Skip to Content

THEROFLAN 0.5 MG TABLETS

Active substance(s): REPAGLINIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user
Theroflan
0.5 mg tablets
Theroflan 1.0 mg tablets
Theroflan 2.0 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.
• I f you have any further questions, ask your
doctor or pharmacist.
•T
 his 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.
• I f 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 Theroflan is and what it is used for
2. W
 hat you need to know before you take
Theroflan
3. How to take Theroflan
4. Possible side effects
5. How to store Theroflan
6. Contents of the pack and other information
1. What Theroflan is and what it is used for
Theroflan 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.
Theroflan 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. Theroflan can also
be given with metformin, another medicine for
diabetes.
Theroflan 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
Theroflan
Do not take Theroflan
• I f you are allergic to repaglinide or any of the
other ingredients of this medicine (listed in
section 6).
• I f you have type 1 diabetes
• I f the acid level in your blood is raised (diabetic
ketoacidosis)
• I f you have a severe liver disease
• I f you take gemfibrozil (a medicine used to lower
increased fat levels in the blood).
Warnings and precautions
Talk to your doctor before taking Theroflan:
• I f you have liver problems. Theroflan is not
recommended in patients with moderate liver
disease. Theroflan should not be taken if you
have a severe liver disease (see Do not take
[Repaglinide]).
• I f you have kidney problems. Theroflan should be
taken with caution.
• I f 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.
• I f you are under 18 or over 75 years of age.
Theroflan is not recommended. It has not been
studied in these age groups.
Talk to your doctor if any of the above applies to
you. Theroflan 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:
• I f you take too much Theroflan
• I f you exercise more than usual
• I f you take other medicines or suffer from liver or
kidney problems (see other sections of 2. What
you need to know before you take Theroflan).
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 Theroflan 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.
• I f severe hypoglycaemia is not treated, it can
cause brain damage (temporary or permanent)

and even death.
• I f you have a hypo that makes you pass out,
or a lot of hypos, talk to your doctor. The amount
of Theroflan, 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:
• I f you take too little Theroflan
• I f you have an infection or a fever
• I f you eat more than usual
• I f 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 Theroflan, food
or exercise may need to be adjusted.
Other medicines and Theroflan
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
You can take Theroflan 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 Theroflan.
Your body’s response to Theroflan may change if
you take other medicines, especially these:
•M
 onoamine oxidase inhibitors (MAOI) (used to
treat depression)
•B
 eta blockers (used to treat high blood pressure
or heart conditions)
•A
 CEinhibitors (used to treat heart conditions)
•S
 alicylates (e.g. aspirin)
•O
 ctreotide (used to treat cancer)
•N
 onsteroidal anti-inflammatory drugs (NSAID) (a
type of painkillers)
•S
 teroids (anabolic steroids and corticosteroids –
used for anemia or to treat inflammation)
•O
 ral contraceptives (birth control pills)
•T
 hiazides (diuretics or ‘‘water pills’’)
•D
 anazol (used to treat breast cysts and
endometriosis)
•T
 hyroid products (used to treat low levels of
thyroid hormones)
•S
 ympathomimetics (used to treat asthma)
•C
 larithromycin, trimethoprim, rifampicin
(antibiotic medicines)
• I traconazole, ketokonazole (antifungal medicines)
•G
 emfibrozil (used to treat high blood fats)
•C
 iclosporin (used to suppress the immune
system)
•D
 eferasirox (used to reduce chronic iron
overload)
•C
 lopidogrel (prevents blood clots)
•P
 henytoin, carbamazepine, phenobarbital (used
to treat epilepsy)
•S
 t. John’s wort (herbal medicine).
Theroflan with alcohol
Alcohol can change the ability of Theroflan 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 Theroflan if you are pregnant
or you are planning to become pregnant.
You should not take Theroflan if you are breastfeeding.
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:
•H
 ave frequent hypos
•H
 ave few or no warning signs of hypos.
3. How to take Theroflan
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.
•T
 he 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.
•T
 he 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 Theroflan than your doctor has
recommended.
If you take more Theroflan 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 Theroflan
If you miss a dose, take the next dose as usual do not double the dose.
If you stop taking Theroflan
Be aware that the desired effect is not achieved
if you stop taking Theroflan. 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, medical assistance is
needed 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 1000 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,
reddening of the skin, swelling of the skin)
• Feeling sick (nausea).
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 the Yellow Card Scheme (www.
mhra.gov.uk/yellowcard). By reporting side effects
you can help provide more information on the
safety of this medicine.
5. How to store Theroflan
Keep this medicine out of the sight and reach of
children.
This product does not need any special storage
conditions
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 Theroflan contains
The active substance is repaglinide.
The other ingredients are:
Microcrystalline cellulose (E460), calcium hydrogen
phosphate anhydrous, maize starch, amberlite
(polacrilin potassium), poloxamer 407, meglumine,
glycerol, Povidone and silica, colloidal anhydrous ,
magnesium stearate, iron oxide yellow (E172) only
in the 1.0 mg tablets and iron oxide red (E172)
only in the 2.0 mg tablets.
What Theroflan looks like and contents of
the pack
Theroflan tablets are round and biconvex.
0.5 mg tablets are white, 1.0 mg tablets are
yellow, mottled and 2.0 mg tablets are pink,
mottled.
Theroflan are available in blister packs of 30, 90
and 120 tablets.
Not all pack sizes may be marketed.
Marketing authorisation holder and
manufacturer

Marketing Authorisation Holder
Pharmathen S.A., Dervenakion 6, 15351 Pallini,
Attiki, Greece
tel.: +30 210 666 4300
fax: +30 210 666 6749
e-mail: info@pharmathen.com

Manufacturer
Pharmathen S.A., Dervenakion 6, 15351 Pallini,
Attiki, Greece
tel.: +30 210 666 4300
fax: +30 210 666 6749
e-mail: info@pharmathen.com
Pharmathen International S.A
Industrial Park Sapes Rodopi Perfecture, Block 5,
Rodopi 69300, Greece
tel: +30 25320 31376
fax: +30 25320 31471
e-mail: info@pharmathen.com

This medicinal product is authorised in
the Member States of the EEA under the
following names:
United Kingdom Theroflan 0.5 mg, 1 mg, 2 mg
Cyprus Theroflan 0.5 mg, 1 mg, 2 mg
Greece Theroflan 0.5 mg, 1 mg, 2 mg
Italy
Theroflan0.5 mg, 1 mg, 2 mg
This leaflet was last revised in March
2016

Expand view ⇕

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.

Hide