Rosuvastatin/acetylsalicylic acid teva: detailed information

Package leaflet: Information for the patient

Rosuvastatin/Acetylsalicylic acid Teva, 5 mg + 100 mg, hard capsules
Rosuvastatin/Acetylsalicylic acid Teva, 10 mg + 100 mg, hard capsules
Rosuvastatin/Acetylsalicylic acid Teva, 20 mg + 100 mg, hard capsules
Rosuvastatin + Acetylsalicylic acid
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 further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Rosuvastatin/Acetylsalicylic acid Teva is and what it is used for
Important information before taking Rosuvastatin/Acetylsalicylic acid Teva
How to take Rosuvastatin/Acetylsalicylic acid Teva
Possible side effects
How to store Rosuvastatin/Acetylsalicylic acid Teva
Contents of the pack and other information

1. What Rosuvastatin/Acetylsalicylic acid Teva is and what it is used for

Rosuvastatin/Acetylsalicylic acid Teva contains two active substances: rosuvastatin and acetylsalicylic acid.

Rosuvastatin belongs to a group of medicines called statins, which are lipid-lowering agents used to reduce blood levels of lipids known as cholesterol and triglycerides, when a low-fat diet and lifestyle changes alone have not been sufficient. Cholesterol is a fatty substance (lipid) that can cause narrowing of the blood vessels in the heart, leading to coronary heart disease. If you are at risk of a further heart attack, rosuvastatin may also be used to reduce this risk, even if your cholesterol levels are normal. A cholesterol-lowering diet should be maintained during treatment.
Acetylsalicylic acid, in low doses, belongs to a group of medicines called antiplatelet agents. Platelets are small blood cells that cause blood clotting and are involved in thrombosis. When a blood clot forms in an artery, it blocks blood flow and cuts off the oxygen supply. If this occurs in the heart, it may cause a heart attack or angina. These two active substances, taken together, reduce the risk of a further heart attack in patients who have already had a heart attack or who have episodes of chest pain (unstable angina).

Rosuvastatin/Acetylsalicylic acid Teva is indicated for patients already taking rosuvastatin and acetylsalicylic acid at these doses. Instead of taking separate tablets of rosuvastatin and acetylsalicylic acid, the patient will receive one capsule of Rosuvastatin/Acetylsalicylic acid Teva containing both components at the same strength as previously used.

2. Important information before using Rosuvastatin/Acetylsalicylic acid Teva

When not to use Rosuvastatin/Acetylsalicylic acid Teva:

if the patient is allergic to rosuvastatin, acetylsalicylic acid, any other salicylates or non-steroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6).
if the patient is pregnant or breastfeeding, or if she becomes pregnant while taking Rosuvastatin/Acetylsalicylic acid Teva, she should immediately stop taking it and inform her doctor. Women should avoid becoming pregnant while taking Rosuvastatin/Acetylsalicylic acid Teva by using appropriate contraceptive methods.
if the patient has liver disease.
if the patient has severe kidney disease.
if the patient has recurrent or unexplained muscle pain.
if the patient is taking the combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat viral hepatitis C infection).
if the patient is taking a medicine called cyclosporine (e.g. after organ transplantation).
if the patient has previously experienced asthma attack or swelling of certain body parts such as face, lips, throat or tongue (angioedema) after taking salicylates or NSAIDs.
if the patient has ever experienced severe skin rash, skin peeling, blisters and/or mouth ulcers after taking Rosuvastatin/Acetylsalicylic acid Teva or other similar medicines.
if the patient currently has or has previously had stomach or small intestine ulcers or any other bleeding, such as stroke.
if the patient has ever had blood clotting disorders.
if the patient suffers from gout.
if the patient has decompensated heart failure.
if the patient is taking a medicine called methotrexate (e.g. for cancer or rheumatoid arthritis) at doses higher than 7.5 mg per day (i.e. more than 15 mg per week).
if the patient is allergic to peanuts or soya.

Warnings and precautions
Before starting treatment with Rosuvastatin/Acetylsalicylic acid Teva, discuss this with your doctor or pharmacist:

if the patient has impaired kidney function.
if the patient has liver disease.
if the patient has previously experienced recurrent or unexplained muscle pain, muscle problems in the patient or family members, or muscle problems while previously taking other cholesterol-lowering medicines. The patient should immediately inform the doctor if unexplained muscle pain occurs, especially if the patient feels unwell or has fever. The patient should also inform the doctor or pharmacist if persistent muscle weakness occurs.
if the patient regularly consumes large amounts of alcohol.
if the patient’s thyroid gland does not function properly.
if the patient is taking other medicines called fibrates to lower cholesterol levels. The patient should carefully read the package leaflet, even if they have previously taken other cholesterol-lowering medicines.
If the patient is taking antiviral HIV medicines such as ritonavir with lopinavir and/or atazanavir, see section “Rosuvastatin/Acetylsalicylic acid Teva with other medicines”.
if the patient is taking or has taken within the last 7 days an oral or injectable medicine containing fusidic acid (used for bacterial infections); taking Rosuvastatin/Acetylsalicylic acid Teva with fusidic acid may lead to severe muscle problems (rhabdomyolysis); see section “Rosuvastatin/Acetylsalicylic acid Teva with other medicines”.
if the patient has severe respiratory insufficiency.
if the patient is over 70 years old.
if the patient is of Asian origin (i.e. Japan, China, Philippines, Vietnam, Korea and India). The doctor must choose the appropriate starting dose of Rosuvastatin/Acetylsalicylic acid Teva suitable for the patient.
if the patient currently has or has previously had stomach or small intestine problems (ulcers or gastrointestinal bleeding).
if the patient has hypertension.
if the patient suffers from asthma, hay fever, nasal polyps or other chronic respiratory diseases; acetylsalicylic acid may trigger an asthma attack.
in case of hypersensitivity (allergy) to other painkillers and anti-inflammatory medicines, other anti-rheumatic drugs or other allergens.
if the patient has other allergies (e.g. with skin reactions, itching).
if the patient is taking other anticoagulant medicines (e.g. coumarin derivatives, heparin – except low-dose heparin).
in case of impaired kidney function or reduced blood flow to the heart and blood vessels (e.g. renal vascular disease, weakened heart muscle, reduced blood volume, severe surgery, blood infection or increased bleeding): acetylsalicylic acid may further increase the risk of kidney dysfunction and acute kidney failure.
if the patient has heavy menstrual periods.

The patient should immediately seek medical advice if symptoms worsen or if serious or unexpected adverse effects occur, such as unusual bleeding symptoms, severe skin reactions or any other symptoms of severe allergy (see section “Possible side effects”).
Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of rosuvastatin. If any of the symptoms described in section 4 occur, the patient should stop taking Rosuvastatin/Acetylsalicylic acid Teva and contact their doctor immediately.
In a small number of people, statins may affect the liver. This is detected by a simple blood test that shows increased liver enzyme activity. For this reason, the doctor will usually recommend this blood test (liver function test) before starting and during treatment with Rosuvastatin/Acetylsalicylic acid Teva.
While taking this medicine, the doctor will closely monitor the patient if they have diabetes or are at risk of developing diabetes. The risk of developing diabetes is higher if the patient has high blood sugar and fat levels, is overweight and has high blood pressure.
Care should be taken to avoid dehydration (the patient may feel thirsty with dry mouth), as concomitant use of acetylsalicylic acid may lead to worsening of kidney function.
The patient should inform their doctor if they are planning a surgical procedure (even minor, such as tooth extraction), as acetylsalicylic acid thins the blood and may increase the risk of bleeding.
Acetylsalicylic acid may cause Reye's syndrome when given to children. Reye's syndrome is a very rare condition affecting the brain and liver, which may lead to death. For this reason, Rosuvastatin/Acetylsalicylic acid Teva should not be given to children and adolescents under 18 years of age.
In patients with severe glucose-6-phosphate dehydrogenase deficiency: acetylsalicylic acid may cause accelerated or excessive breakdown of red blood cells or a certain form of anaemia. This risk may be increased by factors such as high doses, fever or acute infections.
Low-dose acetylsalicylic acid may reduce uric acid excretion. This may trigger an attack of gout in patients at risk.
In case of cuts or injuries, bleeding may last slightly longer than usual. This is related to the effect of acetylsalicylic acid. Minor cuts and injuries (e.g. during shaving) are usually not significant. If the patient experiences unusual bleeding (in an unusual location or of unusual duration), they should contact their doctor.

Children and adolescents
Rosuvastatin/Acetylsalicylic acid Teva should not be used in children and adolescents.

Rosuvastatin/Acetylsalicylic acid Teva with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
Rosuvastatin/Acetylsalicylic acid Teva may affect the following medicines or these medicines may affect it:

fibrates (such as gemfibrozil, fenofibrate) or other medicines used to lower cholesterol (such as ezetimibe).
antacids (used to neutralize stomach acid).
oral contraceptives ("the pill").
hormone replacement therapy.
regorafenib, darolutamide, capmatinib (used in cancer treatment).
fostamatinib (used to treat low platelet count).
febuxostat (used to treat and prevent high blood uric acid levels).
teriflunomide (used to treat multiple sclerosis).
any of the following medicines used to treat viral infections, including HIV or hepatitis C virus, administered alone or in combination with other medicines (see: Warnings and precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
ketoconazole, itraconazole (antifungal medicines).
rifampicin, erythromycin, clarithromycin (antibiotics).
medicines that reduce blood clotting and prevent blood clots (e.g. warfarin, heparin, coumarin, clopidogrel, ticlopidine, ticagrelor): acetylsalicylic acid may increase the risk of bleeding when taken with medicines that dissolve blood clots or thin the blood. Therefore, if such treatment is used, attention should be paid to signs of external or internal bleeding (e.g. bruising).
organ transplant rejection (cyclosporine, tacrolimus).
high blood pressure (e.g. diuretics and ACE inhibitors).
heart rhythm regulation (digoxin).
bipolar disorder (lithium).
pain and inflammation (e.g. non-steroidal anti-inflammatory drugs such as ibuprofen, naproxen or steroid medicines).
gout (e.g. probenecid, benzbromarone).
glaucoma (acetazolamide).
cancer or rheumatoid arthritis (methotrexate; at doses lower than 15 mg per week).
medicines that lower blood sugar (antidiabetic medicines) (e.g. glibenclamide) – may lead to reduced blood sugar levels.
depression (selective serotonin reuptake inhibitors (SSRIs), such as sertraline or paroxetine).
medicines used as hormone replacement therapy in case of adrenal or pituitary gland damage or removal (except topical products or cortisone replacement therapy due to Addison's disease) or in the treatment of inflammatory conditions, including rheumatic diseases and inflammatory bowel disease (corticosteroids). Concomitant use increases the risk of gastrointestinal adverse effects.
epileptic seizures (valproic acid).
medicines causing increased urine output (diuretics: so-called aldosterone antagonists, e.g. spironolactone and canrenoate, loop diuretics e.g. furosemide).
metamizole (a substance with analgesic and antipyretic effects) may reduce the effect of acetylsalicylic acid on platelet aggregation (clumping of blood cells and clot formation) if these medicines are used simultaneously. Therefore, caution should be exercised when using metamizole in patients receiving low-dose acetylsalicylic acid for cardioprotection.
alcohol: increases the risk of gastrointestinal ulcers and bleeding.

If the patient needs to take oral fusidic acid to treat a bacterial infection, Rosuvastatin/Acetylsalicylic acid Teva must be temporarily discontinued. The doctor will inform the patient when it is safe to resume taking this medicine. Taking Rosuvastatin/Acetylsalicylic acid Teva with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). More information on rhabdomyolysis is provided in section 4.
Rosuvastatin/Acetylsalicylic acid Teva may further lower blood pressure if the patient is taking other medicines used to treat high blood pressure.

Taking Rosuvastatin/Acetylsalicylic acid Teva with food and drink
Rosuvastatin/Acetylsalicylic acid Teva should be taken with food.
During treatment with Rosuvastatin/Acetylsalicylic acid Teva, grapefruit juice should be avoided.
Alcohol consumption may potentially increase the risk of gastrointestinal bleeding and prolong bleeding time.

Pregnancy and breastfeeding
Do not take Rosuvastatin/Acetylsalicylic acid Teva if the patient is pregnant or breastfeeding. If pregnancy occurs while taking Rosuvastatin/Acetylsalicylic acid Teva, the patient should immediately stop taking it and inform her doctor. Women should avoid becoming pregnant while taking Rosuvastatin/Acetylsalicylic acid Teva by using appropriate contraceptive methods.

Driving and using machines
Most people can drive and operate machinery while taking Rosuvastatin/Acetylsalicylic acid Teva – it will not affect their ability to drive motor vehicles. However, some people may experience dizziness while taking Rosuvastatin/Acetylsalicylic acid Teva. If the capsules cause nausea, dizziness or fatigue or headache, the patient should not drive or operate machinery and should contact their doctor immediately.

Rosuvastatin/Acetylsalicylic acid Teva contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

Rosuvastatin/Acetylsalicylic acid Teva contains soya lecithin
Rosuvastatin/Acetylsalicylic acid Teva contains trace amounts of soya lecithin, which may contain soya oil. Do not use this medicine if the patient has been diagnosed with hypersensitivity to peanuts or soya.

3. How to use Rosuvastatin/Acetylsalicylic acid Teva

This medicine should always be taken exactly as instructed by the doctor or pharmacist.
In case of doubt, consult your doctor or pharmacist.
Adults
The doctor will determine the appropriate dose for the patient, depending on the health status, current
treatment, and individual risk.
This medicine is not suitable for initiating treatment. Treatment should be started with separate
administration of the active substances; after appropriate doses have been established, a switch to
Rosuvastatin/Acetylsalicylic acid Teva at the appropriate strength may be considered.
The recommended dose is one capsule daily.
This medicine should be taken with food. The medicine should be taken every day at the same time.
Capsules should be swallowed whole with plenty of fluid; do not crush or chew them.
Rosuvastatin/Acetylsalicylic acid Teva should not be taken with grapefruit juice.
If the patient is admitted to hospital or is being treated for another illness, inform the medical staff
that the patient is taking Rosuvastatin/Acetylsalicylic acid Teva.
Use in elderly patients
There is no need to modify the dose in elderly patients.
Use in children and adolescents
Rosuvastatin/Acetylsalicylic acid Teva should not be used in children and adolescents.
Patients with renal impairment
Dose adjustment is not necessary in patients with mild or moderate renal impairment.
Rosuvastatin/Acetylsalicylic acid Teva is contraindicated in patients with severe renal impairment.
Patients with hepatic impairment
Dose adjustment is not necessary in patients with mild or moderate hepatic impairment.
Rosuvastatin/Acetylsalicylic acid Teva is contraindicated in patients with severe hepatic impairment.
Taking more than the recommended dose of Rosuvastatin/Acetylsalicylic acid Teva
To obtain advice, contact your doctor or nearest hospital immediately.
Missed dose of Rosuvastatin/Acetylsalicylic acid Teva
Do not worry. If a capsule is missed, skip that dose completely. Take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
Stopping Rosuvastatin/Acetylsalicylic acid Teva
The doctor will inform the patient how long the medicine should be taken. After stopping
Rosuvastatin/Acetylsalicylic acid Teva, cholesterol levels may rise again. If the patient stops taking the
medicine before receiving appropriate advice, the condition may recur.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Stop taking Rosuvastatin/Acetylsalicylic acid Teva and seek medical help immediately if any of the following very rare, serious adverse reactions occur after taking this medicine:

Sudden wheezing, chest pain, shortness of breath or difficulty breathing
Swelling of the eyelids, face or lips
Swelling of the tongue and throat, causing significant difficulty in breathing and/or swallowing
Severe itching of the skin (with lumps)
Red, flat, disc-shaped or round spots on the trunk, often with blisters in the centre, peeling skin, mouth, throat, nose, genital or eye ulcers. These potentially life-threatening skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
Widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome)
Black stools or vomiting blood (signs of severe gastrointestinal bleeding)

You should also stop taking Rosuvastatin/Acetylsalicylic acid Teva and contact your doctor immediately:

if you experience unusual muscle pain that persists longer than expected. As with other statins, a small number of patients have experienced unpleasant muscle-related effects, which in rare cases led to potentially life-threatening muscle damage known as rhabdomyolysis.
if you experience a muscle tear.
if you develop a lupus-like syndrome (including rash, joint disorders and effects on blood cells).

The following adverse reactions have been reported. If any of these cause discomfort to the patient or persist for longer than one week, contact your doctor.

ROZUVASTATIN
Common (occurring in up to 1 in 10 people):

Headache
Abdominal pain
Constipation
Nausea
Muscle pain
Feeling of weakness
Dizziness
Diabetes. The risk of developing diabetes is higher if the patient has high blood sugar and fat levels, is overweight and has high blood pressure. While using this medicine, your doctor will monitor your condition.

Uncommon (occurring in up to 1 in 100 people):

Rash, itching, hives or other skin reactions
Increased protein in urine – usually resolves spontaneously without the need to discontinue Rosuvastatin/Acetylsalicylic acid Teva capsules (for doses 5–20 mg only)

Rare (occurring in up to 1 in 1000 people):

Severe allergic reaction – symptoms include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe skin itching (with raised bumps). If an allergic reaction is suspected, stop taking Rosuvastatin/Acetylsalicylic acid Teva and seek immediate medical help.
Muscle damage in adults – as a precaution, stop taking Rosuvastatin/Acetylsalicylic acid Teva and contact your doctor immediately if you experience unusual muscle pain that persists longer than expected.
Severe abdominal pain (pancreatitis)
Increased liver enzyme levels in blood
Decreased platelet count, increasing the risk of bleeding or bruising (thrombocytopenia)
Lupus-like syndrome (including rash, joint disorders and effects on blood cells)

Very rare (occurring in up to 1 in 10,000 people):

Jaundice (yellowing of the skin and eyes)
Hepatitis (liver inflammation)
Blood in urine
Nerve damage in the arms and legs (e.g. numbness)
Joint pain
Memory loss
Gynaecomastia (enlargement of breast tissue in men)

Frequency not known (cannot be estimated from available data):

Diarrhoea (loose stools)
Cough
Shortness of breath
Swelling (oedema)
Sleep disorders, including insomnia and nightmares
Sexual problems
Depression
Breathing problems, including persistent cough and/or shortness of breath or fever
Tendon damage
Nerve disorder causing weakness, tingling or numbness
Persistent muscle weakness

ACETYLSALICYLIC ACID
Common (occurring in up to 1 in 10 people):

Gastrointestinal disturbances such as heartburn, nausea, vomiting, abdominal pain and diarrhoea
Minor gastrointestinal blood loss (microbleeding)
Bleeding, such as nosebleeds, bleeding gums, skin bleeding or bleeding from urinary tract and genital organs, possibly with prolonged bleeding time. This effect may last 4 to 8 days after taking the medicine.

Uncommon (occurring in up to 1 in 100 people):

Bleeding from the stomach or intestines. Long-term use of acetylsalicylic acid may lead to anaemia (iron deficiency anaemia) due to occult blood loss from the stomach or intestines.
Intracranial bleeding, blood in urine
Stomach or intestinal ulcers, which very rarely may lead to perforation
Inflammation of the gastrointestinal tract
Skin reactions

Rare (occurring in up to 1 in 1000 people):

Hypersensitivity reactions affecting the skin, respiratory tract, gastrointestinal tract and cardiovascular system, especially in patients with asthma. Symptoms may include: e.g. drop in blood pressure, breathing attacks, inflammation of the nasal mucosa, nasal obstruction, anaphylactic shock, swelling of the face, tongue and larynx (Quincke's oedema).
Serious bleeding, such as bleeding in the brain, especially in patients with uncontrolled hypertension and/or those taking anticoagulant medicines, which in individual cases may be life-threatening.
Confusion (state of disorientation)
Dizziness, headache
Hearing impairment or ringing in the ears (tinnitus), particularly in children and elderly patients, which may be signs of overdose (see also section “Taking more than the recommended dose of Rosuvastatin/Acetylsalicylic acid Teva”)

Very rare (occurring in up to 1 in 10,000 people):

Elevated liver function test results
Kidney function disorders and acute kidney failure
Decreased blood sugar levels (hypoglycaemia)
Small doses of acetylsalicylic acid reduce uric acid excretion. This may trigger an attack of gout in patients at risk.
Fever-related rash with mucous membrane involvement (erythema multiforme)

Frequency not known (cannot be estimated from available data):

In patients with severe glucose-6-phosphate dehydrogenase deficiency, accelerated breakdown or destruction of red blood cells and a certain form of anaemia have been observed.

If any of these adverse reactions are severe, or if the patient experiences any adverse symptoms not listed in this leaflet, inform the doctor or pharmacist.
Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Rosuvastatin/Acetylsalicylic acid Teva

Keep this medicine out of 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 the specified month.
Store below 30°C. Keep in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Rosuvastatin/Acetylsalicylic acid Teva contains
The active substances are rosuvastatin (as rosuvastatin calcium) and acetylsalicylic acid.
Rosuvastatin/Acetylsalicylic acid Teva 5 mg + 100 mg: each hard capsule contains 5 mg of rosuvastatin (as rosuvastatin calcium) and 100 mg of acetylsalicylic acid.
Rosuvastatin/Acetylsalicylic acid Teva 10 mg + 100 mg: each hard capsule contains 10 mg of rosuvastatin (as rosuvastatin calcium) and 100 mg of acetylsalicylic acid.
Rosuvastatin/Acetylsalicylic acid Teva 20 mg + 100 mg: each hard capsule contains 20 mg of rosuvastatin (as rosuvastatin calcium) and 100 mg of acetylsalicylic acid.

Other ingredients are:
Tablet coated with rosuvastatin:
Tablet core
Lactose monohydrate (see section 2 “Rosuvastatin/Acetylsalicylic acid Teva contains lactose”)
Microcrystalline cellulose
Magnesium oxide, heavy
Crospovidone (type A)
Anhydrous colloidal silica
Magnesium stearate
Coating
Partially hydrolysed polyvinyl alcohol
Titanium dioxide (E 171)
Talc
Iron oxide yellow (E 172)
Lecithin (soy) (see section 2 “Rosuvastatin/Acetylsalicylic acid Teva contains soy lecithin”)
Iron oxide red (E 172)
Xanthan gum
Iron oxide black (E 172)

Tablet containing acetylsalicylic acid:
Microcrystalline cellulose
Corn starch
Anhydrous colloidal silica
Stearic acid

Capsule shell:
Gelatin
Titanium dioxide (E 171)
Indigotine (E 132)
Iron oxide yellow (E 172)

Black ink:
Shellac
Propylene glycol
Dehydrated alcohol
Butyl alcohol
Isopropyl alcohol
Ammonium hydroxide solution
Iron oxide black (E 172)
Potassium hydroxide
Purified water

What Rosuvastatin/Acetylsalicylic acid Teva looks like and contents of the pack
Rosuvastatin/Acetylsalicylic acid Teva 5 mg + 100 mg: size 2 hard gelatin capsules with an opaque white body and a dark green opaque cap. Each capsule contains one white or almost white, biconvex, oval, uncoated tablet of acetylsalicylic acid and one coated, brown, biconvex, round tablet of rosuvastatin 5 mg.

Rosuvastatin/Acetylsalicylic acid Teva 10 mg + 100 mg: size 1 hard gelatin capsules with an opaque white body printed in black with “ASA 100” and a light green opaque cap printed in black with “RSV 10”. Each capsule contains one white or almost white, biconvex, oval, uncoated tablet of acetylsalicylic acid and one coated, brown, biconvex, round tablet of rosuvastatin 10 mg.

Rosuvastatin/Acetylsalicylic acid Teva 20 mg + 100 mg: size 0 hard gelatin capsules with an opaque white body printed in black with “ASA 100” and a green opaque cap printed in black with “RSV 20”. Each capsule contains one white or almost white, biconvex, oval, uncoated tablet of acetylsalicylic acid and two coated, brown, biconvex, round tablets of rosuvastatin 10 mg.

Rosuvastatin/Acetylsalicylic acid Teva is available in blister packs containing 20, 28, 30, 56, 60, 90 and 100 hard capsules.
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

For further information about this medicinal product and its names in the Member States of the European Economic Area, please contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel. (22) 345 93 00