Rosuvastatin/amlodipine Teva

Leaflet accompanying the packaging: patient information

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

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Rosuvastatin/Amlodipine Teva and what is it used for
• 2. Important information 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 packaging and other information

1. What is Rosuvastatin/Amlodipine Teva and what is it 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 the level of fatty substances in the blood called lipids, the most common of which is cholesterol. High cholesterol levels can cause fatty deposits to build 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 that can be caused by narrowed blood vessels can be reduced.
Amlodipine is used to treat high blood pressure. It widens the blood vessels, making it easier for blood to flow through them.
Rosuvastatin/Amlodipine Teva is indicated for the treatment of high blood pressure and high cholesterol in adult patients when diet and physical activity have not been sufficient to reduce cholesterol levels.
Rosuvastatin/Amlodipine Teva is also indicated for the prevention of cardiovascular events if there are other factors that increase the risk of heart attack, stroke, or related health disorders.
Rosuvastatin/Amlodipine Teva is indicated for patients who are already taking rosuvastatin and amlodipine in the same doses as in Rosuvastatin/Amlodipine Teva. Patients who are already taking rosuvastatin and amlodipine in separate tablets can take one tablet of Rosuvastatin/Amlodipine Teva, which contains both active substances in the same doses.
During treatment with Rosuvastatin/Amlodipine Teva, a cholesterol-lowering diet and physical exercise should be continued.

2. Important information before taking Rosuvastatin/Amlodipine Teva

When not to take Rosuvastatin/Amlodipine Teva:

• if the patient is allergic to rosuvastatin, amlodipine, another calcium channel blocker, or any of the other ingredients of this medicine (listed in section 6)
• if the patient has ever had a severe skin rash or scaling, blisters, and (or) ulcers in the mouth after taking Rosuvastatin/Amlodipine Teva or other similar medicines
• if the patient is pregnant or breastfeeding. If the patient becomes pregnant while taking Rosuvastatin/Amlodipine Teva, treatment should be stopped immediately and the doctor informed. Women of childbearing age taking Rosuvastatin/Amlodipine Teva should use effective methods of contraception
• if the patient has liver disease
• if the patient has severe kidney problems
• if the patient has recurring or unexplained muscle pain
• if the patient is taking cyclosporin (a medicine used, for example, after organ transplants)
• if the patient has very low blood pressure (hypotension)
• if the patient has narrowing of the aortic valve in the heart (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply the body with enough blood)
• if the patient has heart failure after a heart attack

Warnings and precautions

Before starting treatment with Rosuvastatin/Amlodipine Teva, the doctor or pharmacist should be consulted:

• if the patient has kidney problems
• if the patient has liver problems
• if the patient has recurring or unexplained muscle pain, if muscle pain has occurred in the patient or their family in the past, or if muscle disorders have occurred in the past when taking other cholesterol-lowering medicines. If unexplained muscle pain occurs, especially if accompanied by a feeling of illness or fever, the doctor should be informed immediately. The doctor or pharmacist should also be informed if there is persistent muscle weakness
• if the patient regularly drinks large amounts of alcohol
• if the thyroid gland does not work properly
• if the patient is taking other cholesterol-lowering medicines called fibrates. The leaflet should be read carefully, even if the patient has taken other cholesterol-lowering medicines in the past
• if the patient is taking medicines used to treat HIV infection, such as ritonavir with lopinavir and (or) atazanavir, see section "Rosuvastatin/Amlodipine Teva and other medicines"
• if the patient is taking or has taken a medicine containing fusidic acid (used to treat bacterial infections) orally or by injection within the last 7 days; 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 failure
• if the patient has recently had a heart attack
• if the patient has heart failure
• if the patient has had a large 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 will determine the appropriate initial dose of Rosuvastatin/Amlodipine Teva for the patient's needs

In a small number of people, statins may affect the liver. This can be determined by a simple test that shows increased liver enzyme activity in the blood. For this reason, the doctor usually performs a blood test (liver function tests) before and during treatment with Rosuvastatin/Amlodipine Teva.
Severe skin reactions, including Stevens-Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS), have been reported in association with Rosuvastatin/Amlodipine Teva. If any of the symptoms described in section 4 occur, Rosuvastatin/Amlodipine Teva should be stopped and medical attention should be sought immediately.
Patients with diabetes or at risk of developing diabetes will be closely monitored by their doctor while taking this medicine. People with high sugar and fat levels in the blood, overweight, and high blood pressure may be at risk of developing diabetes.

Children and adolescents

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

Rosuvastatin/Amlodipine Teva and other medicines

The doctor or pharmacist should be told about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
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)
• antacids (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 in infusion for severe body temperature disorders)
• everolimus, tacrolimus, sirolimus, temsirolimus, cyclosporin, or other medicines used to control the patient's immune system
• simvastatin (a medicine used to lower cholesterol levels)
• regorafenib (used to treat cancer)
• any of the following medicines used to treat viral infections, including HIV or hepatitis C, 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
• tikagrelor (a medicine that prevents platelet aggregation and blocks arteries)

If it is necessary to take fusidic acid to treat a bacterial infection, Rosuvastatin/Amlodipine Teva should be stopped during this time. The doctor will inform the patient when it is safe to restart Rosuvastatin/Amlodipine Teva. Taking Rosuvastatin/Amlodipine Teva with fusidic acid may rarely lead to weakness, sensitivity, or muscle pain (rhabdomyolysis). More information on rhabdomyolysis can be found in 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 with or without food.
Patients taking Rosuvastatin/Amlodipine Teva should not drink grapefruit juice or eat grapefruits, as grapefruits and grapefruit juice may increase the level of the active substance amlodipine in the blood, which may cause an unexpected increase in the blood pressure-lowering effect of Rosuvastatin/Amlodipine Teva.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Rosuvastatin/Amlodipine Teva should not be used during pregnancy or breastfeeding.
If the patient becomes pregnant while taking Rosuvastatin/Amlodipine Teva, they should stop taking the medicine immediately and contact their doctor. Women of childbearing age taking Rosuvastatin/Amlodipine Teva should use effective methods of contraception while taking this medicine.
Before taking any medicine, the doctor or pharmacist should be consulted.

Driving and using machines

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

Rosuvastatin/Amlodipine Teva contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is considered "sodium-free".

3. How to take Rosuvastatin/Amlodipine Teva

This medicine should always be taken as directed by the doctor or pharmacist. If there are any doubts, the doctor or pharmacist should be consulted.
The recommended dose is one capsule per day.
The medicine can be taken before or after a meal. The medicine should be taken at the same time every day, with a glass of water. Rosuvastatin/Amlodipine Teva should not be taken with grapefruit juice.

Use in children and adolescents

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

Regular cholesterol level checks

It is essential to visit the doctor for regular cholesterol level checks to ensure that the level has reached and is maintained at the appropriate values.

Taking more than the recommended dose of Rosuvastatin/Amlodipine Teva

The doctor or the nearest hospital should be contacted for advice. Taking too many tablets may cause low or even dangerously low blood pressure. Dizziness, fainting, or weakness may occur. If the blood pressure drop is significant, it may lead to shock. The patient's skin may become cold and clammy, and they may lose consciousness. If the patient goes to the hospital or is treated for another illness, the medical staff should be informed about the use of Rosuvastatin/Amlodipine Teva.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may occur within 24-48 hours after taking the medicine.

Missing a dose of Rosuvastatin/Amlodipine Teva

There is no need to worry. If the patient forgets to take a capsule, they should skip that dose completely. The next dose should be taken at the usual time. A double dose should not be taken to make up for the missed dose.

Stopping treatment with Rosuvastatin/Amlodipine Teva

The doctor will determine how long the patient should take this medicine. Stopping treatment with Rosuvastatin/Amlodipine Teva may cause cholesterol levels to rise again. If the patient stops taking the medicine earlier than recommended by the doctor, the disease may return.
If there are any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following serious side effects occur, the patient should stop taking the medicine and contact their doctor immediately:

• sudden, wheezing breath, chest pain, shortness of breath, or difficulty breathing
• swelling of the eyelids, face, or lips
• swelling of the tongue or throat, causing severe difficulty breathing and (or) swallowing
• severe rash, redness of the skin all over the body, blistering, peeling, or scaling of the skin (toxic epidermal necrolysis)
• red, flat, round, or oval patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and 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 drug hypersensitivity syndrome)
• other allergic reactions
• heart attack, irregular heartbeat
• pancreatitis, which can cause severe abdominal and back pain, with very poor general condition

In addition, the patient should stop taking Rosuvastatin/Amlodipine Teva and contact their doctor immediately:

• if the patient experiences any unusual muscle painthat lasts longer than expected. Like other statins, rosuvastatin has rarely caused unpleasant muscle symptoms, which in rare cases have developed into a potentially life-threatening muscle damage called rhabdomyolysis
• if the patient experiences muscle rupture
• if the patient develops a lupus-like syndrome (including rash, joint disorders, and effects on blood cells)

SIDE EFFECTS ASSOCIATED WITH ROSUVASTATIN
Common side effects(may affect up to 1 in 10 people):

• headache
• abdominal pain
• constipation
• nausea
• muscle pain
• feeling weak
• dizziness
• diabetes. The risk of developing diabetes is higher if the patient's blood sugar and fat levels are high, they are overweight, and have high blood pressure. During treatment with this medicine, the doctor will monitor the patient

Uncommon side effects(may affect up to 1 in 100 people):

• rash, itching, or other skin reactions
• increased protein in the urine - usually returns to normal without the need to stop taking Rosuvastatin/Amlodipine Teva

Rare side effects(may affect up to 1 in 1,000 people):

• increased liver enzyme activity in the blood
• bleeding or easier bruising due to a low platelet count
• severe allergic reaction - symptoms include swelling of the face, lips, tongue, and (or) throat, difficulty swallowing and breathing, severe itching of the skin (with hives). If the patient thinks they have had an allergic reaction, they should stop taking Rosuvastatin/Amlodipine Teva and seek medical attention immediately
• lupus-like syndrome (including rash, joint disorders, and effects on blood cells)
• muscle rupture

Very rare side effects(may affect up to 1 in 10,000 people):

• jaundice (yellowing of the skin and eyes)
• liver inflammation
• blood in the urine
• nerve damage in the legs and arms (e.g., numbness)
• joint pain
• memory loss
• gynecomastia (breast enlargement in men)

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

• diarrhea (loose stools)
• cough
• shortness of breath
• swelling
• sleep disorders, including insomnia and nightmares
• sexual problems
• depression
• breathing difficulties, including prolonged cough and (or) shortness of breath or fever
• tendon damage
• nerve damage that can cause muscle weakness, numbness, and tingling

SIDE EFFECTS ASSOCIATED WITH AMLODIPINE
If the patient experiences any of the following side effects, they should contact their doctor:

• very common side effects (may affect more than 1 in 10 people):
• swelling (fluid retention)

Common side effects(may affect up to 1 in 10 people):

• headache, dizziness, drowsiness (especially at the start of treatment)
• palpitations (feeling of a strong heartbeat), flushing
• abdominal pain, nausea
• swelling of the ankles
• changes in bowel movements, diarrhea, or constipation
• indigestion
• muscle cramps
• feeling weak, tired
• vision disturbances, double vision

The following list includes other reported side effects. If any of the following side effects worsen or if side effects not listed in the leaflet occur, the doctor or pharmacist should be informed:

• changes in mood, anxiety, depression, insomnia
• tremors, taste disturbances, fainting, weakness
• numbness or tingling sensation in the limbs, loss of sensation
• ringing in the ears
• low blood pressure
• coughing or runny nose due to nasal inflammation (rhinitis)
• cough
• dry mouth, vomiting
• hair loss, increased sweating, itching, redness of the skin, skin discoloration
• urination disorders, increased need to urinate at night, increased frequency of urination
• impotence, discomfort, or breast enlargement in men
• pain, poor general condition
• joint or muscle pain, back pain
• weight gain or loss

Rare side effects(may affect up to 1 in 1,000 people):

• confusion

Very rare side effects(may affect up to 1 in 10,000 people):

• decreased white blood cell count, decreased platelet count, which can lead to increased bruising and bleeding
• increased blood sugar levels (hyperglycemia)
• nerve damage that can cause muscle weakness, numbness, and tingling
• gum swelling
• abdominal bloating (gastritis)
• liver function disorders, liver inflammation, jaundice (yellowing of the skin and eyes), increased liver enzyme activity, which can affect the results of some laboratory tests
• increased muscle tone
• vasculitis, often with a skin rash
• photosensitivity
• disorders including stiffness, tremors, and (or) movement disorders

If any of the above side effects worsen or if side effects not listed in the leaflet occur, the doctor or pharmacist should be informed.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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; Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Rosuvastatin/Amlodipine Teva

The medicine should be stored out of sight and reach of children.
This medicine should not be used 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 light.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

The active substances of the medicine are rosuvastatin (in the form of rosuvastatin calcium) and amlodipine (in the form of amlodipine besylate).
10 mg + 5 mg: Each hard capsule contains 10 mg of rosuvastatin (in the form of rosuvastatin calcium) and 5 mg of amlodipine (in the form of amlodipine besylate).
10 mg + 10 mg: Each hard capsule contains 10 mg of rosuvastatin (in the form of rosuvastatin calcium) and 10 mg of amlodipine (in the form of amlodipine besylate).
20 mg + 5 mg: Each tablet contains 20 mg of rosuvastatin (in the form of rosuvastatin calcium) and 5 mg of amlodipine (in the form of amlodipine besylate).
20 mg + 10 mg: Each tablet contains 20 mg of rosuvastatin (in the form of rosuvastatin calcium) and 10 mg of amlodipine (in the form of amlodipine besylate).
Other ingredients are:
Contents of the capsule:cornstarch (including pregelatinized cornstarch), microcrystalline cellulose type 102, crospovidone (type A), sodium stearylfumarate (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
A hard gelatin capsule, size 1, with a white opaque body with a red print "Aml 5 mg" and a white opaque cap with a green print "Rsv 10 mg".
10 mg + 10 mg
A hard gelatin capsule, size 00, with a white opaque body with a line and a red print "Aml 10 mg" and a white opaque cap with a green print "Rsv 10 mg".
20 mg + 5 mg
A hard gelatin capsule, size 00, with a white opaque body with a red print "Aml 5 mg" and a white opaque cap with a line and a green print "Rsv 20 mg".
20 mg + 10 mg
A hard gelatin capsule, size 00, with a white opaque body with a line and a red print "Aml 10 mg" and a white opaque cap with a line and a green print "Rsv 20 mg".
Rosuvastatin/Amlodipine Teva is available in PA/Aluminum/PVC/Aluminum blisters containing 10, 28, 30, and 100 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands

Manufacturer

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

Merckle GmbH

Ludwig-Merckle-Strasse 3,
89143 Blaubeuren
Germany
Date of last revision of the leaflet:June 2022