CIQORIN 10 mg Soft Capsule

Зміст інструкції

1. Ciqorin 10 mg soft capsules, 25 mg soft capsules, 50 mg soft capsules, 100 mg soft capsules
   1. What is Ciqorin and what is it used for
   2. What you need to know before taking Ciqorin
   3. How to take Ciqorin
   4. Possible side effects
   5. How to store Ciqorin
   6. Package Contents and Other Information

Ciqorin 10 mg soft capsules, 25 mg soft capsules, 50 mg soft capsules, 100 mg soft capsules

Cyclosporine
Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Ciqorin is and what it is used for
• 2. What you need to know before you take Ciqorin
• 3. How to take Ciqorin
• 4. Possible side effects
• 5. How to store Ciqorin
• 6. Contents of the pack and other information

1. What is Ciqorin and what is it used for

What is Ciqorin
The name of the medicine is Ciqorin. It contains the active substance cyclosporine. Cyclosporine
belongs to a group of medicines known as immunosuppressants. These
medicines are used to decrease the body's immune reactions.

What Ciqorin is used for and how Ciqorin works

• If you have had an organ transplant, bone marrow transplant or stem cell transplant, the function of Ciqorin is to control the body's immune system. Ciqorin prevents rejection of transplanted organs by blocking the development of certain cells that would normally attack the transplanted tissue.
• If you suffer from an autoimmune disease, in which your body's immune response attacks the body's cells, Ciqorin blocks the immune reaction. These diseases include eye problems that put your vision at risk (endogenous uveitis, including Behçet's uveitis), severe cases of some skin diseases (atopic dermatitis or eczema and psoriasis), severe rheumatoid arthritis and a kidney disease known as nephrotic syndrome.

2. What you need to know before taking Ciqorin

If you are taking Ciqorin following a transplant, the medicine will only be prescribed to you by a
doctor with experience in transplants and/or autoimmune diseases.
medicine for a transplant or for an autoimmune disease.
Follow all the doctor's instructions carefully. These may be different from the

Do not take Ciqorin

• if you are allergic to cyclosporine or any of the other ingredients of this medicine (listed in section 6).
• with products containing Hypericum perforatum (St John's Wort).
• with medicines containing dabigatran etexilate (used to prevent blood clots after surgery) or bosentan and aliskiren (used to reduce high blood pressure). Do not take Ciqorin and tell your doctorif any of the above conditions apply to you. If you are unsure, ask your doctor before taking Ciqorin.

Warnings and precautions
Before and during treatment with Ciqorin, tell your doctor immediately:

• if you have any signs of infection, such as fever or sore throat. Ciqorin suppresses the immune system and can also affect the body's ability to fight infections.
• If you have liver problems.
• If you have kidney problems. The doctor will perform regular blood tests and, if necessary, may adjust the dose.
• If you develop high blood pressure. The doctor will check your blood pressure regularly and, if necessary, may give you medicine to lower your blood pressure.
• If you have low levels of magnesium in your body. The doctor may prescribe magnesium supplements, especially shortly after a transplant.
• If you have high levels of potassium in your blood.
• If you have gout.
• If you need a vaccination. If any of the above conditions apply to you, tell your doctor immediately before or during treatment with Ciqorin.

Exposure to the sun and sun protection
Ciqorin suppresses the immune system. This increases the risk of developing cancer,
particularly of the skin and the lymphatic system. You must limit exposure to the sun and UV light:

• By wearing appropriate protective clothing.
• By frequently applying a sunscreen with a high protection factor.

Tell your doctor before taking Ciqorin:

• if you have or have had problems with alcoholism.
• If you have epilepsy.
• If you have any liver problems.
• If you are pregnant.
• If you are breastfeeding.
• If this medicine is to be prescribed to a child.

If you develop any of the above conditions (or are unsure), tell your doctor before
taking Ciqorin. This is because this medicine contains alcohol (see the section below
“Ciqorin contains ethanol”).

Monitoring during treatment with Ciqorin
The doctor will check:

• the levels of cyclosporine in the blood, especially if you have had a transplant,
• the blood pressure before starting treatment and regularly during treatment,
• how the liver and kidneys are functioning,
• the lipids in the blood (fats). If you have any questions about how Ciqorin works or why this medicine has been prescribed to you, ask your doctor.

In addition, if you are taking Ciqorin for a disease other than transplant(intermediate uveitis or
posterior uveitis and Behçet's uveitis, atopic dermatitis, severe rheumatoid arthritis or nephrotic
syndrome), do not take Ciqorin:

• if you have kidney problems (except nephrotic syndrome).
• if you have an infection that is not controlled with therapy.
• if you have any type of cancer.
• if you have high blood pressure (hypertension) that is not controlled with therapy. If high blood pressure problems occur during treatment and cannot be kept under control, Ciqorin must be stopped by the doctor. If you develop any of the above conditions, do not take Ciqorin. If you are unsure, tell your doctor or pharmacist before taking Ciqorin.

If you are being treated for Behçet's uveitis, the doctor will carefully check if
you present any neurological symptoms (for example: increased forgetfulness, personality changes
observed over time, psychiatric or mood disorders, burning sensation
in the limbs, decreased sensitivity in the limbs, tingling sensation in the limbs, weakness of the
limbs, gait disturbances, headache with or without nausea and vomiting, visual disturbances including
limited eye movements).
If you are elderly and are being treated for psoriasis or atopic dermatitis, the doctor will
monitor you carefully. If you have been prescribed Ciqorin for the treatment of psoriasis or
atopic dermatitis, you must not be exposed to UVB radiation or phototherapy during treatment.

Children and adolescents
Ciqorin should not be given to children for diseases other than transplant, except
for the treatment of nephrotic syndrome.

Elderly (65 years of age and over)
There is limited experience with Ciqorin in elderly patients. The doctor must check the good
function of the kidneys. If you are over 65 years of age and suffer from psoriasis or atopic dermatitis, you
must be treated with Ciqorin only if the condition is particularly severe.

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:

• Medicines that can affect potassium levels. These include medicines that contain potassium, potassium supplements, water tablets (diuretics) called potassium-sparing diuretics and some medicines that lower blood pressure.
• Methotrexate. It is a medicine used to treat tumors, severe psoriasis and severe rheumatoid arthritis.
• Medicines that can increase or decrease the level of cyclosporine (the active ingredient of Ciqorin) in the blood. The doctor may check the level of cyclosporine in the blood at the start or end of treatment with other medicines.
• Medicines that can increase the level of cyclosporine in the blood include: antibiotics (such as erythromycin or azithromycin), antifungals (voriconazole, itraconazole), medicines used for heart problems or high blood pressure (diltiazem, nicardipine, verapamil, amiodarone), metoclopramide (used against nausea), oral contraceptives, danazol (used to treat menstrual problems), medicines used to treat gout (allopurinol), bile acid and derivatives (used to treat gallstones), protease inhibitors used to treat HIV, imatinib (used to treat leukemia or tumors), colchicine, telaprevir (used to treat hepatitis C).
• Medicines that can decrease the level of cyclosporine in the blood include: barbiturates (used to promote sleep), some anticonvulsant medicines (such as carbamazepine or phenytoin), octreotide (used to treat acromegaly or neuroendocrine tumors of the intestine), antibacterial medicines used to treat tuberculosis, orlistat (used to promote weight loss), herbal medicines containing St John's Wort, ticlopidine (used after a stroke), certain medicines that lower blood pressure (bosentan) and terbinafine (an antifungal medicine used to treat foot and nail infections).
• Medicines that can have effects on the kidneys. These include: antibacterial medicines (gentamicin, tobramycin, ciprofloxacin), antifungal medicines containing amphotericin B, medicines used for urinary tract infections containing trimethoprim, cancer medicines containing melphalan, medicines used to lower the amount of acid in the stomach (acid secretion inhibitors of the H2 receptor antagonist type), tacrolimus, painkillers (non-steroidal anti-inflammatory drugs such as diclofenac), fibric acid medicines (used to lower the amount of fat in the blood).
• Nifedipine. It is used to treat high blood pressure and chest pain. If you are taking nifedipine during treatment with cyclosporine, you may experience swelling of the gums that thickens around the teeth.
• Digoxin (used to treat heart problems), medicines that lower cholesterol (HMG-CoA reductase inhibitors also called statins), prednisolone, etoposide (used to treat cancer), repaglinide (an antidiabetic medicine), immunosuppressants (everolimus, sirolimus), ambrisentan and specific medicines against cancer called anthracyclines (e.g. doxorubicin). If you develop any of the above conditions (or are unsure), tell your doctor or pharmacist before taking Ciqorin.

Ciqorin with food and drink
Do not take Ciqorin with grapefruit or grapefruit juice. This is because they can have an effect
on the action of Ciqorin.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking this medicine. The doctor
will discuss with you the potential risks of taking Ciqorin during pregnancy.

• Tell your doctor if you are pregnant or intend to become pregnant. Experience with Ciqorin in pregnancy is limited. In general, Ciqorin should not be taken during pregnancy. If taking this medicine is necessary, the doctor will discuss with you the benefits and potential risks of taking it during pregnancy.
• Tell your doctor if you are breastfeeding. Breastfeeding is not recommended during treatment with Ciqorin. This is because cyclosporine, the active ingredient, passes into breast milk. This can have effects on the baby.

Driving and using machines
Ciqorin contains alcohol. This can affect your ability to drive vehicles and use
machinery..

Ciqorin contains ethanol
Ciqorin contains approximately 14.7% ethanol (alcohol), which corresponds to up to 797.5
mg per dose used in transplant patients. This is equivalent to almost 20 ml of beer or about 8 ml
of wine per dose.
Alcohol can be harmful if you suffer from alcohol-related problems, epilepsy, brain injury,
liver problems or if you are pregnant or breastfeeding. It can also be harmful if
the medicine is given to children.

Ciqorin contains hydroxy stearic macrogolglycerides
Ciqorin contains hydroxy stearic macrogolglycerides which can cause stomach upset and diarrhea.

Ciqorin contains sorbitol.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.

For those who engage in sporting activity, the use of medicines containing ethyl alcohol may determine

positive doping tests in relation to the limit of alcohol concentration indicated by some

sports federations.

3. How to take Ciqorin

Take this medicine following exactly the instructions of your doctor. If you have doubts,
consult your doctor.
Do not take more than the recommended dose.
The dose of this medicine will be carefully adjusted to your personal needs by the doctor.
Too much medicine can affect kidney function. You will be regularly subjected to blood tests and hospital visits, especially after a transplant. This will give you the opportunity to
talk to your doctor about the treatment and any problems you may have.

How much Ciqorin to take
The doctor will establish the correct dose of Ciqorin for you. It depends on your body weight and the reason
why you are taking the medicine. The doctor will also tell you how often to take the
medicine.

• In adults:Organ, bone marrow or stem cell transplant
• The total daily dose is usually between 2 mg and 15 mg per kilogram of body weight. It should be divided into two doses.
• Usually the higher doses are used before and immediately after the transplant. Lower doses are used once the transplanted organ or bone marrow has stabilized.
• The doctor will adjust the dose to the appropriate one for you. To do this, the doctor may need to perform some blood tests. Endogenous uveitis
• The total daily dose is usually between 5 mg and 7 mg per kilogram of body weight. It should be divided into two doses. Nephrotic syndrome
• For adults, the total daily dose is usually 5 mg per kilogram of body weight. It should be divided into two doses. In patients with kidney problems, the initial dose taken each day 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. It should be divided into two doses. 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. It should be divided into two doses.
• In children:Nephrotic syndrome
• For children, the total daily dose is usually 6 mg per kilogram of body weight. It should be divided into two doses. In patients with kidney problems, the initial dose taken each day should not exceed 2.5 mg per kilogram of body weight. Follow your doctor's instructions exactly and never change the dose on your own, even if you feel well.

Switching from oral cyclosporine to oral microemulsion cyclosporine
You may have already taken another oral cyclosporine. The doctor may decide to switch to this
medicine, Ciqorin.

• All these medicines contain cyclosporine as the active ingredient.
• Ciqorin is a different, improved formulation of cyclosporine. Cyclosporine is better absorbed into the blood with Ciqorin and it is less likely that absorption will be affected by taking the medicine with food. This means that cyclosporine levels in the blood will remain more constant with Ciqorin. If the doctor changes the medicine from oral cyclosporine to oral microemulsion cyclosporine:
• Do not return to taking the previous medicine unless your doctor tells you to.
• Following the switch, the doctor will monitor you more closely for a short period. This is due to the change in how cyclosporine is absorbed into the blood. The doctor will make sure you take the right dose for your individual needs.
• You may experience some unwanted effects. If this happens, contact your doctor or pharmacist. The dose may need to be reduced. Never reduce the dose on your own, unless your doctor tells you to.

If the doctor switches you from one oral cyclosporine formulation to another
After switching from one oral cyclosporine formulation to another:

• The doctor will monitor you more closely for a short period.
• You may experience some unwanted effects. If this happens, contact your doctor or pharmacist. The dose may need to be changed. Never change the dose on your own, unless your doctor tells you to.

When to take Ciqorin
Take Ciqorin every day at the same time. This is very important if you have had a
transplant.

How to take Ciqorin
Daily doses must always be taken in 2 divided doses.
Remove the capsules from the blister. Swallow the capsules whole with water.

How long to take Ciqorin
The doctor will tell you how long you will need to take Ciqorin. This depends on whether you are
taking the medicine after a transplant or for the treatment of a severe skin condition, rheumatoid arthritis, uveitis or nephrotic syndrome. For severe skin rash, the duration of
treatment is usually 8 weeks.
Continue to take Ciqorin until your doctor has told you to stop.
If you have any questions about how long to take Ciqorin, talk to your doctor or pharmacist.

If you take more Ciqorin than you should
If you have accidentally taken too much medicine, immediately inform your doctor or go to the
nearest hospital emergency room. You may need medical care.

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 the next dose, skip the missed dose. Then continue as before.
• Do not take a double dose to make up for a missed dose.

If you stop taking Ciqorin
Do not stop taking Ciqorin unless your doctor tells you to.
Continue to take Ciqorin even if you feel well. Stopping treatment with Ciqorin can
increase the risk of rejection of the organ you have transplanted.
If you have any further questions about the use of this medicine, 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
Immediately inform your doctor ifyou experience any of the following serious side effects:

• As with other medicines that act on the immune system, ciclosporin can affect the body's ability to fight infections and can cause tumors or other types of cancer, particularly of the skin. Signs of infection may include fever or sore throat.
• Changes in vision, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others are saying, and muscle weakness. These could be signs of a brain infection called progressive multifocal leukoencephalopathy.
• Brain problems with signs such as seizures, confusion, feeling disoriented, decreased responsiveness, personality changes, feeling agitated, insomnia, changes in vision, blindness, coma, paralysis of a part or all of the body, stiff neck, loss of coordination with or without unusual speech or eye movements.
• Swelling in the back of the eye. This may be associated with blurred vision. It can also affect vision due to increased pressure inside the head (benign intracranial hypertension).
• Liver problems and damage with or without yellowing of the skin and eyes, nausea, loss of appetite, and dark urine.
• Kidney problems that can significantly reduce the amount of urine produced.
• Low levels of red blood cells or platelets. Signs include paleness, feeling tired, difficulty breathing, dark urine (this is a sign of red blood cell breakdown), bruising or bleeding for no apparent reason, feeling confused, feeling disoriented, decreased attention, and 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.
• Uncontrollable body shaking.
• Excessive hair growth on the body and face.
• High levels of lipids in the blood. If any of these effects become severe, inform your doctor.

Common side effects:These side effects may affect between 1 and 10 people out of 100.

• Seizures (convulsions).
• Liver problems.
• High blood sugar levels.
• Fatigue.
• Loss of appetite.
• Nausea (feeling sick), vomiting, abdominal pain, constipation, diarrhea.
• Excessive hair growth.
• Acne, hot flashes.
• Fever.
• Low levels of white blood cells in the blood.
• Feeling of numbness or tingling.
• Muscle pain, muscle spasms.
• Stomach ulcer.
• Excessive growth of the gums and covering of the teeth.
• High levels of uric acid or potassium in the blood, low levels of magnesium in the blood.
• If any of these effects become severe, inform your doctor.

Uncommon side effects:These side effects may affect between 1 and 10 people out of

• 1,000.
• Symptoms of brain disorders including sudden attacks, mental confusion, insomnia, disorientation, visual disturbances, loss of consciousness, weakness of the limbs, reduced movements.
• Skin rash.
• Generalized swelling.
• Weight gain.
• Low levels of red blood cells, low levels of platelets in the blood, which may increase the risk of bleeding. If any of these effects become severe, inform your doctor.

Rare side effects:These side effects may affect between 1 and 10 people out of 10,000.

• Nerve problems with numbness or tingling in the fingers of the hands and feet.
• Inflammation of the pancreas with severe pain in the upper abdomen.
• Muscle weakness, loss of muscle strength, pain in the leg or arm muscles, or in any part of the body.
• Destruction of red blood cells, which involve kidney problems with symptoms such as swelling of the face, stomach, hands and/or feet, decreased urine volume, difficulty breathing, chest pain, convulsions, loss of consciousness.
• Changes in the menstrual cycle, enlargement of the breast gland in men. If any of these effects become severe, inform your doctor.

Very rare side effects:These side effects may affect between 1 and 10 people out of

• 100,000.
• Swelling in the back of the eye that may be associated with increased pressure inside the head and visual disturbances. If this effect becomes severe, inform your doctor.

Other side effects with unknown frequency:Frequency cannot be estimated on the basis of

available data.

• Severe liver problems with and without yellowing of the skin or eyes, nausea (feeling sick), loss of appetite, dark urine, swelling of the face, feet, hands and/or the whole body.
• Bleeding under the skin or purple spots, sudden bleeding for no apparent reason.
• Migraine or severe headache often with feeling unwell (nausea, vomiting) and sensitivity to light.

If any of these effects become severe, inform your doctor.

Additional side effects in children and adolescents
There are no additional side effects to be expected in children and adolescents compared to

adults.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the website: http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ciqorin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister after
EXP.
The expiry date refers to the last day of that month.
Store at a temperature below 30° C. Do not freeze. Store in the original package
to protect the medicine from light and moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Ciqorin contains

• Each soft capsule contains 10 mg of cyclosporine. Each soft capsule contains 25 mg of cyclosporine. Each soft capsule contains 50 mg of cyclosporine. Each soft capsule contains 100 mg of cyclosporine.
• The other components of the capsule content are macrogolglycerol hydroxystearate, glycerol monolinooleate, diethylene glycol monoethyl ether, anhydrous ethanol and D,L-α-tocopherol.
• The other components of the capsule shell are (10 mg)gelatin, glycerol (85 percent), sorbitol liquid non-crystallizable 70% (E420), glycine, titanium dioxide (E171) and light liquid paraffin. (25 mg and 50 mg)gelatin, glycerol (85 percent), sorbitol liquid non-crystallizable 70% (E420), glycine, titanium dioxide (E171), yellow iron oxide (E172) and light liquid paraffin. (100 mg)gelatin, glycerol (85 percent), sorbitol liquid non-crystallizable 70% (E420), glycine, titanium dioxide (E171), brown iron oxide (E172) and light liquid paraffin.
• (25 mg, 50 mg and 100 mg).The other components of the printing ink are shellac (E904), propylene glycol, concentrated ammonia solution and indigo carmine (E132).

Description of the appearance of Ciqorin and package contents
Ciqorin 10 mg soft capsules are soft gelatin capsules of color from opaque white to whitish
containing an oily liquid from colorless to slightly yellowish. Approximate dimensions: 9.0
x 5.5 mm.
Ciqorin 25 mg soft capsules are soft gelatin capsules of opaque yellow color containing a
oily liquid from colorless to slightly yellowish, bearing the IVAX “hourglass” “25” logo.
Approximate dimensions: 12.2 x 7.6 mm.
50 mg soft capsules are soft gelatin capsules of opaque yellowish-ochre color containing a
oily liquid from colorless to slightly yellowish, bearing the IVAX “hourglass” “50” logo.
Approximate dimensions: 20.7 x 7.8 mm.
Ciqorin 100 mg soft capsules are soft gelatin capsules of opaque brown color containing
an oily liquid from colorless to slightly yellowish, bearing the IVAX “hourglass” “100” logo.
Approximate dimensions: 24.7 x 9.9 mm.
The capsules are available in packs of 20, 30, 50, 60, 90 and 100 in OPA/Alu/PVC blisters -
aluminum.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Teva Italia S.r.l. – Via Messina, 38 – 20154 Milan

Manufacturer responsible for batch release
Teva Czech Industries s.r.o.
Ostravska 29, c.p. 305 - 74770 Opava-Komarov
Czech Republic
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 – Debrecen
Hungary
TEVA UK Ltd
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG
United Kingdom
Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem
Netherlands
TEVA Santé
Rue Bellocier, 89100 Sens
France
Merckle GmbH
Ludwig-Merckle-Straße
3, 89143 Blaubeuren
Germany
Teva Operations Poland
Sp. z.o.o
ul. Mogilska 80, 31-546, Krakow
Poland