Package Leaflet: Information for the Patient

Rosuvastatina Macleods 5 mg Film-Coated Tablets

Rosuvastatina Macleods 10 mg Film-Coated Tablets

Rosuvastatina Macleods 20 mg Film-Coated Tablets

Rosuvastatina Macleods 40 mg Film-Coated Tablets

Read this 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.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you onlyand should not be given to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isRosuvastatina Macleodsand what it is used for

2. What you need to know before you start takingRosuvastatina Macleods

3. How to takeRosuvastatina Macleods

4. Possible side effects

5. Storage ofRosuvastatina Macleods

6. Contents of the pack and additional information

Rosuvastatin belongs to a group of medications called statins.

You have been prescribed Rosuvastatin because:

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

•Your doctor has indicated that you should take a statin because the changes made to your diet and the increase in physical exercise have not been sufficient to correct your cholesterol levels. You should maintain a diet that helps to lower your cholesterol and continue to exercise while you are being treated with Rosuvastatin.

Or

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

A heart attack, stroke, and other health problems can be caused by a disease called atherosclerosis. Atherosclerosis is caused by the formation of fatty deposits in your arteries.

Why it is important to continue taking Rosuvastatin

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

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 acts by blocking the production of bad cholesterol and improving the body's ability to remove it from the blood.

In most people, high cholesterol levels do not affect how they feel since they do not produce any symptoms. However, if left untreated, fatty deposits can form in the walls of blood vessels, causing them to narrow.

Sometimes, these narrowed vessels can become blocked and prevent blood supply to the heart or brain, causing a heart attack or stroke. By reducing your cholesterol levels, you can reduce your risk of having a heart attack, stroke, or other health problems.

You needto continue taking rosuvastatin, even if you have already achieved the correct cholesterol levels, as itprevents cholesterol levels from increasing againand forming fatty deposits. However, you should stop treatment if your doctor advises you to or if you become pregnant.

Do not take Rosuvastatina:

•If you are allergic (hypersensitive) to rosuvastatina or to any of the other components 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 unjustified muscle pain and cramps.

•If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir medications (used to treat a liver infection called hepatitis C).

•If you are taking a medication called ciclosporina (used, for example, after an organ transplant).

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

Also, do not take Rosuvastatina 40 mg (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 unjustified muscle pain and cramps, a personal or family history of muscle problems, or a previous history of muscle problems during treatment with other cholesterol-lowering medications.

•If you regularly consume large amounts of alcohol.

•If you are of Asian origin (for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).

•If you are taking other medications called fibrates to lower cholesterol.

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

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 unjustified muscle pain and cramps, a personal or family history of muscle problems, or a previous history of muscle problems during treatment with other cholesterol-lowering medications. Inform your doctor immediately if you have unjustified muscle pain or cramps, especially if you experience general discomfort or fever. Also, inform your doctor or pharmacist if you experience persistent muscle weakness.

• If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking Rosuvastatina or other related medications.

•If you regularly consume 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 previously.

•If you are taking medications to treat HIV (AIDS virus) or hepatitis C infection, such as ritonavir with lopinavir and/or atazanavir or simeprevir, see Other medications and Rosuvastatina

•If you are taking or have taken within the last 7 days a medication called fusidic acid (an antibiotic), either orally or injectable. The combination of fusidic acid and Rosuvastatina may cause severe muscle problems (rhabdomyolysis), please see “Other medications and Rosuvastatina”.

•If you are over 70 years old (since your doctor must establish the appropriate starting dose of rosuvastatina for you).

•If you have severe respiratory failure,

•If you are of Asian origin, for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian. Your doctor must establish the appropriate starting dose of rosuvastatina for you.

•If you have or have had myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).

If you find yourself in any of these situations mentioned above (or are unsure):

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

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 and seek medical attention immediately if you notice any of the symptoms described in section 4.

In a small number of people, statins can affect the liver. This is detected by a simple test that measures elevated liver enzymes (transaminases) in the blood. For this reason, your doctor will usually perform blood tests (liver function test) 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 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: Rosuvastatina should not be administered to children under 6 years of age.

•If the patient is under 18 years of age: Rosuvastatina 40 mg tablets should not be administered to children and adolescents under 18 years of age.

Other medications and Rosuvastatina Macleods

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

• Ciclosporina (used after an organ transplant),
• Warfarina, ticagrelor, or clopidogrel (or any other anticoagulant medication, such as acenocoumarol),
• Fibrates (such as gemfibrozil, fenofibrate), or any other medication used to lower cholesterol (such as ezetimiba),
• Medications for indigestion (used to neutralize stomach acid),
• Erythromycin (an antibiotic),Fusidic acid (an antibiotic - please see below and in Warnings and precautions),
• Oral contraceptives (the pill),
• Regorafenib (used to treat cancer),
• Darolutamida (used to treat cancer),
• Capmatinib (used to treat cancer),
• Teriparatide (used to treat osteoporosis),
• Fostamatinib (used to treat low platelet count),
• Febuxostat (used to treat and prevent high uric acid levels in the blood),
• Teriflunomida (used to treat multiple sclerosis),
• 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, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

The effects of these medications may be modified by rosuvastatina or may change the effect of rosuvastatina.

If you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop taking this medication. Your doctor will indicate when it is safe to start taking Rosuvastatina again. Taking Rosuvastatina with fusidic acid may rarely cause muscle weakness, sensitivity, or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.

Pregnancy and breastfeeding

Do not take rosuvastatina 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.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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.

Rosuvastatina Macleods contains lactose

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars (lactose or milk sugar), consult with them before taking this medication.

The complete list of components is found in section 6.

Follow exactly the administration instructions of this medication as indicated 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 rosuvastatin treatment should start witha dose of 5 mg or 10 mg, even if you have taken a higher dose of another statin previously.

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 factor that makes you more vulnerable to potential side effects.

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

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

•If you are of Asian origin (for example, Japanese, Chinese, Filipino, Vietnamese, Korean or Indian).

•If you are over 70 years old.

•If you have moderate kidney problems.

•If you have a risk of developing muscle pain and cramps (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose. This is to ensure you are taking the right dose of rosuvastatin for you. If you started with a dose of 5 mg, 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 dose of 10 mg, your doctor may decide to double the dose to 20 mg and later to 40 mg, if necessary. There will be a four-week interval 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 having a heart attack or stroke, whose cholesterol levels do not decrease enough with 20 mg.

If you are taking rosuvastatin to reduce the risk of having a heart attack, a 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 earlier.

Recommended doses in children and adolescents aged 6-17 years

The dose range in children and adolescents aged 6 to 17 years is 5 mg to 20 mg once a day. The usual recommended starting dose is 5 mg and your doctor may increase your dose gradually to reach the rosuvastatin dose that is right for your condition. The maximum recommended daily dose of rosuvastatin is 10 or 20 mg for children aged 6 to 17 years, depending on the underlying disease being treated. Take the dose indicated by your doctor once a day.Norosuvastatin tablets40 mgshould be administered to children and adolescents.

Tablet intake

• Swallow each tablet whole with water.
• Take rosuvastatin once a day.You can take it at any time of the day with or without food.
• Try to take the tablets at the same time every day. This will help you remember to take them.

Regular cholesterol level checks

It is essential that you attend your doctor regularly for cholesterol level checks, to ensure that your cholesterol levels have normalized and remain at appropriate levels.

Your doctor may decide to increase your dose so that you are taking the right dose of rosuvastatin 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, 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 enter a hospital or receive treatment for another illness, inform the healthcare staff that you are taking Rosuvastatina.

If you forget to take Rosuvastatin

Do not worry, simply take the next scheduled dose at the scheduled time. Do not take a double dose to compensate for a missed dose.

If you interrupt treatment with Rosuvastatin

Consult your doctor if you want to stop taking rosuvastatin. Your cholesterol levels may increase again if you stop taking rosuvastatin.

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

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

It is essential that you know which side effects may occur. They are usually mild and disappear within a short period of time.

Stop taking rosuvastatin and seek medical attention immediatelyif 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.

•Intense skin itching (with rashes).

•Reddish patches on the trunk, flat or circular, often with central blisters, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin eruptions may 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 unexplained muscle pain and crampsthat last longer than expected. Muscle symptoms are more common in children and adolescents than in adults. Like other statins, a very small number of people have experienced unpleasant muscle effects, which, very rarely, have resulted in a potentially fatal muscle injury calledrabdomiolysis.
• If you experience muscle rupture.
• If you experience a syndrome with symptoms similar to lupus(including urticaria, joint disorders, and blood cell effects).

Frequent: may affect up to 1 in 10 people

•Headache.

•Stomach pain.

•Constipation.

•Nausea.

•Muscle pain.

•Weakness.

•Dizziness.

•Increased protein in urine – this usually returns to normal on its own without the need to stop taking rosuvastatin (frequent side effect only with the daily dose of 40 mg of rosuvastatin).

•Diabetes. This is more likely if you have high blood sugar and lipid levels, obesity, and high blood pressure. Your doctor will closely monitor you while taking this medicine.

Rare: may affect up to 1 in 100 people

•Urticaria, itching, and other skin reactions.

•Increased protein in urine – this usually returns to normal on its own without the need to stop taking rosuvastatin (only for rosuvastatin 5 mg, 10 mg, and 20 mg).

Very rare: 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 skin itching (with rashes). If you think you are having an allergic reaction, stop taking rosuvastatinand seek medical attention immediately.

•Muscle injury in adults – as a precaution,stop taking rosuvastatin and consult your doctor immediately if you experience unexplained muscle pain and crampsthat last longer than expected.

•Severe stomach pain (possible sign of pancreatitis).

•Increased liver enzymes (transaminases) in the blood.

•Bleeding or bruising more easily than normal due to low platelet count in the blood.

•Syndrome with symptoms similar to lupus (including urticaria, joint disorders, and blood cell effects).

Very rare: 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.

•Enlargement of the breasts in men (gynecomastia).

Frequency not known (the frequency cannot be estimated from available data):

•Diarrhea (loose stools).

•Cough.

•Shortness of breath.

•Swelling.

•Sleep disturbances, including insomnia and nightmares.

•Sexual difficulties.

•Depression.

•Respiratory problems, including persistent cough and/or shortness of breath or fever.

•Tendon damage.

•Constant muscle weakness.

•Myasthenia gravis (a disease that causes generalized muscle weakness, which, in some cases, affects the muscles used for breathing).

•Myasthenia ocular (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, eyelid drooping, difficulty swallowing, or difficulty breathing.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• This medication does not require special conditions for conservation.
• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging/container/label after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Rosuvastatina Macleods:

• The active ingredient of Rosuvastatina Macleods film-coated tablets is rosuvastatina calcium.
• Rosuvastatina Macleods film-coated tablets contain rosuvastatina calcium equivalent to 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin.
• The other components are: microcrystalline cellulose, lactose monohydrate, calcium hydrogen phosphate, hypromellose 2910, crospovidone, magnesium stearate, titanium dioxide (E171), triacetin, red iron oxide (E172) [for 10 mg, 20 mg, and 40 mg tablets] and yellow iron oxide (E172) [for 5 mg tablets].

Appearance of the product and packaging content

5 mg: yellow film-coated, round, biconvex tablets with “CL” engraved on one face and “86” on the other face (Approximate Size: 5.1 mm).

10 mg: pink film-coated, round tablets with the engraving “CL87” on one face and smooth on the other face. (Approximate Size: 6.1 mm).

20 mg: pink film-coated, round tablets with the engraving “CL88” and smooth on the other face. (Approximate Size: 8.1 mm).

40 mg: pink film-coated, oval, biconvex tablets with the engraving “CL89” on one face and smooth on the other face. (Approximate Size: 13.6 x 7.6 mm).

Blister conforming to cold:The blister packaging consists of a cold-formed laminated material composed of 25µ OPA/45µ aluminum foil /60µ PVC as the base material and 30 µ smooth aluminum foil/ 6-8gsm HSL as the lid material.

Packaging sizes: 7, 28, 30, 60, 90, 100 tablets.

Only some packaging sizes may be commercially available.

Bottle:HDPE bottle with a child-resistant safety closure, round, white, and containing a gelatin capsule inside.

Packaging sizes: 7, 28, 30, 90, 100 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Macleods Pharma España S.L.U.

World Trade Center Barcelona

Moll de Barcelona, s/n,

08039 Barcelona, Spain

Responsible manufacturer

Macleods Pharma UK Limited

Wynyard Park House,

Wynyard Avenue,

Wynyard, Billingham,

TS22 5TB,

United Kingdom

Or

Synoptis Industrial Sp. z o.o

ul. Rabowicka 15, Swarzedz,

62-020,

Poland

Local representative:

UXA FARMA S.A.

Last review date of this leaflet:December 2023

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)