АТОРВАСТАТИНА 10 мг Фильм-coated таблетки

Содержание инструкции

1. ATORVASTATINA ALMUS PHARMA 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets, 80 mg film-coated tablets
   1. What is ATORVASTATINA ALMUS PHARMA and what is it used for
   2. What you need to know before taking ATORVASTATINA ALMUS PHARMA
   3. How to take ATORVASTATINA ALMUS PHARMA
   4. Possible side effects
   5. How to store ATORVASTATINA ALMUS PHARMA
   6. Package Contents and Other Information

ATORVASTATINA ALMUS PHARMA 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 their symptoms are the same as yours, 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 ALMUS PHARMA is and what it is used for
• 2. What you need to know before you take ATORVASTATINA ALMUS PHARMA
• 3. How to take ATORVASTATINA ALMUS PHARMA
• 4. Possible side effects
• 5. How to store ATORVASTATINA ALMUS PHARMA
• 6. Contents of the pack and other information

1. What is ATORVASTATINA ALMUS PHARMA and what is it used for

ATORVASTATINA ALMUS PHARMA belongs to a class of medicines called statins, which
regulate lipid (fat) levels.
ATORVASTATINA ALMUS PHARMA 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 ALMUS PHARMA 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 ATORVASTATINA ALMUS PHARMA

Do not take ATORVASTATINA ALMUS PHARMA

• if you are allergic to atorvastatin or to any of the medicines used to reduce levels of lipids in the blood, or to any of the other components of this medicine (listed in section 6),
• if you have or have had a disease that affects the liver,
• if the results of 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 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 infection) orally or by injection. The combination with fusidic acid and ATORVASTATINA ALMUS PHARMA can lead to serious muscle problems (rhabdomyolysis).
• If you have had a previous stroke with cerebral haemorrhage or if you have few fluid reserves in the brain due to 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 (for example other medicines in the statin class or fibrates).
• If you regularly consume significant amounts of alcohol.
• If you have a history of liver disease.
• If you are over 70 years of age.

If any of these conditions apply to you, your doctor will need to perform a blood test before and possibly during treatment with ATORVASTATINA ALMUS
PHARMA to predict the risk of muscle-related side effects. It is known that the risk of
muscle-related side effects (for example rhabdomyolysis) increases when certain
medicines are taken at the same time (see Section 2 “Other medicines and
ATORVASTATINA ALMUS PHARMA”).
Also, tell your doctor or pharmacist if you have persistent muscle weakness. Further
tests and medicines may be needed to diagnose and treat 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. If you are at risk of developing diabetes if
you have high levels of sugars and fats in the blood, if you are overweight and have high
blood pressure.

Other medicines and ATORVASTATINA ALMUS PHARMA
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 ALMUS PHARMA or the effect of these medicines can be changed by
ATORVASTATINA ALMUS PHARMA.
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, for example 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, cholestipol
• 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 to treat hepatitis C, for example telaprevir, boceprevir and the combination of elbasvir/grazoprevir.
• Other medicines that are known to interact with ATORVASTATINA ALMUS PHARMA include ezetimibe (which lowers cholesterol), warfarin (reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (pain reliever), colchicine (used to treat gout) and antacids (products for indigestion containing aluminium and magnesium).
• Non-prescription medicines: St John's Wort
• If you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop using this medicine. Your doctor will tell you when it is safe to restart ATORVASTATINA ALMUS PHARMA. Taking ATORVASTATINA ALMUS PHARMA with fusidic acid may rarely lead to muscle weakness, soreness or pain (rhabdomyolysis). For more information about rhabdomyolysis see Section 4. Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription.

ATORVASTATINA ALMUS PHARMA with food, drinks and alcohol
See Section 3 for instructions on how to take ATORVASTATINA ALMUS PHARMA.
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 ALMUS PHARMA.

Alcohol
Avoid drinking too much alcohol when taking this medicine. For further
details see Section 2. “Warnings and precautions”.

Pregnancy, breastfeeding and fertility
Do not take ATORVASTATINA ALMUS PHARMA if you are pregnant or planning a
pregnancy.
Do not take ATORVASTATINA ALMUS PHARMA if you are of childbearing potential unless you are using an effective method
of contraception.
Do not take ATORVASTATINA ALMUS PHARMA if you are breastfeeding.
The safety of ATORVASTATINA ALMUS PHARMA during pregnancy and breastfeeding has not
been demonstrated yet.
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 ALMUS PHARMA contains lactose monohydrate
If your doctor has diagnosed you with an intolerance to some sugars, contact him before taking
this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e.
essentially ‘sodium-free’.
For the full list of ingredients see Section 6 Contents of the pack and other
information.

3. How to take ATORVASTATINA ALMUS PHARMA

Before starting treatment, your doctor will prescribe you a low-cholesterol diet, and you should continue to follow this diet during therapy with ATORVASTATINA ALMUS PHARMA.
The usual initial dose of ATORVASTATINA ALMUS PHARMA is 10 mg once a day in adults and children aged 10 years and over. If necessary, this dose may be increased by your doctor until the dose you need is reached. Your doctor will adjust the dosage at intervals of 4 weeks or more. The maximum dose of ATORVASTATINA ALMUS PHARMA is 80 mg once a day for adults.
ATORVASTATINA ALMUS PHARMA tablets must be swallowed whole with water and can be taken at any time of the 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 instructed. If you have
any doubts, consult your doctor or pharmacist.

The duration of treatment with ATORVASTATINA ALMUS PHARMA is established by your doctor.
If you feel that the effect of ATORVASTATINA ALMUS PHARMA is too strong or too weak, contact your doctor.

If you take more ATORVASTATINA ALMUS PHARMA than you should
If you accidentally take too many ATORVASTATINA ALMUS PHARMA tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.

If you forget to take ATORVASTATINA ALMUS PHARMA
If you forget to take a dose, take the next dose at the right time. Do not take a double dose to make up for a missed tablet.

If you stop taking ATORVASTATINA ALMUS PHARMA
If you have any doubts about using this medicine, or want to stop treatment, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience 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

• Severe 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 swelling, 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 develop into blisters.
• If you experience muscle weakness, soreness, pain, tearing or reddish-brown discoloration of the urine, and especially if you do not feel well and have a high fever at the same time, this may be caused by abnormal muscle deterioration. Abnormal muscle deterioration does not always go away, even after stopping ATORVASTATINA ALMUS PHARMA, it can be life-threatening and can lead to kidney problems.

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

• If you experience problems with unexpected or unusual bleeding or bruising, this may suggest liver dysfunction. See your doctor as soon as possible.
• Lupus-like syndrome (including rash, joint problems and effects on blood cells).

Other side effects that may occur with ATORVASTATINA ALMUS PHARMA
Common side effects (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 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 tests showing a possible abnormality in liver function.

Uncommon side effects (may affect up to 1 in 100 people) include:

• 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 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 with stomach pain)
• hepatitis (inflammation of the liver)
• skin rash, skin rash and itching, hives, hair loss
• neck pain, muscle fatigue
• fatigue, malaise, weakness, chest pain, swelling especially in the ankles (edema), increased body temperature
• urine tests positive for white blood cells.

Rare side effects (may affect up to 1 in 1,000 people) include:

• vision disorders
• unexpected or unusual bleeding or bruising
• cholestasis (yellowing of the skin and whites of the eyes)
• tendon damage.

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

• 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 (increase in breast volume in men and women).

Side effects of unknown frequency:

• persistent muscle weakness.

Possible side effects reported with some statins (medicines of the same type):

• sexual difficulties
• depression
• difficulty breathing including persistent cough and/or shortness of breath or fever
• diabetes. This is more likely if you have high blood sugar and fat levels, 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 experience any side effects, including those not listed in this leaflet, please
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 contribute to providing more information on the safety of this medicine.

5. How to store ATORVASTATINA ALMUS PHARMA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the package
after “Exp.:”. The expiry date refers to the last day of that month.
10 mg and 80 mg:
Store at a temperature below 25  C.
20 mg and 40 mg:
Store at a temperature below 30  C.
Do not dispose of any medicine in 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 ALMUS PHARMA 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: 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: hypromellose, titanium dioxide (E171) and macrogol 400.

Description of the appearance of ATORVASTATINA ALMUS PHARMA and package contents
10 mg: ATORVASTATINA ALMUS PHARMA film-coated tablets, white in colour, round,
biconvex with a fracture line on one side and imprinted with “10” on the other side. The dimensions of
each tablet are approximately 7.0 mm.
20 mg: ATORVASTATINA ALMUS PHARMA film-coated tablets, white in colour, round,
biconvex with a fracture line on one side and imprinted with “20” on the other side. The dimensions of
each tablet are approximately 9.0 mm.
40 mg: ATORVASTATINA ALMUS PHARMA film-coated tablets, white in colour, round,
biconvex with a fracture line on one side and imprinted with “40” on the other side. The dimensions of
each tablet are approximately 11.0 mm.
80 mg: ATORVASTATINA ALMUS PHARMA film-coated tablets, white in colour,
oblong, biconvex with a fracture line on one side and imprinted with “80” on the other side. The
dimensions of each tablet are approximately 20.0 mm.
ATORVASTATINA ALMUS PHARMA film-coated tablets are available in
blister packs containing 28, 30 and 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Almus S.r.l.
Via Cesarea 11/10
16121 Genoa

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-Črnuče
Slovenia

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:
Italy ATORVASTATINA ALMUS PHARMA 10 mg, 20 mg, 40 mg, 80 mg film-coated
tablets
Spain ATORVASTATINA ALMUS PHARMA 10 mg, 20 mg, 40 mg, 80 mg comprimidos
recubiertos con película EFG
France ATORVASTATINE ALMUS PHARMA 10 mg, 20 mg, 40 mg, 80 mg comprimé pelliculé