Patient leaflet - INDIPAM XL 1.5MG PROLONGED-RELEASE TABLETS
1 What Indipam XL is and what it is used for
The active substance in Indipam XL is indapamide. 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.
It is used to treat high blood pressure (essential hypertension).
2 What you need to know before you take Indipam XL
Do not take Indipam XL if you:
- are allergic to indapamide or any other sulfonamide or any of the other ingredients of this medicine (listed in section 6)
- have severe liver disease or a condition called Hepatic Encephalopathy (damage to the brain and nerves which can occur as a complication of liver problems)
- have severe kidney disease
- have been told by your doctor that you have low levels of potassium in your blood.
Warnings and precautions
Talk to your doctor or pharmacist before taking Indipam XL if you suffer from or have previously suffered from any of the following:
- any heart rhythm problems
- diabetes
- gout
- kidney problems
- liver problems
- If you need to have a test to check how well your parathyroid gland is working
if you have muscle disorders including muscle pain,
tenderness, weakness or cramps.
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 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 this medicine contains an active ingredient which may give a positive reaction in doping tests.
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 weeks of taking Indipam XL. 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.
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.
Other medicines and Indipam XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
You should not take Indipam XL 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 and schizophrenia (e.g. tricyclic antidepressants, antipsychotic drugs (such as pimozide), 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 gastro-intestinal problems)
- Sparfloxacin, moxifloxacin, intravenous erythromycin (antibiotics used to treat infections)
- Intravenous vincamine (used to treat symptomatic cognitive disorders in the elderly including memory loss)
- Halofantrine (antiparasitic drug used to treat certain types of malaria)
- Pentamidine (used to treat certain types of pneumonia)
- Antihistamines used to treat allergic reactions, such as hayfever (e.g. mizolastine, astemizole, terfenadine)
- Non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief (e.g. ibuprofen) or high doses of acetylsalicylic acid (aspirin)
- Angiotensin converting enzyme (ACE) inhibitors (used to treat high blood pressure and heart failure)
- Intravenous amphotericin B (anti-fungal medicine)
- Oral corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis
- Stimulant laxatives
- Baclofen (used in the treatment of muscle spasm)
- Allopurinol (for the treatment of gout)
- 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 teat 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 recommended if you are taking this medicine.
Driving and using machines
This medicine can cause side effects due to lowering of the blood pressure such as dizziness or tiredness (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.
Indipam XL 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 Indipam XL
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 each day which should preferably be taken in the morning. approved for print/date
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Indapamide 1.5mg Prolonged-release Tablets PIL - UK
Black BBBB2605
Version 7 12.02.2020 Cartons and label leaflets only
(labels only when specified) German GTIN 14 (incorporating PZN):
BBBB2605
The tablets can be taken
irrespective of meals. They should be swallowed whole with water. Do not crush or chew them.
Treatment for high blood pressure is usually life-long.
If you take more Indipam XL than you should
If you have taken too many tablets, contact your doctor or pharmacist immediately. Symptoms of an overdose may include 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 Indipam XL
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 Indipam XL
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 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 the medicinal product and see a doctor immediately if you experience any of the following side effects: Very rare (may affect up to 1 in 10,000 people):
- Angioedema and/or urticaria, characterised by swelling of the hands, feet, face, lips or tongue, swelling of the mucous membranes of the throat or airways resulting in shortness of breath or difficulty swallowing. If this occurs, contact your doctor immediately.
- 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 (Toxic Epidermal Necrolysis, Stevens-Johnson syndrome) or other allergic reactions
Inflammation of the pancreas, which may cause severe
abdominal and back pain accompanied with feeling very unwell (Pancreatitis).
Not known (frequency cannot be estimated from the available data):
- Life-threatening irregular heartbeat
If you have existing liver
problems, taking Indapamide may cause a condition called Hepatic Encephalopathy (damage to the brain and nerves which can occur as a complication of liver disease)
- Inflammation of the liver (hepatitis)
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)
- Fainting
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.
Other side effects include:
Common (may affect up to 1 in 10 people):
- Red raised skin rash
- Allergic reactions, mainly dermatological, especially in people who tend to have allergic or asthmatic reactions.
- Low potassium in the blood.
Uncommon (may affect up to 1 in 100 people):
- Vomiting
- Purple spots or patches on the skin (purpura)
- Low sodium in the blood that may lead to dehydration and low blood pressure
- Impotence (intability to obtain or maintain an erection).
Rare (may affect up to 1 in 1,000 people):
- Dizziness (vertigo)
- Tiredness
- Headache
- Pins and needles (paraesthesia)
- Nausea (feeling sick)
- Constipation
- Dry mouth
- Low chloride in the blood
- Low magnesium in the blood.
Very rare (may affect up to 1 in 10,000 people):
- Reduction in blood platelets, which increases risk of bleeding or bruising
Reduction in the number of white blood cells, which may cause unexplained fever, soreness of the throat or other flu-like symptoms
- if this occurs contact your doctor
Reduction in red blood cells (anaemia)
- Irregular heartbeat (causing palpitations, feeling of the heart pounding)
- Low blood pressure
- Kidney disease (causing symptoms of tiredness, increased need to urinate, itchy skin, feeling sick, swollen extremities)
- Abnormal liver function
- High level of calcium in your blood.
Not known (frequency cannot be estimated from the available data):
- If you suffer from Systemic Lupus Erythematosus (a disorder of the immune system leading to inflammation and damage to the joints, tendons and organs with symptoms including skin rashes, tiredness, loss of appetite, weight gain and joint pain), this might get worse
- Cases of photosensitivity reactions (changes in skin appearance) after exposure to the sun or artificial UVA have also been reported
- Short sightedness (myopia)
- Blurred vision
- Visual impairment
Changes may occur in your blood and your doctor may need to give you blood tests to check your condition. The following changes in laboratory tests may occur:
- increase in uric acid, a substance which may cause or worsen gout (painful joint(s), especially in the feet)
- increase in blood sugar levels
- increased levels of liver enzymes
- Abnormal ECG heart tracing.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard 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 Indipam XL
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not take this medicine after the expiry date stated on the carton and container. 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 throw away medicines you no longer use. These measures will help protect the environment.
6 Contents of the pack and other information
What Indipam XL contains
- The active substance is indapamide. Each prolonged-release tablet contains 1.5mg of indapamide.
The other ingredients are: Tablet core: lactose monohydrate, starch, pregelatinised, hypromellose, silica, colloidal anhydrous, magnesium stearate (vegetable).
Tablet coating: hypromellose, macrogol 6000, titanium dioxide (E171).
What Indipam XL looks like and contents of the pack
Indipam XL 1.5mg Prolonged-Release Tablets are white to off white, round, biconvex prolonged-release film-coated tablets. Indipam XL 1.5mg Prolonged-Release Tablets are available in packs containing 30 prolonged-release tablets in blister packs (PVC / aluminium).
Marketing Authorisation Holder
Accord, Barnstaple, EX32 8NS, UK
Manufacturer
Balkanpharma-Dupnitsa AD 3 Samokovsko Shosse Str., Dupnitsa 2600,
Bulgaria
This leaflet was last revised in October 2021.