EQUORAL. 100 mg. 50 capsules
EQUORAL. 100 mg. 50 capsules
WHAT EQUORAL 100 mg capsules, soft AND WHAT IT IS USED
Pharmacotherapeutic group: immunosuppressants.
The active ingredient in 100 mg capsules EKUORAL soft is cyclosporine . EQUORAL 100 mg capsules , soft inhibit primary immune response of the body to the foreign transplanted tissues and thus allows them to survive . Moreover , it has beneficial effects in diseases induced by an excessive production of antibodies against the body's own cells and tissues ( autoimmune diseases ) .
EQUORAL 100 mg capsules , soft is used for the prophylaxis and treatment of rejection of organ transplants ( kidney, liver, heart , lung, pancreas and bone marrow ) and graft versus organism (graft-versus-host disease (GVHD)) following bone marrow transplantation . It is also used in the treatment of autoimmune diseases: intraocular inflammation ( uveitis endogenous ) , nephrotic syndrome ( a complex of symptoms caused by various renal diseases , manifested mainly by edema and the presence of protein in the urine ) , rheumatic inflammation of joints ( rheumatoid arthritis ) , psoriasis, and skin inflammation with allergic origin ( atopic dermatitis) .
The product can be used in adults and children over the age of three .
2 . WHAT YOU SHOULD KNOW BEFORE YOU TAKE EQUORAL 100 mg capsules, soft
Do not take EQUORAL 100 mg capsules, soft :
If you have received symptoms of hypersensitivity to cyclosporine or any of the other ingredients ( excipients are described in section 6. Additional Information - What's in EQUORAL 100 mg capsules, soft ) ;
In indications other than organ transplantation (skin complaints or rheumatoid arthritis) , as should not be administered to patients with impaired renal (except nephrotic syndrome) and hepatic function , hypertension refractory infections (especially herpes zoster and varicella ) or malignancies ;
During pregnancy ( use of EQUORAL 100 mg capsules, soft during pregnancy must be justified by compelling reasons ) ;
If you are breastfeeding ;
If you are using tacrolimus ;
If you are using rosuvastatin .
Do not apply EQUORAL 100 mg capsules, soft in children under 6 years of age and in patients with rheumatoid arthritis are under 18 years of age.
Warnings and recommendations
If you have liver problems or have ever had any medical condition that may have affected your liver ;
If you have impaired kidney function;
If you have high blood pressure;
If you have high levels of potassium in your blood if you are taking potassium-sparing diuretics (water tablets) , potassium supplements or your diet is rich in potassium. EKUORAL 100 mg capsules, soft can increase potassium levels in the blood ;
If you have gout ;
If you have increased pressure in the head. EKUORAL 100 mg capsules, soft can increase the risk of increased intracranial pressure. If this happens , your doctor may stop your prescribed EKUORAL 100 mg capsules, soft ;
If there is a possibility you may be exposed to direct sunlight without protection of the skin from sunscreen regularly or sunbathe ;
If you have a skin disease other than severe psoriasis or severe eczema, or are undergoing radiation therapy (PUVA or other UV- treatment) skin disease ;
If the drug is prescribed for the treatment of eczema in someone under 16 as there is no experience with EKUORAL 100 mg capsules, soft in children with eczema.
The dose of this medicine should be carefully determined by your doctor. Too high a dose can affect the kidneys. So you need to do regular blood tests and hospital visits , especially after transplantation. This will give you a chance to talk to your doctor about your treatment and let the problems you have.
Taking other medicines
Taking any other medications (whether prescription or not) ? Some medicines may interact with your treatment , so before taking any medication , consult your doctor or pharmacist.
It is important to let your doctor if you are taking any of the following :
Medicines to treat infections, including antibiotics and antifungal agents ;
Oral contraceptives (medicines to prevent pregnancy ) ;
Medicines for heart problems or high blood pressure;
Medicines for epilepsy;
Cholesterol-lowering drugs ;
Sleeping pills ;
Potassium supplements ;
Diuretics or " water pills " that change the amount of urine ;
Anti-inflammatory drugs , including drugs used to treat rheumatoid arthritis , osteoarthritis, ankylosing spondylitis, gout , pain, and recurring muscle disorders ;
Radiation therapy (PUVA or other UV- treatment) skin disease ;
Danazol (used to treat menstrual disorders , endometriosis or problems of the breast ) ;
Tacrolimus. As tacrolimus suppresses your immune system in a similar way as cyclosporine, tacrolimus , and if you are taking cyclosporin , your immune system can suppress too much . If this happens , you may be very susceptible to infections ;
Everolimus , sirolimus ;
St. John's wort : the herb St. John's wort (Hypericum perforatum) should not be taken at the same time as this medicine. If you are already taking St. John's wort before you stop to talk to your doctor ;
Drugs for treatment of tuberculosis ;
Medicines for gout
Metoclopramide (used to prevent vomiting ) ;
Melphalan (used for the treatment of tumors or lymphomas ) ;
Orlistat (used for weight loss ) ;
Corticosteroids (used to treat conditions such as asthma , allergic conditions , inflammatory diseases including inflammatory bowel disease , adrenocortical insufficiency, and rheumatic diseases) ;
Ursodeoxycholic acid ( treatment of gallstones ) ;
Protease inhibitors (used for the treatment of infection with human immunodeficiency virus (HIV));
Vaccines - If you've recently received a vaccination or are planning to be vaccinated , especially live vaccines should be avoided because of side effects ;
Repaglinide (used for the treatment of diabetes ) .
Please tell your doctor if you are being treated with PUVA phototherapy or other UV-B radiation.
Taking EQUORAL 100 mg capsules, soft food and drinks
Do not take this product with grapefruit juice . Do not drink grapefruit juice even one hour before and after taking this medicine. Use EQUORAL 100 mg capsules, soft always at the same time in relation to meals (always before meals or after meals or between meals ) .
Pregnancy and lactation
If you are pregnant or become pregnant while taking EKUORAL 100 mg capsules, soft , or breast-feeding , tell your doctor. Moreover, carefully read the point below containing information about some of the ingredients of EQUORAL 100 mg soft capsules .
Driving and using machines
Not found EQUORAL 100 mg capsules, soft affect your ability to drive and use machines. Still contains a small amount of alcohol. See section below contains information about some of the ingredients of EKUORAL 100 mg capsules, soft (see " Additional Information - What's in EQUORAL 100 mg capsules, soft ').
Important information about some of the ingredients of EKUORAL 100 mg capsules, soft
EQUORAL 100 mg capsules , soft capsules contain 14.7 % by weight ethyl alcohol ; at a dose ( 175 mg cyclosporine) contains up to 280 mg of ethyl alcohol ( at a dose of 5 mg / kg body weight per day , twice a day). This amount is equivalent to a 7 ml beer (5% ) and 3 ml of wine (12%) . It is dangerous for people suffering from alcoholism. Should be taken into account in pregnant or lactating women, children and high-risk groups such as patients with liver disease or epilepsy.
This medicinal product contains macrogol glycerol Hydroxystearate , which may be cause of indigestion or diarrhea.
3 . HOW TO TAKE EQUORAL 100 mg capsules, soft
Treatment with this product require periodic medical examinations . These checks include determining the general state of health , blood pressure , level of the cyclosporin in the blood and the control of the function of various organs , particularly the liver and kidneys. The patient should not be exposed to direct UV light or sunlight during therapy EKUORAL 100 mg soft capsules . In case of overdose or accidental ingestion of EQUORAL 100 mg soft capsules for children, a consultation with a doctor.
The dosage is determined by the doctor according to the type and severity of the disease . Therefore, you should carefully follow the recommendations of your doctor and do not change the set dose alone.
The starting dose for an organ transplant is usually 10-15 mg / kg daily. The usual maintenance dose is 2-6 mg / kg daily. The initial dose after a bone marrow transplant is 12,5 -15 mg / kg per day with gradual reduction during treatment , according to the levels of cyclosporine in the blood and individual patient tolerance . In autoimmune diseases , the initial dose is usually not more than 5 mg / kg daily , and in the course of the treatment is adjusted according to the clinical status of the patient, and tolerance . Doctor recommended daily dose is administered in two separate doses with an interval of twelve hours.
Method of administration
Swallow the capsules whole and take them insoluble in water.
Use in children and adolescents
The dose for children is the same as in adults.
The capsules should not be administered to children over 6 years old.
Oral solution should be used in children over 1 year.
If you take more than the dose of 100 mg EKUORAL capsules, soft
If you have accidentally taken too much of your medicine , tell your doctor or go to the nearest emergency room .
If you forget to take EQUORAL 100 mg capsules, soft
In the event that you forget to take your dose EKUORAL 100 mg capsules, soft , take it as soon as possible after you remember, but never take a double dose. However, if it is almost time for your next dose , skip the missed dose and after consulting with your doctor , continue to take the medicine of twelve- intervals.
4 . POSSIBLE SIDE EFFECTS
As with all medications , EQUORAL 100 mg capsules , soft can cause side effects, although not everyone gets them.
If you get a sore throat, any infection or you start to feel exhausted , immediately contact your doctor.
Very common adverse reactions reported in more than 1 in 10 users include: kidney problems , high blood pressure , headaches , tremors and increased levels of lipids (eg cholesterol) in the blood.
Common side effects reported in 1 in 10 to 1 in 100 users include:
Numbness or tingling in the extremities , loss of appetite , nausea or vomiting , abdominal pain , diarrhea , swelling of the gums, liver problems , high levels of uric acid or potassium in the blood , low levels of magnesium in the blood , muscle pain or cramps , severe body hair and tiredness .
Uncommon side effects reported in 1 in 100 to 1 in 1000 users include:
Seizures , confusion , disorientation, decreased ability to respond , agitation, drowsiness , visual disturbances, blindness , coma, partial paralysis , loss of coordination, changes in the blood (eg, anemia) , allergic rash, water retention , which can lead to swelling and weight gain .
Rare side effects reported in 1 in 1000 to 1 in 10,000 users include:
Problems with the nerves that control muscle , pancreas inflammation , high levels of blood glucose , muscle weakness , muscle wasting , destruction of red blood cells, which can be associated with kidney problems , changes in the menstrual cycle in women and mild edema of breast tissue in males and females .
Very rare side effects reported in less than 1 in 10,000 users include:
Swelling of the tissues around the eyes, which may be associated with increased intracranial pressure ( benign intracranial hypertension) , and visual disturbances .
Like other drugs that suppress the immune system EKUORAL 100 mg capsules, soft can cause the formation of tumors or other malignancies , particularly of the skin.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet , please tell your doctor or pharmacist.
5 . HOW TO STORE EQUORAL 100 mg capsules, soft
Do not store above 30 ° C. Keep capsules in original package to protect from light. Do not store in the cold and not frozen.
Keep out of reach of children.
Do not use EQUORAL 100 mg capsules, soft after the expiry date stated on the pack . The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . FURTHER INFORMATION
After opening a blister , you may notice the distinctive smell of the product.
What does EKUORAL 100 mg capsules, soft
Active substance: 100 mg Ciclosporin per capsule .
Excipients: absolute ethanol , polyglyceryl -3 oleate, polyglyceryl -10 oleate, polyoxyl hydroxystearate , alpha -tocopherol , gelatin , 85% glycerol , 70% sorbitol, amorphous , glycine , iron oxide brown , titanium dioxide .
Looks like EQUORAL 100 mg capsules, soft and contents of the pack
EQUORAL 100 mg: Soft gelatin capsules with an elongated shape and dimensions 26 x 10 mm, a light brown color , containing yellowish to yellowish brown oily liquid. Each capsule has a logo IVAH shaped hourglass and labeled " 100 mg".
Pack size: 50 soft capsules per pack.