Package leaflet: Information for the patient

Atorvastatin 10 mg Film-coated Tablets

Atorvastatin 20 mg Film-coated Tablets
Atorvastatin 40 mg Film-coated Tablets
Atorvastatin 80 mg Film-coated Tablets

Atorvastatin

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
- 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 only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Atorvastatin is and what it is used for
2. What you need to know before you take Atorvastatin
3. How to take Atorvastatin
4. Possible side effects
5. How to store Atorvastatin
6. Contents of the pack and other information.

1. What Atorvastatin is and what it is used for

Atorvastatin belongs to a group of medicines known as statins, which are lipid (fat) regulating
medicines.

Atorvastatin 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, Atorvastatin 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.

2. What you need to know before you take Atorvastatin

Do not take Atorvastatin:

 if you are allergic to Atorvastatin, to any similar medicines used to lower blood lipids or
any of the other ingredients of this medicine (listed in section 6).
 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 use the combination of glecaprevir/pibrentasvir in the treatment of hepatitis C
 if you are a woman able to have children and not using reliable contraception.
 if you are pregnant, or trying to become pregnant.

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  if you are breast-feeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Atorvastatin
 If you are taking or have taken in the last 7 days a medicine called fusidic acid, (a medicine
for bacterial infection) orally or by injection. The combination of fusidic acid and
Atorvastatin can lead to serious muscle problems (rhabdomyolysis).

The following are reasons why Atorvastatin may not be suitable for you.
 if you have had a previous stroke with bleeding into the brain, or have small pockets of
fluid 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 ‘-fibrate’ medicines)
 if you regularly drink a large amount of alcohol
 if you have a history of liver disease
 if you are older than 70 years.

Check with your doctor or pharmacist before taking Atorvastatin

 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 Atorvastatin 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 “Other medicines and Atorvastatin”).

Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional
tests and medicines may be needed to diagnose and treat this.

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.

Other medicines and Atorvastatin

There are some medicines that may change the effect of Atorvastatin or their effect may be
changed by Atorvastatin. 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 “Possible
side effects”:

 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 regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol
 Some calcium channel blockers used for angina or high blood pressure, e.g. amlodipine,

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 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, the combination of tipranavir/ritonavir etc.
 Some medicines used in the treatment of hepatitis C e.g. telaprevir, boceprevir and the
combination of elbasvir/grazoprevir
 Other medicines known to interact with Atorvastatin 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), colchicines (used to treat gout) and antacids (indigestion
products containing aluminium or magnesium)
 Medicines obtained without a prescription: St John’s Wort

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

 If you need to take oral fusidic acid to treat a bacterial infection you will need to
temporarily stop using this medicine. Your doctor will tell you when it is safe to
restart Atorvastatin. Taking Atorvastatin with fusidic acid may rarely lead to
muscle weakness, tenderness or pain (rhabdomyolysis). See more information
regarding rhabdomyolysis in section 4.

Atorvastatin with food, drink and alcohol

See section 3 for instructions on how to take Atorvastatin.

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.

Alcohol
Avoid drinking too much alcohol while taking this medicine. See above in this section “Warnings
and precautions” for details.

Pregnancy and breast-feeding

Do not take Atorvastatin if you are pregnant, or if you are trying to become pregnant.
Do not take Atorvastatin if you are able to become pregnant unless you use reliable contraceptive
measures.
Do not take Atorvastatin if you are breast-feeding.
The safety of Atorvastatin 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.

Atorvastatin contains lactose

If you have been told by your doctor that you have intolerance to some sugars, contact your
doctor before taking this medicine

Atorvastatin contains less than 1 mmol sodium (23 mg) per tablet, i.e. essentially ‘sodium- free’.

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3. How to take Atorvastatin

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.

Before starting treatment, your doctor will place you on a low-cholesterol diet, which you should
maintain also during therapy with Atorvastatin.

The recommended starting dose of Atorvastatin 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 is 80 mg once daily for adults and 20 mg once daily for children.

Atorvastatin 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.

The duration of treatment with Atorvastatin is determined by your doctor.

Please ask your doctor if you think that the effect of Atorvastatin is too strong or too weak.

If you take more Atorvastatin than you should

If you accidently take too many Atorvastatin tablets (more than your usual daily dose), contact
your doctor or nearest hospital for advice

If you forget to take Atorvastatin

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

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, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects or symptoms, stop taking your
tablets and tell your doctor immediately or go to the nearest hospital accident and
emergency department.

Rare (may affect 1 to 10 patients in 10,000)

 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, pain or rupture, red-brown discolouration of urine 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

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 away, even after you have stopped taking atorvastatin it can be life-threatening and lead to
kidney problems.

Very rare (may affect up to 1 in 10,000 patients)

 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.
 lupus-like disease syndrome (including rash, joint disorders and effects on blood
cells)

Other possible side effects with Atorvastatin

Common side effects (may affect 1 to 10 patients in 100) include

 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

Uncommon side effects (may affect 1 to 10 patients in 1,000) 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
 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)
 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 (may affect 1 to 10 patients 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 (may affect up to 1 in 10,000 patients) include

 an allergic reaction - symptoms may include 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).

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Not known (frequency cannot be estimated from the available data)
• muscle weakness that is constant

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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play
or Apple App store. By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Atorvastatin

Keep this medicine out of the sight and reach of children.

Store below 25ºC. Do not use this medicine after the expiry date which is stated on the carton and
blister after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Atorvastatin 10 mg, 20 mg, 40 mg, 80 mg film-coated tablets contain:

The active substance in Atorvastatin film-coated tablets is atorvastatin as atorvastatin calcium
trihydrate. Each film-coated tablet contains 10 mg, 20 mg, 40 mg or 80 mg atorvastatin.

The other ingredients are:

Tablet core: Microcrystalline cellulose (E460), Lactose monohydrate, Colloidal anhydrous silica,
Croscarmellose sodium (E468), Sodium hydrogen carbonate, Sodium carbonate, anhydrous,
Hyproxypropylcellulose (E463), Magnesium stearate (E470b), Butylhydroxyanisole,
Butylhydroxytoluene

Film coating: Opadry White YS-1-7040 (Hypromellose (E464), macrogol 8000, titanium dioxide
(E171), talc (E553b)

What Atorvastatin 10 mg, 20 mg, 40 mg, 80 mg film-coated tablets look like and contents of the
pack

Atorvastatin 10 mg:
White to off white, film-coated oval tablets about 6.1 mm wide and about 8.6 mm long, debossed
with ‘A30’ on one side and plain on other side

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Atorvastatin 20 mg:
White to off white, film-coated oval tablets about 6.6 mm wide and about 12.1 mm long,
debossed with ‘A31’ on one side and plain on other side

Atorvastatin 40mg:
White to off white, film-coated oval tablets about 8.1 mm wide and about 16.9 mm long,
debossed with ‘A32’ on one side and plain on other side

Atorvastatin 80mg:
White to off white, film-coated oval tablets about 10.8 mm wide and about 21.7 mm long,
debossed with ‘A33’ on one side and plain on other side

Atorvastatin is supplied in the pack of:

Cold form blister laminate (structure: oriented polyamide/ aluminium foil/ PVC) with the backing
of hard tempered, aluminium foil coated with heat seal lacquer on inner side

Packs of 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 film-coated tablets each.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ranbaxy (UK) Limited

5th floor, Hyde Park, Hayes 3
11 Millington Road
Hayes, UB3 4AZ
United Kingdom

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Terapia S.A.
124 Fabricii Street,
400 632 Cluj Napoca,
Romania

This medicinal product is authorised in the Member States of the EEA under the following
names:

Bulgaria: ATORVISTAT K 10/20 mg филмирани таблетки

Finland: Atorvastatin Orion 10/20/40/80 mg tabletti, kalvopäällysteinen
France: ATORVASTATINE SUN 10/20/40/80 mg, comprimé pelliculé
Ireland: Atorvastatin 10/20/40/80 mg film-coated tablets
Latvia: Atorvastatin SUN 10/20/40/80mg apvalkotās tabletes
Lithuania: Atorvastatin SUN 10/20/40/80 mg plėvele dengtos tabletės

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Poland: Storvas CRT
Romania: Atorvastatin Terapia 10/20/40/80 mg comprimate filmate
Spain: ATORVASTATINA SUN 10-20-40-80 mg COMPRIMIDOS
RECUBIERTOS CON PELÍCULA EFG
United Kingdom: Atorvastatin 10/20/40/80 mg Film-coated Tablets

This leaflet was last revised in February 2020.

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