Rosuvastatin Almus: detailed information

Package leaflet: Information for the patient

Rosuvastatin Almus 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before 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. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet

What Rosuvastatin Almus is and what it is used for
What you need to know before taking Rosuvastatin Almus
How to take Rosuvastatin Almus
Possible side effects
How to store Rosuvastatin Almus
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.
You have been prescribed Rosuvastatina Almus because:

Your cholesterol level is high. This means you are at risk of 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 prescribed a statin because changing your diet and increasing physical activity have not been sufficient to correct your cholesterol levels. While taking Rosuvastatina Almus, you must continue a cholesterol-lowering diet and maintain regular physical exercise.

You have other risk factors that increase the likelihood of developing heart attack, stroke or related health problems. Heart attack, stroke and related health problems can be caused by a disease called atherosclerosis. Atherosclerosis is due to the buildup of fatty deposits inside the arteries.

Why is it important to keep taking Rosuvastatina Almus?
Rosuvastatina Almus is used to correct levels of fatty substances in the blood called lipids, the most common of which is cholesterol.
There are different types of cholesterol in the blood: so-called “bad” cholesterol (LDL-C) and so-called “good” cholesterol (HDL-C).

Rosuvastatina Almus film-coated tablets can reduce “bad” cholesterol and increase “good” cholesterol.
It works by helping to block the body’s production of “bad” cholesterol. It also improves the body’s ability to remove “bad” cholesterol from the blood.

For many people, high cholesterol does not affect how they feel, as it causes no symptoms.
However, if high cholesterol is not treated, fatty deposits can build up in the walls of blood vessels, leading to narrowing.
Sometimes, these narrowed blood vessels can become blocked, interrupting blood flow to the heart or brain and causing a heart attack or stroke.
By lowering cholesterol levels, the risk of having a heart attack, stroke or related health problems is reduced.
You must continue taking Rosuvastatina Almus, even if your cholesterol levels have returned to normal, to prevent them from rising again, which could lead to the formation of fatty deposits. However, you must stop taking Rosuvastatina Almus on medical advice 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 rosuvastatin or to any of the other ingredients of this medicine (listed in section 6)
If you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatina Almus, stop taking it immediately and inform your doctor. Women must avoid pregnancy while taking Rosuvastatina Almus by using appropriate contraceptive measures.
If you have liver disease
If you have severe kidney problems
If you have repeated or unexplained muscle pain or tenderness
If you are taking a medicine called cyclosporine (used, for example, after organ transplant)
If you have ever developed a severe skin rash, skin peeling, blisters and/or mouth ulcers after taking Rosuvastatina Almus or other related medicines. If you fall into any of the above categories (or have any doubts), you must go back to your doctor and inform him/her.

Also, do not take Rosuvastatina Almus 40 mg (the highest dose):

If you have moderate kidney problems (if in doubt, ask your doctor)
If your thyroid gland is not functioning properly
If you have repeated or unexplained muscle pain or tenderness, a personal or family history of muscle disorders, or have previously experienced 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, and Indian)
If you are taking other cholesterol-lowering medicines called fibrates. If you fall into any of the above categories (or have any doubts), you must go back to your doctor and inform him/her.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rosuvastatina Almus.

If you have kidney problems
If you have liver problems
If you have had repeated or unexplained muscle pain or tenderness, a personal or family history of muscle disorders, or have previously experienced muscle problems while taking other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or tenderness, especially if accompanied by malaise or fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness.
If you have or have had myasthenia gravis (a disease characterized by generalized muscle weakness, including in some cases the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), since statins may sometimes worsen myasthenia or trigger its onset (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 other medicines for high cholesterol.
If you are taking medicines used to treat HIV infection or hepatitis C infection, such as ritonavir with lopinavir and/or atazanavir or simeprevir; please read section “Other medicines and Rosuvastatina Almus”.
If you are taking antibiotics containing fusidic acid. If you are currently taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) orally or by injection. The combination of fusidic acid and Rosuvastatina Almus may lead to 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 Almus 40 mg is not suitable for use in children and adolescents under 18 years of age.

If you are over 70 years of age (your doctor needs to choose the appropriate starting dose for you)
If you have severe respiratory insufficiency
If you are of Asian origin – i.e., Japanese, Chinese, Filipino, Vietnamese, Korean, and Indian. Your doctor needs to choose the appropriate starting dose for you. If you fall into any of the above categories (or are unsure):
Do not take Rosuvastatina Almus 40 mg film-coated tablets (the highest dose), and check with your doctor or pharmacist before starting Rosuvastatina Almus at any dosage. Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with Rosuvastatina Almus. Discontinue use of 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 have a negative effect on the liver. This can be detected by a simple blood test that measures increased levels of liver enzymes. For this reason, your doctor will ask you to have this test (liver function test) before and during treatment with Rosuvastatina Almus.
During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fats in your blood, if you are overweight, and if you have high blood pressure.

Other medicines and Rosuvastatina Almus
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If you need to take oral fusidic acid for the treatment of bacterial infections, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe for you to resume treatment with Rosuvastatina Almus. Taking Rosuvastatina Almus with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). See section 4 for more information on rhabdomyolysis.

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

cyclosporine (used, for example, after organ transplant)
warfarin or clopidogrel (or any other medicine used to thin the blood)
fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe)
remedies for indigestion (used to neutralize stomach acids)
erythromycin (an antibiotic)
an oral contraceptive (the pill)
hormone replacement therapy
regorafenib (used to treat tumors)
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 the effect of Rosuvastatina Almus may be altered by these medicines.

Pregnancy and breastfeeding
Do not take Rosuvastatina Almus if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatina Almus, you must stop taking it immediately and inform your doctor.
Women must avoid pregnancy during treatment with Rosuvastatina Almus by using appropriate contraceptive measures.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Most people can drive cars and operate machinery while taking Rosuvastatina Almus, as this medicine does not affect their ability to drive or operate machinery. However, some people may experience dizziness during treatment with Rosuvastatina Almus.
If you feel dizzy, consult your doctor before driving or operating machinery.

Rosuvastatina Almus contains lactose and sodium.
Lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e., essentially ‘sodium-free’.
For the complete list of other ingredients, see section “Contents of the pack and other information”.

3. How to take Rosuvastatina Almus film-coated tablets

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Usual dosage in adults
If you are taking Rosuvastatina Almus for high cholesterol:
Starting dose
Treatment with Rosuvastatina Almus should begin with a dose of 5 mg or 10 mg, even if you have previously taken higher doses of other statins. The choice of starting dose depends on:

your cholesterol level
your risk of having a heart attack or stroke
whether you have any factors that may make you more susceptible to possible side effects. Check with your doctor or pharmacist which starting dose of Rosuvastatina Almus is most suitable for you.

Your doctor may decide to prescribe the lowest dose (5 mg) if you:

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

Dose increase and maximum daily dose
Your doctor may decide to increase your dose in order to determine the most appropriate dose of Rosuvastatina Almus for you. If treatment is started at 5 mg, your doctor may decide to double the dose to 10 mg, then to 20 mg, and subsequently to 40 mg if necessary. If treatment is started at 10 mg, your doctor may decide to double the dose to 20 mg and then to 40 mg if necessary. There should be an interval of 4 weeks between each dose adjustment.
The maximum daily dose of Rosuvastatina Almus is 40 mg. This dose is only given to patients with high cholesterol levels and a high risk of heart attack or stroke whose cholesterol levels have not been sufficiently reduced with the 20 mg dose.
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 risk factors listed above.
Use in children aged 6 to 17 years
The usual starting dose is 5 mg. Your doctor may increase the dose to achieve the most appropriate dose of Rosuvastatina Almus for you. The maximum daily dose of Rosuvastatina Almus is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years. The dose should be taken once daily. Rosuvastatina Almus 40 mg tablets must not be used in children.
Administration of the tablets
Swallow each tablet whole with a glass of water.
Rosuvastatina Almus should be taken once daily. Rosuvastatina Almus can be taken at any time of day, with or without food. Try to take the tablets at approximately the same time each day; this may help you remember to take them.
Regular cholesterol checks
It is important to return to your doctor for regular cholesterol checks to ensure that your cholesterol has reached and remains at the correct levels.
Your doctor may decide to increase your dose to achieve the most appropriate amount of Rosuvastatina Almus for you.
If you take more Rosuvastatina Almus than you should
Contact your doctor or the nearest hospital for advice.
If you go to hospital or receive treatment for another condition, inform the hospital doctor that you are taking Rosuvastatina Almus.
If you forget to take Rosuvastatina Almus
Do not panic; take the next dose at your usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Rosuvastatina Almus
Inform your doctor if you intend to stop taking Rosuvastatina Almus. If you stop taking Rosuvastatina Almus, your cholesterol levels may rise again.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
It is important to be aware of which of these side effects may occur. They are usually mild and disappear quickly.

Stop taking Rosuvastatin Almus and seek immediate medical help if 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
Severe itching of the skin (with raised hives)
Reddish, flat spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome)
Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome)

Also, stop taking Rosuvastatin Almus and contact your doctor immediately if you have:

Unusual muscle pains or aches lasting 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, and rarely these have progressed to a condition causing muscle damage, potentially life-threatening, known as rhabdomyolysis.
Lupus-like syndrome (including skin rash, joint problems, and effects on blood cells)
Muscle tear (pain and/or inability to use the affected body part, muscle pain, tenderness, mild swelling, marked loss of strength, and sometimes bruising)

Possible common side effects (may occur in 1 out of 10 people):

Headache
Stomach pain
Constipation
Feeling unwell
Muscle pain
Feeling weak
Dizziness
Increased levels of protein in the urine – values usually return to normal on their own without the need to stop taking Rosuvastatin Almus (only for Rosuvastatin Almus 40 mg)
Diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, or have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Possible uncommon side effects (may occur in 1 out of 100 people):

Skin rash, itching, and other skin reactions
Increased levels of protein in the urine – these usually return to normal on their own without stopping treatment with Rosuvastatin Almus (only for Rosuvastatin Almus 5 mg, 10 mg and 20 mg)

Possible rare side effects (may occur in 1 out of 1,000 people):

Severe allergic reactions – signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe itching of the skin (with raised hives). If you suspect you are having an allergic reaction, stop taking Rosuvastatin Almus and seek immediate medical help
Muscle damage in adults – as a precaution, stop taking Rosuvastatin Almus and contact your doctor immediately if you have unusual muscle pains or aches that last longer than expected
Severe stomach pain (inflamed pancreas)
Increased liver enzymes in the blood

Possible very rare side effects (may occur in less than 1 out of 10,000 people):

Jaundice (yellowing of the skin and eyes)
Hepatitis (inflammation of the liver)
Blood in the urine
Nerve damage in arms and legs (such as numbness)
Joint pain
Memory loss
Breast enlargement in men (gynecomastia)

Side effects of unknown frequency may include:

Diarrhoea (passing loose stools)
Cough
Shortness of breath
Oedema (swelling)
Sleep disorders, including insomnia and nightmares
Sexual problems
Depression
Breathing problems, including persistent cough and/or shortness of breath or fever
Tendon injury
Persistent muscle weakness
Myasthenia gravis (a disease causing generalized muscle weakness, including in some cases the muscles used for breathing)
Ocular myasthenia (a disease causing weakness of the eye muscles)

Contact your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing, or laboured breathing.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Rosuvastatin Almus film-coated tablets

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 refers to the
last day of that month.
Blister packs:
Do not store above 30°C.
Bottles:
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Rosuvastatina Almus film-coated tablets contain
The active substance is rosuvastatin.
Rosuvastatina Almus 5, 10, 20, 40 film-coated tablets contain rosuvastatin calcium salt
equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.
The other components are:
Tablet core:
Microcrystalline cellulose
Lactose monohydrate
Crospovidone (type B)
Hydroxypropylcellulose
Sodium hydrogen carbonate
Magnesium stearate
Coating:
Lactose monohydrate
Hypromellose 6 cp
Titanium dioxide (E171)
Triacetin
Yellow iron oxide (E 172) in Rosuvastatina Almus 5 mg film-coated tablets
Red iron oxide (E 172) in Rosuvastatina Almus 10 mg, 20 mg and 40 mg film-coated tablets

Description of the appearance of Rosuvastatina Almus film-coated tablets and package contents
Rosuvastatina Almus 5 mg film-coated tablets: yellow, round, biconvex tablets.
Rosuvastatina Almus 10 mg film-coated tablets: pink, round, biconvex tablets, with a score line.
Rosuvastatina Almus 20 mg film-coated tablets: pink, round, biconvex tablets, with a score line.
Rosuvastatina Almus 40 mg film-coated tablets: pink, oval, biconvex tablets, with a score line.
Rosuvastatina Almus 10, 20, 40 mg film-coated tablets:
The tablets may be divided into two equal parts.

Rosuvastatina Almus film-coated tablets are 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 tablets, and in HDPE containers containing 30 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Almus S.r.l.
Via Cesarea 11/10
16121 Genova
Italy
E-mail: [email protected]

Manufacturers
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovića 25
10000 Zagreb
Croatia
TEVA PHARMA S.L.U.
C/ C, nº 4
Poligono Industrial Malpica
50016 Zaragoza
Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
Denmark Rocasium
France Rosuvastatine Almus
Italy Rosuvastatina Almus
Portugal Rosuvastatina Almus
United Kingdom Rosuvastatin 5 mg, 10 mg, 20 mg, 40 mg Film-coated Tablets
Spain Rosuvastatina Almus 5 mg, 10 mg, 20 mg, 40 mg comprimidos recubiertos con película EFG