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REGLINEP 2 MG TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Reglinep 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 only. 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.
What is in this leaflet:
1. What Reglinep is and what it is used for
2. What you need to know before you take Reglinep
3. How to take Reglinep
4. Possible side effects
5. How to store Reglinep
6. Contents of the pack and other information

1. What Reglinep is and what it is used for
Reglinep is an oral antidiabetic medicine 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.
Reglinep is used to control type 2 diabetes in adults 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. Reglinep can also be given with metformin, another medicine for diabetes.
Reglinep has been shown to lower the blood sugar, which helps to prevent complications from your
diabetes.

2. What you need to know before you take Reglinep
Do not take Reglinep
• If you are allergic to repaglinide or any of the other ingredients in this medicine (listed in
section 6).
• If you have type 1 diabetes
• If the acid level in your body is raised (diabetic ketoacidosis).
• If you have a severe liver disease.
• If you take gemfibrozil (a medicine used to lower increased fat levels in the blood).
Warning and precautions
Talk to your doctor before taking Reglinep
• If you have liver problems. Reglinep is not recommended in patients with moderate liver
disease. Reglinep should not be taken if you have a severe liver disease (see Do not take
Reglinep).
• If you have kidney problems. Reglinep 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. Reglinep is not recommended. It has not been
studied in these age groups.
Talk to your doctor if any of the above applies to you. Reglinep may not be suitable for you. Your
doctor will advise you.
Children and adolescents
Do not take this medicine if you are under 18 years of age.
If you get a hypo ((low blood sugar)(You may get a hypo (short for hypoglycaemia) if your blood
sugar gets too low. This may happen:
• If you take too much Reglinep.
• 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 Reglinep).
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 stabilized
continue Reglinep 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.
If your blood sugar gets too high
Your blood sugar may get too high (hyperglycaemia). This may happen:
• If you take too little Reglinep.
• If you have an infection or a fever.
• If you eat more than usual.
• If you exercise less than usual.
The warning signs of too high blood sugar appear gradually. They include: increased urination;
feeling thirsty; dry skin and dry mouth. Talk to your doctor. The amount of Reglinep, food or exercise
may need to be adjusted.
Other medicines and Reglinep
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
You can take Reglinep with metformin, another medicine for diabetes, if your doctor prescribes it.
If you take gemfibrozil (used to lower increased fat levels in the blood) you should not take Reglinep.
Your body's response to Reglinep 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).
• Salicylates (e.g. aspirin ).
• Octreotide (used to treat cancer).
• Nonsteroidal anti-inflammatory drugs (NSAID) (a type of painkiller).
• Steroids (anabolic steroids and corticosteroids - used for anemia 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 (used to treat asthma).
• Clarithromycin, trimethoprim, rifampicin (antibiotic medicines).
• Itraconazole, ketokonazole (antifungal medicines).
• Gemfibrozil (used to treat high blood fats).
• Ciclosporin (used to suppress the immune system).
• Deferasirox (used to reduce chronic iron overload)• Phenytoin, carbamazepine, phenobarbital
(used to treat epilepsy).
• St. John's wort (herbal medicine).
Reglinep with alcohol
Alcohol can change the ability of Reglinep to reduce the blood sugar. Watch for signs of a hypo.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor for advice before taking this medicine.
You should not take Reglinep if you are pregnant or you are planning to become pregnant.
You should not take Reglinep if you are breast-feeding.
Driving and using machines
Your ability to drive or use 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 Reglinep
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not
sure.
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 Reglinep than your doctor has recommended. Reglinep
If you take more Reglinep 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 Reglinep
If you miss a dose, take the next dose as usual - do not double the dose.

If you stop taking Reglinep
Be aware that the desired effect is not achieved if you stop taking Reglinep. 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 medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Hypoglycaemia
The most frequent side effect is hypoglycaemia which may affect up to 1 in 10 patients (see If you get
a hypo in section 2). Hypoglycaemic reactions are generally mild/moderate but may occasionally
develop into hypoglycaemic unconsciousness or coma. If this happens, contact medical assistance
immediately.
Allergy
Allergy is very rare (may affect up to 1 in 10,000 patients). Symptoms such as swelling, difficulty in
breathing, rapid heartbeat, feeling dizzy and sweating could be signs of anaphylactic reaction. Contact
a doctor immediately.
Other side effects
Common: (may affect up to 1 in 10 patients)
• • Stomach pain
• Diarrhoea.
Rare: (may affect up to 1 in 1,000 patients)
• Acute coronary syndrome (but it may not be due to the medicinal product).
Very rare: (may affect up to 1 in 10,000 patients)
• • Vomiting
• Constipation
• Visual disturbances
• Severe liver problems, abnormal liver function, such as increased liver enzymes in your
blood.
Frequency not known
• Hypersensitivity (such as rash, itchy skin, redening of the skin, swelling of the skin)
• Feeling sick (nausea).
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.

5. How to store Reglinep
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 carton and the blister foil after
EXP. The expiry date refers to the last date of that month.
Store in the original package in order to protect from moisture.
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 Reglinep contains
The active substance is repaglinide.
Each Reglinep 2mg tablet contains 0.5 mg repaglinide.
The other ingredients are:
Microcrystalline cellulose (E460)
Calcium hydrogen phosphate, anhydrous
Maize starch
Polacrilin potassium
Povidone K-30
Glycerol 99.5%
Magnesium stearate
Poloxamer 188
Meglumine Iron Oxide Yellow (E172)
What Reglinep looks like and contents of the pack
Reglinep 2 mg tablets are peach, round, biconvex tablets, having a diameter of 6.0 mm approximately
and bearing a breakline on one side.
The tablets can be divided into equal halves.
Reglinep is available in pack sizes of 30, 90, 120 and 270 tablets in blister and 90 and 270 tablets in
bottle.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Specifar S.A.
1, 28 Octovriou str.,
Ag. Varvara,
123 51 Athens
Greece
This medicinal product is authorised in the Member States of the EEA under the following
names:
Germany: Reglinep 0.5 mg, 1 mg, 2 mg tabletten
Sweden: Reglinep 0.5 mg, 1 mg, 2 mg tabletter
Greece : Reglinep 0.5 mg, 1 mg, 2 mg δισκία
Finland: Reglinep 0.5 mg, 1 mg, 2 mg tabletit
United Kingdom : Reglinep 0.5 mg, 1 mg, 2 mg tablets

This leaflet was last approved in 2013-01-15

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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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