10 mg, 25 mg, 50 mg and 100 mg capsules, soft
ciclosporin, respectively
1. What Ciqorin is and what it is used for
What Ciqorin is
The name of this medicine is Ciqorin. It contains the active substance ciclosporin. It belongs to a group of medicines called immunosuppressants. These drugs are used to suppress the body’s immune reactions.
What Ciqorin is used for and how Ciqorin works
- If you have had an organ transplant or undergone a bone marrow and stem cell transplant, Ciqorin is used to control the body’s immune system. Cicorin prevents transplanted organs from being rejected by blocking the development of certain cells that would normally attack the transplanted tissue.
- If you have an autoimmune disease, which means that the body’s immune system attacks your own cells, Ciqorin stops this immune response. Such diseases can be eye problems that threaten your vision ( endogenous uveitis, also Behçets uveitis ), severe cases of certain skin diseases (atopic dermatitis ie eczema, and psoriasis ), severe rheumatoid arthritis, and a kidney disease called nephrotic syndrome .
Ciclosporin contained in Ciqorin may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.
2. What you need to know before taking Ciqorin
Do not use Ciqorin
If you are taking Ciqorin after a transplant, it will only be prescribed to you by a doctor who has experience with transplants and/or autoimmune diseases.
The advice given in this leaflet may vary depending on whether you are taking the medicine after a transplant or because of an autoimmune disease.
Always follow your doctor’s instructions carefully. They may differ from the general information contained in this leaflet.
Do not take Ciqorin:
- if you are allergic to ciclosporin or any of the other ingredients of this medicine (listed in section 6).
- together with agents containing Hypericum perforatum ( St. John’s wort ).
- together with agents containing dabigatran etexilate (used to prevent blood clots after surgery) or bosentan and aliskiren (used to lower high blood pressure ).
Do not take Ciqorin and tell your doctor if the above applies to you. If you are not sure, talk to your doctor before taking Ciqorin.
Warnings and cautions
Before and during treatment with Ciqorin, tell your doctor immediately:
- if you have any signs of infection, such as fever or sore throat. Ciqorin weakens the immune system and can also affect the body’s ability to fight infections.
- if you have liver problems.
- if you have kidney problems. Your doctor will take blood samples at regular intervals and may change your dose if necessary.
- if you get high blood pressure. Your doctor will check your blood pressure at regular intervals and may, if necessary, give you a medicine that lowers your blood pressure.
- if you have low magnesium levels in your body. Your doctor may give you magnesium supplements, especially immediately after surgery.
- if you have high potassium levels in your blood.
- if you have gout.
- if you are to be vaccinated.
If any of the above applies to you before or during treatment with Ciqorin, tell your doctor immediately.
Sunlight and sun protection
Ciqorin weakens your immune system. This increases your risk of getting cancer, especially skin cancer and cancer of the lymphatic system. You should limit your exposure to sunlight and UV light by:
- wear appropriate protective clothing.
- often apply sunscreen with a high protection factor.
Check during treatment with Ciqorin
Your doctor will check:
- the level of cyclosporine in your blood, especially if you have had a transplant,
- your blood pressure before starting treatment and at regular intervals during treatment,
- how well your liver and kidneys are working,
- your blood fats.
If you have any further questions on the use of Ciqorin or why it has been prescribed for you, ask your doctor.
If you are prescribed Ciqorin for reasons other than transplantation ( intermediate or posterior uveitis and Behçet’s uveitis, atopic dermatitis, severe rheumatoid arthritis, or nephrotic syndrome ), you should not take Ciqorin:
- if you have kidney problems (except nephrotic syndrome ).
- if you have an infection that has not healed after drug treatment.
- if you have any type of cancer.
- if you have high blood pressure ( hypertension ) that has not improved with medication. If you get high blood pressure during treatment and it can not be controlled with drug treatment, your doctor should stop treatment with Ciqorin.
Do not take Ciqorin if any of the above apply to you. Talk to your doctor or pharmacist before taking Ciqorin if you feel unsure.
If you are being treated for Behçet’s uveitis , your doctor will check you especially closely if you have neurological symptoms (for example, if you become more forgetful, notice that your personality changes, get psychiatric illnesses or mood swings, a burning sensation in the arms or legs, decreased sensation in arms or legs, tingling in arms or legs, weakness in arms or legs, difficulty walking, headache with or without nausea and vomiting, visual disturbances including restriction of eyeball movements).
Your doctor will monitor you closely if you are elderly and being treated for psoriasis or atopic dermatitis. If you have been prescribed Ciqorin for the treatment of psoriasis or atopic dermatitis, you must not be exposed to UVB radiation or phototherapy (light therapy) during treatment.
Children and young people
Ciqorin should not be given to children for a non-transplant disease, with the exception of the treatment of the nephrotic syndrome.
Elderly people (from 65 years)
Experience in treating elderly patients with Ciqorin is limited. Your doctor should monitor how well your kidneys are working. If you are over 65 years of age and have psoriasis or atopic dermatitis, you should only be treated with Ciqorin if your disease is very serious.
Other medicines and Ciqorin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines before or during treatment with Ciqorin:
- Drugs that can affect your potassium levels. These include drugs that contain potassium, potassium supplements, diuretics, so-called potassium-sparing diuretics, and certain drugs that lower blood pressure.
- Methotrexate used to treat tumors, severe psoriasis, and severe rheumatoid arthritis.
- Drugs that can increase or decrease the level of ciclosporin (the active substance in Ciqorin) in the blood. Your doctor may need to check the level of ciclosporin in your blood when you start or stop taking other medicines.
- Drugs that can increase ciclosporin levels in the blood are antibiotics (for example erythromycin or azithromycin), antifungals (voriconazole, itraconazole), medicines for heart problems or high blood pressure ( diltiazem, nicardipine, verapamil, amiodarone ), metokamide pills, danazol (for menstrual disorders), medicines for gout (allopurinol), cholic acid and its derivatives (used for gallstones ), protease inhibitors for HIV , imatinib (used for leukemia or tumors ), colchicine, telaprevir (used for hepatitis C).
- Drugs that can lower the ciclosporin level in the blood are barbiturates (for sleep disorders), certain medicines for seizures (such as carbamazepine or phenytoin ), octreotide (used for acromegaly or neuroendocrine tumors in the stomach), antibacterial drugs for tuberculosis (or listen), an herbal medicine containing St. John’s wort, ticlopidine (used after stroke ), certain medicines that lower blood pressure ( bosentan ), and terbinafine (a medicine used to treat fungus on the toes and nails).
- Drugs that can affect your kidneys. These include antibacterial drugs (gentamycin, tobramycin, ciprofloxacin ), antifungal drugs that contain amphotericin B, drugs for urinary tract infections that contain trimethoprim, cancer drugs that contain melphalan, drugs that lower the acid content of the stomach, taksimar2 painkillers (non-steroidal anti-inflammatory drugs such as diclofenac ), drugs that contain fibrates (used to lower blood fats).
- Nifedipine is used to treat high blood pressure and heart pain. You can get swollen gums that grow down over your teeth if you take nifedipine while taking ciclosporin.
- Digoxin (cardiac problems), drugs that lower blood cholesterol (HMG CoA reductase inhibitors, also called statins), prednisolone, etoposide (used in cancer), repaglinide (for diabetes ), immunosuppressants (everolimus, sirolimus), ambrisentan, and specific cancer drugs called anthracycline s (for example doxorubicin).
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Ciqorin.
Hepatitis C
Tell your doctor if you have hepatitis C. Your liver function may change when you treat hepatitis C and this may affect the levels of ciclosporin in your blood. Your doctor may need to monitor your ciclosporin levels in the blood closely and make dose adjustments after starting treatment for hepatitis C.
Ciqorin with food and drink
Do not take Ciqorin with grapefruit or grapefruit juice. These can affect how Ciqorin works.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking this medicine. Your doctor will talk to you about the possible risks of taking Ciqorin during pregnancy.
- Tell your doctor if you are pregnant or planning to become pregnant. Experience with Ciqorin during pregnancy is limited. In general, Ciqorin should not be taken during pregnancy. If you need to be treated with this medicine, your doctor will talk to you about the benefits and possible risks of taking it during pregnancy.
- Tell your doctor if you are breast-feeding. Breastfeeding is not recommended during treatment with Ciqorin. The active substance ciclosporin passes into breast milk. This can affect the baby.
Driving and using machines
There is no information on whether cyclosporine may affect your ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Chicorin contains ethanol and sorbitol
Chicorin contains ethanol
10 mg
This medicine contains 15.95 mg of alcohol ( ethanol ) per capsule.
25 mg
This medicine contains 39.86 mg of alcohol ( ethanol ) per capsule.
50 mg
This medicine contains 79.75 mg of alcohol ( ethanol ) per capsule.
100 mg
This medicine contains 159.50 mg of alcohol ( ethanol ) per capsule.
The amount in a 500 mg dose of this medicine (797.5 mg ethanol ) is equivalent to less than 20 ml beer or 8 ml wine. The low amount of alcohol in this medicine does not produce any noticeable effects.
Chicorin contains sorbitol
10 mg
This medicine contains 2.93 mg sorbitol per capsule.
25 mg
This medicine contains 4.92 mg sorbitol per capsule.
50 mg
This medicine contains 11.03 mg sorbitol per capsule.
100 mg
This medicine contains 19.06 mg sorbitol per capsule.
Chicorin contains macrogol glycerol hydroxy stearate
May cause stomach upset and diarrhea.
How to take Ciqorin
Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
Do not take more than the recommended dose.
The dose of one of these medicines will be carefully adjusted by your doctor to suit you. Too high a dose of medicine can affect your kidneys. Blood tests and visits to the hospital will take place regularly, especially after a transplant. Then you get the opportunity to talk to the doctor about the treatment and any problems.
How much Ciqorin to take
Your doctor will decide which dose of Ciqorin is right for you. It depends on your body weight and the reason you are taking the medicine. Your doctor will also tell you how often to take this medicine.
- For adults: Organ, bone marrow, or stem cell transplantation
- The total daily dose is usually between 2 mg and 15 mg per kilogram of body weight. This is divided into two occasions per day.
- Higher doses are often used before and shortly after transplantation. Lower doses are used as soon as the transplanted organ or bone marrow has stabilized.
- Your doctor will adjust the dose so that it is the best for you. To be able to do this, the doctor may need to take some blood samples. Endogenous uveitis
- The total daily dose is usually between 5 mg and 7 mg per kilogram of body weight. This is divided into two occasions per day.Nephrotic syndrome
- The total daily dose for adults is usually 5 mg per kilogram of body weight. This is divided into two occasions per day. In patients with kidney problems, the first dose taken daily should not exceed 2.5 mg per kilogram of body weight. Severe rheumatoid arthritis
- The total daily dose is usually between 3 mg per kilogram of body weight and 5 mg per kilogram of body weight. This is divided into two occasions per day.Psoriasis and atopic dermatitis
- The total daily dose is usually between 2.5 mg per kilogram of body weight and 5 mg per kilogram of body weight. This is divided into two occasions per day.
- For children:
Nephrotic syndrome- The total daily dose for children is usually 6 mg per kilogram of body weight. This is divided into two occasions per day. In patients with kidney problems, the first dose taken daily should not exceed 2.5 mg per kilogram of body weight.
Follow your doctor’s instructions exactly and never change the dose yourself, even if you are feeling well.
Switching from oral ciclosporin to oral microemulsified ciclosporin (Ciqorin)
You may have previously taken another oral drug (the drug to be swallowed) of ciclosporin. Your doctor may decide to switch you to this medicine (Ciqorin) instead.
- The active substance in all these medicines is cyclosporine.
- Cicorin is another improved form of ciclosporin. Ciclosporin is better absorbed into the bloodstream with Ciqorin. The risk that the uptake will be affected by the medicine being taken with food is also less. This means that the ciclosporin level in your blood is kept more constant with Ciqorin.
If your doctor changes medicines from oral ciclosporin to oral microemulsified ciclosporin (Ciqorin): - Do not switch back to your old medicine unless your doctor tells you to.
- After the change, the doctor will follow you up particularly closely for a short period. This is due to the change in how ciclosporin is absorbed into your bloodstream. Your doctor will make sure you get the dose you need.
- You may experience some side effects. If this happens, tell your doctor or pharmacist immediately. Your dose may need to be reduced. Never reduce the dose yourself unless your doctor tells you to.
If your doctor changes a cyclosporine preparation to be swallowed for another
After switching from one ciclosporin preparation to be swallowed to another:
- Your doctor will follow your extra closely for a short time.
- You may experience some side effects. If this happens, tell your doctor or pharmacist immediately. Your dose may need to be changed. Never change the dose yourself unless your doctor tells you to.
When you take Ciqorin
Take Ciqorin at the same times each day. This is very important if you have undergone a transplant.
How to take Ciqorin
Your daily doses should always be divided into two occasions.
Remove the capsules from the blister. Swallow the capsules whole with water.
How long to take Ciqorin
Your doctor will tell you how long you need to take Ciqorin. It depends on whether you take it after a transplant or to treat a severe skin disease, rheumatoid arthritis, uveitis, or nephrotic syndrome . In case of severe skin rash, the treatment usually lasts for about 8 weeks.
Keep taking Ciqorin for as long as your doctor tells you to.
If you have any further questions on the use of Ciqorin, ask your doctor or pharmacist.
If you forget to take Ciqorin
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Then continue as usual.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Ciqorin
Do not stop taking Ciqorin unless your doctor tells you to.
Keep taking Ciqorin even if you feel well. Discontinuation of treatment with Ciqorin may increase the risk of rejection of the transplanted organ.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious
Tell your doctor immediately if you get any of the following serious side effects:
- Like other drugs that act on the immune system, cyclosporine can affect the body’s ability to fight infections and can also cause tumors or other cancers, especially in the skin. Signs of infection can be fever or sore throat.
- Visual changes, coordination difficulties, clumsiness, memory loss, difficulty speaking or understanding what others are saying, and muscle weakness. This may be a sign of an infection in the brain, called progressive multifocal leukoencephalopathy.
- Impact on the brain with signs such as seizures, confusion, disorientation, less contact ability, personality changes, agitation, insomnia, vision changes, blindness, coma, paralysis in all or parts of the body, neck stiffness, impaired coordination with or without unusual speech or unusual eye movements.
- Swelling in the back of the eye. This can lead to blurred vision. It can also affect vision due to higher pressure in the head ( benign intracranial hypertension ).
- Liver problems and liver damage with or without yellowing of the skin and eyes, nausea, loss of appetite, and dark urine.
- Kidney problems, which can lead to significantly less urine being produced in the body.
- A low number of red blood cells or platelets. Signs of this are pale skin, fatigue, shortness of breath, dark urine (a sign that the red blood cells are broken down), bruising or bleeding without an obvious cause, confusion, disorientation, you feel less alert, and have kidney problems.
Other side effects can be:
Very common side effects: may affect more than 1 in 10 people.
- Kidney problems.
- High blood pressure.
- Headache.
- Uncontrollable tremors in the body.
- Abnormally strong growth of body and facial hair.
- High levels of blood fats.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Common side effects: may affect up to 1 in 10 people.
- Seizures.
- Liver problem.
- High blood sugar.
- Fatigue.
- Loss of appetite.
- Nausea, vomiting, abdominal pain, constipation, diarrhea.
- Abnormal hair growth.
- Acne, hot flashes.
- Fever.
- Low white blood cell count.
- Numbness or tingling.
- Muscle pain, muscle twitching.
- Gastric ulcer.
- Overgrowth of the gums on the teeth.
- High levels of uric acid or potassium in the blood, low levels of magnesium in the blood.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Uncommon side effects: may affect up to 1 in 100 people.
- Symptoms of brain disease including sudden seizures, mental confusion, insomnia, disorientation, visual disturbances, unconsciousness, the feeling of weakness in arms and legs, impaired movement patterns.
- Rash.
- General swelling.
- Weight gain.
- The low number of red blood cells, low number of platelets can increase the risk of bleeding.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Rare side effects: may affect up to 1 in 1 000 people.
- Nerve problems with numbness or tingling in fingers and toes.
- Inflammation of the pancreas with severe pain in the upper abdomen.
- Weakness in the muscles, loss of muscle strength, muscle pain in the legs or hands, or in the whole body.
- Degradation of red blood cells that includes kidney problems with symptoms such as swelling of the face, abdomen, hands, and/or feet, decreased urination, difficulty breathing, chest pain, seizures, unconsciousness.
- Altered menstrual cycle, enlargement of the mammary glands in men.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Very rare side effects: may affect up to 1 in 10 000 people.
- Swelling in the posterior parts of the eye may be associated with increased pressure in the head and with visual disturbances.
If this side effect affects you severely, tell your doctor.
Other side effects that have been reported: Occurs in an unknown number of people.
- Severe liver problems both with and without yellowing of the eyes and skin, nausea, loss of appetite, dark-colored urine, swelling of the face, feet, hands, and/or the whole body.
- Bleeding under the skin or purple spots on the skin, sudden bleeding for no apparent reason.
- Migraine or severe headache, often with nausea, vomiting and photosensitivity.
- Pain in legs and feet
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Additional side effects are in children and adolescents
No further side effects are expected in children and adolescents compared to adults.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Ciqorin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C. Do not freeze. Store in the original package. Sensitive to light. Moisture sensitive.
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. Contents of the packaging and other information
Content declaration
- The active substance is cyclosporine.10 mgEach soft capsules contains 10 mg of ciclosporin.
25 mgEach soft capsule contains 25 mg of ciclosporin.
50 mgEach soft capsule contains 50 mg of ciclosporin.
100 mgEach soft capsule contains 100 mg of ciclosporin. - The other ingredients in the capsule filling are macrogol glycerol hydroxy stearate, glycerol monolinoleate, diethylene glycol monoethyl ether, anhydrous ethanol D, L-α-tocopherol.
- The other ingredients in the capsule shell are:10 mg gelatin, glycerol (85%), liquid sorbitol (non-crystallizing) (E420), glycine, titanium dioxide (E171), and light liquid paraffin.
25 mg and 50 mg gelatin, glycerol (85%), liquid sorbitol (non-crystallizing) (E420), glycine, titanium dioxide (E171), yellow iron oxide (E172), and light liquid paraffin.
100 mg gelatin, glycerol (85%), liquid sorbitol (non-crystallizing) (E420), glycine, titanium dioxide (E171), brown iron oxide (E172), and light liquid paraffin.
What the medicine looks like and the contents of the pack
10 mg
Opaque white to off-white soft gelatin capsules containing a colorless to slightly yellowish oily liquid, approximately 9.0 x 5.5 mm in size.
25 mg
Opaque yellow soft gelatin capsules containing a colorless to slightly yellowish oily liquid, marked with the IVAX “hourglass” logo “25 mg”, approximate size 12.2 x 7.6 mm.
50 mg
Opaque ocher-yellow soft gelatin capsules containing a colorless to slightly yellowish oily liquid, marked with the IVAX “hourglass” logo “50 mg”, approximate size 20.7 x 7.8 mm.
100 mg
Opaque brown soft gelatin capsules containing a colorless to slightly yellowish oily liquid, marked with the IVAX “hourglass” logo “100 mg”, approximate size 24.7 x 9.9 mm.
The capsules are available in packs of 20, 30, 50, 50×1, 60, 60×1, 90 and 100 in OPA / Alu / PVC – Aluminum blister.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
Teva Czech Industries sro
Ostravaská 29
747 70 Opava-Komárov
Czech Republic