Repaglinide Mylan 0.5 Mg Tablets
Package Leaflet: Information for the patient
REPAGLINIDE 0.5 mg TABLETS
REPAGLINIDE 1 mg TABLETS
REPAGLINIDE 2 mg TABLETS
(repaglinide)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Repaglinide is and what it is used for
2. What you need to know before you take Repaglinide
3. How to take Repaglinide
4. Possible side effects
5. How to store Repaglinide
6. Contents of the pack and other information
1. WHAT REPAGLINIDE IS AND WHAT IT IS USED FOR
Repaglinide is an oral antidiabetic agent containing repaglinide which helps your pancreas produce more insulin and thereby lower your blood sugar (glucose).
Type 2 diabetes is a disease in which your pancreas does not make enough insulin to control the sugar in your blood or where your body does not respond normally to the insulin it produces (formerly known as non-insulin-dependent diabetes mellitus or maturity onset diabetes).
Repaglinide is used to control type 2 diabetes as an add-on to diet and exercise: treatment is usually started if diet, exercise and weight reduction alone have not been able to control (or lower) your blood sugar. Repaglinide can also be given with metformin, another medicine for diabetes.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE REPAGLINIDE
Do not take Repaglinide if you
• are allergic (hypersensitive) to repaglinide or any of the other ingredients of this medicine (listed in Section 6)
• suffer from type 1 (insulin dependent) diabetes
• have been diagnosed with raised body acid levels (a condition called diabetic ketoacidosis)
• suffer from severe liver disease
• take gemfibrozil (a medicine used to lower increased fat levels in the blood)
If any of these apply to you, tell your doctor and do not take Repaglinide.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Repaglinide
Take special care:
• if you suffer from liver problems. Repaglinide is not recommended if you have moderate liver disease and should not be taken if you have severe liver disease (see 'Do not take Repaglinide').
• if you have kidney problems. Repaglinide should be taken with caution.
• if you have recently had major surgery or suffered from a severe illness or infection because your body's glycaemic control may have been affected.
In these cases your doctor may advise you to stop taking repaglinide and prescribe insulin until your blood sugar levels have stabilised.
• if you are under 18 or over 75 years of age. Repaglinide is not recommended. It has not been studied in these age groups.
If any of the above applies to you, Repaglinide may not be suitable for you. Your doctor will advise you.
If you get a hypo
You may get a hypo (short for a hypoglycaemic reaction and is a symptom of low blood sugar) if your blood sugar gets too low. This may happen:
• if you take too much Repaglinide
• if you exercise more than usual
• if you take other medicines or suffer from liver or kidney problems (see other sections of 2. 'What you need to know before you take Repaglinide').
The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
If your blood sugar is low or you feel a hypo coming
on: eat glucose tablets or a high sugar snack or drink, then rest.
When the symptoms of hypoglycaemia have disappeared or when your blood sugar levels are stabilised continue with your Repaglinide treatment.
Tell people you have diabetes and that if you pass
out (become unconscious) due to a hypo, they must turn you on your side and get medical help straight away. They must not give you any food or drink. It could choke you.
• If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death.
• If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor. The amount of Repaglinide, food or exercise may need to
be adjusted.
If your blood sugar gets too high
Your blood sugar may get too high (hyperglycaemia). This may happen:
• if you take too little Repaglinide
• if you have an infection or a fever
• if you eat more than usual
• if you exercise less than usual.
The warning signs appear gradually. They include: increased urination; feeling thirsty; dry skin and dry mouth. Talk to your doctor. The amount of Repaglinide, food or exercise may need to be adjusted.
Other medicines and Repaglinide
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
You can take Repaglinide with metformin (another medicine for diabetes) if your doctor prescribes it.
If you are already taking another medicine for your diabetes and you are also prescribed repaglinide, please tell your doctor before you start to take this medicine.
Do not take repaglinide if you are already taking gemfibrozil to lower fat levels in your blood.
Your body's response to repaglinide may change if you are also taking any of the following medicines:
• monoamine oxidase inhibitors (MAOI) used to treat depression
• beta-blockers used to treat high blood pressure or heart conditions
• ACE-inhibitors used to treat heart conditions
• salicylates (such as aspirin)
• non-steroidal anti-inflammatory drugs (NSAIDs) used as painkillers
• octreotide used to treat some cancers
• steroids (both anabolic steroids and corticosteroids) used to treat anaemia or inflammation
• oral contraceptives (birth control pills)
• thiazides (referred to as diuretics or 'water pills')
• danazol to treat breast cysts and endometriosis
• thyroid products (used to treat low levels of thyroid hormones)
• sympathomimetics used to treat asthma
• clarithromycin, trimethoprim or rifampicin to treat bacterial infections (antibiotic medicines)
• gemfibrozil (used to treat high blood fats)
• ciclosporin (used to suppress the immune system)
• deferasirox (used to reduce chronic iron overload)
• i traconazole or ketoconazole to treat fungal infections
• phenytoin, carbamazepine or phenobarbital to treat epilepsy
• St John's wort, a herbal medicine
Repaglinide with food, drink and alcohol
Take Repaglinide before main meals.
Alcohol can alter the way this medicine works to reduce your blood sugar levels. You should watch for the signs or symptoms of hypo (low blood sugar levels) if you consume alcohol.
Pregnancy and breast-feeding
You should not take repaglinide if you are pregnant or you are planning to become pregnant.
See your doctor as soon as possible if you become pregnant or are planning to become pregnant during treatment. You should not take repaglinide if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Your ability to drive or operate a machine may be affected if your blood sugar is low or high. Bear in mind that you could endanger yourself or others. Please ask your doctor whether you can drive a car if you:
• have frequent hypos
• have few or no warning signs of hypos.
3. HOW TO TAKE REPAGLINIDE
Always take this medicine exactly as your doctor or pharmacist has told you. Do not take more Repaglinide than your doctor has told you. Check with your doctor or pharmacist for advice before taking this medicine.
Your doctor will work out your dose.
• The normal starting dose is 0.5 mg before each main meal. Swallow the tablets with a glass of water immediately before or up to 30 minutes before each main meal.
• The dose may be adjusted by your doctor by up to 4 mg to be taken immediately before or up to 30 minutes before each main meal. The maximum recommended daily dose is 16 mg.
Use in children and adolescents
Repaglinide is not recommended for children and adolescents under 18 years of age.
If you take more Repaglinide than you should
If you take too many tablets your blood sugar levels may become too low leading to hypo (hypoglycaemia). Please see If you get a hypo (Section 2) on what a hypo is and how to treat it.
If you forget to take Repaglinide
Do not double the dose to make up for a forgotten dose, take the next dose as usual.
If you stop taking Repaglinide
Be aware that the desired effect is not achieved if you stop taking Repaglinide. Your diabetes may get worse. If any change of your treatment is necessary contact your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in
10 patients):
• low blood sugar (Hypoglycaemia, see If you get a hypo). The risk of getting a hypo may increase if you take other medicines
• stomach pain
• diarrhoea
Rare side effects (may affect up to 1 in 1000 patients):
• acute coronary syndrome (but it may not be due to the drug)
Very rare side effects (may affect up to 1 in 10,000 patients):
• allergy (such as swelling, difficulty breathing, rapid heartbeat, feeling dizzy and sweating which could be signs of anaphylactic reaction). Contact a doctor immediately
• vomiting
• constipation
• visual disturbances
• severe liver problems including abnormal liver function and raised liver enzymes in your blood
Not known (cannot be estimated from the available data):
• hypoglycaemic coma or unconsciousness (very severe hypoglycaemic reactions - see If you get a hypo). Contact a doctor immediately.
• feeling sick (nausea)
• hypersensitivity (such as rash, itchy skin, reddening of the skin, swelling of the skin).
Reporting of side effects
If you get any of the 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 the Yellow Card System at: 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 REPAGLINIDE
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the blister, carton or bottle label after 'EXP'. The expiry date refers to the last day of that month.
Repaglinide supplied in HDPE bottle packs should be used for no longer than 3 months after the bottle has first been opened.
Do not use this medicine if you notice any discolouration of tablets.
This medicinal product does not require any special storage conditions.
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 Repaglinide contains:
• The active substance is repaglinide. Each tablet contains 0.5 mg, 1 mg, and 2 mg of repaglinide.
• The other ingredients are:
*Povidone (PVP K-30)
*Sodium laurilsulphate *Butylhydroxyanisole
*Calcium hydrogen phosphate, anhydrous *Cellulose, microcrystalline (E460)
*Maize starch
*Meglumine
*Croscarmellose sodium
*Polacrilin potassium
*Magnesium stearate
*Silica, colloidal anhydrous
*Iron oxide yellow (E172) [1 mg tablets only]
*Iron oxide red (E172) [2 mg tablets only]
What Repaglinide looks like and contents of the pack
The 0.5 mg tablets are white to off-white, round, biconvex tablets debossed with 'M' on one side of the tablet and 'R21' on the other side.
The 1 mg tablets are yellow, round, biconvex tablets debossed with 'M' on one side of the tablet and 'R22' on the other side.
The 2 mg tablets are peach-coloured, round, biconvex tablets debossed with 'M' on one side of the tablet and 'R23' on the other side.
The medicinal product is available in aluminium/ aluminium blister packs of 30, 90, 120, 180, 200 and 270 or bottles with a child resistant closure and desiccant containing 120, 200 and 270 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan Potters Bar Hertfordshire EN61TL
United Kingdom
Manufacturer
Mylan Hungary Kft.
H-2900 Komarom Hungary
This leaflet was last approved In 02/2013 00000000 10005120