ROSUVASTATINA 5 mg Film-Coated Tablets

Содержание инструкции

1. Rosuvastatina Pensa 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets
   1. What is Rosuvastatina Pensa and what it is used for
2. Rosuvastatina Pensa is used to correct levels of fatty substances in the blood
   1. What you need to know before taking Rosuvastatina Pensa
   2. How to take Rosuvastatina Pensa
3. Rosuvastatina Pensa must be taken once a day. It can be taken at
   1. Possible side effects
   2. 1,000 patients)
   3. 10,000 patients)
   4. How to store Rosuvastatina Pensa
   5. Contents of the pack and other information
4. Rosuvastatina Pensa 5 mg film-coated tablets are yellow, round and biconvex.
5. Rosuvastatina Pensa 20 mg film-coated tablets are pink, oval and biconvex with
6. Rosuvastatina Pensa 40 mg film-coated tablets are pink, oblong and biconvex

Rosuvastatina Pensa 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 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 they have the same symptoms as you, as it may 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 Pensa is and what it is used for
• 2. What you need to know before you take Rosuvastatina Pensa
• 3. How to take Rosuvastatina Pensa
• 4. Possible side effects
• 5. How to store Rosuvastatina Pensa
• 6. Contents of the pack and other information

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

Rosuvastatina belongs to a group of medicines called statins.

Rosuvastatina Pensa has been prescribed to you because:

• your cholesterol level is high. This means that you are at risk of heart attack and stroke. Rosuvastatina 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 physical exercise have not been sufficient to correct your cholesterol levels. While taking Rosuvastatina, you should continue to follow a diet to reduce your cholesterol levels and continue exercising.
Or

• You have other factors that increase the risk of 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 fat deposits
inside the arteries.

Why it is important to continue taking Rosuvastatina Pensa

Rosuvastatina Pensa is used to correct 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 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 give any 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, the risk of having a heart attack, stroke, or related health problems is reduced.

You must continue to take Rosuvastatina Pensa, even if your cholesterol levels have
returned to normal, to prevent these levels from rising again, causing the formation of
fatty deposits. However, you must stop taking Rosuvastatina Pensaon
medical advice or if you become pregnant.

2. What you need to know before taking Rosuvastatina Pensa

Do not take Rosuvastatina Pensa:

• if you have previously had an allergic reaction to Rosuvastatina Pensaor to any of the ingredients of this medicine;
• if you are pregnantor breastfeeding. If you become pregnant while taking Rosuvastatina Pensa,stop taking it immediately and inform yourdoctor. Women must avoid pregnancy while taking Rosuvastatina, 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 have ever developed a severe skin rash or peeling of the skin, blisters and/or ulcers in the mouth after taking Rosuvastatina Pensa or other related medicines. 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 Pensa 40 mg (the highest dose):

• if you have moderate kidney problems(ask your doctor for any doubt);
• 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 medicinesto lower cholesterol called fibrates.If you fall into any of the above cases (or have doubts), you should return to your doctor andinform them.

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

• 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 does notwork properly ;
• if you are taking other medicines to lower cholesterol called fibrates. Read

medicines for high cholesterol;

• if you are taking medicines used to treat HIV infection,such as ritonavir with lopinavir and/or atazanavir, please read the “Other medicines and Rosuvastatina Pensa”section;
• 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 rosuvastatin can lead to serious muscle problems (rhabdomyolysis).
• if you are over 70 years old(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 Pensa 40 mg (the highest dose) and check with your doctoror pharmacist before starting to takeRosuvastatina Pensaatany dosage.

In a small number of people, statins can have a negative effect on the liver, which 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 undergo this test (liver function test) before and during treatment with Rosuvastatina Pensa. 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.
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with Rosuvastatina Pensa. Stop using Rosuvastatina Pensa and seek immediate medical attention if you notice any of the symptoms described in section 4.

Children and adolescents

• if the patient is under 6 years of age: Rosuvastatina Pensa should not be given to children under 6 years of age.
• if the patient is under 18 years of age: Rosuvastatina Pensa 40 mg tablets are not suitable for use in children and adolescents under 18 years of age.

Other medicines and Rosuvastatina Pensa
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking any of the following medicines: ciclosporin (used, for example, after organ transplantation), warfarin, ticagrelor 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), oral contraceptive (the pill), regorafenib (used to treat cancer), hormone replacement therapy or any of the following medicines 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 modified by Rosuvastatina Pensa, or the effect of Rosuvastatina Pensa may be modified by these medicines.
If you need to take oral fusidic acid to treat a bacterial infection, you should temporarily stop taking this medicine. Your doctor will tell you when it is safe to resume Rosuvastatina. Taking rosuvastatin with fusidic acid can rarely lead to muscle weakness, soreness, and serious muscle problems (rhabdomyolysis). See further information on rhabdomyolysis in section 4.

Pregnancy and breastfeeding
Do not take Rosuvastatina Pensaif you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatina Pensa, you must stop taking it immediatelyand inform your doctor. Women must avoid pregnancy while being treated with Rosuvastatina Pensa using appropriate contraceptive measures.
Ask your doctor or pharmacist for advice before taking any medicine.

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

Rosuvastatina Pensacontains lactose.
If your doctor has diagnosed you with intolerance to some sugars (lactose or milk sugar), contact them before taking Rosuvastatina Pensa.

Rosuvastatina Pensa contains azo dyes
May cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
For a complete list of other ingredients see section “Contents of the pack and other information”.

3. How to take Rosuvastatina Pensa

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

Usual dosage in adults
If you are taking Rosuvastatina Pensa for high cholesterol:
Starting dose
Treatment with Rosuvastatina Pensa should begin with a dose of 5 mg or 10 mg, even if
you have previously taken higher dosages 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 initial dose of Rosuvastatina Pensa 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. This is to determine the most
suitable dose 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 Pensa is 40 mg. It is only administered to
patients with high cholesterol levels and a high risk of heart attack or stroke, whose
cholesterol levels have not lowered sufficiently with the 20 mg dose.

If you are taking Rosuvastatina Pensa 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 starting dose is 5 mg. The doctor may increase the dose to reach the
most appropriate dosage of Rosuvastatina Pensa for you. The maximum daily dose of
Rosuvastatina Pensa 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. The
Rosuvastatina Pensa 40 mg tablets should not be used in children.

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

Rosuvastatina Pensa must be taken once a day. It 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 for periodic cholesterol level checks,
to ensure that your cholesterol has reached and maintains the correct levels. Your doctor may
decide to increase the dose up to the amount of Rosuvastatina most suitable for you.

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

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

If you stop taking Rosuvastatina Pensa
Inform your doctor if you intend to stop taking Rosuvastatina Pensa. If
you stop taking Rosuvastatina Pensa, 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.
They are usually mild and disappear in a short time.

Stop taking Rosuvastatina Pensa and seek immediatemedical help if any of the following allergic reactions occur:

• difficulty in breathing, with or without swelling of the face, lips, tongue and/or throat;
• swelling of face, lips, tongue and/or throat that can cause difficulty in swallowing;
• severe skin itching (with raised bumps);
• reddish, non-raised, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also, stop taking Rosuvastatina Pensa and consult your doctor immediately if you experience:

• unusual muscle aches or pains, which 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 muscle side effects, and rarely these have progressed to a condition leading to muscle damage, potentially life-threatening, known as rhabdomyolysis;
• symptoms of a lupus-like syndrome (including rash, joint disorders and effects on blood cells);
• muscle rupture

Possible common side effects (these may affect 1 in 10 to 1 in 100
patients)

• headache
• stomach pain
• constipation
• feeling unwell
• muscle pain
• feeling weak
• dizziness
• an increase in the amount of protein in the urine - usually the values return to normal on their own without having to stop taking Rosuvastatina Pensa (only for Rosuvastatina Pensa 40 mg)
• diabetes. This is more likely if you have high levels of sugar and fats in your blood, if you are overweight and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Possible uncommon side effects (these may affect 1 in 100 and 1 in

1,000 patients)

• 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 stop treatment with Rosuvastatina Pensa (only for Rosuvastatina Pensa 5 mg, 10 mg and 20 mg).

Possible rare undesirable effects (these can occur in 1 to 1,000 and 1 to 10,000
patients)

• severe allergic reactions - signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe skin itching (with raised bumps). If you suspect you are having an allergic reaction,stop taking Rosuvastatina Pensaand seek immediate medical help
• muscle damage in adults - as a precaution, stop takingRosuvastatina Pensa and consult your doctor immediately if you have unusual muscle aches ormuscle painthat persists longer than expected
• severe stomach pain (inflamed pancreas)
• increased liver enzymes in the blood.

Possible very rare undesirable effects (these can occur in less than 1 in

10,000 patients)

• 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).

Adverse reactions of unknown frequency may include:

• diarrhea (loose stools)
• 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
• constant muscle weakness.

Reporting of adverse reactions
If you experience any side effects, including those not listed in this leaflet, please
consult 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 Pensa

• 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 box/blisters/label, after SCAD. The expiry date refers to the last day of that month.
• This medicine does not require any particular storage conditions.
• 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. Contents of the pack and other information

What Rosuvastatina Pensa contains

• The active substanceis rosuvastatin. Rosuvastatina Pensa film-coated tablets contain rosuvastatin calcium salt equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.
• The other ingredients are: calcium citrate, microcrystalline cellulose, hydroxypropylcellulose, mannitol, anhydrous lactose, crospovidone and magnesium stearate.
• Rosuvastatina Pensa 5 mg film-coated tablets also contain polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, tartrazine (E102), sunset yellow FCF (E110) and indigo carmine (E132)
• Rosuvastatina Pensa 10 mg, 20 mg and 40 mg film-coated tablets also contain polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, tartrazine (E102), allura red AC (E129), sunset yellow FCF (E110) and indigo carmine (E132).

Description of the appearance of Rosuvastatina Pensa and contents of the pack
Rosuvastatina Pensa is supplied in tablets of four dosages:

Rosuvastatina Pensa 5 mg film-coated tablets are yellow, round and biconvex.

Rosuvastatina Pensa 10 mg film-coated tablets are pink, round and biconvex.

Rosuvastatina Pensa 20 mg film-coated tablets are pink, oval and biconvex with

a score line on one side. The tablets can be divided into equal doses.

Rosuvastatina Pensa 40 mg film-coated tablets are pink, oblong and biconvex

with a score line on one side. The tablets can be divided into equal doses.
Rosuvastatina Pensa is supplied in blister packs containing 28 film-coated
tablets.

Marketing Authorisation Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini 12
20124 Milano

Manufacturers
Biofarm Sp. z o.o
Ul.Walbrzyska 13
60-198 Poznan, Poland
SAG Manufaturing, S.L.U
Ctra. N-I, Km 36, San Agustín de Guadalix
28750 Madrid, Spain
Galenicum Health, S.L.
Avda. Cornellá 144, 7ª-1ª,
Edificio Lekla
Esplugues de Llobregat
08950, Barcelona
Spain

This medicinal product is authorised in the Member States of the European Economic Area
under the following denominations:
Italy: Rosuvastatina Pensa