Rosuvastatin Almus 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rosuvastatin Almus 5 mg film-coated tablets EFG

Read all of 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Rosuvastatina Almus belongs to a group of medicines called statins.

Your doctor has 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 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 continue to follow a cholesterol-lowering diet and maintain regular physical activity while taking Rosuvastatina Almus.
• You have other risk factors that increase your likelihood of experiencing a heart attack, stroke, or other related health problems.

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

Why it is important that you continue taking Rosuvastatina Almus

Rosuvastatina Almus 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 they 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 heart attack, stroke, or other related health problems.

You need to continue taking Rosuvastatina Almus, 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 advises you to do so, or if you become pregnant.

2. What you need to know before taking Rosuvastatina Almus

Do not take Rosuvastatina Almus:

• If you are allergic to the active substance rosuvastatin or to any of the other components 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 should avoid becoming pregnant during treatment with Rosuvastatina Almus 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 organ transplantation).
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking Rosuvastatina Almus or other related medicines.

If you are 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 medicine):

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If your thyroid gland is not functioning properly.
• If you have repeated or unexplained muscle pain and cramps, a personal or family history of muscle disorders, or a previous history of muscle problems while taking other cholesterol-lowering medicines.
• 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 medicines called fibrates to lower cholesterol.

If you are 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 unexplained muscle pain and cramps, a personal or family history of muscle disorders, or a previous history of muscle problems while taking 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 have or have had myasthenia gravis (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 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 for HIV or hepatitis C infection, such as ritonavir with lopinavir and/or atazanavir or simeprevir. Please see the section: "Taking Rosuvastatina Almus with other medicines".
• If you are taking antibiotics containing fusidic acid. If you are taking or have taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infection). The combination of fusidic acid and Rosuvastatina Almus may cause serious muscle problems (rhabdomyolysis).

Children and adolescents

If the patient is under 6 years of age: Rosuvastatina Almus must not be given to children under 6 years of age.

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

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

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

• Do not take Rosuvastatina 40 mg (the highest dose of this medicine) and consult your doctor or pharmacist before starting 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 immediate medical attention if you notice any of the symptoms described in section 4.

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. For this reason, your doctor will usually perform blood tests (liver function tests) before and during treatment with rosuvastatin.

While taking this medicine, your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely at risk of developing diabetes if you have high blood sugar levels, are overweight, and have high blood pressure.

Taking Rosuvastatina Almus with other medicines

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

• If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will advise you when you can restart treatment with Rosuvastatina Almus. Taking Rosuvastatina Almus with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.

Inform your doctor if you are taking any of the following medicines:

• cyclosporine (used after organ transplantation)
• warfarin or clopidogrel (or any other anticoagulant)
• fibrates (such as gemfibrozil, fenofibrate) or 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
• 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 Rosuvastatina Almus, or they may alter the effect of Rosuvastatina Almus.

Pregnancy and breastfeeding

Do not take Rosuvastatina Almus if 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 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 taking Rosuvastatina Almus, as it will not affect their ability. However, some people may experience dizziness during treatment with Rosuvastatina Almus. If you feel dizzy, consult your doctor before attempting to drive or use machinery.

Rosuvastatina Almus contains lactose and sodium.

Lactose

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

Sodium

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

For the full list of excipients, please see the section "Contents of the pack and other information".

3. How to take Rosuvastatina Almus

Follow exactly the instructions for taking this medicine as given 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 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 factors that make you more susceptible to possible side 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 smallest dose (5 mg) if:

• You are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• You are over 70 years old.
• You have moderate kidney problems.
• You are at risk of 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 appropriate dose of Rosuvastatina Almus for your condition. 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 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 Rosuvastatina Almus 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.

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 needed 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 prescribed by your doctor once daily. Rosuvastatin 40 mg tablets must not be administered to children.

How to take the tablets

Swallow each tablet whole with water.

Take Rosuvastatina Almus 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 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating 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 Rosuvastatina Almus

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 Rosuvastatina Almus

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

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 Rosuvastatina Almus and seek immediate medical attention if you experience 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.
• Severe itching of the skin (with hives).
• Red, flat, non-elevated skin rashes on the trunk, often in the shape of a target or circles, sometimes 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 Rosuvastatina Almus and consult your doctor immediately if you experience:

• Unexplained muscle pain and cramps that last longer than expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have experienced unpleasant muscle effects, which rarely have resulted in a potentially life-threatening muscle injury called rhabdomyolysis.
• Lupus-like syndrome (including skin rashes, joint disorders, and effects on blood cells).
• Muscle breakdown (pain and/or inability to use the affected part of the body, muscle pain, tenderness, mild swelling, marked loss of strength, and sometimes bruising).

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

• Headache.
• Stomach pain.
• Constipation.
• Nausea.
• Muscle pain.
• Weakness.
• Dizziness.
• Increased levels of protein in urine – this usually returns to normal on its own without the need to stop treatment with Rosuvastatina Almus tablets (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):

• Hives, itching, and other skin reactions.
• Increased levels of protein in urine – this usually returns to normal on its own without the need to stop treatment with Rosuvastatina Almus tablets (only with the 5 mg, 10 mg, and 20 mg doses 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, and severe itching of the skin (with hives). If you think you are having an allergic reaction, stop taking Rosuvastatina Almus and seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking Rosuvastatina Almus and consult your doctor immediately if you experience unexplained muscle pain or cramps that last longer than expected.
• Severe stomach pain (possible sign of inflammation of the pancreas).
• 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 arms and legs (with numbness).
• Joint pain.
• Memory loss.
• Enlargement of the breasts in men (gynecomastia).

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

• Diarrhea (loose stools).
• Cough.
• Shortness of breath.
• Edema (swelling).
• Sleep disturbances, including insomnia and nightmares.
• Sexual difficulties.
• Respiratory problems, including persistent cough and/or shortness of breath or fever.
• Tendon injuries.
• Persistent muscle weakness.
• Myasthenia gravis (a condition causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a condition 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 adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rosuvastatin Almus

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Blister:

Store below 30 °C.

HDPE bottle:

No special storage conditions required.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point located at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rosuvastatina Almus

The active substance is rosuvastatin.

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

The other components are:

Tablet core:

Microcrystalline cellulose
Lactose monohydrate
Crospovidone (type B)
Hydroxypropyl cellulose
Sodium hydrogen carbonate
Magnesium stearate.

Coating:

Lactose monohydrate
Hypromellose 6 Cp
Titanium dioxide (E171)
Triacetin
Iron oxide yellow (E172)

Appearance of the product and contents of the pack

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 available in packs with blisters containing 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 in HDPE bottles containing 30 and 100 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Almus Farmacéutica, S.A.U.
Marie Curie, 54
08840 Viladecans (Barcelona), Spain
Telephone: 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 medicinal product is authorized in the EEA Member States under 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 most recent review of this leaflet: 10/2023

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/