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GLICLAZIDE TABLETS BP 80MG

Active substance(s): GLICLAZIDE

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Gliclazide 80mg tablets
Read all of this leaflet carefully before you start
taking this medicine.
• 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.

• have an inherited condition where your red blood
cells don’t produce enough of the enzyme G6PD
(glucose 6 phosphate dehydrogenase).
• suffer from particular hormone-induced
disorders (functional disorders of the thyroid
gland, of the pituitary gland or adrenal cortex)
• are at risk of developing low blood sugar
(hypoglycaemia) - take meals irregularly or skip
meals altogether, are fasting, malnourished,
change your diet, increase your physical activity
and carbohydrate intake does not match this
increase, drink alcohol, especially in combination
with skipped meals
• take other medicines or natural remedies at the
same time
• take too high doses of gliclazide

Index
1 What Gliclazide tablets are and what
they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information

Taking other medicines

Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Especially:
• medicines to treat high blood pressure such as
beta blockers (eg propranolol, atenolol), ACE
inhibitors (eg captopril), Angiotensin-II antagonists
(eg losartan), nifedipine, diazoxide
• medicines used to treat infections such as
co-trimoxazole, fluconazole, rifampicin,
chloramphenicol, oral forms of miconazole (see
section 2), sulfonamides such as sulfafurazole or
tetracycline compounds (eg tetracycline)
• medicines used to prevent blood clotting (eg
warfarin)
• medicines used to treat depression such as
monoamine oxidase inhibitors (MAOIs eg
moclobamide)
• medicines used to treat mental health problems
such as lithium, phenothiazine derivatives (eg
prochlorperazine)
• corticosteroids used to reduce inflammation in the
body (eg prednisolone)
• phenylbutazone, azapropazone and other NSAIDs
(non steroidal anti-inflammatory pain killers)
• diuretics (water tablets) such as
bendroflumethiazide, hydrochlorothiazide,
furosemide
• oral contraceptives (the “pill”)
• salicylates (used for muscular or skeletal disorders
eg aspirin)
• sulfinpyrazone (used for gout)
• aminoglutethimide (used to treat breast or
prostate cancer)
• hormones such as testosterone, octreotide or
thyroid hormones (eg thyroxine)
• cimetidine (used to treat stomach ulcers)
• clofibrate (used to treat high cholesterol in the
blood)
• disopyramide (for irregular heart beats)
• laxatives

1 What Gliclazide tablets are and what
they are used for

Gliclazide is one of a group of medicines called
sulfonylureas that are used to lower the blood sugar level.
Gliclazide tablets are used to treat maturity onset
diabetes in patients that is not controlled by diet alone.
They are not for use in children or in patients with
diabetes requiring insulin.

2 Before you take

Do not take Gliclazide tablets and tell your
doctor if you:

• have ever had an allergic reaction to Gliclazide
tablets or any of the ingredients in the tablet (Please
refer to section 6, further information) An allergic
reaction may include a rash, itching, difficulty
breathing or swelling of the face, lips, throat or
tongue
• are breast feeding.
• have severe liver or kidney disease.
• have porphyria (a hereditary disease affecting the
liver or bone marrow).
• have ever had a severe diabetic reaction (such as
“acidosis” or diabetic coma).
• have Type I diabetes.
• are diabetic and need an operation, suffered a
severe trauma or infection, tell your doctor you are
taking Gliclazide tablets.
• take miconazole (for fungal infections)

Check with your doctor or pharmacist
before taking Gliclazide tablets if you:
• have liver or kidney problems.
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50814133 AAAH0158

148x210 Leaflet Reel Fed Profile (BST)

Gliclazide 80mg tablets PIL - UK
item no:
print proof no:
origination date:
approved for print/date

AAAH0158
2
02.07.14

originated by:

DR

revision date:

05.09.14

revised by:
supplier:

DR
Actavis UK

dimensions:

148x210

1. Black

JDE No.:

2.
3.

pharmacode:
min pt size:

colours/plates:

Gliclazide Tablets 80mg
x 28 & 60’s (UK)

7pt

4.
5.
6.
Non Printing Colours

Technical Approval
date sent:
technically app. date:

02.07.14

1. Profile
2.
3.

50814133

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 6668
Date Sent:
27/06/14
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Tell your doctor if you notice any of the following
side effects or notice any other effects not listed:
Gastrointestinal - feeling or being sick, abdominal
pain or discomfort, indigestion, diarrhoea,
constipation.
Liver - hepatitis or liver failure causing fatigue,
weakness, loss of appetite, weight loss, fever,
changes in liver enzymes (seen in tests), jaundice
(yellowing of the skin or whites of the eyes).
Skin - skin rashes or pale skin, redness, itching and
hives, skin reactions to sunlight.
Blood - Gliclazide may rarely affect the cells in your
blood, which can cause anaemia or mean that you
are more likely to catch infections or have a fever or
sore throat, or develop bruising or bleeding.
Symptoms of hypoglycaemia (low blood sugar
level) – sweating, clammy skin, trembling, weakness,
double vision, palpitations, confusion, headache,
hunger, feeling or being sick, sleep disorders, feeling
agitated, unable to concentrate, drowsiness, loss of
consciousness, slowed reactions, depression, trouble
seeing or speaking, paralysis, numbness, dizziness,
loss of self control, sensing or seeing things that are
not there, difficulty breathing, slowed or faster heart
beat, chest pains (angina).
Other - general feeling of being unwell.
If you have an infection, an operation or a serious
injury, tell your doctor that you take gliclazide.

• other medicines used to treat high blood sugar
• medicines containing alcohol
• chlorpromazine to treat disorders of the central
nervous system
• medicines to treat asthma or used during labour
(intravenous salbutamol, ritodrine and terbutaline)
• danazol to treat breast disorders, heavy menstrual
bleeding and endometriosis

Taking Gliclazide tablets with food and
drink

Patients should not consume alcohol in combination
with Gliclazide tablets.

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or
are breast-feeding ask your doctor or pharmacist for
advice before taking this medicine. Patients breastfeeding should not take this medicine (see section 2).

Driving and using machines

Make sure your blood sugar levels are under control
before you drive or operate machinery.

3 How to take

Always take Gliclazide tablets exactly as your doctor
has told you. If you are not sure, check with your
doctor or pharmacist.
These tablets should be taken with a glass of water
before meals. The tablet can be cut in half.
Doses:
Adults and the elderly
The starting dose is usually 40-80mg once daily and
may be increased to a total daily dose of 40-320mg.
Do not take more than the maximum of 160mg as
single dose, for doses of 320mg this will be split over
the day.
Children
Not recommended.

Reporting of side effects

If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

If you take more than you should

5 How to store

If you (or someone else) swallow a lot of tablets
at the same time, or you think a child may have
swallowed any, contact your nearest hospital
casualty department or tell your doctor
immediately. Signs of an overdose include
symptoms of low blood sugar such as sweating,
trembling, weakness, double vision, palpitations,
confusion.

Keep out of the reach and sight of children.
Store below 25°C in a dry place.
Do not use Gliclazide tablets after the expiry date
stated on the label/carton/bottle. The expiry date
refers to the last day of that month.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

If you forget to take the tablets

Take it as soon as you remember, unless it is nearly
time for your next dose. Then carry on as before. Do
not take a double dose to make up for a missed dose.

6 Further information

What Gliclazide tablets contain

• The active substance (the ingredient that makes
the tablets work) is gliclazide. Each tablet contains
80mg of gliclazide.
• The other ingredients are maize starch, stearic acid,
magnesium stearate, microcrystalline cellulose
(E460).

If you stop taking the tablets

Talk to your doctor before you stop taking the
tablets and follow their advice.

4 Possible side effects

Like all medicines, Gliclazide tablets can cause
side-effects although not everybody gets them.

What Gliclazide tablets look like and size of
the pack

Gliclazide tablets are white circular uncoated tablets.

Contact your doctor at once if you experience:
• An allergic reaction: skin rash, swelling of the
face, lips, tongue or throat, or difficulty breathing
or swallowing.

Pack sizes are 28 and 60.
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK
Date of last revision: April 2014

Continued top of next column

Actavis, Barnstaple, EX32 8NS, UK

50814133 AAAH0158

148x210 Leaflet Reel Fed Profile (BST)

Gliclazide 80mg tablets PIL - UK
item no:
print proof no:
origination date:
approved for print/date

AAAH0158
2
02.07.14

originated by:

DR

revision date:

05.09.14

revised by:
supplier:

DR
Actavis UK

dimensions:

148x210

1. Black

JDE No.:

2.
3.

pharmacode:
min pt size:

colours/plates:

Gliclazide Tablets 80mg
x 28 & 60’s (UK)

7pt

4.
5.
6.
Non Printing Colours

Technical Approval
date sent:
technically app. date:

02.07.14

1. Profile
2.
3.

50814133

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 6668
Date Sent:
27/06/14
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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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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