ROSUVASTATINA 5 mg Film-Coated Tablets

Зміст інструкції

1. Rosuvastatina Aristo 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets
   1. What is Rosuvastatina Aristo and what it is used for
2. Rosuvastatina Aristo is used to modify the levels of fatty substances in the blood
   1. What you need to know before taking Rosuvastatina Aristo
   2. How to take Rosuvastatina Aristo
   3. Possible side effects
   4. How to store Rosuvastatina Aristo
   5. Package Contents and Other Information

Rosuvastatina Aristo 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Rosuvastatina

Generic medicine

Read this leaflet carefully before you start 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 or pharmacist.
• 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 or pharmacist. See section 4.

Contents of this leaflet:

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

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

Rosuvastatina Aristo belongs to a group of medicines called statins.

Rosuvastatina Aristo has been prescribed for you because:

• Your cholesterol level is high. This means you are at risk of a heart attack or stroke. Rosuvastatina Aristo is used in adults, adolescents and children aged 6 years or older to treat high cholesterol. You have been advised to take a statin because changes to your diet and increased exercise are not enough to correct your cholesterol levels. You must continue with a low-fat diet and exercise during treatment with Rosuvastatina Aristo. Or
• You have other factors that increase the risk of developing a heart attack, stroke or heart-related disorders.

Heart attack, stroke and other disorders can be caused by a disease called
atherosclerosis.
Atherosclerosis is due to the formation of fat deposits in the arteries.

Why it is important to continue taking Rosuvastatina Aristo:

Rosuvastatina Aristo is used to modify the levels of fatty substances in the blood

called lipids, among which the most common is cholesterol.
There are different types of cholesterol present in the blood – “bad” cholesterol (LDL-C) and
“good” cholesterol (HDL-C).

• Rosuvastatina Aristo can reduce “bad” cholesterol and increase “good” cholesterol.
• It has the ability to inhibit the production of “bad” cholesterol by the body. Furthermore, it improves the body's ability to remove it from the blood. For most people, high cholesterol levels do not cause any symptoms. However, if left untreated, fat deposits can accumulate in the walls of blood vessels causing them to narrow.

Sometimes, this narrowing of the blood vessels can cause a blockage of blood flow
to the heart or brain resulting in a heart attack or stroke. By lowering cholesterol levels, it can reduce the risk of a heart attack, stroke, or other health
problems.
You must continue to take Rosuvastatina Aristo, even if your cholesterol levels
are normal, because it prevents a new increase in cholesteroland the accumulation of
fat deposits. However, you must stop taking it if your doctor decides to or in
case of pregnancy.

2. What you need to know before taking Rosuvastatina Aristo

Do not take Rosuvastatina Aristo

• If you are allergic to Rosuvastatina Aristo, or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnantor breastfeeding. If you become pregnant during treatment with Rosuvastatina Aristo stop taking it immediately and tell your doctor. Women must avoid pregnancy during treatment with Rosuvastatina Aristo by using suitable contraception.
• If you have a liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pain, tenderness or weakness.
• If you are taking a medicine called ciclosporin(used, for example, after organ transplantation). If any of these apply to you (or if you are unsure), consult your doctor.

Also, do not take Rosuvastatina Aristo 40 mg (the highest dose):

• If you have moderate kidney problems(if you are unsure, ask your doctor).
• If you have a thyroid glandthat is not functioning properly.
• If you have had repeated or unexplained muscle pain, tenderness or weakness, a personal or family history of muscle problems, or if you have previously experienced muscle problems during treatment with other medicines that lower cholesterol.
• If you regularly consume significant amounts of alcohol.
• If you are of Asian origin(Japanese, Chinese, Filipino, Vietnamese, Korean or Indian).
• If you are taking other medicines called fibratesto lower cholesterol. If any of these apply to you (or if you are unsure), please consult your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rosuvastatina Aristo:

• If you have kidney problems.
• If you have liver problems.
• If you have had repeated or unexplained muscle pain, tenderness or weakness, a personal or family history of muscle problems, or if you have previously experienced muscle problems during treatment with other medicines that lower cholesterol. Tell your doctor or pharmacist immediately if you experience unexplained muscle pain, tenderness or weakness, especially if you feel unwell or have a fever. Also inform your doctor or pharmacist if you have persistent muscle weakness.
• If you regularly consume significant amounts of alcohol.
• If you have a thyroid glandthat is not functioning properly.
• If you are taking other medicines called fibratesto lower cholesterol. Please read

for high cholesterol levels.

• If you are taking medicines used to fight HIV infectionsuch as ritonavir with lopinavir and/or atazanavir, see section “Other medicines and Rosuvastatina Aristo”.
• If you are taking or have taken within the last 7 days a medicine called fusidic acid(an antibiotic for bacterial infections) by mouth or by injection. The combination of fusidic acid and Rosuvastatina Aristocan lead to serious muscle problems (rhabdomyolysis), see section “Other medicines and Rosuvastatina Aristo”.
• If you are over 70 years of age(your doctor may need to choose the correct starting dose of Rosuvastatina Aristo suitable for you).
• If you have severe breathing difficulties.
• If you are of Asian origin- Japanese, Chinese, Filipino, Vietnamese, Korean or Indian. Your doctor may need to choose the correct starting dose of Rosuvastatina Aristo suitable for you.

If any of these apply to you (or if you are unsure):

• Do not take Rosuvastatina Aristo 40 mg (the highest dose) and consult your doctor orpharmacist before actually starting to take any dose ofRosuvastatina Aristo.

Statins can cause changes in liver function in a small number of people.
This is detected with a simple test, which allows monitoring of increased levels of
liver enzymes in the blood. For this reason, your doctor will usually request this blood test
before and during treatment with Rosuvastatina Aristo.
During treatment with this medicine, your doctor will carefully check if you 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.

Children and adolescents

• If the patient is under 6 years of age: Rosuvastatina Aristo should not be given to children under 6 years of age.
• If the patient is under 18 years of age: The 40 mg Rosuvastatina Aristo tablet is not suitable for use in children and adolescents under 18 years of age.

Other medicines and Rosuvastatina Aristo
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including those listed below: ciclosporin (used, for
example, after organ transplantation), warfarin or clopidogrel (or any other medicine for
preventing blood clots), fibrates (such as gemfibrozil, fenofibrate) or any other medicine used
to
lower cholesterol (such as ezetimibe), remedies for indigestion (used for
neutralizing acid in the stomach), erythromycin (an antibiotic), fusidic acid (an
antibiotic - see section “Warnings and precautions”), oral contraceptives (the pill),
regorafenib (used for the treatment of tumors), hormone replacement therapy, one of
the following medicines used to treat viral infections, including HIV or
Hepatitis C, alone or in combination (see Warnings and Precautions): ritonavir, lopinavir,
atazanavir, simepravir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir,
glecaprevir, pibrentasvir. The effects of these medicines may alter the effect of
Rosuvastatina Aristo or the effect of these medicines may be changed by
Rosuvastatina Aristo.

If you need to take oral fusidic acid to treat a bacterial
infection, you must temporarily stop using this medicine. Your doctor
will tell you when it is safe to start taking Rosuvastatina Aristo again. Taking
Rosuvastatina Aristo with fusidic acid can rarely cause weakness, fatigue or
muscle pain (rhabdomyolysis). See more information regarding
rhabdomyolysis in section 4.
Pregnancy and breastfeeding
Do not take Rosuvastatina Aristoif you are pregnant or breastfeeding. If you become pregnant
during treatment with Rosuvastatina Aristo stop taking it immediatelyand
tell your doctor. Women must avoid pregnancy during treatment with
Rosuvastatina Aristo by using suitable contraception.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
Most people can drive vehicles and operate machinery during
treatment with Rosuvastatina Aristo - treatment does not alter their ability to drive or
operate machinery. However, some people may experience dizziness during
treatment with Rosuvastatina Aristo. If you experience dizziness, consult your doctor before
driving vehicles or using machinery.

Rosuvastatina Aristo contains lactose
Each film-coated tablet 5 mg contains 96.8 mg of lactose (as lactose
monohydrate).
Each film-coated tablet 10 mg contains 91.9 mg of lactose (as lactose
monohydrate).
Each film-coated tablet 20 mg contains 183.9 mg of lactose (as lactose
monohydrate).
Each film-coated tablet 40 mg contains 166.2 mg of lactose (as lactose
monohydrate).
If you have been diagnosed with lactose intolerance by your doctor, contact him or
her before taking this medicine.

3. How to take Rosuvastatina Aristo

Take this medicine always exactly as your doctor has told you. If you have
any doubts, ask your doctor or pharmacist.

Usual doses in adults:
If you are taking Rosuvastatina Aristo for high cholesterol:
Starting dose
Treatment with Rosuvastatina Aristo must begin with a dose of5 mg or 10 mg,
even if you were previously taking a different statin at a higher dose. The choice
of the starting dose depends on:

• Your cholesterol level
• Your risk of heart attack or stroke
• If you are more exposed to the risk of developing possible side effects.

Please consult your doctor or pharmacist to find out which initial doses of Rosuvastatina
Aristo are most suitable for you.
The doctor may decide to give you the lowest dose (5 mg), if:

• You are of Asian origin(Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
• You are over 70 yearsof age.
• You have moderate kidney problems.
• You are at risk of muscle soreness and pain (myopathy).

Dose increase and maximum daily dose
The doctor may decide to increase the dose. This will allow you to take a
quantity of Rosuvastatina Aristo that is right for you. If you started with a 5 mg dose, the doctor
may decide to double it to 10 mg, then to 20 mg and then to 40 mg, if necessary. If you
started with a 10 mg dose, the doctor may decide to double it to 20 mg and then to 40
mg, if necessary. There will be a 4-week interval between each dose adjustment.
The maximum daily dose of Rosuvastatina Aristo is 40 mg. It is only recommended for
patients who have high cholesterol levels and are at high risk of heart attacks or
stroke, whose cholesterol levels are not sufficiently lowered with a 20 mg dose.

If you are taking Rosuvastatina Aristo to reduce the risk of heart attack, stroke or
health problems related to them:
The recommended dose is 20 mg per day. However, the doctor may prescribe lower doses if one of the conditions listed above applies to you.

Use in children and adolescents aged 6-17 years
The dosage range in children and adolescents aged 6-17 years is from 5 to 20
mg once a day. The usual starting dose is 5 mg per day and the doctor may
gradually increase the dose until the amount of Rosuvastatina
Aristo you need is reached. The maximum daily dose of Rosuvastatina Aristo is 10 mg or 20
mg for children aged 6-17 years depending on the treatment of the underlying condition. Take the dose once a day. Rosuvastatina Aristo 40 mg tablets should not
be used in children.

Taking the tablets
Swallow each tablet whole with a glass of water.

Take Rosuvastatina Aristo once a day.It can be taken at any time
of the day with or without food. Try to take the tablet at the same time each day
to help you remember.

Regular checks of cholesterol levels
It is important to return to your doctor to check your cholesterol levels regularly and
make sure they have been reached and maintained within normal values.
The dose of Rosuvastatina Aristo may be increased by the doctor until the amount you need is reached.

If you take more Rosuvastatina Aristo than you should
Contact your doctor or the nearest hospital for advice.
If you go to hospital or are being treated for another condition, tell the medical staff
that you are taking Rosuvastatina Aristo.

If you forget to take Rosuvastatina Aristo
Do not worry; take the next dose at the right time. Do not take a double dose to
make up for the missed dose.

If you stop taking Rosuvastatina Aristo
Talk to your doctor if you want to stop taking Rosuvastatina Aristo. Cholesterol levels may increase again if you stop taking Rosuvastatina Aristo.
If you have any further questions about the use of the medicine, you can contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
It is important that you are aware of these side effects. They are generally mild and disappear after a
short period of time.

Stop taking Rosuvastatina Aristo and see your doctor immediatelyif you experience any of the
following allergic reactions:

• Difficulty breathing, with or without swelling of the face, lips, tongue and/or throat
• Swelling of the face, lips, tongue and/or throat that can cause difficulty swallowing
• Severe itching of the skin (with raised bumps)
• Lupus-like syndrome (including skin rash, joint disorders and effects on blood cells)
• Muscle breakdown

Also, stop taking Rosuvastatina Aristo and talk to your doctor immediately if you have unexplained
muscle tenderness or painthat lasts longer than expected. Muscle symptoms are more common in
children and adolescents than in adults. As with other statins, a few people have experienced
unpleasant muscle effects that rarely became muscle damage potentially life-threatening known as
rhabdomyolysis.

Common side effects (may affect up to 1 in 10 people):

• Headache
• Stomach pain
• Constipation
• Feeling unwell
• Muscle pain
• Feeling weak
• Dizziness
• Increased amount of protein in the urine - which usually returns to normal without having to stop
  taking Rosuvastatina Aristo tablets (only Rosuvastatina Aristo 40 mg)
• Diabetes. You are at risk of developing diabetes if you have high blood sugar and fat levels, if you
  are overweight and have high blood pressure. Your doctor will monitor you while you are taking this
  medicine.

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

• Skin rash, itching or other skin reactions
• Increased amount of protein in the urine - which usually returns to normal, without having to stop
  taking Rosuvastatina Aristo tablets (only Rosuvastatina Aristo 5 mg, 10 mg and 20 mg)

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

• Serious allergic reactions - including swelling of the face, lips, tongue and/or throat, difficulty
  swallowing and breathing, severe itching of the skin (with raised bumps). If you think you are
  having an allergic reaction, stop takingRosuvastatina Aristoand talk to your doctor
  immediately.
• Muscle damage in adults - as a precaution, stop takingRosuvastatina Aristo and talk to your
  doctor immediately if you have unusual muscle tenderness or painthat lasts longer than
  expected.
• Severe stomach pain (this may be a sign of inflammation of the pancreas).
• Increased liver enzymes in the blood.
• Bleeding or bruising more easily than usual due to a low level of platelets in the blood.

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

• Jaundice (yellowing of the skin and eyes)
• Hepatitis (inflamed liver)
• Blood in the urine
• Damage to the nerves of the legs and arms (such as numbness)
• Joint pain
• Memory loss
• Breast enlargement in men (gynecomastia)

Side effects with frequency not known (frequency cannot be estimated based on available data):

• Diarrhea (loose stools)
• Stevens-Johnson syndrome (serious blistering condition of the skin, mouth, eyes and genitals)
• Cough
• Shortness of breath
• Edema (swelling)
• Sleep disorders, including difficulty sleeping and nightmares
• Sexual difficulties
• Depression
• Respiratory problems, including persistent cough and/or shortness of breath or fever
• Tendon problems
• Constant muscle weakness
• Peripheral neuropathy

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. 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 Rosuvastatina Aristo

• 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 package and on the blister after Exp. The expiry date refers to the last day of that month.
• Store at a temperature below 30°C. Store in the original package to protect the medicine from light.
• 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 Rosuvastatina Aristo contains

• The active ingredient is rosuvastatin. Each film-coated tablet contains 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin as rosuvastatin calcium salt, respectively
• Other ingredients are: microcrystalline cellulose PH-101, anhydrous colloidal silicon dioxide, crospovidone Type A, microcrystalline cellulose PH-102, lactose monohydrate, magnesium stearate. The film coating contains: Rosuvastatina Aristo 5 mg film-coated tablets: Opadry II Yellow 33K12488 containing: hypromellose, titanium dioxide (E171), lactose monohydrate, triacetin, yellow iron oxide (E172). Rosuvastatina Aristo 10 mg film-coated tablets: Opadry II Pink 33K94423 containing: hypromellose, titanium dioxide (E171), lactose monohydrate, triacetin, red iron oxide (E172). Rosuvastatina Aristo 20 mg film-coated tablets: Opadry II Pink 33K94423 containing: hypromellose, titanium dioxide (E171), lactose monohydrate, triacetin, red iron oxide (E172). Rosuvastatina Aristo 40 mg film-coated tablets: Opadry II Pink 33K94423 containing: hypromellose, titanium dioxide (E171), lactose monohydrate, triacetin, red iron oxide (E172).

Description of the appearance of Rosuvastatina Aristo and package contents
Rosuvastatina Aristo 5 mg film-coated tablets: yellow, round, biconvex coated tablet, with "ROS" inscribed above “5” on one side and nothing on the other side, with a diameter of 7 mm.
Rosuvastatina Aristo 10 mg film-coated tablets: pink, round, biconvex coated tablet, with "ROS" inscribed above “10” on one side and nothing on the other side, with a diameter of 7 mm.
Rosuvastatina Aristo 20 mg film-coated tablets: pink, round, biconvex coated tablet, with "ROS" inscribed above “20” on one side and nothing on the other side, with a diameter of 9 mm.
Rosuvastatina Aristo 40 mg film-coated tablets: pink, oval, biconvex coated tablet, with "ROS" inscribed on one side and “40” on the other side, with dimensions 6.8 x 11.4 mm.
The tablets are packaged in OPA-A1-PVC/A1 blisters.
Blister packs of 28, 30, 90 and 100 film-coated tablets are available.
Not all pack sizes may be marketed.

Marketing Authorisation Holderand manufacturer
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

Manufacturer
Medochemie Ltd – Central Factory
1-10 Costantinoupoleos Str.,
Limassol, 3011, Cyprus
or
Medochemie LTD (Factory AZ)
2 Michael Erakleous Street, Agios Athanassios Industrial Area, Agios Athanassios,
Limassol, 4101, Cyprus

Distributor for sales
Aristo Pharma Italy S.r.l.
Strada Milanofiori Str. 6 Palazzo n. 3,
20089 Rozzano (MI)

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:
Denmark Rosuvastatin Aristo
Germany Rosuvastatin Aristo 5 mg/10 mg/20 mg/40 mg Filmtabletten
Italy Rosuvastatina Aristo
Netherlands Rosuvastatine Aristo 5 mg/10 mg/20 mg/40 mg filmomhulde tabletten
Spain Rosuvastatina Aristo 5 mg/10 mg/20 mg/40 mg comprimidos recubierto con
película EFG
United Kingdom Rosuvastatin Aristo 5 mg/10 mg/20 mg/40 mg film-coated tablet