Atorvastatin Umedica 80 mg film-coated tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to atorvastatin 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 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
• if you use the combination of glecaprevir/pibrentasvir in the treatment of hepatitis C

Talk to your doctor, pharmacist or nurse before taking Atorvastatin Umedica:

• if you have severe respiratory failure
• 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 Umedica can lead to serious muscle problems (rhabdomyolysis)
• 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
• if you have or have had myasthenia (a disease with general muscle weakness including in some cases muscles used when breathing), or ocular myasthenia (a disease causing eye muscle weakness) as statins may sometimes aggravate the condition or lead to the occurrence of myasthenia (see section 4).

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

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.

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 Atorvastatin Umedica or their effect may be changed by Atorvastatin Umedica. 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
• Letermovir, a medicine that helps stop you from getting ill from cytomegalovirus
• 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, ledipasvir/sofosbuvir
• Other medicines known to interact with Atorvastatin Umedica 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), and antacids (indigestion products containing aluminium or magnesium)
• 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 Umedica. Taking Atorvastatin Umedica with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteria present in the blood).

See section 3 for instructions on how to take Atorvastatin Umedica. 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 Umedica.

Alcohol

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

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

Do not take Atorvastatin Umedica if you are able to become pregnant unless you use reliable contraceptive measures. Do not take Atorvastatin Umedica if you are breast-feeding.

The safety of Atorvastatin Umedica during pregnancy and breast-feeding has not yet been proven. Ask your doctor or pharmacist for advice before taking any medicine.

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.

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

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free’

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

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.

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, pain or rupture or 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 (rhabdomyolysis). 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.
• Lupus-like disease syndrome (including rash, joint disorders and effects on blood cells).

Common: may affect up to 1 in 10 people

• inflammation of the nasal passages, pain in the throat, nose bleeding
• 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: may affect up to 1 in 100 people

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

• visual disturbance
• unexpected bleeding or bruising
• cholestasis (yellowing of the skin and whites of the eyes)
• tendon injury
• rash that may occur on the skin or sores in the mouth (lichenoid drug reaction)
• purple skin lesions (signs of blood vessel inflammation, vasculitis)

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

• 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:

• muscle weakness that is constant
• Myasthenia gravis (a disease causing general muscle weakness including in some cases muscles used when breathing)
• ocular myasthenia (a disease causing eye muscle weakness).

Talk to your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision or drooping of your eyelids, difficulty swallowing, or shortness of breath.

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 you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme: 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.

• The active substance is atorvastatin.

Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin calcium trihydrate).

Each film-coated tablet contains 20 mg atorvastatin (as atorvastatin calcium trihydrate).

Each film-coated tablet contains 40 mg atorvastatin (as atorvastatin calcium trihydrate).

Each film-coated tablet contains 80 mg atorvastatin (as atorvastatin calcium trihydrate).

• The other ingredients are:

Cellulose, microcrystalline, lactose monohydrate, croscarmellose sodium, precipitated calcium carbonate, hydroxylpropyl cellulose (E464), polysorbate 80 and magnesium stearate (E572).

The coating of Atorvastatin Umedica film-coated tablets contain hypromellose 2910 (E464), macrogol 8000 (E1521), titanium dioxide (E171), and talc (E553b).

Atorvastatin Umedica 10 mg film-coated tablets are white to off white, about 9.0 mm X 4.00 mm oval shaped debossed with ‘ATO’ on one side and ‘10’ on other side.

Atorvastatin Umedica 20 mg film-coated tablets are white to off white, about 11.80 mm X 5.50 mm oval shaped debossed with ‘ATO’ on one side and ‘20’ on other side.

Atorvastatin Umedica 40 mg film-coated tablets are white to off white, about 15.00 mm X 6.50 mm oval shaped debossed with ‘ATO’ on one side and ‘40’ on other side.

Atorvastatin Umedica 80 mg film-coated tablets are white to off white, about 19.20 mm X 9.00 mm oval shaped debossed with ‘ATO’ on one side and ‘80’ on other side.

The blisters consist of an OPA/Al/PVC cold forming base foil and aluminium lid.

Atorvastatin Umedica film-coated tablets are available in blister packs containing 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, and 100, 200 and 500 film-coated tablets.

Not all pack sizes may be marketed.

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