Romazic

Package leaflet: Information for the patient

Romazic, 5 mg, film-coated tablets
Romazic, 10 mg, film-coated tablets
Romazic, 20 mg, film-coated tablets
Romazic, 40 mg, film-coated tablets
Rosuvastatinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Romazic is and what it is used for
2. Important information before taking Romazic
3. How to take Romazic
4. Possible side effects
5. How to store Romazic
6. Contents of the package and other information

1. What Romazic is and what it is used for

Romazic belongs to a group of medicines called statins.
Romazic is recommended for use because:

• The patient has been diagnosed with high cholesterol levels. This indicates an increased risk of heart attack (myocardial infarction) or stroke. Romazic is used in adults, adolescents, and children aged 6 years and older for the treatment of high cholesterol.

Your doctor has prescribed Romazic because diet and increased physical activity have not been sufficient to achieve normal cholesterol levels in the blood.
Patients taking Romazic should continue to follow a cholesterol-lowering diet and engage in regular physical activity.
or

• Romazic is also recommended if the patient has other risk factors that increase the likelihood of heart attack (myocardial infarction), stroke, or similar conditions. Myocardial infarction, stroke, and other related problems may be caused by atherosclerosis. Atherosclerosis results from the buildup of atherosclerotic plaques in blood vessels.

Why is it important to take Romazic
Romazic is used to achieve normal levels of blood lipids (fats). The most common of these is cholesterol.
There are different types of cholesterol in the blood – "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).
Romazic reduces the amount of "bad" cholesterol and increases the amount of "good" cholesterol.
Romazic works by reducing the production of "bad" cholesterol in the body and helps remove it from the blood.
In most people, high cholesterol causes no symptoms and does not affect how they feel. However, if left untreated, fatty deposits build up in the walls of blood vessels, leading to narrowing of the vessels.
Sometimes, narrowed blood vessels may become completely blocked, cutting off blood supply to the heart or brain, leading to a heart attack or stroke.
By lowering cholesterol levels, the risk of heart attack or stroke is reduced.
Romazic should be taken continuously, even after cholesterol levels have returned to normal, because it helps prevent cholesterol from rising again. However, treatment should be discontinued if your doctor advises so, or if the patient is pregnant.

2. Important information before using Romazic

When not to use Romazic

• if the patient is allergic to rosiglitazone or any of the other ingredients of this medicine (listed in section 6)
• in pregnant women or breastfeeding women. If a woman becomes pregnant while taking Romazic, she must stop taking it immediately and inform her doctor. Women should avoid becoming pregnant during treatment with Romazic by using an effective method of contraception.
• if the patient has liver disease
• if the patient has severe kidney disease
• if the patient experiences recurrent or unexplained muscle pain
• if the patient is taking cyclosporine (e.g. after organ transplantation)
• if the patient has ever developed a severe skin rash, skin peeling, blisters and/or mouth ulcers after taking Romazic or other similar medicines.

If any of the above apply to the patient or if the patient has any doubts, they should
consult their doctor again.
Additionally, do not use Romazic at the 40 mg dose (the highest dose) in the following
cases:

• if the patient has moderate kidney impairment (if in doubt, ask the doctor)
• if the patient has thyroid dysfunction
• if the patient has experienced recurrent or unexplained muscle pain, or if in the past the patient or family members have had muscle disorders related to taking other cholesterol-lowering medicines
• if the patient regularly consumes large amounts of alcohol
• if the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean or Indian)
• if the patient is taking other cholesterol-lowering medicines called fibrates.

If any of the above apply to the patient (or if in doubt), they should
consult their doctor again.
Warnings and precautions
Before starting Romazic, discuss with your doctor or pharmacist:

• if the patient has or has had myasthenia gravis (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may sometimes worsen symptoms or lead to the development of myasthenia (see section 4),
• if the patient has kidney disease
• if the patient has liver disease
• if the patient has experienced recurrent or unexplained muscle pain, or if in the past the patient or family members have had muscle disorders related to taking other cholesterol-lowering medicines. The patient should inform the doctor immediately if unexplained muscle pain occurs, especially if accompanied by malaise or fever. The patient should also inform the doctor or pharmacist if persistent muscle weakness occurs.
• if the patient regularly consumes large amounts of alcohol
• if the patient has thyroid dysfunction
• if the patient is taking other cholesterol-lowering medicines called fibrates. The patient should read this leaflet carefully, even if they have previously taken other cholesterol-lowering medicines.
• if the patient is taking medicines used to treat HIV infection, e.g. ritonavir with lopinavir and/or atazanavir (see "Romazic and other medicines").
• if the patient is currently taking or has taken within the last 7 days, orally or by injection, a medicine containing fusidic acid (used to treat bacterial infections). Concomitant administration of rosuvastatin and fusidic acid may lead to severe muscle damage (rhabdomyolysis), see "Romazic and other medicines".
• if the patient is over 70 years old (the doctor should select an appropriate starting dose of Romazic)
• if the patient has severe respiratory insufficiency
• if the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean or Indian). The doctor should select an appropriate starting dose of Romazic.

If any of the above situations apply to the patient (or if they are uncertain), they should
not take Romazic at the 40 mg dose and should consult their doctor or pharmacist before
starting any dose of the medicine.
Statins may rarely affect liver function. These changes can be detected by measuring liver enzyme activity in the blood. For this reason, the doctor will usually recommend liver function tests before and during treatment with Romazic.
Patients with diabetes or those at risk of developing diabetes will be under close medical supervision during treatment with this medicine. Patients with high blood sugar and fat levels, overweight and high blood pressure may be at increased risk of developing diabetes.
Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of rosuvastatin. If any of the symptoms described in section 4 occur, treatment with Romazic should be discontinued immediately and the patient should contact their doctor without delay.
Children and adolescents

• if the patient is under 6 years of age: Romazic should not be used in children under 6 years of age
• if the patient is under 18 years of age: Romazic at the 40 mg dose should not be used in children and adolescents under 18 years of age

Romazic and other medicines
Tell your doctor or pharmacist about any other medicines the patient is currently taking, has recently taken or might take, especially:

• cyclosporine (e.g. used after organ transplantation)
• warfarin, clopidogrel or ticagrelor (or other anticoagulant medicines)
• fibrates (such as gemfibrozil, fenofibrate) or other cholesterol-lowering medicines (such as ezetimibe)
• medicines used for indigestion (which neutralize stomach acid)
• erythromycin (an antibiotic), fusidic acid (an antibiotic - see below and section "Warnings and precautions")
• oral contraceptives
• regorafenib (used in cancer treatment)
• hormone replacement therapy
• any of the following medicines used to treat viral infections, including HIV or hepatitis C virus, used alone or in combination with other medicines (see: "Warnings and precautions"): ritonavir, lopinavir, atazanavir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir. Romazic may alter the effect of these medicines, and these medicines may alter the effect of Romazic.

If treatment with fusidic acid (oral or injectable) is required for a bacterial infection,
temporarily discontinue Romazic. The doctor will inform the patient when it is safe to
restart Romazic. Concomitant use of Romazic with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.
Romazic with food and drink
Romazic can be taken independently of meals.
Pregnancy and breastfeeding
Do not use Romazic during pregnancy or breastfeeding. If a woman becomes pregnant
while taking Romazic, she must stop taking it immediately and contact her doctor. Women taking Romazic should avoid becoming pregnant by using appropriate contraceptive methods.
Before taking any medicine, consult a doctor or pharmacist.
Driving and using machines
Most patients can drive and operate machinery while taking Romazic, as it does not affect the ability to perform these activities. However, dizziness may occur in some patients during treatment. If such symptoms occur, consult a doctor before driving or operating machinery.
Romazic contains lactose and sodium
If the patient has been previously diagnosed with intolerance to certain sugars, they should
consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Romazic

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

Usual doses for adults

If Romazic is being used to treat high cholesterol levels:

Starting dose
Treatment is initiated at a dose of 5 mg or 10 mg, even if higher doses of other statins have previously been used. The choice of starting dose depends on:

• Blood cholesterol levels
• The level of risk for heart attack or stroke
• The presence of factors that may increase the risk of adverse effects.

You should consult your doctor or pharmacist regarding the appropriate starting dose. Your doctor may recommend using the lowest dose (5 mg) if:

• The patient is of Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian)
• The patient is over 70 years old
• The patient has moderate kidney impairment
• The patient is at risk of muscle disorders (myopathy).

Dose escalation and maximum daily dose
Your doctor may decide to increase the dose of Romazic to find the most appropriate dose for you. If the starting dose is 5 mg, your doctor may increase it as needed to 10 mg, then to 20 mg, and up to the maximum dose of 40 mg. If the starting dose is 10 mg, your doctor may decide to double it to 20 mg, and then increase it further to the maximum dose of 40 mg. Doses should not be increased more frequently than every four weeks.

The maximum daily dose of Romazic is 40 mg and should be used only in patients with high cholesterol and a high risk of heart attack or stroke, in whom the desired reduction in cholesterol levels has not been achieved with a 20 mg dose.

If Romazic is being used to reduce the risk of heart attack, stroke, or related problems
The recommended daily dose is 20 mg. However, your doctor may decide to use a lower dose if any of the risk factors listed above are present.

Use in children and adolescents aged 6–17 years
The dose range for children and adolescents aged 6 to 17 years is 5 to 20 mg once daily. The usual starting dose is 5 mg, and your doctor may gradually increase the dose as appropriate for the individual patient. The maximum daily dose of Romazic in children and adolescents aged 6 to 17 years is either 10 mg or 20 mg, depending on the condition being treated. Romazic should be taken once daily. Romazic 40 mg must not be used in children.

Taking the tablets

• Swallow the tablets whole with liquid.
• Take once daily, at any time of day.
• Take at the same time each day.

Regular monitoring of cholesterol levels
It is important to attend regular medical check-ups to monitor cholesterol levels and ensure that target cholesterol levels are achieved and maintained during treatment. Your doctor may decide to increase the dose of Romazic to find the most appropriate dose for you.

Taking more than the prescribed dose of Romazic
Contact your doctor or the nearest hospital immediately.
If you are in hospital or being treated for another condition, inform your doctor or medical staff that you are taking Romazic.

If you miss a dose of Romazic
If you miss a dose, take the next dose at the usual time the following day. Do not take a double dose to make up for the missed dose.

Stopping Romazic
Talk to your doctor if you are considering stopping treatment with Romazic. After stopping Romazic, cholesterol levels may rise again.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
It is important that the patient knows which adverse reactions may occur. Usually, they are
mild and resolve shortly after starting treatment.
If any of the following allergic reactions occur, the use of Romazic must be discontinued
and the patient should immediately contact a doctor:

• Difficulty breathing, with (or without) accompanying swelling of the face, lips, tongue, and (or) throat
• Swelling of the face, lips, tongue, and (or) throat, which may cause difficulty swallowing
• Severe skin itching (with hives)

The use of Romazic must be discontinued and the patient should immediately contact a doctor if
the following occur:

• Unexplained muscle pain or other muscle symptoms persisting longer than expected. Muscle-related symptoms occur more frequently in children and adolescents than in adult patients. As with other statins, a small number of patients may experience significant muscle-related symptoms, which in rare cases may lead to potentially life-threatening muscle damage known as rhabdomyolysis.
• Muscle rupture
• Symptoms of a lupus-like syndrome (including rash, joint problems, and effects on blood cells)
• Red, flat, disc-shaped or round spots on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital organs, and around the 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).

Common adverse reactions (may occur in less than 1 in 10 patients):

• Headache
• Abdominal pain
• Constipation
• Nausea
• Muscle pain
• Weakness
• Dizziness
• Increased protein in urine, which usually resolves without the need to discontinue Romazic (occurs only with the 40 mg dose)
• Diabetes. The risk of developing diabetes is higher in people with high blood sugar and fat levels, overweight, and high blood pressure. The doctor will monitor the patient's condition during treatment with this medicine.

Uncommon adverse reactions (may occur in less than 1 in 100 patients):

• Rash, itching, or other skin reactions
• Increased protein in urine, which usually resolves without the need to discontinue Romazic (occurs only with the 5 mg, 10 mg, and 20 mg doses).

Rare adverse reactions (may occur in less than 1 in 1,000 patients):

• Severe allergic reaction – symptoms include: swelling of the face, lips, tongue, and (or) throat, difficulty swallowing and breathing, severe skin itching (with hives). If a patient suspects an allergic reaction, they should stop taking Romazic and immediately contact a doctor.
• Muscle damage in adults – if unexplained muscle pain occurs, treatment with Romazic should be discontinued and the doctor should be notified
• Severe abdominal pain (pancreatitis)
• Increased liver enzyme activity in blood
• Increased tendency to bleeding or bruising due to low platelet count
• Symptoms of a lupus-like syndrome (including rash, joint problems, and effects on blood cells).

Very rare adverse reactions (may occur in less than 1 in 10,000 patients):

• Jaundice (yellowing of the skin and whites of the eyes)
• Hepatitis
• Trace amounts of blood in urine
• Numbness in hands and feet (nerve damage)
• Joint pain
• Memory loss
• Breast enlargement in men (gynecomastia).

Frequency unknown (frequency cannot be estimated from available data):

• Diarrhea (loose stools)
• Cough
• Shortness of breath
• Swelling (edema)
• Sleep disturbances, including insomnia and nightmares
• Sexual dysfunction
• Depression
• Breathing difficulties, including persistent cough and (or) shortness of breath or fever
• Tendon damage
• Persistent muscle weakness
• Myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing)
• Ocular myasthenia (a disease causing weakness of eye muscles). Patients should talk to their doctor if they experience weakness in arms or legs worsening after periods of activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Romazic

Keep this medicine out of the sight and reach of children.
There are no special requirements for storage of this medicine.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the stated month.
The marking on the packaging following EXP indicates the expiry date, and following Lot/LOT indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Romazic contains

• The active substance is rosuvastatin. Each tablet contains 5 mg, or 10 mg, or 20 mg, or 40 mg of rosuvastatin (as calcium salt).
• The other ingredients are:
  Tablet core: monohydrate lactose, microcrystalline cellulose, disodium citrate dihydrate, crospovidone (Type B), colloidal anhydrous silica, magnesium stearate.
  Tablet coating: hypromellose 6 cP, monohydrate lactose, polyethylene glycol 3350, triacetin, titanium dioxide (E 171).

What Romazic looks like and contents of the pack
Romazic 5 mg are white or almost white, round, biconvex film-coated tablets
with the imprint "5" on one side.
Romazic 10 mg are white or almost white, round, biconvex film-coated tablets
with the imprint "10" on one side.
Romazic 20 mg are white or almost white, round, biconvex film-coated tablets
with the imprint "20" on one side.
Romazic 40 mg are white or almost white, elongated, biconvex film-coated tablets.
Pack size: 30 tablets.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01