Atorvastatine STADA 20 mg, filmomhulde tabletten

1. WHAT IS AND WHAT IT IS USED FOR

<Product Name> belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines.

<Product Name> 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, <Product Name> 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. BEFORE YOU TAKE

Do not take <Product Name>

• if you are hypersensitive (allergic) to <Product Name> 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.

Take special care with <Product Name>

The following are reasons why <Product Name> 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.

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.

Check with your doctor or pharmacist before taking <Product Name>

• 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 <Product Name> 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”).

Taking other medicines

There are some medicines that may change the effect of <Product Name> or their effect may be changed by <Product Name>. 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 regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol

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 <Product Name> 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.

Taking <Product Name> with food and drink

See Section 3 for instructions on how to take <Product Name>. 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 <Product Name>.

Alcohol

Avoid drinking too much alcohol while taking this medicine. See Section 2 “Take special care with <Product Name>” for details

Pregnancy and breast-feeding

Do not take <Product Name> if you are pregnant, or if you are trying to become pregnant.

Do not take <Product Name> if you are able to become pregnant unless you use reliable contraceptive measures.

Do not take <Product Name> if you are breast-feeding.

The safety of <Product Name> 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.

3. HOW TO TAKE

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

The usual starting dose of <Product Name> 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 <Product Name> is 80 mg once daily for adults and 20 mg once daily for children.

<Product Name> 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 <Product Name> 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 <Product Name> is determined by your doctor.

Please ask your doctor if you think that the effect of <Product Name> is too strong or too weak.

If you take more <Product Name> than you should

If you accidently take too many <Product Name> tablets (more than your usual daily dose), contact your doctor or nearest hospital for advice.

If you forget to take <Product Name>

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 <Product Name>

If you have any further questions on the use of this medicine or wish to stop your treatment, ask your doctor or pharmacist.

Like all medicines, <Product Name> 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 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 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.

Other possible side effects with <Product Name>:

Common side effects (affects 1 to 10 users 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 (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
• 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 (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, difficulty breathing, collapse
• hearing loss
• gynecomastia (breast enlargement in men and women).

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.

What <Product Name> contains

The active substance is atorvastatin.

<Product Name> 10 mg film-coated tablets

Each tablet contains 10 mg of atorvastatin as atorvastatin calcium.

<Product Name> 20 mg film-coated tablets

Each tablet contains 20 mg of atorvastatin as atorvastatin calcium.

<Product Name> 40 mg film-coated tablets

Each tablet contains 40 mg of atorvastatin as atorvastatin calcium.

<Product Name> film-coated tablets also contain other ingredients: Mannitol, microcrystalline cellulose, Crospovidone, sodium carbonate, Povidone, Methionine and magnesium stearate.

The coating of <Product Name> film-coated tablets contains:

Hypromellose 6cP, titanium dioxide (E171) and macrogol 6000.

What <Product Name> looks like and contents of the pack

<Product Name> 10 mg film-coated tablet

White, oval biconvex film-coated tablets with 10 on one side and A on the other side.

<Product Name> 20 mg film-coated tablet

White oval, biconvex film-coated tablets with 20 on one side and A on the other side.

<Product Name> 40 mg film-coated tablet

White oval, biconvex film-coated tablets with 40 on one side and A on the other side.

Al/Al Blister packs or bottles that consist of a plastic LDPE, white, round plastic cap with opening tear-band and a sealing ring and a canister plastic HDPE filled with silica gel desiccant, containing:

NL/H/1782/001-003/DC

Blisters of 7 or 10 tablets:

7, 10, 14, 28, 30, 50, 56, 84, 98, 100, 112, 126, 140, 168, 500

Bottles:

10 mg: 10, 28, 30, 100, 200 tablets

20 mg: 7, 10, 14, 28, 30, 90, 98, 100 tablets 40 mg: 10, 14, 28, 30, 50 ,56, 98, 100 tablets

(Not all pack-sizes may be marketed)

NL/H/1783/001-003/DC

Blisters of 7 or 10 tablets:

7, 10 ,14, 28, 30, 50, 56, 84, 100, 112, 126, 140, 168, 500

Bottles:

10 mg: 10, 28, 30, 100, 200 tablets

20 mg: 7, 10, 14, 28, 30, 100 tablets

40 mg: 10, 14, 28, 30, 50 ,56, 100 tablets

(Not all pack-sizes may be marketed)

NL/H/1784/001-003/DC

Blisters of 7 or 10 tablets:

7, 10 ,14, 28, 30, 50, 56, 84, 90, 98, 100, 112, 126, 140, 168, 500

Bottles:

10 mg: 10, 28, 30, 100, 200 tablets

20 mg: 7, 10, 14, 28, 30, 90, 98, 100 tablets 40 mg: 10, 14, 28, 30, 50 ,56, 98, 100 tablets

(Not all pack-sizes may be marketed)

Marketing Authorisation Holder and Manufacturer

STADA Arzneimittel AG

Stadastraße 2-18

D-61118 Bad Vilbel

Duitsland

Manufacturers:

STADA Arzneimittel AG

Stadastraße 2-18

D-61118 Bad Vilbel

Duitsland

Stada Arzneimittel GmbH

Muthgasse 36/2

1190 Wenen

Oostenrijk

Eurogenerocs N.V. Heizel Esplanada B22 1020 brussel

Belgie

PharmaCoDane ApS Marielundvej 46A 2730 herlev Denemarken

STADA Production Ireland

Waterford Road Clonmel

Co. Tipperary

Ierland

Clonmel healthcare ltd

Waterford Road, Clonmel,

Co. Tipperary

Ierland

Aliud Pharma GmbH

Gottlieb-Daimler-Strasse 19

89150 Laichingen

Duitsland

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

[To be completed nationally]

This leaflet was last approved in {MM/YYYY}. [To be completed nationally]