ATORVASTATIN PHARMA COMBIX 20 mg FILM-COATED TABLETS

2. What you need to know before you take Atorvastatin Pharma Combix

Do not take AtorvastatinPharmaCombix

• if you are allergic to atorvastatin or to any other similar medicine used to lower blood lipid levels or to any of the other ingredients of this medicine (listed in section 6).
• if you have or have had a 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 are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Atorvastatin Pharma Combix.

For the following reasons, Atorvastatin Pharma Combix may not be suitable for you:

• 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 while taking other medicines to lower lipid levels (e.g. with another statin or fibrates).
• if you have or have had myasthenia (a disease that causes general 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.
• If you are taking or have taken in the last 7 days a medicine that contains fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Atorvastatin Pharma Combix can cause serious muscle problems (rhabdomyolysis).

Tell your doctor or pharmacist before taking Atorvastatin Pharma Combix

• if you have severe respiratory failure.
• if you have constant muscle weakness. You may need additional tests and medications to diagnose and treat this problem.

In any of these cases, your doctor may indicate that you should have a blood test before and possibly during treatment with Atorvastatin Pharma 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 "Taking Atorvastatin Pharma Combix with other medicines").

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.

Taking AtorvastatinPharmaCombixwith other medicines

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 Pharma Combix or the effects of these medicines may be altered by Atorvastatin Pharma 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 important muscle damage, known as rhabdomyolysis, described in section 4:

• Medicines used to modify the functioning of your immune system, for example, ciclosporin.
• Certain antibiotics or antifungal medicines, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medicines for regulating lipid levels, for example, gemfibrozil, other fibrates, colestipol.
• Certain calcium channel blockers used to treat angina or high blood pressure, for example, amlodipine, diltiazem; medicines to regulate your heart rhythm, for example, digoxin, verapamil, amiodarone.
• Medicines used to treat AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, 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 atorvastatin include ezetimibe (which lowers 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), and antacids (indigestion products containing aluminum or magnesium).
• Medicines obtained without a prescription: St. John's Wort.
• If you have to take oral fusidic acid to treat a bacterial infection, you will have to stop using this medicine. Your doctor will tell you when you can restart treatment with Atorvastatin Pharma Combix. The use of Atorvastatin Pharma Combix with fusidic acid can cause muscle weakness, sensitivity, 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).

Taking AtorvastatinPharmaCombixwith food, drinks, and alcohol

See section 3 for instructions on how to take Atorvastatin Pharma Combix. 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 Atorvastatin Pharma 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

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.

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

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

Do not take Atorvastatin Pharma Combix if you are breast-feeding.

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

Driving and using machines

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.

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

3. How to take Atorvastatin Pharma Combix

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

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

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

The 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.

Your doctor will decide the duration of treatment with atorvastatin.

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

If you take more AtorvastatinPharmaCombixthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take AtorvastatinPharmaCombix

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 AtorvastatinPharmaCombix

If you have any further questions about the use of this medicine or want to stop 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 emergency department of the nearest hospital.

Rare: affects between 1 and 10 in every 10,000 patients:

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which can cause great difficulty breathing.
• Severe skin 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, sensitivity, pain, rupture, or change in urine color to reddish-brown, and especially if you also 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 potentially fatal and cause kidney problems.

Very rare: affects less than 1 in every 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.
• Lupus-like syndrome (which includes rash, joint disorders, and effects on blood cells).

Other possible side effects with atorvastatin:

Common side effects (affect between 1 and 10 in every 100 patients) include:

• nasal inflammation, sore throat, nosebleeds
• allergic reactions
• increases in blood sugar levels (if you are diabetic, monitor your blood sugar levels), increased 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 side effects (affect between 1 and 10 in every 1,000 patients) include:

• loss of appetite, 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)
• skin 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 side effects (affect between 1 and 10 in every 10,000 patients) include:

• vision changes
• unexpected 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 side effects (affect less than 1 in every 10,000 patients) include:

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

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.

Side effects of unknown frequency:

• Constant muscle weakness.
• Severe myasthenia (a disease that causes general 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.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them 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. Storage of Atorvastatina Pharma Combix

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Atorvastatina Pharma Combix

• The active ingredient is atorvastatin.

Each film-coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium trihydrate).

• The other ingredients (excipients) are:

Tablet core: Microcrystalline cellulose (E460i), precipitated calcium carbonate (E509), sodium croscarmellose, lactose monohydrate, hydroxypropylcellulose (E463), and magnesium stearate (E470b)

Tablet coating: Opadry white YS17040 (hypromellose (E464), macrogol 8000 (E1521), titanium dioxide (E171), and talc (E553b)).

Appearance of the Product and Package Contents

Film-coated tablets, white or almost white, round, biconvex, with the engraving "20" on one face and smooth on the other.

OPA/Al/PVC-Aluminum blisters (standard or perforated).

Packages of 28 or 100 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U. C/ Badajoz, 2. Edificio 2. 28223 Pozuelo de Alarcón (Madrid) Spain

Manufacturer

Zydus France ZAC Les Hautes Patures Parc d'activités des Peupliers 25 Rue des Peupliers 92000 Nanterre France

Or

Centre Spécialités Pharmaceutiques

ZAC des Suzots 35 rue de la Chapelle 63450

Saint Amant Tallende

France

Date of the Last Revision of this Leaflet:October 2024

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