Atova 20 Tab

Before you take Atova^®
Do not take Atova^®

• if you are hypersensitive (allergic) to Atova^® or to any similar medicines used to lower blood lipids or to any of the other ingredients of the medicine
• 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.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Atova^®.
The following are reasons why Atova^® 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 Atova^®
− 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 Atova^®treatment to predict your risk of muscle related side effects. The riskof muscle related side effects e.g rhabdomyolysis is known to increase when certain medicines are taken at the same time.
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 Atova^®
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. There are some medicines that may change the effect of Atova^® or their effect may be changed by Atova^®.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:

• 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 Atova^® 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)

Please tell your doctor or pharmacist ifyou are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Atova^® with food and drink
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 Atova^®.
Alcohol
Avoid drinking too much alcohol while taking this medicine.

Pregnancy and breast-feeding
Do not take Atova^® if you are pregnant, or if you are trying to become pregnant.
Do not take Atova^® if you are able to become pregnant unless you use reliable contraceptive measures.
Do not take Atova^® if you are breast-feeding.
The safety of Atova^®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 operatemachines. 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 Atova^®
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Atova^®
Before starting treatment, your doctor will place you on a low-cholesterol diet, which you should maintain also during therapy withAtova^®.

The usual starting dose of Atova^®is 10 mg once a day in adults and children aged 10 years or older. Thismay 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 weeksor more. The maximum dose of Atova^® is 80 mg once daily for adults and 20 mg once daily for children.

Atova^®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 this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The duration of treatment with Atova^® is determined by your doctor.
Please ask your doctor if you think that the effect of Atova^® is too strong or too weak.

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

If you forget to take Atova^®
If you forget to take a dose, just take your next scheduled dose at thecorrect time. Do not take a double dose to make up for a forgotten dose.

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

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Ifyou 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

• 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 sametime, you feel unwell or have a high temperature it may be caused by anabnormal muscle breakdown. The abnormal muscle breakdown does not always go away, even after you have stopped taking atorvastatin, and it can be life-threatening and lead to kidney problems.

Very rare:
may affect up to 1 in 10,000 people
− 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 Atova^®:
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, diarrhea
• 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 and women).

Side effects of unknown frequency:

• 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.

How to store Atova^®
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the container and outer packaging. The expiry date refers to the last day ofthat 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 to protect the environment.