ATORVASTATIN ADAIR 40 mg FILM-COATED TABLETS

2. What you need to know before taking Atorvastatina Adair

Do not take Atorvastatina Adair

• If you are allergic to atorvastatin or to any other similar medicine used to lower blood lipids or to any of the other components of this medicine (listed in section 6).
• If you have or have had any liver disease.
• If you have or have had unexplained abnormal liver function test results.
• 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 breastfeeding.

Warnings and precautions

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

• if you have severe respiratory failure.
• If you are taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Atorvastatina 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 in the past while taking other lipid-lowering medicines (e.g., 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 Atorvastatina 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 Atorvastatina 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 Atorvastatina Adair

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicine. There are some medicines that can affect the proper functioning of Atorvastatina Adair or whose effects may be altered by Atorvastatina 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., cyclosporin.
• Certain antibiotics or antifungal medicines, e.g., erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medicines for regulating 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 for regulating your heart rhythm, e.g., digoxin, verapamil, amiodarone.
• Medicines used to treat HIV, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Certain medicines used to treat hepatitis C, such as telaprevir.
• Other medicines known to interact with Atorvastatina Adair include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), 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 temporarily stop using this medicine. Your doctor will indicate when it is safe to restart treatment with Atorvastatina Adair. Taking Atorvastatina Adair in combination with fusidic acid can rarely cause muscle weakness, pain, or tenderness (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 Atorvastatina Adair with food, drinks, and alcohol

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

Grapefruit juice

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

Alcohol

Avoid drinking large amounts of alcohol while taking this medicine. See the details in Section 2 "Warnings and precautions".

Pregnancy, breastfeeding, and fertility

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

Do not take Atorvastatina Adair if you are of childbearing age unless you use adequate contraceptive measures.

Do not take Atorvastatina Adair if you are breastfeeding.

The safety of Atorvastatina Adair during pregnancy and breastfeeding 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 operate machinery. However, do not drive if this medicine affects your ability to drive. Do not operate tools or machinery if this medicine affects your ability to operate them.

Atorvastatina Adair contains lactose and sucrose.

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

3. How to take Atorvastatina Adair

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

The usual initial dose of Atorvastatina 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 Atorvastatina Adair is 80 mg once a day for adults and 20 mg once a day for children.

The tablets of Atorvastatina Adair 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 the administration instructions of this medicine exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the duration of treatment with Atorvastatina Adair

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

If you take more Atorvastatina Adair than you should

If you accidentally take too many Atorvastatina 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 package so that hospital staff can easily identify the medicine you have taken.

If you forget to take Atorvastatina 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 missed doses.

If you stop treatment with Atorvastatina Adair

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

4. Possible side effects

Like all medicines, Atorvastatina Adair can cause side effects, although not everyone 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 between 1 and 10 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 scaling and inflammation of the skin; blisters on the skin, mouth, genitals, and eyes, and fever. Skin rash with pink-red spots, especially on the palms of the hands or soles of the feet, which can form blisters.

• Muscle weakness, pain, or tenderness, 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 disappear, 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 with Atorvastatina Adair:

Frequent (may affect between 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 between 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 between 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 mouth ulcers (drug-induced lichenoid reaction).
• purple-colored skin lesions (signs of blood vessel inflammation, vasculitis).

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

• 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).

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 for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Atorvastatina Adair

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

Do not use this medicine after the expiration date stated on the blister pack and carton 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. Additional information

Composition of Atorvastatina Adair

• The active substance is atorvastatin.

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

• The other components (excipients) of Atorvastatina Adair are:

Lactose monohydrate (lactose), magnesium stearate, sodium lauryl sulfate, microcrystalline cellulose (E-460), anhydrous colloidal silica, butylhydroxyanisole (E-420), 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 package contents

Atorvastatina Adair 40 mg are cylindrical, biconvex, scored on one side, and white.

The tablet can be divided into two equal halves.

Aluminum-Aluminum blisters.

Atorvastatina Adair 40 mg 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 the 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/