Atorvastatin 4mg/ml Oral Suspension

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

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

• 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 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 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”). 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 Atorvastatin

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 or their effect may be changed by Atorvastatin. 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 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. Taking Atorvastatin 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. 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.

Alcohol

Avoid drinking too much alcohol while taking this medicine. You should not drink more than 14 units of alcohol a week. See section 2 “Warnings and precautions” for details.

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

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

Do not take Atorvastatin if you are breast-feeding.

The safety of Atorvastatin 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.

Atorvastatin Oral Suspension contains methyl, ethyl and propyl parahydroxybenzoate, and benzyl alcohol.

• Methyl, ethyl and propyl parahydroxybenzoate. May cause allergic reactions (possibly delayed).
• This medicine contains 0.39 µg benzyl alcohol (E1519) in each 1 ml dose. Benzyl alcohol may cause allergic reactions. Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding or if you have a liver of kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
• This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.

The oral suspension must be shaken well before use

• Open the bottle: press the cap and turn it anticlockwise (figure 1)
• Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3). Ensure it is well fixed.
• Take the syringe and put it in the adaptor opening (figure 4). Turn the bottle upside down (figure 5).
• Fill the syringe with a small amount of suspension by pulling the piston down (figure 5A), then push the piston upward in order to remove any possible bubble (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure 5C).
• Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).
• Close the bottle with the plastic screw cap.
• Empty the contents of the syringe into your mouth (figure 7).
• After dosing, wash the syringe with water only (figure 8).

The duration of treatment with Atorvastatin Oral suspension 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 accidently take too many Atorvastatin Oral Suspension (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.

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, 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 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 substance(s) is atorvastatin. Each ml of oral suspension contains 4 mg of atorvastatin (as 4.14 mg atorvastatin calcium trihydrate)
• The other ingredients are carmellose sodium (E466), magnesium aluminium silicate, methyl parahydroxybenzoate (E218), ethyl parahydroxybenzoate (E214), propyl parahydroxybenzoate (E216), sucralose, acesulfame potassium (E950), orange flavour (501071 AP0551) (containing flavouring preparation, flavouring substances, natural flavouring substances, maize maltodextrin, Alpha-tocopherol (E307), moisture and benzyl alcohol) and purified water.

Atorvastatin Oral Suspension is a white to brownish white suspension.

Atorvastatin 4mg/ml Oral Suspension is packaged in amber glass bottle, with a polypropylene white child resistant closure tamper evident expanded polyethylene (TEEPE), containing 150ml of liquid product.

The package contains a 5ml oral syringe with a polypropylene body, purple HDPE plunger and graduations printed at every 0.25 ml, with a low density polyethylene bottle adaptor.

The Marketing Authorisation Holder is:

The Manufacturer is: