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Package leaflet: Information for the user

Atorvastatin Krka 30 mg film-coated tablets

Atorvastatin Krka 60 mg film-coated tablets

Atorvastatin Krka 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 Krka is and what it is used for

2. What you need to know before you take Atorvastatin Krka

3. How to take Atorvastatin Krka

4. Possible side effects

6. Contents of the pack and other information

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

Atorvastatin Krka 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 Krka 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.

Do not take Atorvastatin Krka

Warnings and precautions

Talk to your doctor or pharmacist before taking Atorvastatin Krka.The following are reasons why Atorvastatin Krka 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. 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.

• 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

• 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 Krka can lead to serious muscle problems (rhabdomyolysis).

Check with your doctor or pharmacist before taking Atorvastatin Krka

If any of these apply to you, your doctor will need to carry out a blood test before and possibly during your Atorvastatin Krka 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 Krka”).

Other medicines and Atorvastatin Krka

There are some medicines that may change the effect of Atorvastatin Krka or their effect may be changed by Atorvastatin Krka. 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, the combination of tipranavir/ritonavir etc.

• Some medicines used in the treatment of hepatitis C e.g. telaprevir

• Other medicines known to interact with Atorvastatin Krka 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), colchicine (used to treat gout), antacids (indigestion products containing aluminium or magnesium) and boceprevir (used to treat liver disease such as hepatitis C)

• Medicines obtained without a prescription: St John’s Wort

• 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 Krka. Taking Atorvastatin Krka with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.

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

Taking Atorvastatin Krka with food, drink and alcohol

See Section 3 for instructions on how to take Atorvastatin Krka. 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 Krka.

Alcohol

Avoid drinking too much alcohol while taking this medicine. See Section 2 “Warnings and precautions” for details

Pregnancy and breast-feeding

Do not take Atorvastatin Krka if you are pregnant, or if you are trying to become pregnant.

Do not take Atorvastatin Krka if you are able to become pregnant unless you use reliable contraceptive measures.

Do not take Atorvastatin Krka if you are breast-feeding.

The safety of Atorvastatin Krka during pregnancy and breast-feeding has not yet been proven. Ask your doctor or pharmacist for advice before taking this 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 Krka contains lactose

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

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 Krka.

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 Krka is 80 mg once daily for adults and 20 mg once daily for children.

Atorvastatin Krka 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.

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

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

If you take more Atorvastatin Krka than you should

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

If you forget to take Atorvastatin Krka

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 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, stop taking your tablets and tell your doctor immediately or go to the nearest hospital accident and emergency department.

Rare: may affect up to 1 in 1,000 people:

Very rare: may affect up to 1 in 10,000 people:

Other possible side effects with Atorvastatin Krka:

Common side effects (may affect up to 1 in 10 people) 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 up to 1 in 100 people) 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 up to 1 in 1,000 people) 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 people) 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)

Not known: frequency cannot be estimated from the available data

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Atorvastatin Krka

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

Store in the original package in order to protect from moisture.

This medicinal product does not require any special temperature storage conditions.

Do not use this medicine after the expiry date which is stated on the carton box 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 Krka contains

What Atorvastatin Krka looks like and contents of the pack

30 mg film-coated tablets are white to almost white, round, slightly convex, film-coated tablets, bevel-edged, tablet diameter 9 mm.

60 mg film-coated tablets are white to almost white, oval, biconvex, film-coated tablets, tablet dimensions 16 mm x 8.5 mm.

80 mg film-coated tablets are white to almost white, capsule shape, biconvex, film-coated tablets, tablet dimensions 18 mm x 9 mm.

Boxes of 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 and 100 film-coated tablets in blisters are available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

[To be completed nationally]

Manufacturer

[To be completed nationally]

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

<{Name of the Member State}> <{Name of the medicinal product}>

<{Name of the Member State}> <{Name of the medicinal product}>

This leaflet was last revised in 29 September 2016