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What is ARSTATIN FH?
- ARSTATIN FH contains Atorvastatin and Fenofibrate
- Atorvastatin belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines
- Fenofibrate belongs to a group of medicines, commonly known as fibrates. These medicines are used to lower the level of fats (lipids) in the blood
CONSUMER MEDICINE INFORMATION
THERAPEUTIC USES
WARNING & PRECAUTIONS
INTERACTIONS
DIRECTIONS FOR USE
SIDE EFFECTS
MORE INFORMATION
What ARSTATIN FH is used for?
- ARSTATIN FH is used to lower lipids known as cholesterol and triglycerides in the blood when a low-fat diet and life style changes on their own have failed
- If you are at an increased risk of heart disease, ARSTATIN FH can also be used to reduce such risk even if your cholesterol levels are normal
Talk to your doctor before taking this medicine, If you
- have had a previous stroke with bleeding into the brain
- have kidney or liver problems
- have an under-active thyroid gland (hypothyroidism) have had impaired kidney
- have severely increased levels of a type of fat (triglycerides) in the blood (severe hypertriglyceridemia)
- impaired kidney function
- have had or have a family member with a history of hereditary muscular disorders
- have decreased levels of a certain protein in the blood (hypoalbuminemia)
- have poorly controlled diabetes mellitus (type II)
- have nephrotic syndrome
- have a condition which effects the amount of protein in the blood (dysproteinemia)
- have severe respiratory failure
Talk to your doctor, if you are taking,
- medicines used to alter the way your immune system works, e.g. ciclosporin
- certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole
- some calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem
- medicines to regulate your heart rhythm e.g. digoxin, verapamil, amiodarone.
- medicines used in the treatment of HIV e.g. ritonavir, lopinavir
- warfarin (which reduces blood clotting)
- oral contraceptives, stiripentol (an anti-convulsant for epilepsy)
- cimetidine (used for heartburn and peptic ulcers)
- phenazone (a painkiller)
- colchicines (used to treat gout)
- antacids (indigestion products containing aluminium or magnesium)
- oral fusidic acid to treat a bacterial infection
- statins e.g. atorvastatin (used to lower cholesterol)
- ciclosporin (used to suppress the immune system)
- phenylbutazone (a non-steroidal anti-inflammatory drug)
- oestrogen or medicines which contain oestrogen
- Always take this medicine exactly as your doctor has told you
- ARSTATIN FH should be swallowed whole with a drink of water, and can be taken at any time of day, with or without food
- However, try to take your tablet at the same time every day
If you take more ARSTATIN FH
- If you accidently take too many ARSTATIN FH tablets (more than your usual daily dose), contact your doctor or nearest hospital for advice
If you forget to take ARSTATIN FH
- If you forget to take a dose, just take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose
If you stop taking ARSTATIN FH
- Do not stop taking this medicine before consulting your doctor
Like all medicines, this medicine can cause side effects, although not everybody gets them.
SERIOUS
COMMON
UNCOMMON
RARE
VERY RARE
Atorvastatin
- serious allergic reaction which causes swelling of face, tongue and throat that can cause great difficulty in breathing
- serious illness with severe peeling and swelling of the skin, blistering of the skin, mouth, eyes, genitals and fever. skin rash with pink-red blotches especially on palms of hands or soles of feet which may blister
- muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown. the abnormal muscle breakdown does not always go away, even after you have stopped taking atorvastatin it can be life-threatening and lead to kidney problems
Fenofibrate
- muscle pain, breakdown, inflammation, cramps or weakness, increase in the levels of a certain enzyme within the body (seen in a blood test)
- swelling of the face, lips, tongue or throat, itchy skin rash, narrowing of the airways causing difficulty breathing or swallowing
- yellowing of the skin or whites of the eyes (jaundice), itching
Atorvastatin
- inflammation of the nasal passages, pain in the throat, nose bleed
- allergic reactions
- increases in blood sugar levels (if you have diabetes continue careful monitoring of your blood sugar levels), increase in blood creatine kinase
- headache
- nausea, constipation, wind, indigestion, diarrhoea
- joint pain, muscle pain and back pain
- blood test results that show your liver function can become abnormal
Fenofibrate
- headache
- tiredness
- spinning sensation
- stomach or intestine disorders such as feeling or being sick
- stomach pains, diarrhoea and wind
Atorvastatin
- anorexia (loss of appetite), weight gain, decreases in blood sugar levels (if you have diabetes you should continue careful monitoring of your blood sugar levels)
- having nightmares, insomnia
- dizziness, numbness or tingling in the fingers and toes, reductions of sensation to pain or touch, change in sense of taste, loss of memory
- blurred vision
- ringing in the ears and/or head
- vomiting, belching, abdominal pain upper and lower, pancreatitis (inflammation of the pancreas leading to stomach pain)
- hepatitis (liver inflammation)
- neck pain, muscle fatigue
- fatigue, feeling unwell, weakness, chest pain, swelling especially in the ankles (oedema), raised temperature
- urine tests that are positive for white blood cells
Fenofibrate
- increased levels of a certain enzyme within the body (seen in a test)
- muscle toxicity (muscle pain, inflammation, cramps and weakness)
- blood clotting
- inflammation of the pancreas causing stomach and back pain
Atorvastatin
- visual disturbance
- unexpected bleeding or bruising
- cholestasis (yellowing of the skin and whites of the eyes)
- tendon injury
Fenofibrate
- disorder of the nerves causing weakness
- tingling and numbness (peripheral neuropathy)
- hair loss
- increase in blood levels of creatinine and urea
- loss of sex drive
- decreased levels of haemoglobin and white blood cells
Atorvastatin
- sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
- hearing loss
- gynaecomastia (breast enlargement in men)
Fenofibrate
- lung disease (interstitial pneumopathies)
- development of gallstones
- abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis)
