Rosuvastatin Vir 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rosuvastatina Vir 5mg film-coated tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Rosuvastatina Vir is and what it is used for

Rosuvastatina Vir belongs to a group of medicines called statins.

Your doctor has prescribed Rosuvastatina because:

• You have high cholesterol levels. This means you are at risk of having a heart attack or stroke. Rosuvastatina 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 in your diet and increased physical activity have not been sufficient to correct your cholesterol levels. You must maintain a cholesterol-lowering diet and continue exercising while taking Rosuvastatina.

Or

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

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

Why it is important that you continue taking Rosuvastatina

Rosuvastatina 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).

• Rosuvastatina 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 produce 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, preventing blood supply to the heart or brain, leading to a heart attack or stroke. By lowering your cholesterol levels, you can reduce the risk of having a heart attack, stroke, or other related health problems.

You need to keep taking rosuvastatina, even after your cholesterol levels have reached the desired level, 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 Rosuvastatin Vir

Do not take Rosuvastatin

• If you are allergic (hypersensitive) to rosuvastatin or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatin, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant during treatment with Rosuvastatin 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 an organ transplant).
  • If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking Rosuvastatin Vir or other related medicines.

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

Also, do not take Rosuvastatin 40 mg (the highest dose):

• 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 disorders, 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 Rosuvastatin

• 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 disorders, 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 (AIDS virus) infection or hepatitis C infection, such as ritonavir with lopinavir and/or atazanavir or simeprevir – see Other medicines and Rosuvastatin.
• If you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine used to treat bacterial infections), either orally or by injection. The combination of fusidic acid and Rosuvastatin may cause serious muscle problems (rhabdomyolysis).
• 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 rosuvastatin for you.
• If you are over 70 years old (as your doctor must determine the appropriate starting dose of rosuvastatin for you).
  • Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin treatment. Stop using Rosuvastatin Vir and seek immediate medical attention if you notice any of the symptoms described in section 4.
  • If you have or have had myasthenia (a disease characterized by generalized muscle weakness that, 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 Rosuvastatin.

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 test) before and during treatment with rosuvastatin.

While taking this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are likely to 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: Rosuvastatin must not be given to children under 6 years of age.

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

Other medicines and Rosuvastatin

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 using any of the following medicines:

• cyclosporine (used after organ transplant),
• warfarin, ticagrelor, or clopidogrel (or any other anticoagulant medicine, such as acenocoumarol),
• fibrates (such as gemfibrozil, fenofibrate),
• any other medicine used to lower cholesterol (such as ezetimibe),
• treatments for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• oral contraceptives (the pill),
• hormone replacement therapy,
• antiviral medicines such as ritonavir with lopinavir and/or atazanavir or simeprevir (used to treat infections including AIDS or hepatitis C – see Warnings and precautions).
• 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 rosuvastatin, or they may alter the effect of rosuvastatin.

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 Rosuvastatin. Taking rosuvastatin with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.

Taking Rosuvastatin with food and drinks

You may take this medicine with or without food.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

This medicine contains lactose

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

3. How to take Rosuvastatin Vir

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

Usual doses in adults

If you are taking rosuvastatin for high cholesterol levels:

Starting dose

Your treatment with rosuvastatin should begin with a dose of 5 mg or 10 mg, even if you have previously taken 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 any factors that make you more susceptible to possible side effects.

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

Your doctor may decide to start treatment with the lowest 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 a specific genetic variation (known as a genetic polymorphism) that may cause increased levels of rosuvastatin.
• If you have moderate kidney problems.
• If you are at risk of developing muscle pain and cramps (myopathy).
• If you are taking rosuvastatin together with other medicines that may increase rosuvastatin levels in the blood.

Dose increase and maximum daily dose

Your doctor may decide to increase your dose so that you are taking the dose of rosuvastatin 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 will 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 levels and a high risk of heart attack or stroke whose cholesterol levels do not decrease sufficiently with 20 mg.

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

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

Recommended doses in children and adolescents aged 6–17 years

The usual recommended starting dose is 5 mg. Your doctor may increase your dose to reach the dose of rosuvastatin appropriate for treating your condition. The recommended maximum daily dose of rosuvastatin is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years. Take the dose prescribed by your doctor once daily. Rosuvastatin 40 mg tablets must not be administered to children and adolescents.

How to take the tablets

Swallow each tablet whole with water.

Take rosuvastatin 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 monitoring of cholesterol levels

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 are taking the dose of rosuvastatin appropriate for you.

If you take more rosuvastatin 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 medicine and the amount ingested.

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

If you forget to take rosuvastatin

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 rosuvastatin

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

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 experiences 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 rosuvastatin and seek immediate medical attention if you experience 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 swallowing.
• Severe itching of the skin (with hives).
  • Non-elevated reddish skin lesions on the trunk, target-shaped or circular, often with central blisters, skin peeling, and 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 rosuvastatin and consult your doctor immediately if you experience:

• Unexplained muscle pain and cramps lasting 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.
• Lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells).
• Muscle rupture.

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

• Headache.
• Stomach pain.
• Constipation.
• Nausea.
• Muscle pain.
• Weakness.
• Dizziness.
• Increased amount of protein in urine – this usually returns to normal on its own without the need to discontinue treatment with rosuvastatin tablets (frequent adverse effect only with the 40 mg daily dose of rosuvastatin).
• Diabetes. This is more likely if you have high levels of blood sugar and lipids, 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 amount of protein in urine – this usually returns to normal on its own without the need to discontinue treatment with rosuvastatin tablets (only for rosuvastatin 5 mg, 10 mg, and 20 mg).

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, and 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 lasting longer than expected.
• Severe stomach pain (possible sign of pancreas inflammation).
• Increased liver enzymes in blood.
• Reduced platelets in blood.
  • Lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells).
  • Muscle rupture.

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.
• Enlargement of breasts in men (gynecomastia).

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

• Diarrhea (loose stools).
• Stevens-Johnson syndrome (severe blistering rash on the skin, mouth, eyes, and genitals).
• Cough.
• Shortness of breath.
• Edema (swelling).
• Sleep disturbances, including insomnia and nightmares.
• Sexual difficulties.
• Depression.
• Respiratory problems, including persistent cough and/or shortness of breath or fever.
• Tendon injuries.
• Persistent muscle weakness.
• Peripheral neuropathy (a disorder affecting the function of nerves surrounding the spinal cord).
  • Myasthenia gravis (a disease causing generalized muscle weakness that, in some cases, affects the muscles used for breathing). Ocular myasthenia (a disease 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://wwwnotificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rosuvastatin Vir

Keep this medicine out of 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 packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Rosuvastatina Vir

• The active substance is rosuvastatin (as rosuvastatin calcium). One film-coated tablet contains 5 mg of rosuvastatin (equivalent to 5.20 mg of rosuvastatin calcium).
• The other components are:

Tablet core: monohydrate lactose, microcrystalline cellulose, sodium citrate (E331), crospovidone B, anhydrous colloidal silica, and magnesium stearate.

Tablet coating: Opadry II White 33G28523, which contains: hypromellose, monohydrate lactose, macrogol (E1521), triacetin (E1518), and titanium dioxide (E171).

Appearance of the product and pack contents

Rosuvastatina Vir 5 mg tablets are film-coated, white or almost white, round and biconvex tablets, marked with "5" on one side.

The tablets are supplied in aluminum/OPA/PVC-Aluminum blister packs containing 28 tablets.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Manufacturer:

Pharmaceutical Works POLPHARMA S.A.

19, Pelplinska Street

83-200 Starogard Gdanski

Poland

And

Industria Química y Fca. VIR, S.A.

C/Laguna 66-70. P.I. Urtinsa II

28923 Alcorcón (Madrid) Spain

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

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.