Diurelix Xl 1.5 Mg Prolonged-Release Tablets
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SZ86506LT01A
Read all of this leaflet carefully before you start using this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
What Diurelix XL is and what is used for
Before you take Diurelix XL
How to take Diurelix XL
Possible side effects
How to store Diurelix XL
Further information
1 What Diurelix XL is and what is used for
Diurelix XL belongs to a group of medicines known as sulfonamide diuretics (water tablets).
The active ingredient in Diurelix XL is indapamide. 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.
Diurelix XL is used to treat high blood pressure (hypertension).
2 Before you take Diurelix XL
Do NOT take Diurelix XL if you:
• are allergic (hypersensitive) to indapamide or any other sulfonamide or to any of the ingredients in preparation (see Section 6 Further information)
• have severe liver disease or suffer from a condition called hepatic encephalopathy (degenerative disease of the brain)
• have a severe kidney disease or if you are receiving dialysis
• have low blood potassium
• halofantrine (a medicine to treat malaria)
• pentamidine (an antibiotic used to treat infections)
• sparfloxacin, moxifloxacin (antibiotics)
• bepridil (a medicine to control angina pectoris)
• cisapride (a gastrointestinal agent), diphemanil (a medicine to treat functional bowel disorders)
• lithium (a medicine for treatment of mania or depression)
• medicines used for heart rhythm problems (e.g. digitalis, quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide and ibutilide)
• baclofen (to treat muscle stiffness occurring in diseases such as multiple sclerosis)
• medicines to treat diabetes such as metformin
• iodinated contrast media (used for tests involving X-rays)
• calcium
• stimulant laxatives (e.g. senna)
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen), including selective cyclooxigenase-2 (COX-2) inhibitors (e.g. celecoxib) or high dose of salicylic acid
• amphotericin B by injection (a medicine to treat severe fungal disease)
• tetracosactide (a medicine to treat Crohn’s disease)
• vincamine by injection (a medicine used to treat circulatory problems in the brain)
Ask your doctor if you are not sure what these medicines are.
Take special care with Diurelix XL
Before your take Diurelix XL tell your doctor if you:
• have liver problems
• have diabetes
• suffer from gout
• have any other heart problems
• have problems with your kidneys
• if you need to have a test to check how well your parathyroid gland is working
• have had or develop increased sensitivity of the skin to
sun (photosensitivity)
Taking Diurelix XL with food and drink
Take your tablet with a glass of water preferably in the morning. It is important that you swallow whole tablet. Tablets must NOT be crushed or chewed.
Pregnancy and breast-feeding
Pregnancy
Before taking Diurelix XL, tell your doctor if you are pregnant or trying to become pregnant as Diurelix XL can affect your baby. Diurelix XL is not recommended during pregnancy. If you become pregnant while taking this medicine, stop taking it immediately and tell your doctor.
Your doctor may give you blood tests to check for low sodium or Breast-feeding
potassium levels or high calcium levels. Do not take this medicine if you are breast-feeding.
Talk to your doctor if you are an athlete taking a doping test, as Diurelix XL contains an active ingredient that can cause positive results in a doping test.
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 other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines including medicines obtained without a prescription.
In particular, before taking Diurelix XL, you must check with your doctor if you are taking any of the following:
• other medicines for treating high blood pressure and heart failure (ACE inhibitors)
• medicines used to treat mental disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, antipsychotic drugs, neuroleptics),
• potassium-sparing diuretics (water tablets like amiloride, spironolactone, triamterene)
• mizolastine (a medicine to treat for hay fever or allergies)
• corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis
• medicines used to prevent rejection in transplant patients (e.g. ciclosporin, tacrolimus)
• erythromycin by injection (an antibiotic used to treat infections)
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Diurelix XL does not affect alertness but different reactions such as dizziness or weakness in relation to the decrease in blood pressure may occur in certain patients. These side effects are more likely to occur after initiation of the treatment and after dose increases. If affected, your ability to drive or to operate machinery may be impaired.
Important information about some of the ingredients of Diurelix XL
This medicine 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 Diurelix XL
Always take Diurelix XL exactly as your doctor has told you.You should check with your doctor or pharmacist if you are not sure.
The normal dose is one tablet once a day.
Take your tablet with a glass of water preferably in the morning.
It is important that you swallow whole tablet. The tablet must NOT be chewed or crushed.
Treatment for high blood pressure is usually life-long.
Elderly
Elderly patients can be treated with Diurelix XL when kidney function is normal or only minimally impaired.
Children and adolescents
Use of Diurelix XL is not recommended for use in children and adolescents.
If you take more Diurelix XL than you should
If you (or someone else) swallow a lot of the tablets all together or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department / your doctor immediately / a poison centre. An overdose is likely to cause heart and dehydration problems. If marked low blood pressure occurs (symptoms such as dizziness or faintness), lying down with the legs raised can help. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know what tablets were consumed.
If you forget to take Diurelix XL It is important to take your medicine every day as regular treatment is more effective. However, if you forget to take one or more doses, take another as soon as you remember and then go on as prescribed. DO NOT take a double dose to make up for the forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
• low sodium that may lead to dehydration and low blood pressure
• increase in uric acid, a substance associated with gout
• increase in blood glucose (especially important for diabetic patients)
• very rarely: increased calcium in the blood
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.
5 How to store Diurelix XL
Keep out of the reach and sight of children.
Do not take Diurelix XL after the expiry date which is stated on tablet blister and carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C and in the original package to protect from moisture.
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.
4 Possible side effects
6 Further information
Like all medicines, Diurelix XL can cause side effects, although not everybody gets them.
The following side effects are important and will require immediate action if you experience them.You should stop taking Diurelix XL and see your doctor immediately if the following symptoms occur:
Very rare side effects affecting less than 1 in 10,000 patients
• swelling of the face, lips, mouth, tongue, eyes or windpipe which can cause great difficulty in breathing
• severe, extensive, blistering skin rash
• unexplained fever, soreness of the throat or other flu-like symptoms caused by a profound fall in the numbers of white blood cells
Other possible side effects
Common (affects 1 to 10 users in 100)
• allergic reactions mainly in people who are prone to allergic and asthmatic reactions and causing skin rashes with macules (flat discoloured area) and papules (small raised lumps)
Uncommon (affects 1 to 10 user in 1,000 ):
• vomiting
• allergic reactions mainly in people prone to allergic and asthmatic reactions and mainly affecting the skin causing purpura (red pinpoints on skin)
Rare (affects 1 to 10 user in 10,000):
• dizziness (spinning sensation)
• feeling of tiredness
• headache
• pins and needles (paresthesia)
• nausea (feeling sick)
• constipation
• dry mouth
Very rare (affects less than 1 user in 10,000)
• heart rhythm irregularities (causing palpitations, feeling of the heart pounding)
• low blood pressure (hypotension)
• inflammation of the pancreas leading to upper abdominal pain
• liver problems that may become severe
• kidney problems that may become severe
• easy bruising and bleeding, anaemia or flu-like symptoms (caused by a fall in the numbers of blood cells)
• skin hives
What Diurelix XL contains
The active substance is indapamide. Each tablet contains 1.5 mg indapamide.
The other ingredients are:
Tablet core:
lactose monohydrate (for further information on lactose see end of Section 2); povidone K30; hypromellose; silica, colloidal anhydrous; cellulose, microcrystalline; magnesium stearate
Film coating:
hypromellose, macrogol 6000, titanium dioxide (E171)
What Diurelix XL looks like and contents of the pack
Diurelix XL is a white, round, biconvex film-coated prolonged-release tablet.
Diurelix XL is packed in blisters (PVC/PVDC/Al blister or Al/Al blister) of various pack sizes.
10, 14, 15, 20, 28, 30, 50, 60, 90, 100 prolonged-release tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
United Kingdom:
Sandoz Ltd.,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Malta:
Sandoz d.d.,
Verovskova 57,
1000 Ljubljana,
Slovenia.
Manufacturer
Lek Pharmaceuticals d.d.,
Verovskova 57,
1526 Ljubljana,
Slovenia.
This leaflet was last approved in 11/2010.
Not known (frequency can not be estimated from available
data)
• hepatic encephalopathy (severe liver disease that affects the brain)
• increased sensitivity of the skin to sunlight
• If you have systemic lupus erythematosus (a disorder of the immune system leading to inflammation and damage to the joints, tendons and organs) then your symptoms may worsen.
The following changes in your blood may occur (your doctor may
need to order blood tests to check your condition):
• low potassium