Zaranta

Package Leaflet: Information for the User

Zaranta, 5 mg, film-coated tablets

Zaranta, 10 mg, film-coated tablets

Zaranta, 15 mg, film-coated tablets

Zaranta, 20 mg, film-coated tablets

Zaranta, 30 mg, film-coated tablets

Zaranta, 40 mg, film-coated tablets

Rosuvastatin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

1. What Zaranta is and what it is used for

Zaranta belongs to a group of medicines called statins.

• Your doctor has prescribed Zaranta because you have a high level of cholesterol in your blood. This means that you are at risk of getting a heart attack or stroke.

Your doctor has prescribed Zaranta to lower your cholesterol level and reduce your risk of heart attacks or strokes.

Zaranta can lower the level of bad cholesterol and raise the level of good cholesterol.

Zaranta works by stopping an enzyme in the liver from producing cholesterol.

High levels of cholesterol can cause fatty deposits to build up in your arteries. This can lead to heart attacks or strokes.

Lowering your cholesterol level can help prevent heart attacks and strokes.

2. What you need to know before you take Zaranta

Do not take Zaranta

• if you are allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6),
• if you have severe kidney problems,
• if you have severe liver problems,
• if you are pregnant or breast-feeding,
• if you have repeated or unexplained muscle pains,
• if you take certain other medicines (see section 2, “Other medicines and Zaranta”)

If any of the above applies to you, do not take Zaranta and talk to your doctor.

Warnings and precautions

Before taking Zaranta, tell your doctor:

• if you have any kidney problems,
• if you have any liver problems,
• if you have had any repeated or unexplained muscle pains,
• if you have a history of muscle disease,
• if you are over 70 years old,

It is important to take Zaranta at the right dose and for as long as your doctor tells you to.

Children and adolescents

• Children under 6 years: Zaranta should not be given to children under 6 years.
• Children and adolescents under 18 years: Zaranta should not be given to children and adolescents under 18 years at a dose greater than 20 mg.

Zaranta with food, drink and alcohol

Zaranta can be taken with or without food.

Avoid drinking too much alcohol while taking Zaranta.

Pregnancy and breast-feeding

Do not take Zaranta if you are pregnant or breast-feeding.

If you become pregnant while taking Zaranta, stop taking it immediately and tell your doctor.

Driving and using machines

Zaranta is unlikely to affect your ability to drive or use machines.

However, some people may feel dizzy while taking Zaranta.

If you feel dizzy, do not drive or use machines.

Zaranta contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking Zaranta.

3. How to take Zaranta

Always take Zaranta exactly as your doctor has told you.

The usual starting dose is 5 mg or 10 mg once daily.

Your doctor may increase your dose to 20 mg once daily if necessary.

The maximum dose is 40 mg once daily.

Swallow the tablet whole with water.

You can take Zaranta at any time of day, with or without food.

If you take more Zaranta than you should

Contact your doctor or pharmacist immediately.

If you forget to take Zaranta

Take the next dose at the usual time.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Zaranta

Do not stop taking Zaranta without talking to your doctor.

4. Possible side effects

Like all medicines, Zaranta can cause side effects, although not everybody gets them.

Stop taking Zaranta and seek medical help immediately if you have 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, which may cause difficulty in swallowing,
• severe itching of the skin (with raised lumps),
• blistering of the skin, mouth, eyes, and genitals, which may be a sign of a condition called Stevens-Johnson syndrome or toxic epidermal necrolysis,
• rash with widespread blistering of the skin and high fever, which may be a sign of a condition called DRESS syndrome.

Other possible side effects:

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.

5. How to store Zaranta

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiry date which is stated on the carton.

6. Contents of the pack and other information

What Zaranta contains

• The active substance is rosuvastatin.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, magnesium hydroxide, magnesium stearate, hypromellose, titanium dioxide, macrogol 3350, talc.

What Zaranta looks like and contents of the pack

Zaranta 5 mg film-coated tablets are white, round, biconvex tablets, approximately 5.5 mm in diameter and 2.7-3.3 mm in thickness, with “C33” engraved on one side.

Zaranta 10 mg film-coated tablets are white, round, biconvex tablets, approximately 7.0 mm in diameter and 3.3-4.2 mm in thickness, with “C34” engraved on one side.

Zaranta 20 mg film-coated tablets are white, round, biconvex tablets, approximately 9.0 mm in diameter and 4.2-4.9 mm in thickness, with “C35” engraved on one side.

Zaranta 40 mg film-coated tablets are white, oval, biconvex tablets, approximately 15.5 mm in length, 8 mm in width and 4.5-5.5 mm in thickness, with “C36” engraved on one side.

Zaranta is available in packs of 28, 30, 56, 90 film-coated tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: GEDEON RICHTER POLSKA Sp. z o.o., ul. Ks. J. Poniatowskiego 5, 05-825 Grodzisk Mazowiecki, Poland

Manufacturer: Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary

Update of the leaflet

May 2023