ATORVASTATIN 10MG FILM COATED TABLETS

Active substance: ATORVASTATIN CALCIUM

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Atorvastatin Tablets
1.3: Product information

[LOGO: KENT PHARMACEUTICALS LTD.]
PACKAGE LEAFLET: INFORMATION FOR THE USER

Atorvastatin 10 mg film-coated tablets
Atorvastatin 20 mg film-coated tablets
Atorvastatin 40 mg film-coated tablets
Atorvastatin
Read all of this leaflet carefully before you start taking this medicine.
− Keep this leaflet. 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
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Atorvastatin Tablets are and what are they used for
2. Before you take Atorvastatin Tablets
3. How to take Atorvastatin Tablets
4. Possible side effects
5. How to store Atorvastatin Tablets
6. Further information

1. WHAT ATORVASTATIN TABLETS ARE AND WHAT ARE THEY USED FOR
Atorvastatin Tablets belongs to a group of medicines known as statins. Statins lower blood
cholesterol (and triglycerides).
Atorvastatin Tablets are advised when a low-fat diet and lifestyle changes have not been
adequate to lower blood cholesterol as recommended.
If you are at an increased risk of heart disease, Atorvastatin Tablets may also be used to
reduce such risk even if your blood cholesterol is “normal”. You should maintain a standard
cholesterol-lowering diet during treatment.

2. BEFORE YOU TAKE ATORVASTATIN TABLETS
Do not take Atorvastatin Tablets if you
• are hypersensitive (allergic) to Atorvastatin Tablets or to any similar medicines used to
lower blood cholesterol or to any of the other ingredients of the medicine – see Section 6
for details
• have or have ever had a disease that affects the liver
• have had any unexplained abnormal blood tests for liver function
• are a woman able to have children and not using reliable contraception
• are pregnant or trying to become pregnant
• are breast-feeding
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Atorvastatin Tablets
1.3: Product information

Take special care with Atorvastatin Tablets if you have:
• had a previous stroke caused by bleeding
• kidney problems
• an under-active thyroid gland (hypothyroidism)
• (or have had) repeated or unexplained muscle aches or pains or a family history of muscle
problems
• had previous muscle problems during treatment with other cholesterol -lowering
medicines (i.e. other ‘statin’ or ‘fibrate’ medicines)
• had liver disease
also take special care with Atorvastatin Tablets and if you:
• regularly drink a large amount of alcohol
• are older than 70 years
Check with your doctor or pharmacist before taking Atorvastatin Tablets
• if you have severe respiratory failure
• 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
The above are reasons why Atorvastatin Tablets may not be suitable for you: if any of the
above reasons apply to you, your doctor will need to carry out a blood test before and possibly
during your treatment with Atorvastatin Tablets especially to predict your risk of muscle
related side effects. The risk of muscle related side effects is known to increase when certain
medicines are taken at the same time (see Section 2 “Taking other medicines”).
Taking other medicines
There are some medicines that may change the effect of Atorvastatin Tablets or their effect
may be changed by Atorvastatin Tablets. 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, fluconazole, posaconazole,
rifampin, fusidic acid
• Other medicines to lower cholesterol e.g. gemfibrozil, other fibrates, colestipol
• Medicines used for angina or high blood pressure known as “calcium channel blockers”
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
• Other medicines known to interact with Atorvastatin Tablets include ezetimibe (lowers
cholesterol), warfarin (reduces blood clotting), oral contraceptives, stiripentol (for
epilepsy), cimetidine (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

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Atorvastatin Tablets
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Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Taking Atorvastatin Tablets with food and drink
See Section 3 for instructions on how to take Atorvastatin 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 Atorvastatin Tablets.
Alcohol
Avoid drinking too much alcohol while taking this medicine. See Section 2 “Take special care
with Atorvastatin Tablets” for details.
Pregnancy and Breast-feeding
Do not take Atorvastatin Tablets if you are pregnant, or if you are trying to become pregnant.
Do not take Atorvastatin Tablets if you are able to become pregnant unless you use reliable
contraceptive measures.
Do not take Atorvastatin Tablets if you are breast-feeding.
The safety of Atorvastatin Tablets during pregnancy and breast-feeding has not yet been
proven. Ask your doctor or pharmacist for advice before taking any medicine.
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.
Important information about some of the ingredients of Atorvastatin Tablets
If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicine.

3. HOW TO TAKE ATORVASTATIN TABLETS
Before starting treatment, your doctor will advise a low-cholesterol diet: you should continue
this diet whilst taking Atorvastatin Tablets.
The usual starting dose of Atorvastatin Tablets 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 Atorvastatin Tablets is 80 mg once daily for adults and 20 mg once daily
for children.
Atorvastatin 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.
Always take Atorvastatin Tablets exactly as your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.

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Atorvastatin Tablets
1.3: Product information

The duration of treatment with Atorvastatin Tablets is determined by your doctor.
Please ask your doctor if you think that the effect of Atorvastatin Tablets is too strong or too
weak.
If you take more Atorvastatin Tablets than you should
If you accidently take too many Atorvastatin Tablets (more than your usual daily dose) then
contact your doctor or nearest hospital for advice.
If you forget to take Atorvastatin 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 a forgotten dose.
If you stop taking Atorvastatin Tablets
If you have any further questions on the use of this medicine or wish to stop your treatment,
ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Atorvastatin Tablets 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.
Uncommon: affects 1 to 10 users in 1000:
• Inflammation of the pancreas causing abdominal pain and vomiting
Rare: affects 1 to 10 users in 10,000:
• swelling of the face, tongue and windpipe that can cause great difficulty in breathing
• severe, extensive, blistering skin rash
• unexpected or unusual bleeding or bruising
• severe muscle disease: symptoms include muscle weakness, tenderness or pain and if you
also feel unwell or have a high temperature then the symptoms may be caused by
abnormal muscle breakdown that can be life-threatening and lead to kidney problems.
Very rare: affect less than 1 user in 10,000:
• a sudden allergic reaction with shortness of breath, rash, wheezing and drop of blood
pressure
• severe liver problems
The following side-effects have also been reported:
Common: affects 1 to 10 users in 100:
• inflammation and pain in the upper airways, nose bleed
• allergic reactions
• increases in blood sugar (if you have diabetes continue careful monitoring of your blood
sugar levels)

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Atorvastatin Tablets
1.3: Product information






headache
nausea, constipation, wind, indigestion, diarrhoea
joint pain, muscle pain and back pain
changes in blood test results that report on your muscles and liver

Uncommon: affects 1 to 10 users in 1000:
• loss of appetite, vomiting, belching, abdominal pain
• weight gain
• nightmares, insomnia
• dizziness, ringing in the ears (tinnitus)
• numbness or tingling in the fingers and toes, reductions of sensation to pain or touch
• change in sense of taste
• loss of memory
• visual disturbance
• liver problems
• skin rash, itching, hives, hair loss
• neck pain, chest pain
• fatigue, feeling unwell, weakness
• fluid retention causing swelling of the extremities
• fever
• a urine test that gives a positive result for the presence of white blood cells
Rare: affects 1 to 10 users in 10,000:
• jaundice (yellowing of skin)
• sore muscle tendons that may rupture
Very rare: affects less than 1 user in 10,000:
• hearing loss
• increase in breast tissue in men
Possible side effects reported with some statins (medicines of the same type):
• Sexual difficulties
• 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 leaflet,
please tell your doctor or pharmacist.

5. HOW TO STORE ATORVASTATIN TABLETS
Keep out of the reach and sight of children.
Store in the original package in order to protect from moisture.
Store below 25⁰C.
Do not use Atorvastatin Tablets 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.
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Atorvastatin Tablets
1.3: Product information

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.

6. FURTHER INFORMATION
What Atorvastatin Tablets contains
The active substance is atorvastatin.
Each film-coated tablet contains 10 mg of atorvastatin as Atorvastatin calcium hemi-hydrate.
Each film-coated tablet contains 20 mg of atorvastatin as Atorvastatin calcium hemi-hydrate.
Each film-coated tablet contains 40 mg of atorvastatin as Atorvastatin calcium hemi-hydrate.
The other ingredients of Atorvastatin Tablets are: Starch pregelatinized, lactose monohydrate,
crospovidone, hydroxypropyl cellulose, silica colloidal anhydrous, magnesium stearate.
The film-coating of Atorvastatin Tablets contains lactose monohydrate, hypromellose,
titanium dioxide (E-171), macrogol 4000 and carnauba wax.
What Atorvastatin Tablets looks like and contents of the pack
Atorvastatin 10, 20 and 40 mg film-coated tablets are white with a round shape, embossed
“10”, “20” and “40”, respectively, on one side.
Atorvastatin Tablets are available in blister packs containing 28 film-coated tablets.
Marketing Authorisation Holder and Manufacturer
Dexcel®-Pharma Ltd. 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11
8PB, UK
Distributed by:
Kent Pharmaceuticals Ltd., Repton Road, Measham, DE 12 7DT, UK
This medicinal product is authorised in the Member States of the EEA under the
following names:
Ireland, UK
France, Germany

Atorvastatin 10 mg/20 mg/40 mg film-coated tablets
Atorvastatin Dexcel 10 mg/20 mg/40 mg film-coated tablets

This leaflet was last revised in 11/2013.

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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