Rosuvastatin/acetilsalicilic acid Teva

Leaflet accompanying the packaging: Patient information

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

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Rosuvastatin/Acetylsalicylic acid Teva and what is it used for
• 2. Important information before taking Rosuvastatin/Acetylsalicylic acid Teva
• 3. How to take Rosuvastatin/Acetylsalicylic acid Teva
• 4. Possible side effects
• 5. How to store Rosuvastatin/Acetylsalicylic acid Teva
• 6. Contents of the packaging and other information

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

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

• Rosuvastatin belongs to a group of substances called statins, which are lipid-regulating medicines used to lower the level of lipids (fats) such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes are not enough. Cholesterol is a fatty substance that can cause narrowing of the blood vessels in the heart, leading to coronary artery disease. If you are at risk of having another heart attack, rosuvastatin can also be used to reduce this risk, even if your cholesterol level is normal. During treatment, you should follow a standard cholesterol-lowering diet.
• Acetylsalicylic acid in low doses belongs to a group of medicines called antiplatelet agents. Platelets are small blood cells that cause blood to clot and participate in thrombosis. When a blood clot forms in an artery, it can block the flow of blood and cut off the supply of oxygen. When this happens in the heart, it can cause a heart attack or angina. These two active substances taken together reduce the risk of having another heart attack if you have had a heart attack or if you have angina (unstable angina).

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

2. Important information before taking Rosuvastatin/Acetylsalicylic acid Teva

When not to take Rosuvastatin/Acetylsalicylic acid Teva:

• if you are 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 you are pregnant or breastfeeding, or if you become pregnant while taking Rosuvastatin/Acetylsalicylic acid Teva, you should stop taking it immediately and inform your doctor. Women should avoid becoming pregnant while taking Rosuvastatin/Acetylsalicylic acid Teva by using appropriate methods of contraception.
• if you have liver disease.
• if you have severe kidney disease.
• if you have recurring or unexplained muscle pain.
• if you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat viral hepatitis C infection).
• if you are taking a medicine called ciclosporin (used, for example, after organ transplantation).
• if you have had an asthma attack or swelling of some parts of the body (e.g. face, lips, throat or tongue) (angioedema) after taking salicylates or NSAIDs.
• -if you have ever had a severe skin rash or peeling of the skin, blisters, and (or) ulcers in the mouth after taking Rosuvastatin/Acetylsalicylic acid Teva or other similar medicines.
• if you have had stomach or duodenal ulcers or any other bleeding, such as a stroke.
• if you have had bleeding disorders.
• if you have gout.
• if you have uncontrolled heart failure.
• if you are taking a medicine called methotrexate (e.g. for cancer or rheumatoid arthritis) in doses greater than 15 mg per week.
• if you are allergic to peanuts or soy.

Warnings and precautions

Before starting treatment with Rosuvastatin/Acetylsalicylic acid Teva, you should discuss it with your doctor or pharmacist

• if you have kidney problems.
• if you have liver disease.
• if you have had recurring or unexplained muscle pain, muscle problems in you or your family, or muscle problems while taking other cholesterol-lowering medicines in the past. You should inform your doctor immediately if you experience unexplained muscle pain, especially if you feel unwell or have a fever. You should also inform your doctor or pharmacist if you experience persistent muscle weakness.
• if you regularly drink large amounts of alcohol.
• if your thyroid gland does not work properly.
• if you are taking other medicines called fibrates to lower your cholesterol. You should carefully read the leaflet, even if you have taken other cholesterol-lowering medicines before.
• If you are taking medicines for HIV infection, e.g. ritonavir with lopinavir and (or) atazanavir, see "Rosuvastatin/Acetylsalicylic acid Teva and other medicines".
• if you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) orally or by injection; taking Rosuvastatin/Acetylsalicylic acid Teva with fusidic acid may lead to severe muscle problems (rhabdomyolysis); see "Rosuvastatin/Acetylsalicylic acid Teva and other medicines".

if you have severe respiratory failure.

• if you are over 70 years old.
• if you are of Asian origin (i.e. Japan, China, Philippines, Vietnam, Korea and India). Your doctor will choose an appropriate starting dose of Rosuvastatin/Acetylsalicylic acid Teva that is suitable for you.
• if you currently have or have had stomach or duodenal problems (ulcers or bleeding from the gastrointestinal tract).
• if you have high blood pressure.
• if you have asthma, hay fever, nasal polyps or other chronic respiratory diseases; acetylsalicylic acid may cause an asthma attack.
• in case of hypersensitivity (allergy) to other pain and anti-inflammatory medicines, other anti-rheumatic medicines or other allergens.
• if you have other allergies (e.g. skin reactions, itching).
• if you are taking other anticoagulant medicines (e.g. coumarin derivatives, heparin - except for low-dose heparin).
• in case of impaired kidney function or reduced blood flow to the heart and blood vessels (e.g. kidney vessel disease, heart muscle weakness, reduced blood volume, serious operations, blood infection or increased bleeding): acetylsalicylic acid may further increase the risk of kidney function disorders and acute kidney failure.
• if you have heavy menstrual bleeding.

You should immediately consult your doctor if your symptoms worsen or if you experience severe or unexpected side effects, e.g. unusual bleeding symptoms, severe skin reactions or any other symptoms of severe allergy (see "Possible side effects").

Severe skin reactions, including Stevens-Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin. If you experience any of the symptoms described in section 4, you should stop taking Rosuvastatin/Acetylsalicylic acid Teva and contact your doctor immediately.

In a small number of people, statins may affect the liver. This is identified by a simple blood test that can detect elevated liver enzyme activity. For this reason, your doctor will usually recommend that you have this blood test (liver function test) before and during treatment with Rosuvastatin/Acetylsalicylic acid Teva.

During treatment with this medicine, your doctor will closely monitor your condition if you have diabetes or are at risk of developing diabetes. The risk of developing diabetes is likely if you have high blood sugar and fat levels, are overweight and have high blood pressure.

You should be careful not to become dehydrated (you may feel thirsty with dry mouth) as taking acetylsalicylic acid at the same time may worsen kidney function.

You should inform your doctor if you are planning to have surgery (even minor, e.g. 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 disease that affects the brain and liver and can be fatal. 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 breakdown or breakdown of red blood cells or a certain form of anemia. This risk may be caused by factors such as high doses, fever or acute infections.

Small doses of acetylsalicylic acid can reduce the excretion of uric acid. This may cause a gout attack in patients at risk.

In case of injury or trauma, bleeding may take a little longer than usual. This is due to the effect of acetylsalicylic acid. Minor injuries and trauma (e.g. during shaving) are usually not significant. If you experience unusual bleeding (in an unusual location or duration), you should contact your doctor.

Children and adolescents

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

Rosuvastatin/Acetylsalicylic acid Teva and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.

Rosuvastatin/Acetylsalicylic acid Teva may affect the following medicines or the following 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, camptothecin (used to treat cancer).
• fostamatinib (used to treat low platelet count).
• febuxostat (used to treat and prevent high uric acid levels in the blood).
• teriflunomide (used to treat multiple sclerosis).
• any of the following medicines used to treat viral infections, including HIV or hepatitis C virus, given alone or in combination with other medicines (see "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• ketokonazole, itraconazole (antifungal medicines).
• rifampicin, erythromycin, clarithromycin (antibiotics).
• medicines that thin the blood and prevent blood clots (e.g. coumarin derivatives, heparin, warfarin, clopidogrel, ticlopidine, ticagrelor): acetylsalicylic acid may increase the risk of bleeding if taken before medicines that dissolve blood clots or thin the blood. Therefore, if such treatment is to be used, attention should be paid to signs of external or internal bleeding (e.g. bruising).
• organ rejection after transplantation (ciclosporin, tacrolimus).
• high blood pressure (e.g. diuretics and ACE inhibitors).
• heart rate regulation (digoxin).
• bipolar disorder (lithium).
• pain and inflammation (e.g. non-steroidal anti-inflammatory drugs, such as ibuprofen, naproxen or corticosteroids).
• gout (e.g. probenecid, benzbromarone).
• glaucoma (acetazolamide).
• cancer or rheumatoid arthritis (methotrexate; in doses less than 15 mg per week).
• medicines that lower blood sugar levels (oral antidiabetics) (e.g. glibenclamide) - may lead to decreased blood sugar levels.
• depression (selective serotonin reuptake inhibitors (SSRIs), such as sertraline or paroxetine).
• hormone replacement therapy in case of adrenal or pituitary gland damage or removal (except for products used on the skin or cortisol replacement therapy for Addison's disease) or for the treatment of inflammatory conditions, including rheumatoid diseases and inflammatory bowel disease (corticosteroids). Concomitant use increases the risk of gastrointestinal side effects.
• seizures (valproic acid).
• medicines that increase urine production (diuretics: so-called aldosterone antagonists, e.g. spironolactone and canrenone, 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 taken together. Therefore, caution should be exercised when using metamizole in patients receiving low-dose acetylsalicylic acid for heart protection.
• alcohol: increases the risk of stomach ulcers and bleeding.

If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking Rosuvastatin/Acetylsalicylic acid Teva. Your doctor will tell you when you can safely restart this medicine. Taking Rosuvastatin/Acetylsalicylic acid Teva with fusidic acid may rarely lead to weakness, tenderness or pain in the muscles (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

Rosuvastatin/Acetylsalicylic acid Teva may further lower your blood pressure if you are taking other medicines for high blood pressure.

Taking Rosuvastatin/Acetylsalicylic acid Teva with food and drink

Rosuvastatin/Acetylsalicylic acid Teva should be taken with food.

You should avoid drinking grapefruit juice during treatment with Rosuvastatin/Acetylsalicylic acid Teva.

Drinking alcohol may potentially increase the risk of gastrointestinal bleeding and prolong bleeding time.

Pregnancy and breastfeeding

You should not take Rosuvastatin/Acetylsalicylic acid Teva if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin/Acetylsalicylic acid Teva, you should stop taking it immediately and inform your doctor. Women should avoid becoming pregnant while taking Rosuvastatin/Acetylsalicylic acid Teva by using appropriate methods of contraception.

Driving and using machines

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

Rosuvastatin/Acetylsalicylic acid Teva contains lactose

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

Rosuvastatin/Acetylsalicylic acid Teva contains soya lecithin

Rosuvastatin/Acetylsalicylic acid Teva contains small amounts of soya lecithin, which may contain soybean oil. This medicine should not be taken if you are allergic to peanuts or soy.

3. How to take Rosuvastatin/Acetylsalicylic acid Teva

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

Adults

Your doctor will determine the appropriate dose for you, depending on your health, current treatment and individual risk.

This medicine is not suitable for starting treatment. Treatment should be started with separate administration of the active substances; after determining the appropriate doses, it is possible to switch to Rosuvastatin/Acetylsalicylic acid Teva with the appropriate strength.

The recommended dose is one capsule per day.

This medicine should be taken with food. The medicine should be taken every day at the same time.

The capsules should be swallowed with a large amount of liquid; they should not be crushed or chewed.

Rosuvastatin/Acetylsalicylic acid Teva should not be taken with grapefruit juice.

If you are hospitalized or treated for another disease, you should inform the medical staff that you are taking Rosuvastatin/Acetylsalicylic acid Teva.

Use in elderly patients

No dose adjustment is necessary in elderly patients

Use in children and adolescents

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

Patients with kidney problems

No dose adjustment is necessary in patients with mild or moderate kidney problems.

Treatment with Rosuvastatin/Acetylsalicylic acid Teva is contraindicated in patients with severe kidney problems.

Patients with liver problems

No dose adjustment is necessary in patients with mild or moderate liver problems.

Treatment with Rosuvastatin/Acetylsalicylic acid Teva is contraindicated in patients with severe liver problems.

Taking a higher dose of Rosuvastatin/Acetylsalicylic acid Teva than recommended

You should contact your doctor or the nearest hospital for advice.

Missing a dose of Rosuvastatin/Acetylsalicylic acid Teva

You should not worry. If you miss a capsule, you should completely miss that dose.

The next dose should be taken at the right time. You should not take a double dose to make up for the missed dose.

Stopping treatment with Rosuvastatin/Acetylsalicylic acid Teva

Your doctor will tell you how long to take the medicine. If you stop taking Rosuvastatin/Acetylsalicylic acid Teva, your cholesterol level may rise again. If you stop taking the medicine without consulting your doctor, your condition may worsen.

If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should stop taking Rosuvastatin/Acetylsalicylic acid Teva and immediatelyseek medical attention if you experience any of the following very rare, serious side effects 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 breathing and (or) swallowing problems
• Severe itching of the skin (with lumps)
• -Red, flat, plate-like or round patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, on the genitals and in the eyes. The occurrence of this type of severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high fever and enlarged lymph nodes (DRESS or hypersensitivity syndrome)
• If you experience black stools or vomit blood (signs of severe stomach bleeding)

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

• if you experience unusual muscle painthat lasts longer than expected. Like other statins, rosuvastatin has caused unpleasant muscle effects in a very small number of patients, which in rare cases have led to potentially life-threatening muscle damage, known as rhabdomyolysis.
• if you experience muscle rupture
• if you experience a lupus-like syndrome(including rash, joint disorders and effects on blood cells)

The following side effects have been reported. If any of them cause you trouble or last longer than a week, you should contact your doctor.

ROSUVASTATIN

Common(occurring in no more than 1 in 10 people):

• Headache
• Abdominal pain
• Constipation
• Nausea
• Muscle pain
• Feeling weak
• Dizziness
• Diabetes. Its occurrence is more likely if you have high blood sugar and fat levels, are overweight and have high blood pressure. During treatment with this medicine, your doctor will monitor your condition.

Uncommon(occurring in no more than 1 in 100 people):

• Skin rash, itching, hives or other skin reactions
• Increased amount of protein in the urine - usually resolves on its own without the need to stop taking the capsules of Rosuvastatin/Acetylsalicylic acid Teva (only doses of 5-20 mg)

Rare(occurring in no more than 1 in 1000 people):

• Severe allergic reaction - its symptoms include swelling of the face, lips, tongue and (or) throat, difficulty swallowing and breathing, severe itching of the skin (with lumps)

Very rare(occurring in no more than 1 in 10,000 people):

• Jaundice (yellowing of the skin and eyes)
• Hepatitis
• Blood in the urine
• Nerve damage in the limbs (e.g. numbness)
• Joint pain
• Memory loss
• Gynecomastia (breast enlargement in men)

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

• Diarrhea (loose stools)
• Cough
• Shortness of breath
• Swelling (edema)
• 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 that can cause weakness, numbness or tingling
• Persistent muscle weakness

ACETYLSALICYLIC ACID

Common(occurring in no more than 1 in 10 people):

• Gastrointestinal disorders, such as heartburn, nausea, vomiting, abdominal pain and diarrhea
• Mild gastrointestinal bleeding (microbleeding)
• Bleeding, such as nosebleeds, bleeding gums, skin bleeding or bleeding from the urinary and genital tracts, with possible prolongation of bleeding time. This effect may persist for 4 to 8 days after taking the medicine

Uncommon(occurring in no more than 1 in 100 people):

• Gastrointestinal bleeding. Long-term use of acetylsalicylic acid may cause iron deficiency anemia due to occult gastrointestinal bleeding.
• Bleeding in the brain, blood in the urine
• Ulcers in the stomach or intestines, which can very rarely lead to perforation
• Gastrointestinal inflammation
• Skin reactions

Rare(occurring in no more than 1 in 1000 people):

• Allergic reactions, especially in asthmatic patients: the disease symptoms include a drop in blood pressure, shortness of breath, nasal congestion, angioedema, anaphylactic shock
• Severe bleeding, such as brain bleeding, especially in patients with uncontrolled hypertension and (or) concomitantly taking anticoagulant medicines, which in individual cases can be life-threatening
• Confusion (disorientation)
• Dizziness, headache
• Hearing loss or ringing in the ears (tinnitus), especially in children and the elderly, may be symptoms of overdose (see also "Taking a higher dose of Rosuvastatin/Acetylsalicylic acid Teva than recommended")

Very rare(occurring in no more than 1 in 10,000 people):

• Elevated liver function test results
• Kidney function disorders and acute kidney failure
• Decreased blood sugar levels (hypoglycemia)
• Small doses of acetylsalicylic acid can reduce the excretion of uric acid. This may cause a gout attack in patients at risk
• Fever-induced rash with mucosal involvement (erythema multiforme)

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

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

If you experience any of these side effects or any other side effects not listed in this leaflet, you should tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor, pharmacist or nurse. Side effects can be reported directly to:

Department for the Surveillance of Adverse Reactions to Medicinal Products

Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych

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

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rosuvastatin/Acetylsalicylic acid Teva

The medicine should be stored 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 the month stated.

Store in a temperature below 30°C. Store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Rosuvastatin/Acetylsalicylic acid Teva contains

The active substances of the medicine are rosuvastatin (in the form of rosuvastatin calcium) and acetylsalicylic acid.

Rosuvastatin/Acetylsalicylic acid Teva 5 mg + 100 mg: each hard capsule contains 5 mg of rosuvastatin (in the form of rosuvastatin calcium) and 100 mg of acetylsalicylic acid.

Rosuvastatin/Acetylsalicylic acid Teva 10 mg + 100 mg: each hard capsule contains 10 mg of rosuvastatin (in the form of rosuvastatin calcium) and 100 mg of acetylsalicylic acid.

Rosuvastatin/Acetylsalicylic acid Teva 20 mg + 100 mg: each hard capsule contains 20 mg of rosuvastatin (in the form of rosuvastatin calcium) and 100 mg of acetylsalicylic acid.

The other ingredients are:

Coated tablet containing rosuvastatin:

Core

Lactose monohydrate (see section 2 "Rosuvastatin/Acetylsalicylic acid Teva contains lactose")

Microcrystalline cellulose

Heavy magnesium oxide

Crospovidone (type A)

Silica, colloidal, anhydrous

Magnesium stearate

Coating

Partially hydrolyzed polyvinyl alcohol

Titanium dioxide (E 171)

Talc

Yellow iron oxide (E 172)

Soya lecithin (see section 2 "Rosuvastatin/Acetylsalicylic acid Teva contains soya lecithin")

Red iron oxide (E 172)

Xanthan gum

Black iron oxide (E 172)

Tablet containing acetylsalicylic acid:

Microcrystalline cellulose

Corn starch

Silica, colloidal, anhydrous

Stearic acid

Capsule shell:

Gelatin

Titanium dioxide (E 171)

Indigo carmine (E 132)

Yellow iron oxide (E 172)

Black ink:

Shellac

Propylene glycol

Anhydrous ethanol

Butyl alcohol

Isopropyl alcohol

Ammmonium hydroxide, solution

Black iron oxide (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: hard gelatin capsules, size 2, with a white opaque body and 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: hard gelatin capsules, size 1, with a white opaque body with black print "ASA 100" and light green opaque cap with black print "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: hard gelatin capsules, size 0, with a white opaque body with black print "ASA 100" and green opaque cap with black print "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 blisters of 20, 28, 30, 56, 60, 90 and 100 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Manufacturer:

Adamed Pharma S.A.

ul. Marszałka Józefa Piłsudskiego 5

95-200 Pabianice

Poland

To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, you should contact the representative of the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Warsaw

tel. (22) 345 93 00

Date of last revision of the leaflet: February 2025