Rosuvastatin and ezetimibe Teva: detailed information

Package leaflet: Information for the patient

Rosuvastatin and Ezetimibe Teva 5 mg/10 mg tablets, 10 mg/10 mg tablets, 20 mg/10 mg 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 could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Rosuvastatin and Ezetimibe Teva is and what it is used for

Rosuvastatin and Ezetimibe Teva contains two different active substances in one tablet. One of the active substances is rosuvastatin, which belongs to a group of medicines called statins; the other active substance is ezetimibe.
Rosuvastatin and Ezetimibe Teva is a medicine used to lower blood levels of total cholesterol, so-called "bad" cholesterol (LDL cholesterol), and other fats called triglycerides. It also increases levels of "good" cholesterol (HDL cholesterol). This medicine works by reducing cholesterol in two ways: it reduces both the cholesterol absorbed from the digestive tract and the body's own production of cholesterol.
For most people, high cholesterol levels do not affect how they feel, as they cause no symptoms. However, if left untreated, cholesterol can build up as fatty deposits in the walls of blood vessels, causing them to narrow.
Sometimes these narrowed blood vessels can become blocked, interrupting blood flow to the heart and brain, leading to a heart attack or stroke. By lowering cholesterol levels, the risk of heart attack, stroke, or other related health problems can be reduced.
Rosuvastatin and Ezetimibe Teva is used in patients whose cholesterol levels cannot be controlled by a cholesterol-lowering diet alone. A cholesterol-lowering diet must always be maintained while taking this medicine.
Your doctor may prescribe Rosuvastatin and Ezetimibe Teva if you are already taking rosuvastatin and ezetimibe separately at the same dosage.
Rosuvastatin and Ezetimibe Teva tablets are used in the following cases:

excess cholesterol in the blood (primary hypercholesterolemia);
heart disease: Rosuvastatin and Ezetimibe Teva reduces the risk of heart attack, stroke, surgical procedures to improve blood flow to the heart, or hospitalizations due to chest pain.

Rosuvastatin and Ezetimibe Teva tablets do not help with weight loss.

2. What you should know before taking Rosuvastatin and Ezetimibe Teva

Do not take Rosuvastatin and Ezetimibe Teva if:

you are allergic to rosuvastatin, ezetimibe, or any of the other ingredients of this medicine (listed in section 6).
you have liver disease.
you have severe renal impairment.
you have recurrent and unexplained muscle pain (myopathy).
you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking Rosuvastatin and Ezetimibe Teva or other related medicines.
you are taking a medicine called ciclosporin (used, for example, after organ transplants).
you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin and Ezetimibe Teva, stop taking the medicine immediately and consult your doctor. Women must avoid pregnancy while using Rosuvastatin and Ezetimibe Teva by using adequate contraceptive measures (see section "Pregnancy and breastfeeding").

If any of the above apply to you (or if you are unsure), contact your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rosuvastatin and Ezetimibe Teva if:

you have kidney problems.
you have liver problems.
you have experienced recurrent or unexplained muscle pain, or have a personal or family history of muscle disorders, or have previously experienced muscle problems while taking other cholesterol-lowering medicines. Contact your doctor immediately if you experience recurrent and unexplained muscle pain, especially if you feel unwell or have a fever. Also consult a doctor or pharmacist if you have persistent muscle weakness.
you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). In such cases, your doctor must select the appropriate dose of Rosuvastatin and Ezetimibe Teva.
you are taking medicines for infections, including HIV or hepatitis C (e.g. lopinavir/ritonavir and/or atazanavir or simeprevir). See section "Other medicines and Rosuvastatin and Ezetimibe Teva".
you have severe respiratory insufficiency.
you are taking other medicines called fibrates to lower cholesterol levels. See section "Other medicines and Rosuvastatin and Ezetimibe Teva".
you regularly drink large amounts of alcohol.
you have an underactive thyroid gland (hypothyroidism).
you are over 70 years of age (your doctor must determine the appropriate dose of Rosuvastatin and Ezetimibe Teva for you).
you are currently taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and Rosuvastatin and Ezetimibe Teva may lead to serious muscle problems (rhabdomyolysis). If any of the above circumstances apply to you (or if you are unsure), consult your doctor or pharmacist before taking any dose of Rosuvastatin and Ezetimibe Teva.

Take special care with Rosuvastatin and Ezetimibe Teva

Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with Rosuvastatin and Ezetimibe Teva. Stop using Rosuvastatin and Ezetimibe Teva and seek immediate medical attention if you notice any of the symptoms described in section 4.

Statins may cause liver problems in a small number of people. This condition can be easily detected with a simple blood test measuring liver enzyme levels. For this reason, your doctor must regularly perform this blood test (liver function test) during treatment with Rosuvastatin and Ezetimibe Teva. It is important to attend all scheduled laboratory tests prescribed by your doctor.

While taking this medicine, your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. The risk of developing diabetes is higher if you have high levels of sugar and fats in the blood, are overweight, or have high blood pressure.

If you are hospitalized or receiving treatment for another medical condition, inform the medical staff that you are taking Rosuvastatin and Ezetimibe Teva.

Children and adolescents

The use of Rosuvastatin and Ezetimibe Teva is not recommended in children and adolescents under 18 years of age.

Other medicines and Rosuvastatin and Ezetimibe Teva

Tell 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:

Ciclosporin (used, for example, after organ transplantation to prevent organ rejection). The effect of rosuvastatin is increased when taken together with this medicine. Do not take Rosuvastatin and Ezetimibe Teva while taking ciclosporin.
Anticoagulants, such as warfarin, acenocoumarol, or fluindione (their anticoagulant effect and risk of bleeding may increase when taken together with Rosuvastatin and Ezetimibe Teva tablets), or clopidogrel.
Other medicines used to lower cholesterol levels, called fibrates, which also correct triglyceride levels (e.g. gemfibrozil and other fibrates). When taken together with fibrates, the effect of rosuvastatin is increased.
Colestyramine (a medicine used to lower cholesterol levels), as it alters the action of ezetimibe.
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 section "Warnings and precautions"): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
Antacids containing aluminium and magnesium (used to neutralize stomach acid; these reduce rosuvastatin levels in the blood). This effect may be minimized by taking these medicines 2 hours after taking rosuvastatin.
Erythromycin (an antibiotic). Concomitant use of this antibiotic reduces the effects of rosuvastatin.
Fusidic acid. If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop treatment with this medicine. Your doctor will tell you when it is safe to resume treatment with Rosuvastatin and Ezetimibe Teva. The combination of Rosuvastatin and Ezetimibe Teva and fusidic acid may, rarely, cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
Oral contraceptives (the pill). These increase levels of sex hormones regulated by the pill.
Hormone replacement therapy (increases hormone levels in the blood).

If you are hospitalized or receiving treatment for another medical condition, inform the medical staff that you are taking Rosuvastatin and Ezetimibe Teva.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take Rosuvastatin and Ezetimibe Teva if you are pregnant, think you may be pregnant, or are planning to become pregnant. If you become pregnant while taking Rosuvastatin and Ezetimibe Teva tablets, stop taking the medicine immediately and consult your doctor. Women must always use effective contraceptive measures during treatment with Rosuvastatin and Ezetimibe Teva.

Breastfeeding

Do not take Rosuvastatin and Ezetimibe Teva during breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines

Rosuvastatin and Ezetimibe Teva is not expected to affect your ability to drive or use machines. However, you should be aware that some people may experience dizziness after taking Rosuvastatin and Ezetimibe Teva. If you experience dizziness, consult your doctor before driving or operating machinery.

Rosuvastatin and Ezetimibe Teva contains lactose monohydrate

If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Rosuvastatin and Ezetimibe Teva contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Rosuvastatin and Ezetimibe Teva

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
You must continue to follow a low-cholesterol diet and maintain regular physical activity while taking Rosuvastatin and Ezetimibe Teva.
The recommended daily dose for adults is one tablet of the prescribed strength.
Take Rosuvastatin and Ezetimibe Teva once daily.
Take the tablet at any time of day, with or without food. Swallow the tablet whole with a glass of water.
Take the medicine at the same time every day.
Rosuvastatin and Ezetimibe Teva is not intended for initiating treatment. Treatment initiation or, if necessary, dose adjustment should only be done by administering the active substances separately. Once the appropriate dose has been established, switching to Rosuvastatin and Ezetimibe Teva at the corresponding strength is possible.
Regular cholesterol monitoring
It is important to have your cholesterol levels checked regularly by your doctor to ensure that cholesterol reaches and maintains the correct level.
If you take more Rosuvastatin and Ezetimibe Teva than you should
Contact your doctor or the nearest hospital emergency department, as you may require medical attention.
If you forget to take Rosuvastatin and Ezetimibe Teva
Do not worry. Skip the missed dose and take the next scheduled dose (at the usual time). Do not take a double dose to make up for the forgotten dose.
If you stop taking Rosuvastatin and Ezetimibe Teva
Consult your doctor if you wish to discontinue treatment with Rosuvastatin and Ezetimibe Teva.
Please note that your cholesterol levels may rise again if you stop treatment.
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 everybody gets them.
It is important to be aware of the possible side effects.
Stop treatment with Rosuvastatin and Ezetimibe Teva immediately and seek medical help
if you experience even one of the following allergic reactions:

swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing and swallowing.
skin ulcers or blisters, in the mouth, eyes and genital area. These could be signs of Stevens-Johnson syndrome (a potentially life-threatening allergic reaction affecting the skin and mucous membranes).

Also, stop treatment with Rosuvastatin and Ezetimibe Teva and contact your doctor immediately:

if you experience unusual muscle pain or pain lasting longer than expected. Rarely, this may progress to potentially fatal muscle damage known as rhabdomyolysis, which may lead to malaise, fever and kidney damage.
if you develop lupus-like syndrome (including skin rash, joint problems and effects on blood cells).
in case of muscle breakdown.

Stop taking Rosuvastatin and Ezetimibe Teva and seek immediate medical assistance if you experience any of the following symptoms:

flat, red, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, 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 swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

The following terms are used to describe how frequently side effects have been reported:

Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people, including isolated cases)

Common side effects

headache
constipation
malaise
muscle pain
feeling of weakness
dizziness
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 should monitor you during treatment.
stomach pain
diarrhoea
flatulence (excess gas in the intestinal tract)
feeling of fatigue
increased levels in blood laboratory tests related to liver function (transaminases)

Uncommon side effects

rash, itching, urticaria
increase in protein content in urine; these usually return to normal levels without discontinuing Rosuvastatin and Ezetimibe Teva.
increased levels in blood laboratory tests related to muscle function (CK)
cough
difficulty in digestion
heartburn
joint pain
muscle spasms
neck pain
loss of appetite
pain
chest pain
hot flushes
high blood pressure
tingling sensation
dry mouth
inflammation of the stomach
back pain
muscle weakness
pain in arms and legs
swelling, especially in hands and feet

Rare side effects:

inflammation of the pancreas, causing severe abdominal pain radiating to the back, reduced platelet count, lupus-like syndrome, muscle breakdown.

Very rare side effects:

jaundice (yellowing of the skin and eyes), inflammation of the liver (hepatitis), presence of blood in the urine, nerve damage in arms and legs (such as numbness), memory loss, enlargement of the breast in men (gynaecomastia)

Frequency not known:

shortness of breath, oedema (swelling), sleep disorders, including insomnia and nightmares, sexual dysfunction, depression, respiratory problems, including persistent cough and/or shortness of breath or fever, tendon injuries, persistent muscle weakness, gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting)

Reporting of side effects
If you get any side effects, 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 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 and Ezetimibe Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light. This medicine does not require any special storage temperature.
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 e Ezetimibe Teva contains
The active substances are rosuvastatin (as rosuvastatin calcium) and ezetimibe. The tablets contain rosuvastatin calcium equivalent to 5 mg, 10 mg or 20 mg of rosuvastatin. Each tablet contains 10 mg of ezetimibe.
The other components are: Lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, cross-linked povidone type A, povidone K-30, sodium lauryl sulphate and magnesium stearate.
Rosuvastatina e Ezetimibe Teva contains lactose and sodium – for further information see section 2.

Description of the appearance of Rosuvastatina e Ezetimibe Teva and package contents
Rosuvastatina e Ezetimibe Teva 5 mg/10 mg tablets: white or almost white, round, flat, uncoated tablet, marked with "E2" on one side and "2" on the other. The tablet diameter is 10 mm.
Rosuvastatina e Ezetimibe Teva 10 mg/10 mg tablets: white or almost white, oval, biconvex, uncoated tablet, marked with "E1" on one side and "1" on the other. The tablet size is 15 mm x 7 mm.
Rosuvastatina e Ezetimibe Teva 20 mg/10 mg tablets: white or almost white, round, biconvex, uncoated tablet. The tablet diameter is 11 mm.
Pack sizes of 10, 28, 30, 84, 90, 98 or 100 tablets in blister packs (PA/AL/PVC/AL).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
TEVA B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Manufacturer:
Adamed Pharma S.A.; ul. Marszałka Józefa Piłsudskiego 5, 95-200 Pabianice, Poland