Rosuvastatin Teva: detailed information

Package leaflet: Information for the patient

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

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as 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 could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Rosuvastatin Teva is and what it is used for
What you need to know before taking Rosuvastatin Teva
How to take Rosuvastatin Teva
Possible side effects
How to store Rosuvastatin Teva
Contents of the pack and other information

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

Rosuvastatina Teva belongs to a group of medicines called "statins".
You have been prescribed Rosuvastatina Teva because:

Your cholesterol level is high. This means you are at risk of heart attack or stroke. Rosuvastatina Teva is used in adults, adolescents, and children aged 6 years and older for the treatment of high cholesterol levels.

You have been prescribed a statin because dietary changes and increased physical activity have not been sufficient to correct your cholesterol levels. While taking Rosuvastatina Teva, you must continue your cholesterol-lowering diet and maintain physical activity.
Or

You have other factors that increase your risk 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 Teva?
Rosuvastatina Teva is used to correct levels of fatty substances in the blood known as 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 Teva 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, stopping blood flow to the heart or brain and 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 Teva, 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 Teva on the advice of your doctor or if you become pregnant.

2. What you need to know before taking Rosuvastatin Teva

Do not take Rosuvastatin Teva:

if you are allergic to rosuvastatin or to any of the other ingredients of this medicine (listed in section 6);
if you have ever developed a severe skin rash, skin peeling, blisters and/or mouth ulcers after taking rosuvastatin or other related medicines;
if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin Teva, you must stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with Rosuvastatin Teva by using appropriate contraceptive measures;
if you have liver disease;
if you have severe kidney problems;
if you have repeated or unexplained muscle spasms or muscle pain;
if you are taking a combination of medicines containing sofosbuvir/velpatasvir/voxilaprevir (used for a viral liver infection called hepatitis C);
if you are taking a medicine called cyclosporine (used, for example, after organ transplantation). If you fall into any of the above categories (or have any doubts), you must consult your doctor and inform him/her.

In addition, do not take Rosuvastatin Teva 40 mg film-coated tablets (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 spasms or muscle pain, 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 medicines called fibrates to lower cholesterol. If you fall into any of the above categories (or have any doubts), you must consult your doctor and inform him/her.

Warnings and precautions
Consult your doctor or pharmacist before taking Rosuvastatin Teva.

If you have kidney problems
If you have liver problems
If you have had repeated or unexplained muscle spasms or muscle pain, 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 spasms or pain, 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), as 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 infections, such as ritonavir with lopinavir and/or atazanavir; see section Other medicines and Rosuvastatin Teva
If you are currently taking, or have taken within the last 7 days, a medicine called fusidic acid, (a medicine for bacterial infections) taken orally or by injection. The combination of fusidic acid and Rosuvastatin Teva can lead to serious muscle problems (rhabdomyolysis); see “Other medicines and Rosuvastatin Teva”.
If you are over 70 years old (your doctor needs to choose the appropriate starting dose of Rosuvastatin Teva for you)
If you have severe respiratory failure
If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, and Indian). Your doctor needs to choose the appropriate starting dose of Rosuvastatin Teva for you. If you fall into any of the above categories (or are unsure):
Do not take Rosuvastatin Teva 40 mg film-coated tablets (the highest dose) and consult your doctor or pharmacist before starting Rosuvastatin Teva at any dosage.

In a small number of people, statins may affect the liver. This can be detected by 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 Teva.
Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with rosuvastatin. Discontinue use of Rosuvastatin Teva and seek immediate medical attention if you notice any of the symptoms described in section 4.
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 the blood, if you are overweight, and if you have high blood pressure.

Children and adolescents

If the patient is under 6 years of age: Rosuvastatin Teva film-coated tablets must not be given to children under 6 years of age.
If the patient is under 18 years of age: Rosuvastatin Teva 40 mg film-coated tablets is not suitable for administration to children and adolescents under 18 years of age.

Other medicines and Rosuvastatin Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking any of the following medicines:

cyclosporine (used, for example, after organ transplantation)
warfarin, clopidogrel, ticagrelor (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)
fusidic acid (an antibiotic). 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 tell you when it is safe to restart Rosuvastatin Teva. Taking Rosuvastatin Teva with fusidic acid may rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). See section 4 for more information about rhabdomyolysis
an oral contraceptive (the pill)
regorafenib (used to treat tumors)
darolutamide (used to treat cancer)
capmatinib (used to treat cancer)
hormone replacement therapy
fostamatinib (used to treat low platelet levels)
febuxostat (used to treat and prevent high levels of uric acid in the blood)
teriflunomide (used to treat multiple sclerosis)
leflunomide (used to treat rheumatoid arthritis)
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, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir
roxadustat (used to treat anemia in patients with chronic kidney disease)
tafamidis (used to treat a disease called transthyretin amyloidosis)
momelotinib (used to treat myelofibrosis in adults with anemia).

The effects of these medicines may be altered by Rosuvastatin Teva, or the effect of Rosuvastatin Teva may be altered by these medicines.

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

Rosuvastatin Teva 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’.

3. How to take Rosuvastatin Teva

Take Rosuvastatin Teva exactly as prescribed by your doctor. If you have any doubts, you should consult your doctor or pharmacist.
Usual dosage for adults
If you are taking Rosuvastatin Teva for high cholesterol:
Starting dose
Treatment with Rosuvastatin Teva should begin with a 5 mg or 10 mg dose, even if you have previously taken higher doses of other statins. The choice of initial 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 to determine the most appropriate starting dose of Rosuvastatin Teva for you.

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

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

Dose increase and maximum daily dose
Your doctor may decide to increase your dose in order to determine the most suitable dose of Rosuvastatin Teva for you. If treatment is started at 5 mg, your doctor may, if necessary, decide to double the dose to 10 mg, then to 20 mg, and then to 40 mg if needed. If treatment is started at 10 mg, your doctor may, if necessary, decide to double the dose to 20 mg and then to 40 mg if needed.
There should be an interval of 4 weeks between each dose adjustment.
The maximum daily dose of Rosuvastatin Teva is 40 mg. This dose is given 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 Rosuvastatin Teva 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 and adolescents aged 6–17 years
The dosage range for children and adolescents aged 6 to 17 years is 5 to 20 mg once daily. The usual starting dose is 5 mg daily, and your doctor may decide to gradually increase the dose to determine the most appropriate dose of Rosuvastatin Teva for you.
The maximum daily dose of Rosuvastatin Teva is 10 mg or 20 mg for children aged 6 to 17 years, depending on the underlying condition being treated. Take the dose once daily.
Rosuvastatin Teva 40 mg film-coated tablets must not be used in children.
How to take the tablets
Swallow each tablet whole with a glass of water.
Rosuvastatin Teva must be taken once daily. Rosuvastatin Teva 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 remains at the appropriate levels.
Your doctor may decide to increase your dose until the amount of Rosuvastatin Teva most suitable for you is reached.
If you take more Rosuvastatin Teva than you should
Contact your doctor or the nearest hospital for advice.
If you go to hospital or receive treatment for another condition, inform healthcare professionals that you are taking Rosuvastatin Teva.
If you forget to take Rosuvastatin Teva
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 Rosuvastatin Teva
Inform your doctor if you intend to stop taking Rosuvastatin Teva. If you stop taking Rosuvastatin Teva, your cholesterol levels may rise again.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rosuvastatin Teva can cause side effects, although not everyone experiences them.
It is important to be aware of which side effects may occur. They are usually mild and disappear in a short time.

Stop taking Rosuvastatin Teva and contact a doctor immediately 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 that may cause difficulty swallowing;
severe itching of the skin (with raised hives);
flat, red, target-shaped or circular spots 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 Teva and contact your doctor immediately:

if you have unusual muscle aches or pains lasting longer than expected. Muscle-related symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have experienced muscle-related side effects, and rarely these have progressed to a condition causing muscle damage, potentially fatal, known as rhabdomyolysis;
if you experience muscle breakdown;
if you develop a lupus-like syndrome (including rash, joint problems and effects on blood cells).

Possible common side effects (may occur in up to 1 in 10 patients):

headache
stomach pain
constipation
malaise
muscle pain
feeling of weakness
dizziness
increased amount of protein in urine – values usually return to normal on their own without needing to stop taking Rosuvastatin Teva (only for Rosuvastatin Teva 40 mg film-coated tablets)
diabetes. This is more likely if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Possible uncommon side effects (may occur in up to 1 in 100 patients):

skin rash, itching and other skin reactions
increased amount of protein in urine – these usually return to normal on their own without needing to stop treatment with Rosuvastatin Teva (only for Rosuvastatin Teva 5-10 mg and 20 mg).

Possible rare side effects (may occur in up to 1 in 1,000 patients):

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 an allergic reaction, stop taking Rosuvastatin Teva and contact a doctor immediately
muscle damage in adults – as a precaution, stop taking Rosuvastatin Teva 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
bleeding or bruising more easily than normal due to low platelet levels in the blood
lupus-like disease syndrome (including rash, joint problems and effects on blood cells).

Possible very rare side effects (may occur in up to 1 in 10,000 patients):

jaundice (yellowing of the skin and eyes)
hepatitis (liver inflammation)
traces of blood in urine
nerve damage in arms and legs (numbness)
joint pain
memory loss
breast enlargement in men (gynaecomastia).

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
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 worsening weakness in the arms or legs 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, inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rosuvastatin Teva

Keep 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.
For blisters:
Do not store above 30°C.
For bottles:
This medicine does not require any special storage conditions.
Do not dispose of any medicine 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 Teva Contains
The active substance is rosuvastatin.
Rosuvastatin 5, 10, 20, 40 mg film-coated tablets contain rosuvastatin calcium
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 bicarbonate
Magnesium stearate
Film coating:
Lactose monohydrate
Hypromellose 6 cP
Titanium dioxide (E 171)
Triacetin
Iron oxide yellow (E 172) in Rosuvastatina Teva 5 mg
Iron oxide red (E 172) in Rosuvastatina Teva 10 mg, 20 mg and 40 mg

Description of the Appearance of Rosuvastatin Film-Coated Tablets and Packaging Contents
Rosuvastatina Teva 5 mg film-coated tablets: yellow, round, biconvex tablets, with "5" engraved on one side, approximately 5.5 mm in diameter.
Rosuvastatina Teva 10 mg film-coated tablets: pink, round, biconvex tablets, with "10" engraved on one side and a score line on the other side, approximately 7 mm in diameter.
Rosuvastatina Teva 20 mg film-coated tablets: pink, round, biconvex tablets, with "20" engraved on one side and a score line on the other side, approximately 9 mm in diameter.
Rosuvastatina Teva 40 mg film-coated tablets: pink, oval, biconvex tablets, with "40" engraved on one side and a score line on the other side, approximately 11.5 x 7 mm in size.

Rosuvastatin film-coated tablets 10, 20, 40 mg:
The tablets can be divided into two equal parts.

Rosuvastatina Teva is supplied in blisters containing 7, 14, 15, 20, 28, 28 (calendar pack), 30, 30 x 1, 42, 50, 50 x 1, 56, 60, 84, 90, 90 x 1, 98, 100 and 100 x 1 film-coated tablets, and in HDPE bottles containing 28, 30, 100 and 250 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy

Manufacturer
Merckle GmbH
Ludwig-Merckle-Straße 3, Blaubeuren 89143
Germany
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovića 25,
Zagreb, 10000
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:
Austria Rosuvastatin Actavis Group 5 mg, 10 mg, 20 mg, 40 mg Filmtabletten
Belgium Rosuvastatine Teva 5 mg, 10 mg, 20 mg, 40 mg, filmomhulde tabletten/comprimés pelliculés/Filmtabletten
Croatia Epri 5 mg, 10 mg, 20 mg, 40 mg filmom obložene tablete
Czech Republic Rosuvastatin Teva Pharma 40 mg, potahované tablety
Denmark Rosuvastatin Teva
Estonia Rosuvastatin Teva Pharma
Finland Rosuvastatin Actavis 5 mg, 10 mg, 20 mg, 40 mg tabletti, kalvopäällysteinen
France ROSUVASTATINE TEVA 5 mg, 10 mg, 20 mg, comprimé pelliculé
Hungary Rozuva-Teva 5 mg, 10 mg, 20 mg, 40 mg filmtabletta
Ireland Rosuvastatin Teva Pharma 5 mg, 10 mg, 20 mg, 40 mg Film-coated Tablets
Italy ROSUVASTATINA TEVA
Latvia Rosuvastatin Teva Pharma 10 mg, 20 mg, 40 mg apvalkotās tabletes
Lithuania Rosuvastatin Teva Pharma 5 mg, 10 mg, 20 mg plėvele dengtos tabletės
Netherlands Rosuvastatine Teva 5 mg, 10 mg, 20 mg, 40 mg, filmomhulde tabletten
Portugal Rosuvastatina Teva
Romania ROSUVASTATINĂ TEVA 10 mg, 20 mg comprimate filmate
Slovenia Rustavo 5 mg, 10 mg, 20 mg, 40 mg filmsko obložene tablete
Spain Rosuvastatina Teva 5 mg, 10 mg, 20 mg comprimidos recubiertos con película EFG
Sweden Rosuvastatin Teva
United Kingdom Rosuvastatin 5 mg, 10 mg, 20 mg, 40 mg Film-coated Tablets
(Northern Ireland)