Kastel

Leaflet attached to 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

Rosuvastatine + Ramipril

You should read the leaflet carefully 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 your doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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: rosuvastatine and ramipril.
Rosuvastatine 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 expands 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 rosuvastatine and ramipril in separate
tablets. Instead of two separate tablets of rosuvastatine and ramipril, one Kastel capsule can be taken, containing these two active substances in the same strengths.
While taking the medicine, you 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 you are allergic to ramipril, another ACE inhibitor, rosuvastatine, or any of the other ingredients of the medicine (listed in section 6). The symptoms of an allergic reaction may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue;
• If you have 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 you have taken sacubitril/valsartan recently (within the last 36 hours) or are currently taking it, a medicine used to treat chronic heart failure;
• If you are undergoing dialysis or another type of blood filtration. Depending on the device used, treatment with Kastel may not be suitable;
• If you have kidney diseases that reduce blood flow to the kidney (renal artery stenosis) or if you have severe kidney dysfunction;
• If you are pregnant or breastfeeding. If you become pregnant while taking Kastel, you should stop taking the medicine and inform your doctor. While taking Kastel, women should avoid becoming pregnant using appropriate contraceptive methods (see also section "Pregnancy and breastfeeding");
• If you have abnormally low or unstable blood pressure. This requires an assessment by your doctor;
• If you have diabetes or kidney disease and are taking a blood pressure-lowering medicine containing aliskiren;
• If you have liver disease;
• If you have recurring muscle pain of unknown cause (myopathy);
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (medicines used to treat hepatitis C virus infection);
• If you are taking cyclosporine (used, for example, after organ transplants to prevent rejection of the transplanted organ);
• If you have ever had a severe skin reaction after taking Kastel or other medicines containing rosuvastatine: severe rash, skin peeling, or blistering, and (or) mouth ulcers.

If any of the above situations occur, you should not take Kastel. If in doubt, you should consult your doctor before taking Kastel.

Warnings and precautions:

Before starting to take Kastel, you should consult your doctor or pharmacist:

• If you have heart, liver, or kidney disease;
• If you have 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 you plan to undergo allergy treatment for bee or wasp stings (desensitization);
• If you are to be anesthetized. This may be anesthesia for surgery or dental procedures. It may be necessary to stop taking Kastel the day before anesthesia; in such a case, you should consult your doctor.
• If you have high levels of potassium in your blood (detected in a blood test);
• If you are taking medicines or have conditions that may lower sodium levels in your blood. Your doctor may recommend regular blood tests to check sodium levels in your blood, especially in the elderly;
• If you are taking medicines that may 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. For information on sacubitril/valsartan, see section 2. "When not to take Kastel";
• If you have collagenosis, such as scleroderma or systemic lupus erythematosus;
• If you are taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (ARB) (also known as sartans, including valsartan, telmisartan, irbesartan), especially if you have diabetic kidney disease.
• aliskiren. Your 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 you experience recurring or unexplained muscle pain, if you or your family members have had muscle diseases, or if you have had muscle problems while taking other cholesterol-lowering medicines. If you experience unexplained muscle pain, especially if you feel unwell or have a fever, you should tell your doctor immediately. Your doctor should also be informed if you experience persistent muscle weakness;
• If you have 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 may sometimes exacerbate the symptoms of the disease or lead to the development of myasthenia (see section 4);
• If you regularly drink large amounts of alcohol;
• If you have abnormal thyroid function (hypothyroidism);
• If you are taking other cholesterol-lowering medicines called fibrates (see section "Kastel and other medicines");
• If you are taking medicines used to treat HIV infection, such as ritonavir with lopinavir and (or) atazanavir, see sections "When not to take Kastel" and "Warnings and precautions";
• If you are taking or have taken within the last 7 days, orally or by injection, a medicine containing fusidic acid (an antibiotic). If you need to take fusidic acid to treat a bacterial infection, you will need to stop taking Kastel for a while. Your doctor will determine when it is safe to resume taking Kastel. Taking Kastel with fusidic acid may rarely lead to muscle weakness, tenderness, and pain (rhabdomyolysis), see section 4;
• If you are over 70 years old (as your doctor will need to select an appropriate dose of Kastel);
• If you have severe respiratory failure;
• If you are of Asian origin (Japan, China, Philippines, Vietnam, Korea, or India). Your doctor will need to select an appropriate dose of Kastel.

If any of the above situations occur (or if you have any doubts), you should consult your doctor or pharmacist before taking Kastel.
In connection with the use of rosuvastatine, severe skin reactions have been reported, such as Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS). If you notice any of the symptoms described in section 4, you should stop taking Kastel immediately and consult your doctor.
In a small number of patients, statins may damage the liver. This can be detected by a simple blood test to measure liver enzyme levels.
For this reason, during treatment with Kastel, your doctor will regularly order blood tests (liver function tests). It is essential that you undergo the laboratory tests ordered by your doctor.
During treatment with this medicine, your 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 their 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

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken. This is necessary because Kastel may affect the action of other medicines. Other medicines may also affect the action of Kastel.
You should tell your 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. Your doctor will monitor your 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 organ 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 may increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, trimetoprim 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 your doctor will need to change the dose and (or) take other precautions if you are 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 may lower blood sugar levels. While taking Kastel, you should carefully monitor your blood sugar levels;
• Lithium (used to treat mental illnesses). Kastel may increase lithium levels in the blood. You will need to be closely monitored by your doctor;
• Warfarin, ticagrelor, or clopidogrel, or other blood-thinning medicines (if taken with Kastel, their blood-thinning effect may be enhanced, 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 rosuvastatine may be enhanced;
• Antacids containing aluminum and magnesium (used to neutralize stomach acid; they may decrease rosuvastatine levels in the blood). This effect can be reduced by taking this type of medicine 2 hours after taking rosuvastatine;
• Erythromycin (an antibiotic). If taken with Kastel, the effect of rosuvastatine may be reduced;
• Fusidic acid (an antibiotic). If you need to take fusidic acid to treat a bacterial infection, you will need to stop taking Kastel for a while. Your doctor will determine when it is safe to resume taking Kastel. Taking Kastel with fusidic acid may 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 virus infection). See sections "When not to take Kastel" and "Warnings and precautions".

If any of the above situations occur (or if you have any doubts), you should consult your doctor before taking Kastel.
If you are going to the hospital or receiving treatment for another illness, you should inform the medical staff that you are taking Kastel.

Kastel and alcohol

Drinking alcohol while taking Kastel may cause dizziness. If you have any doubts about how much alcohol you can drink while taking Kastel, you should consult your doctor, as blood pressure-lowering medicines may have an additive effect with alcohol.

Pregnancy and breastfeeding

Pregnancy
You should not take Kastel during pregnancy, planning a pregnancy, or suspected pregnancy, as taking the medicine during pregnancy may harm the baby. If you become pregnant while taking Kastel, you should stop taking the medicine and inform your doctor. While taking Kastel, women should avoid becoming pregnant using appropriate contraceptive methods.
Breastfeeding
You should not take Kastel while breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines

Some people may feel dizzy while taking Kastel. If you experience dizziness, you should consult your 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 that the medicine is considered "sodium-free".

3. How to take Kastel

This medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts, you should consult your doctor or pharmacist.
While taking Kastel, you should continue to follow a cholesterol-lowering diet.
The recommended daily dose is one capsule of the prescribed 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

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

Missing a dose of Kastel

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

Stopping Kastel

If you want to stop taking Kastel, you should tell your doctor.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Kastel can cause side effects, although not everybody gets them.
It is essential to know what side effects may occur.

If you notice any of the following severe side effects, you should stop taking Kastel and consult your 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, mouth ulcers, genital ulcers, and eye ulcers, these severe skin reactions may 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 that lasts longer than expected. In rare cases, this may lead to potentially life-threatening muscle damage, called rhabdomyolysis, which can cause general muscle breakdown, fever, and kidney impairment.
• Systemic lupus erythematosus-like syndrome (rash, joint disorders, and blood disorders).
• Muscle rupture.

You should tell your doctor immediately if you experience:

• Rapid 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 spotted rash 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, you should tell your doctor:
Common(may occur in up to 1 in 10 patients)

• Headache or feeling of tiredness, feeling of 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
• High potassium levels in blood tests
• Diabetes. The increased risk of developing diabetes applies to people who have high levels of sugar and fat in their blood, are overweight, and have high blood pressure. While taking Kastel, you will be closely monitored by your doctor.

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

• Balance disorders (dizziness)
• Itching or abnormal sensations, such as tingling, numbness, prickling, or burning of the skin (paresthesia)
• Taste disorders or loss of taste
• Sleep disorders, including excessive sleepiness
• Feeling of depression, anxiety, or restlessness
• Nasal congestion, difficulty breathing, or worsening of asthma
• Severe abdominal pain (pancreatitis)
• Intestinal edema, characterized by abdominal pain, vomiting, and diarrhea, known as "angioedema of the intestine"
• Heartburn, dry mouth
• Frequent urination
• Excessive sweating
• Loss of appetite (anorexia)
• Rapid 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 shakiness or confusion
• Vasoconstriction, decreased perfusion (hypoperfusion), vasculitis (inflammation of blood vessels)
• Tongue redness and swelling
• Severe skin peeling or detachment, 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 the 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 you experience such symptoms, you should consult your doctor as soon as possible
• Depression
• Change in finger and toe color after cold exposure 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). You should consult your doctor if you experience muscle weakness in your arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, 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
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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Kastel

Store in a place inaccessible to children.
Store at a temperature below 25 °C in the original packaging, protected from light and moisture.
Do not use the medicine after the expiry date stated on the carton and blister pack after the abbreviation EXP: The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 rosuvastatine and ramipril.
Kastel, 10 mg + 5 mg, hard capsules:
The capsules contain calcium rosuvastatine in an amount equivalent to 10 mg of rosuvastatine and 5 mg of ramipril.
Kastel, 10 mg + 10 mg, hard capsules:
The capsules contain calcium rosuvastatine in an amount equivalent to 10 mg of rosuvastatine and 10 mg of ramipril.
Kastel, 20 mg + 5 mg, hard capsules:
The capsules contain calcium rosuvastatine in an amount equivalent to 20 mg of rosuvastatine and 5 mg of ramipril.
Kastel, 20 mg + 10 mg, hard capsules:
The capsules contain calcium rosuvastatine in an amount equivalent to 20 mg of rosuvastatine 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 a 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 a 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 a 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 a 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 authorized 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
твърда капсула
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 medicine, you 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