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NEOPAMID SR 1.5 mg. 30 tablets

€15
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This medicine is intended to reduce 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.

Quantity

What NEOPAMID SR is and what it is used for

This medicine is intended to reduce 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 diuretics in that it causes only a slight increase in the amount of urine produced.

2. What you need to know before you take NEOPAMIDE SR

Do not take NEOPAMIDE SR

if you are allergic to indapamide or another sulphonamide, 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 if you suffer from a disease called liver 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 NEOPAMIDE SR:

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 it works around the thyroid gland.

Tell your doctor if you have had photosensitivity reactions.

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

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 NEOPAMID SR

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

Do not take NEOPAMIDE SR 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, ibutilide, dofetilide, digitalis);

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

bepridil (used to treat angina pectoris - a disease that causes chest pain);

cisapride, diphemanil (used to treat gastrointestinal problems);

sparfloxacin, moxifloxacin, injectable erythromycin (antibiotics used to treat infections);

injectable vincamine (used for the symptomatic treatment of cognitive impairment in the elderly, including memory loss);

halofantrine (an antiparasitic drug 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;

stimulating laxatives;

baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis);

potassium-sparing diuretics (amiloride, spironolactone, triamterene);

metformin (used to treat diabetes);

iodinated contrast agents (used for research, including X - ray;

calcium or other calcium supplements;

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

dermatological diseases;

tetracosactide (used to treat Crohn's disease).

Pregnancy, lactation and fertility

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 during pregnancy. When a pregnancy is planned or confirmed, alternative treatment should be started as soon as possible. Please tell your doctor if you are pregnant or want to become pregnant.

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 as a result of lowering blood pressure, 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 refrain from driving and other activities that require extra care

Possible side effects

Like all medicines, NEOPAMID SR can cause side effects, although not everybody gets them.

Stop taking this medicine and talk to your doctor straight away if you get any of the following side effects:

Angioedema and / or urticaria. Angioedema is characterized by swelling of the face, swelling of the lips or tongue, swelling of the lining of the throat or airways, manifested by shortness of breath or difficulty swallowing. If this happens, contact your doctor immediately. (Very rare) (may affect up to I in 10,000 patients);

Severe skin reactions, including a severe skin rash, reddening of the skin all over the body, severe itching, blistering, flaking 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 heart rhythm disorder (frequency not known);

Inflammation of the pancreas, which can cause severe pain in the abdomen and back, accompanied by a feeling of severe malaise (very rare) (may affect up to 1 in 10,000 patients);

Brain disease caused by liver disease (hepatic encephalopathy) (Not known);

Inflammation of the liver (hepatitis) (Not known).

In descending order of frequency, other side effects include:

Common (may affect up to 1 in 10 people)

Red skin rash;

Allergic reactions, mainly skin, in people with a predisposition to allergic and asthmatic reactions.

Uncommon (may affect up to 1 in 100 people)

Vomiting;

Red spots on the skin (purple).

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

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

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

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

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

High levels of calcium in the blood;

Cardiac arrhythmias, low blood pressure;

Kidney disease;

Abnormal liver function.

Not known (frequency cannot be calculated from the available data)

Fainting;

If you suffer from systemic lupus erythematosus (a type of collagenosis), it can get worse

Cases of photosensitivity reactions (changes in skin appearance) have been reported following sun exposure or artificial UVA rays;

Myopia;

Blurred vision;

Visual impairment;

There may be some changes in your laboratory tests and your doctor may refer you to have blood tests to check your condition.

The following changes in laboratory parameters may occur:

Low levels of potassium in the blood;

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

Increased uric acid - a condition that can cause or worsen gout (painful joints, especially on the feet);

Elevated blood glucose levels in diabetics;

Elevated levels of liver enzymes;

ECG changes.

How to store NEOPAMIDE SR

Keep out of reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

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.

6. Contents of the package and additional information

What NEOPAMID SR 1.5 mg contains

The active substance is indapamide. Each tablet contains 1.5 mg of indapamide.

The other ingredients are:

tablet core: lactose monohydrate, hypromellose K100MCR, corn starch, pregelatinized, silica, colloidal anhydrous, magnesium stearate

film-coated tablet: hypromellose, titanium dioxide, macrogol 6000, purified water.

What NEOPAMID SR looks like and contents of the pack

White to off-white round, biconvex film-coated tablets.

10 film-coated tablets in a PVC / A1 blister.

Package size: 30 pieces.

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