GEMFIBROZIL 600 MG TABLETS, LOPID 600 MG TABLETS - patient leaflet, side effects, dosage

LopidTM600mg Tablets / Gemfibrozil 600mg Tablets

(gemfibrozil)

Patient Information Leaflet

Your medicine is called Lopid 600mg Tablets / Gemfibrozil 600mg Tablets, but will be referred to as Lopid throughout this leaflet.

Please note that the leaflet also contains information about another strength of the medicine Lopid 300mg Capsules.

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.

What is in this leaflet:

riB What Lopid is and what it is used for.

^2B What you need to know before you take Lopid.

How to take Lopid.

^B Possible side effects.

^B How to store Lopid.

r6B Contents of the pack and other information.

jHWhat 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.

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”)

• dasabuvir, a drug used to treat hepatitis C infection (see “Do not take Lopid” above)

• selexipag, a treatment for pulmonary hypertension (see “Do not take Lopid” above)

• statins used to lower bad cholesterol and triglycerides, and increase good cholesterol such as atorvastatin, lovastatin, pravastatin, rosuvastatin and simvastatin (for simvastatin and rosuvastatin at 40 mg see “Do not take Lopid” and see “Warnings and precautions”)

• 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)

• 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

• enzalutamide, a treatment for prostate 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.

Dietary sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet and therefore is essentially ‘sodium-free’.

rflWhat 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 medicine called repaglinide (a drug used to reduce blood sugar levels in diabetes), simvastatin or rosuvastatin at 40 mg (cholesterol lowering medicines) or dasabuvir (a drug used to treat hepatitis C infection) or selexipag (a drug used to treat pulmonary arterial hypertension)

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 used to lower bad cholesterol and triglycerides, and increase good cholesterol such as rosuvastatin and simvastatin (for simvastatin and rosuvastatin 40 mg see “Do not take Lopid” and see “Other medicines and Lopid”

• mild or moderate kidney disease

• * under-active thyroid

diabetes

^How to take Lopid

LopidTM600mg Tablets / Gemfibrozil 600mg Tablets

(gemfibrozil)

Patient Information Leaflet (continued)

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 a double dose to make up for a forgotten dose.

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.

^■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

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 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

• * 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: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

^■How to store Lopid

EXPIRY DATE.

Do not use Lopid 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 doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist (chemist) for safe disposal. Only keep this medicine, if your doctor tells you to. If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.

STORING YOUR MEDICINE

• * Keep this medicine out of the sight and reach of children.

• * Do not store above 25°C.

• * Do not take your tablets out of the blister strip until it is time to take your dose.

^■Contents of the pack and other information

What Lopid contains

Each tablet contains 600mg of Gemfibrozil as the active ingredient.

Your medicine also contains the following inactive ingredients: Colloidal anhydrous silica, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, sodium starch glycollate.

The film coat for the tablets contains: hypromellose, titanium dioxide (E-171), macrogol 6000, simethicone & talc.

What Lopid looks like and contents of the pack

They are white, oval shaped tablets.

The blister packs contain 60 tablets.

Manufacturer and Licence Holder

The tablets are manufactured by Pfizer Manufacturing Deutschland GmbH, Mooswaldallee 79090 Freiburg, Germany and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

Lopid 600mg Tablets / Gemfibrozil 600mg Tablets

Lopid is a registered trademark of Parke Davis.

Revision date: 14/07/2021

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