Zahron Combi

Leaflet accompanying the packaging: patient information

Zahron Combi, 10 mg + 5 mg, hard capsules

Zahron Combi, 10 mg + 10 mg, hard capsules

Zahron Combi, 20 mg + 5 mg, hard capsules

Zahron Combi, 20 mg + 10 mg, hard capsules

Rosuvastatine + Amlodipine

It is essential to carefully read the contents of the leaflet 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 patient should consult a doctor or pharmacist.
• 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 inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Zahron Combi and what is it used for

Zahron Combi contains two active substances - rosuvastatine and amlodipine.
Zahron Combi is indicated in adult patients for the treatment of high blood pressure and high cholesterol levels when diet and physical activity have proven insufficient to achieve a reduction in cholesterol levels and (or) prevention of cardiovascular events, if other risk factors are present that increase the risk of myocardial infarction, stroke, or related health disorders.
Zahron Combi is indicated in patients who are already taking rosuvastatine and amlodipine in the same doses as in Zahron Combi. Patients already taking rosuvastatine and amlodipine in separate tablets may take one tablet of Zahron Combi, containing both active substances in the same doses.
During treatment with Zahron Combi, the patient should continue to follow a cholesterol-lowering diet and exercise.

2. Important information before taking Zahron Combi

When not to take Zahron Combi:

• if the patient is allergic to rosuvastatine, amlodipine, another calcium channel blocker, or any of the other ingredients of this medicine (listed in section 6);
• if the patient is pregnant or breastfeeding, if the patient becomes pregnant while taking Zahron Combi, they should stop taking the medicine and consult a doctor; women of childbearing age taking Zahron Combi 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 to prevent organ rejection);
• if the patient has very low blood pressure (severe 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 sufficient blood);
• if the patient has heart failure after a myocardial infarction.

Warnings and precautions

Before starting treatment with Zahron Combi, 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 while taking other cholesterol-lowering medicines; if unexplained muscle pain occurs, especially if accompanied by malaise or fever, the patient should immediately inform their doctor; the patient should also inform their doctor or pharmacist if they experience persistent muscle weakness;
• if the patient regularly consumes large amounts of alcohol;
• if the patient has thyroid problems;
• if the patient is taking other cholesterol-lowering medicines, called fibrates; the patient should carefully read the leaflet, even if they have taken other cholesterol-lowering medicines in the past;
• if the patient is taking medicines used to treat HIV, such as ritonavir with lopinavir and (or) atazanavir, see section "Zahron Combi and other medicines";
• if the patient is taking or has taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) orally or by injection; taking Zahron Combi with fusidic acid may lead to severe muscle problems (rhabdomyolysis);
• if the patient has severe respiratory failure;
• if the patient has recently had a myocardial infarction;
• if the patient has heart failure;
• if the patient has had a significant increase in blood pressure (hypertensive crisis);
• if the patient is elderly;
• if the patient is of Asian origin: Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian; the doctor must choose an appropriate initial dose of Zahron Combi for the patient.

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 Zahron Combi.
Patients with diabetes or at risk of developing diabetes will be closely monitored by their doctor while taking this medicine. People with high blood sugar and fat levels, overweight, and high blood pressure may be at risk of developing diabetes.

Children and adolescents

Zahron Combi should not be taken by children and adolescents.

Zahron Combi 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.
Zahron Combi may change the effect of the following medicines or these medicines may change the effect of Zahron Combi:

• 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;
• ritonavir with lopinavir and (or) atazanavir, indinavir, nelfinavir (medicines used to treat HIV infection, see section "Warnings and precautions");
• 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);
• temsirolimus or other medicines used to treat cancer (chemotherapy);
• everolimus, tacrolimus, cyclosporine, or other medicines (used to control the patient's immune system, allowing the acceptance of a transplanted organ);
• 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, given alone or in combination with other medicines (see "Warnings and precautions"): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

If it is necessary to take fusidic acid to treat a bacterial infection, the patient should stop taking Zahron Combi during this time. The doctor will inform the patient when it is safe to restart taking Zahron Combi. Taking Zahron Combi with fusidic acid may rarely lead to muscle weakness, sensitivity, or pain (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.
Zahron Combi may further lower blood pressure in patients already taking other antihypertensive medicines.

Zahron Combi with food and drink

Zahron Combi can be taken with or without food.
Patients taking Zahron Combi should not drink grapefruit juice or eat grapefruits, as grapefruits and grapefruit juice may increase the levels of the active substance amlodipine in the blood, which may lead to unexpected intensification of the blood pressure-lowering effect of Zahron Combi.

Pregnancy and breastfeeding

Zahron Combi should not be taken during pregnancy or breastfeeding. If the patient becomes pregnant while taking Zahron Combi, they should stop taking the medicine and consult a doctor. Women of childbearing age taking Zahron Combi should use effective methods of contraception.

Driving and using machines

Zahron Combi may impair the ability to drive and use machines. Some patients may experience dizziness while taking Zahron Combi. If the medicine causes nausea, dizziness, fatigue, or headache, the patient should not drive or operate machines and should consult a doctor immediately.

3. How to take Zahron Combi

This medicine should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult a doctor or pharmacist.
The recommended dose is one tablet 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. Zahron Combi should not be taken with grapefruit juice.

Use in children and adolescents

Zahron Combi 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 been reduced and are being maintained within the appropriate range.
The doctor may decide to increase the dose so that the patient takes the appropriate amount of Zahron Combi for their needs.

Taking a higher dose of Zahron Combi than recommended

The patient should consult a doctor or the nearest hospital for advice. Taking too many tablets may cause low or even dangerously low blood pressure. The patient may experience dizziness, fainting, or weakness. 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 receives treatment for another illness, they should inform the medical staff that they are taking Zahron Combi.

Missing a dose of Zahron Combi

There is no need to worry. If the patient forgets to take a tablet, 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 Zahron Combi

The doctor will determine how long the patient should take the medicine. Stopping treatment with Zahron Combi may cause cholesterol levels to rise again. If the patient stops taking the medicine earlier than recommended by the doctor, the illness may return.
If the patient has any further doubts about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Zahron Combi can cause side effects, although not everybody gets them.
If the patient experiences any of the following very rare, serious side effects, they should immediately consult a doctor:

• 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 breathing or swallowing difficulties;
• severe skin reactions, including intense rash, hives, redness of the skin, severe itching, blistering, peeling, or swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome) or other allergic reactions;
• myocardial infarction, abnormal heartbeat;
• pancreatitis, which may cause severe abdominal and back pain, with very poor general condition.

In addition, the patient should stop taking Zahron Combi and immediately consult a doctor if they experience any unusual muscle pain

that lasts longer than expected. As with other statins, very rare, unpleasant muscle symptoms have occurred, which have rarely worsened, leading to potentially life-threatening muscle damage called rhabdomyolysis.
If any of the following commonly reported side effects are troublesome or last longer than a week, the patient should consult a doctor.
ROSUVASTATINE
Common side effects(may affect up to 1 in 10 people):

• headache
• abdominal pain
• constipation
• nausea
• muscle pain
• feeling weak
• dizziness
• slightly increased protein in the urine - usually returns to normal without the need to stop taking Zahron Combi
• 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 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 Zahron Combi (applies to doses of 5-20 mg)

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

• 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 immediately stop taking Zahron Combi and seek medical attention
• muscle damage in adults - as a precaution, the patient should stop taking Zahron Combi and immediately consult a doctor if they experience any unusual muscle painthat lasts longer than expected
• severe abdominal pain (pancreatitis)
• increased liver enzyme activity in the blood
• reduced platelet count, which may increase the risk of bleeding or bruising (thrombocytopenia)

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)
• Stevens-Johnson syndrome (a severe disease with blisters on the skin, mouth, eyes, and genitals)
• cough
• shortness of breath
• swelling
• sleep disorders, including insomnia and nightmares
• breathing difficulties, including prolonged cough and (or) shortness of breath or fever
• tendon damage
• nerve damage that can cause weakness, numbness, and tingling

AMLODIPINE
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 beginning of treatment)
• palpitations (feeling of strong heartbeat), sudden flushing, especially of the face
• abdominal pain, nausea
• swelling of the ankles, rapid fatigue
• diarrhea or constipation
• indigestion
• muscle cramps
• feeling weak
• vision disturbances, double vision

If the patient experiences any of the following other side effects or if they worsen or last longer than a week, they should consult a doctor or pharmacist.
Uncommon side effects(may affect up to 1 in 100 people):

• mood changes, anxiety, depression, insomnia
• tremors, taste disturbances, fainting, feeling of fainting
• numbness or tingling in the limbs, loss of pain sensation
• ringing in the ears
• low blood pressure
• cough or runny nose due to nasal mucosal inflammation (rhinitis)
• dry mouth, vomiting
• hair loss, increased sweating, itching, skin rash, skin discoloration
• urination disorders, increased need to urinate at night, frequent urination
• impotence, discomfort, or breast enlargement in men
• abnormal heart rhythm
• shortness of breath
• cough
• rash, itching, hives
• pain, abdominal pain, malaise
• joint or muscle pain, back pain
• weight gain or loss

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

• disorientation

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

• reduced white blood cell count, reduced platelet count, which may lead to increased bruising and bleeding (bone marrow failure)
• increased blood sugar levels (hyperglycemia)
• nerve damage that can cause weakness, numbness, and tingling
• gum swelling
• abdominal bloating (gastritis)
• liver function disorders, liver inflammation, yellowing of the skin (jaundice), increased liver enzyme activity, which may affect the results of some laboratory tests
• increased muscle tension
• blood vessel inflammation, often with accompanying skin rash
• sensitivity to light
• disorders including stiffness, tremors, and (or) movement disorders
• myocardial infarction
• allergic reaction
• severe abdominal pain (pancreatitis)
• severe skin reactions, including intense rash, hives, redness of the skin, severe itching, blistering, peeling, or swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome) or other allergic reactions

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Zahron Combi

The medicine should be stored out of sight and reach of children.
The medicine should not be taken 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. Contents of the packaging and other information

The active substances of the medicine are rosuvastatine (in the form of rosuvastatine calcium) and amlodipine (in the form of amlodipine besylate).
10 mg + 5 mg: each hard capsule contains 10 mg of rosuvastatine (in the form of rosuvastatine calcium) and 5 mg of amlodipine (in the form of amlodipine besylate).
10 mg + 10 mg: each hard capsule contains 10 mg of rosuvastatine (in the form of rosuvastatine calcium) and 10 mg of amlodipine (in the form of amlodipine besylate).
20 mg + 5 mg: each film-coated tablet contains 20 mg of rosuvastatine (in the form of rosuvastatine calcium) and 5 mg of amlodipine (in the form of amlodipine besylate).
20 mg + 10 mg: each film-coated tablet contains 20 mg of rosuvastatine (in the form of rosuvastatine calcium) and 10 mg of amlodipine (in the form of amlodipine besylate).
The other ingredients are:
Capsule content:cornstarch, pregelatinized cornstarch, microcrystalline cellulose, crospovidone (type A), sodium stearyl fumarate
Capsule shell: gelatin, titanium dioxide (E171)
Body of the capsule (red ink): shellac, propylene glycol (E1520), ammonium hydroxide, iron oxide red (E172), potassium hydroxide
Capsule cap (green ink): shellac, titanium dioxide (E171), indigo carmine (E132), iron oxide yellow (E172), ammonium hydroxide, propylene glycol

What Zahron Combi looks like and contents of the pack

10 mg + 5 mg: hard gelatin capsule, size 1, with a white matte body with red printing "Aml 5 mg" and a white matte cap with green printing "Rsv 10 mg"
10 mg + 10 mg: hard gelatin capsule, size 00, with a white matte body with red printing "Aml 10 mg and line" and a white matte cap with green printing "Rsv 10 mg"
20 mg + 5 mg: hard gelatin capsule, size 00, with a white matte body with red printing "Aml 5 mg" and a white matte cap with green printing "Rsv 20 mg and line"
20 mg + 10 mg: hard gelatin capsule, size 00, with a white matte body with red printing "Aml 10 mg and line" and a white matte cap with green printing "Rsv 20 mg and line"
Zahron Combi is available in blisters containing 28, 56 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Date of last revision of the leaflet:02.2019