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

Rosuvastatin + Amlodipine

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

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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. Package contents 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 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 lower 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, the patient should continue to follow a cholesterol-lowering diet and exercise.

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, they should stop taking the medicine and inform their doctor. 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 cyclosporine (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 patient should discuss it with their doctor or pharmacist:

• 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 it is accompanied by a feeling of illness or fever, the patient should inform their doctor immediately. The patient should also inform their doctor or pharmacist if they experience persistent muscle weakness
• if the patient regularly drinks large amounts of alcohol
• if the patient has thyroid problems
• if the patient is taking other cholesterol-lowering medicines called fibrates. The patient should read the leaflet carefully, even if they have 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 can lead to serious 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

In a small number of people, statins can 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.
During treatment with Rosuvastatin/Amlodipine Teva, serious skin reactions have been reported, including Stevens-Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS). If any of the symptoms described in section 4 occur, the patient should stop taking Rosuvastatin/Amlodipine Teva and contact their doctor immediately.
Patients with diabetes or those 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 taken by children and adolescents.

Rosuvastatin/Amlodipine Teva and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan 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 (e.g., ezetimibe)
• antacids (used to neutralize stomach acid)
• oral contraceptives
• hormone replacement therapy
• ketokonazole, 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, cyclosporine, or other medicines used to control the patient's immune system
• simvastatin (a medicine used to lower cholesterol)
• 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 platelets from clumping and blocking arteries)

If it is necessary to take fusidic acid to treat a bacterial infection, the patient should stop taking Rosuvastatin/Amlodipine Teva during this time. The doctor will inform the patient when it is safe to restart taking Rosuvastatin/Amlodipine Teva. Taking Rosuvastatin/Amlodipine Teva with fusidic acid can rarely lead to muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
Rosuvastatin/Amlodipine Teva may further lower blood pressure in patients who are already taking other blood pressure-lowering 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 can increase the levels of the active substance amlodipine in the blood, which can lead to unexpected intensification of the blood pressure-lowering effect of Rosuvastatin/Amlodipine Teva.

Pregnancy and breastfeeding

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

Driving and using machines

Rosuvastatin/Amlodipine Teva may affect the patient's ability to drive and use machines. Some patients may experience dizziness when taking Rosuvastatin/Amlodipine Teva. If this medicine causes nausea, dizziness, fatigue, or headaches, the patient should not drive or operate machines 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 the patient has any doubts, they should consult their doctor or pharmacist.
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. The patient should not take Rosuvastatin/Amlodipine Teva with grapefruit juice.

Use in children and adolescents

Rosuvastatin/Amlodipine Teva should not be taken by children and adolescents.

Regular cholesterol level checks

It is essential to visit the doctor for regular cholesterol level checks to ensure that the levels have reached and are maintaining the desired values.

Taking a higher dose of Rosuvastatin/Amlodipine Teva than recommended

The patient should contact their doctor or the nearest hospital for advice. Taking too many tablets can cause low or even dangerously low blood pressure. The patient may experience dizziness, fainting, or weakness. If the blood pressure drop is significant, it can 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 receives treatment for another illness, they should inform the medical staff that they are taking Rosuvastatin/Amlodipine Teva.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which can occur within 24-48 hours of 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 and take the next dose at the usual time. The patient should not take a double dose 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 their doctor recommends, the disease may return.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Rosuvastatin/Amlodipine Teva can cause side effects, although not everyone gets them.
If the patient experiences any of the following serious side effects, they 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 inflammation of the mucous membranes (toxic epidermal necrolysis)
• red, flat, plate-like, or round patches on the torso, often with blisters in the center, peeling, or 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 swollen 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 can occasionally worsen and lead to a potentially life-threatening muscle injury 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 they 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 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 help 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 lead to 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 if they cause problems or last longer than a week.
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 this leaflet occur, the patient should inform their doctor or pharmacist.
Uncommon side effects(may affect up to 1 in 100 people):

• mood changes, anxiety, depression, insomnia
• tremors, taste disorders, fainting, weakness
• numbness or tingling sensation in the limbs, loss of sensation
• ringing in the ears
• low blood pressure
• hay fever or runny nose (nasal congestion)
• cough
• dry mouth, vomiting
• hair loss, increased sweating, itching, red spots on the skin, skin discoloration
• urination disorders, increased need to urinate at night, frequent 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 lead to muscle weakness, numbness, and tingling
• gum swelling
• stomach upset (gastritis)
• liver function disorders, liver inflammation, jaundice, increased liver enzyme activity, which can affect the results of some laboratory tests
• increased muscle tone
• blood vessel inflammation, often with a skin rash
• light sensitivity
• disorders including stiffness, tremors, and (or) movement disorders

If the patient experiences any side effects not listed in this leaflet, they should inform their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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.
Do not take 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 light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents 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:
Capsule contents: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
The hard capsule is size 1, with a white opaque body and a red imprint "Aml 5 mg", and a white opaque cap with a green imprint "Rsv 10 mg".
10 mg + 10 mg
The hard capsule is size 00, with a white opaque body and a red imprint "Aml 10 mg", and a white opaque cap with a green imprint "Rsv 10 mg".
20 mg + 5 mg
The hard capsule is size 00, with a white opaque body and a red imprint "Aml 5 mg", and a white opaque cap with a green imprint "Rsv 20 mg".
20 mg + 10 mg
The hard capsule is size 00, with a white opaque body and a red imprint "Aml 10 mg", and a white opaque cap with a green imprint "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