Ezetimibe/Atorvastatin 10 mg/80 mg Film-coated Tablets

• 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.

1. What Ezetimibe/Atorvastatin Tablets are and what they are used for
2. What you need to know before you take Ezetimibe/Atorvastatin Tablets
3. How to take Ezetimibe/Atorvastatin Tablets
4. Possible side effects
5. How to store Ezetimibe/Atorvastatin Tablets
6. Contents of the pack and other information

• are allergic to atorvastatin, ezetimibe or any of the other ingredients of this medicine (listed in section 6)
• have or have ever had a disease that affects the liver
• have had any unexplained abnormal blood tests for liver function
• are a woman able to have children and are not using reliable contraception
• are pregnant, trying to become pregnant or are breast-feeding
• use the combination of glecaprevir/pibrentasvir in the treatment of hepatitis C

Talk to your doctor or pharmacist before taking Ezetimibe/Atorvastatin Tablets if you:

• have had a previous stroke with bleeding into the brain, or have small pockets of fluid in the brain from previous strokes
• have kidney problems
• have an under-active thyroid gland (hypothyroidism)
• have had repeated or unexplained muscle aches or pains, a personal history or family history of muscle problems
• have had previous muscular problems during treatment with other lipid-lowering medicines (e.g. other "statin" or "fibrate" medicines)
• 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 Ezetimibe/Atorvastatin containing medicines can lead to serious muscle problems (rhabdomyolysis)
• regularly drink a large amount of alcohol
• have a history of liver disease
• are older than 70 years
• 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).

Contact your doctor promptly if you experience unexplained muscle pain, tenderness, or weakness while taking Ezetimibe/Atorvastatin Tablets. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage. Atorvastatin is known to cause muscle problems, and cases of muscle problems have also been reported with ezetimibe.

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.

Check with your doctor or pharmacist before taking Ezetimibe/Atorvastatin Tablets

• if you have severe respiratory failure

If any of these apply to you (or you are not sure), talk to your doctor or pharmacist before taking Ezetimibe/Atorvastatin Tablets because your doctor will need to carry out a blood test before and possible during your treatment to predict your risk of muscle-related side effects. The risk of muscle-related side effects, e.g. rhabdomyolysis (breakdown of damaged skeletal muscle), is known to increase when certain medicines are taken at the same time (see section 2 "Other medicines and Ezetimibe/Atorvastatin Tablets").

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 about all medical conditions including allergies.

Ezetimibe/Atorvastatin Tablets are not recommended for children and adolescents.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without prescription.

Fibrates (medicines for lowering cholesterol) should be avoided while taking Ezetimibe/Atorvastatin Tablets.

There are some medicines that may change the effect of Ezetimibe/Atorvastatin Tablets or the effect of other medicines may be changed by Ezetimibe/Atorvastatin Tablets (see section 3). 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:

• ciclosporin (a medicine often used in organ transplant patients)
• erythromycin, clarithromycin, telithromycin, fusidic acid, rifampicin (medicines for bacterial infections)
• ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (medicines for fungal infections)
• gemfibrozil, other fibrates, nicotinic acid, derivatives, colestipol, colestyramine (medicines for regulating lipid levels)
• some calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem
• digoxin, verapamil, amiodarone (medicines to regulate your heart rhythm)
• 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. (medicines for AIDS)
• some medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir and the combination of elbasvir, grazoprevir, ledipasvir/sofosbuvir
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteria present in the blood)
• 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 Ezetimibe/Atorvastatin Tablets. Taking Ezetimibe/Atorvastatin Tablets with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.

Other medicines known to interact with Ezetimibe/Atorvastatin Tablets

• oral contraceptives (medicines for preventing pregnancy)
• stiripentol (an anticonvulsant medicine for epilepsy)
• cimetidine (a medicine used for heartburn andpeptic ulcers)
• phenazone (a painkiller)
• antacids (indigestion products containing aluminium or magnesium)
• warfarin, phenprocoumon, acenocoumarol or fluindione (medicines to prevent blood clots)
• colchicine (used to treat gout)
• St John's Wort (a medicine to treat depression)

See section 3 for instructions on how to take Ezetimibe/Atorvastatin Tablets. 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 Ezetimibe/Atorvastatin Tablets.

Alcohol

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

Do not take Ezetimibe/Atorvastatin Tablets if you are pregnant, are trying to become pregnant or think you may be pregnant.

Do not take Ezetimibe/Atorvastatin Tablets if you are able to become pregnant unless you use reliable contraceptive measures. If you get pregnant while taking Ezetimibe/Atorvastatin Tablets, stop taking it immediately and tell your doctor.

Do not take Ezetimibe/Atorvastatin Tablets if you are breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Ezetimibe/Atorvastatin Tablets are not expected to interfere with your ability to drive or to use machinery. However, it should be taken into account that some people may get dizzy after taking Ezetimibe/Atorvastatin Tablets. If you feel dizzy after taking this medicine do not drive or use machines.

Ezetimibe/Atorvastatin Tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Ezetimibe/Atorvastatin Tablets contain less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

Please contact your doctor or pharmacist.

Do not take a double dose to make up for a forgotten tablet. Just take your normal dose at the usual time the next day.

• 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, rupture or red-brown discoloration of urine and particularly, if at the same time, you feel unwell or have a high temperature if may be caused by an abnormal muscle breakdown which can be life-threatening and lead to kidney problems
• lupus-like disease syndrome (including rash, joint disorders and effects on blood cells)

You should consult your doctor as soon as possible if you experience problems with unexpected or unusual bleeding or bruising, because this may be suggestive of a liver complaint.

Common (may affect up to 1 in 10 people):

• diarrhoea,
• muscle aches

Uncommon (may affect up to 1 in 100 people):

• the flu,
• depression; trouble sleeping; sleep disorder,
• dizziness; headache; tingling sensation,
• slow heartbeat,
• hot flush,
• shortness of breath,
• abdominal pain; abdominal bloating; constipation; indigestion; flatulence; frequent bowel movements; inflammation of the stomach; nausea; stomach discomfort; upset stomach,
• acne; hives,
• joint pain; back pain; leg cramps; muscle fatigue, spasms, or weakness; pain in arms and legs,
• unusual weakness; feeling tired or unwell; swelling, especially in the ankles (oedema),
• elevations in some laboratory blood tests of liver or muscle (CK) function,
• weight gain

Rare (may affect up to 1 in 1,000 people)

• rash that may occur on the skin or sores in the mouth (lichenoid drug reaction)
• purple skin lesions (signs of blood vessel inflammation, vasculitis)

Not known (frequency cannot be estimated from the available data):

• 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.

Additionally, the following side effects have been reported in people taking statin with ezetimibe, or ezetimibe or atorvastatin tablets (medicines used to lower cholesterol):

• allergic reactions including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing (which requires treatment immediately),
• raised red rash, sometimes with target-shaped lesions,
• liver problems,
• cough,
• heartburn,
• decreased appetite; loss of appetite,
• high blood pressure,
• skin rash and itching; allergic reactions including rash and hives,
• tendon injury,
• gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting),
• inflammation of the pancreas often with severe abdominal pain,
• reduction in blood cell counts, which may cause bruising/bleeding (thrombocytopenia),
• inflammation of the nasal passages; nose bleed,
• neck pain; pain; chest pain; pain in the throat,
• increases and decreases in blood sugar levels (if you have diabetes, you should continue careful monitoring of your blood sugar levels),
• having nightmares,
• numbness or tingling in the fingers and toes,
• reduction of sensation to pain or touch,
• change in sense of taste; dry mouth,
• loss of memory,
• ringing in the ears and/or head; hearing loss,
• vomiting,
• belching,
• hair loss,
• raised temperature,
• urine tests that are positive for white blood cells,
• blurred vision; visual disturbances,
• gynaecomastia (breast enlargement in men).

Possible side effects reported with some statins:

• 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,
• muscle pain, tenderness, or weakness that is constant and particularly if, at the same time, you feel unwell or have a high temperature that may not go away after stopping Ezetimibe/Atorvastatin Tablets (frequency not known).

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 Yellow Card Scheme at: 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 substances are ezetimibe and atorvastatin. Each tablet contains 10 mg of ezetimibe and 10 mg, 20 mg, 40 mg or 80 mg atorvastatin (as atorvastatin calcium trihydrate).

The other ingredients are: Lactose Monohydrate, Cellulose, Microcrystalline, Croscarmellose sodium, Iron Oxide Red (E172), Sodium Laurilsulfate, Povidone K30, Magnesium Stearate, Calcium Carbonate, Polysorbate 80, Opadry White containing Hypromellose 2910 (E464), Titanium Dioxide (E171), Talc (E553b) and Propylene Glycol (E1520).

Ezetimibe/Atorvastatin Tablets are white and light pink oval-shaped, biconvex film-coated tablets, debossed with "10", "20", "40" or "80" on one side and plain on the other side.

Packs of 30 film-coated tablets in cold formed blister (OPA/Alu/PVC-Alu).