ATORVASTATIN COMBIX PHARMA 60 mg FILM-COATED TABLETS

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

Do not take AtorvastatinCombix Pharma

• if you are allergic to atorvastatin or any of the other components of this medication (listed in section 6).
• if you have or have had any disease that affects the liver.
• 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 breastfeeding.
• if you use the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• if you have severe respiratory failure.
• if you are taking or have taken in the last 7 days a medication that contains fusidic acid (a medication 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 blisters in the brain due to previous strokes.
• if you have kidney problems.
• if you have an underactive thyroid gland (hypothyroidism).
• if you have or have had repeated or unexplained muscle pain, personal or family history of muscle problems.
• if you have had muscle problems in the past while taking other medications to lower lipid levels (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.
• if you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects 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).

In any of these cases, your doctor may indicate that you should have blood tests before and, possibly, during treatment with atorvastatin 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 medications are taken at the same time (see section 2 "Other medications and Atorvastatin Combix Pharma").

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

While taking this medication, your doctor will monitor you for diabetes or the 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 medications and Atorvastatin Combix Pharma

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. There are some medications that can affect the proper functioning of atorvastatin or the effects of these medications may be modified by atorvastatin. This type of interaction can decrease the effect of one or both medications. Alternatively, this combined use can increase the risk or severity of side effects, including serious muscle damage, known as rhabdomyolysis, described in section 4:

• Medications used to modify the functioning of your immune system, e.g., cyclosporine.
• Certain antibiotics or antifungal medications, e.g., erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medications 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; medications to regulate your heart rhythm, e.g., digoxin, verapamil, amiodarone.
• Letermovir, a medication that helps prevent diseases caused by cytomegalovirus.
• Medications used to treat AIDS, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Certain medications used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• Other medications that are known to interact with atorvastatin 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 to treat gout), and antacids (indigestion products containing aluminum or magnesium).
• Medications 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 medication. Your doctor will indicate when it is safe to restart treatment with atorvastatin. Taking atorvastatin in combination with fusidic acid can rarely cause muscle weakness, pain, or discomfort (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Daptomycin (a medication used to treat skin and skin structure infections with complications and bacteria present in the blood).

Taking Atorvastatin Combix Pharma with food, drinks, and alcohol

See section 3 for instructions on how to take this medication. 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.

Alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Do not take atorvastatin if you are breastfeeding your child.

Do not take atorvastatin if you are of childbearing age unless you use adequate contraceptive measures. The safety of atorvastatin during pregnancy and breastfeeding has not been established.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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

Atorvastatin Combix Pharma contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

3. How to take Atorvastatin Combix Pharma

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

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

The usual initial dose of atorvastatin recommended for adults and children from 10 years old is 10 mg once a day. 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 is 80 mg once a day.

The atorvastatin 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 Combix Pharma

Ask your doctor if you think the effect of this medication is too strong or too weak.

If you take more Atorvastatin Combix Pharma than you should

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

If you forget to take Atorvastatin Combix Pharma

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 interrupt treatment with Atorvastatin Combix Pharma

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

If you notice any of the following serious side effects or symptoms, 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 1,000 people

• 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. 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 brownish-red color of the urine, 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 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 (including rash, joint disorders, and effects on blood cells).

Other possible side effects with atorvastatin:

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), 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: may affect up to 1 in 100 people

• loss of appetite (anorexia), weight gain, decreased 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 may include sudden wheezing and chest pain or discomfort, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• hearing loss
• gynecomastia (breast enlargement in men).

Frequency not known: cannot be estimated from available data:

• constant muscle weakness
• severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing)
• ocular myasthenia (a disease that causes weakness of the eye muscles)
• consult 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 (medications 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 medication.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Atorvastatin Combix Pharma

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the blister pack and on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Packaging Content and Additional Information

Composition of Atorvastatina Combix Pharma

• The active ingredient is atorvastatin.

Atorvastatina Combix Pharma 10 mg: each film-coated tablet contains 10 mg of atorvastatin (as atorvastatin calcium).

Atorvastatina Combix Pharma 20 mg: each film-coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium).

Atorvastatina Combix Pharma 30 mg: each film-coated tablet contains 30 mg of atorvastatin (as atorvastatin calcium).

Atorvastatina Combix Pharma 40 mg: each film-coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium).

Atorvastatina Combix Pharma 60 mg: each film-coated tablet contains 60 mg of atorvastatin (as atorvastatin calcium).

Atorvastatina Combix Pharma 80 mg: each film-coated tablet contains 80 mg of atorvastatin (as atorvastatin calcium).

• The other components (excipients) are:

Core:microcrystalline cellulose, calcium carbonate, maltose, sodium croscarmellose, mixture of polysorbate 80 and aluminum and magnesium metasilicate, magnesium stearate.

Coating:hypromellose, hydroxypropylcellulose, triethyl citrate, polysorbate 80, titanium dioxide (E171).

Product Appearance and Packaging Content

AtorvastatinaCombix Pharma10 mg:

Film-coated tablets, white to off-white, elliptical, biconvex, marked with a "10" on one side and flat on the other. The length of the tablet is approximately 8 mm and the width is approximately 4.4 mm.

AtorvastatinaCombix Pharma20 mg:

Film-coated tablets, white to off-white, elliptical, biconvex, marked with a "20" on one side and with a score line on the other. The length of the tablet is approximately 10 mm and the width is approximately 5.5 mm.

The tablet can be divided into equal doses.

AtorvastatinaCombix Pharma30 mg:

Film-coated tablets, white to off-white, elliptical, biconvex, marked with a "30" on one side and flat on the other. The length of the tablet is approximately 11.5 mm and the width is approximately 6.3 mm.

AtorvastatinaCombix Pharma40 mg:

Film-coated tablets, white to off-white, elliptical, biconvex, marked with a "40" on one side and with a score line on the other. The length of the tablet is approximately 12.8 mm and the width is approximately 6.9 mm.

The tablet can be divided into equal doses.

AtorvastatinaCombix Pharma60 mg:

Film-coated tablets, white to off-white, elliptical, biconvex, marked with a "60" on one side and flat on the other. The length of the tablet is approximately 14.2 mm and the width is approximately 7.8 mm.

AtorvastatinaCombix Pharma80 mg:

Film-coated tablets, white to off-white, elliptical, biconvex, marked with a "80" on one side and with a score line on the other. The length of the tablet is approximately 16 mm and the width is approximately 8.7 mm.

The tablet can be divided into equal doses.

Atorvastatina Combix Pharma is presented in standard blisters or in single-dose precut blisters, in packs of 28 and 30 tablets for the 10 mg and 20 mg doses, and in packs of 28 tablets for the 30 mg, 40 mg, 60 mg, and 80 mg doses.

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

TEVA PHARMA S.L.U.,

C/C, n. 4, Polígono Industrial Malpica,

50016 Zaragoza, Spain

Or

Teva Operations Poland Sp. z.o.o, ul.

Mogilska 80.

31-546, Krakow, Poland

Date of the Last Revision of this Leaflet: February 2025

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