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GEMFIBROZIL TABLETS 600MG

Active substance(s): GEMFIBROZIL

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TEVA UK Ref:

Version:

231-30-88511-E LEA GEMFIBROZIL 600mg TAB TUK
Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
323 mm
160 mm
N/A
N/A

1

16 June 2016

Colours Used:

BLACK
PANTONE® GREEN C
Template

PAGE 1: FRONT FACE (INSIDE OF REEL)

• other drugs to lower your cholesterol e.g.
simvastatin, lovastatin, pravastatin or
rosuvastatin
• drugs to prevent blood clots (e.g.
Package leaflet: Information
warfarin)
for the user
• rosiglitazone, glimepiride or other drugs
Read all of this leaflet carefully before
for diabetes
taking this medicine because it contains
• paclitaxel (used to treat cancer)
important information for you.
• bexarotene (used to treat skin cancer)
• Keep this leaflet. You may need to read it
• drugs known as bile acid sequestrants (a
again.
class of drugs that prevents bile acids
• If you have any further questions, ask your
being reabsorbed from the digestive
doctor or pharmacist.
system, so promoting conversion of
• This medicine has been prescribed for you
cholesterol into bile acids) e.g.
only. Do not pass it on to others. It may
colestyramine, colestipol (please see
harm them, even if their signs of illness
section 3, Taking in combination with a
are the same as yours.
bile acid sequestrant)
• If you get any side effects, talk to your
Gemfibrozil with food, drink and alcohol
doctor or pharmacist. This includes any
• Keep alcohol intake to a minimum
possible side effects not listed in this
• Your doctor will have explained the
leaflet. See section 4.
importance of a low fat diet as well as
taking Gemfibrozil.
What is in this leaflet:

Pharma code 476

1. What Gemfibrozil is and what it is used for
2. What you need to know before you take
Gemfibrozil
3. How to take Gemfibrozil
4. Possible side effects
5. How to store Gemfibrozil
6. Contents of the pack and other
information

1

What Gemfibrozil is and what it is
used for

Gemfibrozil belongs to a group of medicines
called lipid lowering agents.
It is used to reduce high fat levels
(cholesterol and triglycerides) in the blood
and so help in the prevention of coronary
heart disease. These tablets should be used
along with dieting, exercise and weight
reduction.

Top of page cut-off to middle of registration mark: 44 mm.

GEMFIBROZIL
600 mg TABLETS

Pregnancy and Breast-feeding
Gemfibrozil is not recommended if you are
pregnant or breast-feeding.
If you are pregnant or planning to become
pregnant, ask your doctor for advice before
taking this medicine.
Driving and using machines
Gemfibrozil may cause dizziness and blurred
vision. If affected, do not drive or operate
machinery.

3

How to take Gemfibrozil

Always take this medicine exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure. The tablets
should be swallowed preferably with a glass
of water.

The recommended dose is:
Adults (including the elderly)
• The normal dosage range is between
What
you
need
to
know
before
you
2 take Gemfibrozil
900 mg and 1,200 mg (two tablets) each day
• The 1,200 mg dose is taken as one tablet
Do not take Gemfibrozil:
half an hour before breakfast and one
• if you are allergic to gemfibrozil or any of
tablet half an hour before the evening
the other ingredients of this medicine
meal
(listed in section 6)
• The 900 mg dose is taken as a single dose
• if you have or have had gall bladder
half an hour before the evening meal.
disease, biliary tract disease or gall stones
Please note that there is a 300 mg product
• if you have liver or severe kidney
available which is recommended for the
problems
900 mg dosage.
• if you have experienced sensitivity to light
Taking in combination with a bile acid
when previously treated with similar
sequestrant
cholesterol lowering drugs
Gemfibrozil may be given in combination
• if you are taking repaglinide (used to treat
with a bile acid sequestrant e.g.
diabetes).
colestyramine or cholestipol.
Warnings and precautions
Gemfibrozil should be taken 2 hours before
Talk to your doctor before taking Gemfibrozil: or after taking your bile acid sequestrant, as
• if you are over 70 years of age
the absorption of Gemfibrozil can be
• if you have an under active thyroid gland affected by these medicines if taken too
or diabetes
closely together.
• if you have a hereditary muscular disorder
Patients with Kidney problems
or a family history of such problems
If you have mild to moderate kidney
• if you have previously suffered from side
problems your doctor may reduce the dose
effects affecting your muscles when taking
given above. Gemfibrozil should not be
another cholesterol lowering medicine
used if you have severe kidney problems.
such as a statin or a fibrate
Use in children and adolescents:
• if you have problems with alcohol abuse
Gemfibrozil is not recommended for use in
(regularly drinking large amounts of
children or adolescents.
alcohol)
• if you have kidney problems.
If you take more Gemfibrozil than you
Your doctor may carry out liver function and should
If you (or someone else) swallow a lot of the
other blood tests.
tablets all together, or if you think a child
Other medicines and Gemfibrozil
has swallowed any of the tablets, contact
• Do NOT take repaglinide in combination
your nearest hospital casualty department
with Gemfibrozil.
or your doctor immediately. An overdose is
Tell your doctor if you are taking, have
likely to cause stomach pains, diarrhoea,
recently taken or might take any other
joint and muscle pain, nausea and vomiting.
medicines:
Please take this leaflet, any remaining

REG0063856

Version 2.4

Approved

Page 1 of 3

TEVA UK Ref:

Version:

231-30-88511-E LEA GEMFIBROZIL 600mg TAB TUK
Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
323 mm
160 mm
N/A
N/A

1

Colours Used:

16 June 2016

BLACK
PANTONE® GREEN C
Template

PAGE 2: REAR FACE (OUTSIDE OF REEL)

• hair loss
• joint or muscle pain, cramp, wasting of
the muscles, inflammation of the muscles
(myositis), painful arms and legs,
If you forget to take Gemfibrozil
temporary paralysis or weakness of the
If you forget to take a tablet, take one as
muscles. swelling of the joints
soon as you remember, unless it is nearly
• inflammation of the synovial membrane
time to take the next one. Do not take a
(synovitis)
double dose to make up for the forgotten
• problems getting or maintaining an
tablet.
erection
If you have any further questions on the use • acute appendicitis (inflammation of the
of this product, ask your doctor or
appendix)
pharmacist.
• persistent lack of energy
tablets and the container with you to the
hospital or doctor so that they know which
tablets were consumed.

4

Possible side effects

Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
Serious side effects
If the following happens, stop taking the
tablets and tell your doctor immediately or
go to the casualty department at your
nearest hospital:
• An allergic reaction (swelling of the face
or tongue or neck, muscle and joint pain,
hives, fever, flushing, shortness of breath).
• any unexplained or persistent muscle
pain, tenderness, weakness or cramps,
especially, if at the same time you feel sick
or unwell, are sick, have a high
temperature, dark urine, facial swelling or
a rapid heart beat. In rare cases (affecting
fewer than one person in 1,000) this can
progress to become a serious and
potentially life threatening condition,
called rhabdomyolysis.
Other side effects:
The following side effects have been
reported at the approximate frequencies
shown:
Very common: may affect more than 1 in 10
people
• heartburn, indigestion.
Common: may affect up to 1 in 10 people
• vertigo, headache
• abdominal pain, diarrhoea, wind,
constipation, feeling sick or being sick
• eczema, rash
• fatigue
Uncommon: may affect up to 1 in 100
people
• irregular heart beat.

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 at:
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 Gemfibrozil

Keep this medicine out of the sight and
reach of children.
Store at or below 25°C.
Do not use this medicine after the expiry
date which is stated on the outer packaging.
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

Contents of the pack and other
information

What Gemfibrozil contains:
• The active ingredient is gemfibrozil
600 mg
• The other ingredients are pregelatinised
maize starch, colloidal anhydrous silica,
hydroxypropylcellulose, polysorbate 80,
microcrystalline cellulose, calcium
stearate, methylhydroxypropylcellulose,
macrogol 4000, titanium dioxide (E171)
and polydextrose K.

What Gemfibrozil looks like and contents of
the pack:
• Gemfibrozil tablets are white to off white,
Rare: may affect up to 1 in 10,000 people
oval-shaped, film-coated tablets. Scored
• unusual bleeding or unexplained bruising
on one side with engraving “93” and
• blood disorders that may be characterised
“670” on each side of the score line. The
by fever or chills, sore throat, ulcers in the
other side is plain.
mouth or throat
• The tablets are available in pack sizes* of
• severe anaemia (a reduction in red blood
56, 60, 500 and 1,000 tablets.
cells) causing unusual tiredness or
*Not all pack sizes may be marketed.
weakness
• reduction or increase in white blood cells Marketing Authorisation Holder and
(leucopenia, eosinophilia), bone marrow
Manufacturer
disease (bone marrow failure)
Marketing Authorisation holder and
• dizziness, sleepiness, pins-and-needles,
manufacturer: TEVA UK Limited,
inflammation or damage of the nerves
Eastbourne, BN22 9AG
(peripheral neuropathy), depression,
This leaflet was last revised in June 2016
reduced sex drive
• blurred vision
PL 00289/0788
• jaundice (yellowing of the skin and whites
of the eyes)
• liver problems including hepatitis
(inflammation of the liver)
• inflammation of the gall bladder, gall
stones
• pancreatitis (inflammation of the
pancreas)
• skin problems including dermatitis,
peeling or itching, red, itchy raised areas
of skin
• photosensitivity (a sensitivity to light that
88511-E
can cause skin discolouration or a rash)
160 x 323

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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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