INDAPAMIDE HEMIHYDRATE 2.5 MG TABLETS, NATRAMID/OPUMIDE - patient leaflet, side effects, dosage

Patient leaflet - INDAPAMIDE HEMIHYDRATE 2.5 MG TABLETS, NATRAMID/OPUMIDE

PATIENT INFORMATION LEAFLET Indapamide Hemihydrate 2.5mg Tablets

Indapamide Hemihydrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their symptoms are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any not listed in this

leaflet. See section 4.

What is in this leaflet:

1. What Indapamide Tablets are and what they are 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 Tablets are and what they are used for

Indapamide hemihydrate is related to a group of medicines called sulphonamides. This medicine is intended to reduce high blood pressure (hypertension) in adults.

Indapamide is a diuretic. Most diuretics increase the amount of urine produced by the kidneys.

However, indapamide is different from other diuretics, as it only causes a slight increase in the amount of urine produced. In addition, it widens blood vessels so that blood passes through more easily. This helps to lower blood pressure.

2. what you need to know before you take indapamide tablets if you are allergic to indapamide hemihydrate, any other sulphonamide related medicines, or

any of the other ingredients of this medicine (listed in section 6)

if you have severe liver disease or suffer from a condition called hepatic encephalopathy (liver

problems which affect the brain and central nervous system).

if you have low potassium levels in your blood.
if you have severe kidney disease.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Indapamide Tablets:

if you have liver problems
if you have diabetes
if you suffer from gout
if you need to have a test to check how well your parathyroid gland is working
if you have any heart rhythm problems or kidney problems
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 to 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 higher risk of developing this

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

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

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

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

Other medicines and Indapamide Tablets

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

You should not take Indapamide Tablets with lithium (used to treat depression) due to the risk of increased levels of lithium in the blood.

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

medicines used for heart rhythm problems (e.g. quinidine, hydroquinidine, disopyramide,

amiodarone, sotalol, ibutilide, dofetilide, digitalis, bretylium),

medicines used to treat mental disorders such as depression, anxiety, schizophrenia (e.g.

tricyclic antidepressants, antipsychotic drugs, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol)),

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 gastric problems such as ulcers, too much acid, overactive digestive

system),

sparfloxacin, moxifloxacin, erythromycin by injection (antibiotics used to treat infections),
vincamine by injection (used to treat symptomatic cognitive disorders in elderly including

memory loss),

halofantrine (antiparasitic drug used to treat certain types of malaria),
pentamidine (used to treat certain types of pneumonia),
mizolastine, astemizole, terfenadine (antihistamines used to treat allergic reactions, such as hay

fever),

non-steroidal anti-inflammatory drugs for pain relief (e.g. ibuprofen) or high doses of

acetylsalicylic acid,

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

failure),

amphotericin B by injection (anti-fungal medicines),
oral corticosteroids used to treat various conditions including severe asthma and rheumatoid

arthritis,

stimulant laxatives,
baclofen (to treat muscle stiffness occurring in diseases such as multiple sclerosis),
potassium-sparing diuretics (amiloride, spironolactone, triamterene),
metformin (to treat diabetes),
iodinated contrast media (used for tests involving X-rays),
calcium tablets or other calcium supplements,
ciclosporin, tacrolimus or other medicines to depress the immune system after organ

transplantation, to treat autoimmune diseases, or severe rheumatic or dermatological diseases,

tetracosactide (to treat Crohn’s disease),
methadone (used to treat addiction).

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 during pregnancy. When a pregnancy is planned or confirmed, the switch to an alternative treatment should be initiated as soon as possible. Please tell your doctor if you are pregnant or wish to become pregnant.

The active ingredient is excreted in milk. Breast feeding is not advisable if you are taking this medicine.

Driving and using machines

This medicine can cause side effects such as dizziness or tiredness due to lowering of the blood pressure (see section 4). These side effects are more likely to occur after initiation of the treatment and after dose increases. If this occurs, you should refrain from driving and other activities requiring alertness. However, under good control, these side effects are unlikely to occur.

Indapamide Tablets contains lactose and sucrose

This medicine contains lactose 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.

Information on Sodium

This medicine contains less than 1mmol (23mg) of sodium in each tablet, that is to say essentially sodium-free.

Other Excipients

This medicine also contains: Ponceau 4R (E124), methyl hydroxybenzoate (E218), and propylhydroxybenzoate (E216). These may cause allergic reactions (possibly delayed).

3. how to take indapamide tablets

Always take Indapamide Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The recommended dose is one tablet each day, preferably in the morning.

The tablets can be taken with or without food.

They should be swallowed whole with water.

Treatment for high blood pressure is usually life-long.

If you take more Indapamide Tablets than you should:

If you have taken too many tablets, contact your doctor or pharmacist immediately.

A very large dose of Indapamide Tablets 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 taking a dose of your medicine in the morning, 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:

As the treatment for high blood pressure is usually life-long, you should discuss with your doctor before stopping this medicinal product.

If you have any further questions on the use of this medicine, 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 see a doctor immediately, if you experience any of the following side effects:

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)

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)
Muscle weakness, cramps, tenderness or pain and particularly, if at the same time, you feel

unwell or have a high temperature it may be caused by an abnormal muscle breakdown (Not known).

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

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

Red raised skin rash
Allergic reactions, mainly dermatological, such as skin rashes in subjects with a predisposition

to allergic and asthmatic reactions

Low potassium in the blood

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

vomiting
red pinpoints on skin (Purpura)
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
Gastro-intestinal disorders such as nausea (feeling sick) or constipation, dry mouth
Low chloride in the blood
Low magnesium in the blood

Very rare (less than 1 patient in 10,000):

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
Heart rhythm irregularities (causing palpitations, feeling of the heart pounding), low blood

pressure;

Kidney failure (causing symptoms of tiredness, increased need to urinate, itchy skin, feeling

sick, swollen extremities)

Abnormal hepatic function

Not Known (frequency cannot be estimated from the available data):

Fainting
If you suffer from systemic lupus erythematosus (a type of callegen disease), this might get

worse

Cases of photosensitivity reactions (change in skin appearance) after exposure to the sun or

artificial UVA have also been reported

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 angle-closure 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

increase in uric acid, a substance which may cause or worsen gout (painful joint(s) especially in the feet)
increase in blood glucose levels in diabetic patients
increased levels of liver enzymes
Abnormal ECG heart tracing.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store indapamide tablets

Keep this medicine out of the sight and reach of children.

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

Do not store above 25°C. Store in the original package. Protect from light.

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

6. contents of the pack and other information

What Indapamide Tablet contains

The active substance is indapamide. Each Indapamide Tablet contains 2.5mg of Indapamide hemihydrate.

Other ingredients are lactose, di-basic calcium phosphate, maize starch, magnesium stearate, croscarmellose sodium, shellac, castor oil, titanium dioxide (E171), talc, sucrose, acacia, polyethylene glycol-6000, methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), and a colourant which contains sucrose, sodium benzoate, polyvinylpyrrolidone, talc, Ponceau 4R (E124), and erythrosine E127 and Opalux AS-F-1312.

What Indapamide Tablets look like and contents of the pack:

Indapamide Tablets are round, pink sugar coated tablets. They are supplied in blister packs of 28, 30, 56 or 60 tablets.

Marketing Authorisation Holder and Manufacturer:

Crescent Pharma Limited, Units 3 & 4 Quidhampton Business Units, Polhampton Lane, Overton, Hampshire, RG25 3ED, UK.

This leaflet was last revised in 10/2021.