ATORVASTATIN ALMUS PHARMA 10 mg FILM-COATED TABLETS

2. What you need to know before taking Atorvastatin Almus Pharma

Do not take Atorvastatin Almus Pharma

• If you are allergic to atorvastatin or any other similar medication used to reduce blood lipids or to any of the other components of this medication (listed in section 6).
• If you have or have had any 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 breastfeeding.
• 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 Atorvastatin Almus Pharma.

• If you have severe respiratory insufficiency.
• If you are taking or have taken in the last 7 days a medication called fusidic acid (an antibiotic used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Atorvastatin Almus Pharma can cause serious muscle problems (rhabdomyolysis).
• If you have had a previous 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 repeated or unexplained muscle pain, personal or family history of muscle problems.
• If you have previously had muscle problems during treatment with other medications to reduce lipids (e.g., with another statin or fibrates).
• If you have or have had myasthenia (a disease that causes generalized muscle weakness, which in some cases affects 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).
• 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 indicate that you should have blood tests before and, possibly, during treatment with Atorvastatin Almus Pharma 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 medications are taken at the same time (see section 2 "Using Atorvastatin Almus Pharma with other medications").

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

While you are taking this medication, your doctor will monitor you for diabetes or the 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.

Using Atorvastatin Almus Pharma with other medications

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

There are some medications that can affect the proper functioning of Atorvastatin Almus Pharma or whose effects may be modified by Atorvastatin Almus Pharma. This type of interaction can decrease the effect of one or both medications. Alternatively, this combined use can increase the risk or severity of side effects, including serious muscle damage, known as rhabdomyolysis, described in Section 4:

• Medications used to modify the functioning of your immune system, such as cyclosporine.
• Certain antibiotics or antifungal medications, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medications to regulate lipid levels, such as gemfibrozil, other fibrates, colestipol.
• Certain calcium channel blockers used to treat angina or high blood pressure, such as amlodipine, diltiazem; medications to regulate your heart rate, such as digoxin, verapamil, amiodarone.
• Letermovir, a medication that helps prevent diseases caused by cytomegalovirus.
• Medications used to treat AIDS, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Certain medications used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir and ledipasvir/sofosbuvir.
• Other medications that are known to interact with Atorvastatin Almus Pharma include ezetimibe (which reduces 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).
• Over-the-counter medications: St. John's Wort.
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop using this medication. Your doctor will tell you when you can restart treatment with atorvastatin. The use of atorvastatin with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Daptomycin (a medication used to treat skin and skin structure infections with complications and bacteria present in the blood).

Taking Atorvastatin Almus Pharma with food, drinks, and alcohol

See section 3 for instructions on how to take Atorvastatin 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 can alter the effects of Atorvastatin Almus Pharma.

Alcohol

Avoid drinking large amounts of alcohol while taking this medication. See the details in Section 2 "Be careful with Atorvastatin Almus Pharma".

Pregnancy, breastfeeding, and fertility

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

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

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

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

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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

Atorvastatin Almus Pharma contains lactose monohydrate

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

Atorvastatin Almus Pharma contains sodium

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

3. How to take Atorvastatin Almus Pharma

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

The initial dose of Atorvastatin Almus Pharma is 10 mg once a day in adults and children from 10 years old. 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 Almus Pharma is 80 mg once a day.

The tablets of Atorvastatin Almus Pharma should be swallowed 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. The dividing line is only to facilitate breaking and not to divide into equal doses.

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

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

If you take more Atorvastatin Almus Pharma than you should

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

If you forget to take Atorvastatin 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 missed doses.

If you interrupt treatment with Atorvastatin Almus Pharma

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

4. Possible side effects

Like all medications, Atorvastatin Almus Pharma can cause side effects, although not everyone 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 between 1 and 10 out of 10,000 patients:

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which can cause great difficulty breathing.

• Severe skin 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, muscle pain or rupture, or change in urine color to reddish-brown, 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 potentially fatal and cause kidney problems.

Very rare: may affect less than 1 in 10,000 patients:

• If you experience bleeding or bruising problems, this may suggest 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 side effects with Atorvastatin Almus Pharma:

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

• nose inflammation, 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 patients):

• loss of appetite, 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 patients):

• vision changes
• unexpected 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 patients):

• 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 (enlargement of the breasts in men and women).

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

• Constant muscle weakness.
• Severe myasthenia (a disease that causes generalized muscle weakness, which in some cases affects 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 (medications 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 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 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 is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Atorvastatin Almus Pharma

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

Do not use Atorvastatin Almus Pharma after the expiration date shown on the blister pack and carton after CAD. The expiration date is the last day of the month indicated.

Store below 25°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Atorvastatina Almus Pharma

• The active ingredient is atorvastatin.

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

The other components are:

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

The coating contains: Mono glyceril and dicaprilocaprato, polyvinyl alcohol, talc, titanium dioxide, and polyvinyl alcohol macrogol (PEG) graft copolymer.

Product Appearance and Container Content

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 packs containing 28, 30, and 90 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Manufacturer:

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 under 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 film-coated tablet

Date of the last revision of this leaflet:October 2024

Detailed and updated 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/