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LOPID 600MG FILM-COATED TABLETS

Active substance(s): GEMFIBROZIL

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Package leaflet: Information for the user

Lopid® 600mg film-coated tablets / Gemfibrozil 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.
• Your medicine is available using either of the above names but will be
referred to as Lopid throughout the remainder of this leaflet.
• Lopid is also available in other strength as capsules.
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
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 LOPID
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
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 with food and drink
Lopid should be taken half an hour before meals (see section 3 “How to
take Lopid”).
Pregnancy and breast-feeding
Pregnancy
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.
Breast-feeding
It is recommended that you do not take Lopid while you breast-feed.
Ask your doctor or pharmacist for advice before taking any 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.
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.
Lopid should be taken orally. It is recommended that the capsules or
tablets are swallowed with a glass of water as the tablets taste
unpleasant if you break them.
Adults and elderly
The usual starting dose is between 900mg and 1200mg daily. Your
doctor will decide the best dose for you, follow the instructions given on
the label.
If you are advised to take a 1200mg dose, one 600mg tablet will need to
be taken, half an hour before your breakfast and a second 600mg tablet
will need to be taken half an hour before your evening meal.
If you are advised to take a 900mg dose, you will need to take the dose
(3 x 300mg capsules) 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 900mg daily and may be increased
up to 1200mg depending on your response. Lopid should not be used in
patients with severe kidney disease.
Use in children
Lopid is not recommended for children.
If you take more Lopid than you should
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 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.
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
− 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 anaemia
− 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

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 LOPID





Do not store above 25oC.
Store in the original package in order to protect from moisture.
Keep 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.
• If your tablets become discoloured or show any sign of deterioration,
return them to your pharmacist.
• Do not throw away 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.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Lopid contains:
The active substance is gemfibrozil.
Each film-coated tablet contains 600mg gemfibrozil.
The other ingredients are:
Pregelatinized starch, Microcrystalline cellulose, Colloidal silica
(anhydrous) (E551), Sodium starch glycolate, Polysorbate 80 (E433),
Magnesium stearate, Hypromellose (E464), Titanium dioxide E171,
Simeticone, Macrogol 6000 and Talc (E553b).
What Lopid looks like and contents of the pack:
Lopid 600mg is a white oval film-coated tablet.
Lopid 600mg comes in a blister pack containing 60 film-coated tablets.
Manufactured by
Pfizer Manufacturing Deutschland GmbH, Betriebsstatte Freiburg,
Mooswaldallee 1, 79090 Freiburg, Germany
Procured from within the EU by Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER. UK
Repackaged by MPT Pharma Ltd.
PL: 33532/0444

POM

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Leaflet dated 4 February 2016
Leaflet coded XXXXXXXXXX
Lopid® is a registered trademark of Parke, Davis & Company LLC

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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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