ROSUVASTATIN ALMUS 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rosuvastatina Almus 5 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

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

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 stroke. Rosuvastatina Almus is used in adults, adolescents, and children aged 6 years or older to treat high cholesterol.
• You have been told to take a statin because changes to your diet and increased physical exercise have not been enough to correct your cholesterol levels. You should continue to follow a diet that helps lower cholesterol and continue to exercise while taking Rosuvastatina Almus.
• You have other factors that increase your risk of having a heart attack, stroke, or other related health problems.

A heart attack, stroke, and other related 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 keep taking Rosuvastatina Almus

Rosuvastatina Almus is used to correct the 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 decreases the amount of "bad" cholesterol and increases the "good" cholesterol.
• It works 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, as 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 blood vessels can become blocked, preventing blood from reaching the heart or brain, causing a heart attack or stroke. By lowering your cholesterol levels, you can reduce the risk of having a heart attack, stroke, or related health problems.

You need to continue taking Rosuvastatina Almus, even if you have already achieved the correct cholesterol levels, as it prevents cholesterol levels from rising againand causing 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 Rosuvastatina Almus

Do not take RosuvastatinaAlmus:

• If you are allergicto the active substance rosuvastatinaor 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 Almus 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 of the skin, blisters, and/or sores in the mouthafter taking Rosuvastatina Almus or other related medications.

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

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

• If you have moderate kidney problems(if you are unsure, consult your doctor).
• If your thyroid glandis not working 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(Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other medications called fibratesto lower cholesterol.

If you are in any of the above situations (or if you are unsure), 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 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 constant 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 ocular myasthenia(a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section 4).
• If you regularly drink large amounts of alcohol.
• If your thyroid glandis not working correctly.
• If you are taking other medications called fibratesto lower cholesterol. Read this package 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 that contain fusidic acid. If you are taking or have taken in the last 7 days a medication that contains fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Rosuvastatina Almus can rarely cause serious muscle problems (rhabdomyolysis).

Children and adolescents

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

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

• If you are over 70 years old(as your doctor will determine the appropriate starting dose of Rosuvastatina Almus 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 will determine the appropriate starting dose of Rosuvastatina Almus for you.

If you are in any of these situations mentioned above (or if you 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. 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 checks for increased levels of liver enzymes 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.

Taking Rosuvastatina Almus with other medications

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

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

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

• ciclosporin (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 ezetimibe)
• treatments 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, 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 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 Almus, stop 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 using machines

Most patients can drive vehicles and use machines while taking Rosuvastatina Almus, as it will not affect their ability. However, some people may feel dizzy while taking 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; this is, essentially "sodium-free".

To see the complete list of excipients, please consult the section "Contents of the pack and further information".

3. How to take Rosuvastatina Almus

Follow the instructions for administration of this medication indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

Usual doses in adults

If you are taking Rosuvastatina Almus for high cholesterol:

Starting dose:

Your treatment with Rosuvastatina Almus should start with a dose of 5 mg or 10 mg, 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 factors that make you more vulnerable to possible side effects.

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

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

• You are of Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• You are over 70 years old.
• You have moderate kidney problems.
• You are at risk of having muscle pain or weakness (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose so that you are taking the correct 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 an interval of four weeks between each dose adjustment.

The maximum daily dose of Rosuvastatina is 40 mg. 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 enough with 20 mg.

If you are taking Rosuvastatina Almus to reduce the risk of having a 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 recommended starting dose is 5 mg. Your doctor may increase your dose to achieve the appropriate dose of Rosuvastatina Almus to treat your condition. The maximum recommended daily dose is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years. Take the dose indicated by your doctor once a day. Do notgive rosuvastatina 40 mgtablets to children.

Taking the tablets

Swallow each tablet whole with water.

Take Rosuvastatina Almus 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 checks of cholesterol levels

It is important to visit your doctor regularly to have your cholesterol levels checked, to ensure that your cholesterol levels have returned to normal and are being maintained at appropriate levels.

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

If you take more Rosuvastatina Almus 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, telephone 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 Almus

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 Almus

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

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 Rosuvastatina Almus and seek immediate medical attentionif 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 can cause difficulty swallowing.
• Intense itching of the skin (with hives).
• Red spots on the torso, not raised, in a target or circular shape, often with central blisters, 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).
• Widespread 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:

• Unjustified 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 suffered unpleasant muscle effects that, rarely, have resulted in a potentially fatal muscle injury called rhabdomyolysis
• Lupus-like syndrome (including skin rashes, joint disorders, and effects on blood cells)
• Muscle rupture (pain and/or functional disability to use the affected body part, muscle pain, sensitivity, mild swelling, significant loss of strength, and occasionally bruising)

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 Rosuvastatina Almus tablets (only with the daily dose of 40 mg of rosuvastatina).
• Diabetes. This is more likely if you have high blood sugar and lipid levels, 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 Rosuvastatina Almus tablets (only with doses of 5 mg, 10 mg, and 20 mg of Rosuvastatina Almus).

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 Rosuvastatina Almusand seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking Rosuvastatina Almus and consult your doctor immediately if you have unjustified muscle pain or crampsthat last longer than expected.
• Severe stomach pain (possible sign of pancreatitis).
• Increased liver enzymes in the 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 the urine.
• Nerve damage in the legs and arms (with numbness).
• Joint pain.
• Memory loss.
• Increased breast size in men (gynecomastia).

Adverse Effects of Unknown Frequency (cannot be estimated from the available data) that may include:

• Diarrhea (loose stools).
• 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.
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (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 Medicines Monitoring System website: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rosuvastatina Almus

Keep this medicine out of the sight and reach of children.

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.

Blister:

Store below 30 ºC.

HDPE bottle:

No special storage conditions are required.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need in the SIGRE point of 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 Rosuvastatina Almus

The active ingredient is rosuvastatina.

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

The other ingredients are:

Core of the tablet:

Microcrystalline cellulose

Lactose monohydrate

Crospovidone (type B)

Hydroxypropyl cellulose

Sodium hydrogen carbonate

Magnesium stearate.

Coating:

Lactose monohydrate

Hypromellose 6 Cp

Titanium dioxide (E171)

Triacetin

Yellow iron oxide (E172)

Appearance of the Product and Package Contents

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

Rosuvastatina Almus is available in packages with blisters 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 marketed.

Marketing Authorization Holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Manufacturer:

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 medicine is authorized in the EEA member states 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

Date of the last revision of this prospectus: 10/2023

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/