Repaglinide Rivopharm 1mg Tablets
PATIENT INFORMATION LEAFLET
Repaglinide 0.5 mg tablets Repaglinide 1 mg tablets Repaglinide 2 mg tablets
Repaglinide
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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Repaglinide is and what it is used for
2. Before you use Repaglinide
3. How to use Repaglinide
4. Possible side effects
5. How to store Repaglinide
6. Further 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. BEFORE YOU TAKE REPAGLINIDE Do not take Repaglinide:
- If you are hypersensitive (allergic) to repaglinide or any of the other components of the medicine
- If you have type 1 diabetes (insulin-dependent diabetes)
- If the acid level in your body is raised (diabetic ketoacidosis)
- If you have a severe liver disease
- If you use 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
Take special care with Repaglinide:
- If you have liver problems. Repaglinide is not recommended in patients with moderate liver disease. Repaglinide should not be taken if you have a severe liver disease (see Do not take Repaglinide).
- If you have kidney problems. Repaglinide should be taken with caution.
- If you are about to have major surgery or you have recently suffered a severe illness or infection. At such times diabetic control may be lost.
- If you are under 18 or over 75 years of age, Repaglinide is not recommended. It has not been studied in these age groups.
Talk to your doctor 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 symptoms 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 disorders (see other sections of 2. Before you take Repaglinide).
The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; 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 symptoms of hypoglycaemia have disappeared or when blood sugar levels are stabilised continue 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.
Using other medicines
You can take Repaglinide with metformin, another medicine for diabetes, if your doctor prescribes it.
Your body's response to Repaglinide may change if you take other medicines, especially these:
• 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)
• Octreotide (used to treat cancer)
• Nonsteroidal anti-inflammatory drug (NSAIDS) (a type of painkiller) and salicylates (e.g. aspirin)
• Steroids (anabolic steroids and corticosteroids - used for anaemia or to treat inflammation)
• Oral contraceptives (birth control pills)
• Thiazides (diuretics or "water pills")
• Danazol (used to treat breast cysts and endometriosis)
• Thyroid products (used to treat low levels of thyroid hormones)
• Sympathomimetics (drugs that mimic the effect of sympathetic nervous system) (used to treat asthma)
• Clarithromycin, trimethoprim, rifampicin (antibiotic medicines)
• Itraconazole, Ketoconazole (antifungal medicines)
• Gemfibrozil (used to treat high blood fats)
• Cidosporin (used to suppress the immune system)
• Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy)
• St. John's wort (herbal medicine).
Tell your doctor if you have recently taken or are planning to take any of these medicines, or any medicines obtained without a prescription.
Using Repaglinide with food and drink
Take Repaglinide before main meals. Alcohol can change the ability of Repaglinide to reduce the blood sugar. Watch for signs of a hypo.
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.
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. HOWTO TAKE REPAGLINIDE
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.
Do not take more Repaglinide than your doctor has recommended. Always take Repaglinide exactly as your doctor has told you. Check with your doctor if you are not sure.
If you take more Repaglinide than you should
If you take too many tablets, your blood sugar may become too low, leading to a hypo. Please see If you get a hypo on what a hypo is and how to treat it.
If you forget to take Repaglinide
If you miss a dose, take the next dose as usual - do not double the dose.
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 Repaglinide, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Repaglinide can cause side effects, although not everybody gets them.
Some side effects can be serious.
Contact your doctor immediately if you experience any of the following:
- Allergy (such as swelling, difficulty in breathing, rapid heart beat, feeling dizzy, sweating which could be signs of anaphylactic reaction)
- Severe hypoglycaemic reaction (see If you get a hypo)
Possible side effects
Common (may affect up to 1 in 10 patients)
- Hypoglycaemia (see If you get a hypo). The risk of getting a hypo may increase if you take other medicines
- Stomach pain
- Diarrhoea.
Rare (may affect up to 1 in 1000 patients)
- Acute coronary syndrome (a disease affecting the coronary arteries) (but it may not be due to the drug).
Very rare (may affect up to 1 in 10,000 patients)
- Allergy
- Vomiting (being sick)
- Constipation
- Visual disturbances
- Severe liver problems, abnormal liver function, increased liver enzymes in your blood.
Frequency unknown
- Hypoglycaemic coma or unconsciousness (very severe hypoglycaemic reactions - see If you get a hypo).
- Hypersensitivity (such as rash, itchy skin, reddening of the skin, swelling of the skin)
- Feeling sick (nausea).
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5. HOWTO STORE REPAGLINIDE
Keep out of the reach and sight of children. Store it in the original package in order to protect from light and moisture.
Do not use the product after the expiry date. This is stated on the outer carton and the blister foil. The expiry date refers to the last day of that month.
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.
6. FURTHER INFORMATION What Repaglinide contains
The active substance is repaglinide. Three strengths of tablets are available. The strengths are 05 mg, 1 mg and 2 mg.The other ingredients are: Microcrystalline cellulose (E460), calcium hydrogen phosphate anhydrous, maize starch, amberlite (polacrilin potassium), povidone (polyvidone), glycerol anhydrous, magnesium stearate, meglumine, poloxamer, iron oxide yellow (El 72) only in the 1 mg tablets and iron oxide red (El 72) only in the 2 mg tablets.
What Repaglinide looks like and contents of the pack
Repaglinide tablets are round. 0.5 mg tablets are white, 1 mg tablets are yellow and 2 mg tablets are red. Each pack contains 30,90,120 or 270 tablets. Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Marketing Authorisation Holder - Rivopharm UK Ltd., 30th Floor,
40 Bank Street, Canary Wharf, London E14 5NR
Manufacturer - Laboratoires BTT, Z.l. de Krafft, 67150 Erstein, France
Distributed by - Creo Pharma Ltd, Felsted Business Centre, Felsted, Essex, CM63LY, UK
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This leaflet was last approved in: 01/2016