РОЗУВАСТАТИНА 5 мг Фильм-coated таблетки

Содержание инструкции

1. Rosuvastatina Adamed 5 mg film-coated tablets,, 10 mg film-coated tablets,, 20 mg film-coated tablets,, 40 mg film-coated tablets
   1. What Rosuvastatina Adamed is and what it is used for
   2. What you need to know before taking Rosuvastatina Adamed
   3. How to take Rosuvastatina Adamed

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

Rosuvastatin (as rosuvastatin calcium)

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

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

Rosuvastatina Adamed belongs to a group of medicines called statins.
You have been prescribed Rosuvastatina Adamed because:
your cholesterol level is high. This means that you are at risk of heart attack or stroke.
Rosuvastatina Adamed is used in adults, adolescents and children aged 6 years and over
to treat high cholesterol.
You have been prescribed a statin because changing your diet and exercising more
have not been enough to correct your cholesterol levels. While taking
Rosuvastatina Adamed you should continue to follow a diet to reduce your cholesterol levels and continue with
exercise.
Or
You have other factors that increase the risk of developing a heart attack, stroke or health problems
related to these.
Heart attack, stroke and related health problems can be caused by a disease called
atherosclerosis. Atherosclerosis is due to the formation of fat deposits inside the arteries.

Why it is important to continue taking Rosuvastatina Adamed
Rosuvastatina Adamed is used to correct the levels of fatty substances in the blood called
lipids, the most common of which is cholesterol.
There are several types of cholesterol in the blood: the so-called "bad" cholesterol (LDL-C) and the
so-called "good" cholesterol (HDL-C).
Rosuvastatina Adamed can reduce "bad" cholesterol and increase "good" cholesterol.
It works by helping to block the production of "bad" cholesterol by the body.
It also improves the body's ability to remove "bad" cholesterol from the blood.
For many people, high cholesterol does not affect how they feel, because it does not cause any
symptoms. However, if high cholesterol is not treated, fat deposits can accumulate in the
walls of blood vessels, leading to their narrowing.
Sometimes, these narrowed blood vessels can become blocked, blocking the flow of blood to the heart or
brain and consequently causing a heart attack or stroke. By lowering cholesterol levels
the risk of having a heart attack, stroke or related health problems is reduced.
You should continue to take Rosuvastatina Adamed, even if your cholesterol levels have returned
to normal, to prevent these levels from rising again, causing the formation of fat deposits.
However, you should stop taking Rosuvastatina Adamed on medical advice or if you become
pregnant.

2. What you need to know before taking Rosuvastatina Adamed

Do not take Rosuvastatina Adamed
If you are allergic to rosuvastatin or any of the other ingredients of this medicine
(listed in section 6).
If you are pregnant or breastfeeding. If you become pregnant while taking
Rosuvastatina Adamed, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant while taking Rosuvastatina Adamed,
using appropriate contraceptive measures.
If you have a liver disease.
If you have severe kidney problems.
If you have repeated or unexplained muscle aches or pains.
If you are taking a medicine called cyclosporine (used for e.g. after organ transplant).
If you fall into any of the above cases (or have doubts), you should return to your doctor and inform them.

Also, do not take Rosuvastatina Adamed40 mg (the highest dose):
If you have moderate kidney problems (ask your doctor for any doubts).
If your thyroid gland is not functioning properly.
If you have repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or have previously had muscle problems while taking other medicines to
lower cholesterol.
If you regularly consume large amounts of alcohol.
If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
If you are taking other medicines to lower cholesterol called fibrates.
If you fall into any of the above cases (or have doubts), you should return to your doctor and inform them.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rosuvastatina Adamed.

• If you have kidney problems.
• If you have liver problems. If you have had repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or have previously had muscle problems while taking other medicines to lower cholesterol. Immediately inform your doctor if you have unexplained muscle aches or pains, especially if accompanied by malaise or fever. Also, inform your doctor or pharmacist if you have constant muscle weakness. If you regularly consume large amounts of alcohol. If your thyroid gland is not functioning properly. If you are taking other medicines to lower cholesterol called fibrates. Read carefully this

If you are taking medicines used to treat HIV infection, e.g. lopinavir/ritonavir, read the
paragraph “Other medicines and Rosuvastatina Adamed”.
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 of fusidic acid and Rosuvastatina Adamed can lead to serious muscle problems (rhabdomyolysis).
If you are over 70 years of age (the doctor needs to choose the appropriate initial dose for you).
If you have severe respiratory failure.
If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). The doctor needs to choose the appropriate initial dose for you.
If you fall into any of the above cases (or are unsure):

Do not take Rosuvastatina Adamed40 mg (the highest dose) and check with your doctor or
pharmacist before starting to take Rosuvastatina Adamed at any dosage.
In a small number of people, statins can have a negative effect on the liver. This can be
identified with a simple test that detects increased levels of liver enzymes in the blood. For
this reason, your doctor will ask you to have this test (liver function test) before and
during treatment with Rosuvastatina Adamed.
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 likely to be at risk of developing
diabetes if you have high levels of sugar and fats in your blood, if you are overweight and if you have high blood pressure.

Children and adolescents
If the patient is under 6 years of age: Rosuvastatina Adamed should not be administered
to children under 6 years of age.
If the patient is under 18 years of age: Rosuvastatina Adamed 40 mg tablets are not
suitable for use in children and adolescents under 18 years of age.

Other medicines and Rosuvastatina Adamed
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Tell your doctor if you are taking any of the following medicines:
cyclosporine (used for example after organ transplants),
warfarin (or any other medicine used to thin the blood),
fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower
cholesterol (such as ezetimibe),
remedies for indigestion (used to neutralize stomach acids),
erythromycin (an antibiotic),
an oral contraceptive (the pill),
hormone replacement therapy,
regorafenib (used to treat cancer),
one of the following drugs used to treat viral infections, including HIV or hepatitis
C, alone or in combination (see section “Warnings and precautions”): ritonavir, lopinavir,
atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir,
glecaprevir, pibrentasvir.
The effects of these medicines may be altered by Rosuvastatina Adamed, or the effect of
Rosuvastatina Adamed may be altered by these medicines.
If you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop
taking this medicine. Your doctor will tell you when it is safe to resume
Rosuvastatina Adamed. Taking Rosuvastatina Adamed with fusidic acid can rarely lead to
weakness, soreness or muscle pain (rhabdomyolysis). See further information on
rhabdomyolysis in section 4.

Rosuvastatina Adamedwith food.
Rosuvastatina Adamed can be taken with or without food.

Pregnancy and breastfeeding
Do not take Rosuvastatina Adamedif you are pregnant or breastfeeding. If you become
pregnant while taking Rosuvastatina Adamed, you must stop taking it immediately
and inform your doctor. Women must avoid becoming pregnant while taking
Rosuvastatina Adamed using appropriate contraceptive measures. Ask your doctor or
pharmacist for advice before taking any medicine.

Driving and operating machinery
Most people can drive vehicles and use machinery while taking
Rosuvastatina Adamed – it has no effect on their ability to drive vehicles or use
tools or machinery.
However, some people may experience dizziness while taking Rosuvastatina Adamed. If
you experience dizziness, consult your doctor before driving vehicles or using machinery.

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

Rosuvastatina Adamed 5 mg contains aluminium lake yellow quinoline (E104)
May cause allergic reactions.

Rosuvastatina Adamed10 mg contains aluminium lake red allura (E129)
May cause allergic reactions.

Rosuvastatina Adamed 40 mg contains sunset yellow (E110) and aluminium lake cochineal red
(E124)
May cause allergic reactions.
For the complete list of other ingredients see section “Contents of the pack and other
information”.

3. How to take Rosuvastatina Adamed

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

Usual dosage in adults
If you are taking Rosuvastatina Adamedfor high cholesterol:
Starting dose
Treatment with Rosuvastatina Adamed should be started with a dose of 5 mg or 10 mg, even if you previously took higher doses with other statins. The choice of the starting dose depends on:
your cholesterol level;
your risk level of having a heart attack or stroke;
the possible presence of factors that may make you more sensitive to possible side effects.
Check with your doctor or pharmacist what the most appropriate starting dose of Rosuvastatina Adamed is 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);

are over 70 years of age;
have moderate kidney problems;
are at risk of muscle aches and pains (myopathy).

Dose increase and maximum daily dose
The doctor may decide to increase your dose. All this in order to determine the most suitable dose of
Rosuvastatina Adamed for you. If you start with a 5 mg dose, the doctor, if necessary, may
decide to double the dose to 10 mg, then to 20 mg and then to 40 mg. If you start with 10 mg the doctor
may decide, if necessary, to double this dose to 20 mg and then to 40 mg. There must be an
interval of 4 weeks between one dose adjustment and another.
The maximum daily dose of Rosuvastatina Adamed is 40 mg. This is only administered to
patients with high cholesterol levels and at high risk of heart attack or stroke, whose cholesterol levels have not lowered sufficiently with the 20 mg dose.

If you are taking Rosuvastatina Adamedto reduce the risk of a heart attack,
stroke or health problems related to it:
The recommended dose is 20 mg per day. However, the doctor may decide to use a lower dosage if you have one of the risk factors mentioned above.

Use in children aged 6 to 17 years
The dose range in children and adolescents from 6 to 17 years of age 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
to reach the most appropriate dose of Rosuvastatina Adamed for you. The maximum
daily dose of Rosuvastatina Adamed is 10 mg or 20 mg for children aged 6 to 17 years
depending on the underlying condition to be treated. The dose must be taken once a day. The
Rosuvastatina Adamed 40 mgtablets must not be usedin children.

Administration of tablets
Swallow each tablet whole with a glass of water.

Rosuvastatina Adamedmust be taken 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, this may help you to remember.

Periodic cholesterol checks
It is important to return to your doctor to periodically check your cholesterol levels, to
make sure that your cholesterol has reached and maintains the correct levels. The doctor may decide to
increase the dose to make you take the most suitable amount of Rosuvastatina Adamed for you.

If you take more Rosuvastatina Adamed than you should
Contact your doctor or the nearest hospital for advice. If you go to hospital or receive
treatment for another condition, tell the hospital doctor that you are taking Rosuvastatina
Adamed.

If you forget to take Rosuvastatina Adamed
Do not worry, take the next dose at the usual time. Do not take a double dose to make up
for the missed tablet.

If you stop taking Rosuvastatina Adamed
Tell your doctor if you intend to stop taking Rosuvastatina Adamed. If you stop
taking Rosuvastatina Adamed your cholesterol levels may increase again.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone
experiences them.
It is important to be aware of which of these side effects may occur.
They are usually mild and disappear in a short time.

Stop taking Rosuvastatina Adamedand seek immediate help from a doctor
if you experience any of the following reactions
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 blisters).
Symptoms of lupus-like syndrome (including skin rash, joint disorders and effects on
blood cells);
Muscle breakdown.

Also, stop taking Rosuvastatina Adamedand seek immediate medical attention if you experience unusual muscle aches or painsthat last longer than you would
expect. Muscle symptoms are more common in children and adolescents than
adults. As with other statins, a very small number of people have experienced muscle side effects and rarely these have evolved into a disease that leads to muscle damage, potentially fatal, known as rhabdomyolysis.

Common possible side effects (may affect up to 1 in 10 people)
headache
stomach pain
constipation
feeling unwell
muscle pain
feeling weak
dizziness
an increase in the amount of protein in the urine – values usually return to normal on
their own without having to stop taking Rosuvastatina Adamed tablets (only
for Rosuvastatina Adamed 40 mg)
diabetes. It is more likely if you have high levels of sugars and fats in the blood, if you are overweight and if you have
high blood pressure. The doctor will monitor you during treatment with this
medicine.

Uncommon possible side effects (may affect up to 1 in 100 people)
skin rash, itching and other skin reactions
an increase in the amount of protein in the urine – these usually return to normal on
their own without the need to interrupt treatment with Rosuvastatina Adamed
tablets (only for Rosuvastatina Adamed 5 mg, 10 mg and 20 mg).

Rare possible side effects (may affect up to 1 in 1000 people)
severe allergic reaction – signs include swelling of the face, lips, tongue and/or
throat, difficulty swallowing and breathing, severe itching of the skin (with raised blisters). If you suspect you are having an allergic reaction, stop taking Rosuvastatina
Adamed and seek immediate medical help
muscle damage in adults - as a precaution, stop taking Rosuvastatina
Adamed and seek immediate medical attention if you have unusual muscle aches that
persist longer than you would expect
severe stomach pain (inflamed pancreas)
increased liver enzyme levels in the blood
bleeding or bruising more easily than normal due to low platelet levels in the blood.

Very rare possible side effects (may affect up to 1 in 10,000 people)
jaundice (yellowing of the skin and eyes)
hepatitis (an inflammation of the liver)
traces of blood in the urine
nerve damage in arms and legs (numbness)
joint pain
memory loss
enlargement of the breast in men (gynecomastia)

Side effects of unknown frequency may include:
diarrhea (loose stools)
Stevens-Johnson syndrome (which manifests through blisters on skin, mouth, eyes and
genitals)
cough
shortness of breath
edema (swelling)
sleep disorders, including insomnia and nightmares
sexual problems
depression
breathing problems, including persistent cough and/or shortness of breath or fever
tendon injury, sometimes complicated by rupture
persistent muscle weakness.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please 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.

How to store Rosuvastatina Adamed
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the blister pack and the box, after
Exp. The expiry date refers to the last day of that month.
Do not use this medicine if you notice visible signs of deterioration.
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.

Contents of the pack and other information
What Rosuvastatina Adamed contains

• The active ingredient is rosuvastatin. Rosuvastatina Adamed film-coated tablets contain rosuvastatin calcium equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.
• The other ingredients are: Tablet coremicrocrystalline cellulose type 102, lactose monohydrate, crospovidone type A, magnesium stearate.

Rosuvastatina Adamed tablet coating5 mg:
lactose monohydrate
hypromellose (E464)
titanium dioxide (E171)
triacetin (E1518)
quinoline yellow aluminum lake (E104)

Rosuvastatina Adamed tablet coating10 mg:
lactose monohydrate
hypromellose (E464)
titanium dioxide (E171)
triacetin (E1518)
allura red aluminum lake (E129)

Rosuvastatina Adamed 20 mg tablet coating:
lactose monohydrate
hypromellose (E464)
titanium dioxide (E171)
triacetin (E1518)
carmine (E120)

Rosuvastatina Adamed tablet coating40 mg:
lactose monohydrate
hypromellose (E464)
titanium dioxide (E171)
triacetin (E1518)
sunset yellow (E110)
cochineal aluminum lake (E124)

Description of Rosuvastatina Adamedand contents of the pack
Rosuvastatina Adamed is available in packs containing 28, 56 and 98 tablets.
Not all pack sizes may be marketed.
Rosuvastatina Adamed 5 mg film-coated tablets are yellowish, round,
biconvex, with “5” engraved on one side.
Rosuvastatina Adamed 10 mg film-coated tablets are light pink, round,
biconvex, with “10” engraved on one side.
Rosuvastatina Adamed 20 mg film-coated tablets are dark pink, round,
biconvex, with “20” engraved on one side.
Rosuvastatina Adamed 40 mg film-coated tablets are red, round, biconvex,
with “40” engraved on one side.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed S.r.l.
Via G. Mazzini, 20
20123 Milan - Italy

Manufacturer
Adamed Pharma S.A.
Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland

Thismedicinal product is authorised in the Member States of the European Economic Area
under the following denominations:
Denmark Zahron
Germany Zahron
Italy Rosuvastatina Adamed