Rosuvastatin Almus 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rosuvastatin Almus 20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the adverse effects are not listed in this leaflet. See section 4.

Leaflet contents

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 having a heart attack, stroke, or other related health problems.

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

Why it is important that you keep 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).

• Rosuvastatin lowers the amount of "bad" cholesterol and increases "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 cause 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 flow to the heart or brain, leading to a heart attack or stroke. By lowering your cholesterol levels, you can reduce the risk of having a heart attack, stroke, or other related health problems.

You need to keep taking Rosuvastatina Almus, even after your cholesterol levels have returned to normal, because it prevents cholesterol levels from rising again and stops 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 Rosuvastatin Almus

Do not take Rosuvastatin Almus:

• If you are allergic to the active substance rosuvastatin or to any of the other ingredients of this medicine (see 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 Rosuvastatin Almus by using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you have 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, skin peeling, blisters, and/or mouth sores after taking Rosuvastatin Almus or other related medicines.

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

Also, do not take Rosuvastatin 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 during treatment with 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 if you have any doubts), please consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Rosuvastatin 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 during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or cramps, especially if you also have general 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 to treat HIV infection or hepatitis C infection, such as ritonavir with lopinavir and/or atazanavir or simeprevir. Please see the section: "Taking Rosuvastatin 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), you must stop taking Rosuvastatin Almus temporarily. The combination of fusidic acid and Rosuvastatin Almus may cause serious muscle problems (rhabdomyolysis).

Children and adolescents

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

If the patient is under 18 years of age: Rosuvastatin 40 mg film-coated tablets are 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 Rosuvastatin 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 Rosuvastatin Almus for you.

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

• Do not take Rosuvastatin 40 mg (the highest dose of this medicine) and consult your doctor or pharmacist before starting any dose of Rosuvastatin.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with Rosuvastatin Almus. Stop using Rosuvastatin 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 after starting treatment with rosuvastatin.

While taking this medicine, 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 Rosuvastatin 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 must temporarily stop taking this medicine. Your doctor will tell you when you can restart treatment with Rosuvastatin Almus. Taking Rosuvastatin Almus with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on 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 cholesterol-lowering medicine (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 Rosuvastatin Almus, or they may alter the effect of Rosuvastatin Almus.

Pregnancy and breastfeeding

Do not take Rosuvastatin Almus if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin Almus, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with Rosuvastatin 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 being treated with Rosuvastatin Almus, as it will not affect their ability. However, some people may experience dizziness during treatment with Rosuvastatin Almus. If you feel dizzy, consult your doctor before attempting to drive or use machinery.

Rosuvastatin 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; this is essentially “sodium-free”.

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

3. How to take Rosuvastatina Almus

Follow exactly the instructions for use of 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 lowest 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 so that you receive the dose of Rosuvastatina Almus appropriate 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 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 dose of Rosuvastatina Almus appropriate for treating your condition. The maximum daily dose recommended 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 tablets of 40 mg should 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 that your cholesterol levels have normalized and remain at appropriate levels.

Your doctor may decide to increase your dose so that you receive the dose of Rosuvastatina Almus appropriate 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 telephone number 91 562 04 20, indicating the medication 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 spots on the trunk, often in a target or circular shape, 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 contact your doctor immediately if you experience:

• Unexplained muscle pain and cramps lasting 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 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 body part, 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 have unexplained muscle pain or cramps that last longer than expected.
• Severe stomach pain (possible sign of pancreas inflammation).
• Increased liver enzymes in 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 urine.
• Nerve damage in 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.
• Depression.
• Respiratory problems, including persistent cough and/or shortness of breath or fever.
• Tendon injuries.
• Persistent muscle weakness.
• Myasthenia gravis (a disease causing generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a disease causing weakness of the eye muscles).

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

Reporting of adverse effects

If you experience any kind of 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 stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Blister pack:

Store below 30 °C.

HDPE bottle:

No special storage conditions required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Rosuvastatina Almus

The active substance is rosuvastatin.

Each film-coated tablet contains calcium rosuvastatin equivalent to 20 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 red (E172)

Appearance of the product and contents of the pack

Rosuvastatina Almus 20 mg film-coated tablets EFG are pink-colored, round, biconvex tablets, scored on one side and marked with "20" on the other.

Rosuvastatina Almus 20 mg film-coated tablets EFG can be divided into equal halves.

Rosuvastatina Almus is available in blister packs 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 EEA member states under the following names:

FR: Rosuvastatine Almus 20 mg, comprimé pelliculé
IT: Rosuvastatina Almus 20 mg compresse rivestite con film
ES: Rosuvastatina Almus 20 mg comprimidos recubiertos con película EFG

Date of the most recent revision 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/