Atorvastatin Pensà

PACKAGE LEAFLET: INFORMATION FOR THE USER

ATORVASTATINA PENSA 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets, 80 mg film-coated tablets

Atorvastatin
Read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT ATORVASTATIN PENSA IS AND WHAT IT IS USED FOR

ATORVASTATIN PENSA belongs to a class of medicines called statins, which regulate lipid (fat) levels.
ATORVASTATIN PENSA is used to reduce lipid levels in the blood, known as cholesterol and triglycerides, when a low-fat diet and lifestyle changes have not been effective. If you are at high risk of cardiovascular disease, ATORVASTATIN PENSA may also be used to reduce this risk, even if cholesterol levels are normal. During treatment, you must continue a standard cholesterol-lowering diet.

2. WHAT YOU SHOULD KNOW BEFORE TAKING ATORVASTATIN PENSA

Do not take ATORVASTATIN PENSA:

• If you are using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C
• if you are hypersensitive (allergic) to atorvastatin, or to medicines similar to it 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 had liver disease
• if liver function tests have shown unexplained abnormal results
• if you are a woman of childbearing age and do not use a reliable method of contraception
• if you are pregnant or planning a pregnancy
• if you are breastfeeding

Warnings and precautions
Talk to your doctor or pharmacist before taking ATORVASTATIN PENSA.
Below are the reasons why ATORVASTATIN PENSA may not be suitable for you:

• if you have previously had a stroke with cerebral haemorrhage or if you have low cerebrospinal fluid volume 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 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. other medicines in the statin or fibrate classes)
• if you regularly consume large amounts of alcohol
• if you have a history of liver disease
• if you are over 70 years of age

Check with your doctor or pharmacist before taking ATORVASTATIN PENSA

• If you suffer from severe respiratory failure

If any of these conditions apply to you, your doctor should perform a blood test before and possibly during treatment with ATORVASTATIN PENSA to assess the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects (e.g. rhabdomyolysis) increases when certain medicines are taken concomitantly (see Section 2 "Other medicines and ATORVASTATIN PENSA").
Additionally, inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and treatments may be required to diagnose and manage this condition.
During treatment with this medicine, your doctor will monitor you regularly if you have diabetes or are at risk of developing diabetes. You may be at risk of developing diabetes if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure.
Other medicines and ATORVASTATIN PENSA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Some medicines may alter the effect of ATORVASTATIN PENSA, or the effect of these medicines may be altered by ATORVASTATIN PENSA. This type of interaction may reduce the effectiveness of one or both medicines. Alternatively, it may increase the risk or severity of adverse effects, including a condition involving muscle breakdown known as rhabdomyolysis, described in Section 4:

• Medicines used to modify the way the immune system works, e.g. cyclosporine
• Certain antibiotics or antifungals, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid
• Other medicines used to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol
• Certain calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem; medicines for controlling heart rhythm, e.g. digoxin, verapamil, amiodarone
• Medicines used for the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.
• Certain medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir
• Other medicines known to interact with Atorvastatin Pensa such as ezetimibe (which lowers cholesterol), warfarin (which reduces blood clot formation), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for stomach upset and peptic ulcers), phenazone (a painkiller), colchicine (used to treat gout), and antacids (for indigestion containing aluminium or magnesium)
• Over-the-counter medicines: St. John’s Wort. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, including those not requiring a prescription.

ATORVASTATIN PENSA with food and drinks
See Section 3 for instructions on how to take ATORVASTATIN PENSA. Please note the following:
Grapefruit juice
You should not drink more than one or two small glasses per day of grapefruit juice, as large quantities of grapefruit juice may alter the effects of ATORVASTATIN PENSA.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For further details, refer to Section 2 "Warnings and precautions".
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take ATORVASTATIN PENSA if you are pregnant or planning a pregnancy. Do not take ATORVASTATIN PENSA if you are of childbearing age unless you are using an effective method of contraception.
Do not take ATORVASTATIN PENSA if you are breastfeeding.
The safety of ATORVASTATIN PENSA during pregnancy and breastfeeding has not yet been established.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
This medicine usually does not affect the ability to drive or use machinery. However, do not drive if this medicine impairs your ability to drive. Do not operate tools or machinery if your ability to use them is impaired by this medicine.
ATORVASTATIN PENSA contains lactose monohydrate and sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. HOW TO TAKE ATORVASTATIN PENSA

Before starting treatment, your doctor will prescribe a low-cholesterol diet, which you must follow also during treatment with ATORVASTATIN PENSA.
The usual starting dose of ATORVASTATIN PENSA is 10 mg once daily in adults and in children over 10 years of age. If necessary, your doctor may increase this dose gradually until the required dose is reached. Your doctor will adjust the dosage at intervals of 4 or more weeks. The maximum dose of ATORVASTATIN PENSA is 80 mg once daily for adults and 20 mg once daily for children.
The ATORVASTATIN PENSA tablets must be swallowed whole with water and can be taken at any time of day, with or without food. However, try to take the tablets at the same time each day.
Always take this medicine exactly as described in this leaflet or as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.
The duration of treatment with ATORVASTATIN PENSA is determined by your doctor.
If you feel that the effect of ATORVASTATIN PENSA is too strong or too weak, consult your doctor.
If you take more ATORVASTATIN PENSA than you should
If you accidentally take too many ATORVASTATIN PENSA tablets (more than the prescribed dose), contact your doctor or the nearest hospital for advice.
If you forget to take ATORVASTATIN PENSA
If you forget to take a dose, take the next dose at the scheduled time.
Do not take a double dose to make up for the missed dose.
If you stop taking ATORVASTATIN PENSA
If you have any doubts about using this medicine or wish to discontinue treatment, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If you experience any of the following serious adverse reactions, stop taking your tablets immediately and contact your doctor or go to the nearest hospital emergency department without delay.

Rare (may affect up to 1 in 1,000 people)

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may lead to significant breathing difficulties;
• A serious condition associated with severe skin peeling and swelling, skin blisters, blisters in the mouth, eyes, genitals, and fever. Skin rash with reddish spots, particularly located on the palms of the hands or soles of the feet, which may develop into blisters;
• If you experience muscle weakness, tenderness, or pain, especially if accompanied by feeling unwell and high fever, this may be due to abnormal muscle breakdown. Abnormal muscle breakdown is not always reversible and may continue even after stopping atorvastatin. It can be life-threatening and may lead to kidney problems.

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

• If you experience unexpected or unusual bleeding or bruising, this may indicate a liver disorder. You should contact your doctor as soon as possible.

Other adverse reactions that may occur with ATORVASTATIN PENSA

Common adverse reactions (may affect up to 1 in 10 people) include:

• Inflammation of the nasal passages, sore throat, nosebleeds
• Allergic reactions
• Increased blood sugar levels (if you have diabetes, you must continue to monitor your blood sugar levels carefully), increased creatine kinase in the blood
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhoea
• Joint pain, muscle pain, and back pain
• Blood test results showing possible liver dysfunction

Uncommon adverse reactions (may affect up to 1 in 100 people) include:

• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you have diabetes, you must continue to monitor your blood sugar levels carefully)
• Nightmares, insomnia
• Dizziness, reduced sensation or tingling in the fingers and toes, reduced sensitivity to pain or touch, altered taste, memory loss
• Blurred vision
• Ringing in the ears and/or head
• Vomiting, belching, abdominal pain, pancreatitis (inflammation of the pancreas with stomach pain)
• Hepatitis (inflammation of the liver)
• Rashes, skin rash and itching, hives, hair loss
• Neck pain, muscle fatigue
• Fatigue, malaise, weakness, chest pain, swelling especially in the ankles (oedema), increased body temperature
• Positive urine test for white blood cells.

Rare adverse reactions (may affect up to 1 in 1,000 people) include:

• Vision disorders
• Unexpected bleeding or bruising
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon damage

Very rare adverse reactions (may affect up to 1 in 10,000 people) include:

• Allergic reaction – symptoms may include sudden shortness of breath and chest pain or tightness in the chest, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
• Hearing loss
• Gynaecomastia (enlargement of the breasts in men)

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data):

• Persistent muscle weakness

Possible adverse reactions reported with some statins (medicines of the same type):

• Sexual difficulties
• Depression
• Breathing difficulties including persistent cough and/or shortness of breath or fever
• Diabetes. This 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 during treatment with this medicine.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ATORVASTATIN PENSA

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions. Store the blister in the original
packaging.
Do not use this medicine after the expiry date stated on the carton or blister after "Exp". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What ATORVASTATINA PENSA contains
The active substance is atorvastatin.
Each film-coated tablet contains 10 mg of atorvastatin (as
atorvastatin calcium).
Each film-coated tablet contains 20 mg of atorvastatin (as
atorvastatin calcium).
Each film-coated tablet contains 40 mg of atorvastatin (as
atorvastatin calcium).
Each film-coated tablet contains 80 mg of atorvastatin (as
atorvastatin calcium).

The other components of ATORVASTATINA PENSA are:
Monohydrate lactose, magnesium stearate (E572), sodium lauryl sulfate, microcrystalline cellulose, anhydrous colloidal silica, butylhydroxyanisole (E320), crospovidone (E1202), sodium hydrogen carbonate (E500), and sinespum (consisting of: sucrose, tristearate sorbitol, polyethylene glycol stearate, dimethicone, silicon dioxide, 2-Bromo-2-nitropropane-1,3-diol). The coating of ATORVASTATINA PENSA contains Opadry OYL-28900 white (consisting of monohydrate lactose, hypromellose, titanium dioxide (E171), and polyethylene glycol 4000).

Description of the appearance of ATORVASTATINA PENSA and contents of the pack
The film-coated tablets of ATORVASTATINA PENSA 10 mg, 20 mg and 40 mg are white, cylindrical, biconvex, with a break line on one side and printed with AT1/AT2/AT4 on the other side.
The film-coated tablets of ATORVASTATINA PENSA 80 mg are white, oblong, biconvex, with a break line on one side and printed with AT8 on the other side.

This medicinal product is available as 10 mg, 20 mg, 40 mg and 80 mg film-coated tablets.
All strengths are available in packs containing 14 (only for 10 mg), 28, 30, 56, or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milano
Italy

Manufacturer
Laboratorios Cinfa, S.A.
Olaz-Chipi, 10 – Polígono Industrial Areta
31620 Huarte – Pamplona
Spain

Galenicum Health, S.L.
Avda Cornellá 144, 7°- 1 Edificio Leklà
Esplugues de Llobregat
08950 Barcelona
Spain

SAG Manufacturing SLU
Crta N-I, Km 36
28750 San Agustin de Guadalix, Madrid
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Portugal: Atorvastatina toLife
Italy: Atorvastatina Pensa

This leaflet was last approved on