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LOPID 600 MG FILM-COATED TABLETS

Active substance(s): GEMFIBROZIL

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Lopid® 600 mg Film-Coated Tablets

2332
30.03.17[11]

(gemfibrozil)
PATIENT INFORMATION LEAFLET
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 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 the above name but will be referred to as
Lopid throughout the leaflet.
This medicine is also available as 300mg 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 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
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 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
- 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) (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 use 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 cancer
- colchicine for the treatment of gout
- paclitaxel, a treatment for cancer
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.
Breast-feeding
It is recommended that you do not take Lopid while you breast-feed.
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
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.
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 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 (angioedema)
- 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 or vomiting
Other reported side effects include:
Very common side effects (may affect more than 1 in 10 people)
- indigestion

Manufacturer and Product Licence Holder
Manufactured by Goedecke GmbH, Mooswaldallee, Freiburg, Germany and
procured from the EU by Product Licence holder: Star Pharmaceuticals Ltd.,
5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by
Servipharm Ltd.
POM

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)
- inflammation of the nerves (peripheral neuropathy)
- unusual bruising or bleeding due to a reduction in blood platelets
(thombocytopaenia)
- 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
- 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
- Keep out of the sight and reach of children.
- Do not store above 25˚C
- Do not take Lopid after the expiry date shown on the carton. The expiry
date refers to the last day of that month.
- If the tablets become discoloured or show any other signs of deterioration,
consult your pharmacist who will tell you what to do.
- Medicines should not be disposed of via wastewater or household waste.
Ask you pharmacist how to dispose of medicine no longer required. 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 600 mg gemfibrozil.
The other ingredients are
pregelatinised starch, colloidal anhydrous silica, polysorbate 80, magnesium
stearate, macrogol 6000, sodium carboxy methyl starch, microcrystalline
cellulose, hypromellose, titanium dioxide (E-171), simethicone and talc.
What Lopid looks like and contents of the pack
Lopid are white, oval, film-coated tablets, plain on both sides.
Pack size: Lopid comes in blister packs of 60 Tablets

PL 20636/2332

Leaflet revision and issue date (Ref.) 30.03.17[11]
Lopid is a trademark of Parke, Davis & Company LLC

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