide Retard Tevagen:

• if you are allergic to indapamide or to 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 levels of potassium in your blood

Warnings and precautions

Talk to 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 disorders 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, which may occur within hours to weeks after taking 2.5 mg of indapamide. If left untreated, this may lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamides, you may have a higher risk of developing this condition
• if you have muscle disorders, including muscle pain, tenderness, weakness, or cramps
• if you need to undergo any test to check whether your parathyroid gland is functioning properly

You must inform your doctor if you have previously experienced photosensitivity reactions.

Your doctor may prescribe blood tests to check whether you have low levels of sodium or potassium, or high levels of calcium.

If you think any of these situations apply to you, or if you have any doubts or questions about how to take your medicine, you should consult your doctor or pharmacist.

Athletes should be aware that this medicine contains an active substance that may result in a positive doping test.

Taking Indapamide Retard Tevagen with other medicines

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

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 taking 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, sultopride, tiapride, haloperidol, droperidol))
• bepridil (used to treat angina pectoris, a condition causing chest pain)
• cisapride, difemanil (used to treat gastrointestinal problems)
• antibiotics used to treat bacterial infections (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin)
• intravenous vincamine (used to treat symptomatic cognitive disorders in elderly patients including memory loss)
• halofantrine (an 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 (NSAIDs) 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 occurring 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 in X-ray examinations)
• calcium tablets or other calcium supplements
• ciclosporin, tacrolimus or other immunosuppressants used after transplantation, 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 are planning 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.

The active substance is excreted in breast milk. Breastfeeding is not recommended if you are taking this medicine.

Driving and use of machines

This medicine may cause adverse effects due to a decrease in blood pressure, leading to fatigue or dizziness (see section 4). These adverse effects are more likely to occur after starting treatment or after increasing the dose. If this happens, you should refrain from driving and from performing activities requiring alertness. However, with proper control, these adverse effects are unlikely to occur.

Indapamide Retard Tevagen contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Indapamida Retard Tevagen

Follow exactly the instructions for use of this medicine as provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The tablets may be taken regardless of meals. They must be swallowed whole with water. Do not break or chew them.

Treatment for high blood pressure is usually lifelong.

Patients with kidney problems

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

Patients with liver problems

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

Elderly patients

Elderly patients may be treated with Indapamida Retard Tevagen provided 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

A very high dose of indapamide may 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 medicine, take the next dose at your usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Indapamida Retard Tevagen

Since treatment for high blood pressure is usually lifelong, you must speak with your doctor before stopping this medicine.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop taking this medicine and contact your doctor immediately if you experience any of the following adverse effects, which may be serious:

• Angioedema and/or urticaria. Angioedema is characterized by swelling of the skin in the limbs or face, swelling of the lips or tongue, or swelling of the mucous membranes in the throat or airways, 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 rash, widespread redness of the skin, intense itching, blisters, peeling and swelling of the skin, inflammation of 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)
• Inflammation of the pancreas, which may 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)
• Inflammation of the liver (Hepatitis) (Frequency not known)
• Muscle weakness, cramps, tenderness or muscle pain, especially if you also feel unwell or have a high temperature, as these may be caused by abnormal muscle breakdown. (Frequency not known)

In order of decreasing frequency, other adverse effects may include:

Common (may affect up to 1 in 10 patients)

• Skin rash with redness
• Allergic reactions, mainly dermatological, in individuals predisposed to allergic and asthmatic reactions
• -Low blood potassium levels

Uncommon (may affect up to 1 in 100 patients)

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

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

• Feeling of tiredness, dizziness, headache, tingling (paresthesia), vertigo
• Gastrointestinal disorders (such as nausea, constipation), dry mouth
• Low blood chloride levels, low blood magnesium levels

Very rare (may affect up to 1 in 10,000 patients)

• Changes in blood cells, such as thrombocytopenia (reduced platelet count, which increases the risk of bruising and nosebleeds), leucopenia (reduced white blood cell count, which may cause fever without apparent cause, sore throat or other flu-like symptoms – if this occurs, contact your doctor), and anemia (reduced 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

• Cases of photosensitivity reactions (skin changes) following exposure to sunlight or artificial UVA radiation have also been reported

• Shortness of vision (myopia)

• Blurred vision

• Visual disturbances

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

• low blood potassium levels

• low blood sodium levels, which may cause dehydration and low blood pressure

• increased uric acid levels, a substance that may cause or worsen gout (joint pain, especially in the feet)

• increased blood glucose levels in diabetic patients

• high blood calcium levels

• increased liver enzyme levels

• Abnormal electrocardiogram

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Indapamide Retard Tevagen

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Indapamide Retard Tevagen

• The active substance is indapamide. Each tablet contains 1.5 mg of indapamide.
• The other components are: monohydrate lactose, 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), monohydrate lactose, macrogol 3000 and triacetin.

Appearance of the product and contents of the pack

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid, Spain

Manufacturer responsible

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

The Netherlands

This medicine 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 coated tablet

Latvia: Indamax 1.5 mg ilgstošas darbibas tabletes

Lithuania: Indamax 1.5 mg pailginto atpalaidavimo tabletes

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 the most recent review of this leaflet: February 2023

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. 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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