1- WHAT NATRILIX SR, sustained-release film-coated tablets IS AND WHAT IT IS USED FOR?
This medicine is intended to reduce high blood pressure (hypertension) . It is a prolonged-release film-coated tablet containing indapamide as active ingredient.
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.
2 – NECESSARY INFORMATION BEFORE YOU TAKE NATRILlX SR sustelned-release fltm-ccated tablets
If you have been told by your doctor that you have an intolerance to some sugars. contact your doctor before taking this medicinal product.
Do not take NATRILlX SR, sustained-release film-coated tablets:
* if you are allergic to indapamide or any other sulphonamide or to any of the other ingredients of NATRIUX SR,
* if you have 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.
Take special care with NATRILlX SR, sustained-release film-coated tablets:
* if you have liver problems,
* if you have diabetes,
* if you suffer from gout.
* if you have any heart rhythm problems or problems with your kidneys,
* if you need to have • lest to check your paralhyroid gland.
You should tell your doctor if you 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 may 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 NA TRIUX SR contains an active ingredient. which may give a positive reaction in doping tests. The use of this medicinal product is not recommended in patients with problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption (rare hereditary diseases).
Taking other medicines:
Please tell your doctor or phannacist if you are taking or have recentty taken any other medicines, including medicines obtained without a prescription. You should not take NATRILlX SR with lithium (used k)..treat depression) due to the risk of increased IeVEHS of lithium in the blood. Make sure to tell your doctor if you are taking any of the foflowing medicines, as special care may be required:
* medicines used for heart rhythm problems (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis),
* medicines used to treat mental disorders such as depression, anxiety, schizophrenia.. (e.g. tricydic antidepressants, antipsychotic drugs, neuroleptics),
* bepridil (used to treat angina pectoris, a condition causing chest pain),
* cisapride. diphemanil (used to treat qastro-lntestinat problems).
* sparfloxacin, moxifloxacin (antibiotics used to treat infections),
* halofantrine (antiparasitic drug used to treat certain types of malaria),
* pentamidine (used to treat certain types of pneumonia),
* mizolastine (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),
* oral corticosterods used to treat various conditions induding severe asthma and rheumatoid arthritis,
* stimulant laxatives,
* baclofen (to treat muscle stiffness occurring in diseases such as multiple sclerosis).
* potassjum-spareq diuretics (amik>ride, 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).
Pregnancy and breast-feeding:
Ask your doctor or pharmacist for advice before taking any 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. Breastfeeding is not advisable 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 diving and other activities requiring alertness. H(MI8Ver, under good control,ihese side effects are unlikely to occur.
Important information about some of the ingredients of NATRllIX SR, sustained-release film-coated tablet:
This medicine contains lactose monohydrate.
3. HOW TO TAKE NATRllIX SR, sustained-release film-coated tablet?
One tablet each day, preferably in the morning. 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 NATRllIX SR, sustained-release film-coated tablet, than you should:
If you have taken too many tablets, contact your doctor or pharmacist immediately.A very large dose of NATRllIX SR could cause nausea, vomiting, low blood pressure, cramps, dizziness, drowsiness, confusion and changes in the amount of urine produced by the kidneys.
If you forget to take NATRILlX SR, sustained-release fllm-coated tablet:
If you forget 10 take a dose of your medicine, take the next dose at the usual lime.
D0 not take a double dose to make up for the forgotten dose.
If you stop taking NATRllIX SR, sustained-release film-coated tablet:
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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS :
Like all medicines, NATRllIX SR, sustained-release film-coated tablet can cause side effects, although not everybody gets them .
* Common «1/10, >1/100): low potassium in the blood, which may cause muscle weakness .
* Uncommon « 11100, >1/1000): vomiting, allergic reactions, mainly dermatological, such as skin rashes, purpura (red pinpoints on skin) in subjects with a predisposition to allergic and asthmatic reactions.
* Rare « 111000, >1/10,000):
– Feeling of tiredness, dizziness, headache, pins and needles (paresthesia);
– Gastro-intestinal disorders (such as nausea, constipation), dry mouth;
– Increased risk of dehydration in the elderly and in patients suffering from heart failure.
* Very rare « 1/10,000):
– Heart rhythm irregularities, low blood pressure;
– Kidney disease;
– Pancreatitis (inflammation of the pancreas which causes upper abdominal pain), abnormal liver function. In cases of liver failure, there is a possibility of getting hepatic encephalopathy (degenerative disease in the brain);
– 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);
– Aogioedema and/Of” urticaria, severe skin manifestations. 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 immediatEHy.
– If you suffer from systemic lupus erythematosus (a type of collagen 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.
* Not known (cannot be estimated from the available data):
— Some changes may occur in your laboratory parameters and your doctor may need to give you blood tests to check your condition. The following changesrin laboratory parameters may occur:
– low potassium in the blood,
– low sodium in the bk>od that may lead to dehydratIOn arid low-bl
– increase in uric acid, a substance Yfhich may cause or worsen gQut
(painful joint(s) especially in the feet),
-increase in blood glucose levels in diabetic patients,
– increase of calcium in blood.
– elevation of liver enzyme levels
–Abnormal electrocardiogram tracing
–Life-threatening irregular heart beat (torsades de pointe).
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
5. HOW TO STORE NATRILlX SR, SUSTAINED RELEASE FILM -COATED TABLET ?
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month. This medicine should be stored at temperature not exceeding 2S”C, in a dry place.
6. FURTHER INFORMATION
What NATRILlX SR, sustained-release fllm-coated tablet contains:
The active substance Is:
lndapamide …. .. .. 1.5 mg for a sustained-release film-coated tablet.
The other Ingredients are:
In the tablet core: anhydrous colloidal silica (ESS1), hypromellose (E464), lactose monohydrate. magnesium stearate (E470B), povidone. In the film-coating: glycerol (E422), hypromellose (E464), macrogol 6000, magnesium stearate (E470B), titanium dioxide (E171).
What NATRILIX SR, sustained-release film-coated tablet contains looks like an’H contents of the pack:
White, round prolonqed-reiease film-coated tablet.
Boxes of 30 tablets.
This leaflet was last approved on 26st September 2012.Keep all medicaments out of the reach and sight of children
Manufactured by :
SERVIER EGYPT INDUSTRIES LIMITED
6th October City· A.R.E.
Under Licence of: Les Laboratoires Servier • France