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Tevaindam 1.5 mg. 30 tablets

€15
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This medicine is intended to lower high blood pressure (hypertension). The prolonged-release film-coated tablets contain indapamide as the active substance. Indapamide is a diuretic.

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What TevaIndam is and what it is used for

This medicine is intended to lower high blood pressure (hypertension). The prolonged-release film-coated tablets contain indapamide as the active substance. Indapamide is a diuretic. Most diuretics increase the amount of urine produced by the kidneys. However, indapamide is different from other dierutics in that it causes only a slight increase in the amount of urine produced.

2. What you need to know before you take TevaIndam

Do not take TevaIndam

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section b)

if you have severe kidney disease

if you have severe liver disease or if you suffer from a condition 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 TevaIndam:

if you have liver problems

if you have diabetes

if you suffer from gout

if you have any heart rhythm problems or kidney problems.

if you need an examination to check how your thyroid is functioning.

Tell your doctor if you have had photosensitivity reactions (sensitivity to light).

Your doctor may order blood tests to check for low levels of sodium or potassium or high levels of calcium.

If you think any of these apply to you, or if you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Athletes should keep in mind that this medicine contains an active substance that may give a positive reaction during a doping test.

Other medicines and TevaIndam

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

Do not take TevaIndam with lithium products (used to treat depression) because of the risk of elevated blood lithium levels.

Tell your doctor if you are taking any of the following medicines, as special care may be needed in this case:

medicines used for heart rhythm problems (for example: quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibugilide, dofetilide, digitalis)

drugs used to treat mental illness such as depression, anxiety, schizophrenia (tricyclic antidepressants, antipsychotics, neuroleptics)

bepridil (used to treat angina pectoris, a condition that causes chest pain)

cisapride, diphemanil (used to treat gastrointestinal problems), sparfloxacin, moxifloxacin (antibiotics used to treat infections)

halofantrine (an antiparasitic medicine used to treat certain types of malaria)

pentamidine (used to treat some types of pneumonia)

mizolastine (used to treat allergic reactions such as pollen allergy)

non-steroidal anti-inflammatory drugs to relieve pain (eg ibuprofen) or high doses of aspirin

angiotensin converting enzyme (ACE) inhibitors (used to treat high blood pressure and heart failure)

oral corticosteroids used to treat a variety of conditions, including 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 (used to treat diabetes)

iodinated contrast agents (used for research, calcium or other calcium supplements

cyclosporine, tacrolimus or other drugs to suppress the immune system after organ transplantation, to treat autoimmune diseases or acute rheumatoid or dermatological diseases

tetracosactide (used to treat Crohn's disease)

Pregnancy and lactation

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. This medicine is not recommended for use during pregnancy. If you are pregnant or think you may be pregnant, your doctor will advise you to stop taking TevaIndam and advise you to switch to alternative treatments as soon as possible.

The active substance is excreted in breast milk. If you are taking this medicine, breast-feeding is not recommended.

Driving and using machines

This medicine may cause side effects such as dizziness or tiredness (see section 4). These side effects occur most often at the beginning of treatment and after increasing the dose. If this happens, you should not drive or perform other activities that require special attention. However, with good control, these side effects are unlikely to occur.

TevaIndam contains lactose myohydrate

This medicine contains lactose monohydrate. If your doctor has told you

Possible side effects

Common:

Low levels of potassium in the blood, which can cause muscle weakness

Uncommon:

Vomiting, allergic skin reactions such as skin rash, purpura (red spots on the skin) in people with a predisposition to allergic and asthmatic reactions

Rare:

Feeling tired, dizzy, headache, tingling (paresthesia),

Gastrointestinal disorders (such as nausea, constipation), dry mouth,

Increased risk of dehydration in elderly patients and in patients with heart failure

Very rare:

Heart rhythm disorders, low blood pressure

Kidney disease

Pancreatitis (inflammation of the pancreas that causes pain in the porn of the abdomen), abnormal liver function. In case of liver failure, hepatic encephalopathy (degenerative brain disease) is possible.

Changes in the number of blood cells - thrombocytopenia (decrease in the number of platelets, which causes easy occurrence of bruising and also nosebleeds); leukopenia (reduction in the number of white blood cells, which may cause fever of unknown origin, sore throat or other flu-like symptoms; if this occurs, contact your doctor immediately) and anemia (reduction in the number of red blood cells);

Angioedema and / or urticaria, severe skin manifestations. Angioedema is characterized by swelling of the skin of the limbs or face, swelling of the lips or tongue, swelling of the lining of the throat or airways, leading to shortness of breath or difficulty swallowing. If this happens, contact your doctor immediately.

If you suffer from systemic lupus erythematosus (a type of connective tissue disease), it can get worse. Cases of photosensitivity reactions (changes in skin appearance) following exposure to the sun or artificial UVA rays have also been reported.

Some changes in your laboratory tests may be seen and your doctor may advise you to have blood tests to check your condition. The following changes in laboratory parameters may be observed:

Low levels of potassium in the blood

Low levels of sodium in the blood, which can lead to dehydration and low blood pressure

Elevated uric acid levels - a condition that can cause or worsen gout (painful joints especially on the feet)

Elevated blood glucose levels in diabetics

Elevated levels of calcium in the blood

How to store TevaIndam

Keep out of reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. Store below 30 ° C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

b. Package contents and additional information

What TevaIndam contains

- The active substance is indapamide. Each prolonged-release tablet contains 1.5 mg indapamide.

- Excipients are: lactose monohydrate, hypromellose, colloidal anhydrous silica, magnesium stearate.

Film coating: hypromellose, glycerol, titanium dioxide.

What TevaIndam looks like and contents of the pack

White, round, prolonged-release film-coated tablets.

Packs of 30 film-coated tablets in a blister (PVC / PVdC-Alu).

Not all pack sizes may be marketed.

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