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REPAGLINIDE 1 MG TABLETS

Active substance(s): REPAGLINIDE

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Package Leaflet:
Information for the User
Repaglinide 0.5 mg, 1 mg & 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.

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 medicine 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.

 Repaglinide 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. Repaglinide can also be given with metformin,
another medicine for diabetes.
 Repaglinide 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
Repaglinide
Do not take Repaglinide:
 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).

Warnings and precautions
Talk to your doctor before taking 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.
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 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 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 of too high blood sugar appear
gradually. They may 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, have
recently taken or might take any other medicines.
You can take Repaglinide 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 Repaglinide.
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)
 Salicylates (e.g. aspirin)
 Octreotide (used to treat cancer)
 Nonsteroidal anti-inflammatory drugs (NSAID) (a type
of painkillers)
 Steroids (anabolic steroids and corticosteroids - 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, ketoconazole (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).

Repaglinide with alcohol
Alcohol can change the ability of Repaglinide 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 Repaglinide if you are pregnant or
you are planning to become pregnant.
You should not take Repaglinide 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 Repaglinide
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.

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, reddening 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 Repaglinide
Keep this medicine out of the sight and reach of children.
Store in the original package.
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.
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

Do not take more Repaglinide than your doctor has
recommended.

The active substance is repaglinide. Each tablet contains
0.5 mg; 1 mg; 2 mg repaglinide.

If you take more Repaglinide than you should

The other ingredients are: Meglumine; Poloxamers;
Glycerol; Povidone; Cellulose, microcrystalline; Maize
Starch; Calcium hydrogen phosphate, anhydrous;
Polacrilin potassium; Magnesium stearate.
Repaglinide 1 mg also contains: Iron oxide yellow (E172);
Repaglinide 2 mg also contains: Iron oxide red E172).

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 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.

What Repaglinide looks like and contents of
the pack
Repaglinide 0.5 mg: White to off white, round, uncoated,
biconvex tablets imprinted with ‘RP’ on one side and ‘0.5’
on the other side.
Repaglinide 1 mg: Yellow coloured, mottled, round,
uncoated, biconvex tablets imprinted with ‘RP’ on one
side and ‘1’ on the other side.
Repaglinide 2 mg: Peach coloured, mottled, round,
uncoated, biconvex tablets imprinted with ‘RP’ on one
side and ‘2’ on the other side.
Each pack contains 30, 90 or 120 tablets.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Dr. Reddy’s Laboratories (UK) Ltd, 6 Riverview Road,
Beverley, East Yorkshire, HU17 0LD, UK
This medicinal product is authorised in the Member
States of the EEA under the following names:
Italy: Repaglinide Dr. Reddy's 0,5; 1; 2 mg compresse
Romania: Repaglinide Dr. Reddy's 0,5; 1; 2 mg
comprimate
United Kingdom: Repaglinide 0.5; 1; 2 mg Tablets
(PL 08553/0416-0418)
This leaflet was last revised in 07/2012

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
medicine)

© Dr. Reddy’s Laboratories (UK) Limited

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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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