ATORVASTATIN COMBIX PHARMA 40 mg FILM-COATED TABLETS

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

Do not take AtorvastatinCombix Pharma

• 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 a 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 breast-feeding.
• 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 medicine:

• if you have severe respiratory failure.
• if you are taking or have taken in the last 7 days a medicine that contains 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 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 medicines 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 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).

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 medicines are taken at the same time (see section 2 "Other medicines 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 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 Atorvastatin Combix Pharma

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 or the effects of these medicines may be altered by atorvastatin. 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 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 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.
• Letermovir, a medicine that helps prevent diseases caused by cytomegalovirus.
• 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, ledipasvir/sofosbuvir.
• 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 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. Taking atorvastatin 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).

Taking Atorvastatin Combix Pharma with food, drinks, and alcohol

See section 3 for instructions on how to take this medicine. 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 atorvastatin.

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

Do not take atorvastatin if you are breast-feeding 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 breast-feeding has not been established.

Ask your doctor or pharmacist for advice before taking 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 Combix Pharma contains sodium

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

3. How to take Atorvastatin Combix Pharma

Follow the instructions for administration of this medicine exactly as indicated by your doctor. 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 medicine.

The usual initial dose of atorvastatin 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 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 medicine 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, 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 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 forgotten doses.

If you stop taking Atorvastatin Combix Pharma

If you have any further questions on the use of this medicine or wish 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 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 discoloration 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:

Common: 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 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).

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

• constant muscle weakness
• severe myasthenia (a disease that causes generalized muscle weakness that can affect 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 (medicines of the same type):

• 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 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. Storage of Atorvastatin Combix Pharma

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

Do not use this medicine after the expiry date that appears on the blister pack and on the carton after EXP. The expiry 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. Return the packaging and any unused medicine to a pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents 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 Package Contents

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/.