MIASTINA 5 мг Фильм-coated таблетки

Содержание инструкции

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

Miastina 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.

C ontents of this leaflet

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

1. What is Miastina and what is it used for

Miastina belongs to a group of medicines called “statins”.

Miastina has been prescribed to you because:

• Your cholesterol level is high. This means you are at risk of heart attack or stroke. Miastina is used in adults, adolescents and children aged 6 years and over for the treatment of high cholesterol levels.

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 Miastina you should continue
the diet to reduce cholesterol levels and continue with exercise.
Or

• You have other factors that increase the risk of developing 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 is it important to continue taking Miastina?
Miastina 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 cholesterol
so-called “good” (HDL-C).

• Miastina can reduce “bad” cholesterol and increase “good” cholesterol.
• It works by blocking 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 gives no symptoms.
However, if high cholesterol is not treated, fat deposits can accumulate in the walls of the 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 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 Miastina, even if your cholesterol levels have returned to normal, to
prevent these levels from rising again, causing the formation of fat deposits. However, you must
stop taking Miastina on medical advice or if you become pregnant.

2. What you need to know before taking Miastina

Do not take Miastina:

• If you are allergicto rosuvastatinor any of the other ingredients of this medicine (listed in section 6);
• If you are pregnant or breastfeeding. If you become pregnant while taking Miastina, you muststop taking it immediately and inform your doctor. Women must avoid pregnancy while taking Miastina, 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 example, after organ transplantation).
• If you have ever developed a severe skin rash or peeling of the skin, blisters and/orulcers in the mouth after taking Miastina or other medicines called “statins”.If you fall into any of the above cases (or have any doubts), you must return to your doctor and inform them.

Also, do not take Miastina 40 mg film-coated tablets(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 you have previously experienced 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 called fibratesto lower cholesterol. If you fall into any of the above cases (or have any doubts), you must return to your doctor and inform them.

Warnings and precautions
Consult your doctor or pharmacist before taking Miastina.

• 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 you have previously experienced 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 persistent muscle weakness;
• If you have or have had myasthenia(a disease characterized by generalized muscle weakness including, in some cases, the muscles used for breathing) or ocular myasthenia(a disease that causes weakness of the eye muscles), as statins can sometimes worsen myasthenia or cause it to appear (see section 4).
• If you regularly consume large amounts of alcohol;
• If your thyroidis not functioning properly;
• If you are taking other medicines called fibratesto lower cholesterol .Read this carefully
• If you are taking medicines used to fight HIV or Hepatitis C infections,such as ritonavir with lopinavir and/or atazanavir or simeprevir, see section Other medicines and Miastina;
• 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 Miastina can lead to serious muscle problems (rhabdomyolysis).
• If you are over 70 years of age(your doctor needs to choose the initial dose of Miastina suitable for the individual person);
• If you have severe respiratory failure;
• If you are of Asian origin(Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). Your doctor needs to choose the initial dose of Miastina suitable for the individual person.

If you fall into any of the above cases (or are unsure):

• Do not take Miastina 40 mg film-coated tablets (the highest dose) and check withyour doctor or pharmacist before starting to take Miastina at any dosage.

In a small number of people, statins can have an 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 Miastina.
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 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.
Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with Miastina. Stop using Miastina and seek immediate medical attention if you notice any of the symptoms described in section 4.

Children and adolescents

• If the patient is less than 6 years of age:Miastina should not be given to children under 6 years of age. If the patient is less than 18 years of age:Miastina 40 mg film-coated tablets are not suitable for use in children and adolescents under 18 years of age

Other medicines and Miastina
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

• if you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop using this medicine. Your doctor will tell you when to safely restart Miastina. Taking Miastina with fusidic acid can rarely cause weakness, soreness or pain in the muscles (rhabdomyolysis). See section 4 for more information regarding rhabdomyolysis;

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

• cyclosporine (used, for example, after organ transplantation);
• blood thinners such as warfarin, acenocoumarol or fluindione (their blood-thinning effect and the risk of bleeding may increase if taken together with this medicine), ticagrelor or clopidogrel;
• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe);
• antacids (used to neutralize stomach acid);
• 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 may be altered by Miastina, or the effect of Miastina may be altered by these medicines.

Pregnancy and breastfeeding
Do not take Miastinaif you are pregnant or breastfeeding. If you become pregnant while taking Miastina, you muststop taking it immediatelyand inform your doctor. Women must avoid pregnancy during treatment with Miastina, 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 Miastina – it has no effect on their ability to drive cars and use machines. However, some people may experience dizziness during treatment with Miastina. If you experience dizziness, consult your doctor before driving or using machines.

Lactose.
If your doctor has told you that you have an intolerance to some sugars, consult him 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’

3. How to take Miastina

Always take Miastina exactly as your doctor has instructed. If you have any doubts, you should consult your
doctor or pharmacist.

Normal doses for adults
If you are taking Miastina for high cholesterol:

Initial dose
Treatment with Miastina 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 initial dose depends on:

• your cholesterol level;
• your risk level of having a heart attack or stroke;
• the possible presence of factors that may make a person more sensitive to possible side effects. Check with your doctor or pharmacist what the most appropriate initial dose of Miastina is for you.

Your 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 of this in order to determine the most suitable dose of Miastina
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 necessary. If you start with 10 mg the doctor may decide, if
necessary, 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 Miastina is 40 mg. It is only administered to patients with high levels of
cholesterol 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 Miastina to reduce the risk of heart attack, stroke or health problems
related to:
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.

Administration to children and adolescents aged 6-17 years
The dosage range in children and adolescents aged between 6 and 17 years is from 5 to 20 mg once
a day. The usual initial dose is 5 mg per day and your doctor may decide to increase it
gradually until finding the Miastina dose suitable for you. The maximum daily dose of Miastina for
children aged between 6 and 17 years is 10 or 20 mg depending on the condition to be treated.
Take the dose once a day. Miastina 40 mgfilm-coated tablets must notbe used by
children.

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

Miastina must be taken once a day. Miastina 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 be
sure that your cholesterol has reached and maintains the correct levels.
The doctor may decide to increase the dose to have you take the amount of Miastina that is most suitable for you.

If you take more Miastina 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 healthcare staff that you are
taking Miastina.

If you forget to take a dose of Miastina
Do not worry, take the next dose at the usual time. Do not take a double dose to make up for the
forgotten dose.

If you stop taking Miastina
Tell your doctor if you intend to stop taking Miastina. If you stop taking Miastina your cholesterol levels may increase again.
If you have any further questions on the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Miastina can cause side effects, although not everybody gets them.
It is important to be aware of what side effects may occur. They are usually mild and
disappear in a short time.

Stop taking Miastina and consult 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);
• 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 Miastina and see your doctor immediately if you
have unusual muscle aches or painsthat last longer than you would expect. Symptoms at
the muscle level 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 fatal, known as rhabdomyolysis.

• Lupus-like syndrome (including rash, joint problems and effects on blood cells)
• Muscle rupture (pain and/or inability to use the affected part of the body, muscle pain, weakness, slight swelling, noticeable loss of strength and sometimes tingling)

Common(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 - values usually return to normal on their own without stopping Miastina (only for Miastina 40 mg film-coated tablets)
• Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

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

• Skin rash, itching and other skin reactions
• Increased amount of protein in the urine - these usually return to normal on their own without the need to stop treatment with Miastina (only for Miastina 5-10 mg and 20 mg).

Rare (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 taking Miastinaand consult your doctor immediately
• Muscle damage in adults - as a precaution, stop taking Miastina and see 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(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
• Breast enlargement in men (gynecomastia).

Not known: frequency cannot be estimated from the available data

• 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
• Myasthenia gravis (a disease that causes generalized muscle weakness including, in some cases, the muscles used for breathing).
• Ocular myasthenia (a disease that causes weakness of the eye muscles).

See your doctor if you experience weakness in your arms or legs that worsens after periods of activity,
double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible 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 Miastina

Keep this medicine out of the sight and reach of children
Do not use this medicine after the expiry date indicated on the blister, the carton or the bottle, after “Exp.”. The expiry date refers to the last day of the month.

For blisters:
Store at a temperature not exceeding 30°C.

For 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. Contents of the pack and other information

What Miastina contains
The active ingredient is rosuvastatin.
Miastina 5, 10, 20, 40 mg film-coated tablets contains rosuvastatin calcium salt equivalent to 5
mg, 10 mg, 20 mg or 40 mg of rosuvastatin.
The excipients are:

Tablet core:
Microcrystalline cellulose
Lactose monohydrate
Crospovidone (type b)
Hydroxypropylcellulose
Sodium bicarbonate
Magnesium stearate

Film coating:
Lactose monohydrate
Hypromellose 6 cp
Titanium dioxide (E 171)
Triacetin
Yellow iron oxide (E 172) in Miastina 5 mg
Red iron oxide (E 172) in Miastina 10 mg, 20 mg and 40 mg

Description of the appearance of Miastina film-coated tablets and contents of the pack
Miastina 5 mg film-coated tablets: yellow, round and biconvex tablets, with a diameter of approximately 5.5 mm.
Miastina 10 mg film-coated tablets: pink, round, biconvex tablets, with a score line, with a diameter of approximately 7 mm.
Miastina 20 mg film-coated tablets: pink, round, biconvex tablets, with a score line, with a diameter of approximately 9 mm.
Miastina 40 mg film-coated tablets: pink, oval, biconvex tablets, with a score line, with dimensions of approximately 11.5 x 7 mm.
Miastina 10, 20, 40 mg film-coated tablets:
The tablets can be divided into two equal halves.
Miastina is supplied in blisters containing 7, 14, 15, 20, 28, 30, 30 x 1, 42, 50, 50 x1, 56, 60, 84, 90, 98, 100 and
100 x 1 film-coated tablets and HDPE bottles containing 30 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
I.B.N. Savio Srl – via del Mare 36 – Pomezia (RM)

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

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Italy MIASTINA