Kastel

Leaflet accompanying the packaging: patient information

Kastel, 10 mg + 5 mg, hard capsules

Kastel, 10 mg + 10 mg, hard capsules

Kastel, 20 mg + 5 mg, hard capsules

Kastel, 20 mg + 10 mg, hard capsules

Rosuvastatinum + Ramiprilum

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

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

Table of contents of the leaflet

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

1. What is Kastel and what is it used for

Kastel contains two different active substances in one capsule: rosuvastatin and ramipril.
Rosuvastatin belongs to a group of medicines called statins, which regulate lipid levels (fats)
in the body.
Ramipril is an angiotensin-converting enzyme (ACE) inhibitor. In patients with high blood pressure, the medicine dilates blood vessels, making it easier for the heart to pump blood.
Kastel is used to treat high blood pressure (hypertension) in adults who also have one of the following disorders:

• high cholesterol levels (primary hypercholesterolemia) or
• high levels of cholesterol and other fats (triglycerides) (mixed hyperlipidemia) and (or)
• increased risk of heart attack, stroke, or other similar diseases, whose risk can be reduced with Kastel.

Kastel is intended for patients who are already taking rosuvastatin and ramipril in separate
tablets. Instead of two separate tablets of rosuvastatin and ramipril, one Kastel capsule can be taken,
containing these two active substances in the same strengths.
During treatment with Kastel, the patient should continue to follow a cholesterol-lowering diet.
Kastel is not a weight loss medicine.

2. Important information before taking Kastel

When not to take Kastel:

• If the patient is allergic to ramipril, another ACE inhibitor, rosuvastatin, or any of the other ingredients of the medicine (listed in section 6). The symptoms of an allergic reaction may be: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue;
• If the patient has ever had a severe allergic reaction called "angioedema". The symptoms include: itching, hives, red spots on the hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and mouth, difficulty breathing and swallowing;
• If the patient has taken sacubitril/valsartan recently (within the last 36 hours) or is currently taking it, a medicine used to treat chronic heart failure;
• If the patient is undergoing dialysis or another type of blood filtration. Depending on the device used, treatment with Kastel may not be suitable;
• If the patient has kidney diseases that reduce blood flow to the kidney (renal artery stenosis) or has severe kidney dysfunction;
• If the patient is pregnant or breastfeeding. If the patient becomes pregnant while taking Kastel, they should stop taking the medicine immediately and inform their doctor. While taking Kastel, women should avoid becoming pregnant using appropriate contraceptive methods (see also the section "Pregnancy and breastfeeding");
• If the patient has abnormally low or unstable blood pressure. This requires an assessment by a doctor;
• If the patient has diabetes or kidney disease and is taking a blood pressure-lowering medicine containing aliskiren;
• If the patient has liver disease;
• If the patient has recurring muscle pain of unknown cause (myopathy);
• If the patient is taking a combination of medicines sofosbuvir/velpatasvir/voxilaprevir (medicines used to treat viral hepatitis C);
• If the patient is taking a medicine called cyclosporine (used, for example, after organ transplants);
• If the patient has ever had severe skin reactions, such as a rash or blistering of the skin, after taking Kastel or other medicines containing rosuvastatin.

If any of the above situations occur, Kastel should not be taken. In case of doubts, before taking Kastel, the patient should consult a doctor.

Warnings and precautions:

Before starting treatment with Kastel, the patient should consult a doctor or pharmacist:

• If the patient has heart, liver, or kidney disease;
• If the patient has lost a large amount of salt or fluids (due to vomiting, diarrhea, excessive sweating, low-salt diet, or prolonged use of diuretics or dialysis);
• If the patient plans to undergo allergy treatment for bee or wasp stings (desensitization);
• If the patient is to undergo anesthesia. This may be anesthesia for surgery or a dental procedure. It may be necessary to stop taking Kastel the day before anesthesia; in such a case, the patient should consult a doctor.
• If the patient has high levels of potassium in the blood (detected in a blood test);
• If the patient is taking medicines or has diseases that can lower sodium levels in the blood. The doctor may recommend regular blood tests to check sodium levels in the blood, especially in elderly patients;
• If the patient is taking medicines that can increase the risk of a severe allergic reaction called angioedema, such as mTOR inhibitors (e.g., temsirolimus, everolimus, sirolimus), wildagliptin, neprilysin inhibitors (NEP) (such as racecadotril) or sacubitril/valsartan. Information about sacubitril/valsartan, see section 2. "When not to take Kastel";
• If the patient has collagenosis, such as scleroderma or systemic lupus erythematosus;
• If the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin receptor antagonist (ARB) (also known as sartans, including valsartan, telmisartan, irbesartan), especially if the patient has diabetic kidney disease.
• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium). See also the information under the heading "When not to take Kastel" and "Warnings and precautions";
• If the patient experiences recurring or unexplained muscle pain, if they or their family members have had muscle diseases, or if they have had muscle problems while 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 immediately inform their doctor. The doctor should also be informed if there is persistent muscle weakness;
• If the patient has myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or myasthenic syndrome (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate the symptoms of the disease or cause myasthenia (see section 4);
• If the patient regularly consumes large amounts of alcohol;
• If the patient has abnormal thyroid function (hypothyroidism);
• If the patient is taking other cholesterol-lowering medicines called fibrates (see the section "Kastel and other medicines");
• If the patient is taking medicines used to treat HIV infection, such as ritonavir with lopinavir and (or) atazanavir, see the sections "When not to take Kastel" and "Warnings and precautions";
• If the patient is taking or has taken within the last 7 days, orally or by injection, a medicine containing fusidic acid (an antibiotic). If it is necessary to take fusidic acid to treat a bacterial infection, the patient will have to stop taking Kastel for a while. The doctor will determine when it is safe to resume taking Kastel. Taking Kastel with fusidic acid can rarely lead to muscle weakness, tenderness, and pain (rhabdomyolysis), see section 4;
• If the patient is over 70 years old (as the doctor will have to choose the appropriate dose of Kastel);
• If the patient has severe respiratory failure;
• If the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea, or India). The doctor will have to choose the appropriate dose of Kastel.

If any of the above situations occur (or in case of any doubts), before taking Kastel, the patient should consult a doctor or pharmacist.
In connection with the use of rosuvastatin, severe skin reactions have been reported, such as Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS). If any of the symptoms described in section 4 are noticed, the patient should stop taking Kastel immediately and consult a doctor.
In a small number of patients, statins can damage the liver. This can be detected by a simple blood test to measure liver enzyme levels.
For this reason, during treatment with Kastel, the doctor will regularly order blood tests (liver function tests). It is essential that the patient undergoes the laboratory tests ordered by the doctor.
During treatment with this medicine, the doctor will carefully monitor patients who have diabetes or are at risk of developing diabetes. The increased risk of developing diabetes applies to people who have high levels of sugar and fat in the blood, are overweight, or have high blood pressure.

Children and adolescents

Kastel should not be used in children and adolescents under 18 years of age.

Kastel and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken. This is necessary because Kastel can affect the action of other medicines. Other medicines can also affect the action of Kastel.
The patient should tell their doctor about the following medicines:

• Medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs, such as ibuprofen, indomethacin, or acetylsalicylic acid) ;
• Medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, norepinephrine, or adrenaline. The doctor will monitor the patient's blood pressure;
• Sacubitril/valsartan - used to treat a certain type of chronic heart failure in adults (see section 2. "When not to take Kastel");
• Cyclosporine (used, for example, after transplants to prevent rejection of the transplanted organ. Do not take Kastel while being treated with cyclosporine;
• Cancer medicines (used in chemotherapy, such as regorafenib, darolutamide);
• Diuretics, such as furosemide;
• Medicines that can increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim - alone or in combination with sulfamethoxazole (used to treat infections) and heparin (used to thin the blood);
• Corticosteroids used to treat inflammation, such as prednisolone;
• Allopurinol (a medicine that lowers uric acid levels in the blood);
• Procainamide (used to treat heart rhythm disorders);
• Temsirolimus (used to treat cancer);
• Sirolimus, everolimus (medicines that prevent transplant rejection);
• Wildagliptin (used to treat type 2 diabetes);
• Racecadotril (a medicine used to treat diarrhea);
• It is possible that the treating doctor will need to change the dose and (or) take other precautions if the patient is taking an angiotensin receptor antagonist (ARB) or aliskiren (see also the information under the heading "When not to take Kastel" and "Warnings and precautions");
• Medicines used to treat diabetes, such as oral hypoglycemic agents and insulin. Kastel can lower blood sugar levels. During treatment with Kastel, the patient's blood sugar levels should be carefully monitored;
• Lithium (used to treat mental illnesses). Kastel can increase lithium levels in the blood. The patient will require careful monitoring of lithium levels in the blood by the doctor;
• Warfarin, ticagrelor, or clopidogrel, or other blood-thinning medicines (if taken with Kastel, their blood-thinning effect may increase, and the risk of bleeding may increase);
• Fibrates (such as gemfibrozil, fenofibrate) or another cholesterol-lowering medicine (such as ezetimibe). If taken with Kastel, the effect of rosuvastatin may increase;
• Antacids containing aluminum and magnesium (used to neutralize stomach acid; they can decrease rosuvastatin levels in the blood). This effect can be reduced by taking such a medicine 2 hours after taking rosuvastatin;
• Erythromycin (an antibiotic). If taken with Kastel, the effect of rosuvastatin may decrease;
• Fusidic acid (an antibiotic). If it is necessary to take fusidic acid to treat a bacterial infection, the patient will have to stop taking Kastel for a while. The doctor will determine when it is safe to resume taking Kastel. Taking Kastel with fusidic acid can rarely lead to muscle weakness, tenderness, and pain (rhabdomyolysis), see section 4;
• Oral contraceptives (the pill). The absorption of sex hormones from the pill may increase;
• Kapmatinib (used to treat cancer)
• Hormone replacement therapy (increased hormone activity in the blood);
• Fosfamatinib (used to treat low platelet count);
• Febuxostat (used to prevent and treat high uric acid levels in the blood);
• Teriflunomide (used to treat multiple sclerosis);
• Antiviral medicines, such as ritonavir, lopinavir, atazanavir, sofosbuvir, velpatasvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir (used to treat infections, including HIV and hepatitis C). See the sections "When not to take Kastel" and "Warnings and precautions".

If any of the above situations occur (or in case of any doubts), before taking Kastel, the patient should consult a doctor.
If the patient is going to the hospital or receiving treatment for another illness, they should inform the medical staff that they are taking Kastel.

Kastel and alcohol

Drinking alcohol while taking Kastel may cause dizziness. If in doubt about the amount of alcohol that can be consumed while taking Kastel, the patient should consult a doctor, as blood pressure-lowering medicines can have an additive effect with alcohol.

Pregnancy and breastfeeding

Pregnancy
Kastel should not be taken during pregnancy, planned pregnancy, or suspected pregnancy, as taking the medicine during pregnancy may be harmful to the fetus. If a woman becomes pregnant while taking Kastel, she should stop taking the medicine immediately and inform her doctor. While taking Kastel, women should avoid becoming pregnant using appropriate contraceptive methods.
Breastfeeding
Kastel should not be taken during breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and operating machinery

Some people may experience dizziness while taking Kastel. If dizziness occurs, the patient should consult a doctor before driving a car or operating machinery.

Kastel contains sodium

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

3. How to take Kastel

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, the patient should consult a doctor or pharmacist.
While taking Kastel, the patient should continue to follow a low-cholesterol diet.
The recommended daily dose is one capsule of Kastel of the specified strength.

Kastel should be taken once a day.

The medicine should be taken every day at the same time, with or without food.
The capsule should be swallowed whole and washed down with water.

Use in children and adolescents

Kastel should not be used in children and adolescents under 18 years of age.

Taking a higher dose of Kastel than recommended

The patient should immediately consult a doctor or go to the nearest hospital, as medical attention may be necessary. The patient should not drive themselves to the hospital, but should ask someone to drive them or call an ambulance. The patient should take the medicine packaging with them.
This will allow the doctor to know what medicine was taken.

Missing a dose of Kastel

There is no need to worry; the patient should simply take the next dose of Kastel at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Kastel

If the patient wants to stop taking Kastel, they should tell their doctor.
In case of further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Kastel can cause side effects, although not everyone will experience them.
It is essential to know what side effects can occur.

If any of the following severe side effects occur, the patient should stop taking Kastel and consult a doctor immediately – urgent medical attention may be necessary:

• Swelling of the face, lips, tongue, and (or) throat, causing difficulty breathing or swallowing, as well as itching and rash. This may be a sign of a severe allergic reaction to Kastel.
• Severe skin reactions, such as red, flat, plate-like, or circular spots on the torso, often with central blistering and peeling of the skin, oral, throat, nose, genital, and eye ulcers, these severe skin reactions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome), exacerbation of existing skin disease (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).
• Widespread rash, high fever, and swollen lymph nodes (DRESS or hypersensitivity syndrome).
• Unusual muscle pain lasting longer than expected. In rare cases, this can lead to potentially life-threatening muscle damage, called rhabdomyolysis, which can cause general breakdown, fever, and impaired kidney function.
• Rheumatoid-like syndrome (rash, joint disorders, and blood disorders).
• Muscle rupture.

The patient should immediately inform their doctor if they experience:

• Fast heartbeat, irregular or strong heartbeat (palpitations), chest pain, feeling of tightness in the chest, or more serious problems, such as a heart attack or stroke.
• Shortness of breath or cough. These may be symptoms of lung disease.
• Easy bruising, prolonged bleeding, bleeding of various types (e.g., bleeding from the gums), red spots on the skin, or increased tendency to infection, sore throat, and fever, feeling of tiredness, fainting, dizziness, or paleness of the skin. These may be symptoms of blood or bone marrow disease.
• Severe abdominal pain that may radiate to the back. This may be a sign of pancreatitis.
• Fever, chills, fatigue, loss of appetite, abdominal pain, nausea, yellowing of the skin or eyes (jaundice). These may be symptoms of liver problems, such as hepatitis or liver damage.

Other side effects:

If any of the following side effects worsen or persist for more than a few days, the patient should inform their doctor:
Common(may occur in up to 1 in 10 patients)

• Headache or feeling of tiredness, weakness
• Dizziness
• Fainting, low blood pressure (hypotension), especially when standing up quickly or sitting up from a lying position
• Dry, persistent cough, sinusitis, or bronchitis, shortness of breath
• Abdominal pain, constipation, diarrhea, indigestion, nausea
• Rash with raised skin lesions or without
• Chest pain
• Muscle cramps or pain
• Higher than normal potassium levels in blood tests
• Diabetes. The increased risk of developing diabetes applies to people who have high levels of sugar and fat in the blood, are overweight, and have high blood pressure. During treatment with Kastel, the patient will be under close medical supervision.

Uncommon(may occur in up to 1 in 100 patients)

• Balance disorders (dizziness)
• Itching or abnormal sensations, such as tingling, numbness, prickling, burning, or tingling of the skin (paresthesia)
• Taste disturbances or loss of taste
• Sleep disorders, including excessive sleepiness
• Feeling of depression, anxiety, increased nervousness, or restlessness
• Nasal congestion, difficulty breathing, or worsening of asthma
• Severe abdominal pain (pancreatitis)
• Intestinal edema, characterized by abdominal pain, vomiting, and diarrhea
• Heartburn, dry mouth
• Frequent urination
• Increased sweating
• Loss of appetite (anorexia)
• Fast or irregular heartbeat
• Swelling of the hands or feet. This may be a sign of increased water retention in the body
• Hot flashes
• Blurred vision
• Joint pain
• Fever
• Impotence in men, decreased libido in men or women
• Increased levels of a certain type of white blood cell (eosinophilia) detected in a blood test
• Blood test results indicating liver, pancreas, or kidney dysfunction
• Rash, itching, or other skin reactions
• Increased protein in the urine - usually resolves on its own without the need to stop taking Kastel

Rare(may occur in up to 1 in 1,000 patients)

• Feeling of trembling or confusion
• Vasoconstriction, decreased perfusion (hypoperfusion), vasculitis (inflammation of blood vessels)
• Tongue redness and swelling
• Severe skin peeling or skin separation, itchy, lumpy rash
• Nail problems (e.g., nail plate movement or separation from the nail bed)
• Skin rash or bruising
• Spots on the skin and discoloration of the extremities
• Redness, itching, swelling, or tearing of the eyes
• Hearing disorders or ringing in the ears
• Blood test results indicating decreased red blood cell, white blood cell, or platelet count, or decreased hemoglobin levels

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

• Increased sensitivity to sunlight
• Jaundice (yellowing of the skin and whites of the eyes), hepatitis, blood in the urine, nerve damage in the hands or feet (numbness), joint pain, memory loss, and breast enlargement in men (gynecomastia)

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

• Concentration disorders
• Lip swelling
• Blood test results indicating low blood cell count (all types)
• Blood test results indicating low sodium levels in the blood
• Concentrated (dark) urine, nausea, or vomiting, muscle cramps, confusion, and seizures, which may be caused by abnormal secretion of antidiuretic hormone. If such symptoms occur, the patient should consult a doctor as soon as possible
• Depression
• Change in finger and toe color after freezing and then tingling or pain after warming (Raynaud's phenomenon)
• Slowed or dulled reactions
• Burning sensation
• Change in sense of smell
• Hair loss
• Cough
• Sleep disorders, including insomnia and nightmares
• Tendon damage and persistent muscle weakness
• Myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing)
• Myasthenic syndrome (a disease that causes muscle weakness in the eyes). The patient should consult a doctor if they experience muscle weakness in the arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02 222 Warsaw
Phone: + 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 to gather more information on the safety of the medicine.

5. How to store Kastel

Store in a place inaccessible to children.
Store in a temperature below 25 °C in the original packaging, protected from light and moisture.
Do not use the medicine after the expiration date stated on the box and blister pack after the abbreviation EXP: The expiration date refers to the last day of the given month.
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

What Kastel contains

The active substances of the medicine are rosuvastatin and ramipril.
Kastel, 10 mg + 5 mg, hard capsules:
The capsules contain calcium rosuvastatin in an amount equivalent to 10 mg of rosuvastatin and 5 mg of ramipril.
Kastel, 10 mg + 10 mg, hard capsules:
The capsules contain calcium rosuvastatin in an amount equivalent to 10 mg of rosuvastatin and 10 mg of ramipril.
Kastel, 20 mg + 5 mg, hard capsules:
The capsules contain calcium rosuvastatin in an amount equivalent to 20 mg of rosuvastatin and 5 mg of ramipril.
Kastel, 20 mg + 10 mg, hard capsules:
The capsules contain calcium rosuvastatin in an amount equivalent to 20 mg of rosuvastatin and 10 mg of ramipril.
Other ingredients are:
Filler:silicified microcrystalline cellulose [microcrystalline cellulose (E460), anhydrous colloidal silica (E551)], magnesium stearate (E572), anhydrous colloidal silica (E551), microcrystalline cellulose (E460), crospovidone type B, hypromellose, sodium stearyl fumarate, hydrophobic colloidal silica, yellow iron oxide (E172).
Capsule shell:
Kastel, 10 mg + 5 mg, hard capsules:
Body: titanium dioxide (E 171), black iron oxide (E 172), gelatin
Caps: titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172), gelatin
Kastel, 10 mg + 10 mg, hard capsules:
Body: titanium dioxide (E 171), red iron oxide (E 172), gelatin
Caps: titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172), gelatin
Kastel, 20 mg + 5 mg, hard capsules:
Body: titanium dioxide (E 171), black iron oxide (E 172), gelatin
Caps: titanium dioxide (E 171), red iron oxide (E 172), gelatin
Kastel, 20 mg + 10 mg, hard capsules:
Body: titanium dioxide (E 171), red iron oxide (E 172), gelatin
Caps: titanium dioxide (E 171), red iron oxide (E 172), gelatin

What Kastel looks like and contents of the pack

Kastel, 10 mg + 5 mg, hard capsules:
Unmarked, self-locking hard gelatin capsules of Coni Snap type, size 2, with a white body and reddish-brown cap, filled with 2 tablets.
Kastel, 10 mg + 10 mg, hard capsules:
Unmarked, self-locking hard gelatin capsules of Coni Snap type, size 0, with a pink body and reddish-brown cap, filled with 2 tablets.
Kastel, 20 mg + 5 mg, hard capsules:
Unmarked, self-locking hard gelatin capsules of Coni Snap type, size 0, with a white body and reddish-brown cap, filled with 2 tablets.
Kastel, 20 mg + 10 mg, hard capsules:
Unmarked, self-locking hard gelatin capsules of Coni Snap type, size 0, with a pink body and reddish-brown cap, filled with 2 tablets.
Packaging: 30, 60, 90, or 100 hard capsules in blister packs made of OPA/Aluminum/PVC//Aluminum, placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Egis Pharmaceuticals PLC
1106 Budapest, Keresztúri út 30-38.
Hungary

Manufacturer(s)

Egis Pharmaceuticals PLC
1165 Budapest, Bökényföldi út 118-120.
Hungary
Egis Pharmaceuticals PLC
9900 Körmend, Mátyás Király u. 65.
Hungary

The medicinal product is registered in the Member States of the European Economic Area under the following names:

Hungary
Romus 10 mg/5 mg, 10 mg/10 mg, 20 mg/5 mg, 20 mg/10 mg
hard capsules
Bulgaria
Розурамлон 10 mg/5 mg, 10 mg/10 mg, 20 mg/5 mg, 20 mg/10 mg
твърдa капсулa
Rosuramlon 10 mg/5 mg, 10 mg/10 mg, 20 mg/5 mg, 20 mg/10 mg
hard capsules
Czech Republic
Kastel
Lithuania
Ramostin 10 mg/5 mg, 10 mg/10 mg, 20 mg/5 mg, 20 mg/10 mg
kietosios kapsulės
Latvia
Ramostin 10 mg/5 mg, 10 mg/10 mg, 20 mg/5 mg, 20 mg/10 mg
cietās kapsulas
Poland
Kastel
Slovakia
Rosuramlon 10 mg/5 mg, 10 mg/10 mg, 20 mg/5 mg, 20 mg/10 mg
tvrdé kapsuly
To obtain more detailed information on this medicinal product, the patient should contact the local representative of the marketing authorization holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00

Date of last revision of the leaflet 4.05.2024