ATORVASTATIN ACCORD

Patient Information Leaflet

Atorvastatina Accord 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets, 80 mg film-coated tablets

Generic Medicine
Please 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

Atorvastatina Accord belongs to a class of medicines called statins, which regulate lipid (fat) levels.
Atorvastatina Accord 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 successful. If you are at high risk of cardiovascular disease, Atorvastatina Accord may also be used to reduce this risk, even if cholesterol levels are normal. You should continue a standard cholesterol-lowering diet during treatment.

2. What you need to know before taking Atorvastatin Accord

Do not take Atorvastatin Accord:

• If you are allergic to atorvastatin 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 are not using a reliable method of contraception
• If you are pregnant or planning 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
Talk to your doctor, pharmacist, or nurse before taking Atorvastatin Accord if:

• You suffer from severe respiratory failure
• You are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used for bacterial infections). The combination of fusidic acid and Atorvastatin Accord can lead to serious muscle problems (rhabdomyolysis)
• You have previously had a stroke with bleeding into the brain or small fluid-filled pockets in the brain as a result of previous strokes
• You have kidney problems
• You have an underactive thyroid gland (hypothyroidism)
• You have experienced repeated or unexplained muscle pain, or have a personal or family history of muscle disorders
• You have previously had muscle problems during treatment with other lipid-lowering medicines (e.g. other medicines in the statin or fibrate class)
• You regularly consume large amounts of alcohol
• You have a history of liver disease
• You are over 70 years old

If any of these conditions apply to you, your doctor should perform a blood test before and possibly during treatment with atorvastatin to assess 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 concomitantly (see section 2 “Other medicines and Atorvastatin Accord”).
Additionally, inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and treatments may be needed to diagnose and manage this condition.
While taking this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are 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 Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines may alter the effect of Atorvastatin Accord, or the effect of these medicines may be altered by Atorvastatin Accord. Such interactions may reduce the effectiveness of one or both medicines.
Alternatively, they may increase the risk or severity of side 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 lipid-regulating medicines, e.g. gemfibrozil, other fibrates, colestipol
• Certain calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem, medicines used to regulate heart rhythm, e.g. digoxin, verapamil, amiodarone
• Medicines used for the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, 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 Accord include ezetimibe (a cholesterol-lowering agent), warfarin (reduces blood clot formation), oral contraceptives, stiripentol (an anticonvulsant used for epilepsy), cimetidine (used for stomach upset and peptic ulcer), phenazone (a painkiller), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium and 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 temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart treatment with Atorvastatin Accord. Taking Atorvastatin Accord with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See further information on rhabdomyolysis in section 4.

Atorvastatin Accord with food, drinks, and alcohol
See section 3 for instructions on how to take Atorvastatin Accord.
Please note the following:
Grapefruit juice
You should not drink more than one or two small glasses of grapefruit juice per day, as larger quantities may alter the effects of Atorvastatin Accord.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For further details, see section 2 “Warnings and precautions”.

Pregnancy and breastfeeding
Do not take Atorvastatin Accord if you are pregnant or planning to become pregnant.
Do not take Atorvastatin Accord if you are of childbearing age unless you are using an effective method of contraception.
Do not take Atorvastatin Accord if you are breastfeeding.
The safety of Atorvastatin Accord 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 your ability to drive or operate machinery. However, do not drive if this medicine impairs your ability to do so. Do not use tools or machines if your ability to operate them is impaired by this medicine.

Atorvastatin Accord contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Atorvastatina Accord

Before starting treatment, your doctor will prescribe a low-cholesterol diet, and you must continue this diet during treatment with Atorvastatina Accord.
The usual starting dose of Atorvastatina Accord is 10 mg once daily in adults and children aged 10 years and older. If necessary, your doctor may increase this dose until the required dose is reached. Your doctor will adjust the dosage at intervals of 4 or more weeks. The maximum dose of Atorvastatina Accord is 80 mg once daily.
Atorvastatina Accord 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 your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The duration of treatment with Atorvastatina Accord is determined by your doctor.
If you feel that the effect of Atorvastatina Accord is too strong or too weak, consult your doctor.
If you take more Atorvastatina Accord than you should
If you accidentally take too many Atorvastatina Accord tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
If you forget to take Atorvastatina Accord
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 dose.
If you stop taking Atorvastatina Accord
If you have any further questions about the use of this medicine or if you wish to stop treatment, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects or symptoms, stop taking your tablets
immediately and contact your doctor right away or go to the nearest hospital emergency department.

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

• Severe allergic reaction causing swelling of the face, tongue and throat, which may cause severe breathing difficulties
• Serious condition associated with severe peeling and swelling of the skin, skin blisters, mouth, eyes, genitals and fever. Skin rash with reddish spots, particularly on the palms of the hands or soles of the feet, which may develop into blisters
• Weakness, tenderness, pain or tearing of muscles, or red-brown colouration of the urine; especially if you also feel unwell and have a high fever, this may be due to unusual muscle breakdown (rhabdomyolysis). Unusual muscle breakdown does not always resolve even after stopping atorvastatin and 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
• Lupus-like illness syndrome (including skin rash, joint disorders and effects on blood cells)

Other side effects that may occur with Atorvastatina Accord
Common: may affect up to 1 in 10 people

• Inflammation of the nasal passages, sore throat, nosebleeds
• Allergic reactions
• Increased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels closely), 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: may affect up to 1 in 100 people

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

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

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

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

• Allergic reaction – symptoms may include sudden wheezing 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)

Not known: frequency cannot be estimated from the available data

• Persistent muscle weakness

Possible side effects 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 fats in the blood, are overweight and have high blood pressure. Your doctor will monitor you during treatment with this medicine

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor,
pharmacist or nurse. You may also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atorvastatina Accord

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date which is stated on the carton and on the blister after
Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

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

The other components are:
Tablet core: calcium carbonate, monohydrate lactose, microcrystalline cellulose,
sodium croscarmellose, hydroxypropylcellulose, polysorbate 80, magnesium stearate
Film coating: hypromellose 2910, macrogol 8000, titanium dioxide (E171), talc

Description of the appearance of Atorvastatina Accord and contents of the pack
Atorvastatina Accord 10 mg film-coated tablets: White to off-white, round, biconvex film-coated tablets with a diameter of approximately 5.6 mm, marked with “FUI” on one side and smooth on the other side.
Atorvastatina Accord 20 mg film-coated tablets: White to off-white, round, biconvex film-coated tablets with a diameter of approximately 7.1 mm, marked with “FU2” on one side and smooth on the other side.
Atorvastatina Accord 40 mg film-coated tablets: White to off-white, round, biconvex film-coated tablets with a diameter of approximately 9.6 mm, marked with “FU3” on one side and smooth on the other side.
Atorvastatina Accord 80 mg film-coated tablets: White to off-white, round, biconvex film-coated tablets with a diameter of approximately 12.1 mm, marked with “FU4” on one side and smooth on the other side.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex, HA1 4HF
United Kingdom
Accord Healthcare Polska Sp. z o.o.,
ul. Lutomierska 50,
95-200 Pabianice,
Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands

This medicinal product is authorised in the European Economic Area Member States under the following names: