Leaflet: Information for thepatient

Ciqorin 100 mg Soft Capsules EFG

Ciclosporin

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

-Keep this leaflet, as you may need to read it again.

-If you have any questions, consult your doctor,or pharmacist.

-This medicine has been prescribed for you only and should not be given to other peoplealthough they may have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor,or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Ciqorin and what it is used for

2.What you need to know before starting Ciqorin

3.How to take Ciqorin

4.Possible side effects

5.Storage of Ciqorin

6.Contents of the pack and additional information

What is Ciqorin

The name of your medication is Ciqorin. It contains the active ingredient ciclosporina. It belongs to a group of medications known as immunosuppressants. These medications are used to decrease the body's immune reactions.

What Ciqorin is used for and how it works

• If you have undergone an organ transplant, bone marrow transplant, and stem cell transplant, the function of Ciqorin is to control your body's immune system. Ciqorin prevents the rejection of transplanted organs by slowing 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 your own body cells, Ciqorin slows down this immune reaction. 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.

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 prospectus may vary depending on whether you are taking the medication for a transplant or for an autoimmune disease.

Follow all the instructions given by your doctor carefully. They may be different from the general information contained in this prospectus.

Do not take Ciqorin

• if you are allergic to cyclosporine or any of the other components of this medication (including those listed in section 6)
• with medications that containHypericum perforatum(St. John's Wort).
• with medications that contain dabigatran etexilate (used to prevent blood clots after surgery) or bosentan and aliskiren (used to lower high blood pressure).

If this applies to you, do not take Ciqorin and inform your doctor. If you are unsure, consult your doctor before taking Ciqorin.

Warnings and precautions

Inform your doctor immediately before and during treatment with Ciqorin:

• if you experience 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 off infections.
• if you have liver problems
• if you have kidney problems. Your doctor will perform regular blood tests and may change your dose as needed.
• if you have high blood pressure. Your doctor will monitor your blood pressure regularly and may administer medication to lower your blood pressure if necessary.
• if you have low levels of magnesium in your body. Your doctor may administer magnesium supplements, especially shortly after your operation if you have undergone a transplant.
• if you have high levels of potassium in your blood.
• if you suffer from 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, particularly skin cancer and lymphatic system cancer. Therefore, you should limit your exposure to the sun and UV rays as follows:

• Wearing protective clothing.
• Applying sunscreen with a high protection factor frequently.

Monitoring during treatment with Ciqorin

Your doctor will monitor:

• the levels of cyclosporine in your blood, especially if you have undergone a transplant,
• your blood pressure before starting treatment and regularly during treatment,
• how your liver and kidneys are functioning,
• your lipid levels in blood (fats).

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

Additionally, 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 high blood pressure (hypertension) that is not controlled with medication. If you experience high blood pressure during treatment and it cannot be controlled, your doctor must interrupt treatment with Ciqorin.

If any of these situations apply to you, do not take Ciqorin. If you are unsure, 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 experience neurological symptoms (such as frequent forgetfulness, changes in personality observed over time, psychiatric or mood disorders, burning sensation in the extremities, decreased sensitivity in the extremities, tingling sensation in the extremities, weakness in the extremities, motor disorders, headaches with or without nausea and vomiting, visual 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 to treat your psoriasis or atopic dermatitis, you should not be exposed to UVB or photochemotherapy during treatment.

Children and adolescents

Ciqorin should not be administered to children for indications other than a transplant, except for the treatment of nephrotic syndrome.

Older population (65 years of age and older)

There is limited experience with Ciqorin in elderly patients. Your doctor should monitor how your kidneys are functioning. 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 medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may take any other medication.

Particularly inform your doctor or pharmacist if you are taking any of the following medications before or during treatment with Ciqorin:

• Medications that may affect your potassium levels. These include medications that contain potassium, potassium supplements, potassium-sparing diuretics, and some medications that lower your blood pressure.
• Metotrexate. It is used to treat tumors, severe psoriasis, and severe rheumatoid arthritis.
• Medications that may increase or decrease the levels of cyclosporine (the active ingredient in Ciqorin) in your blood. Your doctor may check the level of cyclosporine in your blood when you start or stop taking other medications.

-Medications that may increase the level of cyclosporine in your blood include: antibiotics (such as erythromycin or azithromycin), antifungals (voriconazole, itraconazole), medications 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), medications 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), cannabidiol (its use includes, among others, the treatment of epilepsy seizures).

-Medications that may decrease the level of cyclosporine in your blood include: barbiturates (used to help you sleep), certain anticonvulsant medications (such as carbamazepine or phenytoin), octreotide (used to treat acromegaly or neuroendocrine tumors in the intestine), tuberculosis medications, orlistat (used to help you lose weight), herbal medications that contain St. John's Wort, ticlopidine (used after a stroke), certain medications that lower blood pressure (bosentan), and terbinafine (an antifungal medication, used to treat foot and nail infections).

• Medications that may affect your kidneys. These include: antibiotics (gentamicin, tobramycin, ciprofloxacin), antifungal medications that contain amphotericin B, medications used to treat urinary tract infections that contain trimethoprim, medications used to treat cancer that contain melphalan, medications used to reduce stomach acid (H2 receptor antagonists), tacrolimus, analgesics (nonsteroidal anti-inflammatory drugs such as diclofenac), bile acid and derivatives (used to reduce fat in the blood).
• Nifedipine. It is used to treat high blood pressure and chest pain. You may experience inflamed gums that may grow over your teeth if you take nifedipine during treatment with cyclosporine.
• Digoxin (used to treat heart disorders), medications that reduce cholesterol (HMG-CoA reductase inhibitors also called statins), prednisolone, etoposide (used to treat cancer), repaglinide (an oral antidiabetic medication), immunosuppressants (everolimus, sirolimus), ambrisentan, and specific cancer medications 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 unsure), inform your doctor or pharmacist before taking Ciqorin.

Hepatitis C

Inform your doctor if you have hepatitis C. Your liver function may change with hepatitis C treatment and this may affect the levels of cyclosporine in your blood. Your doctor may need to closely monitor the levels of cyclosporine in your blood and adjust the dose after starting hepatitis C treatment.

Taking Ciqorin with food and drinks

Do not take Ciqorin with grapefruit or grapefruit juice. This may affect the functioning of Ciqorin

Pregnancy and breastfeeding

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

• Inform your doctor if you are pregnant or intend to become pregnant. There is limited experience with Ciqorin in pregnant women. In general, Ciqorin should not be administered during pregnancy. If you need to take this medication, your doctor will discuss the benefits and potential risks of taking it during pregnancy.
• Inform 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 and may affect your baby.

Driving and operating machinery

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

Ciqorin contains ethanol

This medicationcontains 159.50 mg of alcohol (ethanol) in each 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 medication will have no notable effect.

Ciqorin contains sorbitol.

This medication contains 19.06 mg of sorbitol in each capsule.

Ciqorin containshydroxyestearate of macrogolglycerol

It may cause stomach discomfort and diarrhea.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of 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. Taking too much of this medication can affect your kidneys. You will have regular blood tests and hospital visits, especially after the transplant. This will allow you to consult with your doctor about your treatment and any problems you may have.

How much Ciqorin should be taken

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

•In adults:

Organ, bone marrow, and stem cell transplant

• The usual total daily dose is between 2 mg and 15 mg per kilogram of body weight. This is divided into two doses.
• Higher doses are usually used before and just 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 do some blood tests.

Endogenous uveitis

• The usual total daily dose is between 5 mg and 7 mg per kilogram of body weight. This is divided into two doses.

Nephrotic syndrome

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

Severe rheumatoid arthritis

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

Psoriasis and atopic dermatitis

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

•In children:

Nephrotic syndrome

• The usual total daily dose for children is 6 mg per kilogram of body weight. This is divided into two doses. In patients with renal impairment, the first daily dose should not exceed 2.5 mg per kilogram of body weight.

Follow exactly the instructions of your doctor and do not change the dose yourself, even if you feel well.

Conversion of cyclosporin to cyclosporin microemulsion

You may have already 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 food intake. This means that the levels of cyclosporin in the blood remain more constant with Ciqorin.

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

• Do not take the previous medication again unless your doctor tells you to.
• After the conversion, your doctor will monitor you more closely for a short period of time. This is because of 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. You may need to reduce your dose. Never reduce your dose yourself, unless your 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 of time.
• You may experience some side effects. If this happens, inform your doctor or pharmacist. You may need to modify your dose. Never modify your dose yourself, unless your doctor tells you to.

When to take Ciqorin

Take Ciqorin at the same time every day. This is very important if you have had 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 tell you for 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 eruption, treatment usually lasts 8 weeks.

Continue taking Ciqorin for as long as your doctor tells you to.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Some side effects can be serious

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

• Like other medicines that act on the immune system, ciclosporin may affect 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.
• Changes in vision, lack of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, 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 sensitivity, changes in personality, agitation, insomnia, changes in vision, 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 blurry vision. It may also affect your vision due to an increase in pressure within the head (benign intracranial hypertension).
• Liver damage and alteration with or without yellow discoloration of the eyes or skin, nausea, vision loss, and dark urine.
• Kidney problems, which may significantly 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 rupture), unexplained bleeding or bruising, 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.
• Uncontrollable body agitation.
• Excessive facial and body hair growth.
• Increased blood lipids.

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

Common (may affect up to 1 in 10 people)

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

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

Rare (may affect up to 1 in 100 people)

• Symptoms of brain changes including sudden attacks, mental confusion, insomnia, disorientation, vision changes, unconsciousness, sensation of weakness in the limbs, movement deterioration.
• Skin rash.
• Generalized inflammation.
• Weight gain.
• Decrease in the number of red blood cells and platelets in the blood that may increase the risk of bleeding.

If any of them severely affect you, 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 increased pressure within the head and vision deterioration.

If this severely affects you,inform your doctor.

Frequency unknown:Cannot be estimated from available data.

• Severe liver problems with and without yellow discoloration of the eyes or skin, nausea (sensation of dizziness), loss of appetite, dark urine, facial, foot, hand, and/or body inflammation.
• Bleeding under the skin or purple-colored skin spots, sudden unexplained bleeding.
• Migraine or severe headache, often with dizziness or sensation of the same (nausea, vomiting) and light sensitivity.
• Pain in the legs and feet.
• Hearing loss.

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

Other side effects in children and adolescents

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

Reporting of 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 prospectus.

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

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the 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..

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need.By doing so, you will help protect the environment.

Composition of Ciqorin

-The active ingredient is cyclosporin.

-Each soft capsule contains 100 mg of cyclosporin

-The other components in the capsule content are hydroxyestearate of macrogolglycerol, monolinoleate of glycerol, monoethyl ether of diethyleneglycol, anhydrous ethanol, and D, L-a-tocopherol

-The other components in the capsule coating are gelatin, glycerol, liquid non-crystallized sorbitol (E420), glycine, titanium dioxide (E171), brown iron oxide (E172), and light liquid paraffin

Appearance of the product and contents of the package

Ciqorin 100 mg soft capsules are soft gelatin capsules of brown opaque color that contain an oil-like, colorless to slightly yellow liquid. Approximate size of 24.7 x 9.9 mm.

The capsules are available in package sizes of 20, 30, 30 x 1, 50, 50x1, 60, 90, and 100 in OPA/Alu/PVC-Aluminum blister.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Teva Pharma S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas

Madrid, Spain

Responsible manufacturer:

Teva Czech Industries s.r.o.

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

Republic of Czech

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

GermanyCiqorin 100 mg Weichkapseln

SpainCiqorin 100mg soft capsules EFG

ItalyCiqorin

United Kingdom (Northern Ireland) Vanquoral 100 mg Capsules, soft

Last review date of this leaflet: January 2024

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