Ciclaid

Leaflet accompanying the packaging: patient information

Cyclaid,25 mg, soft capsules
Cyclaid,50 mg, soft capsules
Cyclaid,100 mg, soft capsules
Cyclosporin

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their disease symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Cyclaid and what is it used for
• 2. Important information before taking Cyclaid
• 3. How to take Cyclaid
• 4. Possible side effects
• 5. How to store Cyclaid
• 6. Contents of the packaging and other information

1. What is Cyclaid and what is it used for

What is Cyclaid

This medicine is called Cyclaid. It contains the active substance cyclosporin. This medicine belongs to a group of medicines called immunosuppressants. These medicines are used to reduce the body's immune response.

What is Cyclaid used for and how does it work

• In patients after organ, bone marrow, or stem cell transplantation, the action of Cyclaid is to control the immune system. Cyclaid prevents the rejection of the transplanted organ by blocking the development of certain cells that would normally attack the transplanted tissue.
• In patients with autoimmune diseases, in which the immune system attacks the body's own cells, Cyclaid stops this immune response. These diseases include eye diseases that threaten vision loss (endogenous uveitis, including Behçet's disease), severe cases of certain skin diseases (atopic dermatitis or psoriasis), severe rheumatoid arthritis, and a kidney disease called nephrotic syndrome.

2. Important information before taking Cyclaid

In patients taking Cyclaid after transplantation, this medicine will be prescribed only by a doctor with experience in transplantation and/or autoimmune diseases. The recommendations in this leaflet may vary depending on whether the patient is taking this medicine due to organ transplantation or autoimmune disease treatment. The doctor's instructions should be followed carefully. They may differ from the general information in this leaflet.

When not to take Cyclaid:

• if the patient is allergic to cyclosporin or any of the other ingredients of this medicine (listed in section 6),
• with medicines 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 lower blood pressure).

Cyclaid should not be taken and the doctor should be toldif such a situation applies to the patient. In case of doubts, the doctor should be consulted before taking Cyclaid.

Warnings and precautions

Before and during treatment with Cyclaid, the doctor should be told immediately if:

• the patient experiences any signs of infection, such as fever or sore throat. Cyclaid suppresses the immune system and may also affect the body's ability to fight infections.
• the patient has liver disease.
• the patient has kidney disease. The doctor will order regular blood tests and may change the dose of the medicine if necessary.
• the patient has high blood pressure. The doctor will regularly check the patient's blood pressure and may prescribe a medicine to lower blood pressure if necessary.
• the patient has a magnesium deficiency. The doctor may recommend that the patient take magnesium supplements, especially immediately after surgery, if the patient has received a transplant.
• the patient has a high level of potassium in the blood.
• the patient has gout.
• the patient is going to be vaccinated.

If any of these situations occur before or during treatment with Cyclaid, the doctor should be told immediately.

Protection from sunlight and sun exposure

Cyclaid suppresses the immune system, which increases the risk of developing malignant tumors, especially skin and lymphatic system tumors. Sun exposure and UV radiation should be limited by:

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

The doctor should be informed before taking Cyclaid if:

• the patient has problems with alcohol consumption, currently or in the past,
• the patient has epilepsy,
• the patient has any liver disease,
• the patient is pregnant,
• the patient is breastfeeding,
• this medicine has been prescribed to a child. If any of the above situations apply to the patient (or the patient is not sure), the doctor should be told before taking Cyclaid, as this medicine contains alcohol (see also below "Cyclaid contains ethanol").

Control tests during Cyclaid treatment

The doctor will monitor the following parameters:

• cyclosporin blood levels, especially in transplant patients,
• blood pressurebefore starting treatment and regularly during treatment,
• liver and kidney function,
• blood lipid levels.

If there are any questions about the action of Cyclaid or the reasons why it has been prescribed to the patient, the doctor should be consulted.

In addition, patients taking Cyclaid for indications other than post-transplantation

(intermediate or posterior uveitis and Behçet's disease, atopic dermatitis, severe rheumatoid arthritis, or nephrotic syndrome), should not take Cyclaid if:

• the patient has kidney disease (except for nephrotic syndrome);
• the patient has an uncontrollable infection;
• the patient has any malignant tumor;
• the patient has uncontrolled high blood pressure. If high blood pressure occurs during treatment and cannot be controlled with medication, the doctor should discontinue Cyclaid. Cyclaid should not be taken if any of these situations apply to the patient. In case of doubts, the doctor or pharmacist should be consulted before taking Cyclaid.

In patients treated for Behçet's disease, the doctor will closely monitor the patient's condition if they experience neurological symptoms (e.g., increased forgetfulness, personality changes during treatment, psychiatric disorders, or mood disorders, burning sensation in the limbs, decreased sensation in the limbs, tingling in the limbs, weakness in the limbs, gait disturbances, headache with nausea and vomiting or without, vision disturbances, including limited eye movement). The doctor will closely monitor treatment in elderly patients and in patients treated for psoriasis or atopic dermatitis. If Cyclaid has been prescribed to the patient for the treatment of psoriasis or atopic dermatitis, the patient should not be exposed to UVB radiation or undergo phototherapy during treatment.

Children and adolescents

Cyclaid should not be given to children for the treatment of post-transplant diseases, except for the treatment of nephrotic syndrome.

Elderly patients (65 years and older)

Experience with the use of Cyclaid in elderly patients is limited. In these patients, the doctor should monitor kidney function. Patients over 65 years of age with psoriasis or atopic dermatitis should be treated with Cyclaid only if their disease is particularly severe.

Cyclaid and other medicines

The doctor or pharmacist should be told about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. In particular, the doctor or pharmacist should be told if the patient is taking any of the following medicines before or during treatment with Cyclaid:

• Medicines that may affect potassium levels. These include potassium-containing medicines, potassium supplements, diuretics called potassium-sparing diuretics, and some blood pressure-lowering medicines.
• Methotrexate. It is used to treat tumors, severe psoriasis, and severe rheumatoid arthritis.
• Medicines that may increase or decrease cyclosporin (the active substance of Cyclaid) blood levels. The doctor may recommend monitoring cyclosporin blood levels when starting or stopping treatment with other medicines.
• Medicines that may increase cyclosporin blood levels include: antibiotics (such as erythromycin or azithromycin), antifungal medicines (voriconazole, itraconazole), medicines used to treat heart diseases or high blood pressure (diltiazem, nicardipine, verapamil, amiodarone), metoclopramide (used to treat vomiting), oral contraceptives, danazol (used to treat menstrual disorders), medicines used to treat gout (allopurinol), cholic acid and its derivatives (used to treat gallstones), HIV protease inhibitors, imatinib (used to treat leukemia or tumors), colchicine, telaprevir (used to treat hepatitis C), and cannabidiol (used to treat epilepsy).
• Medicines that may decrease cyclosporin blood levels include: barbiturates (used as sleeping pills), some antiepileptic medicines (such as carbamazepine or phenytoin), octreotide (used to treat acromegaly or neuroendocrine tumors), antibacterial medicines used to treat tuberculosis, orlistat (used to aid weight loss), herbal medicines containing St. John's Wort, ticlopidine (used after a stroke), and certain blood pressure-lowering medicines (bosentan) and terbinafine (an antifungal medicine used to treat fungal infections of the feet and nails).
• Medicines that affect kidney function. These include: antibacterial medicines (gentamicin, tobramycin, ciprofloxacin), antifungal medicines containing amphotericin B, medicines used to treat urinary tract infections containing trimethoprim, anticancer medicines containing melphalan, medicines used to reduce stomach acid (H2 receptor antagonists), tacrolimus, painkillers (nonsteroidal anti-inflammatory medicines, such as diclofenac), and medicines containing fibrates (used to lower blood lipid levels).
• Nifedipine. A medicine used to treat high blood pressure and chest pain. Taking nifedipine during cyclosporin treatment may cause gum overgrowth and gingival hyperplasia.
• Digoxin (used to treat heart diseases), cholesterol-lowering medicines (HMG-CoA reductase inhibitors, also known as statins), prednisolone, etoposide (used to treat cancer), repaglinide (an antidiabetic medicine), immunosuppressant medicines (everolimus, sirolimus), ambrisentan, and specific anticancer medicines called anthracyclines (such as doxorubicin). If any of these situations apply to the patient (or the patient is not sure), the doctor or pharmacist should be consulted before taking Cyclaid.

Cyclaid with food and drink

Cyclaid should not be taken with grapefruit or grapefruit juice, as they may affect the action of Cyclaid.

Pregnancy and breastfeeding

Before taking any medicine, the doctor or pharmacist should be consulted. The doctor will discuss the risks associated with taking Cyclaid during pregnancy with the patient.

The doctor should be told if the patient is pregnant or plans to become pregnant.

Experience with the use of Cyclaid during pregnancy is limited. Generally, Cyclaid should not be taken during pregnancy. If it is necessary to take this medicine, the doctor will discuss the benefits and risks of taking it during pregnancy with the patient. The doctor should be told if the patient is breastfeeding.Breastfeeding is not recommended during treatment with Cyclaid, as cyclosporin, the active substance of Cyclaid, passes into breast milk. This may affect the breastfed child.

Hepatitis C

The doctor should be informed if the patient has hepatitis C. Liver function may change during hepatitis C treatment, which may affect cyclosporin blood levels. Close monitoring of cyclosporin blood levels by the doctor and dose adjustment after starting hepatitis C treatment may be necessary.

Driving and using machines

Cyclaid contains alcohol, which may impair the ability to drive and use machines. Cyclaid contains macrogolglycerol hydroxystearate, which may cause stomach upset and diarrhea.

Cyclaid contains ethanol

This medicine contains 25 mg, 50 mg, 100 mg of alcohol (ethanol) in each capsule containing 25 mg, 50 mg, 100 mg of cyclosporin, respectively. A dose of 500 mg of cyclosporin contains 500 mg of ethanol, which is equivalent to less than 13 ml of beer or 5 ml of wine. The small amount of alcohol in this medicine will not have noticeable effects.

Cyclaid contains propylene glycol

The medicine contains 47.25 mg of propylene glycol in each 25 mg capsule. The medicine contains 79 mg of propylene glycol in each 50 mg capsule. The medicine contains 136.5 mg of propylene glycol in each 100 mg capsule. Before administering the medicine to a child under 4 weeks of age, the doctor or pharmacist should be consulted, especially if the child is taking other medicines containing propylene glycol or alcohol.

3. How to take Cyclaid

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor should be consulted. The patient should not take more of the medicine than recommended. The doctor will adjust the dose of this medicine according to the patient's health condition. Too much medicine may affect kidney function. The patient will have regular blood tests and hospital visits, especially after transplantation. The patient will be able to discuss treatment and any problems with the doctor.

How much Cyclaid to take

The doctor will adjust the dose of Cyclaid for the patient. The dose depends on the patient's body weight and the reason for taking the medicine. The doctor will also inform the patient how often to take the 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. It is divided into two doses.
• Larger doses are usually used before and immediately after transplantation. Smaller doses are used after the transplanted organ or bone marrow has stabilized.
• The doctor will adjust the dose of the medicine to be optimal for the individual patient. This may require blood tests.

Endogenous uveitis

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

Nephrotic syndrome

• The total daily dose usually is 5 mg per kilogram of body weight. It is divided into two doses. In patients with kidney disease, the first dose taken each day should not be more than 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. It is divided into two doses.

Psoriasis and atopic dermatitis

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

For children:

Nephrotic syndrome

• The total daily dose usually is 6 mg per kilogram of body weight. It is divided into two doses. In patients with kidney disease, the first dose taken each day should not be more than 2.5 mg per kilogram of body weight. The doctor's instructions should be followed carefully and the dose of the medicine should never be changed without consulting the doctor, even if the patient feels well.

If the doctor changes one oral cyclosporin medicine to another

After changing treatment from one oral form of cyclosporin to another: The doctor will closely monitor the patient's condition for a short time. The patient may experience certain side effects. If this happens, the doctor or pharmacist should be told. A dose change may be necessary. The dose should never be changed without the doctor's advice.

When to take Cyclaid

Cyclaid should be taken every day at the same time. This is very important in transplant patients.

How to take Cyclaid

The daily dose should always be taken in two divided doses. The capsules should be removed from the blister pack. The capsules should be swallowed whole, with a glass of water.

How long to take Cyclaid

The doctor will inform the patient how long to take Cyclaid. This depends on whether the patient is taking the medicine after receiving a transplant or for the treatment of severe skin diseases, rheumatoid arthritis, uveitis, or nephrotic syndrome. In the case of severe flare-ups, treatment usually lasts 8 weeks. Cyclaid should be continued for as long as the doctor recommends. If there are any questions about how long to take Cyclaid, the doctor or pharmacist should be consulted.

Taking more than the recommended dose of Cyclaid

If more than the recommended dose of the medicine is taken by accident, the doctor or the emergency department of the nearest hospital should be notified immediately. The patient may need medical attention.

Missing a dose of Cyclaid

If the patient forgets to take a dose of the medicine, it should be taken as soon as possible. If it is almost time for the next dose, the missed dose should be skipped. The medicine should then be taken as before. A double dose should not be taken to make up for a missed dose.

Stopping treatment with Cyclaid

Treatment with Cyclaid should not be stopped unless the doctor recommends it. Cyclaid should be continued even if the patient feels well. Stopping treatment with Cyclaid may increase the risk of rejecting the transplanted organ. If there are any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious

The doctor should be told immediatelyif the patient notices any of the following serious side effects:
Like other medicines that affect the immune system, cyclosporin may change the body's ability to fight infections and may cause the development of tumors or other malignant diseases, especially skin and lymphatic system tumors. Signs of infection may include fever or sore throat.
Changes in vision, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and muscle weakness. These may be symptoms of a brain infection called progressive multifocal leukoencephalopathy.
Brain disorders with symptoms such as seizures, confusion, disorientation, decreased responsiveness, personality changes, agitation, insomnia, changes in vision, blindness, coma, paralysis of part or all of the body, stiffness of the neck, loss of coordination with (or without) speech or eye movement disorders.
Swelling of the back of the eye. This may be related to blurred vision. It may also affect vision due to increased pressure in the head (non-tumor-related intracranial hypertension).
Liver disorders with yellowing of the eyes or skin, or without these symptoms, nausea, loss of appetite, dark urine.
Kidney disorders that can significantly reduce the amount of urine produced.
A low number of red blood cells or platelets. Symptoms include pale skin, feeling tired, shortness of breath, dark urine (a sign of red blood cell breakdown), bruising or bleeding without an apparent cause, feeling confused or disoriented, decreased sensitivity, and kidney disorders.

Other side effects include:

Very common side effects:may affect more than 1 in 10 people.
Kidney function disorders.
High blood pressure.
Headache.
Uncontrolled trembling of the body.
Excessive hair growth on the body and face.
High blood lipid levels.
If any of these symptoms occur, the doctor should be told.
Common side effects:may affect 1 to 10 people in 100.
Seizures (convulsions).
Liver function disorders.
High blood sugar levels.
Fatigue.
Lack of appetite.
Nausea, vomiting, abdominal pain, constipation, diarrhea.
Excessive hair growth.
Acne, sudden flushing.
Fever.
Low white blood cell count.
Numbness or tingling.
Muscle pain, muscle cramps.
Stomach ulcers.
Gum overgrowth covering the teeth.
High levels of uric acid and potassium in the blood, low magnesium levels in the blood.
If any of these symptoms occur, the doctor should be told.
Uncommon side effects:may affect 1 to 10 people in 1,000.
Brain disorders with symptoms such as sudden seizures, confusion, disorientation, insomnia, agitation, changes in vision, loss of consciousness, feeling weak, movement disorders.
Rash.
General swelling.
Weight gain.
Low red blood cell or platelet count, which may increase the risk of bleeding.
If any of these symptoms occur, the doctor should be told.
Rare side effects:may affect 1 to 10 people in 10,000.
Nerve disorders with numbness or tingling in the fingers and toes.
Pancreatitis with severe abdominal pain.
Muscle weakness, loss of muscle strength, muscle pain in the legs or arms or other muscles of the body.
Red blood cell destruction, including kidney disorders with symptoms such as swelling of the face, abdomen, hands, and/or feet, decreased urine production, breathing difficulties, chest pain, seizures, loss of consciousness.
Changes in the menstrual cycle, breast enlargement in men.
If any of these symptoms occur, the doctor should be told.
Very rare side effects:may affect 1 to 10 people in 100,000.
Swelling of the back of the eye, which may be related to increased pressure in the head and vision disturbances.
If any of these symptoms occur, the doctor should be told.
Other side effects with unknown frequency:frequency cannot be estimated from the available data.
Severe liver disorders with yellowing of the eyes or skin, or without these symptoms, nausea, loss of appetite, dark urine, swelling of the face, hands, feet, and/or whole body.
Bleeding under the skin or purple spots on the skin, sudden bleeding without an apparent cause.
Migraine or severe headache, often with nausea or vomiting and sensitivity to light.
Pain in the legs and feet.
Hearing loss.
If any of these symptoms occur, the doctor should be told.

Additional side effects in children and adolescents

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

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be told. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Cyclaid

The medicine should be stored out of sight and reach of children. This medicine does not require special storage temperature conditions. It should be stored in the original packaging to protect it from light and moisture. The capsules should be stored in blister packs. The packaging should be removed just before taking the medicine. The medicine should not be taken after the expiry date stated on the blister pack and carton after "EXP". The expiry date refers to the last day of the month stated. After opening the blister pack, a characteristic smell of the medicine can be noticed. This is normal and does not mean that the capsules are not suitable for use. Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Cyclaid contains

The active substance of Cyclaid is cyclosporin. Each soft capsule contains 25 mg, 50 mg, or 100 mg of cyclosporin. The other ingredients are: Capsule contents: anhydrous ethanol, all-rac-α-tocopheryl acetate (E 307), ethylene glycol monoethyl ether, macrogolglycerol oleate, macrogolglycerol hydroxystearate. Capsule shell: gelatin, glycerol, propylene glycol, titanium dioxide (E171), iron oxide black (E172) (only 25 mg and 100 mg).

What Cyclaid looks like and contents of the pack

Cyclaid is available in three strengths: 25 mg: soft capsule, gray in color. 50 mg: soft capsule, white in color. 100 mg: soft capsule, gray in color. The packaging contains 50 or 60 soft capsules in aluminum/aluminum blister packs. Not all pack sizes may be marketed.

Marketing authorization holder

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lok. 27
01-909 Warsaw
Poland

Manufacturer

Morningside Pharmaceuticals Ltd.
5 Pavilion Way, Castle Business Park
Loughborough
Leicestershire, LE11 5GW
United Kingdom
Monteresearch s.r.l
Via IV Novembre n.92

• 20021 – Bollate (MI) Italy

Medis International a.s., production plant Bolatice
Průmyslová 961/16
747 23 Bolatice
Czech Republic

Date of last revision of the leaflet: 10.2023