ROSUVASTATIN VIR 5 mg FILM-COATED TABLETS

2. What you need to know before taking Rosuvastatina Vir

Do not take Rosuvastatina

• If you are allergic (hypersensitive) to rosuvastatina or any of the other ingredients of this medication (listed in section 6).
• If you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatina, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with Rosuvastatina using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pain or weakness.
• If you are taking a medication called ciclosporin (used, for example, after an organ transplant).
• If you have ever developed a severe skin rash or peeling, blisters, and/or mouth sores after taking Rosuvastatina Vir or other related medications.

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

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

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If your thyroid gland does not function correctly.
• If you have repeated or unexplained muscle pain or weakness, a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medications.
• If you regularly drink large amounts of alcohol.
• If you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other medications 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

Consult your doctor or pharmacist before starting to take Rosuvastatina.

• If you have kidney problems.
• If you have liver problems.
• If you have repeated or unexplained muscle pain or weakness, a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medications. Inform your doctor immediately if you have unexplained muscle pain or weakness, especially if you have general discomfort or fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness.
• If you regularly drink large amounts of alcohol.
• If your thyroid gland does not function correctly.
• If you are taking other medications called fibrates to lower cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medications before.
• If you are taking medications to treat HIV infection (AIDS) or hepatitis C, such as ritonavir with lopinavir and/or atazanavir or simeprevir, see Other medications and Rosuvastatina.
• If you are taking or have taken in the last 7 days a medication called fusidic acid (an antibiotic), orally or by injection. The combination of fusidic acid and Rosuvastatina can 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 should determine the appropriate starting dose of rosuvastatina for you.
• If you are over 70 years old (as your doctor should determine the appropriate starting dose of rosuvastatina for you).
• Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with Rosuvastatina treatment. Stop using Rosuvastatina 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 can affect the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia to appear (see section 4).

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

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

In a small number of people, statins can affect the liver. This is detected by a simple blood test that checks for increased levels of liver enzymes (transaminases) in the blood. For this reason, your doctor will normally perform blood tests (liver function tests) before and after treatment with rosuvastatina.

While taking this medication, 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 old: Rosuvastatina should not be administered to children under 6 years old.
• If the patient is under 18 years old: Rosuvastatina 40mg tablets should not be administered to children and adolescents under 18 years old.

Other medications and Rosuvastatina

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

Inform your doctor if you are using any of the following medications:

• ciclosporin (used after an organ transplant),
• warfarin, ticagrelor, or clopidogrel (or any other anticoagulant medication, such as acenocoumarol),
• fibrates (such as gemfibrozil, fenofibrate),
• any other medication 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 medications, 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 medications 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 medications may be altered by rosuvastatina or may change the effect of rosuvastatina.

If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medication. Your doctor will tell you when it is safe to restart Rosuvastatina. Taking rosuvastatina with fusidic acid can rarely cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Rosuvastatina with food and drinks

You can take this medication with or without food.

Pregnancy and breastfeeding

Do not take rosuvastatinaif you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatina, stop taking it immediatelyand inform your doctor. Women should avoid becoming pregnant during treatment with rosuvastatina using an appropriate contraceptive method.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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

This medication contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Rosuvastatina Vir

Follow the instructions for administration of this medication indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Usual dose in adults

If you are taking rosuvastatina for high cholesterol:

Starting dose

Your treatment with rosuvastatina should start with a dose of 5mg or 10mg, even if you have taken a higher dose of another statin before.

The choice of starting dose will depend on:

• Your cholesterol levels.
• The degree of risk you have of having a heart attack or stroke.
• If you have any factors that make you more vulnerable to possible side effects.

Check with your doctor or pharmacist what the best starting dose of rosuvastatina is for you.

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

• 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 genetic polymorphism) that can cause increased levels of rosuvastatina.
• If you have moderate kidney problems.
• If you are at risk of muscle pain or weakness (myopathy).
• If you are taking rosuvastatina with other medications that can increase the level of rosuvastatina in the blood.

Dose increase and maximum daily dose

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

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

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

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

Recommended dose in children and adolescents aged 6-17 years

The usual recommended starting dose is 5mg. Your doctor may increase your dose to achieve the appropriate dose of rosuvastatina to treat your condition. The maximum recommended daily dose of rosuvastatina is 10mg for children aged 6 to 9 years and 20mg for children aged 10 to 17 years. Take the dose indicated by your doctor once a day. Do nottake rosuvastatina 40mgtablets in children and adolescents.

Taking the tablets

Swallow each tablet whole with water.

Take rosuvastatina once a day. You can 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 essential that you visit your doctor regularly to have your cholesterol levels checked, to ensure that your cholesterol levels have returned to normal and remain at appropriate levels.

Your doctor may decide to increase your dose so that you are taking the appropriate dose of rosuvastatina for you.

If you take more Rosuvastatina than you should

Contact your doctor or the nearest hospital for advice.

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

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

If you forget to take Rosuvastatina

Do not worry, simply take the next scheduled dose at the planned time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Rosuvastatina

Consult your doctor if you want to stop taking rosuvastatina. Your cholesterol levels may rise again if you stop taking rosuvastatina.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

It is essential that you know what these adverse effects can be. They are usually mild and disappear in a short period.

Stop taking rosuvastatin and seek immediate medical attentionif 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 can cause difficulty swallowing.
• Intense itching of the skin (with hives).
  • Red patches on the torso, not elevated, in a target or circular shape, often with blisters

central, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).

• Generalized rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Also, stop taking rosuvastatin and consult your doctor immediately if you experience:

• Unjustified muscle pain and crampsthat 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 suffered unpleasant muscle effects that, very rarely, have resulted in a potentially fatal muscle injury called rhabdomyolysis.
• Lupus-like syndrome (which includes skin rash, joint disorders, and effects on blood cells).
• Muscle rupture

Common Adverse Effects (may affect up to 1 in 10 people)

• Headache.
• Stomach pain.
• Constipation.
• Nausea.
• Muscle pain.
• Weakness.
• Dizziness.
• An increase in the amount of protein in the urine – this usually reverses on its own without the need to interrupt treatment with rosuvastatin tablets (common adverse effect only with the daily dose of 40 mg of rosuvastatin).
• Diabetes. This is more likely if you have high sugar and lipid levels in the blood, are overweight, and have high blood pressure. Your doctor will closely monitor you while you are taking this medicine.

Uncommon Adverse Effects (may affect up to 1 in 100 people)

• Hives, itching, and other skin reactions.
• An increase in the amount of protein in the urine – this usually reverses on its own without the need to interrupt 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, intense 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 unjustified muscle pain or cramps that last longer than expected.
• Severe stomach pain (possible sign of pancreatitis).
• Increased liver enzymes in the blood.
• Reduced platelet count in the blood.
  • Lupus-like syndrome (which includes 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 the urine.
• Nerve damage in the legs and arms (with numbness or tingling).
• Joint pain.
• Memory loss.
• Increased breast size in men (gynecomastia).

Adverse Effects of Unknown Frequency (frequency cannot be estimated from available data):

• Diarrhea (loose stools).
• Stevens-Johnson syndrome (severe skin eruption in the form of blisters 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.
• Constant muscle weakness.
• Peripheral neuropathy (a disorder of the functioning of the nerves surrounding the spinal cord)
  • Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing). Myasthenia gravis (a disease that causes weakness of the eye muscles).

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://wwwnotificaram.es. By reporting adverse effects, you can contribute to providing 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 special storage conditions.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Rosuvastatin Vir

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

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

Tablet coating: opadry II white 33G28523, in its composition: hypromellose, lactose monohydrate, macrogol (E1521), triacetin (E1518), and titanium dioxide (E171).

Appearance of the Product and Package Contents

Rosuvastatin Vir 5 mg tablets are white or almost white, round, and biconvex, marked with "5" on one side.

The tablets are presented 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 Last Revision of this Prospectus: May 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.