Package Leaflet: Information for the User

Rosuvastatina Almus 5 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 only, and you should not give it to others, even if they have the same symptoms as 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 Rosuvastatina Almus is and what it is used for

2. What you need to know before you start taking Rosuvastatina Almus

3. How to take Rosuvastatina Almus

4. Possible side effects

5. Storage of Rosuvastatina Almus

6. Contents of the pack and additional information

Rosuvastatina Almus belongs to a group of medications called statins.

You have been prescribed Rosuvastatina Almus because:

• You have high cholesterol levels. This means you are at risk of having a heart attack or a cerebral infarction. Rosuvastatina Almus is used in adults, adolescents, and children 6 years of age 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 continue to maintain a diet that helps to reduce cholesterol and continue to engage in physical exercise while taking Rosuvastatina Almus.
• You have other factors that increase your risk of suffering a heart attack, cerebral infarction, or other health-related problems.

A heart attack, cerebral infarction, and other health-related problems may 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 Rosuvastatina Almus

Rosuvastatina Almus 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).

• Rosuvastatina decreases 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 eliminate 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 cerebral infarction. By reducing your cholesterol levels, you can reduce the risk of having a heart attack, cerebral infarction, or other health-related problems.

You needto continue taking Rosuvastatina Almus, 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 areallergicto the active ingredientrosuvastatinaor 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 rosuvastatinastop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with Rosuvastatina Almus 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 medication called ciclosporina(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 Almus or other related medications.

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

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

• If you have moderate kidney problems(if in doubt, consult your doctor).
• If your thyroid glanddoes 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(Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other medications called fibratesto lower cholesterol.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rosuvastatina Almus:

• 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 have general discomfort or fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness.
• 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 myasthenia gravis(a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).
• If you regularly consume large amounts of alcohol.
• If your thyroid glanddoes not function correctly.
• If you are taking other medications called fibratesto lower cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medications before.
• If you are taking medications to treat HIV or hepatitis C infection, such as ritonavir with lopinavir and/or atazanavir or simeprevir. Please see the section: “Taking Rosuvastatina Almus with other medications”.
• If you are taking antibiotics containing fusidic acid. If you are taking or have taken within the last 7 days a medication containing fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Rosuvastatina Almus may cause severe muscle problems (rhabdomyolysis).

Children and adolescents

If the patient is under 6 years of age:Rosuvastatina Almusshould not be administeredto children under 6 years of age.

If the patient is under 18 years of age:Rosuvastatina 40 mgis not suitablefor children and adolescents under 18 years of age.

• If you are over 70 years of age(since your doctor should establish the appropriate starting dose of Rosuvastatina Almus for you)
• If you have severe respiratory failure.
• If you are of Asian origin(such as Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor should establish the appropriate starting dose of Rosuvastatina Almus for you.

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

• Do not take Rosuvastatina 40 mg (the highest dose of this medication) 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 Almus treatment. Stop using Rosuvastatina Almus 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 blood test that measures elevated liver enzymes. For this reason, your doctor will usually 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 may be at risk of developing diabetes if you have high blood sugar levels, are overweight, and have high blood pressure.

Taking Rosuvastatina Almus with other medications

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

• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop taking this medication temporarily.Your doctor will tell you when you can restart treatment with Rosuvastatina Almus. The use of Rosuvastatina Almus with fusidic acid may rarely cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

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

• ciclosporina (used after an organ transplant)
• warfarin or clopidogrel (or any other anticoagulant medication)
• 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)
• oral contraceptives (the pill)
• hormone replacement therapy
• regorafenib (used to treat cancer)
• any of the following medications used to treat viral infections, including HIV or hepatitis C infection, 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 modified by Rosuvastatina Almus or may change the effect of Rosuvastatina Almus.

Pregnancy and breastfeeding

Do not take Rosuvastatina Almusif you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatina Almusstop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with Rosuvastatina Almus 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 Almus as it will not affect their ability. However, some people may feel dizzy during treatment with Rosuvastatina Almus. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Rosuvastatina Almus contains lactose and sodium.

Lactose

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

Sodium

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

For a complete list of excipients, please see the section “Contents of the pack and additional information”.

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 Rosuvastatina Almus for high cholesterol levels:

Starting dose:

Your treatment with Rosuvastatina Almus should start withthe 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:

• Cholesterol levels
• The degree of risk you have of suffering a heart attack or cerebral infarction
• If you have factors that make you more vulnerable to possible adverse effects.

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

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

• You areof Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean or Indian).
• You areover 70 years old.
• You have moderate kidney problems.
• You have a risk of suffering muscle pain and cramps (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose. This is so that you are taking the appropriate dose of Rosuvastatina Almus 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 then to 40 mg, if necessary. There will be a four-week interval between each dose adjustment.

The maximum daily dose of Rosuvastatina is 40 mg. This dose is only for patients with high cholesterol levels and a high risk of suffering a heart attack or cerebral infarction, whose cholesterol levels do not decrease enough with 20 mg.

If you are taking Rosuvastatina Almus to reduce the risk of suffering a heart attack, a cerebral infarction 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 usual recommended starting dose is 5 mg. Your doctor may increase your dose to reach the appropriate dose of Rosuvastatina Almus for your condition. The maximum recommended daily dose is 10 mg for children aged 6-9 years and 20 mg for children aged 10-17 years. Take the dose indicated by your doctor once a day.Do not administer the 40 mg rosuvastatina tabletsto children.

Swallowing the tablets

Swallow each tablet whole with water.

Take Rosuvastatina Almus 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, in order to check that your cholesterol levels have normalized and are maintained at appropriate levels.

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

If you take more Rosuvastatina Almus 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 Rosuvastatina Almus

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 Rosuvastatina Almus

Consult your doctor if you want to interrupt treatment with Rosuvastatina Almus. Your cholesterol levels may increase again if you stop taking Rosuvastatina Almus.

If you have any other doubts 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 Rosuvastatina Almus and seek medical attention immediatelyif 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 that may cause difficulty swallowing.
• Intense itching of the skin (with rashes).
• Reddish patches on the trunk, often with blisters, skin peeling, mouth ulcers, 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 Rosuvastatina Almus and consult your doctor immediately if you experience:

• Muscle pain and cramps that 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, rarely, have resulted in a potentially fatal muscle injury calledrabdomiólisis
• Lupus-like syndrome (including skin eruptions, joint disorders, and blood cell effects)
• Muscle rupture (pain and/or functional inability to use the affected body part, muscle pain, sensitivity, mild swelling, significant loss of strength, and occasionally, bruising)

Frequent side 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 urine – this usually reverts to normal on its own without the need to interrupt treatment with Rosuvastatina Almus tablets (only with a daily dose of 40 mg of rosuvastatin).
• Diabetes. This is more likely if you have high blood sugar and lipid levels, being overweight, and high blood pressure. Your doctor will closely monitor you while you are taking this medicine.

Rare side effects (may affect up to 1 in 100 people):

• Urticaria, itching, and other skin reactions.
• An increase in the amount of protein in urine – this usually reverts to normal on its own without the need to interrupt treatment with Rosuvastatina Almus tablets (only with doses of 5 mg, 10 mg, and 20 mg of Rosuvastatina Almus).

Very rare side 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 rashes). If you think you are having an allergic reaction, stop taking Rosuvastatina Almusand seek medical attention immediately.
• Muscle injury in adults – as a precaution,stop taking Rosuvastatina Almus and consult your doctor immediately if you have muscle pain or crampsthat last longer than expected.
• Intense stomach pain (possible sign of pancreatitis).
• Increased liver enzymes in the blood.

Very rare side 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).
• Joint pain.
• Memory loss.
• Enlargement of the breasts in men (gynecomastia).

Side effects of unknown frequency (cannot be estimated from available data) that may include:

• 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 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 Pharmacovigilance of Medicines for Human Use website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 after CAD. The expiration date is the last day of the month indicated.

Blister:

Store below 30 °C.

HDPE Bottle:

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Rosuvastatina Almus

The active ingredient is rosuvastatin.

Each film-coated tablet contains rosuvastatin calcium equivalent to 5 mg of rosuvastatin.

The other components are:

Tablet core:

Microcrystalline cellulose

Monohydrate lactose

Crospovidone (type B)

Hydroxypropyl cellulose

Sodium hydrogen carbonate

Magnesium stearate.

Covering:

Monohydrate lactose

6% Hypromellose

Titanium dioxide (E171)

Triacetin

Yellow iron oxide (E172)

Appearance of the product and contents of the package

Rosuvastatina Almus 5 mg film-coated tablets EFG are yellow, round, biconvex tablets, marked with a “5” on one side and smooth on the other.

Rosuvastatina Almus is presented in blister packs of 7, 14, 15, 20, 28, 30, 30 x 1, 42, 50, 50 x 1, 56, 60, 84, 90, 98, 100 and 100 x 1 film-coated tablets and HDPE bottles of 30 and 100 film-coated tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email:[email protected]

Responsible for manufacturing:

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25

10000- Zagreb, Croatia

Merckle GmbH

Ludwig-Merckle-Strasse 3

D-89143 Blaubeuren, Germany

TEVA PHARMA S.L.U.

C/ C, nº 4

Polígono Industrial Malpica

50016 Zaragoza, Spain

This medicinal product is authorized in the Member States of the EEA with the following names:

DK: Rocasium

FR: Rosuvastatine Almus 5 mg, comprimé pelliculé

IT: Rosuvastatina Almus 5 mg compresse rivestite con film

PT: Rosuvastatina Almus 5 mg comprimidos revestidos por película

UK: Rosuvastatin 5 mg Film-coated Tablets

ES: Rosuvastatina Almus 5 mg comprimidos recubiertos con película EFG

Last review date of this leaflet: 10/2023

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(AEMPS)http://www.aemps.gob.es/