ATORVASTATINA 10 mg Film-Coated Tablets

Зміст інструкції

1. Atorvastatina Accord 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets, 80 mg film-coated tablets
   1. What is Atorvastatina Accord and what is it 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. Content of the pack and other information

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

Equivalent Medicinal Product

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Atorvastatina Accord and what is it used for

Atorvastatina Accord belongs to a class of medicines called statins, which regulate the levels of
lipids (fats).
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 can also be
used to reduce this risk, even if your cholesterol levels are normal. You should continue a standard cholesterol-lowering diet during
treatment.

2. What you need to know before taking Atorvastatina Accord

Do not take Atorvastatina Accord:

• 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 a liver disease
• If liver function tests have shown inexplicably altered values
• If you are a woman of childbearing potential and are not using a reliable method of contraception
• If you are pregnant or planning a pregnancy
• If you are breastfeeding
• If you are using the combination of glecaprevir/pibrentasvir in the treatment of hepatitis C

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Atorvastatina Accord.

• if you suffer from 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) orally or by injection. The combination of fusidic acid and Atorvastatina Accord can lead to serious muscle problems (rhabdomyolysis)
• if you have had a previous stroke with bleeding in the brain or have small fluid pockets in the brain as a result of previous strokes
• if you have kidney problems
• if you have an underactive thyroid gland (hypothyroidism)
• if you have had recurrent or unexplained muscle pain, a personal or family history of muscle problems
• if you have had previous muscle problems while taking other lipid-lowering medicines (e.g. other medicines in the statin or fibrate class)
• if you regularly consume significant amounts of alcohol
• if you have a history of liver disease
• if you are over 70 years old.

If any of these conditions apply to you, your doctor will need to perform a blood test before and possibly during treatment with atorvastatin to predict the risk of muscle-type side effects. It is known that the risk of muscle-type side effects (e.g. rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 “Other medicines and Atorvastatina Accord”).
Also, tell your doctor or pharmacist if you have persistent muscle weakness. Further tests and medicines may be needed for the diagnosis and treatment of this condition.
During treatment with this medicine, your doctor will carefully monitor that you do not have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugars and fats in your blood, if you are overweight and have high blood pressure.

Other medicines and Atorvastatina Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines can alter the effect of Atorvastatina Accord or the effect of these medicines can be changed by Atorvastatina Accord. This type of interaction can reduce the effect of one or both medicines.
Alternatively, it can increase the risk or severity of side effects including a condition of muscle breakdown known as rhabdomyolysis, described in section 4:

• Medicines used to change the way the immune system works, e.g. cyclosporine
• Some 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, cholestyramine
• Some calcium antagonists used for angina or high blood pressure, e.g. amlodipine, diltiazem, medicines 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 tipranavir/ritonavir, etc.
• Some medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir and the combination of elbasvir/grazoprevir
• Other medicines that are known to interact with Atorvastatina Accord include ezetimibe (which lowers cholesterol), warfarin (reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for stomach upset and peptic ulcer), phenazone (pain reliever), colchicine (used to treat gout) and antacids (products against indigestion containing aluminum and magnesium)
• Non-prescription medicines: St. John's Wort
• If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart treatment with Atorvastatina Accord. Taking Atorvastatina Accord with fusidic acid can rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.

Atorvastatina Accord with food, beverages and alcohol
See section 3 for instructions on how to take Atorvastatina Accord.
Keep the following in mind:

Grapefruit juice
You should not drink more than one or two small glasses of grapefruit juice a day because high amounts of grapefruit juice can alter the effects of Atorvastatina Accord.

Alcohol
Avoid drinking excessive amounts of alcohol when taking this medicine. For further details see section 2. “Warnings and precautions”.

Pregnancy and breastfeeding
Do not take Atorvastatina Accord if you are pregnant or planning a pregnancy.
Do not take Atorvastatina Accord if you are of childbearing potential unless you are using effective contraception.
Do not take Atorvastatina Accord if you are breastfeeding.
The safety of Atorvastatina Accord during pregnancy and breastfeeding has not yet been demonstrated. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
This medicine usually does not affect your ability to drive or operate machinery. However, do not drive if this medicine alters your ability to drive. Do not use tools or machinery if your ability to use them is altered by this medicine.

Atorvastatina Accord contains lactose
If your doctor has diagnosed you with an intolerance to certain types of sugar, contact him before taking this medicine.

3. How to take Atorvastatina Accord

Before starting treatment, your doctor will prescribe you a low-cholesterol diet and you should
continue to follow this diet during therapy with Atorvastatina Accord.
The usual initial dose of Atorvastatina Accord is 10 mg once a day in adults and in
children aged 10 years or older. If necessary, this dose may be increased by the
doctor until the dose you need is reached. The doctor will adjust the dosage at intervals
of 4 or more weeks. The maximum dose of Atorvastatina Accord is 80 mg once a day.
Atorvastatina Accord tablets should be swallowed whole with water and can be
taken at any time of day, with or without food. However, try to take the tablets
every day at the same time.
Always take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, ask your doctor or pharmacist.

The duration of treatment with Atorvastatina Accord is established by the doctor.
If you feel that the effect of Atorvastatina Accord is too strong or too weak, contact
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 right time. Do not
take a double dose to make up for a forgotten dose.

If you stop taking Atorvastatina Accord
If you have any further questions about the use of this medicine or if you want to stop treatment,
contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

If you experience any of the following serious side effects or symptoms, stop
taking your tablets and immediately inform your doctor or go to the nearest
hospital emergency room.

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

• Serious allergic reaction causing swelling of the face, tongue and throat which can cause significant difficulty in breathing
• Serious condition associated with severe skin peeling and blistering, skin blisters, mouth, eyes, genitals and fever. Skin rash with reddish spots, especially on the palms of the hands or soles of the feet, which may become blisters
• Weakness, tenderness, pain or rupture of muscle or reddish-brown discoloration of the urine and especially, if at the same time you do not feel well and have a high fever, this may be caused by an unusual muscle breakdown (rhabdomyolysis). Unusual muscle breakdown does not always go away, even after stopping atorvastatin and can be life-threatening and can 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 suggest a liver disorder. You should see your doctor as soon as possible
• Syndrome resembling lupus disease (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 cavities, sore throat, nosebleeds
• allergic reactions
• increased blood sugar levels (if you have diabetes, you should continue to carefully monitor your blood sugar levels), increased creatine kinase in the blood
• headache
• nausea, constipation, flatulence, indigestion, diarrhea
• joint pain, muscle pain and back pain
• blood test results showing possible liver dysfunction

Not common:may affect up to 1 in 100 people

• anorexia (loss of appetite), increased body weight, decreased blood sugar levels (if you have diabetes, you should continue to carefully monitor your blood sugar levels)
• nightmares, insomnia
• dizziness, reduced sensitivity 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, pain in the upper and lower abdomen, pancreatitis (inflammation of the pancreas with manifestation of stomach pain)
• hepatitis (inflammation of the liver)
• skin rash, skin rash and itching, hives, hair loss
• neck pain, muscle fatigue
• fatigue, feeling unwell, weakness, chest pain, swelling especially in the ankles (edema), increased body temperature
• urine test positive 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 a feeling of tightness in the chest, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
• hearing loss
• gynecomastia (enlargement of the breasts in men)

Not known:frequency cannot be estimated based on available data

• Persistent muscle weakness

Possibleside effects reported with some statins (drugs of the same type):

• Sexual dysfunction
• Depression
• Difficulty breathing including persistent cough and/or shortness of breath or fever
• Diabetes. This is more likely if you have high sugar and fat levels in your blood, if you are overweight and have high blood pressure. Your doctor will monitor you during treatment with this medicine

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through 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 at a temperature below 25° C.
Do not use this medicine after the expiry date which is stated on the box and blister after
Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Atorvastatina Accord contains
The active ingredient 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 ingredients are:

Tablet core:calcium carbonate, lactose monohydrate, microcrystalline cellulose ,
sodium croscarmellose, hydroxypropylcellulose, polysorbate 80, magnesium stearate

Film coating:Hypromellose 2910, macrogol 8000, titanium dioxide (E171) and 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 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 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 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 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.zo.o.,
ul. Lutomierska 50,
95-200 Pabianice,
Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
Netherlands

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations: