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Indapamide

The active substance in these tablets is called indapamide. It belongs to a group of medicines called diuretics.


UK Generic Name

Indapamide


Packing

30


Therapeutic Category

Cardiovascular/Antihypertensive


Storage

Do not store above 30 °C.


adobe-pdf-logoProduct Insert(PIL)

adobe-pdf-logoPrescribing Information(SPC)


Product Description

Product Overview


What Indapamide is and what it is used for

The active substance in these tablets is called indapamide. It belongs to a group of medicines called diuretics.

Diuretics increase the amount of urine produced by the kidneys and are sometimes called water tablets.
Indapamide tablets are used to treat high blood pressure without well-known cause (essential hypertension).

Before you take Indapamide 1.5 mg prolonged release tablets

Do not take Indapamid tablets:
•If you are allergic (hypersensitive) to indapamide, to sulphonamides (antibiotic compounds) or any of
•If you have severe kidney or liver problems
•If you have been told you have a low level of potassium in your blood

Take special care with Indapamide tablets
Before starting to take Indapamide tablets, inform your doctor of the following:
•If you have any kidney or liver problems
•If you suffer from diabetes or gout
•If you suffer from heart disease
•If you have been told you have a low level of sodium in your blood
•If you need to have a test to check how well your parathyroid gland is working

Indapamide affects the levels of potassium and sodium in the blood. Your doctor may conduct blood tests to monitor levels of potassium and sodium in your blood before and during your treatment. This is especially important in patients, who are at high risk to develop electrolyte disturbances (such as elderly, patients who are taking many medicines or malnourished patients).

Indapamide tablets may increase the sensitivity of your skin to sunlight. If this happens you should tell your doctor as he/she may decide to stop your treatment. In case of an administration of indapamide, it is recommended to protect exposed areas to the sun or to artificial UVA.

Athletes should be aware that Indapamide 1, 5 mg prolonged release tablets contains an active ingredient which may give a positive reaction in drug tests.

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

Taking Indapamide 1, 5 mg prolonged release tablets with food and drink
Food and drink have no impact on the way that your medicine works. You may take it with or after food or on an empty stomach.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.

•It is not recommended to take Indapamide tablets during pregnancy or while breast-feeding.
•Small amounts of Indapamide tablets may pass to the baby in breast milk.

Driving and using machines

•You may feel dizzy or drowsy when you take Indapamide 1.5 mg prolonged release tablets. This could happen especially at the beginning of the treatment or if you take another blood pressure-lowering medicine at the same time. If this occurs, you should not drive or use machines.

Important information about some of the ingredients of Indapamide
•Indapamide tablets contains lactose monohydrate. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Indapamide 1, 5 mg prolonged release tablets.

How to take Indapamide tablets

•Always take Indapamide 1.5 mg prolonged release tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
•The usual dose is 1 tablet daily, preferably in the morning, with or without food.

Patients with impaired renal function
•Patients with severe renal failure (creatinin-clearance below 30 ml/min) must not be treated with Indapamide tablets. Indapamide tablets are fully effective only when renal function is normal or only minimally impaired.

Patients with impaired liver function
•Patients with severe hepatic impairment must not be treated with Indapamide tablets

Elderly
•Elderly patients can be treated with Indapamide tablets when renal function is normal or only minimally impaired.

Children and adolescents
•Indapamide tablets are not recommended for use in children and adolescents due to a lack of data on safety and efficacy.

If you take more Indapamide tablets than you should:
•Tell your doctor or a hospital immediately if you took more tablets than your doctor has prescribed.
•Overdose symptoms may include nausea, drowsiness, dizziness, vomiting, low blood pressure, headache, confusion, rapid pulse, cramps, excessive production of urine or low production of urine.

If you forget to take Indapamide 1.5 mg prolonged release tablets
•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 Indapamide tablets
•Do not stop using Indapamide tablets until your doctor tells you.
•Treatment for high blood pressure is normally life-long. You should not stop taking your medicine without discussing it with your doctor first.

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

POSSIBLE SIDE EFFECTS

Very common
•Decrease in blood potassium level which may cause muscle weakness (mainly at the beginning of the treatment, in the elderly, in undernourished people)

Common
•Allergic reaction (especially in people who tend to have allergic or asthmatic reactions) leading to skin rashes with macules (flat discoloured area) and papules (small raised lumps)

Uncommon
•vomiting
•Allergic reaction (especially in people who tend to have allergic or asthmatic reactions) leading to purple spots or patches on the skin.

Rare
•Dizziness, fatigue, headache, numbness or tingling in the legs or arms (paresthesia)
•Nausea (feeling sick), constipation, dry mouth

Very rare
•Increase in calcium blood level
•Decrease in certain blood cells (blood platelets, white and/or red blood cells) which causes
– Easy bruising and nasal bleeding (thrombocytopenia)
– Unexplained fever, soreness of the throat or other flu-like symptoms (leucopenia)
– Weakness, paleness, a fast heartbeat and breathlessness (anaemia)
•Irregular heart rhythm, low blood pressure
•Inflammation of the pancreas
•Kidney problems
•Abnormal liver function
•Urticaria, facial and neck swelling and severe skin conditions like blistering of the skin, mouth, eyes and genital organs called toxic epidermic necrolysis or Stevens-Johnson syndrome may appear in the hypersensitive setting

Not known
•Your doctor may need to give you blood tests to monitor your condition.
•The following changes in laboratory parameters may occur:
-Low chloride in the blood
– Low sodium in the blood that may lead to dehydration and low blood pressure
– Increase in uric acid, a substance which may cause or worsen gout (painful swelling and redness in the joints, most commonly in the big toe)
– increase in blood glucose levels in diabetic patients
•In case of reduced liver function, there is a possibility of brain disorders caused by the reduced liver function (hepatic encephalopathy) (see also 2. “Take special care with INDAPAMIDE tablets”)
•worsening of a certain pre-existing autoimmune skin-disease (acute disseminated lupus erythematodus)
•Skin-sensitivity to UV light (photosensitivity reactions)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

HOW TO STORE INDAPAMIDE tablets

•Keep out of the reach and sight of children.
•Do not use Indapamide 1.5 mg prolonged release tablets after the expiry date {EXP} which is stated on the carton or blister. The expiry date refers to the last day of that month.
•Do not store above 30 °C.
•Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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