STARLIX 120 mg. 24 tablets

What is Starlix is and what it is used?
What is Starlix?
Starlix belongs to the group of medicines called oral antidiabetic agents. What is Starlix
Starlix is used to treat patients with diabetes mellitus type 2. It reduces blood sugar (glucose).
Your doctor will prescribe Starlix together with another oral anti-diabetic medicine containing metformin.

How does Starlix
Insulin is a substance which is produced by the pancreas. It helps to reduce blood sugar levels, especially after meals. If you have type 2 diabetes, it is possible your body may not start producing insulin quickly enough after meals. Starlix works by stimulating the pancreas to produce insulin more quickly. This helps to control blood sugar after a meal.
Starlix tablets start to act quickly after you take them and quickly removed from the body.

2. What you need to know before you take Starlix
Follow all instructions of your doctor and pharmacist, even if they differ from what is in this leaflet.

Do not take Starlix
- If you are allergic to nateglinide or any of the other ingredients of this medicine (listed in section 6).
- If you have type 1 diabetes (ie your body does not produce any insulin).
- If you have symptoms of severe hyperglycaemia (too high blood sugar and / or diabetic ketoacidosis) eg excessive thirst, frequent urination, weakness or fatigue, nausea, shortness of breath or confusion.
- If you know that you have a serious liver problem.
- If you are pregnant or planning a pregnancy.
- If you are breastfeeding.
If any of the above applies to you, do not take Starlix and talk to your doctor.

Warnings and Precautions
Diabetes sometimes get symptoms of low blood sugar (also called. Hypoglycemia). Some medicines, including Starlix, may also produce symptoms of low blood sugar.
If you have low blood sugar may feel dizzy, light-headed, hungry, shaky or any of the signs listed in section 4, "Possible side effects". If this happens, eat or drink something containing sugar and talk to your doctor.
Some people are more likely to develop symptoms of low blood sugar than others. Be careful
- If you are older than 65 years
- If you are undernourished / a /.
- If you have another medical condition that may cause low blood sugar (eg. Under-active pituitary or adrenal gland).
If any of these conditions apply to you, you must pay close attention to your blood sugar.

Watch carefully for signs of low blood sugar, in particular:
- If you have trained harder than usual.
- If you have consumed alcohol.
Alcohol can worsen blood sugar control, so consult with your doctor about alcohol consumption during treatment with Starlix.
Talk to your doctor before taking Starlix
- If you know that you have a liver problem.
- If you have severe kidney problem.
- If you have problems of drug metabolism.
- If you have an operation.
- If you have recently suffered a fever, you have suffered injury or infection. Your treatment may need to be adjusted.
If you are intolerant to lactose (a sugar), consult with your doctor before taking Starlix.

Children and adolescents
Starlix is not recommended for children and adolescents (under 18) because its effects in this age group has not been studied.
Other medicines and Starlix
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The amount of Starlix, you need may change if you take other medicines as these may cause low or high blood sugar levels.

Particularly important to tell your doctor or pharmacist if you are taking:
- Beta-blockers or ACE inhibitors (angiotensin converting enzyme) (using, for example, to treat high blood pressure or certain heart conditions).
- Diuretics (used to treat high blood pressure).
- Corticosteroids, such as prednisone or cortisone (used to treat inflammatory diseases).
- Inhibitors of drug metabolism such as fluconazole (used to treat infections caused by fungi), gemfibrozil (used to treat dyslipidaemia) or sulfinpyrazone (used to treat chronic gout).
- Anabolic hormones (eg. Methandrostenolone).
- St. John's wort (herb).
- Somatropin (growth hormone).
- Somatostatin analogs such as octreotide and lanreotide (used for treatment of acromegaly).
- Rifampin (used for example for the treatment of tuberculosis).
- Phenytoin (used for example to treat seizures). Your doctor may adjust your dose of these medicines.

Elderly
Starlix can be used by people over the age of '65 Patients should pay special attention to avoid low blood sugar.

Pregnancy, lactation and fertility
Do not take Starlix, if you are pregnant or planning a pregnancy. See your doctor immediately if you become pregnant during treatment.
Do not breast-feed during treatment with Starlix.
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.

Driving and using machines
Your ability to concentrate or react may be reduced if you have low blood sugar (hypoglycemia). Keep this in mind if you drive or operate machinery, since it is possible to expose yourself to yourself and others.
You should seek advice from your doctor about driving if you have frequent episodes of hypoglycaemia or if you can not recognize the first signs of hypoglycaemia.
Starlix contains lactose
Starlix tablets contain lactose monohydrate. Contact your doctor before taking this medicine if you have been told by your doctor that you have an intolerance to some sugars.

3. How to take Starlix?
Always take this medicine exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
Swallow the tablets whole with a glass of water.

How much to take?
The usual starting dose of Starlix is 60 mg three times daily, taken before the three main meals. Some patients need a higher dose, your doctor will decide the dose that is best for you. The recommended maximum dose is 180 mg three times daily, taken before the three main meals.

When to take Starlix?
Take Starlix before meals. Its effect may be delayed if you take it during meals or after meals.
Premiums Starlix before the three main meals, usually:
- 1 dose before breakfast
- 1 dose before lunch
- 1 dose before dinner
It is best to take it right before a main meal but you can take it up to 30 minutes before.
Do not take it if you will not eat a main meal. If you miss a meal, skip that dose of Starlix and wait until your next meal.
Even if you are taking medicines to treat your diabetes, it is important to continue to follow the diet and / or physical regimen recommended by your doctor.

How long to take Starlix?
Keep taking Starlix daily until your doctor tells you to stop. If you take more than the amount of Starlix
If you accidentally take too many tablets, talk to a doctor. If you experience symptoms of low blood sugar (listed in section 4, "Possible side effects"), eat or drink something containing sugar.
If you feel that it is possible to have a severe hypoglycaemic attack (which may lead to loss of consciousness or seizure), call for urgent medical help or make sure someone else does this for you.

If you forget to take Starlix
If you miss a dose, take the next one before your next meal. Do not take a double dose to make up the missed dose.
Tracking during treatment with Starlix
Your doctor will periodically check the amount of Starlix, you are taking. It is possible to adjust the dose according to your needs. If you have any questions about Starlix or why this medicine has been prescribed, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
These side effects may occur with certain frequencies, which are defined as:
• Very common: may affect more than 1 in 10 people
• common: may affect up to 1 in 10 people
• uncommon: may affect up to 1 in 100 people
• rare: may affect up to 1 in 1000 people
• Very rare: may affect up to 1 in 10 000 people
• Not known: from the available data can not be estimated. Side effects caused by Starlix, are usually mild to moderate. Common side effects:

These are symptoms of low blood sugar (hypoglycemia), which are usually mild. These include:
• sweating
• dizziness
• shaking
• weakness
• hunger
• feeling your heart beating faster
• fatigue
• feeling sick (nausea)
These symptoms may be caused by lack of food or too high a dose of anti-diabetic medicine you are taking. If you experience symptoms of low blood sugar, eat or drink something containing sugar.

Other side effects may include:
• Common: abdominal pain, indigestion, diarrhea, nausea
• Uncommon: vomiting
• Rare: mild abnormalities in liver function tests, allergic (hypersensitivity) reactions such as rash and itching
• Very rare: skin rash with blisters affecting the lips, eyes and / or mouth, sometimes with headache, fever and / or diarrhea

If you get any side effects, tell your doctor or pharmacist. This includes any possible effects not listed in this leaflet.

5. How to store Starlix?
Keep out of the reach and sight of children. Store in the original package.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month. Do not use pack of Starlix, which is damaged or shows signs of tampering. Do not store above 30 ° C.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information

What Starlix?
- The active substance is nateglinide. Each tablet contains 60, 120 or 180 mg nateglinide.
- The other ingredients are lactose monohydrate; mikrkokristalna cellulose; povidone; croscarmellose sodium; magnesium stearate and silica, colloidal anhydrous.
- The tablet coating contains hypromellose; titanium dioxide (E171); talc; macrogol and red (60 tablets of 180 mg) or yellow (tablets of 120 mg) iron oxide (E172).

How Starlix looks like and contents of the pack?
Starlix 60 mg film-coated tablets are pink, round tablets with "STARLIX" marked on one side and "60" on the other.
Starlix 120 mg film-coated tablets are yellow, oval tablets with "STARLIX" marked on one side and "120" on the other.
Starlix 180 mg film-coated tablets are red, oval tablets with "STARLIX" marked on one side and "180" on the other.
Each blister contains 12, 24, 30, 60, 84, 120 or 360 tablets. Not all pack sizes may be marketed in your country.