Ciclosporin-Teva

Ciclosporin.

Soft-gelatin capsule: Each Ciclosporin-Teva 25 mg and 100 mg soft capsule contains 25 mg and 100 mg ciclosporin, respectively.
Oral solution: One ml oral solution contains 100 mg ciclosporin.
Excipients/Inactive Ingredients: Soft-gelatin capsule: Capsule content: ethanol anhydrous, polyglyceryl-3 oleate, polyglyceryl-10 oleate, macrogolglycerol hydroxystearate, alpha-tocopherol.
Capsule shell: gelatin, glycerol 85%, sorbitol 70 per cent (non-crystallising), glycine, iron oxide yellow (for 25-mg), iron oxide brown (for 100-mg), titanium dioxide.
Oral solution: ethanol anhydrous, polyglyceryl-3 oleate, polyglyceryl-10 oleate and macrogolglycerol hydroxystearate (castor oil).

Ciclosporin-Teva contains the active substance ciclosporin. This belongs to a group of medicines known as immunosuppressive agents. These medicines are used to lower the body's immune reactions.

Patients who have had an organ transplant, bone marrow and stem cell transplantation: The function of Ciclosporin-Teva is to control the body's immune system. Ciclosporin-Teva prevents rejection of transplanted organs by blocking the development of certain cells which would normally attack the transplanted tissue.
Patients who have an autoimmune disease, in which the body's immune response attacks the body's own cells: Ciclosporin-Teva stops this immune reaction. Such diseases include eye problems which threaten the vision (endogenous uveitis, including Behçet's uveitis), severe cases of certain skin diseases (atopic dermatitis, or eczema and psoriasis), severe rheumatoid arthritis and a kidney disease called nephrotic syndrome.

How to take Ciclosporin-Teva: Always take this medicine exactly as prescribed by the doctor. Check with the doctor if not sure.
Do not take more than the recommended dose.
The dose of this medicine will be carefully adjusted to individual needs by the doctor. Too much of the medicine can affect the kidneys. The patient will have regular blood tests and visits to the hospital, especially after a transplant. This will give the patient a chance to talk to the doctor about the treatment and talk about any problems he/she may be having.
How much Ciclosporin-Teva to take: The doctor will work out the correct dose of Ciclosporin-Teva for the patient. This depends on the body weight and what the medicine is used for. The doctor will also tell how often to take the medicine.
In adults: Organ, bone marrow and stem cell transplantation: The total dose each day is usually between 2 mg and 15 mg per kilogram body weight. This is divided in two doses.
Usually, higher doses are used before and just after the transplant. Lower doses are used once the transplanted organ or bone marrow has stabilised.
The doctor will adjust the dose to one that is ideal for the patient. To do this, the doctor may need to do some blood tests.
Endogenous uveitis: The total dose each day is usually between 5 mg and 7 mg per kilogram body weight. This is divided in two doses.
Nephrotic syndrome: The total dose each day for adults is usually 5 mg per kilogram body weight. This is divided in two doses. In patients with kidney problems, the first dose taken each day should not be more than 2.5 mg per kilogram body weight.
Severe rheumatoid arthritis: The total dose each day is usually between 3 mg per kilogram of the body weight and 5 mg per kilogram body weight. This is divided in two doses.
Psoriasis and atopic dermatitis: The total dose each day is usually between 2.5 mg per kilogram of the body weight and 5 mg per kilogram body weight. This is divided in two doses.
In children: Nephrotic syndrome: The total dose each day for children is usually 6 mg per kilogram body weight. This is divided in two doses. In patients with kidney problems, the first dose taken each day should not be more than 2.5 mg per kilogram body weight.
Follow the doctor's instructions exactly and patient should never change the dose, even if he/she feels well.
Switch from another oral ciclosporin to Ciclosporin-Teva: The patient may have already been taking another oral ciclosporin soft gelatin capsules or oral solution. The doctor may decide to change to this medicine, Ciclosporin-Teva soft gelatin capsules or Ciclosporin-Teva oral solution.
These medicines all contain ciclosporin as the active ingredient.
If the doctor changes from another oral ciclosporin to Ciclosporin-Teva: Do not go back to taking the previous medicine unless instructed by the doctor.
Following the transfer, the doctor will monitor the patient more closely for a short time. This is because of the change in how ciclosporin is absorbed into the blood. The doctor will make sure that the patient gets the right dose for individual needs.
The patient may have some side effects. If this happens, tell the doctor or pharmacist. The dose may need to be lowered. Patient should never lower the dose, unless instructed by the doctor.
If the doctor switches from one oral formulation of ciclosporin to another: After the patient changes from one oral formulation of ciclosporin to another: The doctor will monitor the patient more closely for a short time.
The patient may have some side effects. If this happens, tell the doctor or pharmacist. The dose may need to be changed. Patient should never change the dose, unless instructed by the doctor.
When to take Ciclosporin-Teva: Take Ciclosporin-Teva at the same time every day. This is very important if the patient has had a transplant.
How to take Ciclosporin-Teva: Soft-gelatin capsule: The daily doses should always be taken in 2 divided doses.
Remove the capsules from the blister. Swallow the capsules whole with water.
Oral solution: The daily doses should always be taken in 2 divided doses.
For initial use, follow steps 1 to 6.
For subsequent use, follow steps 3 to 6.
Starting a new bottle of Ciclosporin-Teva oral solution: 1. Open the bottle with screw cap.
2. At the first opening of the bottle, press the insert with the tube into the bottle neck in which it will stay for the entire period of the product use.
3. Insert the pipette into an aperture of the insert with the tube and suck prescribed amount of the product using a piston. In case there are any big air bubbles, remove them by repeated sucking and extruding the liquid and then suck prescribed amount of the liquid again.
4. Extrude the measured amount for the liquid into a bottle and dilute it according to the instructions in the leaflet before drinking.
5. After measuring the product amount immediately close the bottle with a screw closure.
6. After using the pipette wipe its end with a dry napkin and put it back into its case. Never wash the pipette with water.
How long to take Ciclosporin-Teva: The doctor will tell how long the patient needs to take Ciclosporin-Teva for. This depends on whether the patient is taking it after a transplant or for the treatment of a severe skin condition, rheumatoid arthritis, uveitis or nephrotic syndrome. For severe rash, the treatment usually lasts for 8 weeks.
Keep taking Ciclosporin-Teva for as long as prescribed by the doctor.
If the patient has questions about how long to take Ciclosporin-Teva, talk to the doctor or pharmacist.
If the patient forgets to take Ciclosporin-Teva: If the patient forgets to take a dose, take it as soon as remembered. However, if it is almost time for the next dose, skip the missed dose. Then go on as before.
Do not take a double dose to make up for a forgotten dose.
If the patient stops taking Ciclosporin-Teva: Do not stop taking Ciclosporin-Teva unless instructed by the doctor.
Keep taking Ciclosporin-Teva even if the patient feels well. Stopping the treatment with Ciclosporin-Teva may increase the risk of the transplanted organ being rejected.
If the patient has any further questions on the use of this medicine, ask the doctor or pharmacist.

If the patient accidentally takes too much of the medicine, tell the doctor immediately or go to the nearest hospital emergency unit. The patient may need medical attention.

Do not take Ciclosporin-Teva: if the patient is allergic to ciclosporin or any of the other ingredients of this medicine (listed in Description).
With products containing Hypericum perforatum (St John's Wort).
With products containing dabigatran etexilate (used to avoid blood clots after surgery) or bosentan and aliskiren (used to reduce high blood pressure).
Do not take Ciclosporin-Teva and tell the doctor if these apply to the patient. If not sure, talk to the doctor before taking Ciclosporin-Teva.

Before and during treatment with Ciclosporin-Teva, tell the doctor straight away: if the patient has any signs of infection, such as fever or a sore throat. Ciclosporin-Teva suppresses the immune system and may also affect the body's ability to fight against infection.
If the patient has liver problems.
If the patient has kidney problems. The doctor will carry out regular blood tests and may change the dose if necessary.
If the patient develops high blood pressure. The doctor will check the blood pressure regularly and may give a medicine to lower blood pressure if necessary.
If the patient has low levels of magnesium in the body. The doctor may give magnesium supplements to take, especially just after the operation if the patient has had a transplant.
If the patient has high levels of potassium in the blood.
If the patient has gout.
If the patient needs to have a vaccination.
If any of these applies to the patient before or during treatment with Ciclosporin-Teva, tell the doctor straight away.
Sunlight and sun protection: Ciclosporin-Teva suppresses the immune system. This increases the risk of developing cancers, particularly of the skin and lymphoid system. The patient should limit the exposure to sunlight and UV light by: wearing appropriate protective clothing; often applying a sunscreen with a high protection factor.
Talk to the doctor before taking Ciclosporin-Teva if the patient: has or has had alcohol-related problems; has epilepsy; has any liver problems; is pregnant; is breast-feeding; or if this medicine is being prescribed for a child.
If any of these applies to the patient (or not sure), tell the doctor before taking Ciclosporin-Teva. This is because this medicine contains alcohol (see Ciclosporin-Teva contains ethanol as follows).
Monitoring during the treatment with Ciclosporin-Teva: The doctor will check: the levels of ciclosporin in the blood, especially if the patient has had a transplant; the blood pressure before the start of the treatment and regularly during treatment; how well the liver and kidneys are working; the blood lipids (fats).
For questions about how Ciclosporin-Teva works or why this medicine has been prescribed, ask the doctor.
In addition if the patient is taking Ciclosporin-Teva for a non-transplant disease (intermediary or posterior uveitis and Behçet's uveitis, atopic dermatitis, severe rheumatoid arthritis or nephrotic syndrome), do not take Ciclosporin-Teva: if the patient has kidney problems (except for nephrotic syndrome).
If the patient has an infection which is not under control with medication.
If the patient has any type of cancer.
If the has high blood pressure (hypertension) which is not under control with medication. If the patient gets high blood pressure during treatment and it cannot be controlled, Ciclosporin-Teva should be stopped by the doctor.
Do not take Ciclosporin-Teva if any of these applies to the patient. If not sure, talk to the doctor or pharmacist before taking Ciclosporin-Teva.
If the patient is being treated for Behçet's uveitis, the doctor will monitor particularly carefully if the patient has neurological symptoms (for example: increased forgetfulness, personality changes noticed over time, psychiatric or mood disorders, burning sensation in limbs, decreased sensation in limbs, tingling sensation in limbs, weakness of limbs, walking disturbances, headache with or without nausea and vomiting, vision disturbances including restricted movement of eyeball).
The doctor will closely monitor if the patient is elderly and is being treated for psoriasis or atopic dermatitis. If the patient has been prescribed Ciclosporin-Teva to treat the psoriasis or atopic dermatitis, he/she must not be exposed to any UVB-rays or phototherapy during treatment.
Ciclosporin-Teva with food and drink: Do not take Ciclosporin-Teva with grapefruit or grapefruit juice. This is because these can affect how Ciclosporin-Teva works.
Ciclosporin-Teva contains ethanol: Soft-gelatin capsule: Ciclosporin-Teva contains approximately 18.8 vol. % ethanol (alcohol), which corresponds up to 798 mg per dose used in transplant patients. This is equivalent to nearly 20 ml beer (5%) or 8.3 ml wine (12%) per dose.
Oral solution: Ciclosporin-Teva contains approximately 15.2 vol. % ethanol (alcohol), which corresponds to up to 600 mg per dose used in transplant patients. This is equivalent to nearly 15.2 ml beer (5%) or 6.3 ml wine (12%) per dose.
Alcohol may be harmful if the patient has alcohol-related problems, epilepsy, brain injury, liver problems or if pregnant or breast-feeding. It may also be harmful if this medicine is given to children.
Ciclosporin-Teva contains castor oil: Ciclosporin-Teva contains castor oil, which may cause stomach discomfort and diarrhoea.
Driving and using machines: Ciclosporin-Teva contains alcohol. This may affect the ability to drive and use machines.
Soft-gelatin capsule: Ciclosporin-Teva contains sorbitol: If the patient has an intolerance to some sugars, contact the doctor before taking this medicinal product.
Use in Children: Ciclosporin-Teva should not be given to children for a non-transplant disease, except for treatment of nephrotic syndrome.
Use in Elderly (65 years of age and older): There is limited experience with Ciclosporin-Teva in elderly patients. The doctor should monitor how well the kidneys work. If the patient is over 65 and has psoriasis or atopic dermatitis, he/she should only be treated with Ciclosporin-Teva if the condition is particularly severe.

Pregnancy and breast-feeding: Ask the doctor or pharmacist for advice before taking this medicine. The doctor will discuss the potential risks of taking Ciclosporin-Teva during pregnancy.
Tell the doctor if the patient is pregnant or intends to become pregnant. Experience with Ciclosporin-Teva in pregnancy is limited. In general, Ciclosporin-Teva should not be taken during pregnancy. If it is necessary for the patient to take this medicine, the doctor will discuss the benefits and potential risks of taking it during pregnancy.
Tell the doctor if the patient is breast-feeding. Breast-feeding is not recommended during treatment with Ciclosporin-Teva. This is because ciclosporin, the active substance, passes into breast milk. This may affect the baby.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects could be serious: Tell the doctor straight away if the patient notices any of the following serious side effects: Like other medicines that act on the immune system, ciclosporin may influence the body's ability to fight against infection and may cause tumours or other cancers, particularly of the skin. Signs of infection might be fever or sore throat.
Changes in the sight, loss of coordination, being clumsy, memory loss, difficulty speaking or understanding what others say, and muscle weakness. These might be signs of an infection of the brain called progressive multifocal leukoencephalopathy.
Brain problems with signs such as seizures, confusion, feeling disorientated, being less responsive, personality changes, feeling agitated, sleeplessness, changes to sight, blindness, coma, paralysis of part or all of the body, stiff neck, loss of coordination with or without unusual speech or eye movements.
Swelling at the back of the eye. This may be associated with blurred vision. It may also affect the sight because of the higher pressure inside the head (benign intracranial hypertension).
Liver problems and damage with or without yellow skin and eyes, nausea, loss of appetite and dark urine.
Kidney problems which may greatly reduce the amount of urine produced.
Low level of red blood cells or platelets. The signs include pale skin, feeling tired, being breathless, having dark urine (this is a sign of the breakdown of red blood cells), bruising or bleeding with no obvious reasons, feeling confused, feeling disorientated, being less alert and having kidney problems.
Other side effects include: Very common side effects: These side effects may affect more than 1 in 10 people: Kidney problems; High blood pressure; Headache; Shaking of the body which cannot be control; Excessive growth of body and facial hair; High level of lipids in the blood.
If any of these affects the patient severely, tell the doctor.
Common side effects: These side effects may affect between 1 and 10 in every 100 people: Fits (seizures); Liver problems; High level of sugar in the blood; Tiredness; Loss of appetite; Nausea (feeling sick), vomiting, abdominal pain, constipation, diarrhoea; Excessive hair growth; Acne, hot flushes; Fever; Low level of white blood cells; Feeling numb or tingling; Pain in the muscles, muscle spasm; Stomach ulcer; Gum tissue overgrowing and covering the teeth; High level of uric acid or potassium in the blood, low levels of magnesium in the blood.
If any of these affects the patient severely, tell the doctor.
Uncommon side effects: These side effects may affect between 1 and 10 in every 1,000 people: Symptoms of brain disorders including sudden fits, mental confusion, sleeplessness, disorientation, disturbance of vision, unconsciousness, sense of weakness in the limbs, impaired movements; Rash; General swelling; Weight gain; Low level of red blood cells, low level of platelets in the blood which could increase the risk of bleeding.
If any of these affects the patient severely, tell the doctor.
Rare side effects: These side effects may affect between 1 and 10 in every 10,000 people: Nerve problems with numbness or tingling in fingers and toes; Inflammation of the pancreas with severe upper stomach pain; Muscle weakness, loss of muscle strength, pain in muscles of the legs or hands or anywhere in the body; Destruction of red blood cells, involving kidney problems with symptoms such as swelling of the face, stomach, hands and/or feet, decreased urination, breathing difficulty, chest pain, fits, unconsciousness; Changes in menstrual cycle, breast enlargement in men.
If any of these affects the patient severely, tell the doctor.
Very rare side effects: These side effects may affect between 1 and 10 in every 100,000 people: Swelling at the back of the eye which may be associated with an increase in pressure inside the head and eyesight disturbances.
If this affects the patient severely, tell the doctor.
Other side effects with frequency not known: Frequency cannot be estimated from the available data: Serious liver problems both with and without yellowing of the eyes or skin, nausea (feeling sick), loss of appetite, dark coloured urine, swelling of the face, feet, hands and/or the whole body; Bleeding underneath the skin or purple skin patched, sudden bleeding with no apparent cause; Migraine or severe headache often with feeling and being sick (nausea, vomiting) and being sensitive to light.
If any of these affects the patient severely, tell the doctor.
Reporting of side effects: If the patient gets any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed.
Additional side effects in children and adolescents: There are no additional side effects to be expected in children and adolescents compared to adults.

Tell the doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines.
In particular tell the doctor or pharmacist if the patient is taking any of the following medicines before or during Ciclosporin-Teva treatment: Medicines that may affect the potassium levels. These include medicines which contain potassium, potassium supplements, water tablets (diuretics) called potassium-sparing diuretics and some medicines which lower the blood pressure.
Methotrexate. This is used to treat tumours, severe psoriasis and severe rheumatoid arthritis.
Medicines which may increase or decrease the level of ciclosporin (the active substance of Ciclosporin-Teva) in the blood. The doctor might check the level of ciclosporin in the blood when starting or stopping treatment with other medicines.
Medicines which may increase the level of ciclosporin in the blood include: antibiotics (such as erythromycin or azythromycin), anti-fungals (voriconazole, itraconazole), medicines used for heart problems or high blood pressure (diltiazem, nicardipine, verapamil, amiodarone), metoclopramide (used to stop sickness), oral contraceptives, danazol (used to treat menstrual problems), medicines used to treat gout (allopurinol), cholic acid and derivatives (used to treat gallstones), protease inhibitors used to treat HIV, imatinib (used to treat leukaemia or tumours), colchicine, telaprevir (used to treat hepatitis C).
Medicines which may decrease the level of ciclosporin in the blood include: barbiturates (used to help sleep), some anti-convulsant medicines (such as carbamazepine or phenytoine), octreotide (used to treat acromegaly or neuroendocrine tumours in the gut), anti-bacterial medicines used to treat tuberculosis, orlistat (used to help weight loss), herbal medicines containing St. John's wort, ticlopidine (used after a stroke), certain medicines which lower blood pressure (bosentan), and terbinafine (an anti-fungal medicine used to treat infections of the toes and nails).
Medicines which may affect the kidneys. These include: anti-bacterial medicines (gentamycin, tobramycin, ciprofloxacin), anti-fungal medicines which contain amphotericin B, medicines used for urinary tract infections which contain trimethoprim, medicines for cancer which contain melphalan, medicines used to lower the amount of acid in the stomach (acid secretion inhibitors of the H2-receptor antagonist type), tacrolimus, pain killers (non-steroid anti-inflammatory medicines such as diclofenac), fibric acid medicines (used to lower the amount of fat in the blood).
Nifedipine. This is used to treat high blood pressure and heart pain. The patient might get swollen gums that might grow over the teeth if he/she is taking nifedipine during the treatment with ciclosporin.
Digoxin (used to treat heart problems), medicines which lower cholesterol (HMG-CoA reductase inhibitors also called statins), prednisolone, etoposide (used to treat cancer), repaglinide (oral anti-diabetic medicine), immunosuppressives (everolimus, sirolimus), ambrisentan and specific anti-cancer medicines called anthracyclines (such as doxorubicin).
If any of these applies to the patient (or not sure), talk to the doctor or pharmacist before taking Ciclosporin-Teva.

Soft-gelatin capsule: Store below 25°C.
When a blister is opened, a characteristic smell is noticeable. This is normal and does not mean that there is anything wrong with the capsules.
Oral solution: Store below 25°C.
The product may become turbid at temperature lower than 20°C. In this case it is recommended to heat the product to room temperature (25°C) in order to remove the turbidity. Provided any turbidity arises it does affect neither the product efficacy nor dosage.
Do not use the medicine more than 2 months after opening the bottle.
Do not store in a cold place, protect from freezing.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer use. These measures will help to protect the environment.

Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants

L04AD01 - ciclosporin ; Belongs to the class of calcineurin inhibitors. Used as immunosuppressants.

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