Rosuvastatin/amlodipine teva

Package leaflet: Information for the patient

Rosuvastatin/Amlodipine Teva, 10 mg + 5 mg, hard capsules
Rosuvastatin/Amlodipine Teva, 10 mg + 10 mg, hard capsules
Rosuvastatin/Amlodipine Teva, 20 mg + 5 mg, hard capsules
Rosuvastatin/Amlodipine Teva, 20 mg + 10 mg, hard capsules
Rosuvastatinum + Amlodipinum
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 personally. Do not give it to others. It may harm them, 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

1. What Rosuvastatin/Amlodipine Teva is and what it is used for
2. What you need to know before taking Rosuvastatin/Amlodipine Teva
3. How to take Rosuvastatin/Amlodipine Teva
4. Possible side effects
5. How to store Rosuvastatin/Amlodipine Teva
6. Contents of the pack and other information

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

Rosuvastatin/Amlodipine Teva contains two active substances – rosuvastatin and amlodipine.
Rosuvastatin belongs to a group of medicines called statins, and amlodipine belongs to a group of medicines called calcium channel blockers.
Rosuvastatin is used to correct levels of fatty substances in the blood called lipids, the most common of which is cholesterol. High cholesterol levels may lead to fatty deposits building up in the walls of blood vessels, causing them to narrow. By lowering cholesterol levels, the risk of heart attack, stroke, or other health problems caused by narrowed blood vessels can be reduced.
Amlodipine is used to treat high blood pressure. It works by relaxing blood vessels, allowing blood to flow more easily.
Rosuvastatin/Amlodipine Teva is indicated in adult patients for the treatment of both high blood pressure and elevated cholesterol levels when diet and physical activity have not been sufficient to lower cholesterol.
Rosuvastatin/Amlodipine Teva is also indicated for the prevention of cardiovascular events when other risk factors are present that increase the likelihood of heart attack, stroke, or related health problems.
Rosuvastatin/Amlodipine Teva is indicated for patients who are already taking rosuvastatin and amlodipine at the same doses as those contained in Rosuvastatin/Amlodipine Teva. Patients currently taking separate tablets of rosuvastatin and amlodipine may switch to a single tablet of Rosuvastatin/Amlodipine Teva containing both active substances at the same doses.
While taking Rosuvastatin/Amlodipine Teva, you should continue a cholesterol-lowering diet and regular physical exercise.

2. Important information before using Rosuvastatin/Amlodipine Teva

When not to use Rosuvastatin/Amlodipine Teva:

• if the patient is allergic to rosuvastatin, amlodipine, any other calcium channel blocker, or any of the other ingredients of this medicine (listed in section 6)
• if the patient has ever experienced severe skin rash, skin peeling, blisters, and/or oral ulcers after taking Rosuvastatin/Amlodipine Teva or similar medicines
• if the patient is pregnant or breastfeeding. If pregnancy occurs during treatment with Rosuvastatin/Amlodipine Teva, treatment must be stopped immediately and the doctor informed. Women of childbearing potential must use effective contraception during treatment with Rosuvastatin/Amlodipine Teva.
• if the patient has liver disease
• if the patient has severe kidney function impairment
• if the patient has recurrent or unexplained muscle pain
• if the patient is taking cyclosporine (a medicine used, for example, after organ transplantation)
• if the patient has very low blood pressure (hypotension)
• if the patient has aortic valve stenosis (narrowing of the heart's aortic valve) or cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body)
• if the patient has heart failure following myocardial infarction.

Warnings and precautions
Before starting treatment with Rosuvastatin/Amlodipine Teva, discuss the following with your doctor or pharmacist:

• if the patient has kidney problems
• if the patient has liver problems
• if the patient has recurrent or unexplained muscle pain, if muscle pain has occurred previously in the patient or their family, or if muscle disorders occurred in the past during treatment with other cholesterol-lowering medicines. If unexplained muscle pain occurs, especially if accompanied by malaise or fever, the doctor must be informed immediately. The doctor or pharmacist should also be informed if persistent muscle weakness occurs.
• if the patient regularly consumes large amounts of alcohol
• if the thyroid gland is not functioning properly
• if the patient is taking other cholesterol-lowering medicines called fibrates. Read the package leaflet carefully, even if the patient has previously used other cholesterol-lowering medicines
• if the patient is taking medicines used to treat HIV infection, e.g. ritonavir with lopinavir and/or atazanavir; see section "Rosuvastatin/Amlodipine Teva and other medicines"
• if the patient is taking or has taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infections); taking Rosuvastatin/Amlodipine Teva with fusidic acid may lead to severe muscle problems (rhabdomyolysis); see section "Rosuvastatin/Amlodipine Teva and other medicines"
• if the patient has severe respiratory insufficiency
• if the patient has recently had a myocardial infarction
• if the patient has heart failure
• if the patient has experienced a significant increase in blood pressure (hypertensive crisis)
• if the patient is over 70 years old
• if the patient is of Asian origin: Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian. The doctor must determine the appropriate starting dose of Rosuvastatin/Amlodipine Teva for the patient.

In a small number of people, statins may affect the liver. This can be detected by a simple blood test showing increased liver enzyme activity. For this reason, the doctor usually performs blood tests (liver function tests) before and during treatment with Rosuvastatin/Amlodipine Teva.
Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of Rosuvastatin/Amlodipine Teva. If any of the symptoms described in section 4 occur, treatment with Rosuvastatin/Amlodipine Teva must be stopped and the doctor contacted immediately.
Patients with diabetes or at risk of developing diabetes will be under close medical supervision during treatment with this medicine. Individuals with high blood sugar and fat levels, overweight, and high blood pressure may be at increased risk of developing diabetes.

Children and adolescents
Rosuvastatin/Amlodipine Teva must not be used in children and adolescents.

Rosuvastatin/Amlodipine Teva and other medicines
Tell your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Rosuvastatin/Amlodipine Teva may affect the action of other medicines, or other medicines may affect the action of Rosuvastatin/Amlodipine Teva:

• warfarin or clopidogrel (or any other medicine used to thin the blood)
• fibrates (e.g. gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol levels (e.g. ezetimibe)
• medicines for indigestion (used to neutralize stomach acid)
• oral contraceptives
• hormone replacement therapy
• ketoconazole, itraconazole (antifungal medicines)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• medicines containing St John's wort (Hypericum perforatum)
• verapamil, diltiazem (heart medicines)
• dantrolene (used intravenously for severe disturbances in body temperature)
• everolimus, tacrolimus, sirolimus, temsirolimus, cyclosporine, or other medicines used to control the patient's immune system
• simvastatin (a medicine used to lower cholesterol)
• regorafenib (used in cancer treatment)
• any of the following medicines used to treat viral infections, including HIV or hepatitis C virus, taken alone or in combination with other medicines (see section "Warnings and precautions"): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir, indinavir, nelfinavir.
• ticagrelor (a medicine preventing platelet aggregation and arterial blockage)

If fusidic acid is required for the treatment of a bacterial infection, treatment with Rosuvastatin/Amlodipine Teva must be temporarily discontinued. The doctor will inform the patient when it is safe to resume treatment with Rosuvastatin/Amlodipine Teva. Taking Rosuvastatin/Amlodipine Teva with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
Rosuvastatin/Amlodipine Teva may further lower blood pressure in patients already taking other antihypertensive medicines.

Rosuvastatin/Amlodipine Teva with food and drink
Rosuvastatin/Amlodipine Teva can be taken regardless of meals.
Patients taking Rosuvastatin/Amlodipine Teva should not drink grapefruit juice or eat grapefruits, as grapefruits and grapefruit juice may increase blood levels of the active substance amlodipine, potentially causing an unexpected intensification of the blood pressure-lowering effect of Rosuvastatin/Amlodipine Teva.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before taking this medicine.
Rosuvastatin/Amlodipine Teva must not be used during pregnancy or breastfeeding.
If pregnancy occurs during treatment with Rosuvastatin/Amlodipine Teva, the patient must stop taking the medicine immediately and contact her doctor. Women of childbearing potential must use effective contraception during treatment with Rosuvastatin/Amlodipine Teva.

Driving and using machines
Rosuvastatin/Amlodipine Teva may impair the ability to drive and operate machinery. Some patients may experience dizziness while taking Rosuvastatin/Amlodipine Teva. If this medicine causes nausea, dizziness, fatigue, or headache, the patient should not drive or operate machinery and should contact the doctor immediately.

Rosuvastatin/Amlodipine Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is considered "sodium-free".

3. How to take Rosuvastatin/Amlodipine Teva

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
please consult your doctor or pharmacist.
The recommended dose is one capsule daily.
Rosuvastatin/Amlodipine Teva can be taken before or after food. The medicine should be taken at the same time
each day, with water. Do not take Rosuvastatin/Amlodipine Teva with grapefruit juice.

Use in children and adolescents
Rosuvastatin/Amlodipine Teva must not be used in children and adolescents.

Regular monitoring of cholesterol levels
It is important to visit your doctor regularly for monitoring of cholesterol levels to ensure that
cholesterol has reached and remains at appropriate levels.

Taking more than the recommended dose of Rosuvastatin/Amlodipine Teva
Contact your doctor or the nearest hospital for advice immediately. Taking too many capsules may cause
blood pressure to become low or even dangerously low. Dizziness, lightheadedness, fainting, or weakness may occur.
If blood pressure drops significantly, shock may develop. The patient's skin may become cold and clammy, and the patient
may lose consciousness. If the patient goes to the hospital or receives treatment for another illness,
medical staff must be informed about the use of Rosuvastatin/Amlodipine Teva.
Excess fluid may accumulate in the lungs (pulmonary edema), causing breathlessness, which may occur
within 24–48 hours after ingestion.

Missed dose of Rosuvastatin/Amlodipine Teva
There is no need to worry. If the patient forgets to take a capsule, the missed dose should be skipped completely.
The next dose should be taken at the usual time. Do not take a double dose to make up for a missed dose.

Stopping treatment with Rosuvastatin/Amlodipine Teva
Your doctor will determine how long treatment with this medicine should continue. Stopping treatment
with Rosuvastatin/Amlodipine Teva may cause cholesterol levels to rise again. If the patient stops taking the medicine
earlier than advised by the doctor, the condition may return.

If you have any further questions about the use of this medicine, please consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following serious adverse reactions occur, the medicine must be discontinued immediately and medical advice must be sought without delay:

• sudden wheezing, chest pain, shortness of breath or difficulty breathing
• swelling of the eyelids, face or lips
• swelling of the tongue or throat causing significant difficulty in breathing and (or) swallowing
• severe rash, redness of the entire skin, blister formation, skin peeling, mucosal inflammation (toxic epidermal necrolysis)
• red, flat, disc-shaped or circular spots on the trunk, often with blisters in the centre, skin peeling, mouth, throat, nose, genital or eye ulcers. These potentially life-threatening skin reactions 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)
• other allergic reactions
• myocardial infarction, irregular heartbeat
• pancreatitis, which may cause severe abdominal and back pain accompanied by a very poor general condition.

Additionally, discontinue use of Rosuvastatin/Amlodipine Teva and contact a doctor immediately:

• if the patient experiences any unusual muscle pain lasting longer than expected. As with other statins, in a very small number of people taking rosuvastatin, muscle-related symptoms have occurred, which rarely progressed to a potentially life-threatening muscle damage called rhabdomyolysis.
• if muscle rupture occurs.
• if the patient develops a lupus-like illness (including rash, joint disorders and effects on blood cells).

ADVERSE REACTIONS ASSOCIATED WITH ROSUVASTATIN
Common adverse reactions (may occur in up to 1 in 10 patients):

• 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. During treatment with this medicine, the doctor will monitor the patient.

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• rash, itching or other skin reactions
• increased protein in urine – usually resolves spontaneously without the need to discontinue Rosuvastatin/Amlodipine Teva

Rare adverse reactions (may occur in up to 1 in 1000 patients):

• increased liver enzyme activity in blood
• bleeding or easier bruising due to low platelet count
• 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 the patient suspects an allergic reaction, Rosuvastatin/Amlodipine Teva must be discontinued immediately and medical help sought
• lupus-like syndrome (including rash, joint disorders and effects on blood cells)
• muscle rupture

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):

• jaundice (yellowing of skin and eyes)
• hepatitis
• blood in urine
• nerve damage in arms and legs (e.g. numbness)
• joint pain
• memory loss
• gynaecomastia (enlargement of breasts in men)

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

• diarrhoea (loose stools)
• cough
• shortness of breath
• swelling
• sleep disturbances, including insomnia and nightmares
• sexual dysfunction
• depression
• breathing disorders, including persistent cough and (or) shortness of breath or fever
• tendon damage
• nerve function disorders leading to muscle weakness, tingling or numbness

ADVERSE REACTIONS ASSOCIATED WITH AMLODIPINE
The following adverse reactions have been reported after taking amlodipine. If they cause problems or persist for more than one week, contact a doctor.
Very common adverse reactions (may occur in more than 1 in 10 patients):

• swelling (fluid retention)

Common adverse reactions (may occur in up to 1 in 10 patients):

• headache, dizziness, drowsiness (especially at the beginning of treatment)
• palpitations (sensation of strong heartbeat), facial flushing
• abdominal pain, nausea
• ankle swelling
• changes in bowel habits, diarrhoea or constipation
• indigestion
• muscle cramps
• feeling of weakness, fatigue
• visual disturbances, double vision

The list below includes other reported adverse reactions. If any of the following observed adverse reactions worsen, or if any unlisted adverse reactions occur, inform a doctor or pharmacist.
Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• mood changes, anxiety, depression, insomnia
• tremor, taste disturbances, fainting, weakness
• sensation of numbness or tingling in limbs, loss of pain sensation
• ringing in the ears
• low blood pressure
• sneezing or nasal discharge due to inflammation of the nasal mucosa (rhinitis)
• cough
• dry mouth, vomiting
• hair loss, increased sweating, skin itching, red skin spots, skin discolouration
• urinary problems, increased need to urinate at night, increased frequency of urination
• inability to achieve erection, discomfort or enlargement of breasts in men
• pain, malaise
• joint or muscle pain, back pain
• weight gain or weight loss

Rare adverse reactions (may occur in up to 1 in 1000 patients):

• disorientation

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):

• decreased white blood cell count, decreased platelet count, which may lead to increased bruising and bleeding
• increased blood sugar (hyperglycaemia)
• nerve function disorders leading to weakness, tingling or numbness
• gum swelling
• abdominal bloating (dyspepsia)
• liver function disorders, hepatitis, jaundice (yellowing of the skin), increased liver enzyme activity, which may affect results of certain laboratory tests
• increased muscle tone
• vasculitis, often accompanied by skin rash
• photosensitivity
• disorders involving rigidity, tremor and (or) movement disorders

If any of the listed adverse reactions worsen, or if unlisted adverse reactions occur, contact a doctor or pharmacist.
Reporting of adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 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 to provide more information on the safety of the medicine.

5. How to store Rosuvastatin/Amlodipine Teva

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

6. Contents of the pack and other information

The active substances in this medicinal product are rosuvastatin (as rosuvastatin calcium) and amlodipine (as amlodipine besylate).
10 mg + 5 mg: Each hard capsule contains 10 mg of rosuvastatin (as rosuvastatin calcium) and 5 mg of amlodipine (as amlodipine besylate).
10 mg + 10 mg: Each hard capsule contains 10 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of amlodipine (as amlodipine besylate).
20 mg + 5 mg: Each coated tablet contains 20 mg of rosuvastatin (as rosuvastatin calcium) and 5 mg of amlodipine (as amlodipine besylate).
20 mg + 10 mg: Each coated tablet contains 20 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of amlodipine (as amlodipine besylate).

The other ingredients are:
Capsule contents: maize starch (including pregelatinised starch, maize), microcrystalline cellulose type 102, crospovidone (type A), sodium stearyl fumarate (see section 2 “Rosuvastatin/Amlodipine Teva contains sodium”)
Capsule shell: gelatin, titanium dioxide (E 171)
Red ink: shellac (E 904), propylene glycol (E 1520), ammonium hydroxide, iron oxide red (E 172), potassium hydroxide
Green ink: shellac, titanium dioxide (E 171), indigo carmine (E 132), iron oxide yellow (E 172), ammonium hydroxide, propylene glycol.

What Rosuvastatin/Amlodipine Teva looks like and contents of the pack
10 mg + 5 mg
Hard gelatin capsule, size 1, with an opaque white body printed in red with “Aml 5 mg” and an opaque white cap printed in green with “Rsv 10 mg”.
10 mg + 10 mg
Hard gelatin capsule, size 00, with an opaque white body with a band and printed in red with “Aml 10 mg” and an opaque white cap printed in green with “Rsv 10 mg”.
20 mg + 5 mg
Hard gelatin capsule, size 00, with an opaque white body printed in red with “Aml 5 mg” and an opaque white cap with a band and printed in green with “Rsv 20 mg”.
20 mg + 10 mg
Hard gelatin capsule, size 00, with an opaque white body with a band and printed in red with “Aml 10 mg” and an opaque white cap with a band and printed in green with “Rsv 20 mg”.

Rosuvastatin/Amlodipine Teva is available in PA/Aluminium/PVC/Aluminium blisters containing 10, 28, 30 or 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturer
Balkanpharma-Dupnitsa AD
3-Samokovsko Shosse Str.,
Dupnitsa 2600, Bulgaria

Merckle GmbH
Ludwig-Merckle-Strasse 3,
89143 Blaubeuren
Germany