LIPITOR 20MG CHEWABLE TABLET
Active substance: ATORVASTATIN CALCIUM
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IRELAND
you are at an increased risk of heart disease, Lipitor can also be used to reduce such risk even if your cholesterol levels are normal. You should maintain a standard cholesterol lowering diet during treatment.
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if you regularly drink a large amount of alcohol if you have a history of liver disease if you are older than 70 years.
Lipitor
2. BEFORE YOU TAKE LIPITOR
Do not take Lipitor
if you are hypersensitive (allergic) to Lipitor or to any similar medicines used to lower blood lipids or to any of the other ingredients of the medicine see Section 6 for details. if you have or have ever had a disease which affects the liver if you have had any unexplained abnormal blood tests for liver function if you are a woman able to have children and not using reliable contraception if you are pregnant or trying to become pregnant if you are breast-feeding.
Check with your doctor or pharmacist before taking Lipitor
if you have severe respiratory failure. If any of these apply to you, your doctor will need to carry out a blood test before and possibly during your Lipitor treatment to predict your risk of muscle related side effects. The risk of muscle related side effects e.g rhabdomyolysis is known to increase when certain medicines are taken at the same time (see Section 2 Taking other medicines ). While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.
5 mg, 10 mg, 20 mg and 40 mg Chewable Tablets Atorvastatin
Read all of this lea et carefully before you start taking this medicine.
Keep this lea et. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this lea et, please tell your doctor or pharmacist.
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, atazanavir, indinavir, darunavir, etc. Other medicines known to interact with Lipitor include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anti-convulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller) and antacids (indigestion products containing aluminium or magnesium) Medicines obtained without a prescription: St John s Wort 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
Do not take Lipitor if you are pregnant, or if you are trying to become pregnant. Do not take Lipitor if you are able to become pregnant unless you use reliable contraceptive measures. Do not take Lipitor if you are breastfeeding. The safety of Lipitor during pregnancy and breast-feeding has not yet been proven. Ask your doctor or pharmacist for advice before taking any medicine.
However, try to take your tablet at the same time every day. Always take Lipitor exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The duration of treatment with Lipitor is determined by your doctor.
Please ask your doctor if you think that the effect of Lipitor is too strong or too weak.
Driving and using machines
Normally this medicine does not affect your ability to drive or operate machines. However, do not drive if this medicine affects your ability to drive. Do not use any tools or machines if your ability to use them is affected by this medicine.
If you take more Lipitor than you should
If you accidently take too many Lipitor chewable tablets (more than your usual daily dose), contact your doctor or nearest hospital for advice.
If you forget to take Lipitor
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.
Take special care with Lipitor
The following are reasons why Lipitor may not be suitable for you: if you have had a previous stroke with bleeding into the brain, or have small pockets of uid in the brain from previous strokes if you have kidney problems if you have an under-active thyroid gland (hypothyroidism) if you have had repeated or unexplained muscle aches or pains, a personal history or family history of muscle problems if you have had previous muscular problems during treatment with other lipid-lowering medicines (e.g. other -statin or - brate medicines)
Taking other medicines
There are some medicines that may change the effect of Lipitor or their effect may be changed by Lipitor. This type of interaction could make one or both of the medicines less effective. Alternatively it could increase the risk or severity of side-effects, including the important muscle wasting condition known as rhabdomyolysis described in Section 4: 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, voriconazole, uconazole, posaconazole, rifampin, fusidic acid Other medicines to regulate lipid levels, e.g. gem brozil, other brates, colestipol
Important information about some of the ingredients of Lipitor
Contains a source of phenylalanine. May be harmful for people with phenylketonuria.
If you stop taking Lipitor
If you have any further questions on the use of this medicine or wish to stop your treatment, ask your doctor or pharmacist.
In this lea et:
1. What LIPITOR is and what it is used for 2. Before you take LIPITOR 3. How to take LIPITOR 4. Possible side effects 5. How to store LIPITOR 6. Further information
Taking Lipitor with food and drink
See Section 3 for instructions on how to take Lipitor chewable tablets. Please note the following: Grapefruit juice Do not take more than one or two small glasses of grapefruit juice per day because large quantities of grapefruit juice can change the effects of Lipitor. Alcohol Avoid drinking too much alcohol while taking this medicine. See Section 2 Take special care with Lipitor for details
3. HOW TO TAKE LIPITOR
Before starting treatment, your doctor will place you on a low-cholesterol diet, which you should maintain also during therapy with Lipitor. The usual starting dose of Lipitor is 10 mg once a day in adults and children aged 10 years or older. This may be increased if necessary by your doctor until you are taking the amount you need. Your doctor will adapt the dose at intervals of 4 weeks or more. The maximum dose of Lipitor is 80 mg once daily for adults and 20 mg once daily for children. Lipitor chewable tablets can be chewed or swallowed whole with a drink of water, and can be taken at any time of day, with or without food.
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4. POSSIBLE SIDE EFFECTS
Like all medicines, Lipitor can cause side effects, although not everybody gets them. If you experience any of the following serious side effects, stop taking your tablets and tell your doctor immediately or go to the nearest hospital accident and emergency department. Rare: affects 1 to 10 users in 10,000: Serious allergic reaction which causes swelling of the face, tongue and throat that can cause great dif culty in breathing.
You will nd more about LIPITOR on the back of this lea et 451493
1. WHAT LIPITOR IS AND WHAT IT IS USED FOR
Lipitor belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. Lipitor 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
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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 which can be life-threatening and lead to kidney problems. Very rare: affect less than 1 user in 10,000: If you experience problems with unexpected or unusual bleeding or bruising, this may be suggestive of a liver complaint. You should consult your doctor as soon as possible.
dizziness, numbness or tingling in the ngers 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 (in ammation of the pancreas leading to stomach pain) hepatitis (liver in ammation) rash, skin rash and itching, hives, hair loss 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 Rare side effects (affects 1 to 10 users in 10,000) include: visual disturbance unexpected bleeding or bruising cholestasis (yellowing of the skin and whites of the eyes) tendon injury Very rare side effects (affects less than 1 user in 10,000) include: an allergic reaction symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, dif culty breathing, collapse hearing loss gynecomastia (breast enlargement in men and women). Possible side effects reported with some statins (medicines of the same type): Sexual dif culties Depression Breathing problems including persistent cough and/or shortness of breath or fever
Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine. If any of the side effects gets serious, or if you notice any side effects not listed in this lea et, please tell your doctor or pharmacist.
cellulose, croscarmellose sodium, polysorbate 80, hydroxypropyl cellulose, amylum pregeli catum, mannitol, aspartame, sucralose, grape avour and magnesium stearate.
This medicinal product is authorised in the Member States of the EEA under the following names: Austria, Bulgaria, Czech Republic, Estonia, Germany, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia, Slovenia Belgium, Cyprus, Finland, Greece, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Sweden, UK Denmark, Greece, Iceland, Portugal, Spain Finland France Germany Greece Hungary Italy Portugal Sortis
What Lipitor looks like and contents of the pack
Lipitor 5 mg chewable tablets are white to off-white with pink to purple specks with a round shape. They are marked with 5 on one side and LCT on the other side. Lipitor 10 mg chewable tablets are white to off-white with pink to purple specks with a round shape. They are marked with 10 on one side and LCT on the other side. Lipitor 20 mg chewable tablets are white to off-white with pink to purple specks with a round shape. They are marked with 20 on one side and LCT on the other side. Lipitor 40 mg chewable tablets are white to off-white with pink to purple specks with a round shape. They are marked with 40 on one side and LCT on the other side. Lipitor chewable tablets are available in blister packs containing 30 chewable tablets.
5. HOW TO STORE LIPITOR
Keep out of the reach and sight of children. This medicine does not require any special storage conditions. Do not use Lipitor after the expiry date which is stated on the blister and outer packaging after {EXP}. 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.
Lipitor
Zarator Orbeos Tahor Atorvastatin P zer, Liprimar Edovin Obradon Torvast, Totalip, Xarator Atorvastatina Parke-Davis, Texzor Atorvastatina Pharmacia
Other possible side effects with Lipitor:
Common side effects (affects 1 to 10 users in 100) include: in ammation 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 Uncommon side effects (affects 1 to 10 users in 1000) include: 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
6. FURTHER INFORMATION
What Lipitor chewable tablets contains
The active substance is atorvastatin. Each tablet contains 5 mg atorvastatin (as atorvastatin calcium trihydrate). Each tablet contains 10 mg atorvastatin (as atorvastatin calcium trihydrate). Each tablet contains 20 mg atorvastatin (as atorvastatin calcium trihydrate). Each tablet contains 40 mg atorvastatin (as atorvastatin calcium trihydrate). The other ingredients of Lipitor chewable tablets are: calcium carbonate, microcrystalline
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: P zer Ireland Pharmaceuticals, Operations Support Group, Ringaskiddy, Co Cork, Ireland Manufacturer: P zer Manufacturing Deutschland GmbH Betriebsst tte Freiburg Mooswaldallee 1 79090 Freiburg, Germany
Spain
This lea et was last approved in 06/2012. Ref: LR 5_0
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Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

