Atorvastatin Pharma Combix 80 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Atorvastatine Pharma Combix 80 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Atorvastatine Pharma Combix is and what it is used for
2. What you need to know before taking Atorvastatine Pharma Combix
3. How to take Atorvastatine Pharma Combix
4. Possible side effects
5. How to store Atorvastatine Pharma Combix
6. Contents of the pack and other information

1. What Atorvastatina Pharma Combix is and what it is used for

Atorvastatina Pharma Combix belongs to a group of medicines known as statins, which are drugs that regulate lipids (fats).

Atorvastatina Pharma Combix is used to reduce lipids such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes alone have failed. If you are at high risk of heart disease, Atorvastatina Pharma Combix may also be used to reduce this risk, even if your cholesterol levels are normal. A standard low-cholesterol diet should be followed during treatment.

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

Do not take Atorvastatina Pharma Combix

• if you are allergic to atorvastatin, to any other similar medicine used to lower blood lipids, or to 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 liver function blood tests
• if you are a woman of childbearing age and are not using adequate contraceptive measures
• if you are pregnant or trying to become pregnant
• if you are breastfeeding.
• 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 Atorvastatina Pharma Combix.

Atorvastatina Pharma Combix may not be suitable for you for the following reasons:

• if you have previously had a stroke with bleeding in the brain, or have small fluid-filled pockets in the brain due to prior strokes
• if you have kidney problems
• if you have an underactive thyroid gland (hypothyroidism)
• if you have recurrent or unexplained muscle pain, or personal or family history of muscle disorders
• if you have previously experienced 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 causing generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (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 within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection) taken orally or by injection. The combination of fusidic acid and Atorvastatina Pharma Combix may cause serious muscle problems (rhabdomyolysis).

Inform your doctor or pharmacist before taking Atorvastatina Pharma Combix

• if you have severe respiratory insufficiency.
• if you experience persistent muscle weakness. Additional tests or medications may be needed to diagnose and treat this condition.

In any of these cases, your doctor may decide to perform blood tests before and possibly during treatment with Atorvastatina Pharma Combix to assess the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects (e.g., rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 “Taking Atorvastatina Pharma Combix with other medicines”).

While taking this medicine, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. This risk increases if you have high levels of sugar and fats in the blood, are overweight, or have high blood pressure.

Taking Atorvastatina Pharma Combix with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Some medicines may interfere with the proper functioning of Atorvastatina Pharma Combix, or the effects of these medicines may be altered by Atorvastatina Pharma Combix. Such interactions may reduce the effect of one or both medicines. Alternatively, taking them together may increase the risk or severity of adverse effects, including the serious muscle damage known as rhabdomyolysis described in section 4:

• Medicines used to modify the function of your immune system, for example, cyclosporine.
• Certain antibiotics or antifungal medicines, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medicines to regulate lipid levels, for example, gemfibrozil, other fibrates, colestipol.
• Some 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 in the treatment of HIV/AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.
• Some medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir.
• Other medicines known to interact with atorvastatin include ezetimibe (cholesterol-lowering), warfarin (reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (a painkiller), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium or magnesium).
• Over-the-counter medicines: St. John’s wort.
• If you need to take oral fusidic acid to treat a bacterial infection, you must stop taking this medicine. Your doctor will advise you when you can restart treatment with Atorvastatina Pharma Combix. Using Atorvastatina Pharma Combix with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bloodstream infections caused by bacteria).

Taking Atorvastatina Pharma Combix with food, drinks, and alcohol

See section 3 for instructions on how to take Atorvastatina 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 amounts of grapefruit juice may alter the effects of Atorvastatina Pharma Combix.

Alcohol

Avoid drinking large amounts of alcohol while taking this medicine. See details in section 2 “Warnings and precautions”.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

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

Do not take Atorvastatina Pharma Combix if you are breastfeeding.

The safety of Atorvastatina Pharma Combix during pregnancy and breastfeeding has not been established.

Driving and using machines

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 Pharma Combix contains lactose. This medicine contains lactose. 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 Pharma Combix

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Before starting treatment, your doctor will place you on a low-cholesterol diet, which you must continue to follow during treatment with Atorvastatina Pharma Combix.

The usual starting dose is 10 mg once daily in adults and children aged 10 years and older. Your doctor may increase this dose if necessary to reach the dose you require. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose is 80 mg once daily for adults and 20 mg once daily for children.

The tablets should be swallowed whole with a glass of water and may 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 that the effect of Atorvastatina Pharma Combix is too strong or too weak.

If you take more Atorvastatina Pharma Combix than you should

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

If you forget to take Atorvastatina Pharma Combix

If you forget to take a dose, take the next dose at the scheduled time. Do not take a double dose to make up for missed doses.

If you stop taking Atorvastatina Pharma Combix

If you have any further questions about using this medicine or wish to discontinue treatment, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you notice any of the following serious adverse effects, stop taking these tablets immediately and contact your doctor right away or go to the nearest hospital emergency department.

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

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may cause severe breathing difficulties.
• Serious illness with severe skin peeling and inflammation; skin blisters, 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 may develop into blisters.
• Muscle weakness, tenderness, pain, muscle breakdown, or change in urine color to red-brown, and particularly if you also have malaise or high fever, this may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always resolve even after stopping atorvastatin, and may be potentially fatal and lead to kidney problems.

Very rare: affects fewer than 1 in 10,000 patients:

• If you experience problems with unexpected or unusual bleeding or bruising, this may indicate 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 adverse effects with atorvastatina:

Frequent adverse effects (affect between 1 and 10 in 100 patients) include:

• Inflammation of the nasal passages, sore throat, nosebleeds
• Allergic reactions
• Increased blood sugar levels (if you are diabetic, monitor your blood sugar levels closely), increased blood creatine kinase
• Headache
• Nausea, constipation, gas, indigestion, diarrhea
• Joint pain, muscle pain, and back pain
• Blood test results that may show abnormal liver function

Uncommon adverse effects (affect between 1 and 10 in 1,000 patients) include:

• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you are diabetic, continue to monitor your blood sugar levels carefully)
• Nightmares, insomnia
• Dizziness, numbness or tingling in the fingers and toes, reduced sensitivity to pain or touch, changes in taste sensation, memory loss
• Blurred vision
• Ringing in the ears and/or head
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas causing stomach pain)
• Hepatitis (liver inflammation)
• Rash, skin rash and itching, hives, hair loss
• Neck pain, muscle fatigue
• Fatigue, feeling unwell, weakness, chest pain, swelling, especially in the ankles (edema), increased body temperature
• Positive urine tests for white blood cells

Rare adverse effects (affect between 1 and 10 in 10,000 patients) include:

• Vision disturbances
• Unexpected bleeding or bruising
• Cholestasis (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 adverse effects (affect fewer than 1 in 10,000 patients) include:

• Allergic reaction – symptoms may include sudden wheezing, chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
• Hearing loss
• Gynaecomastia (enlargement of the breasts in men and women)

Possible side effects reported with 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 fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Adverse effects of unknown frequency:

• Persistent muscle weakness.
• Myasthenia gravis (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Ocular myasthenia (a disease causing weakness of the eye muscles).

Consult your doctor if you experience worsening arm or leg weakness after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Atorvastatin 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their packaging should be handed over to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of AtorvastatinaPharmaCombix

• The active substance is atorvastatin.

Each film-coated tablet contains 80 mg of atorvastatin (as atorvastatin calcium trihydrate).

• The other components (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 contents of the pack

Film-coated tablets, white or almost white, round, biconvex, engraved with "80" on one side and smooth on the other.

Blister packs made of OPA/Al/PVC-Aluminum (standard or perforated).

Packs containing 28 or 90 tablets.

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 most recent revision of this leaflet: October 2024

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