ROSUVASTATINA 5 mg Film-Coated Tablets

Зміст інструкції

1. Rosuvastatina Almus 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets
   1. What Rosuvastatina Almus is and what it is used for
   2. What you need to know before taking Rosuvastatina Almus
   3. How to take Rosuvastatina Almus film-coated tablets
   4. Possible side effects
   5. How to store Rosuvastatina Almus film-coated tablets
   6. Package contents and other information

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

Generic medicine

Read this leaflet carefully before you start 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 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

Rosuvastatina Almus belongs to a group of medicines called statins.

Rosuvastatina Almus has been prescribed to you because:

• Your cholesterol level is high. This means that you are at risk of heart attack or stroke. Rosuvastatina Almus is used in adults, adolescents and children aged 6 years and over to treat high cholesterol.

You have been prescribed a statin because changes to your diet and increased exercise
have not been sufficient to correct your cholesterol levels. While taking
Rosuvastatina Almus you should continue 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 related health problems.

Heart attack, stroke and related health problems can be caused by a disease called
atherosclerosis. Atherosclerosis is due to the formation of fatty deposits inside the arteries.

Why is it important to continue taking Rosuvastatina Almus?
Rosuvastatina Almus 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: so-called “bad” cholesterol (LDL-C) and
so-called “good” cholesterol (HDL-C).

• Rosuvastatina Almus film-coated tablets 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 you feel, because it gives no
symptoms. However, if high cholesterol is not treated, fatty deposits can accumulate in the
walls of blood vessels, leading to their narrowing.
Sometimes, these narrowed blood vessels can become blocked, blocking blood flow to the heart or
brain and consequently causing a heart attack or stroke. By lowering cholesterol levels
reduces the risk of having a heart attack, stroke or related health problems.
You must continue to take Rosuvastatina Almus, even if your cholesterol levels have returned
to normal, to prevent these levels from rising again, causing the formation of fatty deposits.
However, you should stop taking Rosuvastatina Almus on medical advice or if you become
pregnant.

2. What you need to know before taking Rosuvastatina Almus

Do not take Rosuvastatina Almus

• If you are allergicto rosuvastatin or to 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 Almus, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with Rosuvastatina Almus by 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 ciclosporin(used for example after organ transplantation). If you fall into any of the above categories (or have doubts), you must return to your doctor and inform them.

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

• If you have moderate kidney problems(ask your doctor if you are unsure)
• If your thyroidis 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 categories (or have doubts), you must return to your doctor and inform them.

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

• 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. Tell your doctor immediately if you have unexplained muscle aches, pains, tenderness or weakness, especially if accompanied by fever or malaise. Also, inform your doctor or pharmacist if you have persistent muscle weakness
• If you regularly consume large amounts of alcohol
• If your thyroidis not functioning properly
• If you are taking other medicines called fibrates to lower cholesterol. Read carefully

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• If you are taking medicines used to treat HIV infections or hepatitis C infection, such as ritonavir with lopinavir and/or atazanavir or simeprevir, please read the section “Other medicines and Rosuvastatina Almus”
• If you are taking antibiotics containing fusidic acid. 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 Rosuvastatina Almus can lead to serious muscle problems (rhabdomyolysis).

Children and adolescents
If the patient is under 6 years of age:Rosuvastatina Almus should not be administered to children under 6 years of age.

If the patient is under 18 years of age:Rosuvastatina Almus 40 mg is not suitable for use in children and adolescents under 18 years of age.

• 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- i.e. 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 categories (or are unsure):
• Do not take Rosuvastatina Almus 40 mg film-coated tablets (the highest dose) andcheck with your doctor or pharmacist before starting to take Rosuvastatina Almus atany 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 Almus. During treatment with this medicine, your doctor will carefully check 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 Rosuvastatina Almus
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

• If you need to take fusidic acid orally to treat bacterial infections, you will need to temporarily stop taking this medicine. Your doctor will tell you when it is safe for you to resume treatment with Rosuvastatina Almus. Taking Rosuvastatina Almus with fusidic acid can rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See section 4 for more information on rhabdomyolysis.

Tell your doctor if you are taking any of the following medicines:

• ciclosporin (used for example after organ transplantation)
• warfarin or clopidogrel (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 tumors)
• one of the following medicines used to treat viral infections, including HIV or Hepatitis C infections, alone or in combination (see Warnings and Precautions): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

The effects of these medicines can be altered by Rosuvastatina Almus, or the effect of Rosuvastatina Almus can be altered by these medicines.

Pregnancy and breastfeeding
Do not take Rosuvastatina Almusif you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatina Almus, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with Rosuvastatina Almus by using appropriate contraceptive measures. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Most people can drive cars and use machines while taking Rosuvastatina Almus as this medicine does not affect their ability to drive cars and use machines. However, some people may experience dizziness during treatment with Rosuvastatina Almus. If you experience dizziness, consult your doctor before driving or using machines.

Rosuvastatina Almus contains lactose and sodium.

Lactose
If your doctor has diagnosed you with intolerance to some sugars, contact them before taking this medicine.

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially ‘sodium-free’. For the complete list of other ingredients see section “Contents of the pack and other information”.

3. How to take Rosuvastatina Almus film-coated tablets

Take this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor or pharmacist.

Usual dosage in adults
If you are taking Rosuvastatina Almus for high cholesterol:
Initial dose
Treatment with Rosuvastatina Almus must begin with a dose of 5 mg or 10 mg, even if in
the past you have taken higher dosages with other statins. The choice of the initial dose depends on:

• your cholesterol level
• the level of risk 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 initial dose of Rosuvastatina Almus is 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)
• are over 70 years old
• 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 the dose. All this in order to determine the dose of
Rosuvastatina Almus most suitable for you. If you start with a 5 mg dose, your doctor may decide to
double the dose to 10 mg, then to 20 mg and then to 40 mg if necessary. If you start with 10 mg the
doctor may decide to double this dose to 20 mg and then to 40 mg if necessary. There must be
an interval of 4 weeks between one dose adjustment and another.
The maximum daily dose of Rosuvastatina Almus is 40 mg. It is administered only 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 Almus 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 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 usual initial dose is 5 mg. The doctor may increase the dose up to the most appropriate dosage of
Rosuvastatina Almus for you. The maximum daily dose of Rosuvastatina Almus is
10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to
17 years. The dose must be taken once a day. Rosuvastatina Almus 40
mgmust notbe used in children.

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

Rosuvastatina Almus must be taken once a day.Rosuvastatina Almus can be
taken at any time of the day with or without food. Try to take the tablets
at approximately the same time each day; this may help you not to forget to take them.

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 up to having you take the amount of Rosuvastatina Almus
most suitable for you.

If you take more Rosuvastatina Almus 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 Almus.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
It is important to be aware of which of these side effects may occur.
Usually they are mild and disappear in a short time.

Stop taking Rosuvastatina Almus and seek immediate medical helpif 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).

Also, stop taking Rosuvastatina Almus and consult your doctor immediately if you

• experience unusual muscle aches or pains that last longer than you would expect. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have experienced unpleasant muscle effects and, rarely, these have progressed to a condition leading to muscle damage, potentially life-threatening, known as rhabdomyolysis.
• develop lupus-like syndrome (including rash, joint problems and effects on blood cells).
• muscle tearing (pain and/or inability to use the affected part of the body, muscle pain, soreness, mild swelling, significant loss of strength and sometimes bruising).

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 your urine - usually the values return to normal on their own without having to stop taking Rosuvastatina Almus (only for Rosuvastatina Almus 40 mg)
• 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.

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

• Rash, itching and other skin reactions
• An increase in the amount of protein in your urine - these usually return to normal on their own without the need to stop treatment with Rosuvastatina Almus (only for Rosuvastatina Almus 5 mg, 10 mg and 20 mg).

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

• Severe allergic reactions - signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe itching of the skin (with raised bumps). If you suspect you have an allergic reaction, stop takingRosuvastatina Almusand seek immediate medical help
• Muscle damage in adults - as a precaution, stop takingRosuvastatina Almus and consult your doctor immediately if you have unusual muscle aches or painsthat persist longer than you would expect
• Severe stomach pain (inflamed pancreas)
• Increased liver enzymes 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)
• Blood in your urine
• Nerve damage in arms and legs (such as numbness)
• Joint pain
• Memory loss
• Breast enlargement in men (gynecomastia).

Side effects with frequency not known can include:

• Diarrhea (loose stools)
• Stevens-Johnson syndrome (severe blisters on skin, mouth, eyes and genitals)
• Cough
• Shortness of breath
• Edema (swelling)
• Sleep disturbances, including insomnia and nightmares
• Sexual problems
• Depression
• Breathing problems, including persistent cough and/or shortness of breath or fever
• Tendon injury
• Persistent muscle weakness.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. 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 Almus film-coated tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after Exp.:. The expiry date refers to the last day of that month.
Blisters:
Do not store above 30°C.
Bottles:
This medicine does not require any special storage conditions.
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 Almus film-coated tablets contain
The active ingredient is rosuvastatin.
Rosuvastatina Almus 5, 10, 20, 40 film-coated tablets contain rosuvastatin calcium salt equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.
The other ingredients are:

Tablet core:
Microcrystalline cellulose
Lactose monohydrate
Crospovidone (type B)
Hydroxypropylcellulose
Sodium hydrogen carbonate
Magnesium stearate

Coating:
Lactose monohydrate
Hypromellose 6 cp
Titanium dioxide (E171)
Triacetin
Yellow iron oxide (E 172) in Rosuvastatina Almus 5 mg film-coated tablets
Red iron oxide (E 172) in Rosuvastatina Almus 10 mg, 20 mg and 40 mg film-coated tablets

Description of the appearance of Rosuvastatina Almus film-coated tablets and package contents
Rosuvastatina Almus 5 mg film-coated tablets: round, biconvex, yellow tablets.
Rosuvastatina Almus 10 mg film-coated tablets: round, biconvex, pink tablets, with a
break line.
Rosuvastatina Almus 20 mg film-coated tablets: round, biconvex, pink tablets, with a
break line.
Rosuvastatina Almus 40 mg film-coated tablets: oval, biconvex, pink tablets, with a
break line.
Rosuvastatina Almus 10, 20, 40 mg film-coated tablets:
The tablets can be divided into two equal halves.
Rosuvastatina Almus film-coated tablets are available in blister packs containing 7,
14, 15, 20, 28, 30, 30 x 1, 42, 50, 50 x 1, 56, 60, 84, 90, 98, 100 and 100 x 1 tablets and in HDPE containers containing 30 and 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder
Almus S.r.l.
Via Cesarea 11/10
16121 Genoa
Italy
E-mail: [email protected]

Manufacturers
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovića 25
10000 Zagreb
Croatia
TEVA PHARMA S.L.U.
C/ C, nº 4
Poligono Industrial Malpica
50016 Zaragoza
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:
Denmark Rocasium
France Rosuvastatine Almus
Italy Rosuvastatina Almus
Portugal Rosuvastatina Almus
United Kingdom Rosuvastatin 5 mg, 10 mg, 20 mg, 40 mg Film-coated Tablets
Spain Rosuvastatina Almus 5 mg, 10 mg, 20 mg, 40 mg comprimidos recubiertos con
película EFG