ATORVASTATIN ALMUS PHARMA 80 mg FILM-COATED TABLETS

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

Do not take Atorvastatin Almus Pharma

• If you are allergic to atorvastatin or to any other medicine used to lower blood lipid levels or to any of the other ingredients of this medicine (listed in section 6).
• If you have or have ever had a liver disease.
• If you have had any unexplained abnormal blood test results indicating liver function problems.
• If you are a woman able to have children and are not using reliable contraception.
• If you are pregnant or trying to become pregnant.
• If you are breast-feeding.
• 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 taking Atorvastatin Almus Pharma.

• if you have severe respiratory failure.
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) by mouth or by injection. The combination of fusidic acid and Atorvastatin Almus Pharma can cause muscle problems (rhabdomyolysis).
• if you have had a previous stroke with bleeding in the brain, or have small pockets 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 had repeated or unexplained muscle pains or have a family history of muscle problems.
• if you have had muscle problems while taking other lipid-lowering medicines (e.g. other statins or fibrates).
• if you have or have had muscle weakness that is constant (myasthenia), or muscle weakness in the eyes (ocular myasthenia), as statins can sometimes make these conditions worse 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 to carry out 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 medicines are taken at the same time (see section 2 “Using Atorvastatin Almus Pharma with other medicines”).

Also, tell your doctor or pharmacist if you experience any muscle weakness that persists.

While you are on this medicine your doctor will check you for signs of diabetes or increased risk of developing diabetes. This risk of diabetes increases if you have high levels of sugars and fats in your blood, are overweight, and have high blood pressure.

Using Atorvastatin Almus Pharma with other medicines

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

There are some medicines that may affect the way Atorvastatin Almus Pharma works, or the effect of these medicines may be altered by Atorvastatin Almus Pharma. This type of interaction can reduce the effect of one or both medicines. Alternatively, this combined use may increase the risk or severity of side effects, including serious muscle damage, known as rhabdomyolysis, described in Section 4:

• Medicines used to modify the functioning of your immune system, e.g. ciclosporin.
• Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medicines for lowering lipid levels, e.g. gemfibrozil, other fibrates, colestipol.
• Certain calcium channel blockers used for the treatment of high blood pressure or angina, e.g. amlodipine, diltiazem; medicines used to regulate your heart rhythm, e.g. digoxin, verapamil, amiodarone.
• Letermovir, a medicine that helps prevent diseases caused by cytomegalovirus.
• Medicines used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Certain 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 Atorvastatin Almus Pharma include ezetimibe (which lowers 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 gout), and antacids (indigestion products containing aluminum or magnesium).
• Medicines obtained without a prescription: St. John's Wort.
• If you have to take oral fusidic acid to treat a bacterial infection, you will have to stop using this medicine. Your doctor will tell you when you can restart the 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 medicine used to treat skin and skin structure infections and bacteremia).

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 take more than one or two small glasses of grapefruit juice per day, as large quantities of grapefruit juice can affect the effects of Atorvastatin Almus Pharma.

Alcohol

Avoid drinking too much alcohol while taking this medicine. See the details in Section 2 “Be careful with Atorvastatin Almus Pharma”.

Pregnancy, breast-feeding, and fertility

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

Do not take Atorvastatin Almus Pharma if you are of childbearing age and are not using reliable contraception.

Do not take Atorvastatin Almus Pharma if you are breast-feeding.

The safety of Atorvastatin Almus Pharma during pregnancy and breast-feeding has not been established.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Atorvastatin Almus Pharma contains lactose monohydrate

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

Atorvastatin Almus Pharma contains sodium

This medicine contains less than 1mmol 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 of age. Your doctor may increase the dose 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 the day with or without food. However, try to take your tablet at the same time every day. The break line is only to facilitate breaking and not to divide into equal doses.

Follow exactly the administration instructions of this medicine given 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 medicine 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 forgotten doses.

If you stop taking Atorvastatin Almus Pharma

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

4. Possible side effects

Like all medicines, Atorvastatin Almus Pharma can cause side effects, although not everybody 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 up to 1 in 10,000 patients:

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which can cause great difficulty in 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 go away, even after stopping atorvastatin, and can be potentially fatal and cause kidney problems.

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

• If you experience bleeding or bruising problems or unexpected or unusual bruising, 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):

• inflammation of the nasal passages, 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 (anorexia), 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
• urine tests positive 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 (breast enlargement in men and women).

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

• Constant muscle weakness.
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a disease that causes weakness of the eye muscles).
• Talk to 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 (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 levels of sugars 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 side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side 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 expiration date stated on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

Store below 25 ºC.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicinal products in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicinal products. 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 80 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 macrogol (PEG) graft copolymer of polyvinyl alcohol.

Appearance of the Product and Container Content

The film-coated tablets of Atorvastatina Almus Pharma 80 mg are round, biconvex, and white, scored on one side and marked with 80 on the other. The dimension of each tablet is approximately 13.0 mm.

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

Only some package 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 80 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/