• New

Indolen SR 1.5 mg. 30 tablets

€15
Tax included

This medicine is intended to reduce high blood pressure (hypertension). Indole SR contains indapamide as an 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.

Quantity

What Indolen SR is and what it is used for

This medicine is intended to reduce high blood pressure (hypertension). Indolen SR contains indapamide as an 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 Indolen SR

Do not take Indolen SR:

if you are allergic (hypersensitive) to indapamide, another sulphonamide or any of the other ingredients of this medicine (listed in section 6);

if you are hypersensitive to sulfonamide derivatives;

if you have severe kidney failure;

if you have hepatic encephalopathy (degenerative brain disease) or severe liver failure;

if you have low levels of potassium in your blood (hypokalaemia).

Warning and precautions

Talk to your doctor, pharmacist or nurse before taking Indole 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 your thyroid gland.

Tell your doctor if you have had light sensitivity 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 Indole SR contains an active substance that can give a positive reaction during a doping test.

Children and adolescents

Indole SR is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.

Other drugs and Indole SR

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Do not take Indolen SR with lithium medicines (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:

drugs used for heart rhythm problems (for example: quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, digitalis);

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

chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine, amisulpride, sulpiride, sultopride, tiapride, droperidol, haloperidol);

bepridil (used to treat angina pectoris - a condition 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);

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

pentamidine (used to treat some types of pneumonia); 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);

injectable amphotericin B (antifungal drugs);

oral corticosteroids used to treat a variety of conditions, including severe asthma and rheumatoid arthritis;

tetracosactide (used to treat Crohn's disease);

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);

iodine contrast agents (used for research, including X-rays)

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;

allopurinol (used to treat gout).

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.

Breastfeeding

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 special attention. However, with good control, these side effects are unlikely to occur.

Indole SR contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Indole SR

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.

Unless otherwise prescribed, the usual dose is one tablet of Indole SR once a day, taken in the morning. The tablets can be taken with or without food. The tablets should be swallowed whole (without breaking or chewing) with a sufficient amount of liquid (eg a glass of water).

Patients with impaired renal function

In severe renal insufficiency (creatinine clearance below 30 ml / min), treatment with Indole SR is contraindicated.

Patients with hepatic impairment

In severe liver damage, treatment is contraindicated.

Elderly patients

Elderly patients can be treated with Indole SR when their renal function is normal or only slightly impaired.

Use in children and adolescents

Indole SR is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.

The duration of treatment will be determined by your doctor.

If you have the impression that the effect of indapamide is too strong or too weak, talk to your doctor or pharmacist.

If you take more Indole SR than you should

If you take too many tablets, contact your doctor or pharmacist immediately. Very high doses of Indole SR can 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 Indole SR

If you forget to take a dose of your medicine, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Indole SR

As the treatment of high blood pressure usually lasts a lifetime, talk to your doctor before stopping this medicine.

If you stop taking indapamide, your blood pressure may rise again.

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

4. Possible side effects

Like all medicines, this medicine 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 skin of the limbs or 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 1 in 10,000 patients);

severe skin reactions, including severe skin rash, reddening of the skin all over the body, severe itching, blistering, scaling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome and toxic epidermal necrolysis) or other allergic reactions rare: may affect up to 1 in 10,000 patients);

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 (liver disease)

encephalopathy) (not known);

inflammation of the liver (hepatitis) (not known).

In descending order of frequency, other side effects include:

Common (affects 1 to 10 users in 100)

red skin rash;

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

Uncommon (affects 1 to 10 users in 1,000)

vomiting;

red spots on the skin (purpura).

Rare (affects 1 to 10 users in 10,000)

feeling tired, headache, tingling (paresthesia), dizziness;

gastrointestinal (such as nausea, constipation), dry mouth.

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

changes in blood cells such as thrombocytopenia (reduction in the number of platelets, which causes easy bruising and also nosebleeds), leukopenia (reduction in the number of white blood cells)

How to store Indolen SR

This medicine does not require any special storage conditions.

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 use this medicine if you notice that the packaging is damaged or there are signs of counterfeiting.

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 Indolen SR contains

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

The other ingredients are: tablet core: lactose monohydrate; corn starch, pregelatinised; hypromellose; silica, colloidal, anhydrous; magnesium stearate; Film coating: hypromellose; macrogol 6000; titanium dioxide (E171).

What Indole SR looks like and contents of the pack

Indolen SR 1.5 mg prolonged-release tablets are white to off-white, round, biconvex film-coated tablets.

Pack of 30 tablets (3 blisters of 10 tablets).

1000 Items