Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
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.
e = 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
e 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)
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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
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'.
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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 a double dose to make up for a forgotten dose.
If you stop taking Lopid
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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.
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
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- 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 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.
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 25°C in the original package in order to protect from moisture. Lopid 600 mg film-coated tablets: Store below 25°C.
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.
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, titantum dioxide (E171), erythrosine (E127) and indigo carmine (E132).
The printing ink contains shellac glaze and iron oxide black (E172).
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Lopid 600 mg film-coated tablets
The active substance is gemfibrozil. Each film-coated tablet contains 600 mg gemfibrozil. The other ingredients are pregelatinised starch, microcrystalline cellulose, colloidal silica (anhydrous), sodium starch glycollate, polysorbate 80 (E433) and magnesium stearate.
The film coat for tablets contains hydoxypropylmethylcellulose (E464), titanium dioxide (E171), polydimethyl siloxane, polyethylene glycol 6000 and talc (E553b).
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.
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.
Not all pack sizes may be marketed.
Marketing Authorisation Holder Pfizer Ltd, Ramsgate Rd, Sandwich, Kent, CT13 9NJ, UK.
Manufacturer
Pfizer Manufacturing Deutschland GmbH Mooswaldallee |
79108 Freiburg Im Breisgau
Germany
This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Lopid: Denmark, Greece, Iceland, Ireland, Italy, Netherlands, Portugal, Spain, Sweden and United Kingdom (Northern Ireland)
Gevilon: Austria, Germany
Lipur: France
This leaflet was last revised in 10/2024.
Ref: LP 21 0
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Lopid 600 mg Film-coated Tablets comes as tablet containing 600 mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Lopid 600 mg Film-coated Tablets is gemfibrozil.
Medicines with the same active substance include: Gemfibrozil 600mg Film-Coated Tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Lopid 600 mg Film-coated Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Lopid is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following:
- Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol.
- Mixed hyperlipidaemia when a statin is contraindicated or not tolerated.
- Primary hypercholesterolaemia when a statin is contraindicated or not tolerated.
Primary prevention
Reduction of cardiovascular morbidity in males with increased non-HDL cholesterol and at high risk for a first cardiovascular event when a statin is contraindicated or not tolerated (see section 5.1).
Prior to initiating gemfibrozil, other medical problems such as hypothyroidism and diabetes mellitus must be controlled as best as possible and patients should be placed on a standard lipid-lowering diet, which should be continued during treatment. Lopid should be taken orally.
Posology
Adult
The dose range is 900 mg to 1200 mg daily.
The only dose with documented effect on morbidity is 1200 mg daily.
See Method of administration.
Elderly (over 65 years old)
As for adults
Children and adolescents
Gemfibrozil therapy has not been investigated in children. Due to the lack of data the use of Lopid in children is not recommended.
Renal impairment
In patients with mild to moderate renal impairment (Glomerular filtration rate 50 - 80 and 30 < 50 ml/min/1.73 m2, respectively), start treatment at 900 mg daily and assess renal function before increasing dose. Lopid should not be used in patients with severely impaired renal function (see section 4.3).
Hepatic impairment
Gemfibrozil is contraindicated in hepatic impairment (see section 4.3).
Method of administration
The 1200 mg dose is taken as 600 mg twice daily, half an hour before breakfast and half an hour before the evening meal.
The 900 mg dose is taken as a single dose half an hour before the evening meal.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Hepatic impairment
• Severe renal impairment
• History of/or pre-existing gall bladder or biliary tract disease, including gallstones
• Concomitant use of repaglinide, dasabuvir, selexipag (see section 4.5), simvastatin, or rosuvastatin at 40 mg (see sections 4.4 and 4.5)
• Patients with previous history of photoallergy or phototoxic reaction during treatment with fibrates
The interaction profile of gemfibrozil is complex. In vivo studies indicate that gemfibrozil and its metabolite gemfibrozil 1-O-β-glucuronide are potent inhibitors of CYP2C8 (an enzyme important for the metabolism of e.g. dabrafenib, enzalutamide, loperamide, montelukast, repaglinide, rosiglitazone, pioglitazone, dasabuvir, selexipag and paclitaxel). Co-administration of gemfibrozil with repaglinide, dasabuvir or selexipag is contraindicated (see section 4.3). In addition, dosing reduction of drugs that are mainly metabolised by CYP2C8 enzyme may be required when gemfibrozil is used concomitantly. In vitro studies have shown that gemfibrozil is a strong inhibitor of CYP2C9 (an enzyme involved in the metabolism of e.g. warfarin and glimepiride), but also of CYP 2C19, CYP1A2, OATP1B1 and UGTA1 and UGTA3 (see section 4.4). Gemfibrozil 1-O-β-glucuronide also inhibits OATP1B1.
Repaglinide
In healthy volunteers, co-administration with gemfibrozil increased the AUC and Cmax of repaglinide by 8.1-fold and 2.4-fold, respectively. In the same study, co-administration with gemfibrozil and itraconazole increased the AUC and Cmax of repaglinide by 19.4-fold and 2.8-fold, respectively. In addition, co-administration with gemfibrozil or with gemfibrozil and itraconazole prolonged its hypoglycaemic effects. Therefore, co-administration of gemfibrozil and repaglinide increases the risk for severe hypoglycaemia and is contraindicated (see section 4.3).
Dasabuvir
Co-administration of gemfibrozil with dasabuvir increased dasabuvir AUC and Cmax (ratios: 11.3 and 2.01, respectively) due to CYP2C8 inhibition. Increased dasabuvir exposure may increase the risk of QT prolongation, therefore, co-administration of gemfibrozil with dasabuvir is contraindicated (see section 4.3).
Selexipag
Co-administration of gemfibrozil with selexipag, a substrate for CYP2C8, doubled exposure (AUC) to selexipag and increased exposure (AUC) to the active metabolite, ACT-333679, by approximately 11- fold. Concomitant administration of gemfibrozil with selexipag is contraindicated (see section 4.3).
Enzalutamide
In healthy volunteers given a single 160 mg dose of enzalutamide after gemfibrozil 600 mg twice daily, the AUC of enzalutamide plus active metabolite (N-desmethyl enzalutamide) was increased by 2.2-fold and corresponding Cmax was decreased by 16%. Increased enzalutamide exposure may increase the risk of seizures. Concomitant treatment of gemfibrozil and enzalutamide should be avoided; if co-administration is considered necessary, the dose of enzalutamide should be reduced (see section 4.4).
Rosiglitazone
The combination of gemfibrozil with rosiglitazone should be approached with caution. Co-administration with rosiglitazone has resulted in 2.3-fold increase in rosiglitazone systemic exposure, probably by inhibition of the CYP2C8 isozyme (see section 4.4).
HMG CoA reductase inhibitors
The concomitant administration of gemfibrozil with simvastatin, as well as with rosuvastatin at 40 mg is contraindicated (see sections 4.3 and 4.4). The combined use of gemfibrozil and a statin should generally be avoided (see section 4.4). The use of fibrates alone is occasionally associated with myopathy. An increased risk of muscle related adverse events, including rhabdomyolysis, has been reported when fibrates are co-administered with statins.
Gemfibrozil has also been reported to influence the pharmacokinetics of simvastatin, lovastatin, pravastatin, rosuvastatin and atorvastatin. Gemfibrozil caused an almost 3-fold increased in AUC of simvastatin acid possibly due to inhibition of glucoronidation via UGTA1 and UGTA3, and a 3-fold increase in pravastatin AUC which may be due to interference with transport proteins. One study indicated that the co-administration of a single rosuvastatin dose of 80 mg to healthy volunteers on gemfibrozil (600mg twice daily) resulted in a 2.2-fold increase in mean Cmax and a 1.9-fold increase in mean AUC of rosuvastatin. The co-administration of a single lovastatin dose of 40 mg with gemfibrozil (600 mg twice daily for 3 days) in healthy volunteers resulted in a 2.8-fold increase of the mean AUC and Cmax of lovastatin acid. The co-administration of a single atorvastatin dose of 40 mg with gemfibrozil (600 mg twice daily for 7 days) in healthy volunteers resulted in a 1.35-fold increase in mean AUC and no increase in mean Cmax of atorvastatin.
Anticoagulants
Gemfibrozil may potentiate the effects of coumarin type vitamin K antagonist anticoagulants such as warfarin, acenocoumarol, or phenprocoumon. The concomitant administration of gemfibrozil with these anticoagulants necessitates careful monitoring of prothrombin time (INR) (see section 4.4).
Bexarotene
Concomitant administration of gemfibrozil with bexarotene is not recommended. A population analysis of plasma bexarotene concentrations in patients with cutaneous T-cell lymphoma (CTCL) indicated that concomitant administration of gemfibrozil resulted in substantial increases in plasma concentrations of bexarotene.
Bile acid – binding resins
Reduced bioavailability of gemfibrozil may result when given simultaneously with resin-granule drugs such as colestipol. Administration of the products two hours or more apart is recommended.
Colchicine
Risk of myopathy and rhabdomyolysis may be increased with concomitant administration of colchicine and gemfibrozil. This risk may be increased in the elderly and in patients with hepatic or renal dysfunction. Clinical and biological monitoring are recommended, especially at the start of combined treatment.
Gemfibrozil is highly bound to plasma proteins and there is potential for displacement interactions with other drugs.
Pregnancy
There are no adequate data on use of Lopid in pregnant women. Animal studies are insufficiently clear to allow conclusions to be drawn on pregnancy and foetal development (see section 5.3). The potential risk for humans is unknown. Lopid should not be used during pregnancy unless it is clearly necessary.
Breast-feeding
There are no data on excretion of gemfibrozil in milk. Lopid should not be used when breast-feeding.
Fertility
Reversible decreases in male fertility have been observed in reproductive toxicity studies in rats (see section 5.3).
No studies on the effects on the ability to drive and use machines have been performed. In isolated cases dizziness and visual disturbances can occur which may negatively influence driving.
Overdose has been reported. Symptoms reported with overdosage were abdominal cramps, abnormal LFT's, diarrhea, increased CPK, joint and muscle pain, nausea and vomiting. The patients fully recovered. Symptomatic supportive measures should be taken if overdose occurs.
Ask anything about Lopid 600 mg Film-coated Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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