Romazic

Patient Information Leaflet

Romazic, 15 mg, coated tablets
Romazic, 30 mg, coated tablets
Rosuvastatin
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. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

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 pack 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:

• You have been diagnosed with high cholesterol levels. This increases the risk of heart attack (myocardial infarction) or stroke. Romazic is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol levels.

Your doctor has prescribed a statin because changes in diet and increased physical activity have not been sufficient to achieve normal cholesterol levels in the blood.
While taking Romazic, you should also follow a cholesterol-lowering diet and engage in regular physical exercise.
or

• Romazic is also recommended if you have other risk factors that increase the likelihood of heart attack (myocardial infarction), stroke, or similar conditions.

Heart attack, stroke, and other related problems may be caused by atherosclerosis.
Atherosclerosis results from the buildup of atherosclerotic plaques in blood vessels.
Why it is important to take Romazic regularly
Romazic is used to achieve normal levels of blood lipids (fats).
The most common lipid is cholesterol.
There are different types of cholesterol in the blood: so-called "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

• Romazic may reduce levels of "bad" cholesterol and increase levels of "good" cholesterol.
• Romazic works by inhibiting the production of "bad" cholesterol in the body. It also helps remove "bad" cholesterol from the blood.

In most people, high cholesterol does not cause any noticeable symptoms or changes in how you feel. However, if left untreated, fatty deposits build up in the walls of blood vessels, causing them to narrow.
Sometimes, a narrowed blood vessel may become completely blocked, cutting off blood supply to the heart or brain, leading to a heart attack or stroke.
Achieving normal cholesterol levels in the blood reduces the risk of heart attack, stroke, or similar diseases.
Even if cholesterol levels return to normal after taking Romazic, you must continue taking the medicine. This prevents cholesterol levels from rising again, which could lead to further accumulation of fatty deposits. You should stop taking Romazic only if your doctor advises you to do so, or if you become pregnant.

2. Important information before using Romazic

When not to use Romazic

• if the patient is allergic to rosuvastatin or to any of the other ingredients of this medicine (listed in section 6),
• if the patient is pregnant or breastfeeding. If a woman taking Romazic becomes pregnant, she must immediately stop taking the medicine and inform her doctor. Women using Romazic should use effective contraceptive methods,
• if the patient has liver disease,
• if the patient has severe kidney disease,
• if the patient experiences frequent or unexplained muscle pain or discomfort,
• if the patient is taking cyclosporine (a medicine used, for example, after organ transplantation),
• if the patient has ever developed severe skin rash or skin peeling, blisters and (or) oral ulcers after taking Romazic or other similar medicines.

If any of the above situations apply to the patient or if the patient has any doubts,
the patient should contact their doctor again.
Additionally, do not use rosuvastatin at a dose of 30 mg or 40 mg in the following
situations:

• if the patient has moderately severe kidney disease (if in doubt, consult the doctor),
• if the patient has thyroid disease,
• if the patient experiences frequent or unexplained muscle pain or discomfort, or if the patient or their family members have previously had muscle disorders, or if muscle-related side effects occurred during prior treatment with lipid-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 fibrates (i.e., other cholesterol-lowering medicines).

If any of the above situations apply to the patient (or if the patient has any doubts),
the patient should contact their doctor again.
Warnings and precautions
Before starting Romazic, discuss the following with your doctor or pharmacist:

• if the patient has or has had myasthenia gravis (a disease causing general muscle weakness, including in some cases the muscles involved in breathing) or ocular myasthenia (a disease causing weakness of the 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 experiences frequent or unexplained muscle pain or discomfort, or if the patient or their family members have previously had muscle disorders, or if muscle-related side effects occurred during prior treatment with lipid-lowering medicines. The patient should contact their doctor immediately if unexplained muscle pain or discomfort occurs, especially if accompanied by general malaise or fever. The patient should also inform the doctor if persistent muscle weakness develops.
• if the patient regularly consumes large amounts of alcohol,
• if the patient has thyroid disease,
• if the patient is taking fibrates (other cholesterol-lowering medicines). Read this leaflet carefully, even if the patient has 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; refer to the section: "Romazic and other medicines",
• if the patient is taking or has taken within the last 7 days an oral or injectable medicine containing fusidic acid (a medicine used for bacterial infections). Concurrent use of fusidic acid with Romazic may lead to severe muscle damage (rhabdomyolysis); see section "Romazic and other medicines",
• if the patient is over 70 years of age (because the doctor must 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). In these patients, the doctor will determine the appropriate starting dose of Romazic.

If any of the above situations apply to the patient (or if the patient is uncertain), the patient
should not take rosuvastatin at doses of 30 mg or 40 mg (the highest doses) and should consult their
doctor or pharmacist before starting any dose of Romazic.
In a small number of patients, statins may affect liver function. To confirm this effect, a blood test
assessing liver enzyme activity is performed. Usually, the doctor will recommend checking liver
enzyme activity in the blood before and during treatment with Romazic.
Patients with diabetes or those at risk of developing diabetes will be under close medical supervision
while taking this medicine. Patients with high blood sugar and lipid 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, the patient should stop taking Romazic and contact their doctor
immediately.
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 doses of 30 mg or 40 mg should not be used in children and adolescents under 18 years of age.

Romazic and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used, especially:

• cyclosporine (used, for example, 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 (neutralizing 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, administered 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 the patient needs to take oral fusidic acid to treat a bacterial infection,
Romazic should be temporarily discontinued. The doctor will inform the patient when it is safe to
resume Romazic. Concurrent use of Romazic with fusidic acid may rarely lead to muscle weakness,
tenderness, or pain (rhabdomyolysis). More information about rhabdomyolysis is provided in section 4.
Romazic with food and drink
Romazic can be taken independently of meals.
Pregnancy and breastfeeding
Romazic must not be used during pregnancy or while breastfeeding. If a woman becomes pregnant
while taking Romazic, treatment must be stopped immediately
and the doctor should be contacted. Women taking Romazic should avoid pregnancy
and use effective contraceptive methods.
Before taking any medicine, consult a doctor or pharmacist.
Driving and operating machinery
Most people can drive and operate machinery while taking Romazic – the medicine does not impair
these abilities. However, some patients may experience dizziness during treatment with Romazic.
If this symptom occurs, the patient should contact their doctor before driving or operating machinery.
Romazic contains lactose and sodium
If the patient has previously been 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 directed by your doctor. If in doubt, consult your doctor or pharmacist.

Adults

Use of Romazic to lower cholesterol levels

Starting dose
Treatment should be initiated with a 5 mg or 10 mg dose, even if the patient has previously used higher doses of other statins. The choice of starting dose depends on:

• cholesterol levels,
• the patient's risk level for heart attack or stroke,
• the presence of factors that increase susceptibility to adverse effects.

Ask your doctor which starting dose of Romazic is most appropriate for you.

Your doctor may decide to use a 5 mg dose as the starting dose if:

• the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea, or India),
• the patient is over 70 years of age,
• the patient has moderate kidney disease,
• the patient is at risk of developing muscle disorders or muscle pain (myopathy).

Dose escalation and maximum daily dose
Your doctor may decide to increase the dose of Romazic to find the appropriate dose for the individual patient. If the starting dose is 5 mg, your doctor may increase it as needed to 10 mg, then to 15 mg or 20 mg, and subsequently to 30 mg or 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 40 mg. Doses should not be increased more frequently than every four weeks.

The maximum daily dose of rosuvastatin is 40 mg. This dose is used in patients with high cholesterol levels and a high risk of heart attack or stroke, in whom a 20 mg dose was insufficient to reduce cholesterol levels.

Use of Romazic to reduce the risk of heart attack, stroke, or similar health problems
The recommended daily dose is 20 mg. However, your doctor may decide to reduce this dose if the patient has any of the risk factors described above.

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 rosuvastatin dose to suit the individual patient. The maximum daily dose of rosuvastatin is 10 mg or 20 mg in children and adolescents aged 6 to 17 years, depending on the condition being treated. The medicine should be taken once daily. Doses of 30 mg and 40 mg must not be used in children and adolescents under 18 years of age.

How to take the medicine
The tablet should be swallowed whole with water.

Romazic should be taken once daily, at any time of day.
It is recommended to take the medicine at the same time each day to help with remembering.

Monitoring cholesterol levels
Regular check-ups and blood tests are necessary to ensure that cholesterol levels have decreased and remain within the target range.
Your doctor may decide to adjust the dose of Romazic to suit your individual needs.

If you take more Romazic than you should
If you take more than the prescribed dose of Romazic, contact your doctor or go to the nearest hospital immediately.

If you are in hospital or being treated for another medical condition, inform your doctor or healthcare staff that you are taking Romazic.

If you forget to take Romazic
Take the next dose at your usual time. Do not take a double dose to make up for a missed dose.

Stopping Romazic
Tell your doctor if you wish to stop taking Romazic. Cholesterol levels may rise again if treatment with Romazic is stopped.

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 not everyone will experience them.
It is important for the patient to be aware of possible adverse reactions. Usually they are
mild and resolve shortly after starting treatment.
The patient should immediately stop taking Romazic and seek medical advice without delay if
any of the following occur:

• Difficulty breathing, with (or without) swelling of the face, lips, tongue and (or) throat
• Swelling of the face, lips, tongue and (or) throat, possibly causing difficulty in swallowing
• Severe skin itching (with raised, itchy rash)

The patient should stop taking Romazic and contact a doctor immediately if any of the
following occur:

• Unexplained muscle pain or other muscle symptoms that persist 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 troublesome muscle symptoms, which in rare cases may lead to potentially life-threatening muscle damage called rhabdomyolysis.
• Muscle rupture
• Symptoms of lupus-like syndrome (including rash, joint problems and effects on blood cells)
• Red, flat, disc-shaped or round skin lesions on the trunk, often with blisters in the center, skin peeling, oral, throat, nasal, genital or ocular mucosal ulcers. These potentially severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome)
• Widespread rash, high fever and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Adverse reactions occurring commonly (in more than 1 in 100 but less than 1 in 10 patients)

• Headache
• Abdominal pain
• Constipation
• Nausea
• Muscle pain
• Fatigue
• Dizziness
• Increased protein in urine. This symptom usually resolves spontaneously and does not require discontinuation of Romazic (applies only to the 40 mg dose).
• Diabetes. The risk of developing diabetes is higher if the patient has high blood sugar and lipid levels, overweight and high blood pressure. The treating physician will monitor patients at risk during treatment with this medicine.

Adverse reactions occurring uncommonly (in more than 1 in 1,000 but less than 1 in 100
patients)

• Rash, itching or other skin reactions
• Increased protein in urine. This symptom usually resolves spontaneously and does not require discontinuation of Romazic (applies only to the 5 mg, 10 mg and 20 mg doses).

Adverse reactions occurring rarely (in more than 1 in 10,000 but less than 1 in 1,000
patients)

• Severe allergic reactions – symptoms include swelling of the face, lips, tongue and (or) throat, difficulty swallowing and breathing, severe skin itching (with hives). If the patient suspects an allergic reaction, Romazic should be stopped immediately and medical help sought.
• Muscle damage in adults – caution is advised, i.e. Romazic should be discontinued and medical advice sought promptly if muscle pain or other symptoms occur and persist longer than expected.
• Severe abdominal pain (pancreatitis)
• Increased liver enzyme levels in blood
• Increased tendency to bleeding or bruising due to low platelet count
• Lupus-like syndrome symptoms (including rash, joint problems and effects on blood cells).

Adverse reactions occurring very rarely (in less than 1 in 10,000 patients)

• Jaundice (yellowing of the skin and eyes)
• Hepatitis
• Blood in urine
• Nerve damage in upper and lower limbs (felt as numbness)
• Joint pain
• Memory loss
• Breast enlargement in men (gynaecomastia).

Adverse reactions with unknown frequency (frequency cannot be estimated from available data)

• Diarrhea (loose stools)
• Cough
• Shallow breathing
• Swelling
• Sleep disturbances (insomnia and nightmares)
• Sexual dysfunction
• Breathing problems (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 the eye muscles). Patients should consult a doctor if they experience weakness in hands or legs worsening with activity, double vision or drooping eyelids, difficulty swallowing or breathing.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 provide more information on the safety of this medicine.

5. How to store Romazic

Keep this medicine out of sight and reach of children.
No special storage conditions are required for 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 label on the packaging shows the expiry date after the abbreviation EXP, and the batch number after the abbreviation Lot/LOT.
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 15 mg or 30 mg of rosuvastatin (as calcium salt).
• Other ingredients are:
  Tablet core: monohydrate lactose, microcrystalline cellulose, disodium citrate dihydrate, crospovidone (Type B), colloidal anhydrous silica, magnesium stearate.
  Tablet coating: hypromellose 2910 (6 cP), monohydrate lactose, macrogol 3350, triacetin, titanium dioxide (E171).

What Romazic looks like and contents of the pack
Romazic 15 mg are white or almost white, oblong, biconvex coated tablets with the engraving "15" on one side.
Romazic 30 mg are white or almost white, oblong, biconvex coated tablets with the engraving "30" on one side and a division line on the other side. The tablet can be divided into equal doses.
Pack sizes: 30, 60, 90 tablets.
Not all pack sizes may be marketed.

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