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LOPID 600 MG FILM-COATED TABLET

Active substance(s): GEMFIBROZIL

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UNITED KINGDOM
®

Lopid

300mg hard Capsules
600mg film-Coated Tablets
gemfibrozil
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 pharmacist.
• 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. 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
take Lopid
3 How to take Lopid
4 Possible side effects
5 How to store Lopid
6 Contents of the pack and other
information

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1. What Lopid is and what it is
used for
• Lopid 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 triglycerides.
• Lopid is used, alongside a low fat diet and other
non-medical 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
Do not use 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)

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
• diabetes

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)
• 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 (see “Do not use Lopid” and simvastatin)
• colestipol resin granules for the treatment of high
levels of fat (cholesterol) in your blood
• bexarotene medication for the treatment of skin
cancer
• colchicine for the treatment of gout

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.

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, one 600 mg
tablet will need to be taken, half an hour before your
breakfast and a second 600 mg tablet will need to be
taken half an hour before your evening meal.

Lopid with food and drink
Lopid should be taken half an hour before meals (see
section 3 ’How to take Lopid’).

If you are advised to take a 900 mg dose, you will need
to take the dose (3 x 300 mg capsules) half an hour
before your evening meal.

Pregnancy and breast-feeding
Pregnancy

Adults with mild or moderate kidney disease

Breast-feeding

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.

It is recommended that you do not take Lopid while you
breast-feed.

Use in children

Ask your doctor or pharmacist for advice before taking
any medicine.

If you take more Lopid than you should

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.

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.

Lopid is not recommended for children.

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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

````

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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 allergic reactions are very
rare, you are advised to contact your doctor
immediately if you get any of the following
symptoms after taking Lopid:
– any sudden wheeziness, difficulty in breathing or
dizziness, swelling of the eyelids, face, lips or throat
– peeling and blistering of the skin, mouth, eyes and
genitals
– rash affecting your whole body
– muscle weakness or weakness accompanied by dark
urine, fever, rapid heart rate (palpitations), nausea,
vomiting and facial swelling.
Other reported side effects include:
Very common side effects
(may affect more than 1 in 10 people)
– indigestion
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)
– headache
– stomach pain

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diarrhoea
feeling sick
being sick
constipation
wind
tiredness

Uncommon side effects
(may affect up to 1 in 100 people)
– irregular heartbeat
Rare
(may affect up to 1 in 1,000 people)
– reduction or increase in white blood cells (leucopenia,
eosinophilia), bone marrow disease (bone marrow
failure)
– reduction of blood platelets (thrombocytopenia)
– allergic reaction in which the face, tongue or throat
may start to swell up, causing difficulty in breathing
(angioedema)
– inflammation of the nerves (peripheral neuropathy)
– unusual bruising or bleeding due to a reduction in
blood platelets (thombocytopaenia)
– painful muscles or muscle breakdown
(rhabdomyolysis)
– severe anemia
– loss of feeling and a tingling sensation (paraesthesia)
– pancreatitis
– blurred vision
– jaundice (yellowing of the skin), disturbed liver function
– inflammation of the liver (hepatitis)
– gallstones (cholelithiasis), inflammation of the gall
bladder (cholecystitis)
– appendicitis
– depression
– dizziness
– sleepiness
– painful joints and extremities
– muscle disease (myopathy) muscle weakness
– 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
– impotence
– decreased libido
– hair loss

– photosensitivity (a sensitivity to light that can cause
skin discolouration or a rash)
– red, itchy raised areas of skin
– itching

The other ingredients are pregelatinised starch,
microcrystalline cellulose, colloidal silica (anhydrous),
sodium starch glycollate, polysorbate 80 (E433) and
magnesium stearate.

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
pack
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.

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.

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 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.

Marketing Authorisation Holder
Pfizer Ltd, Ramsgate Rd, Sandwich, Kent, CT13 9NJ, UK.

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.

Manufacturer
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg,
Germany.

6. Contents of the pack and other
Information

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
Kingdom
Gevilon: Austria, Germany
Lipur: France

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 black iron
oxide (E172).
Lopid 600 mg film-coated tablets:
The active substance is gemfibrozil. Each film-coated
tablet contains 600 mg gemfibrozil

This leaflet was last revised in 02/2015
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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 13_0

21.03.15 13:11

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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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