Patient leaflet - Diurelix XL 1.5 mg prolonged-release tablets

1. What Diurelix XL is and what it is used for

Diurelix XL belongs to a group of medicines known as sulfonamide diuretics (water tablets).

The active substance in Diurelix 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.

Diurelix XL is used to treat high blood pressure (hypertension) in adults.

2. What you need to know before you take Diurelix XL

Do NOT take Diurelix XL:

if you are allergic to indapamide or any other sulfonamide or to any of the other ingredients of this medicine (listed in section 6)
if you have a severe kidney disease
if you have severe liver disease or suffer from a condition called hepatic encephalopathy (degenerative disease of the brain)
if you have low potassium levels in your blood

Warnings and precautions Talk to your doctor or pharmacist before taking Diurelix XL:

if you have liver problems
if you have diabetes
if you suffer from gout
if you have any other heart problems
if you have problems with your kidneys
if you need to have a test to check how well your parathyroid gland is working
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 Diurelix 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 have muscle disorders including muscle pain, tenderness, weakness or cramps

You should tell your doctor if you had photosensitivity reactions (sensitivity of the skin to sun.

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

Talk to your doctor if you are an athlete taking a doping test, as Diurelix XL contains an active substance 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.

Children and adolescents

Do not give this medicine to children and adolescents due to a lack of data on safety and efficacy.

Other medicines and Diurelix XL

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

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

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 medicines, neuroleptics), (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol)
potassium-sparing diuretics (water tablets like amiloride, spironolactone, triamterene)
mizolastine, astemizole, terfenadine (a medicine used to treat allergic reactions, such as hay fever)
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)
halofantrine (a medicine to treat malaria)
pentamidine (an antibiotic used to treat infections)
sparfloxacin, moxifloxacin (antibiotics used to treat infections)
bepridil (a medicine to control angina pectoris)
cisapride (a gastrointestinal agent), diphemanil (a medicine to treat functional bowel disorders)
•
medicines used for heart rhythm problems (e.g. digitalis, quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide and ibutilide and bretylium)
baclofen (to treat muscle stiffness occurring in diseases such as multiple sclerosis)
allopurinol (for the treatment of gout)
medicines to treat diabetes such as metformin
iodinated contrast media (used for tests involving X-rays) • calcium • stimulant laxatives
non-steroidal anti-inflammatory drugs for pain relief (e.g. ibuprofen), including selective cyclooxigenase-2 (COX-2) inhibitors (e.g. celecoxib) or high dose of acetylsalicylic 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)
methadone (used to treat addiction)

Ask your doctor if you are not sure what these medicines are.

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.

Pregnancy

Diurelix XL is not recommended during pregnancy. If you become pregnant while taking this medicine, stop taking it immediately and tell your doctor.

Breast-feeding

Do not take this medicine if you are breast-feeding.

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.

Diurelix 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 medicine.

3. How to take Diurelix 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 once a day. The tablets can be taken irrespective of meals.

Take your tablet with a glass of water preferably in the morning.

It is important that you swallow whole tablet. Tablet must NOT be chewed or crushed.

Treatment for high blood pressure is usually life-long.

Elderly

The elderly can be treated with Diurelix XL when kidney function is normal or only minimally impaired.

Use in children and adolescents

Use of Diurelix XL is not recommended for use in children and adolescents (see also section 2: Warnings and precautions).

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 a forgotten dose.

If you stop taking Indapamide:

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 Diurelix and see a doctor immediately, if you experience any of the following side effects that can be serious:

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)

Other possible side effects

Common (may affect up to 1 in 10 people)

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 (may affect up to 1 in 100 people)

vomiting
allergic reactions mainly in people prone to allergic and asthmatic reactions and mainly affecting the skin causing purpura (red pinpoints on skin)

Rare (may affect up to 1 in 1,000 people)

feeling of tiredness
headache
pins and needles (paresthesia)
vertigo
nausea (feeling sick)
constipation
dry mouth

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

heart rhythm irregularities (causing palpitations, feeling of the heart pounding)
low blood pressure (hypotension)
abnormal hepatic function kidney disease
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)
changes in your blood may occur (your doctor may need to order blood tests to check your condition): increased calcium in the blood

Not known (frequency can not be estimated from the available data)

fainting
cases of photosensitivity reactions (change in skin appearance) after exposure to the sun or artificial UVA have also been reported
abnormal ECG heart tracing
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)
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
low sodium that may lead to dehydration and low blood pressure
increase in uric acid, a substance associated with gout (painful joint(s) especially in the feet)
increase in blood glucose (especially important for diabetic patients)

increased levels of liver enzymes

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 Yellow Card Scheme: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Diurelix XL

Keep this medicine out of the sight and reach of children. Do not

use this medicine after the expiry date which is stated on blister and 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 to protect from moisture.

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 Diurelix XL contains

The active substance is indapamide. Each tablet contains 1.5 mg of 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 (E 171)

What Diurelix XL looks like and contents of the pack

Diurelix XL is a white, round, biconvex film-coated prolonged-release tablet.

The prolonged-release tablets are packed in blisters PVC/PVDC/Alu blisters or Alu/Alu blisters and inserted in a carton.

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

Sandoz Limited

Park View, Riverside Way

Watchmoor Park

Camberley, Surrey

GU15 3YL

United Kingdom

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana

Slovenia

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany