Nivosar 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nivosar 20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

  1. If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Nivosar is and what it is used for

Nivosar belongs to a group of medicines called statins.

You have been prescribed Nivosar because:

• You have high cholesterol levels. This means you are at risk of having a heart attack or stroke. Nivosar is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol.

You have been advised to take a statin because changes to your diet and increased physical activity have not been sufficient to correct your cholesterol levels. You must maintain a cholesterol-lowering diet and continue regular exercise while taking Nivosar.

Or

• You have other risk factors that increase your chance of having a heart attack, stroke, or other related health problems.

Heart attacks, strokes, and other related health problems may be caused by a condition called atherosclerosis. Atherosclerosis is caused by the buildup of fatty deposits in your arteries.

Why it is important that you continue taking Nivosar

Nivosar is used to correct levels of fatty substances in the blood called lipids, the most well-known being cholesterol.

There are different types of cholesterol in the blood: "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

• Rosuvastatin reduces the amount of "bad" cholesterol and increases "good" cholesterol.
• It works by blocking the production of "bad" cholesterol and improves the body's ability to remove it from the blood.

In most people, high cholesterol levels do not affect how you feel, as they cause no symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, causing them to narrow.

Sometimes, these narrowed vessels can become blocked, cutting off blood supply to the heart or brain, leading to a heart attack or stroke. By lowering your cholesterol levels, you can reduce your risk of having a heart attack, stroke, or related health problems.

You need to continue taking Nivosar, even after your cholesterol levels have returned to normal, because it prevents cholesterol levels from rising again and stops the formation of fatty deposits. However, you should stop treatment if your doctor tells you to, or if you become pregnant.

2. What you need to know before taking Nivosar

Do not take Nivosar

• If you are allergic (hypersensitive) to the active substance or to any of the other components of Nivosar (listed in section 6).
• If you are pregnant or breastfeeding. If you become pregnant while taking Nivosar, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant during treatment with Nivosar by using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you experience repeated or unexplained muscle pain and cramps.
• If you are taking a medicine called cyclosporine (used, for example, after organ transplantation).
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking rosuvastatin or other related medicines.

If you are in any of the above situations (or are unsure), please consult your doctor again.

In addition, do not take the highest dose (Rosuvastatin 40 mg)

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If your thyroid gland is not functioning properly.
• If you experience repeated or unexplained muscle pain and cramps, have a personal or family history of muscle problems, or a previous history of muscle problems during treatment with other cholesterol-lowering medicines.
• If you regularly consume large amounts of alcohol.
• If you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other medicines called fibrates to lower cholesterol.

If you are in any of the above situations (or are unsure), please consult your doctor again.

Warnings and precautions

Talk to your doctor or pharmacist before starting Nivosar.

• If you have kidney problems.
• If you have liver problems.
• If you experience repeated or unexplained muscle pain and cramps, have a personal or family history of muscle problems, or a previous history of muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or cramps, especially if accompanied by malaise or fever. Also inform your doctor or pharmacist if you experience persistent muscle weakness.
• 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 cholesterol-lowering medicines.
• If you are taking medicines to treat HIV infection (AIDS virus), such as ritonavir with lopinavir and/or atazanavir. See Other medicines and Nivosar.
• If you are taking or have taken within the last 7 days a medicine called fusidic acid, (a medicine for bacterial infection), taken orally or by injection. The combination of fusidic acid and rosuvastatin may cause serious muscle problems (rhabdomyolysis). Please see Other medicines and Nivosar.
• If you are over 70 years old, as your doctor must determine the appropriate starting dose of Nivosar for you.
• If you have severe respiratory failure.
• If you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must determine the appropriate starting dose of Nivosar for you.
• If you have or have had myasthenia (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

If you are in any of the above situations (or are unsure):

• Do not take the highest dose of 40 mg and consult your doctor or pharmacist before starting any dose of Nivosar.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin treatment. Stop using rosuvastatin and seek immediate medical attention if you notice any of the symptoms described in section 4.

In a small number of people, statins may affect the liver. This is detected by a simple blood test showing increased levels of liver enzymes (transaminases). For this reason, your doctor will usually perform blood tests (liver function tests) before and during treatment with Nivosar.

While taking this medicine, your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You may be at risk of developing diabetes if you have high blood sugar levels, are overweight, and have high blood pressure.

Children and adolescents

• If the patient is under 6 years of age: Nivosar must not be given to children under 6 years of age.
• If the patient is under 18 years of age: The 40 mg tablets of Nivosar must not be given to children and adolescents under 18 years of age.

Other medicines and Nivosar

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Inform your doctor if you are taking any of the following medicines: cyclosporine (used after organ transplantation), warfarin, acenocoumarol or fluindione (their anticoagulant effect and risk of bleeding may increase when taken with this medicine), ticagrelor or clopidogrel, fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe), treatments for indigestion (used to neutralize stomach acid), erythromycin (an antibiotic), fusidic acid (an antibiotic – please see below and Warnings and precautions), oral contraceptives (the pill), hormone replacement therapy, regorafenib (used to treat cancer),

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 Nivosar, or they may change the effect of Nivosar.

If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart Nivosar. Taking Nivosar with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.

Pregnancy and breastfeeding

Do not take Nivosar if you are pregnant or breastfeeding. If you become pregnant while taking Nivosar, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant during treatment with Nivosar by using an appropriate contraceptive method.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Most patients can drive vehicles and operate machinery while being treated with Nivosar, as it will not affect their ability. However, some people may feel dizzy during treatment with Nivosar. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Nivosar contains lactose.

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Nivosar contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Nivosar

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Usual doses in adults

If you are taking Nivosar for high cholesterol levels:

Starting dose

Your treatment with Nivosar should begin with a dose of 5 mg or 10 mg, even if you previously took a higher dose of another statin. The choice of starting dose will depend on:

• Your cholesterol levels.
• Your risk level of having a heart attack or stroke.
• Whether you have factors that make you more susceptible to possible side effects.

Check with your doctor or pharmacist which starting dose of Nivosar is best for you.

Your doctor may decide to start treatment with the smallest dose (5 mg):

• If you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are over 70 years old.
• If you have moderate kidney problems.
• If you are at risk of muscle pain and cramps (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose so that you receive the dose of Nivosar appropriate for you. If you started with a 5 mg dose, your doctor may decide to double the dose to 10 mg, then to 20 mg, and later to 40 mg, if necessary. If you started with a 10 mg dose, your doctor may decide to double the dose to 20 mg and then to 40 mg, if necessary. There should be an interval of four weeks between each dose adjustment.

The maximum daily dose of rosuvastatin is 40 mg. This dose is only for patients with high cholesterol and a high risk of heart attack or stroke whose cholesterol levels do not decrease sufficiently with 20 mg.

If you are taking Nivosar to reduce the risk of heart attack, stroke, or related health problems:

The recommended dose is 20 mg per day. However, your doctor may decide to use a lower dose if you have any of the factors mentioned above.

Use in children and adolescents aged 6–17 years

The dose range for children and adolescents aged 6 to 17 years is 5 mg to 20 mg once daily. The usual starting dose is 5 mg per day, and your doctor may gradually increase the dose until reaching the appropriate dose of Nivosar for you. The maximum recommended daily dose of Nivosar is 10 mg or 20 mg for children aged 6 to 17 years, depending on the underlying condition being treated. Take your dose once daily. Nivosar 40 mg tablets must not be administered to children.

How to take the tablets

Swallow each tablet whole with water.

Take Nivosar once daily. You may take it at any time of day, with or without food.

Try to take the tablets at the same time each day. This will help you remember to take them.

Regular cholesterol level checks

It is important that you visit your doctor regularly for cholesterol checks to ensure your cholesterol levels have normalized and remain at appropriate levels.

Your doctor may decide to increase your dose so that you receive the dose of Nivosar appropriate for you.

If you take more Nivosar than you should

Contact your doctor or nearest hospital for advice.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, stating the medication and the amount ingested.

If you are admitted to hospital or receive treatment for another condition, inform the healthcare staff that you are taking Nivosar.

If you forget to take Nivosar

Do not worry; simply take the next scheduled dose at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Nivosar

Consult your doctor if you wish to stop treatment with Nivosar. Your cholesterol levels may rise again if you stop taking Nivosar.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

It is important that you are aware of what these adverse effects may be. They are usually mild and disappear within a short period of time.

Stop taking Nivosar and seek immediate medical attention if you notice any of the following symptoms:

• 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 swallowing.
• Severe itching of the skin (with hives).
• Lupus-like syndrome (including skin rashes, joint disorders and effects on blood cells).
• Muscle rupture.
• Flat, red, non-elevated spots on the trunk, often target-shaped or circular, sometimes with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also stop taking Nivosar and consult your doctor immediately if you experience unexplained muscle pain and cramps that last longer than expected. Muscle symptoms are more frequent in children and adolescents than in adults. As with other statins, a very small number of people have experienced unpleasant muscle effects, which very rarely have resulted in a potentially fatal muscle injury called rhabdomyolysis.

Common adverse effects (may affect up to 1 in 10 people)

• Headache, stomach pain, constipation, nausea, muscle pain, weakness, dizziness.
• Increased levels of protein in urine – this usually returns to normal on its own without the need to stop treatment with rosuvastatin tablets (common adverse effect only with the 40 mg daily dose of rosuvastatin).
• Diabetes. This is more likely if you have high levels of sugar and lipids in your blood, are overweight, and have high blood pressure. Your doctor will monitor you closely while you are taking this medicine.

Uncommon adverse effects (may affect up to 1 in 100 people)

• Urticaria, itching and other skin reactions.
• Increased levels of protein in urine – this usually returns to normal on its own without the need to stop treatment with rosuvastatin tablets (uncommon adverse effect with the 5 mg, 10 mg and 20 mg daily doses of rosuvastatin).

Rare adverse effects (may affect up to 1 in 1,000 people)

• Severe allergic reaction – symptoms include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe itching of the skin (with hives). If you think you are having an allergic reaction, stop taking rosuvastatin and seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking rosuvastatin and consult your doctor immediately if you have unexplained muscle pain or cramps that last longer than expected.
• Severe stomach pain (possible sign of pancreas inflammation).
• Increased liver enzymes (transaminases) in blood.

Very rare adverse effects (may affect up to 1 in 10,000 people)

Jaundice (yellowing of the skin and eyes), hepatitis (inflamed liver), traces of blood in urine, nerve damage in arms and legs (with numbness or tingling), joint pain, memory loss, and enlargement of the breasts in men (gynecomastia).

Adverse effects of unknown frequency (cannot be estimated from available data) which may include

Diarrhea (loose stools), cough, shortness of breath, edema (swelling), sleep disturbances, including insomnia and nightmares, sexual difficulties, depression, breathing problems, including persistent cough and/or shortness of breath or fever, tendon injuries, and persistent muscle weakness.

Myasthenia gravis (a condition causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).

Ocular myasthenia (a condition causing weakness of the eye muscles).

Consult your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nivosar

• Keep this medicine out of the sight and reach of children.
• This medicine does not require any special storage conditions.
• Do not use this medicine after the expiry date stated on the container/blister/label after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nivosar 20 mg film-coated tablets EFG

The active substance is rosuvastatin. Each film-coated tablet contains 20 mg of rosuvastatin.

The other components are: Tablet core: anhydrous lactose, microcrystalline cellulose, crospovidone, crospovidone, talc, colloidal anhydrous silica, sodium stearyl fumarate. Coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, and red iron oxide (E172).

Appearance of the product and contents of the pack

Nivosar 20 mg film-coated tablets EFG are supplied in blister packs containing 28 tablets. The tablets are round, convex, film-coated tablets and pink in colour.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, nº 13. 3ºD

28108 - Alcobendas (Madrid)

SPAIN

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, nº2, Abrunheira

2710-089 Sintra

Portugal

Date of the most recent review of this leaflet: March 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/