ATORVASTATIN COMBIX 80 mg FILM-COATED TABLETS

2. What you need to know before taking Atorvastatina Combix

Do not take Atorvastatina Combix

• If you are allergic to atorvastatin or 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.
• If you use the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Atorvastatina Combix:

• 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 used to treat bacterial infections) orally or by injection. The combination of fusidic acid and atorvastatin 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 during treatment with other lipid-lowering medicines (e.g. with another statin or fibrates).
• if you have or have had myasthenia (a disease that causes generalised muscle weakness that can affect the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia to appear (see section 4).
• 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 Combix 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 "Using Atorvastatina Combix with other medicines").

Also, inform your doctor or pharmacist if you have 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 the blood, are overweight, and have high blood pressure.

Other medicines and Atorvastatina Combix

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 Atorvastatina Combix or the effects of these medicines may be altered by Atorvastatina Combix. This type of interaction can reduce the effect of one or both medicines. Alternatively, this combined use can increase the risk or severity of side effects, including serious 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 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 AIDS, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Certain medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir.
• Other medicines that are known to interact with Atorvastatina Combix include: ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (a pain reliever), colchicine (used for treating 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 have to stop using this medicine temporarily. Your doctor will tell you when it is safe to restart treatment with Atorvastatina Combix. Taking Atorvastatina Combix in combination with fusidic acid can rarely cause muscle weakness, 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).

Taking Atorvastatina Combix with food, drinks, and alcohol

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

Grapefruit juice

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

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 Atorvastatina Combix if you are pregnant, think you may be pregnant, or are planning to become pregnant.

Do not take Atorvastatina Combix if you are of childbearing age and do not use adequate contraceptive measures.

Do not take Atorvastatina Combix if you are breast-feeding your child.

The safety of Atorvastatina Combix 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.

3. How to take Atorvastatina Combix

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

The initial dose of Atorvastatina Combix is 10 mg once a day in adults and in 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 Combix is 80 mg once a day.

The tablets of Atorvastatina Combix 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 Atorvastatina Combix

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

If you take more Atorvastatina Combix than you should

If you accidentally take too many tablets of Atorvastatina Combix (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 the hospital staff can easily identify the medicine you have taken.

If you forget to take Atorvastatina Combix

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 interrupt treatment with Atorvastatina Combix

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

4. Possible side effects

Like all medicines, this medicine 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 casualty department of the nearest hospital.

Rare: may affect up to 1 in 1,000 people

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which can cause great difficulty in breathing.
• Severe disease with severe scaling 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, pain, rupture, or change in urine color to reddish-brown, and especially if you have discomfort or have a high fever, may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always disappear, even after stopping atorvastatin, and can be fatal and cause kidney problems.

Very rare: may affect up to 1 in 10,000 people

• If you experience unexpected or unusual bleeding or bruising, this may suggest a liver problem. You should consult your doctor as soon as possible.
• Lupus-like syndrome (which includes rash, joint disorders, and effects on blood cells).

Other possible side effects with Atorvastatina Combix:

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

• 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 people):

• loss of appetite (anorexia), weight gain, decrease in blood sugar levels (if you are diabetic, you should continue to carefully monitor your blood sugar levels)
• 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
• positive urine tests for white blood cells

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

• 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 up to 1 in 10,000 people):

• allergic reaction - symptoms can include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• hearing loss
• gynaecomastia (breast enlargement in men)

Frequency not known: cannot be estimated from the available data:

• constant muscle weakness
• severe myasthenia (a disease that causes generalised muscle weakness that can affect the muscles used for breathing)
• ocular myasthenia (a disease that causes weakness of the eye muscles)

Tell your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or difficulty breathing.

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

• sexual difficulties
• depression
• respiratory problems such as persistent cough and/or difficulty breathing or fever
• diabetes. It is more likely if you have high levels of sugar and fat in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine

Reporting of side effects

If you experience 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 through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Atorvastatina Combix

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

Do not store above 30°C.

Do not use Atorvastatina Combix after the expiry date stated on the blister and carton after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Atorvastatina Combix 80 mg tablets

The active ingredient is atorvastatin. Each tablet contains 80 mg of atorvastatin as atorvastatin calcium.

The other components are microcrystalline cellulose, anhydrous sodium carbonate, maltose, sodium croscarmellose, magnesium stearate, hypromellose, hydroxypropylcellulose, triethyl citrate, polysorbate 80, titanium dioxide (E171).

Appearance of the product and packaging content

White, elliptical, biconvex, smooth, film-coated tablets, with dimensions of 18.8 mm x 10.3 mm.

Each package contains 28 tablets, packaged in aluminum/aluminum blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Combix Laboratories, S.L.U.

Badajoz 2, Building 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Teva Pharma, S.L.U.

Malpica Industrial Estate, Street C No. 4

50016 Zaragoza

Date of the last revision of this prospectus:October 2024

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