ZARANTA 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Zaranta, 5 mg, film-coated tablets
3. Zaranta, 10 mg, film-coated tablets
4. Zaranta, 15 mg, film-coated tablets
5. Zaranta, 20 mg, film-coated tablets
6. Zaranta, 30 mg, film-coated tablets
7. Zaranta, 40 mg, film-coated tablets
   1. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
   2. Contents of the pack and other information
8. What Zaranta is and what it is used for
9. What you need to know before you take Zaranta
   1. Do not take Zaranta:
   2. Warnings and precautions
   3. Children and adolescents
   4. Zaranta with food, drink and alcohol
   5. Pregnancy and breast-feeding
   6. Driving and using machines
   7. Zaranta contains lactose
10. How to take Zaranta
    1. If you take more Zaranta than you should
    2. If you forget to take Zaranta
    3. If you stop taking Zaranta
11. Possible side effectsLike all medicines, this medicine can cause side effects, although not everybody gets them.Stop taking Zaranta and seek medical help immediately if you have: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 a red, scaly, and flaky appearance, fever, and swollen lymph nodes, which may be a sign of a condition called DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms),Other possible side effects:Common (may affect up to 1 in 10 people)headache, stomach pain, constipation, nausea, muscle pain, weakness, dizziness, increased blood sugar levels, increased blood creatine kinase levelsUncommon (may affect up to 1 in 100 people)skin rash, itching, hives, increased liver enzymes, increased blood creatine kinase levelsRare (may affect up to 1 in 1,000 people)severe allergic reactions, including anaphylaxis, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, muscle damage, rhabdomyolysis, liver damage, pancreatitis, increased blood sugar levels, diabetes, depression, sleep disorders, memory loss, confusion, sexual dysfunction, respiratory problems, neuropathy, tendonitis, gynecomastiaVery rare (may affect up to 1 in 10,000 people)jaundice, liver failure, hepatitis, thrombocytopenia, anemia, neutropenia, agranulocytosis, pancytopenia, interstitial lung diseaseNot known (frequency cannot be estimated from the available data)suicidal thoughts or behavior, hallucinations, seizures, tremors, paraesthesia, muscle spasms, peripheral neuropathy, interstitial nephritis, gout, erectile dysfunction, decreased libidoReporting of side effectsIf you get any side effects, talk to your doctor or pharmacist.5. How to store Zaranta
12. Contents of the pack and other information
    1. What Zaranta contains
    2. What Zaranta looks like and contents of the pack
    3. Marketing Authorisation Holder and Manufacturer
    4. Marketing Authorisation Holder
    5. Manufacturer
    6. Date of revision of the text

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. This means you are at risk of heart attack or stroke.

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

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

Zaranta works by inhibiting an enzyme in the liver (HMG-CoA reductase) that is necessary for the production of cholesterol.

High cholesterol is a risk factor in the development of coronary artery disease (‘hardening of the arteries’).

Cholesterol is a type of fat found in the blood. Cholesterol is either carried to the cells by low-density lipoproteins (LDL) or away from the cells by high-density lipoproteins (HDL).

Too much cholesterol in the blood can lead to the narrowing and hardening of arteries, which can reduce or block blood flow.

Reducing the level of bad cholesterol and increasing the level of good cholesterol can help to prevent heart disease, including heart attack and stroke.

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 taking ciclosporin (an immunosuppressant medicine),
• if you are taking any of the following medicines: gemfibrozil, fenofibrate, or any other fibrate (medicines used to lower cholesterol),
• if you are taking any of the following medicines: sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C),

If any of the above applies to you (or you are not sure), please go back and see your doctor.

Warnings and precautions

Before taking Zaranta, tell your doctor or pharmacist if:

• you have moderate kidney problems,
• you have liver problems,
• you have repeated or unexplained muscle pain,
• you have a history of muscle disease,
• you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infection) by mouth or by injection,

While you are on this medicine your doctor will monitor you closely if:

• you have diabetes or are at risk of developing diabetes.

Children and adolescents

• Children under 6 years: Zaranta should not be used in children under 6 years.
• Children and adolescents under 18 years: Zaranta 30 mg or 40 mg tablets should not be used in children and adolescents under 18 years.

Zaranta with food, drink and alcohol

Zaranta can be taken with or without food.

Avoid drinking too much alcohol while you are taking this medicine.

Pregnancy and breast-feeding

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

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

Driving and using machines

Most people can drive a car and operate machinery while using Zaranta.

However, some people may feel dizzy while taking Zaranta.

Zaranta contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Zaranta

Always take this medicine exactly as your doctor or pharmacist has told you.

The recommended dose is:

• 5-40 mg once daily.

Swallow the tablet whole with water.

Take the tablet at the same time every day.

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.

If you stop taking Zaranta

Do not stop taking Zaranta without talking to your doctor.

4. Possible side effects

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

Stop taking Zaranta and seek medical help immediately if you have:

• 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 a red, scaly, and flaky appearance, fever, and swollen lymph nodes, which may be a sign of a condition called DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms),

Other possible side effects:

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.

5. How to store Zaranta

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

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

Do not throw away any medicines via wastewater or household waste.

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, crospovidone, hypromellose, titanium dioxide (E171), 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 15 mg and 30 mg film-coated tablets are also available.

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

Date of revision of the text

May 2023