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LOPID 600 MG FILM-COATED TABLET
Active substance(s): GEMFIBROZIL / GEMFIBROZIL
300mg hard capsules
600mg ﬁlm-coated 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 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
• If 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 Lopid is and what it is used for
2 What you need to know before you
3 How to take Lopid
4 Possible side effects
5 How to store Lopid
6 Contents of the pack and other
1. What Lopid is and what it is
Lopid contains the active substance gemﬁbrozil which
belongs to a group of medicines commonly known as
ﬁbrates. These medicines are used to lower the level of
fats (lipids) in the blood. For example the fats known as
Lopid is used, alongside a low fat diet and other nonmedical treatment such as exercise and weight loss, to
lower levels of fat in the blood. Lopid can be used when
other medicines (statins) are unsuitable, to reduce the
occurrence of heart problems in men who are at high risk
and who have increased ‘bad cholesterol’.
Lopid may also be prescribed to people who cannot be
prescribed other lipid-lowering medicines for lowering
blood cholesterol levels.
2. What you need to know before
you take Lopid
Do not take Lopid
• if you are allergic to gemﬁbrozil or any of the other
ingredients of this medicine (listed in section 6)
• if you have liver disease
• if you have severe kidney disease
• if you have a history of gall stones, bile and gall
bladder disease (biliary tract disease)
• if in the past you have had photoallergy or a
phototoxicity reaction (allergic reaction triggered
by exposure to sunlight) during treatment with ﬁbrates
• if you are currently taking a drug called repaglinide (a
drug used to reduce blood sugar levels in diabetes)
or simvastatin (a cholesterol lowering medicine) or
dasabuvir (a drug used to treat hepatitis C infection)
Warnings and precautions
Talk to your doctor or pharmacist before taking Lopid.
Tell your doctor if you have any of the following conditions
to help decide if Lopid is suitable for you:
• high risk of muscle breakdown (rhabdomyolysis): risk
factors include kidney impairment; under-active thyroid;
over 70 years; excessive use of alcohol; previous history
of muscular pain and weakness (muscular toxicity) with
another ﬁbrate or statin; a history of inherited muscular
disorders; use of Lopid in combination with statins
• mild or moderate kidney disease
• under-active thyroid
3. How to take Lopid
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure. Your blood lipid levels will
be closely monitored and regularly assessed before and
during your treatment with Lopid. If you are diabetic or
have problems with your thyroid, your doctor will try to
treat these conditions before you start treatment. Your
doctor will also give you advice about eating the correct
diet, exercising, giving up smoking, cutting down on
alcohol and if necessary, losing weight.
Other medicines and Lopid
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
• anti-diabetic medication particularly rosiglitazone or
repaglinide (used to help reduce blood sugar levels)
(for repaglinide see “Do not take Lopid”)
• dabrafenib, a treatment for melanoma
• loperamide, a treatment for diarrhoea
• montelukast, a treatment for asthma
• pioglitazone, a treatment used for diabetes
• warfarin, acenocoumarol, and phenprocoumon
(anticoagulants used to thin blood)
• statins used to lower bad cholesterol and
triglycerides, and increase good cholesterol such as
atorvastatin, lovastatin, pravastatin, rosuvastatin and
simvastatin (for simvastatin see “Do not take Lopid”)
• dasabuvir, a drug used to treat hepatitis C infection
(see “Do not take Lopid” above)
• colestipol resin granules for the treatment of high
levels of fat (cholesterol) in your blood
• bexarotene medication for the treatment of skin
• colchicine for the treatment of gout
• paclitaxel, a treatment for cancer
Lopid should be taken orally. It is recommended that the
capsules or tablets be swallowed with a glass of water as
the tablets taste unpleasant if you break them.
Lopid with food and drink
Lopid should be taken half an hour before meals.
Adults and elderly:
The usual starting dose is between 900 mg and 1200 mg
daily. Your doctor will decide the best dose for you, follow
the instructions given on the label.
If you are advised to take a 1200 mg dose, you will need
to take 600 mg half an hour before your breakfast and a
second 600 mg half an hour before your evening meal.
If you are advised to take a 900 mg dose, you will need
to take the dose half an hour before your evening meal.
Adults with mild or moderate kidney disease:
Your doctor will assess your condition before and during
your treatment with Lopid. Your treatment will start at
900 mg daily and may be increased up to 1200 mg
depending on your response. Lopid should not be used in
patients with severe kidney disease.
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.
Use in children
Lopid is not recommended for children.
It is recommended that you do not take Lopid while you
Driving and using machines
In rare cases Lopid may cause dizziness and affect
your eyesight, if this happens, do not drive or operate
machinery. You can drive or operate machinery as long
as you feel well.
If you take more Lopid than you should
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Package leaﬂet: Information for the user
If you accidentally take too much Lopid contact your
doctor at once or go to the nearest hospital accident
and emergency department. Always take the labelled
You will ﬁnd more about LOPID
on the back of this leaﬂet
If you forget to take Lopid
If you forget to take a dose, do not worry. Simply miss
that dose and take your next dose at the right time.
Do not take two doses at the same time.
If you stop taking Lopid
Do not stop taking Lopid unless your doctor tells you to.
It is recommended that you follow all the advice
given while you are taking Lopid so as to gain the
full beneﬁt of the treatment. 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.
Serious side effects
Although serious reactions can occur, you are advised
to contact your doctor immediately if you get any
of the following symptoms after taking Lopid:
Rare (may affect up to 1 in 1,000 people)
– allergic reaction in which the face, tongue or throat
may start to swell up, causing difficulty in breathing
– peeling and blistering of the skin, mouth, eyes and
– rash affecting your whole body
– muscle weakness or weakness accompanied by dark
urine, fever, rapid heart rate (palpitations), nausea or
Other reported side effects include:
Very common side effects
(may affect more than 1 in 10 people)
Common side effects
(may affect up to 1 in 10 people)
– sense of spinning or swaying (vertigo)
– eczema, rash (particularly an itchy or puffy rash)
Uncommon side effects
(may affect up to 1 in 100 people)
– irregular heartbeat
(may affect up to 1 in 1,000 people)
– reduction or increase in white blood cells (leucopenia,
eosinophilia), bone marrow disease (bone marrow
– reduction of blood platelets (thrombocytopenia)
– inﬂammation of the nerves (peripheral neuropathy)
– unusual bruising or bleeding due to a reduction in
blood platelets (thombocytopaenia)
– severe anaemia
– loss of feeling and a tingling sensation (paraesthesia)
– blurred vision
– jaundice (yellowing of the skin), disturbed liver function
– inﬂammation of the liver (hepatitis)
– gallstones (cholelithiasis), inﬂammation of the gall
– painful joints and extremities
– inﬂammation of the skin or inﬂamed skin which ﬂakes
or falls off
– inﬂammation of the muscles (myositis)
– inﬂammation of the synovial membrane (synovitis)
– persistent lack of energy
– decreased libido
– hair loss
– photosensitivity (a sensitivity to light that can cause
skin discolouration or a rash)
– red, itchy raised areas of skin
Reporting of side effects
The ﬁlm coat for tablets contains hydoxypropylmethylcellulose
(E464), titanium dioxide (E171), polydimethyl siloxane,
polyethylene glycol 6000 and talc (E553b).
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.
What Lopid looks like and contents of the
Lopid 300 mg capsules contain a ﬁne white powder
in a hard gelatine capsule with a white opaque body
and maroon cap, with ‘Lopid 300’ imprinted on each
capsule half. It is packaged in aluminium foil blister strips
containing 20, 60, 100 and 112 capsules.
5. How to store Lopid
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton label and blister foil after EXP. The
expiry date refers to the last day of that month.
Lopid 600 mg is a white oval ﬁlm-coated tablet. It is
packaged in transparent PVC blister strips with an
aluminium foil back in packs containing 14, 20, 28,
30, 50, 56, 60, 98, 100, 196, 500 and 600 tablets.
Lopid 300 mg hard capsules: Store below 25ºC in the
original package in order to protect from moisture.
Lopid 600 mg ﬁlm-coated tablets: Store below 25ºC.
Not all pack sizes may be marketed.
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.
Marketing Authorisation Holder
Pﬁzer Ltd, Ramsgate Rd, Sandwich, Kent, CT13 9NJ, UK.
Pﬁzer Manufacturing Deutschland GmbH
6. Contents of the pack and other
What Lopid contains
Lopid 300 mg hard capsules:
The active substance is gemﬁbrozil. Each hard capsule
contains 300 mg gemﬁbrozil.
The other ingredients are polysorbate (E433), colloidal
silica and maize starch.
The capsule shell contains gelatin, titanium dioxide
(E171), erythrosine (E127) and indigo carmine (E132).
The printing ink contains shellac glaze and iron oxide black
Lopid 600 mg ﬁlm-coated tablets:
The active substance is gemﬁbrozil. Each ﬁlm-coated
tablet contains 600 mg gemﬁbrozil
The other ingredients are pregelatinised starch,
microcrystalline cellulose, colloidal silica (anhydrous),
sodium starch glycollate, polysorbate 80 (E433) and
This medicinal product is authorised in the Member
States of the EEA under the following names:
Lopid: Denmark, Finland, Greece, Iceland, Ireland,
Italy, Netherlands, Portugal, Spain, Sweden and United
Gevilon: Austria, Germany
This leaﬂet was last revised in 04/2016
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medicine package with you, whether there is any Lopid
left or not. Signs of overdose may be abdominal cramps,
diarrhoea, joint and muscle pain, nausea and vomiting.
Ref: LP 14_1
Source: Medicines and Healthcare Products Regulatory Agency