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REPAGLINIDE APOTEX 0.5 MG TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Repaglinide Apotex 0.5 mg Tablets
Repaglinide Apotex 1 mg Tablets
Repaglinide Apotex 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 symptoms 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 Apotex is and what it is used for
2. What you need to know before you take Repaglinide Apotex
3. How to take Repaglinide Apotex
4. Possible side effects
5. How to store Repaglinide Apotex
6. Content of the pack and other information
1.

What Repaglinide Apotex is and what it is used for

Repaglinide Apotex 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.
Repaglinide Apotex 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 Apotex can also be given with metformin, another medicine for
diabetes.
2.

What you need to know before you take Repaglinide Apotex

Do not take Repaglinide Apotex:






If you are allergic to repaglinide or any of the other ingredients of this medicine (listed in section
6)
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 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 Apotex.
Warnings and precautions
Talk to your doctor or pharmacist before taking Repaglinide Apotex.

If you have liver problems. Repaglinide Apotex is not recommended in patients with moderate
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liver disease. Repaglinide Apotex should not be taken if you have a severe liver disease (see Do
not take Repaglinide Apotex).
If you have kidney problems. Repaglinide Apotex 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 Apotex 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 Apotex 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 a hypoglycaemica if your blood sugar gets too low. This may happen:

If you take too much Repaglinide Apotex

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 Apotex).
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 Apotex 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 Apotex, 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 Apotex

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 Apotex, food or exercise may need to be
adjusted.

Other medicines and Repaglinide Apotex
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
You can take Repaglinide Apotex with metformin, another medicine for diabetes, if your doctor
prescribes it.
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If you take gemfibrozil (used to lower increased fat levels in the blood) you should not take
Repaglinide Apotex.
Your body’s response to Repaglinide Apotex 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 – 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).
Repaglinide Apotex with food, drink and alcohol
Alcohol can change the ability of Repaglinide Apotex to reduce the blood sugar. Watch for signs of a
hypo.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine. See your doctor as soon as possible
if you become pregnant or are planning to become pregnant during treatment.
You should not take Repaglinide Apotex 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 Apotex

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 recommended 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.
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Do not take more Repaglinide Apotex than your doctor has recommended.
If you take more Repaglinide Apotex 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 Apotex
If you miss a dose, take the next dose as usual - do not double the dose.
If you stop taking Repaglinide Apotex
Be aware that the desired effect is not achieved if you stop taking Repaglinide Apotex. 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 Apotex, 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 medicine).
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.
Reporting of side effects
If you get any 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 Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.
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5.

How to store Repaglinide Apotex

Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the outer carton and the blister foil
after EXP. The expiry date refers to the last day 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.

Content of the pack and other information

What Repaglinide Apotex contains

The active substance is repaglinide.

The other ingredients are:
dibasic calcium phosphate dihydrate, polacrilin
potassium, meglumine, poloxamer, butylated hydroxytoluene, microcrystalline cellulose,
magnesium stearate, colloidal anhydrous silica.
dibasic calcium phosphate dihydrate, polacrilin
potassium, meglumine, poloxamer, butylated hydroxytoluene, microcrystalline cellulose,
magnesium stearate, colloidal anhydrous silica, yellow iron oxide.
dibasic calcium phosphate dihydrate, polacrilin
potassium, meglumine, poloxamer, butylated hydroxytoluene, microcrystalline cellulose,
magnesium stearate, colloidal anhydrous silica, red iron oxide.
What Repaglinide Apotex looks like and contents of the pack

Repaglinide Apotex 0.5 mg tablets are white to off-white, round, biconvex tablets, diameter 6
mm, engraved “APO” on one side and “R.5” on the other side.

Repaglinide Apotex 1 mg tablets are yellow, mottled, round, biconvex tablets, diameter 6 mm,
engraved “APO” on one side and “R1” on the other side.

Repaglinide Apotex 2 mg tablets are light pink, mottled, round, biconvex tablets, diameter 6 mm,
engraved “APO” on one side and “R2” on the other side.
The tablets are available in blister packs of 90 and 120 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Apotex Europe BV

Darwinweg 20
2333 CR Leiden
The Netherlands

Manufacturer:
Apotex Nederland BV
Archimedesweg 2
2333 CN Leiden
The Netherlands

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This leaflet was last approved in 09/2014.

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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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