Atorvastatin Alter Genericos 30 mg film-coated tablets

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Atorvastatina Alter Genéricos 10 mg film-coated tablets EFG

Atorvastatina Alter Genéricos 20 mg film-coated tablets EFG

Atorvastatina Alter Genéricos 30 mg film-coated tablets

Atorvastatina Alter Genéricos 40 mg film-coated tablets EFG

Atorvastatina Alter Genéricos 60 mg film-coated tablets

Atorvastatina Alter Genéricos 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 Atorvastatina Alter Genéricos is and what it is used for
2. What you need to know before taking Atorvastatina Alter Genéricos
3. How to take Atorvastatina Alter Genéricos
4. Possible adverse effects
5. How to store Atorvastatina Alter Genéricos
6. Contents of the pack and other information

1. What Atorvastatine Alter Genéricos is and what it is used for

Atorvastatin belongs to a group of medicines known as statins, which are lipid-regulating (fat-regulating) medicines.

Atorvastatin 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, atorvastatin 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 Atorvastatin Alter Generics

Do not take Atorvastatin Alter Generics

• 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 liver function blood tests.
• if you are a woman of childbearing age and you 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 this medicine:

• if you have severe respiratory failure.
• if you are taking or have taken in the last 7 days an oral or injectable medicine containing fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and atorvastatin may cause serious muscle problems (rhabdomyolysis).
• if you have previously had a 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 or have had repeated or unexplained muscle pain, or personal or family history of muscle disorders.
• if you previously experienced muscle problems while being treated with other lipid-lowering medicines (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 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).

In any of these cases, your doctor may decide whether you need blood tests before and possibly during treatment with atorvastatin to assess your 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 “Other medicines and Atorvastatin Alter Generics”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests or treatments may be needed to diagnose and manage this condition.

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

Other medicines and Atorvastatin Alter Generics

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some medicines may affect how atorvastatin works, or the effects of these medicines may be altered by atorvastatin. This type of interaction may reduce the effect of one or both medicines. Alternatively, it may increase the risk or severity of adverse effects, including a serious condition causing muscle damage known as rhabdomyolysis, described in section 4:

• Medicines used to modify the function of your immune system, e.g. cyclosporine.
• Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other lipid-regulating medicines, 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 used to prevent cytomegalovirus infections.
• Medicines used in the treatment of HIV/AIDS, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, 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 (anticoagulant), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (an analgesic), 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 temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart atorvastatin treatment. Taking atorvastatin together with fusidic acid may rarely 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 Atorvastatin Alter Generics with food, drinks and alcohol

See section 3 for instructions on how to take this medicine. Please note the following:

Grapefruit juice

Do not drink more than one or two small glasses of grapefruit juice per day, as large amounts may alter the effects of atorvastatin.

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

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 baby.

Do not take atorvastatin if you are of childbearing age unless you are using adequate contraceptive measures.

The safety of atorvastatin during pregnancy and breastfeeding has not been established.

Driving and using machines

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

Atorvastatin Alter Generics contains lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Atorvastatina Alter Genéricos

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

Before starting treatment, your doctor will place you on a low-cholesterol diet, which you must continue during treatment with atorvastatin.

The usual initial dose of atorvastatin recommended 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 need. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of atorvastatin is 80 mg once daily.

Atorvastatin 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 Atorvastatina Alter Genéricos.

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

If you take more Atorvastatina Alter Genéricos 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 at 91 562 04 20, indicating the medicine and the amount ingested. Take any remaining tablets, the carton, and the full packaging so that hospital staff can easily identify the medicine you have taken.

If you forget to take Atorvastatina Alter Genéricos

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 Atorvastatina Alter Genéricos

Consult your doctor or pharmacist again.

If you have any further questions about using this medicine or wish to stop treatment, ask 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 adverse effects or serious symptoms, stop taking these tablets immediately and contact your doctor or go to the nearest hospital emergency department straight away.

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

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may cause severe difficulty breathing.
• 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 rupture, or brownish-red discoloration of the urine, especially if accompanied by malaise or high fever, may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always resolve, 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 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 atorvastatin:

Common: may affect up to 1 in 10 people

• Nasal inflammation, sore throat, nosebleeds
• Allergic reactions
• Increased blood sugar levels (if you are diabetic, monitor your blood sugar levels), increased blood creatine kinase
• Headache
• Nausea, constipation, gas, indigestion, diarrhea
• Joint pain, muscle pain, and back pain
• Blood test results that may indicate abnormal liver function.

Uncommon: may affect up to 1 in 100 people

• 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 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 (inflammation of the liver)
• Rash, skin rash and itching, hives, hair loss
• Neck pain, muscle fatigue
• Fatigue, feeling unwell, weakness, chest pain, swelling, especially in the ankles (oedema), increased body temperature
• Urine tests positive for white blood cells.

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

• 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: 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
• Gynaecomastia (enlargement of breast tissue in men)

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

• Persistent muscle weakness
• Myasthenia gravis (a disease causing generalized muscle weakness, which in some cases affects muscles used for breathing)
• Ocular myasthenia (a disease causing weakness of the eye muscles)
• Consult your doctor if you experience worsening weakness in arms or legs 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 fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may 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 Alter Generics

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

Do not use this medicine after the expiry date stated on the blister pack and container after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Atorvastatin Alter Generics

• The active substance is atorvastatin.

Atorvastatin Alter Generics 10 mg: Each film-coated tablet contains 10 mg of atorvastatin (as atorvastatin calcium trihydrate).

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

Atorvastatin Alter Generics 30 mg: Each film-coated tablet contains 30 mg of atorvastatin (as atorvastatin calcium trihydrate).

Atorvastatin Alter Generics 40 mg: Each film-coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium trihydrate).

Atorvastatin Alter Generics 60 mg: Each film-coated tablet contains 60 mg of atorvastatin (as atorvastatin calcium trihydrate).

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

• The other components (excipients) are: calcium carbonate (E170i), lactose monohydrate, microcrystalline cellulose (E460i), hydroxypropylcellulose (E463), polysorbate 80, sodium croscarmellose (E468) and magnesium stearate (E470b).

The coating contains: partially hydrolysed poly(vinyl alcohol), titanium dioxide (E171), macrogol 4000 (E1521) and talc (E553b).

Appearance of the product and contents of the pack

Atorvastatin Alter Generics 10 mg: Film-coated tablets, white, round, biconvex, smooth.

Atorvastatin Alter Generics 20 mg: Film-coated tablets, white, round, biconvex, with a score line on one side. The score line is not intended for dividing the tablet.

Atorvastatin Alter Generics 30 mg: Film-coated tablets, white, round, biconvex, marked with "30" on one side.

Atorvastatin Alter Generics 40 mg: Film-coated tablets, white, round, biconvex, marked with a cross on one side.

Atorvastatin Alter Generics 60 mg: Film-coated tablets, white, round, biconvex, with a score line on one side and marked with "60" on the other. The score line is not intended for dividing the tablet.

Atorvastatin Alter Generics 80 mg: Film-coated tablets, white, round, biconvex, with a score line on one side and marked with "80" on the other. The score line is not intended for dividing the tablet.

Atorvastatin Alter Generics is marketed in PA/Al/PVC-Aluminium or PVC/PVDC/PVC-Aluminium blister packs.

Doses of 10 mg and 20 mg:

Packs with blisters containing 28 and 30 tablets.

Doses of 30 mg, 40 mg, 60 mg and 80 mg:

Packs with blisters containing 28 tablets.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

or

Laboratorios Alter, S.A.

C/ Zeus, 6

Polígono Industrial R2

28880 Meco (Madrid)

Spain

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/.