Atorvastatin Almus Pharma 80 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Atorvastatin Almus Pharma 80 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine, as 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 must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Atorvastatina Almus Pharma 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 Almus Pharma 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 Atorvastatine Almus Pharma

Do not take Atorvastatine Almus Pharma

• If you are allergic to atorvastatin or 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 blood tests for liver function.
• 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 Atorvastatine Almus Pharma:

• if you have severe respiratory failure.
• if you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and Atorvastatine Almus Pharma may cause serious muscle problems (rhabdomyolysis).
• if you have previously had a stroke with bleeding in the brain, or have small collections of fluid 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, or a 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.

In any of these cases, your doctor may decide whether you need blood tests before and possibly during treatment with Atorvastatine Almus Pharma to assess your risk of experiencing 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 “ Use of Atorvastatine Almus Pharma with other medicines”).

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

Use of Atorvastatine Almus Pharma with other medicines

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

Some medicines may affect how Atorvastatine Almus Pharma works, or the effects of these medicines may be altered by Atorvastatine Almus Pharma. This type of interaction 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 lipid-regulating medicines, 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.
• Letermovir, a medicine that helps prevent cytomegalovirus-related diseases.
• Medicines used in the treatment of AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Some medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combinations elbasvir/grazoprevir and ledipasvir/sofosbuvir.
• Other medicines known to interact with Atorvastatine Almus Pharma include ezetimibe (which lowers cholesterol), warfarin (which 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 using this medicine. Your doctor will advise you when you can restart treatment with atorvastatin. Taking atorvastatin 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 Atorvastatine Almus Pharma with food, drinks and alcohol

See section 3 for instructions on how to take Atorvastatine Almus Pharma. 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 Atorvastatine Almus Pharma.

Alcohol

Avoid drinking large amounts of alcohol while taking this medicine. See details in section 2 “Take special care with Atorvastatine Almus Pharma”.

Pregnancy, breastfeeding and fertility

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

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

Do not take Atorvastatine Almus Pharma if you are breastfeeding your baby.

The safety of Atorvastatine Almus Pharma during pregnancy and breastfeeding has not been established.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Atorvastatine Almus Pharma contains lactose monohydrate

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Atorvastatine Almus 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 Atorvastatine Almus Pharma

Before starting treatment, your doctor will prescribe a low-cholesterol diet, which you must continue to follow during treatment with Atorvastatine Almus Pharma.

The usual starting dose of Atorvastatine Almus Pharma 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 of Atorvastatine Almus Pharma is 80 mg once daily.

Atorvastatine Almus Pharma tablets should be swallowed 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. The score line is intended only to facilitate tablet splitting for ease of ingestion and is not intended for dividing the tablet into equal doses.

Always follow exactly the dosage instructions given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the duration of treatment with Atorvastatine Almus Pharma

Ask your doctor if you think that the effect of Atorvastatine Almus Pharma is too strong or too weak.

If you take more Atorvastatine Almus Pharma 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 medication and the amount ingested.

If you forget to take Atorvastatine Almus Pharma

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

If you stop taking Atorvastatine Almus Pharma

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Atorvastatin Almus Pharma can cause adverse effects, although not everyone experiences them.

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

Rare: may affect 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, or muscle breakdown or change in urine color to red-brown, particularly 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 potentially fatal and cause kidney problems.

Very rare: may affect 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 skin rashes, joint disorders, and effects on blood cells).

Other possible adverse effects with Atorvastatin Almus Pharma:

Frequent (may affect up to 1 in 10 patients):

• Inflammation of the nasal passages, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose levels (if you are diabetic, monitor your blood glucose levels), increased creatine kinase in blood
• 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 patients):

• Anorexia (loss of appetite), weight gain, decreased blood glucose levels (if you are diabetic, continue to monitor your blood glucose 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 (edema), increased body temperature
• Urine tests positive for white blood cells

Rare (may affect up to 1 in 1,000 patients):

• 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 patients):

• 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 (breast enlargement in men and women)

Frequency not known (frequency cannot be estimated from available data):

• Persistent muscle weakness.
• Myasthenia gravis (a condition causing generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Ocular myasthenia (a condition 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. More likely if you have high levels of sugar and fats in the 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 a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Atorvastatin Almus Pharma

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

Do not use Atorvastatin Almus Pharma after the expiry date stated on the blister and outer packaging following EXP. The expiry date refers to the last day of the month indicated.

Store below 25 °C.

Medicines should 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 have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and additional information

Composition of Atorvastatina Almus Pharma

• The active substance is atorvastatin.

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

The other components are:

Monohydrate lactose, microcrystalline cellulose, calcium carbonate, copovidone, crospovidone type B, sodium croscarmellose, sodium lauryl sulfate, colloidal anhydrous silica, talc and magnesium stearate.

The coating contains: Monoglyceride and dicaprylocaprate, polyvinyl alcohol, talc, titanium dioxide and polyethylene glycol (PEG) grafted polyvinyl alcohol copolymer.

Appearance of the product and contents of the container

Film-coated tablets of Atorvastatina Almus Pharma 80 mg are white, round, biconvex tablets, scored on one side and marked with "80" on the other. Each tablet is approximately 13.0 mm in size.

Atorvastatina Almus Pharma 80 mg is available in packaging containing 28, 30 and 90 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer responsible:

Laboratorios Liconsa, S.A.

Avda. Miralcampo, nº 7. Polígono Industrial Miralcampo.

19200 Azuqueca de Henares (Guadalajara)

Spain

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Crnuce

Republic of Slovenia

This medicinal product is authorized in the Member States of the European Economic Area

with the following names:

Spain: Atorvastatina Almus Pharma 80 mg film-coated tablets EFG

Italy: Atorvastatina Almus Pharma

France: Atorvastatine Almus Pharma 10/20/40/80 mg comprimé pelliculé

Date of the most recent review 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/