CIQORIN 50 mg SOFT GEL CAPSULES

Introduction

Package Leaflet: Information for thepatient

Ciqorin 50 mg soft capsules EFG

Ciclosporin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Ciqorin and what is it used for
2. What you need to know before you take Ciqorin
3. How to take Ciqorin
4. Possible side effects
5. Storage of 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 your medicine is Ciqorin. It contains the active substance ciclosporin. It belongs to a group of medicines known as immunosuppressants. These medicines are used to decrease the immune reactions of the body.

What Ciqorin is used for and how it works

• If you have had an organ, bone marrow, and stem cell transplant, the function of Ciqorin is to control your body's immune system. Ciqorin prevents the rejection of transplanted organs by inhibiting the development of certain cells that would normally attack the transplanted tissue.
• If you have an autoimmune disease, in which your body's immune response attacks its own cells, Ciqorin inhibits this immune response. These diseases include eye problems that can affect your 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.

2. What you need to know before you take Ciqorin

If you are taking Ciqorin after a transplant, it can only be prescribed by a doctor with experience in transplants and/or autoimmune diseases.

The recommendations in this leaflet may vary depending on whether you are taking the medicine for a transplant or for an autoimmune disease.

Follow your doctor's instructions carefully. They may be different 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)
• with medicines that contain Hypericum perforatum(St. John's Wort).
• with medicines that contain dabigatran etexilate (used to prevent blood clots after an operation) or bosentan and aliskiren (used to lower high blood pressure).

If any of these apply to you, do not take Ciqorin and inform your doctor. If you are not sure, consult your doctor before taking Ciqorin.

Warnings and precautions

Tell your doctor immediately before and during treatment with Ciqorin:

• if you have any signs of infection, such as fever or sore throat. Ciqorin suppresses the immune system and may also affect your body's ability to fight infections.
• if you have liver problems
• if you have kidney problems. Your doctor will perform regular blood tests and may change your dose if necessary.
• if you have high blood pressure. Your doctor will check your blood pressure regularly and may give you a medicine to lower your blood pressure if necessary.
• if you have low magnesium levels in your body. Your doctor may give you magnesium supplements, especially just after your operation if you have had a transplant.
• if you have high potassium levels in your blood.
• if you have gout.
• if you need to receive a vaccine.

If you experience any of the above situations before or during treatment with Ciqorin, inform your doctor immediately.

Sun protection and sunlight

Ciqorin suppresses your immune system. This may increase the risk of developing cancer, mainly of the skin and lymphatic system. Therefore, you should limit your exposure to the sun and UV rays as follows:

• Wearing protective clothing.
• Applying a high-factor sunscreen frequently.

Monitoring during your treatment with Ciqorin

Your doctor will check:

• ciclosporin levels in your blood, especially if you have had a transplant,
• your blood pressure before starting treatment and regularly during treatment,
• how your liver and kidneys are working,
• your lipid levels in your blood (fats).

If you have any questions about how Ciqorin works or why you have been prescribed this medicine, ask your doctor.

In addition, if you are taking Ciqorin for a disease other than a transplant(intermediate 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 for nephrotic syndrome).
• if you have an uncontrolled infection.
• if you have any type of cancer.
• if you have uncontrolled high blood pressure. If you develop high blood pressure during treatment and it cannot be controlled, your doctor should stop treatment with Ciqorin.

If any of these situations apply to you, do not take Ciqorin. If you are not sure, consult your doctor or pharmacist before taking Ciqorin.

If you are being treated for Behçet's uveitis, your doctor will monitor you closely, especially if you have neurological symptoms (e.g., frequent memory loss, changes in personality over time, psychiatric or mood disorders, burning sensation in the limbs, decreased sensitivity in the limbs, tingling sensation in the limbs, weakness in the limbs, motor disorders, headache with or without nausea and vomiting, vision disorders that include limited eye movement).

Your doctor will monitor you closely if you are an elderly person and are being treated for psoriasis or atopic dermatitis. If you have been prescribed Ciqorin for psoriasis or atopic dermatitis, you should not be exposed to UVB rays or photochemotherapy during treatment.

Children and adolescents

Ciqorin should not be given to children for indications other than transplantation, except for the treatment of nephrotic syndrome.

Elderly population (65 years of age and over)

There is limited experience with Ciqorin in elderly patients. Your doctor should monitor how your kidneys are working. If you are over 65 years old and have psoriasis or atopic dermatitis, you should only be treated with Ciqorin if your condition is particularly severe.

Taking Ciqorin with other medicines

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 may affect your potassium levels. These include medicines that contain potassium, potassium supplements, potassium-sparing diuretics, and some medicines that lower your blood pressure.
• Methotrexate. It is used to treat tumors, severe psoriasis, and severe rheumatoid arthritis.
• Medicines that may increase or decrease ciclosporin levels (the active substance of Ciqorin) in your blood. Your doctor may check the ciclosporin level in your blood when you start or stop treatment with other medicines.

• Medicines that may increase ciclosporin levels in your blood include: antibiotics (such as erythromycin or azithromycin), antifungals (voriconazole, itraconazole), medicines used for heart disorders or high blood pressure (diltiazem, nicardipine, verapamil, amiodarone), metoclopramide (used to stop vomiting), oral contraceptives, danazol (used to treat menstrual disorders), medicines used to treat gout (allopurinol), cholic acid and derivatives (used to treat bile stones), HIV protease inhibitors, imatinib (used to treat leukemia or tumors), colchicine, telaprevir (used to treat hepatitis C), cannabidiol (its use includes, among others, the treatment of epileptic seizures).
• Medicines that may decrease ciclosporin levels in your blood include: barbiturates (used to help you sleep), certain anticonvulsants (such as carbamazepine or phenytoin), octreotide (used to treat acromegaly or neuroendocrine tumors in the intestine), antibacterial medicines used to treat tuberculosis, orlistat (used to help with weight loss), herbal medicines that contain St. John's Wort, ticlopidine (used after a stroke), certain medicines that lower blood pressure (bosentan), and terbinafine (an antifungal medicine, used to treat infections of the toes and fingernails).

Medicines that may affect your kidneys. These include: antibacterial medicines (gentamicin, tobramycin, ciprofloxacin), antifungal medicines that contain amphotericin B, medicines used for urinary tract infections that contain trimethoprim, cancer medicines that contain melphalan, medicines used to reduce the amount of acid in your stomach (H2 receptor antagonists), tacrolimus, painkillers (non-steroidal anti-inflammatory medicines like diclofenac), fibrates (used to lower the amount of fat in your blood).

• Nifedipine. It is used to treat high blood pressure and chest pain. You may have swollen gums that may grow over your teeth if you are taking nifedipine during your treatment with ciclosporin.
• Digoxin (used to treat heart disorders), cholesterol-lowering medicines (HMG-CoA reductase inhibitors, also called statins), prednisolone, etoposide (used to treat cancer), repaglinide (an oral antidiabetic), immunosuppressants (everolimus, sirolimus), ambrisentan, and specific anticancer medicines called anthracyclines (such as doxorubicin).
• Mycophenolate sodium or mycophenolate mofetil (an immunosuppressant) and eltrombopag (used to treat bleeding disorders).

If any of these situations apply to you (or you are not sure), inform your doctor or pharmacist before taking Ciqorin.

Hepatitis C

Tell your doctor if you have hepatitis C. Your liver function may change with hepatitis C treatment, and this may affect ciclosporin levels in your blood. Your doctor may need to monitor your ciclosporin levels in your blood and adjust your dose after starting hepatitis C treatment.

Taking Ciqorin with food and drinks

Do not take Ciqorin with grapefruit or grapefruit juice. This is because it may affect how Ciqorin works.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking this medicine. Your doctor will discuss the potential risks of taking Ciqorin during pregnancy.

• Tell your doctor if you are pregnant or plan to become pregnant. Experience with Ciqorin in pregnant women is limited. In general, Ciqorin should not be taken during pregnancy. If it is necessary for you to take this medicine, your doctor will discuss 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 ciclosporin, the active substance, passes into breast milk and may affect your child.

Driving and using machines

You may feel drowsy, disoriented, or have blurred vision after taking ciclosporin. Be careful when driving or operating machinery while taking ciclosporin until you know how it affects you.

Ciqorin contains ethanol

This medicine contains 79.75 mg of alcohol (ethanol) per capsule. A dose of 500 mg (797.5 mg of ethanol) is equivalent to less than 20 ml of beer or 8 ml of wine. The small amount of alcohol in this medicine will not have a noticeable effect.

Ciqorin contains sorbitol

This medicine contains 11.03 mg of sorbitol per capsule.

Ciqorin containsmacrogolglycerol hydroxystearate

It may cause stomach upset and diarrhea.

3. How to take Ciqorin

Follow your doctor's instructions for administering this medication exactly as indicated. If in doubt, consult your doctor again.

Do not take more than the recommended dose.

Your doctor will carefully adjust the dose of this medication to your individual needs. Too much of this medication can affect your kidneys. You will have regular blood tests and hospital visits, especially after transplantation. This will allow you to consult with your doctor about your treatment and any problems you may have.

How much Ciqorin should you take

Your doctor will indicate the correct dose of Ciqorin for you. This depends on your body weight and what you are taking this medication for. Similarly, your doctor will inform you how often you should take your medication.

• In adults:

Organ, bone marrow, and 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 doses.
• Normally, high doses are used before and immediately after your transplant. Lower doses are used once your transplanted organ or bone marrow is stabilized.
• Your doctor will adjust the dose to one that is ideal for you. To do this, your 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. This is divided into two doses.

Nephrotic syndrome

• The total daily dose for adults is usually 5 mg per kilogram of body weight. This is divided into two doses. In patients with kidney problems, the first daily dose should not exceed 2.5 mg per kilogram of body weight.

Severe rheumatoid arthritis

• The total daily dose is usually between 3 mg and 5 mg per kilogram of body weight. This is divided into two doses.

Psoriasis and atopic dermatitis

• The total daily dose is usually between 2.5 mg and 5 mg per kilogram of body weight. This is divided into two doses.

• In children:

Nephrotic syndrome

• The total daily dose for children is usually 6 mg per kilogram of body weight. This is divided into two doses. In patients with kidney problems, the first daily dose 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 feel well.

Conversion from cyclosporin to cyclosporin in microemulsion

You may have been taking another oral cyclosporin. Your doctor may decide to switch you to this medication, Ciqorin.

• All these medications contain cyclosporin as the active ingredient.
• Ciqorin is a different and improved formulation of cyclosporin. Cyclosporin is better absorbed into the blood with Ciqorin and is less likely to be affected by taking the medication with food. This means that cyclosporin levels in the blood remain more constant with Ciqorin.

If your doctor switches you from oral cyclosporin to oral cyclosporin in microemulsion:

• Do not go back to taking the previous medication unless your doctor tells you to.
• After conversion, your doctor will monitor you more closely for a short period. This is due to the change in how cyclosporin is absorbed into the blood. Your doctor will ensure that you take the correct dose according to your individual needs.
• You may experience some side effects. If this happens, inform your doctor or pharmacist. It may be necessary to reduce your dose. Never reduce your dose yourself, unless a doctor tells you to.

If your doctor switches you from one oral cyclosporin formulation to another

After you switch from one oral cyclosporin formulation to another:

• Your doctor will monitor you more closely for a short period.
• You may experience some side effects. If this happens, inform your doctor or pharmacist. It may be necessary to modify your dose. Never modify your dose yourself, unless a doctor tells you to.

When to take Ciqorin

Take Ciqorin at the same time every day. This is very important if you have undergone a transplant.

How to take Ciqorin

Your daily dose should always be divided into 2 doses.

Remove the capsules from the blister pack. Swallow the capsules whole with a glass of water.

How long to take Ciqorin

Your doctor will indicate how long you need to take Ciqorin. This depends on whether you are taking it after a transplant or for the treatment of severe skin diseases, rheumatoid arthritis, uveitis, or nephrotic syndrome. In the case of severe skin rash, treatment usually lasts 8 weeks.

Continue taking Ciqorin for as long as your doctor indicates.

If you have doubts about how long you should take Ciqorin, consult your doctor or pharmacist.

If you take more Ciqorin than you should

If you accidentally take an excessive dose of the medication, inform your doctor immediately or go to the emergency department of the nearest hospital. You may need medical attention.

You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Ciqorin

If you forget to take a dose, take it as soon as you remember. However, if it is close to the next dose, skip the missed dose. Then continue as before. Do not take a double dose to make up for missed doses.

If you interrupt treatment with Ciqorin

Do not interrupt treatment with Ciqorin unless your doctor tells you to.

Continue taking Ciqorin even if you feel well. Interrupting treatment with Ciqorin may increase the risk of rejection of your transplanted organ.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Some side effects can be serious

Tell your doctor immediatelyif you notice any of the following serious side effects:

• Like other medications that act on the immune system, cyclosporin can influence your body's ability to fight certain infections and may cause tumors or other malignant diseases, especially of the skin. Signs of infection could be fever or sore throat.
• Visual disturbances, lack of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the muscles. These could be signs of a brain infection called progressive multifocal leukoencephalopathy.
• Brain problems with signs such as seizures, confusion, disorientation, decreased sensitivity, changes in personality, agitation, insomnia, visual disturbances, blindness, coma, paralysis of part or all of the body, torticollis, lack of coordination with or without abnormal speech or eye movement.
• Inflammation in the back of the eye that may be associated with blurred vision. It can also affect your vision due to an increase in pressure inside the head (benign intracranial hypertension).
• Liver damage and alteration with or without yellowing of the eyes or skin, nausea, loss of vision, and dark urine.
• Kidney problems, which can greatly reduce the amount of urine you produce.
• Decrease in the number of red blood cells or platelets. These signs include pale skin, fatigue, shortness of breath, dark urine (sign of red blood cell breakdown), bleeding or bruising without apparent reason, confusion, disorientation, lack of attention, and kidney problems.

Other side effects include:

Very common (may affect more than 1 in 10 people)

• Kidney problems.
• High blood pressure.
• Headache.
• Body tremors that cannot be controlled.
• Excessive hair growth on the face and body.
• Increased lipids in the blood.

If any of these affect you severely, inform your doctor.

Common (may affect up to 1 in 10 people)

• Seizures (convulsions).
• Liver problems.
• Increased blood sugar.
• Fatigue.
• Lack of appetite.
• Nausea (feeling of dizziness), vomiting, discomfort/pain in the abdomen, diarrhea.
• Excessive hair growth.
• Acne, hot flashes.
• Fever.
• Decrease in the number of white blood cells.
• Feeling of numbness or tingling.
• Muscle pain, muscle spasms.
• Stomach ulcer.
• Excessive growth of gum tissue that can cover your teeth.
• Excess uric acid or potassium in the blood, decreased magnesium levels in the blood.

If any of these affect you severely, inform your doctor.

Uncommon (may affect up to 1 in 100 people)

• Symptoms of brain disorders including sudden attacks, mental confusion, insomnia, disorientation, visual disturbances, unconsciousness, feeling of weakness in the limbs, movement impairment.
• Skin rash.
• Generalized inflammation.
• Weight gain.
• Decrease in the number of red blood cells and platelets in the blood, which can lead to a higher risk of bleeding.

If any of these affect you severely, inform your doctor.

Rare (may affect up to 1 in 1,000 people)

• Nerve damage with numbness or tingling in the fingers of the hands and feet.
• Pancreatitis with severe pain in the upper part of the stomach.
• Muscle weakness, loss of muscle strength, muscle pain in the legs or hands or any part of the body.
• Destruction of red blood cells, which includes kidney problems with symptoms such as swelling of the face, stomach, hands, and/or feet, decreased urine production, difficulty breathing, chest pain, seizures, unconsciousness.
• Changes in the menstrual cycle, breast growth in men.

• If any of these affect you severely, inform your doctor.

Very rare (may affect up to 1 in 10,000 people)

• Inflammation in the back of the eye that may be associated with an increase in pressure inside the head and vision impairment.

If this affects you severely, tell your doctor.

Frequency not known:Cannot be estimated from available data.

• Severe liver problems with or without yellowing of the eyes or skin, nausea (feeling of dizziness), loss of appetite, dark urine, inflammation of the face, feet, hands, and/or whole body.
• Bleeding under the skin or purple spots on the skin, sudden bleeding without apparent cause.
• Migraine or severe headache, often with dizziness or feeling of the same (nausea, vomiting) and sensitivity to light.

• Pain in the legs and feet.
• Hearing impairment

If any of these affect you severely, inform your doctor.

Other side effects in children and adolescents

No additional side effects are expected in children and adolescents compared to adults.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.

You can also report them directly through the Spanish Medicines Monitoring System, https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ciqorin

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the box and blister pack after CAD. The expiration date is the last day of the month indicated.

Store below 30°C. Do not freeze. Store in the original packaging to protect it from light and moisture.

Medications should not be thrown away in drains or trash. Deposit the containers and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Ciqorin composition

• The active ingredient is cyclosporin.
• Each soft capsule contains 50 mg of cyclosporin.
• The other ingredients in the capsule contents are hydroxyethylated macrogolglyceride, glycerol monolinoleate, diethylene glycol monoethyl ether, anhydrous ethanol, and D, L-alpha-tocopherol.
• The other ingredients in the capsule shell are gelatin, glycerol, non-crystallized liquid sorbitol (E420), glycine, titanium dioxide (E171), yellow iron oxide (E172), and light liquid paraffin.

Product appearance and package contents

Ciqorin 50 mg soft capsules are opaque yellow-ochre gelatin soft capsules that contain a colorless to slightly yellowish oily liquid. Approximate size: 20.7 x 7.8 mm.

The capsules are available in pack sizes of 20, 30, 50, 50x1, 60, 90, and 100 in OPA/Alu/PVC-Aluminum blister packs.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Teva Pharma S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1ª planta

28108 Alcobendas

Madrid, Spain

Manufacturer:

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305, 74770 Opava-Komarov

Czech Republic

or

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

or

Merckle GmbH

Ludwig-Merckle-Straße 3, 89143 Blaubeuren

Germany

or

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80. 31-546, Krakow

Poland

This medication is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany Ciqorin 50 mg Weichkapseln

Spain Ciqorin 50mg soft capsules EFG

Italy Ciqorin

United Kingdom (Northern Ireland) Vanquoral 50 mg Capsules, soft

Date of last revision of this leaflet: January 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.