Lopid (Gemfibrozil)

Lopid 300mg Capsules

Lopid 600mg Film-Coated Tablets

Gemfibrozil

What Lopid is and what it is used for

• Lopid belongs to a class of medicines called fibrates that control fats (lipids). It works by reducing fats (lipids) known as bad cholesterol (LDL) and triglycehdes in your blood while increasing good cholesterol (HDL).
• Lopid prevents the build-up of cholesterol and fats along the walls of your arteries (a process known as atherosclerosis) which causes blockage of your blood supply to vital organs. It decreases your chances of getting heart disease, angina (chest pain), strokes, and heart attacks. Lopid may be used to prevent heart attacks in men (who may not have ‘bad cholesterol’), in cases where other medicines (statins) cannot be used.
• Lopid should be used together with other means of lowering fats in the body such as exercise, dietary changes and weight reduction.

Before you take Lopid

Do not use Lopid if you have the following conditions:

• Hypersensitivity (allergy) to Gemfibrozil or other similar lipid regulating medicines or any of the other ingredients in Lopid.
• Liver disease.
• Severe kidney disease.
• History of gall stones, bile and gall bladder disease (biliary tract disease).
• Photoallergy or 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).

Take special care with Lopid:

Tell your doctor if you have any of the following conditions to help him or her decide if Lopid is suitable for you:

• Mild or moderate kidney disease.
• Under-active thyroid.
• 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; a history of inherited muscular disorders.
• Diabetes.
• If you are taking or have recently taken any other medicines, even those not prescribed.

Taking other medicines:

Please tell your doctor or pharmacist if you are taking any of the following medication:

• Anti-diabetic medication particularly rosiglitazone or repaglinide (used to help reduce blood sugar levels).
• Anticoagulants like warfarin (used to thin the blood).
• Statins used to lower bad cholesterol and triglycerides, and increase good cholesterol such as atorvastatin, simavastatin, lovastatin, pravastatin, and rosuvastatin.
• Colestipol resin granules for the treatment of high levels of fat (cholesterol) in your blood.
• Bexarotene medication for the treatment of skin cancer.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

It is recommended that you do not take Lopid during pregnancy unless it is necessary. Tell your doctor if you are pregnant or trying to become pregnant.

It is recommended that you do not take Lopid while you breast-feed unless it is necessary. Ask your doctor or pharmacist for advice before taking any medicine while breast-feeding.

Driving and using machinery

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.

How to take Lopid

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.

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 increase up to 1200mg or until you respond to treatment.

Lopid is not recommended for children

If you take too many capsules or tablets

If you accidentally take too many capsules or tablets 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.

If you forget to take a dose

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.

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.

Possible side effects

Lopid can cause side effects although not everybody gets them. 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, around the 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:

Common side effects (occurs in less than 1 in 10 patients)

• Indigestion.
• Sense of spinning or swaying (vertigo).
• Headache.
• Stomach pain.
• Diarrhoea.
• Wind.
• Feeling sick.
• Being sick.
• Constipation.
• Rash (particularly an itchy or puffy rash).
• Tiredness.

Uncommon side effects (occurs in less than 1 in 100 patients)

• Irregular heartbeat.

Rare (occurs in less than 1 in 1,000 patients)

• Persistent lack of energy.
• Problems with bleeding and bruising.
• Dizziness.
• Sleepiness.
• Paraesthesia (loss of feeling and a tingling sensation).
• Depression.
• Decreased libido.
• Blurred vision.
• Pancreatitis.
• Jaundice (yellowing of the skin).
• Hair loss.
• Appendicitis.
• Painful joints.
• Muscle disease (myopathy), muscle weakness, painful muscles or muscle breakdown (rhabdomyolysis).
• Impotence and photosensitivity (a sensitivity to light that can cause skin discolouration or a rash).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

How to store Lopid

• The unopened packs should be stored in the original container until ready for use.
• Lopid 300mg Capsules: Store below 25°C, in the original package in order to protect from moisture.
• Lopid 600mg tablets: Store below 25°C.
• Keep out of the reach and sight of children.
• Lopid should not be used after the expiry date printed on the pack.

Further Information

What Lopid contains

The active substance in Lopid capsules is 300mg of Gemfibrozil. The other ingredients are:

Polysorbate (E433), Colloidal silica, Maize starch, Gelatin, Titanium dioxide (E171), Indigo carmine (E132) Erythrosine (E127), Shellac glaze, Iron oxide black (E172), N-butyl alcohol, Propylene glycol, Isopropyl alcohol, Industrial Methylated spirit 740P, Purified water

The active substance in Lopid tablets is 600mg of Gemfibrozil. The other ingredients are:

Microcrystalline cellulose, Pregelatinized starch

Colloidal silica (anhydrous) (E551), Polysorbate 80 (E433),Sodium starch glycollate, Magnesium stearate, Hyproxypropylmethyl cellulose (E464), Titanium dioxide (E171), Talc(E553b), Polydimethyl siloxane, Polyethylene glycol 6000.

What Lopid looks like and contents of the pack

Lopid 300mg capsules contains a fine white powder in a hard gelatin capsule with a white opaque body and maroon cap., It is packaged in aluminium foil blister strips containing 112capsules.

Lopid 600mg tablet is a white oval film-coated tablet. It is packaged in transparent PVC blister strips with an aluminium foil back in packs containing 56 tablets.