300 mg capsules, hard, 450 mg, and 600 mg film-coated tablets
gemfibrozil
What Lopid is and what it is used for
Lopid contains the active substance gemfibrozil which belongs to a group of medicines called fibrates. These drugs are used to lower the fat content ( lipids ) in the blood. For example, fats are called triglycerides.
Lopid is used in combination with diet and other non-medical treatments, e.g. exercise and weight loss, to lower blood fat levels.
Lopid can be used, when other drugs (statins) are inappropriate, to reduce the incidence of heart problems in men at high risk and who have increased levels of “bad” cholesterol.
Lopid can also be prescribed to people who cannot be prescribed other lipid-lowering drugs that lower blood cholesterol levels.
What you need to know before you use 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 previously had gallstones or any disease of the bile ducts or gallbladder
- if you have previously had an allergic reaction to sunlight during treatment with fibrates
- if you are being treated with a medicine called repaglinide (used to lower your blood sugar in diabetes ), simvastatin or rosuvastatin 40 mg (cholesterol lowering medicine) or dasabuvir (a medicine used to treat hepatitis C infection ) or selexipag (a drugs used to treat pulmonary arterial hypertension ).
Warnings and cautions
Talk to your doctor or pharmacist before taking Lopid.
Tell your doctor if any of the following apply to you so that he/she can determine if Lopid is suitable for you:
- high risk of muscle breakdown ( rhabdomyolysis ): the risk factors are i.a. renal impairment, underactive thyroid gland , age over 70 years, high alcohol consumption, previous occurrence of muscle aches and weakness (muscle toxicity) when treated with another fibrate or statin, hereditary muscle disease, use of Lopid in combination with statins to lower levels of bad cholesterol and triglyceride and increase the good cholesterol such as rosuvastatin and simvastatin (for simvastatin and rosuvastatin 40 mg, see “Do not take Lopid” and “Other medicines and Lopid”)
- mild or moderate kidney disease
- underactive thyroid gland
- diabetes
Other medicines and Lopid
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
- medicines for diabetes , especially rosiglitazone or repaglinide (used to lower blood sugar levels) (repaglinide, see “Do not take Lopid ‘)
- dasabuvir, a medicine 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 the levels of bad cholesterol and triglycerides and increase the good cholesterol ), e.g. atorvastatin, lovastatin, pravastatin, rosuvastatin and simvastatin (for simvastatin and rosuvastatin 40 mg, see “Do not take Lopid” and “Warnings and precautions”)
- dabrafenib, a treatment for melanoma
- loperamide, a treatment for diarrhea
- montelukast, a treatment for asthma
- pioglitazone, a treatment used in diabetes
- warfarin , acenocoumarol and fenprocumon (used to thin the blood)
- cholestipol resin granules for the treatment of high levels of fats ( cholesterol ) in the blood
- bexarotene for the treatment of skin cancer
- colchicine for the treatment of gout
- paclitaxel, a treatment for cancer
- enzalutamide, a treatment for prostate cancer
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Breast-feeding
You should not take Lopid if you are breastfeeding.
Driving and using machines
In rare cases, Lopid may cause dizziness and affect vision. If this happens, do not drive or use machines. As long as you feel good, you can drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Lopid contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
3. How to use Lopid
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The lipid levels in your blood will be monitored carefully and regularly before and during Lopid treatment. If you are diabetic or have problems with your thyroid gland, your doctor will try to treat this before starting treatment with Lopid. Your doctor will also advise you on the right diet, exercise, smoking cessation, reduced alcohol intake, and, if necessary, weight loss.
Lopid should be taken by mouth. It is recommended that the capsules or tablets be swallowed with a glass of water, as the tablets will not taste good if you divide them.
Lopid with food and drink
Lopid should be taken half an hour before a meal.
Adults and the elderly:
The usual starting dose is between 900 mg and 1200 mg daily. Your doctor will determine the dose for you. Follow the instructions on the label.
If you are advised to take 1200 mg, take 600 mg half an hour before breakfast and a second dose of 600 mg half an hour before dinner.
If you are advised to take 900 mg, take a dose half an hour before dinner.
Adults with mild or moderate kidney disease:
Your doctor will assess your state of health before and during treatment with Lopid. The treatment starts with 900 mg daily and can be increased up to 1200 mg, depending on how you respond to the treatment. Lopid should not be given to patients with severe kidney disease.
Use for children
Lopid is not recommended for use in children.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Although severe reactions may occur, we advise you to contact your doctor immediately if you experience any of the following symptoms after taking Lopid:
Rare (may affect up to 1 in 1,000 people)
- allergic reaction in which face, tongue or throat may begin to swell, resulting in difficulty breathing ( angioedema )
- dandruff and blisters on the skin, mouth, eyes and genitals
- rash on the whole body
- muscle weakness or weakness followed by dark urine, fever, rapid heartbeat (palpitations), nausea or vomiting
Other side effects that have been reported:
Very common (may affect up to 1 in 10 people):
- indigestion
Common (may affect up to 1 in 10 people):
- feeling dizzy or tingling ( vertigo )
- eczema , rash (especially itchy or puffy rash)
- headache
- stomachache
- diarrhea
- nausea
- vomiting
- constipation
- gases
- fatigue
Uncommon (may affect up to 1 in 100 people):
- irregular heartbeats
Rare (may affect up to 1 in 1,000 people):
- decreased or increased number of white blood cells ( leukopenia , eosinophilia ), bone marrow disease (bone marrow failure)
- decreased platelet count ( platelets )
- nerve inflammation ( peripheral neuritis )
- unusual bruising or bleeding due to decreased platelet count ( thrombocytopenia )
- severe anemia
- loss of sensation and a stinging sensation ( paresthesias )
- pancreatitis
- dimsyn
- jaundice (yellowing of the skin), impaired liver function
- liver inflammation ( hepatitis )
- gallstones ( cholelithiasis ), inflammation of the gallbladder (cholecystitis)
- appendicitis
- Depression
- dizziness
- somnolence
- pain in the joints and in the arms and legs
- dermatitis or inflammation where the skin flakes or falls off
- muscle inflammation (myositis)
- inflammation of the synovial membrane ( synovitis )
- persistent lack of energy
- impotence
- decreased sex drive
- hair loss
- photosensitivity (may cause discoloration of the skin or rash)
- red, itchy, raised skin areas
- itching
How to store Lopid
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label or blister after EXP. alternatively EXP. The expiration date is the last day of the specified month.
Lopid 300 mg hard capsules: Do not store above 25 ° C. Store in the original package. Moisture sensitive.
Lopid 450 mg film-coated tablets, Lopid 600 mg film-coated tablets: Do not store above 25 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
Lopid 300 mg hard capsules
The active substance is gemfibrozil. Each hard capsule contains 300 mg of gemfibrozil.
The other ingredients are polysorbate (E433), colloidal silica, and corn starch.
The capsule shell contains gelatin, titanium dioxide (E171), erythrosine (E127), and indigo carmine (E132).
The printing ink contains shellac lacquer and black iron oxide (E172).
Lopid 450 mg film-coated tablets
The active substance is gemfibrozil. Each film-coated tablet contains 450 mg of gemfibrozil.
The other ingredients are pregelatinized starch, microcrystalline cellulose, colloidal silica
Lopid 600 mg film-coated tablets
The active substance is gemfibrozil. Each film-coated tablet contains 600 mg gemfibrozil.
The other ingredients are pregelatinized starch, microcrystalline cellulose, colloidal silica (anhydrous), sodium starch glycolate, polysorbate 80 (E433), and magnesium stearate.
The film coating for all tablet strengths contains hydroxypropyl methylcellulose (E464), titanium dioxide (E171), polydimethylsiloxane, macrogol 6000, and talc (E553b).
What the medicine looks like and contents of the pack
Lopid 300 mg capsules contain a fine white powder enclosed in a hard gelatin capsule with a white opaque body and reddish-brown opaque body, imprinted with ‘Lopid 300’ on both capsules. They are packed in blister packs of aluminum foil with 20, 60, 100, and 112 capsules in each.
Lopid 450 mg are white oval film-coated tablets. They are packed in transparent blister strips of PVC plastic with a backing of aluminum foil and in cartons with 30, 60, 100, and 180 tablets respectively in each.
Lopid 600 mg are white oval film-coated tablets. They are packaged in clear PVC plastic blister strips with aluminum foil backing and cartons of 14, 20, 28, 30, 50, 56, 60, 98, 100, 196, 500, and 600 tablets respectively.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Pfizer AB
Vetenskapsvägen 10
191 90 Sollentuna
Tel: 08-550 520 00
Email: eumedinfo@pfizer.com
Manufacturer
Pfizer Manufacturing Deutschland GmbH
Operating office Freiburg
Mooswaldallee 1
79090 Freiburg
Germany