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Package leaflet: Information for the patient



5 mg 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.
If you have any further questions, ask your doctor or
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.
What is in this leaflet:
1. What Minodiab is and what it is used for
2. What you need to know before you take Minodiab
3. How to take Minodiab
4. Possible side effects
5. How to store Minodiab
6. Contents of the pack and other information

1. What Minodiab is and what it is used for
This medicine contains glipizide which is one of a group
of medicines called sulphonylureas.
Minodiab is used to treat diabetes (Type II, non-insulindependent diabetes) and helps to lower your blood
glucose (sugar) levels, when a change in diet alone is
not enough to control the condition.
Diabetics produce too much glucose due to a lack of
insulin in the body. This can be controlled by Minodiab,
which reduces high blood glucose (sugar) levels by
increasing insulin production.
You must talk to a doctor if you do not feel better or if
you feel worse.
2. What you need to know before you take Minodiab
Do not take Minodiab if you:
• are allergic to glipizide or any of the other ingredients
of this medicine (listed in section 6) or have previously
had an allergic reaction to glipizide or another similar
antidiabetic drug.
• have insulin-dependent diabetes (also called juvenile
or Type I diabetes) which would have probably started
in your childhood.
• have ketone bodies and sugar in your urine (this may
mean you may have diabetic ketoacidosis).
• suffer from episodes of unconsciousness (this may
mean you may have diabetic coma).
• have problems with your kidneys or liver.
• are pregnant, planning to become pregnant or breastfeeding.
• are currently taking miconazole to treat fungal

Warnings and precautions
Talk to your doctor or pharmacist before using Minodiab
if you:
• have been told that you have problems with your
adrenal or pituitary glands.
• are about to have major surgery, have had a recent
injury (trauma) or develop a fever or severe infection.
(See Section 3 “If you are going to have an operation”
for further information).
• suffer from G6PD deficiency (a disease that causes
abnormal destruction of your red blood cells).
You should test your blood and urine glucose regularly,
particularly if you are elderly, debilitated or malnourished. If
the results of the tests are outside the limits recommended
by your doctor you should contact them immediately.
Minodiab can cause hypoglycaemia (low blood sugar
levels), which is characterised by confusion, faintness,
sweating, dizziness, drowsiness, headache, shakiness
(tremor) and visual disturbances. (These symptoms may
also be unrelated to hypoglycaemia). Low blood sugar
levels can be prevented by taking a regular intake of
carbohydrates (e.g. bread, or other products containing
starch/sugar). You should eat regular meals, and not
exercise heavily or for a long period without eating
something first.
Other medicines and Minodiab
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines obtained without a prescription.

When given with Minodiab, the following medicines may
reduce your blood sugar levels too much:
• Miconazole, fluconazole or voriconazole (used to treat
fungal infections)
• Non-steroidal anti-inflammatory agents (used to treat
muscle and joint pain e.g. phenylbutazone)
• Aspirin or aspirin like medicines known as salicylates
(usually used as pain killers)
• Beta-blockers (used to treat high blood pressure and
certain heart conditions e.g. propranolol)
• Angiotensin converting enzyme (ACE) inhibitors (used
to treat high blood pressure e.g. captopril)
• Cimetidine (used to treat stomach and duodenal ulcers
and other digestive disorders)
• Sulphonamides or chloramphenicol (used to treat
bacterial infections)
• Monoamine oxidase inhibitors (used to treat depression)
• Probenecid (drugs used to treat gout)
• Coumarin anticoagulants (used to treat blood clots
e.g. warfarin)
• Fibrates (used to treat high cholesterol e.g. clofibrate)
The following medicines may increase your blood sugar
levels too much when given with Minodiab:
• Danazol (a hormone treatment)
• Phenothiazines tranquillisers (used to treat psychiatric
conditions e.g. chlorpromazine, thioridazine)
• Corticosteroids (used to treat inflammatory conditions
(e.g. prednisolone)
• Sympathomimetic agents, such as nasal decongestants
and bronchodilators used to treat asthma (e.g.
salbutamol, isoprenaline)

• Hormonal agents, including oral contraceptives (the
Pill) and hormone replacement therapy (HRT)
• Thiazides or other diuretics (water tablets e.g.
• Thyroid products (used to treat patients with a low
production of thyroid hormones)
• Phenytoin (used to treat epilepsy)
• Nicotinic acid (used in vitamin supplements and to
lower cholesterol and other lipid levels)
• Calcium channel blocking agents (used to treat angina
and high blood pressure e.g. nifedepine or verampamil)
• Isoniazid (used to treat tuberculosis).
Minodiab with food, drink and alcohol
As food may delay absorption of the drug, each dose
should be taken 30 minutes before food.
Try to avoid alcohol. Alcoholic drinks (wine, beer, spirits)
can further increase the reduction in blood sugar levels
and could cause unconsciousness (hypoglycaemic
Pregnancy, breast-feeding and fertility
You should not take Minodiab, if you are pregnant,
planning to become pregnant or breast-feeding.
Driving and using machines
Minodiab should not affect your ability to drive or use
machinery. However, you should be careful when you
have just started taking this medicine or if you don’t
use it regularly.
Be aware of the symptoms of low blood sugar levels
(hypoglycaemia). These are characterised by confusion,

faintness, sweating, dizziness, drowsiness, headache
shakiness (tremor) and visual disturbances.
If you are affected, do not drive or operate machinery.
Minodiab contains lactose
Lactose is a type of sugar. If you have been told that you
have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
3. How to take Minodiab
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Minodiab should only be taken by mouth. It is important
that you take your tablets according to the instructions
of your doctor. These will be written on the label of the
pack. Do not take more Minodiab than your doctor has
Your dose will be adapted to your individual requirements.
Some patients, whose condition is usually controlled by
diet alone, may only require Minodiab for a short time.
The initial dose is usually 5 mg, taken approximately 30
minutes before breakfast or the midday meal, although
this may be lower in some patients.
If you are elderly, have mild diabetes or suffer from liver
or kidney problems you may be started on 2.5mg daily.
If your doctor feels your dose needs to be altered, he
will instruct you to adjust the dose in small increments,
usually in 2.5 – 5 mg steps.

The maximum recommended daily dose is 20 mg.
The label on the pack will tell you what dose YOU should
take and how often to take it. If you are still not sure, ask
your doctor or pharmacist.
Do not stop taking the tablets or adjust your dosage
without seeing your doctor. Stopping the medicine may
make your diabetes worse.
Use in Children and adolescents
Minodiab is not recommended for use in children or
If you take more Minodiab than you should
• If you accidentally take too many tablets, seek medical
advice immediately.
• If you suffer faintness, confusion, drowsiness,
headache, dizziness, sweating or shakiness and visual
disturbances, these may be symptoms of low blood
sugar. You should eat or drink something sugary.
• If you suffer fits or loss of consciousness occur, someone
should seek urgent medical assistance for you.
If you forget to take Minodiab
If you miss a dose, it is important that you take your
medicine as soon as you remember or feel faint, otherwise
your blood sugar will become too high and you may go
into a coma (or fall unconscious).
If you stop taking Minodiab
Do not stop taking your tablets or alter the dose you are
currently taking without seeing your doctor first. Stopping
these tablets may make your diabetes worse.

If you are going to have an operation
If you are going to have major surgery or you have recently
suffered a severe illness or infection, diabetic control may
be lost. At such times it may be necessary to temporarily
stop using Minodiab and take insulin.
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. The majority are
temporary and disappear on reducing the dose or on
stopping treatment.
Do not stop taking the tablets or adjust your dosage
without seeing your doctor.
Reasons for contacting your doctor immediately
Tell your doctor immediately if you experience any of the
following symptoms after taking this medicine. Although
they are very rare, these symptoms can be serious.
• An allergic reaction such as sudden wheeziness,
difficulty in breathing, swelling of eyelids, face or lips,
rash or itching (especially affecting the whole body).
Allergic reactions (including very rarely, death) have
been reported with drugs similar to Minodiab
Other side effects that may occur are as follows:
Common: may affect up to 1 in 10 people
hypoglycaemia (not enough sugar in the blood)
feeling sick (nausea)
pain in the stomach

Uncommon: may affect up to 1 in 100 people
shakiness (tremor)
blurred vision
being sick (vomiting)
jaundice (yellowing of the skin and eyes, itching and
dark urine)
eczema (inflammation of skin)
Not known: frequency cannot be estimated from the
available data
agranulocytosis (deficiency of a type of white blood cells)
leukopenia (reduction in white blood cells count)
thrombocytopenia (reduction in Platelet count)
haemolytic anaemia (abnormal breakdown of red blood cells)
pancytopenia (decreased count of all type of blood cells)
porphyria non-acute
redness (erythema)
itching, (pruritus)
rash (red, bumpy, or measle-like)
itching, skin redness or inflammation (dermatitis allergic)
pale red, raised, itchy bumps (urticaria)
sensitivity to light
reduction in blood sodium (hyponatraenamia)
visual disturbances, double vision
inflammation of the liver (hepatitis) and abnormal hepatic
malaise (general discomfort)
abnormal laboratory tests

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:
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Minodiab
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is
printed on the label. 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 to protect the environment.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Limited, Ramsgate Road, Sandwich,
Kent, CT13 9NJ, United Kingdom
Pharmacia Italia S.p.a., Ascoli Piceno Plant,
Ascoli Piceno, Italy.
Company Contact address
For further information on this medicine, please contact
Medical Information at Pfizer Limited in Walton Oaks,
Tadworth, Surrey, Tel: +44 1304 616161
This leaflet was last revised in: 11/2012
Ref: MG 9_1 UK

6. Contents of the pack and other information
What Minodiab contains
• The active ingredient is 5 mg glipizide.
• The other ingredients are microcrystalline cellulose,
starch, stearic acid, and lactose.
What Minodiab looks like and contents of the pack
Minodiab 5 mg tablets are white, biconvex tablets. They
are available in packs of 28 or 60 tablets in blister strips.
Not all pack sizes may be marketed.

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.