INDAPAMIDE TABLETS 2.5 MG - patient leaflet, side effects, dosage

What is in this leaflet:

• 1. What Indapamide is and what it is used for

• 2. What you need to know before you take Indapamide tablets

• 3. How to take Indapamide tablets

• 4. Possible side effects

• 5. How to store Indapamide tablets

• 6. Contents of the pack and other information

1. what indapamide is and what it is used for

Indapamide Tablets are a sugar coated tablets containing indapamide as the active ingredient.

Indapamide is a diuretic (water tablet) which belongs to a group of medicines called sulphonamides. Diuretics increase the amount of water and salts (mostly sodium and chlorides) you pass in your urine. This essentially reduces blood pressure.

Indapamide tablets are used to:

– treat high blood pressure (essential hypertension)

2. what you need to know before you take indapamide tablets- if you are allergic to indapamide, sulphonamides, or any of the other ingredients of this medicine (listed in section 6)

• – if you suffer from

• – severe kidney failure

• – severe impairment of the liver function

• – hepatic encephalopathy

– This is a liver disease causing symptoms that affect your central nervous system such as changes in mood, confusion or drowsiness

– hypokalaemia (low potassium levels in your blood)

• – if you recently suffered a stroke

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Indapamide Tablets:

• – if your liver is not working well, indapamide may cause hepatic encephalopathy. In this case, your doctor will stop your treatment with indapamide tablets

• – diuretics may lead to low blood levels of sodium (hyponatraemia) or potassium (hypokalaemia). Therefore, your doctor will monitor these chemicals in your blood before and during treatment. This is especially important if you:

o are elderly

o are malnourished

o are taking many medicines

o have liver cirrhosis (a chronic liver disease) with or without swelling (oedema or ascites)

o have a coronary artery disease or heart failure

o have certain abnormal patterns on your heart tracing (ECG -electrocardiogram). Hypokalaemia can lead to severe changes in heartbeat, which may sometimes be life-threatening

• – if you have diabetes, you must check your blood sugar levels regularly. This is especially important if you have low potassium levels in your blood

• – if you have kidney problems, these can worsen, particularly at the start of treatment. Tell your doctor if your kidneys are not working well before you start taking indapamide tablets

• – if you have gout, you may experience gout attacks more often

• – if you have high levels of calcium in the blood (hypercalcaemia). This may be due to over activity of your parathyroid glands (hyperparathy­roidism). If the function of your parathyroid gland is to be examined tell your doctor, who will suspend your treatment with indapamide tablets

• – 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 an increase of pressure in your eye and can happen within hours or a week of taking Indapamide tablets. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at a higher risk of developing this.

You should tell your doctor if you have had photosensitivity reactions.

Athletes should be aware that this medicine contains an ingredient that may give a positive reaction in doping tests.

Other medicines and Indapamide tablets

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

The following medicines should not be combined with indapamide tablets

Lithium: It is not recommended to take indapamide tablets during a treatment with lithium. Tell your doctor if you are already taking lithium. Your doctor will take appropriate action.

Make sure to tell your doctor if you are taking any of the following medicines, as special care may be required:

• – medicines that may cause problems in your heartbeat when taken together with indapamide tablets, such as: o halofantrine o pentamidine o vincamine (IV) o terfenadine o astemizole o erythromycin (IV) o sultopride

• – medicines used to treat disorders in your heartbeat, such as: o quinidine o hydroquinidine

o disopyramide

o amiodarone

o sotalol

o bretylium

• – some medicines used to treat high blood pressure (angiotensin converting enzyme (ACE) inhibitors, such as captopril, enalapril, lisinopril, ramipril)

• – some neuroleptics (medicines to treat psychosis, a mental illness), such as:

o phenothiazines (chlorpromazine, thioridazine)

• – certain antidepressants (medicines to treat depression) belonging to the group of imipramines

• – pain-relieving medicines (non-steroidal anti-inflammatory drugs, also known as NSAIDs, e.g. aspirin and ibuprofen) or high doses of salicylic acid

• – medicines to treat infections: amphotericin B (IV)

• – steroids (corticosteroids such as prednisolone, cortisol and tetracosactide) and steroid inducing hormones

• – certain water tablets (diuretics such as amiloride, spironolactone, triamterene, furosemide, piretanide, bumetanide, thiazides and xipamide)

• – digitalis preparations (heart medication, such as digoxin)

• – metformin (tablets to treat diabetes)

• – baclofen (a muscle relaxing drug)

• – laxatives (medicines to treat constipation)

• – medicines that suppress the immune system (ciclosporin, tacrolimus)

• – calcium supplements

• – iodinated contrast media (used to help in examinations such as X-rays)

• – allopurinol (for the treatment of gout)

• – bepridil (used to treat angina pectoris, a condition causing chest pain)

• – cisapride (used to treat reduced movement of the gullet and stomach)

• – diphemanil (used to treat gastro-intestinal problems such as ulcers, too much acid, overactive digestive system)

• – sparfloxacin, moxifloxacin, erythromycin by injection (antibiotics used to treat infections)

• – mizolastine (used to treat allergic reactions, such as hay fever)

Indapamide tablets with food and drink

As far as it is known, indapamide tablets are not influenced by food and drink.

Pregnancy and breast-feeding

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 if you are pregnant. It may harm the unborn child. Tell your doctor if you are pregnant, think you might be pregnant or if you intend to become pregnant.

Do not take indapamide tablets while breast-feeding. Indapamide is passed to your baby through your breast milk. If you have to continue treatment with indapamide tablets, you should stop breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Indapamide may have little effect on the ability to drive or to use machines. Especially at the start of treatment dizziness may occur. Do not drive or use machines if you are affected.

Indapamide tablets contain lactose monohydrate and sucrose

This medicine contains lactose (milk sugar) and sucrose. 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 indapamide tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one tablet daily, taken in the morning. Swallow the tablets with water. Treatment for high blood pressure is usually life-long.

Do not increase the dose if you think indapamide tablets are not working properly. If this is the case, consult your doctor. At higher doses the blood pressure reducing effect is not enhanced, but the excretion of salt in urine is increased.

If you take more indapamide tablets than you should

Tell your doctor or pharmacist or telephone your nearest casualty department. Remember to take the pack and any remaining tablets with you. A very large dose of indapamide could cause nausea (feeling sick), vomiting, low blood pressure, cramps, dizziness, drowsiness, confusion and changes in the amount of urine produced by the kidneys.

If you forget to take indapamide tablets

If you forget to take a dose of your medicines, do not worry. Just 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 or change your treatment before talking to your doctor.

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 everyone gets them.

Stop taking the medicinal product and see a doctor immediately, if you experience any of the following side effects:

• Allergic reactions, mainly dermatological, such as red raised skin rash, skin rashes in subjects with a predisposition to allergic and asthmatic reactions (Common) (may affect up to 1 in 10 people)
• Red pinpoints on skin (Purpura) (Uncommon) (may affect up to 1 in 100 people)
• Angioedema and/or urticaria. Angioedema is characterised by swelling of the skin of extremities or face, swelling of the lips or tongue, swelling of the mucous membranes of the throat or airways resulting in shortness of breath or difficulty of swallowing. If this occurs, contact your doctor immediately (Very rare) (may affect up to 1 in 10,000 people)
• Severe skin reactions including intense skin rash, reddening of the skin over your whole body, severe itching, blistering, 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)
• Heart rhythm irregularities (causing palpitations, feeling of the heart pounding), low blood pressure (Very rare) (may affect up to 1 in 10,000 people)
• Life-threatening irregular beat (Not known)
• Inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell (Very rare) (may affect up to 1 in 10,000 people)
• Disease of the brain caused by liver illness (Hepatic encephalopathy) (Not known)
• Inflammation of the liver (Hepatitis) (Not known)
• If you suffer from systemic lupus erythematosus (a type of collagen disease), this might get worse (Not known)
• Cases of photosensitivity reactions (change in skin appearance) after exposure to the sun or artificial UVA have also been reported (Not known)

In decreasing order of frequency, other side effects can include:

Common (may affect up to 1 in 10 people):

• Low potassium in the blood

Uncommon (may affect up to 1 in 100 people):

• Vomiting
• Low sodium in the blood that may lead to dehydration and low blood pressure
• Impotence (inability to obtain or maintain an erection)

Rare (may affect up to 1 in 1000 people):

• Feeling of tiredness, headache, pins and needles (paraesthesia), vertigo (spinning sensation)
• Gastro-intestinal disorders such as nausea (feeling sick) or constipation, dry mouth
• Low chloride in the blood
• Low magnesium in the blood

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

• Changes in blood cells, such as thrombocytopenia (decrease in the number of platelets which causes easy bruising and nasal bleeding), leucopenia (decrease of white blood cells which may cause unexplained fever, soreness of the throat or other flu-like symptoms – if this occurs, contact your doctor) and anaemia (decrease in red blood cells)
• High level of calcium in blood
• Kidney disease (causing symptoms of tiredness, increased need to urinate, itchy skin, feeling sick, swollen extremities)
• Abnormal hepatic (liver) function

Not known:

• Fainting
• Short sightedness (myopia)
• Blurred vision
• Visual impairment
• Decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angleclosure glaucoma)
• Changes may occur in your blood and your doctor may need to give you blood tests to check your condition. The following changes in your blood test results may occur:

o Increase in uric acid, a substance which may cause or worsen gout (painful joint(s) especially in the feet)

o Increase in blood glucose levels in diabetic patients

o Increased levels of liver enzymes

• Abnormal ECG heart tracing.

5. how to store indapamide tablets

Store below 25 °C. Store in the original package in order to protect from moisture.

Keep out of the sight and reach of children.

Do not use indapamide tablets after the expiry date which is stated on the carton and blister pack. The expiry date refers to the last day of that month.

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.

6. contents of the pack and further informationthe active substance is indapamide. each coated tablet contains 2.5mg indapamide.

The other ingredients are: lactose monohydrate, maize starch, povidone, magnesium stearate, polyvinyl acetate phthalate, stearic acid, talc, calcium carbonate, acacia, sucrose, yellow carnauba wax, white beeswax, shellac, titanium dioxide (E171)

What indapamide tablets look like and contents of the pack:

Indapamide 2.5mg tablets are white, circular, sugar coated tablets.

Indapamide 2.5mg tablets are available in packs containing 28, 30, 50, 56, 60, 100, 120 and 250 tablets in blisters.

Not all pack sizes may be marketed.

Marketing authorisation holder

Manx Healthcare Ltd

Taylor Group House

Wedgnock Lane

Warwick CV34 5YA

Manufacturer

Clonmel Healthcare Ltd

Waterford Road, Clonmel, Co. Tipperary, Ireland

Other formats

To request a copy of this leaflet in Braille, large print or audio please call 01926 482511.

This leaflet was last revised in October 2021