How to take it

atorvastatin 4. Possible side effects 5. How to store atorvastatin 6. Contents of the pack and other information

you need. Your doctor will adapt the dose at intervals of 4 weeks or more. The maximum dose of atorvastatin is 80 mg once a day. Atorvastatin 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 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 accidentally 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.

mouth, tongue or throat, difficulty breathing, collapse

• hearing loss
• gynaecomastia (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. Reporting of side effects

Possible side effects

If you get any side effects, talk to your doctor Like all medicines, this medicine can cause side or pharmacist. This includes any possible side effects not listed in this leaflet. You can also effects, although not everybody gets them. report side effects directly via the Yellow Card If you experience any of the following Scheme at: www.mhra.gov.uk/yellowcard or serious side effects or symptoms, stop search the MHRA Yellow Card in the Google taking your tablets and tell your doctor Play or Apple App Store. By reporting side immediately or go to the nearest hospital effects you can help provide more information accident and emergency department. on the safety of this medicine. Rare (may affect up to 1 in 1,000 people):

How to store it

ATORVASTATIN

• Serious allergic reaction which causes swelling of the face, tongue and throat that Keep this medicine out of the sight and reach can cause great difficulty in breathing. of children.
• Serious illness with severe peeling and swelling of the skin, blistering of the skin, Do not use this medicine after the expiry date mouth, eyes, genitals and fever. Skin rash which is stated on the outer packaging after with pink-red blotches especially on palms "EXP". The expiry date refers to the last day of of hands or soles of feet which may blister. that month.
• Muscle weakness, tenderness, pain, rupture This medicine does not require any special or red-brown discolouration of urine and storage conditions. particularly, if at the same time, you feel unwell or have a high temperature it may be Do not use this medicine if you notice visible signs of deterioration. caused by an abnormal muscle breakdown Do not throw away any medicines via (rhabdomyolysis). The abnormal muscle wastewater or household waste. Ask your breakdown does not always go away, even pharmacist how to throw away medicines after you have stopped taking atorvastatin, you no longer use. These measures will help and it can be life-threatening and lead to protect the environment. kidney problems. Very rare (may affect up to 1 in 10,000 people):
• Lupus-like disease syndrome (including rash, joint disorders and effects on blood cells).
• 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 atorvastatin Common (may affect up to 1 in 10 people):
• 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, joint swelling, muscle pain, muscle spasms, pain in arms and legs 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,

Contents of the pack and other information

What atorvastatin contains The active substance is atorvastatin. Each 10 mg film-coated tablet contains 10 mg atorvastatin (as atorvastatin calcium trihydrate). Each 20 mg film-coated tablet contains 20 mg atorvastatin (as atorvastatin calcium trihydrate). Each 40 mg film-coated tablet contains 40 mg atorvastatin (as atorvastatin calcium trihydrate). Each 80 mg film-coated tablet contains 80 mg atorvastatin (as atorvastatin calcium trihydrate). The other ingredients are: Core: calcium carbonate, cellulose, microcrystalline (E 460), lactose monohydrate, low-substituted hydroxypropyl cellulose, povidone K12, silica, colloidal anhydrous, magnesium stearate (E 572). Coating: hypromellose (E 464), macrogol 6000, titanium dioxide (E 171), talc, iron oxide yellow (E 172), lactose monohydrate. What atorvastatin looks like and contents of the pack Atorvastatin 10 mg film-coated tablets are white to off white, film-coated, round, biconvex tablets. Diameter of the tablet is approx. 6mm. Atorvastatin 20 mg film-coated tablets are yellowish, film-coated, round, biconvex tablets. Diameter of the tablet is approx. 8mm. Atorvastatin 40 mg film-coated tablets are orange-yellow to yellow-orange, film-coated, round, biconvex tablets. Diameter of the tablet is approx. 10mm. Atorvastatin 80 mg film-coated tablets are yellow-orange film-coated round, biconvex tablets. Diameter of the tablet is approx. 12mm. Pack sizes: 10 mg: 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 or 200 film-coated tablets 20 mg: 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 or 200 film-coated tablets 40 mg: 7, 10, 14, 28, 30, 50, 56, 60, 90, 98, 100 or 200 film-coated tablets 80 mg: 7, 10, 14, 28, 30, 50, 56, 60, 90, 98, 100 or 200 film-coated tablets Not all pack sizes may be marketed. The Marketing Authorisation Holder is Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom The manufacturer is Zentiva k.s, U Kabelovny 130, Dolní Měcholupy, 10237 Prague 10, Czech Republic This leaflet was last updated in September 2024 ZV/723 56