Package Insert: Information for the Patient

Atorvastatina Almus Pharma10 mgFilm-Coated Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.,since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

Atorvastatina Almus Pharma is used to reduce lipids such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes on their own have failed. If you have a high risk of heart disease, Atorvastatina Almus Pharmamay also be used to reduce this risk even though your cholesterol levels are normal. During treatment, a standard low-cholesterol diet must be followed.

Do not take Atorvastatina Almus Pharma

• If you are allergic to atorvastatin or to any other medicine used to reduce blood lipids or to any of the other components of this medicine (listed in section 6).
• If you have or have had any liver disease.
• If you have or have had abnormal liver function test results.
• If you are a fertile woman and do not use adequate contraceptive measures.
• If you are pregnant or trying to become pregnant.
• If you are breastfeeding.
• If you are using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Atorvastatina 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 by injection. The combination of fusidic acid and Atorvastatina Almus Pharma may cause severe muscle problems (rhabdomyolysis).
• If you have had a previous stroke with bleeding in the brain, or have small fluid-filled embolisms in the brain due to previous strokes.
• If you have kidney problems.
• If you have a thyroid gland with low activity (hypothyroidism).
• If you have repeated or unjustified muscle pain, personal or family history of muscle problems.
• If you have had muscle problems during previous treatment with other medicines to reduce lipids (for example, with another statin or fibrates).
• 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 may sometimes worsen the disease or cause 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.

Your doctor may instruct you to have blood tests before and possibly during treatment with Atorvastatina Almus Pharma to predict the risk of adverse effects related to muscle. It is known that the risk of adverse effects related to muscle (for example, rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 “Use of Atorvastatina Almus Pharma with other medicines”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

While you are taking this medicine, your doctor will monitor 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 your blood, obesity, and high blood pressure.

Use of Atorvastatina Almus Pharma with other medicines

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

There are some medicines that may affect the proper functioning of Atorvastatina Almus Pharma or the effects of these medicines may be modified by Atorvastatina Almus Pharma. This type of interaction may reduce the effect of one or both medicines. Alternatively, this combined use may increase the risk or severity of adverse effects, including the important muscle deterioration, known as rhabdomyolysis described in section 4:

• Medicines used to modify the functioning of your immune system, for example, ciclosporin.
• 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 in the treatment of angina or hypertension, for example, amlodipine, diltiazem; medicines to regulate your heart rhythm, for example, digoxin, verapamil, amiodarone.
• Letermovir, a medicine that helps prevent diseases caused by cytomegalovirus.
• Medicines used in the treatment of AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Other medicines used in the treatment of hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir and ledipasvir/sofosbuvir.
• Other medicines that are known to interact with Atorvastatina Almus Pharma, including ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a pain reliever), colchicine (used for treating gout) and antacids (products for indigestion that contain aluminum or magnesium).
• Over-the-counter medicines: St. John's Wort.
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop taking this medicine. Your doctor will instruct you when you can resume treatment with atorvastatin. The use of atorvastatin with fusidic acid may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Daptomycin (a medicine used to treat skin and skin structure infections and bacteria present in the blood).

Taking Atorvastatina Almus Pharma with food, drinks, and alcohol

See section 3 for instructions on how to take Atorvastatina Almus Pharma. Please note the following:

Orange juice

Do not take more than one or two small glasses of orange juice per day because large amounts of orange juice may alter the effects of Atorvastatina Almus Pharma.

Alcohol

Avoid drinking large amounts of alcohol while taking this medicine. See details in section 2 “Be careful with Atorvastatina Almus Pharma”.

Pregnancy, breastfeeding, and fertility

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

Do not take Atorvastatina Almus Pharma if you are fertile and do not use adequate contraceptive measures.

Do not take Atorvastatina Almus Pharma if you are breastfeeding your child.

The safety of Atorvastatina Almus Pharma during pregnancy and breastfeeding has not been demonstrated.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

Normally, this medicine 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 machinery if this medicine affects your ability to handle them.

Atorvastatina Almus Pharma contains lactose monohydrate

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

Atorvastatina Almus Pharma contains sodium

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

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

The usual initial dose of Atorvastatina Almus Pharmais 10 mg once a day in adults and children aged 10 years or older. Your doctor may increase it 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 Atorvastatina Almus Pharma is 80 mg once a day.

Atorvastatina Almus Pharma tablets should be swallowed with a glass of water and can be taken at any time of the day with or without food. However, try to take your tablet every day at the same time. The scoring line is only to facilitate breaking the tablet for easier ingestion and not to divide into equal doses.

Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the duration of treatment withAtorvastatina Almus Pharma

Ask your doctor if you think the effect ofAtorvastatina Almus Pharmais too strong or too weak.

If you take more Atorvastatina Almus Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Atorvastatina Almus 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 the missed doses.

If you interrupt treatment with Atorvastatina Almus Pharma

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

Like all medicines, Atorvastatina Almus Pharma can cause side effects, although not everyone will experience them.

If you notice any of the following serious side effects or symptoms, stop taking these tablets and inform your doctor immediately or visit the nearest hospital emergency service.

Rare: may affect between 1 and 10 of every 10,000 patients:

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which may make it difficult to breathe.

• Severe disease with severe peeling and inflammation of the skin; blisters on the skin, mouth, genitals, and eyes, and fever. Skin rash with pink-red spots, especially on the palms of the hands or soles of the feet that may form blisters.

• Muscle weakness, tenderness, pain, or muscle rupture, or a change in urine color to brown-red, and especially if you have discomfort or high fever, it may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown may not always disappear even after stopping atorvastatin, and may be potentially fatal and cause kidney problems.

Very rare: may affect fewer than 1 of every 10,000 patients:

• If you experience unexpected or unusual bleeding or bruising, this may suggest liver problems. You should consult your doctor as soon as possible.
• Lupus-like syndrome (including skin rashes, joint disorders, and effects on blood cells).

Other possible side effects with Atorvastatina Almus Pharma:

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

• Inflammation of the nasal passages, sore throat, nasal bleeding
• 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
• Abnormal results of blood tests that may show abnormal liver function

Occasional (may affect up to 1 in 100 patients):

• 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 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)
• Heptatitis (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 patients):

• Vision changes
• Unexpected bleeding or bruising
• Bile duct obstruction (yellowing of the skin and the white of the eyes)
• Tendon injury
• Skin rash or ulcers in the mouth (drug reaction)
• Lesions on the skin or purple spots (signs of inflammation of blood vessels, vasculitis)

Very rare (may affect up to 1 in 10,000 patients):

• Allergic reaction - symptoms may include sudden hissing while breathing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• Loss of hearing
• Gynecomastia (enlargement of the breasts in men and women).

Frequency unknown (the frequency cannot be estimated from the available data):

• Constant muscle weakness.
• Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Myasthenia ocular (a disease that causes weakness of the eye muscles).
• Consult your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision, eyelid drooping, 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. It is more likely if you have high blood sugar and fat levels, overweight, and high blood pressure. Your doctor will monitor you while 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 that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use Atorvastatina Almus Pharma after the expiration date that appears on the blister and on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 25 °C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Atorvastatina Almus Pharma

• The active ingredient is atorvastatina.

Each film-coated tablet contains 10 mg of atorvastatina (as atorvastatina calcium trihydrate).

The other components are:

Lactose monohydrate, microcrystalline cellulose, calcium carbonate, copovidone,crospovidone type B, croscarmelosa sodium, laurilsulfate sodium, colloidal anhydrous silica, talc, and estearate magnesium.

The coating contains: Mono gliceril and dicaprilocaprato, alcohol polivinílico, talc, dióxido de titanio and copolímero de injerto de macrogol (PEG) de alcohol polivinílico.

Appearance of the product and contents of the package

The film-coated tablets of Atorvastatina Almus Pharma 10 mg are round, biconvex, and white, scored on one side and marked with 10 on the other. The dimension of each tablet is approximately 7.0 mm.

Atorvastatina Almus Pharma 10 mg is presented in boxes containing 28, 30, and 90 film-coated tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email:[email protected]

Responsible for manufacturing:

Laboratorios Liconsa,S.A.

Avda. Miralcampo, nº 7. Industrial Estate Miralcampo.

19200 Azuqueca de Henares (Guadalajara)

Spain

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Crnuce

Republic of Slovenia

This medicine is authorized in the Member States of the European Economic

Space with the following names:

Spain: Atorvastatina Almus Pharma 10 mg film-coated tablets EFG

Italy:Atorvastatina Almus Pharma

France: Atorvastatine Almus Pharma 10/20/40/80 mg coated tablet

Last review date of this leaflet:October 2024

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/