25 mg, 50 mg, 100 mg soft capsules, 100 mg / ml oral solution 
cyclosporine

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not give it to others. It may harm them, even if they show symptoms similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Ciclosporin Ivax is and what it is used for 
2. What you need to know before you use Ciclosporin Ivax 
3. How to use Ciclosporin Ivax 
4. Possible side effects 
5. How to store Ciclosporin Ivax 
6. Contents of the packaging and other information 

What Ciclosporin Ivax is and what it is used for

What Ciclosporin Ivax is

The name of this medicine is Ciclosporin Ivax. 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 Ciclosporin Ivax is used for and how Ciclosporin Ivax works

  • If you have had an organ transplant or bone marrow and stem cell transplant , Ciclosporin Ivax is used to control the body’s immune system. Ciclosporin Ivax 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, Ciclosporin Ivax 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 eczemaand psoriasis ), severe rheumatoid arthritis and a kidney disease called nephrotic syndrome .

Ciclosporin contained in Ciclosporin Ivax 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.

What you need to know before you use Ciclosporin Ivax

If you are taking Ciclosporin Ivax after a transplant, it will only be prescribed to you by a doctor who has experience in 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 use Ciclosporin Ivax

  • if you are allergic (hypersensitive) 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 Ciclosporin Ivax and tell your doctor if the above applies to you.

Talk to your doctor before taking Ciclosporin Ivax if you are not sure.

Warnings and cautions

Before and during treatment with Ciclosporin Ivax, tell your doctor immediately:

  • if you have any signs of infection , such as fever or sore throat. Ciclosporin Ivax 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 Ciclosporin Ivax, tell your doctor immediately.

Sunlight and sun protection

Ciclosporin Ivax 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.

Talk to your doctor before taking Ciclosporin Ivax:

  • if you have or have had alcohol-related problems.
  • if you have epilepsy .
  • if you have any liver problems.
  • if you are pregnant.
  • if you are breast-feeding.
  • if this medicine is prescribed for a child.

If any of the above apply to you (or you are not sure), tell your doctor before taking Ciclosporin Ivax. The reason for this is that the medicine contains alcohol (see section “Ciclosporin Ivax contains alcohol” below).

Check during treatment with Ciclosporin Ivax

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 Ciclosporin Ivax or why it has been prescribed for you, ask your doctor.

If you are prescribed Ciclosporin Ivax 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 Ciclosporin Ivax:

  • 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 Ciclosporin Ivax.

Do not take Ciklosporin Ivax if any of the above apply to you. Talk to your doctor or pharmacist before taking Ciclosporin Ivax if you feel unsure.

If you are being treated for Behçet’s uveit , 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 older and being treated for psoriasisor atopic dermatitis . If you have been prescribed Ciclosporin Ivax 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

Ciclosporin Ivax should not be given to children for a non-transplant disease, with the exception of treatment of nephrotic syndrome .

Elderly people (from 65 years)

Experience in treating elderly patients with Ciclosporin Ivax 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 Ciclosporin Ivax if your disease is very serious.

Other medicines and Ciclosporin Ivax

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, herbal medicines or other natural products.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines before or during treatment with Ciklosporin Ivax:

  • Drugs that can affect your potassium levels. These include medicines containing potassium , potassium supplements, diuretics , so-called potassium-sparing diuretics and certain medicines that lower blood pressure .
  • Methotrexate used to treat tumors , severe psoriasis and severe rheumatoid arthritis .
  • Drugs that may increase or decrease the level of ciclosporin (the active substance in Ciclosporin Ivax) 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), antifungal drugs (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 forhepatitis C).
    • Drugs that can lower ciclosporin levels 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 , orlistin ( weightlifting ), orlistin , herbal medicines 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 containing amphotericin B, drugs for urinary tract infections that contain trimethoprim, anti-cancer drugs that contain melphalan, drugs that lower the acidity of the stomach, taksimar painkillers (non-steroidal anti-inflammatory drugs such as diclofenac ), drugs that contain fibrates (used to lower blood fats).
  • Nifedipine used to treat high blood pressure and pain from the heart. 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 Ciclosporin Ivax.

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 adjustments to the ciclosporin dose after you start treatment for hepatitis C.

Use of Ciclosporin Ivax with food and drink

Do not take Ciclosporin Ivax with grapefruit or grapefruit juice. These can affect how Ciclosporin Ivax works.

Pregnancy and breastfeeding

Talk to your doctor or pharmacist before taking this medicine. Your doctor will talk to you about the possible risks of taking Ciclosporin Ivax during pregnancy.

  • Tell your doctor if you are pregnant or planning to become pregnant. Experience with Ciclosporin Ivax during pregnancy is limited. In general, Ciclosporin Ivax 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. Breast-feeding is not recommended during treatment with Ciclosporin Ivax. The active substance ciclosporin passes into breast milk. This can affect the baby.

Driving and using machines

Ciclosporin Ivax contains alcohol. This 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 increased 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.

Important information about some of the ingredients of Ciclosporin Ivax

Ethanol

Ciclosporin Ivax oral solution and Ciclosporin Ivax soft capsules contain 12% by volume of ethanol (alcohol), ie. up to 800 mg per dose . This corresponds to 20 ml of beer or 8.4 ml of wine per dose . Harmful to people suffering from alcoholism. Attention should be paid to pregnant or lactating women, children and high-risk groups such as patients with liver disease or epilepsy .

Macrogolglycerol hydroxystearate

Ciclosporin Ivax oral solution and Ciclosporin Ivax soft capsules contain macrogolglycerol hydroxystearate which may cause stomach upset and diarrhea.

Sorbitol

Ciclosporin Ivax soft capsules also contain sorbitol. One 25 mg capsule contains 8.6 mg sorbitol, one 50 mg capsule contains 20.20 mg sorbitol and one 100 mg capsule contains 28.7 mg sorbitol.

Sorbitol is a source of fructose. If you (or your child) do not tolerate certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance , a rare, inherited disease that prevents fructose from being broken down, consult a doctor before using this medicine.

How to use Ciclosporin Ivax

Always take Ciclosporin Ivax exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

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 Ciclosporin Ivax to take

Your doctor will decide which dose of Ciclosporin Ivax 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 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 body weight.

Follow your doctor’s instructions exactly and never change the dose yourself, even if you are feeling well.

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 you 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 Ciklosporin Ivax

Take Ciklosporin Ivax at the same time each day. This is very important if you have undergone a transplant.

How to take Ciclosporin Ivax

Your daily doses should always be divided into two occasions.

Ciclosporin Ivax capsules:

Use only capsules in unfolded foil (See section 5, How to store Ciclosporin Ivax). The capsule is swallowed whole with a glass of liquid (not grapefruit juice).

Ciclosporin Ivax oral solution:

  1. Open the bottle and discard the closure.
  2. Firmly push the plastic replacement plug and the attached tube into the bottle neck.
  3. Insert the syringe into the stopper.
  4. Draw up prescribed amount of solution.
  5. Inject large bubbles by pushing in and pulling out the plunger a few times before pulling the syringe containing the prescribed dose out of the bottle. Small bubbles in the syringe have no significance and do not affect dose one in any way.
  6. After use, wipe the outside of the syringe only and put it back in its case. Discard the paper carefully. Seal the bottle with the supplied screw cap.

Use at a later time: Start in step 3.

How long to take Ciclosporin Ivax

Your doctor will tell you how long you need to take Ciclosporin Ivax. It depends on whether you take it after a transplant or to treat a severe skin disease, rheumatoid arthritis or nephrotic syndrome . In case of severe skin rash, the treatment usually lasts for about 8 weeks.

Continue to take Ciclosporin Ivax for as long as your doctor tells you to.

If you forget to use Ciclosporin Ivax

  • 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 Ciclosporin Ivax

Do not stop taking Ciclosporin Ivax unless your doctor tells you to.

Continue to take Ciclosporin Ivax even if you are feeling well. Discontinuation of Ciclosporin Ivax 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, Ciclosporin Ivax 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.
  • Vision 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 multifocalleukoencephalopathy.
  • Impact on the brain with signs such as seizures, confusion, disorientation, less contactability, 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.
  • 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 obvious cause, confusion, disorientation, you feel less alert and have kidney problems.

Other side effects can be:

Very common side effects: These 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: These side effects may affect between 1 and 10 in 100 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: These side effects may affect between 1 and 10 in 1,000 people.

  • Symptoms of brain disease including sudden seizures, mental confusion, insomnia, disorientation, visual disturbances, unconsciousness, feeling of weakness in arms and legs, impaired movement patterns.
  • Rash.
  • General swelling.
  • Weight gain.
  • Low number of red blood cells , low number of platelets that 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: These side effects may affect between 1 and 10 in 10,000 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: These side effects may affect between 1 and 10 in 100,000 people.

  • Swelling in the posterior parts of the eye that may be associated with increased pressure in the head and with visual disturbances.

If this side effect affects you badly, tell your doctor.

Side effects without known frequency: Frequency can not be calculated from the available data.

  • 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 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.

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 additional 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 Ciclosporin Ivax

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton (capsules and oral solution), the label ( oral solution) and on the blister (capsules) after EXP. The expiration date is the last day of the specified month.

Capsules: 
Do not store above 30 ° C. Store in a cold place. 
Store in the original package. 
If the protective package is opened in advance, the effect of the active substance ciclosporin may be attenuated by evaporation of ethanol .

Oral solution: 
Do not store above 25 ° C. Store in a cold place. 
The solution should preferably not be stored below 20 ° C for any long time, as the vegetable oil then contained may solidify. The solution may become gelatinous at temperatures below 20 ° C, but regains its consistency at temperatures above 20 ° C. Minor flakes or turbidity may remain, but this does not affect the efficacy and safety of the drug. Before using the solution, make sure that the seal is unbroken. The solution should be consumed within 3 months after opening the bottle. 
Close the bottle tightly. Otherwise the effect of the active substance ciclosporin may be weakened by theevaporation of ethanol .

The medicine 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.

Soft capsules 25 mg and 50 mg:

  • Each capsule contains 25 mg or 50 mg of cyclosporine
  • The other ingredients in the capsule core are ethanol , polyglycerol oleate, macrogolglycerol hydroxystearate, and alpha-tocopherol.
  • The other ingredients in the capsule shell are gelatin, glycerol 85%, liquid sorbitol (E420), titanium dioxide (E171), glycine , water and yellow iron oxide (E172)

Soft capsules 100 mg:

  • Each capsule contains 100 mg of cyclosporine
  • The other ingredients in the capsule core are ethanol , polyglycerol oleate, macrogolglycerol hydroxystearate, and alpha-tocopherol.
  • The other ingredients in the capsule shell are gelatin, glycerol 85%, liquid sorbitol (E420), titanium dioxide (E171), glycine , water and brown iron oxide (E172).

Oral solution:

  • 1 ml solution contains 100 mg ciclosporin
  • The other ingredients are ethanol , polyglycerol oleate and macrogolglycerol hydroxystearate.

What the medicine looks like and contents of the pack

Ciclosporin Ivax 25 mg soft capsules are yellow and marked with the “hourglass” logo and “25 mg”

Ciclosporin Ivax 50 mg soft capsules are ocher colored and marked with the “hourglass” logo and “50 mg”

Ciclosporin Ivax 100 mg soft capsules are brown and marked with the “hourglass” logo and “100 mg”

Ciclosporin Ivax 100 mg / ml oral solution is a yellow-brown oily liquid.

Ciclosporin Ivax capsules are available as aluminum blisters in PVC / PVDC / Al containing 30, 50, 100, 200 and 250 capsules.

Ciclosporin Ivax oral solution is available in glass bottles containing 50 ml solution in a carton.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer


Manufacturer: 
Teva Czech Industries sro, Ostravská 29, 747 70 Opava-Komárov, Czech Republic

Muhammad Nadeem

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