Package Insert: Information for the User

Aristo Atorvastatina 10 mg Film-Coated Tablets

Read this package insert carefully before you start taking this medicine because it contains important information for you.

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

1. What is Atorvastatina Aristo and what it is used for

2. What you need to know before starting to take Atorvastatina Aristo

3. How to take Atorvastatina Aristo

4. Possible side effects

5. Storage of Atorvastatina Aristo

6.Contents of the pack and additional information

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

Atorvastatina 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 present a high risk of heart disease, atorvastatina may 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 Aristo

• 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 abnormal results in liver function tests,
• 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 taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take atorvastatin

• 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 used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and atorvastatin may cause severe muscle problems (rhabdomyolysis),
• if you have had a previous stroke with bleeding in the brain, or have small fluid-filled cysts 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 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 with general muscle weakness that includes, in some cases, the muscles used for breathing), or myasthenic eye (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the condition or cause myasthenia to appear. (see section 4 “Possible side effects”).

In any of these cases, your doctor may instruct you to have blood tests before and possibly during treatment with atorvastatin to predict the risk of suffering muscle-related side effects. It is known that the risk of suffering muscle-related side effects (for example rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 “Use of Atorvastatina Aristo with other medicines”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medicines may be needed to diagnose and treat this problem.

While taking this medicine, your doctor will check 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, being overweight and high blood pressure.

Other medicines and Atorvastatina Aristo

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 can affect the proper functioning of atorvastatin or the effects of these medicines may be modified by atorvastatin. This type of interaction may reduce the effect of one or both medicines. Alternatively, this combined use may increase the risk or severity of side effects, including the important muscle deterioration, known as rhabdomyolysis described in section 4 “Possible side effects”:

• 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, cholestyramine
• Some calcium channel blockers used in the treatment of 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 diseases caused by cytomegalovirus
• Medicines used in the treatment of HIV, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Other medicines that are known to interact with atorvastatin include: ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (anticonvulsant for treating epilepsy), cimetidine (used for heartburn and stomach ulcers), phenazone (a painkiller), 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 fusidic acid orally to treat a bacterial infection, you will need to stop taking this medicine temporarily. Your doctor will instruct you when it is safe to restart treatment with atorvastatin. Taking atorvastatin in combination with fusidic acid may rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4 “Possible side effects”.
• Daptomycin (a medicine used to treat skin and skin structure infections and bacteria present in the blood).

Taking Atorvastatina Aristo with food, drinks and alcohol

See section 3 for instructions on how to take atorvastatin. 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 can 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

Do not take atorvastatin if you are pregnant, think you may be pregnant or intend to become pregnant.

Do not take atorvastatin if you are fertile unless you take adequate contraceptive measures.

Do not take atorvastatin if you are breastfeeding your child.

The safety of atorvastatin 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 operate them.

Atorvastatina Aristo contains lactose and sodium

Each film-coated tablet of Atorvastatina Aristo 10 mg contains 51.11 mg of lactose (as lactose monohydrate).

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

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

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

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

Dose

The usual initial dose of atorvastatina is 10 mg once a day in adults and children aged 10 years and above. 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 is 80 mg once a day.

Method of administration

Atorvastatina tablets should be swallowed whole 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.

Treatment duration

Your doctor will decide the duration of atorvastatina treatment.

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

If you take more Atorvastatina Aristo than you should

If you accidentally take too many atorvastatina tablets (more than your usual daily dose), consult your doctor or the nearest hospital or call the Toxicological Information Service, phone 91562 04 20, indicating the medication and the amount taken. Bring the remaining tablets, the packaging, and the complete box so that the hospital staff can easily identify the medication you have taken.

If you forgot to take Atorvastatina Aristo

If you forgot 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 Aristo

If you have any other doubts about the use of this medication or want to interrupt treatment, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

• Severe allergic reaction that causes swelling of the face, tongue, and throat that may cause great difficulty breathing.
• Severe disease with severe peeling and inflammation of the skin; blisters on the skin, mouth, eyes, and genitals, 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, pain on palpation, pain, urine discoloration, or brownish-red color, and especially if you have discomfort or high fever, it may be due to abnormal muscle rupture (rhabdomyolysis). Abnormal muscle rupture does not always disappear, even after stopping atorvastatin, and may be fatal and cause kidney problems.

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

• 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 rash, joint disorders, and effects on blood cells).

Other possible side effects with Atorvastatina Aristo:

Frequent: may affect up to 1 in 10 people

• nasal congestion, sore throat, nosebleeds
• Allergic reactions
• Increases in blood sugar levels (if you are diabetic, monitor your blood sugar levels), increased creatine kinase in blood
• Headache
• Nausea, constipation, gas, indigestion, diarrhea
• Joint pain, muscle pain, and back pain
• Abnormal blood test results that may show abnormal liver function

Infrequent: may affect up to 1 in 100 people

• Loss of appetite (anorexia), weight gain, decreased blood sugar levels (if you are diabetic, 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 that causes stomach pain
• Liver inflammation (hepatitis)
• 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 people

• Visual disturbances
• Unexpected or unusual bleeding or bruising
• Yellowing of the skin and white of the eyes (cholestasis)
• Tendon injury
• Skin rash or ulcers in the mouth (drug-induced lichenoid reaction)
• Lesions on the skin or ulcers in the mouth (signs of inflammation of blood vessels, vasculitis)

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

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

Frequency unknown: cannot be estimated from available data:

• Constant muscle weakness
• Myasthenia gravis (a disease that causes general muscle weakness, including in some cases the muscles used for breathing)
• Myasthenia ocular (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 (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 medicine.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is side effects that do not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the blister pack and on the packaging after {CAD}. The expiration date is the last day of the month indicated.

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 at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Atorvastatina Aristo

• The active ingredient is atorvastatina.
• Each film-coated tablet of Atorvastatina Aristo 10 mg contains 10 mg of atorvastatina (as atorvastatina calcium trihydrate).

The other components are:

Core of the tablet:microcrystalline cellulose E460, lactose monohydrate, calcium carbonate E170, hydroxypropylcellulose E463, croscarmellose sodium type A E468, anhydrous colloidal silica E551, magnesium stearate E572

Film coating:hypromellose E464, macrogol, titanium dioxide E171, talc E553b

Appearance of the product and contents of the package

Atorvastatina Aristo 10 mg film-coated tablets are presented in the form of

white, oblong, film-coated tablets with a “10” marked on one face and “ATV” on the other, with a length of: 8.3 mm and a width of: 4.2 mm.

The tablets are presented in PVC/PVDC – Alu blister packs of 14, 28, 30, 50, 56, 90 and 100 tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aristo Pharma GmbH

Wallenroder

Straße 8-10,

13435 Berlin, Germany

Responsible for manufacturing

Haupt Pharma Latina S.r.l

Borgo San Michele S.S. 156 km. 47,600

04100- Latina

Italy

Or

Aristo Pharma GmbH

Wallenroder

Straße 8-10,

13435 Berlin, Germany

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Aristo Pharma Iberia, S.L.

C/Solana, 26

28850 Torrejón de Ardoz, Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Germany: Atorvastatin Aristo 10 mg Filmtabletten

Austria: Atorvastatin Aristo Pharma 10 mg Filmtabletten

Spain: Atorvastatina Aristo 10 mg film-coated tablets

Netherlands: Atorvastatine Aristo 10 mg filmomhulde tabletten

Italy: Atorvastatina Aristo Pharma 10 mg compresse rivestite con film

Portugal: Atorvastatina Aristogen 10 mg film-coated tablets

Date of the last review of this prospectus:November 2024

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