Miaestina

Package leaflet

Miastina 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before 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. Never give it to other people, even if they have the same symptoms as you, because it could be dangerous.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Miastina is and what it is 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

1. What Miastina is and what it is used for

Miastina belongs to a group of medicines called "statins".
You have been prescribed Miastina 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 older for the treatment of high cholesterol levels.

You have been prescribed a statin because changing your diet and increasing physical activity have not been sufficient to correct your cholesterol levels. While taking Miastina, you must continue following a cholesterol-lowering diet and maintain regular physical exercise.
Alternatively

• You have other risk factors that increase the likelihood of developing heart attack, stroke, or related health problems. Heart attack, stroke, and related health problems may be caused by a disease called atherosclerosis. Atherosclerosis is due to the buildup of fatty deposits inside the arteries.

Why is it important to keep taking Miastina?
Miastina is used to correct levels of fatty substances in the blood known as lipids, the most common of which is cholesterol.
There are different types of cholesterol in the blood: so-called "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

• Miastina can reduce "bad" cholesterol and increase "good" cholesterol.
• It works by helping to block the body's production of "bad" cholesterol and 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 causes no symptoms.
However, if high cholesterol is left untreated, fatty deposits can build up in the walls of blood vessels, leading to their narrowing.
Sometimes, these narrowed blood vessels can become blocked, interrupting blood flow to the heart or brain and 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 taking Miastina, even if your cholesterol levels have returned to normal, to prevent them from rising again, which could lead to the formation of fatty 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 allergic to 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 Miastina, you must stop taking it immediately and inform your doctor. Women must avoid pregnancy while taking Miastina by using appropriate contraceptive measures;
• If you have liver disease;
• If you have severe kidney problems;
• If you have repeated or unexplained muscle pain or tenderness;
• If you are taking a medicine called cyclosporine (used, for example, after organ transplant);
• If you have ever developed a severe skin rash, skin peeling, blisters and/or mouth ulcers after taking Miastina or other medicines called "statins". If you fall into any of the above categories (or have any doubts), you must consult your doctor and inform him/her.

In addition, 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 thyroid gland is not functioning properly;
• If you have repeated or unexplained muscle pain or tenderness, a personal or family history of muscle problems, or have previously experienced muscle problems while taking other cholesterol-lowering medicines;
• 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 fibrates to lower cholesterol. If you fall into any of the above categories (or have any doubts), you must consult your doctor and inform him/her.

Warnings and precautions
Talk to 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 pain or tenderness, a personal or family history of muscle problems, or have previously experienced muscle problems while taking other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or tenderness, 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 gravis (a disease characterized by generalized muscle weakness, including in some cases the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), since statins may sometimes worsen myasthenia or cause its onset (see section 4);
• If you regularly consume large amounts of alcohol;
• If your thyroid gland is not functioning properly;
• If you are taking other medicines called fibrates to lower cholesterol. Read this leaflet carefully, even if you have previously taken other medicines for high cholesterol;
• If you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) taken 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 appropriate starting dose of Miastina for you);
• If you have severe respiratory insufficiency;
• If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). Your doctor needs to choose the appropriate starting dose of Miastina for you.

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

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

In a small number of people, statins may affect the liver. This can be detected by a simple blood test showing increased levels of liver enzymes. 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 closely monitor whether you have diabetes or are at risk of developing diabetes. You are 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.
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 under 6 years of age: Miastina must not be given to children under 6 years of age.
• If the patient is under 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 taking this medicine. Your doctor will tell you when it is safe to restart Miastina. Taking Miastina with fusidic acid may rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). See section 4 for more information about rhabdomyolysis.

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

• cyclosporine (used, for example, after organ transplant);
• blood anticoagulants, e.g. warfarin, acenocoumarol or phenindione (their blood-thinning effect and 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 tumours);
• any 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, 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 Miastina if you are pregnant or breastfeeding. If you become pregnant while taking Miastina, you must stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with Miastina by using appropriate contraceptive measures.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Most people can drive and operate machinery while taking Miastina – it does not affect their ability to drive or operate machinery. However, some people may experience dizziness during treatment with Miastina. If you experience dizziness, consult your doctor before driving or operating machinery.

Lactose
If your doctor has told you that you have an intolerance to certain 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 prescribed by your doctor. 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 start with a 5 mg or 10 mg dose, even if you have previously taken higher doses with other statins. The choice of initial dose depends on:

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

Your doctor may decide to prescribe 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 pain or muscle aches (myopathy).

Dose increase and maximum daily dose
Your doctor may decide to increase the dose in order to determine the most appropriate Miastina dose for you. If starting with a 5 mg dose, your doctor may, if necessary, decide to double the dose to 10 mg, then to 20 mg, and then to 40 mg if needed. If starting with 10 mg, your doctor may, if necessary, decide to double this dose to 20 mg and then to 40 mg if needed. There must be an interval of 4 weeks between one dose adjustment and the next.
The maximum daily dose of Miastina is 40 mg. This dose is administered only to patients with high cholesterol levels and at high risk of heart attack or stroke, whose cholesterol levels have not sufficiently decreased with the 20 mg dose.
If you are taking Miastina to reduce the risk of developing heart attack, stroke, or related health problems:
The recommended dose is 20 mg daily. However, your doctor may decide to use a lower dose if you have any of the risk factors listed above.
Administration to children and adolescents aged 6–17 years
The dosage range in children and adolescents aged 6 to 17 years is 5 to 20 mg once daily. The usual initial dose is 5 mg daily, and your doctor may decide to gradually increase it until the appropriate Miastina dose for you is found. The maximum daily dose of Miastina for children aged 6 to 17 years is 10 or 20 mg, depending on the clinical condition being treated.
Take the dose once daily. Miastina 40 mg film-coated tablets must not be used in children.
Taking the tablets
Swallow each tablet whole with a glass of water.
Miastina should be taken once daily. Miastina can be taken at any time of day, with or without food. Try to take the tablets at approximately the same time each day; this may help you remember to take them.
Regular cholesterol checks
It is important to return to your doctor regularly to monitor your cholesterol levels, to ensure that your cholesterol has reached and maintains the correct levels.
Your doctor may decide to increase the dose until the amount of Miastina most suitable for you is reached.
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 healthcare professionals that you are taking Miastina.
If you forget to take a dose of Miastina
Do not panic; 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 Miastina
Inform your doctor if you intend to stop taking Miastina. If you stop taking Miastina, your cholesterol levels may rise again.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Miastina can cause side effects, although not everyone gets them.
It is important to be aware of which side effects may occur. They are usually mild and
disappear in a short time.
Stop taking Miastina and consult a doctor immediately if 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 may cause difficulty swallowing;
• Severe skin itching (with raised hives);
• Reddish, non-elevated spots, target-shaped or circular, on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. 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 contact your doctor immediately if you experience unusual muscle pains or twinges that last longer than expected. Muscle-related symptoms are more frequent in children and adolescents than in adults. As with other statins, a very small number of people have experienced muscle-related side effects, and in rare cases these have progressed to a disease causing muscle damage, potentially fatal, known as rhabdomyolysis.

• Lupus-like syndrome (including rash, joint problems, and effects on blood cells)
• Muscle strain (pain and/or functional inability to use the affected body part, 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
• Malaise
• Muscle pain
• Feeling of weakness
• Dizziness
• Increased amount of protein in the urine – values usually return to normal on their own without needing to stop taking Miastina (only for Miastina 40 mg film-coated tablets)
• Diabetes. This is more likely if you have high levels of sugar and fats in the 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):

• Rash, itching, and other skin reactions
• Increased amount of protein in the urine – these usually return to normal on their own without needing 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 skin itching (with raised hives). If you suspect you are having an allergic reaction, stop taking Miastina and consult a doctor immediately
• Muscle damage in adults – as a precaution, stop taking Miastina and contact your doctor immediately if you have unusual muscle twinges or pain that lasts longer than expected
• 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
• Enlargement of breasts in men (gynecomastia).

Not known: frequency cannot be estimated from the available data

• Diarrhea (passing liquid 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
• Persistent muscle weakness
• Myasthenia gravis (a disease causing generalized muscle weakness, including in some cases the muscles used for breathing).
• Ocular myasthenia (a disease causing weakness of the eye muscles).

Contact your doctor if you experience weakness in the arms or legs that worsens after periods of activity,
double vision or drooping eyelids, difficulty swallowing, or labored breathing.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your
doctor or pharmacist. You may also report side effects directly via 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 stated on the blister, the box 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 medicines via 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 Miastina contains
The active substance is rosuvastatin.
Miastina 5, 10, 20, 40 mg film-coated tablets contain rosuvastatin calcium 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
Iron oxide yellow (E 172) in Miastina 5 mg
Iron oxide red (E 172) in Miastina 10 mg, 20 mg and 40 mg

Description of the appearance of Miastina film-coated tablets and pack sizes
Miastina 5 mg film-coated tablets: yellow, round, biconvex tablets, approximately 5.5 mm in diameter.
Miastina 10 mg film-coated tablets: pink, round, biconvex tablets with a score line, approximately 7 mm in diameter.
Miastina 20 mg film-coated tablets: pink, round, biconvex tablets with a score line, approximately 9 mm in diameter.
Miastina 40 mg film-coated tablets: pink, oval, biconvex tablets with a score line, approximately 11.5 x 7 mm in size.
Miastina 10, 20, 40 mg film-coated tablets:
The tablets may be divided into two equal parts.
Miastina is supplied in blisters 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 film-coated tablets and in HDPE bottles containing 30 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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 authorized in the European Economic Area countries under the following names:
Italy MIASTINA