Atorvastatin LHC tablets belong to a group of medicines known as statins, which are lipid (fat) regulating medicines. Atorvastatin LHC tablets are used to lower lipids known as cholesterol and triglycerides in the blood when a low-fat diet and life style changes with no other measures have failed. If you are at an increased risk of heart disease, Atorvastatin LHC tablets can also be used to reduce such risk even if your cholesterol levels are normal. A standard cholesterol lowering diet should be continued during treatment. Cholesterol is a naturally occurring substance in the body necessary for normal growth. However, if there is too much cholesterol in your blood it can be deposited on the walls of the blood vessels, which may eventually become blocked. This is one of the most common causes of heart disease. It is accepted that raised cholesterol levels increase the risk of heart disease. Other factors that will increase the risk of heart disease include high blood pressure, diabetes, increased weight, lack of exercise, smoking, or a family history of heart disease. In young patients of between 10 – 17 years of age Atorvastatin LHC is used as an additional therapy to diet to reduce cholesterol and triglycerides if after an adequate trial of diet therapy cholesterol level remains 4, 04 mmol/L and there is a positive family history of heart disease.
1. What Atorvastatin LHC tablets are and what they are used for
2. What you need to know before you take Atorvastatin LHC tablets
Do not take Atorvastatin LHC Tablets:
- If you are allergic (hypersensitive) to atorvastatin or any of the ingredients of Atorvastatin LHC tablets (listed in section 6).
- If you suffer from active liver disease such as liver cirrhosis.
- If you have any unexplained persistent elevation of serum trasaminases (enzymes that catalyses transfer of amino group) or any abnormal blood tests for liver function.
- If you are on treatment with rifampicin or diltiazem.
- With grapefruit juice.
- If you are pregnant or breastfeeding your baby.
- if you use the combination of glecaprevir/pibrentasvir in the treatment of hepatitis C.
Warnings and precautions
Take special care with Atorvastatin LHC tablets:
- If you have active liver disease or elevated liver enzymes during treatment with Atorvastatin LHC tablets, your doctor should immediately discontinue your treatment with Atorvastatin LHC tablets. Therefore, it is recommended to perform liver function test before treatment is initiated and continued to be performed periodically thereafter.
- If you experience repeated or unexplained muscle tenderness, weakness, aches or pains particularly if accompanied by general feeling of being unwell and fever, you should report these warning signs immediately to your healthcare professional as you may have had rhabdomyolysis (breaking down of skeletal muscle cells). Your doctor will need to carry out a blood test to check for levels of creatinine phosphokinase (CPK), if the levels are too high treatment should be discontinued.
- If you are taking a medicine called fusidic acid (a medicine for bacterial infection). The combination of fusidic acid and Atorvastatin LHC tablets can lead to serious muscle problems.
- If you have or have had myasthenia (a disease with general muscle weakness including in some cases muscles used when breathing), or ocular myasthenia (a disease-causing eye muscle weakness) as statins may sometimes aggravate the condition or lead to the occurrence of myasthenia.
Tell your doctor if you have ever had any type of stroke; your doctor will need to consider this in deciding the best treatment and dose for you.
Other medicines and Atorvastatin LHC tablets:
Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines). There are some medicines that may change the effect of Atorvastatin LHC tablets or their effect may be changed by Atorvastatin LHC tablets. This type of interaction could make one or both of the medicines less effective. Alternatively, it could increase the risk of severity of side-effects, including the important muscle wasting condition known as rhabdomyolysis. Your doctor will consider this in deciding upon your dose of Atorvastatin LHC.
There are some medicines that may interact with Atorvastatin LHC tablets:
- Medicines used to alter the way your immune system works, e.g. ciclosporin.
- Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, ketoconazole, itraconazole and rifampicin.
- Other medicines to regulate lipid levels, e.g. gemfibrozil, other fibrates, nicotinic acid derivatives, colestipol and ezetimibe.
- Some calcium channel blockers used for angina or high blood pressure, e.g. diltiazem, medicines that regulate your heart rhythm, e.g. digoxin, amiodarone.
- Protease inhibitors used in the treatment of HIV.
- Other medicines known to interact with Atorvastatin LHC include warfarin (which reduces blood clotting), oral contraceptives, phenytoin (an anti-convulsant for epilepsy), antacids (indigestion products containing aluminium or magnesium) and colchicine (used to treat gout).
- Some medicines used in the treatment of hepatitis C (e.g. telaprevir, boceprevir and the combination of elbasvir/grazoprevir).
3. How to take Atorvastatin LHC tablets
Do not share medicines prescribed for you with any other person. Always take Atorvastatin LHC tablets exactly as your doctor or pharmacist has instructed you. You should check with your doctor or pharmacist if you are unsure. The usual starting dose of Atorvastatin LHC tablets is 10 mg once a day. This may be increased if necessary by your doctor until you are taking the amount you need. Your doctor will adapt the dosage at intervals of 4 weeks or more. The maximum dose of Atorvastatin LHC is 80 mg once daily. Atorvastatin LHC tablets 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. Before starting treatment, your doctor will place you on a low-cholesterol diet, which you should maintain also during therapy with Atorvastatin LHC tablets.
If you take more Atorvastatin LHC tablets than you should
In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison Centre.
If you forget to take Atorvastatin LHC tablets
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 forgotten individual doses.
If you stop taking Atorvastatin LHC tablets
If you stop taking Atorvastatin LHC tablets for a longer time, your blood cholesterol may increase again which can increase the risk of heart and blood vessels diseases. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Atorvastatin LHC tablets can have side effects. Not all side-effects reported for Atorvastatin LHC tablets are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Atorvastatin LHC, please consult your health care provider for advice. If any of the following happens, stop taking Atorvastatin LHC tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:
- Swelling of the face, tongue and windpipe which can cause great difficulty in breathing and swallowing.
- Sudden allergic reaction with shortness of breath, rash, wheezing and drop of blood pressure.
- Severe extensive blistering skin rash with redness and peeling of the skin.
- Serious blistering condition of the skin, mouth, eyes and genitals.
- Patchy red rash.
- If you experience problems with unexpected or unusual bleeding or bruising, this may be suggestive of a liver complaint.
- Yellowing of the skin and whites of the eyes.
- Muscle wasting or inflammation and tenderness that may progress to become a serious, potentially life-threatening condition. It can occur for no apparent reason (e.g. not related to muscle exercise). If you have muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell or have a high temperature, stop taking Atorvastatin LHC tablets and tell your doctor immediately.
These are all very serious side effects. If you have them, you may have had a serious reaction to Atorvastatin LHC tablets. You may need urgent medical attention or hospitalization. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
- Chest pain.
- Breathing problems including persistent cough and/or shortness of breath or fever.
These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:
Frequent side effects:
- Nausea.
- Abdominal pain.
- Constipation.
- Wind.
- Indigestion.
- Diarrhoea.
- Headache.
- Muscle pain.
- Weakness.
- Insomnia.
- Dizziness.
Less frequent side effects:
- Loss of appetite.
- Visual disturbance.
- Hearing loss.
- Sleep disturbances including nightmares.
- Ringing in the ears and/or head.
- Change in the sense of taste.
- Hyperglycaemia (high blood sugar).
- Hypoglycaemia (low blood sugar).
- Weight gain.
- Numbness or tingling in the fingers and toes.
- Loss of memory.
- Vomiting.
- Belching.
- Pancreatitis (inflammation of the pancreas leading to stomach pain).
- Hepatitis (liver inflammation).
- Liver failure.
Unknown frequency side effects:
- Myasthenia gravis (a disease with general muscle weakness including in some cases muscles used when breathing).
- Ocular myasthenia (a disease-causing eye muscle weakness).
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
5. How to store Atorvastatin LHC tablets
Store at or below 25 ° C. Store all medicines out of reach of children. Store in the original package until required for use. Do not use Atorvastatin LHC tablets after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month. 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.