REPAGLINIDE 2MG TABLETS

Active substance: REPAGLINIDE

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Repaglinide 0.5mg, 1mg
and 2mg tablets
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.
•   f you have any further questions, ask your doctor or
I
pharmacist.
•   his medicine has been prescribed for you only. Do
T
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
•   f you get any side effects, talk to your doctor or
I
pharmacist. This includes any possible side effects not
listed in this leaflet

What is in this leaflet:

1 What Repaglinide tablets are and what they
are used for
2 What you need to know before you take
3 How to take
4 Possible side effects
5 How to store
6 Contents of the pack and other information
W
1  hat Repaglinide tablets are and what they
are used for

Repaglinide tablets are 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

Do not take Repaglinide tablets:

• f you are allergic to repaglinide or any of the other
i
ingredients in this medicine (listed in section 6).
• if you have type 1 diabetes.
• f the acid level in your body is raised (diabetic
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ketoacidosis).
• if you have a severe liver disease.
• f you take gemfibrozil (a medicine used to lower increased
i
fat levels in the blood).

Warning and precautions

Talk to your doctor before taking Repaglinide:
• f you have liver problems. Repaglinide is not
i
recommended in patients with moderate liver disease.
Repaglinide should not be taken if you have a severe liver
disease (see Do not take Repaglinide tablets).
• f you have kidney problems. Repaglinide should be taken
i
with caution.
• f you are about to have major surgery or you have
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recently suffered a severe illness or infection. At such times
diabetic control may be lost.
• f you are under 18 or over 75 years of age. Repaglinide is
i
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.
• f you take other medicines or suffer from liver or kidney
i
problems (see other sections of 2. What you need to know
before you take).
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.
•  f severe hypoglycaemia is not treated, it can cause brain
I
damage (temporary or permanent) and even death.
•  f you have a hypo that makes you pass out, or a lot of
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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 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:
•  onoamine oxidase inhibitors (MAOI) (used to treat
M
depression)
•  eta blockers (used to treat high blood pressure or heart
B
conditions)
• ACE-inhibitors (used to treat heart conditions)
• Salicylates (e.g. aspirin)
• Octreotide (used to treat cancer)
•  onsteroidal anti-inflammatory drugs (NSAID) (a type of
N
painkiller)
•  teroids (anabolic steroids and corticosteroids – used for
S
anaemia or to treat inflammation)
• Oral contraceptives (birth control pills)
• Thiazides (diuretics or “water pills)
• Danazol (used to treat breast cysts and endometriosis)
•  hyroid products (used to treat low levels of thyroid
T
hormones)
• Sympathomimetics (used to treat asthma)
•  larithromycin, trimethoprim, rifampicin (antibiotic
C
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)
•  henytoin, carbamazepine, phenobarbital (used to treat
P
epilepsy)
• St. John’s wort (herbal medicine)

AAAE6358

Repaglinide 0.5mg, 1mg & 2mg PIL - UK

colours/plates:
1. Black

item no: AAAE6358

dimensions: 190 x 380

print proof no: 5

pharmacode:

origination date: 05.12.12

min pt size: 9pt

3.
4.
5.
6.

originated by: SA
approved for print/date

2.

revision date: 17.04.13

Technical Approval

revised by: DR

date sent: N/A

supplier: Actavis Malta

technically app. date:

Non Printing Colours
1.
2.
3.

Repaglinide with alcohol

Alcohol can change the ability of Repaglinide to reduce the
blood sugar. Watch for signs of a hypo.

5 How to store
Keep this medicine out of the sight and reach of children.

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.

Do not use this medicine after the expiry date which is
stated on the outer carton, tablet container and the blister
after “EXP”. The expiry date refers to the last day of that
month.

You should not take Repaglinide if you are pregnant or you
are planning to become pregnant.

This medicinal product does not require any special storage
precautions.

You should not take Repaglinide if you are breast-feeding.

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.

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
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.
•  he normal starting dose is 0.5mg before each main meal.
T
Swallow the tablets with a glass of water immediately
before or up to 30 minutes before each main meal.
•  he dose may be adjusted by your doctor up to 4mg to
T
be taken immediately before or up to 30 minutes before
each main meal. The maximum recommended daily dose
is 16mg.
Do not take more Repaglinide than your doctor has
recommended.
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 take
a double dose to make up for a forgotten 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 medicines can cause side effects,
although not everybody gets them.

6 Contents of the pack and other information

What Repaglinide tablets contain

•  he active substance is repaglinide. One tablet contains
T
0.5mg, 1mg or 2mg repaglinide.
•  he other ingredients are: microcrystalline cellulose (E460),
T
calcium hydrogen phosphate, anhydrous, poloxamer,
povidone, glycerol 85%, meglumine, polacrilin potassium,
maize starch, magnesium stearate. Repaglinide tablets
1mg contains iron oxide yellow (E172). Repaglinide tablets
2mg contains iron oxide red (E172)

What Repaglinide tablets looks like and contents
of the pack

Repaglinide tablets 0.5mg tablets are white, round,
biconvex and engraved with RE on one side.
Repaglinide tablets 1mg tablets are mottled yellow, round,
biconvex and engraved with RE1 on one side.
Repaglinide tablets 2mg tablets are mottled pink, round,
biconvex and engraved with RE2 on one side.
Blisters (Aluminium/Aluminium).
Pack sizes: 30, 60, 90, 100,120 and 180 tablets
Plastic (polyethylene) container with desiccant canister
(filled with silica gel).
Pack sizes: 100 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf
Reykjavikurvegur 76-78
Hafnarfjordur
IS-220
Iceland
Manufacturer
Actavis Ltd
BLB16, Bulebel Industrial Estate,
Zejtun ZTN 3000,
Malta
This leaflet was last revised in April 2013

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):
•  cute coronary syndrome (but it may not be due to the
A
medicine).
Very rare (may affect up to 1 in 10,000 patients):
• Vomiting
• Constipation
• Visual disturbances
•  evere liver problems, abnormal liver function such as
S
increased liver enzymes in your blood.
Frequency not known
•  ypersensitivity (such as rash, itchy skin, reddening of the
H
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.

Actavis, Barnstaple, EX32 8NS, UK

AAAE6358

Repaglinide 0.5mg, 1mg & 2mg PIL - UK

colours/plates:
1. Black

item no: AAAE6358

dimensions: 190 x 380

print proof no: 5

pharmacode:

origination date: 05.12.12

min pt size: 9pt

3.
4.
5.
6.

originated by: SA
approved for print/date

2.

revision date: 17.04.13

Technical Approval

revised by: DR

date sent: N/A

supplier: Actavis Malta

technically app. date:

Non Printing Colours
1.
2.
3.

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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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