ATORVASTATIN ADAIR 10 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Atorvastatin Adair 10 mg film-coated tablets EFG

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as 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.

Contents of the pack

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

1. What is Atorvastatin Adair and what is it used for

Atorvastatin Adair belongs to a group of medicines known as statins, which are medicines that regulate lipids (fats).

Atorvastatin Adair is used to reduce lipids such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes on their own have not worked. If you are at high risk of heart disease, Atorvastatin Adair can also be used to reduce this risk even if your cholesterol levels are normal. During treatment, you should follow a standard low-cholesterol diet.

2. What you need to know before you take Atorvastatin Adair

Do not take Atorvastatin Adair

• If you are allergic to atorvastatin or to any other similar medicine used to lower blood lipids or to any of the other ingredients of this medicine (listed in section 6).
• If you have or have had any liver disease.
• If you have or have had unexplained abnormal results in blood tests for liver function.
• If you are a woman of childbearing age and do not use adequate contraceptive measures.
• If you are pregnant or trying to become pregnant.
• If you are breast-feeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Atorvastatin Adair:

• if you have severe respiratory insufficiency.
• If you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Atorvastatin Adair can cause serious muscle problems (rhabdomyolysis).
• if you have had a previous stroke with bleeding in the brain, or have small fluid-filled sacs in the brain due to previous strokes.
• if you have kidney problems.
• if you have an underactive thyroid gland (hypothyroidism).
• if you have repeated or unexplained muscle pain, personal or family history of muscle problems.
• if you have had muscle problems before while taking other medicines to lower lipids (e.g. with another statin or fibrates).
• if you regularly drink large amounts of alcohol.
• if you have a history of liver problems.
• if you are over 70 years old.

In any of these cases, your doctor may indicate that you should have blood tests before and possibly during treatment with Atorvastatin Adair to predict the risk of muscle-related side effects. It is known that the risk of muscle-related side effects (e.g. rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 "Other medicines and Atorvastatin Adair").

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Tests and additional medication may be necessary to diagnose and treat this problem.

While taking this medicine, your doctor will check if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure.

Other medicines and Atorvastatin Adair

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. There are some medicines that can affect the proper functioning of Atorvastatin Adair or the effects of these medicines may be altered by Atorvastatin Adair. This type of interaction can decrease the effect of one or both medicines. Alternatively, this combined use can increase the risk or severity of side effects, including important muscle damage, known as rhabdomyolysis described in Section 4:

• Medicines used to modify the functioning of your immune system, e.g. ciclosporin.
• Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medicines to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol.
• Certain calcium channel blockers used to treat angina or high blood pressure, e.g. amlodipine, diltiazem; medicines to regulate your heart rhythm, e.g. digoxin, verapamil, amiodarone.
• Medicines used to treat AIDS, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Certain medicines used to treat hepatitis C, such as telaprevir.
• Other medicines that are known to interact with Atorvastatin Adair include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (a pain reliever), colchicine (used to treat gout), antacids (indigestion products containing aluminum or magnesium), and boceprevir (used to treat liver diseases such as hepatitis C).
• Medicines obtained without a prescription: St. John's Wort.

• If you need to take oral fusidic acid to treat a bacterial infection, you will have to stop using this medicine temporarily. Your doctor will tell you when it is safe to restart treatment with Atorvastatin Adair. Taking Atorvastatin Adair in combination with fusidic acid can rarely cause muscle weakness, pain on palpation, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteria present in the blood).

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Taking Atorvastatin Adair with food, drinks, and alcohol

See section 3 for instructions on how to take Atorvastatin Adair. Please note the following:

Grapefruit juice

Do not drink more than one or two small glasses of grapefruit juice per day, as large amounts of grapefruit juice can alter the effects of Atorvastatin Adair.

Alcohol

Avoid drinking too much alcohol while taking this medicine. See the details in Section 2 "Warnings and precautions".

Pregnancy, breast-feeding, and fertility

Do not take Atorvastatin Adair if you are pregnant, think you may be pregnant, or are planning to become pregnant.

Do not take Atorvastatin Adair if you are of childbearing age unless you are using adequate contraceptive measures.

Do not take Atorvastatin Adair if you are breast-feeding.

The safety of Atorvastatin Adair during pregnancy and breast-feeding has not been established.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Normally, this medicine does not affect your ability to drive or use machines. However, do not drive if this medicine affects your ability to drive. Do not use tools or machines if this medicine affects your ability to use them.

Atorvastatin Adair contains lactose and sucrose.

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Atorvastatin Adair

Before starting treatment, your doctor will put you on a low-cholesterol diet, which you should also follow during treatment with Atorvastatin Adair.

The usual initial dose of Atorvastatin Adair is 10 mg once a day in adults and children from 10 years of age. Your doctor may increase it if necessary until you reach the dose you need. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of Atorvastatin Adair is 80 mg once a day for adults and 20 mg once a day for children.

Atorvastatin Adair tablets should be swallowed whole with a glass 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.

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will decide the duration of treatment with Atorvastatin Adair

Ask your doctor if you think the effect of Atorvastatin Adair is too strong or too weak.

If you take more Atorvastatin Adair than you should

If you accidentally take too many Atorvastatin Adair tablets (more than your usual daily dose), consult your doctor or the nearest hospital or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. Bring the remaining tablets, the box, and the complete packaging so that hospital staff can easily identify the medicine you have taken.

If you forget to take Atorvastatin Adair

If you forget to take a dose, take the next scheduled dose at the correct time. Do not take a double dose to make up for forgotten doses.

If you stop taking Atorvastatin Adair

If you have any further questions on the use of this medicine or want to stop treatment, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Atorvastatin Adair can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, stop taking these tablets and inform your doctor immediately or go to the emergency department of the nearest hospital.

Rare: may affect up to 1 in 10,000 patients:

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which can cause great difficulty breathing.

• Severe disease with severe peeling and inflammation of the skin; blisters on the skin, mouth, genitals, and eyes, and fever. Rash with pink-red spots, especially on the palms of the hands or soles of the feet, which can form blisters.

• Muscle weakness, pain on palpation, or pain, and especially if you also have discomfort or have a high fever, may be due to abnormal muscle breakdown. Abnormal muscle breakdown does not always go away, even after stopping atorvastatin, and can be fatal and cause kidney problems.

Very rare: may affect less than 1 in 10,000 patients:

• If you experience bleeding or bruising problems or unexpected or unusual bleeding, this may suggest a liver problem. You should consult your doctor as soon as possible.

Other possible side effects of Atorvastatin Adair:

Frequent (may affect up to 1 in 10 patients) include:

• inflammation of the nasal passages, sore throat, nosebleeds.
• allergic reactions.
• increases in blood sugar levels (if you are diabetic, monitor your blood sugar levels), increase in creatine kinase in the blood.
• headache.
• nausea, constipation, gas, indigestion, diarrhea.
• joint pain, muscle pain, and back pain.
• blood test results that may show abnormal liver function.

Uncommon (may affect up to 1 in 100 patients) include:

• loss of appetite (anorexia), weight gain, decrease in blood sugar levels (if you are diabetic, you should continue to monitor your blood sugar levels carefully).
• nightmares, insomnia.
• dizziness, numbness or tingling in the fingers of the hands and feet, reduced sensitivity to pain or touch, changes in taste, memory loss.
• blurred vision.
• ringing in the ears and/or head.
• vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas that causes stomach pain).
• hepatitis (inflammation of the liver).
• rash, skin rash, and itching, hives, hair loss.
• neck pain, muscle fatigue.
• fatigue, feeling unwell, weakness, chest pain, inflammation, especially in the ankles (edema), increased temperature.

urine tests positive for white blood cells.

Rare (may affect up to 1 in 1,000 patients) include:

• vision changes.
• unexpected or unusual bleeding or bruising.
• jaundice (yellowing of the skin and whites of the eyes).
• tendon injury.
• skin rash or ulcers in the mouth (drug-induced lichenoid reaction).
• purple-colored skin lesions (signs of inflammation of the blood vessels, vasculitis).

Very rare (may affect less than 1 in 10,000 patients) include:

• allergic reaction - symptoms may include sudden wheezing, coughing, chest pain, or shortness of breath, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse.
• hearing loss.
• gynecomastia (breast enlargement in men).

Side effects of unknown frequency:

• Constant muscle weakness.

Possible side effects of some statins (medicines of the same type):

• Sleep disorders, including insomnia and nightmares.
• Memory loss.
• Sexual difficulties.
• Depression.
• Respiratory problems such as persistent cough and/or difficulty breathing or fever.
• Diabetes. This is more likely if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Atorvastatin Adair

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the blister pack and on the outer packaging after {CAD}. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Further information

Composition of Atorvastatin Adair

• The active substance is atorvastatin.

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

• The other ingredients (excipients) of Atorvastatin Adair are:

Lactose monohydrate (lactose), magnesium stearate, sodium lauryl sulfate, microcrystalline cellulose (E-460), anhydrous colloidal silica, butylhydroxyanisole (E-320), crospovidone, sodium hydrogen carbonate, sucrose, sorbitan triesterate, macrogol 40 stearate, dimethicone, 2-bromo-2-nitropropane-1,3-diol, hypromellose, titanium dioxide (E-171), and macrogol 4000.

Appearance of the product and packaging contents

Atorvastatin Adair 10 mg are cylindrical, biconvex, scored on one side, and white.

The tablet can be divided into two equal halves.

Aluminum-Aluminum blisters.

Atorvastatin Adair 10mg is available in packs with blisters containing 28 and 100 tablets (clinical packaging).

Marketing authorization holder:

Galenicum Health S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

Spain

Manufacturer:

Laboratorios Cinfa, S.A.

Olaz-Chipi, 10. Polig. Areta. 31620 - Huarte-Pamplona

SPAIN

Galenicum Health S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

Spain

SAG Manufacturing SLU

Crta N-I, Km 36

28750 San Agustín de Guadalix (Madrid)

SPAIN

Date of last revision of this leaflet: November 2017

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/