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REPAGLINIDE RIVOPHARM 1MG TABLETS

Active substance(s): REPAGLINIDE / REPAGLINIDE / REPAGLINIDE

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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 gets 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

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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.

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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 drugs (NSAIDS) ( a type of painkillers) 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 the sympathetic nervous system) (used to treat
asthma)
• Clarithromycin, trimethoprim, rifampicin (antibiotic medicines)
• Itraconazole, Ketoconazole (antifungal medicines)
• Gemfibrozil (used to treat high blood fats)
• Ciclosporin (used to suppress the immune system)
• Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy)
• St. John’s wort (herbal medicine)
• Clopidogrel (prevents blood clots).
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. HOW TO TAKE REPAGLINIDE
Your doctor will work out your dose.
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• 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 reactions (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
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• 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, redening 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. HOW TO 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 0.5 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 (E172) only in the 1 mg tablets and iron oxide red (E172) 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,
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January 2017

UK
Manufacturer

Laboratoires BTT,
Z.I. de Krafft, 67150 Erstein,
France
or
Rivopharm UK Ltd.
30th Floor, 40 Bank Street, Canary Wharf
London, E14 5NR
United Kingdom

This leaflet was last approved in 01/2017

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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