ROSUVASTATIN ALMUS

Patient Information Leaflet

Rosuvastatina 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, talk to your doctor or pharmacist. This includes any side effect not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Rosuvastatina Almus is and what it is used for
2. What you need to know before taking Rosuvastatina Almus
3. How to take Rosuvastatina Almus
4. Possible side effects
5. How to store Rosuvastatina 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.
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 to follow a cholesterol-lowering diet and maintain
regular physical exercise.
Or

• 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 condition called
atherosclerosis. Atherosclerosis is due to the buildup of fatty deposits inside the arteries.
Why is it important to continue 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 and 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 their narrowing.
Sometimes, these narrowed blood vessels can become blocked, interrupting blood flow to the heart or brain and thereby causing a heart attack or stroke. Lowering cholesterol levels reduces the risk of having a heart attack, stroke, or related health problems.
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 Rosuvastatin Almus

Do not take Rosuvastatin 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 Rosuvastatin Almus, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with Rosuvastatin Almus by using appropriate contraceptive measures
• If you have liver disease
• If you have severe kidney problems
• If you have repeated or unexplained muscle pains or aches
• If you are taking a medicine called cyclosporine (used, for example, after organ transplant). If any of the above apply to you (or if you have any doubts), you must consult your doctor and inform him/her.

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

• If you have moderate kidney problems (ask your doctor if you are unsure)
• If your thyroid gland is not functioning properly
• If you have repeated or unexplained muscle pains or aches, 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, or Indian)
• If you are taking other cholesterol-lowering medicines called fibrates. If any of the above apply to you (or if you have any doubts), you must consult your doctor and inform him/her.

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

• If you have kidney problems
• If you have liver problems
• If you have had repeated or unexplained muscle pains or aches, 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 aches, especially if accompanied by malaise or fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness
• 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 infections or hepatitis C infection, such as ritonavir with lopinavir and/or atazanavir or simeprevir; please read section “Other medicines and Rosuvastatin Almus”
• If you are taking antibiotics containing fusidic acid. If you are currently taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine for bacterial infections). The combination of fusidic acid and Rosuvastatin Almus may lead to 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 Almus 40 mg film-coated tablets are not suitable for use in children and adolescents under 18 years of age.

• If you are over 70 years old (your doctor needs to choose the appropriate starting dose for you)
• If you have severe respiratory failure
• If you are of Asian origin – that is, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian. Your doctor needs to choose the appropriate starting dose for you. If any of the above apply to you (or if you are unsure):
• Do not take Rosuvastatin Almus 40 mg film-coated tablets (the highest dose) and consult your doctor or pharmacist before starting Rosuvastatin Almus at any dosage.

In a small number of people, statins may have a negative effect on the liver. This can be detected with a simple blood test that measures increased levels of liver enzymes. For this reason, your doctor will request this test (liver function test) before and during treatment with Rosuvastatin 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, are overweight, and have high blood pressure.

Other medicines and Rosuvastatin Almus
Inform 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 Rosuvastatin Almus. Taking Rosuvastatin Almus with fusidic acid may rarely cause 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)
• antacids (used to neutralize stomach acid)
• erythromycin (an antibiotic)
• an oral contraceptive (the pill)
• hormone replacement therapy
• regorafenib (used to treat tumours)
• 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 the effect of Rosuvastatin Almus may be altered by these medicines.

Pregnancy and breastfeeding
Do not take Rosuvastatin Almus if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin Almus, you must stop taking it immediately and inform your doctor.
Women must avoid pregnancy during treatment with Rosuvastatin 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 and operate machinery while taking Rosuvastatin Almus, as this medicine does not affect their ability to drive or operate machinery. However, some people may experience dizziness during treatment with Rosuvastatin Almus.
If you experience dizziness, consult your doctor before driving or operating machinery.

Rosuvastatin Almus contains lactose and sodium.
Lactose
If you have been diagnosed by your doctor 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 initial dose depends on:

• your cholesterol level
• your risk level 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 to determine the most appropriate starting dose of Rosuvastatina Almus 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 weakness (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 starting with a 5 mg dose, your doctor may decide to double the dose to 10 mg, then to 20 mg, and then to 40 mg if necessary. If starting with 10 mg, your doctor may decide to double this 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 administered only to patients with high cholesterol levels and a high risk of heart attack or stroke whose cholesterol levels have not sufficiently decreased 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 between 6 and 17 years
The usual starting dose is 5 mg. Your doctor may increase the dose to achieve the most appropriate Rosuvastatina Almus dosage for you. The maximum daily dose of Rosuvastatina Almus is 10 mg for children aged between 6 and 9 years and 20 mg for children aged between 10 and 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 regularly to monitor your cholesterol levels, to ensure that your cholesterol has reached and maintains 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 missed 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 questions about using 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 in a short time.
Stop taking Rosuvastatina 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 in swallowing
• Severe itching of the skin (with raised hives).

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

• unusual muscle aches or pains 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 tearing (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 of weakness
• Dizziness
• Increased amount of protein in the urine – usually values return to normal on their own without needing to stop Rosuvastatina Almus (only for Rosuvastatina 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 amount of protein in the urine – these usually return to normal on their own without needing to stop treatment with Rosuvastatina Almus (only for Rosuvastatina 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 Rosuvastatina Almus and seek immediate medical help
• Muscle damage in adults – as a precaution, stop taking Rosuvastatina Almus and contact your doctor immediately if you have unusual muscle aches or pains 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 traces in the urine
• Nerve damage in arms and legs (such as numbness)
• Joint pain
• Memory loss
• Breast enlargement in men (gynaecomastia).

Side effects of unknown frequency may include:

• Diarrhoea (passing liquid stools)
• Stevens-Johnson syndrome (severe blisters on skin, mouth, eyes and genitals)
• 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.

Reporting of side effects
If you get any side effects, including ones 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 pack 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 you no longer use. 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
Monohydrate lactose
Crospovidone (type B)
Hydroxypropylcellulose
Sodium hydrogen carbonate
Magnesium stearate
Coating:
Monohydrate lactose
Hypromellose 6 cp
Titanium dioxide (E171)
Triacetin
Ferric oxide yellow (E 172) in Rosuvastatina Almus 5 mg film-coated tablets
Ferric oxide red (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: round, biconvex, yellow tablets.
Rosuvastatina Almus 10 mg film-coated tablets: round, biconvex, pink tablets, with a break line.
Rosuvastatina Almus 20 mg film-coated tablets: round, biconvex, pink tablets, with a break line.
Rosuvastatina Almus 40 mg film-coated tablets: oval, biconvex, pink tablets, with a break line.
Rosuvastatina Almus 10, 20, 40 mg film-coated tablets:
The tablets can 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 Genoa
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