Ciclaid

Patient Information Leaflet: Important Information

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

Read the Leaflet Carefully Before Taking the Medication

• Keep this leaflet as 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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 pack 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 immune response of the body.

What is Cyclaid used for and how does it work

• In patients after organ, bone marrow, or stem cell transplantation, Cyclaid works by controlling 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, where 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 you are taking this medicine due to organ transplantation or autoimmune disease treatment. You must carefully follow all your doctor's instructions. They may differ from the general information contained in this leaflet.

When not to take Cyclaid:

• 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).

Do not take Cyclaid and tell your doctorif any of these apply to you. If in doubt, consult your doctor before taking Cyclaid.

Warnings and precautions

Before and during treatment with Cyclaid, tell your doctor immediately if:

• you experience 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.
• you have liver disease.
• you have kidney disease. Your doctor will regularly check your blood and may change the dose of Cyclaid if necessary.
• you have high blood pressure. Your doctor will regularly check your blood pressure and may prescribe medication to lower it if necessary.
• you have a magnesium deficiency. Your doctor may recommend magnesium supplements, especially after surgery if you have received a transplant.
• you have high levels of potassium in your blood.
• you have gout.
• you are going to be vaccinated.

If any of these situations occur before or during treatment with Cyclaid, tell your doctor immediately.

Protection from sunlight and sun exposure

Cyclaid suppresses the immune system, which increases the risk of developing malignant tumors, especially of the skin and lymphatic system. You should limit exposure to sunlight and UV radiation by:

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

Tell your doctor before taking Cyclaid if:

• you have problems with alcohol consumption, currently or in the past,
• you have epilepsy,
• you have any liver disease,
• you are pregnant,
• you are breastfeeding,
• this medicine has been prescribed for a child. If any of the above apply to you (or you are not sure), tell your doctor before taking Cyclaid, as this medicine contains alcohol (see also below "Cyclaid contains ethanol").

Monitoring during Cyclaid treatment

Your 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 you have any questions about Cyclaid or why it has been prescribed for you, ask your doctor.

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:

• they have kidney disease (except for nephrotic syndrome);
• they have an uncontrolled infection;
• they have any malignant tumor;
• they have uncontrolled high blood pressure. If high blood pressure occurs during treatment and cannot be controlled with medication, the doctor should stop Cyclaid treatment. Do not take Cyclaid if any of these situations apply to you. If in doubt, consult your doctor or pharmacist before taking Cyclaid.

In patients treated for Behçet's disease, the doctor will closely monitor the patient if they experience neurological symptoms (e.g., increased forgetfulness, personality changes during treatment, psychiatric disorders, or mood changes, burning sensation in limbs, decreased sensation in limbs, tingling in limbs, weakness in 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 those treated for psoriasis or atopic dermatitis. If Cyclaid has been prescribed for psoriasis or atopic dermatitis, the patient should not expose themselves to UVB radiation or undergo phototherapy during treatment.

Children and adolescents

Cyclaid should not be given to children for post-transplantation treatment, except for nephrotic syndrome.

Elderly patients (65 years and older)

Experience with Cyclaid in elderly patients is limited. In these patients, the doctor should monitor kidney function. Elderly patients with psoriasis or atopic dermatitis should only be treated with Cyclaid if their disease is particularly severe.

Cyclaid and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

• Medicines that may affect potassium levels. These include potassium-containing medicines, potassium supplements, diuretics (water pills) known as potassium-sparing diuretics, and some blood pressure-lowering medicines.
• Methotrexate. It is used to treat cancer, severe psoriasis, and severe rheumatoid arthritis.
• Medicines that may increase or decrease cyclosporin (the active substance of Cyclaid) blood levels. Your 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), heart medicines or high blood pressure medicines (diltiazem, nicardipine, verapamil, amiodarone), metoclopramide (used to treat nausea and vomiting), oral contraceptives, danazol (used to treat menstrual disorders), gout medicines (allopurinol), bile acid sequestrants (used to treat gallstones), HIV protease inhibitors, imatinib (used to treat leukemia or cancer), colchicine, telaprevir (used to treat hepatitis C), and cannabidiol (used to treat epilepsy).
• Medicines that may decrease cyclosporin blood levels include: barbiturates (used as sedatives), certain antiepileptic medicines (such as carbamazepine or phenytoin), octreotide (used to treat acromegaly or neuroendocrine tumors), tuberculosis medicines, 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).
• Medicines that affect kidney function. These include: gentamicin, tobramycin, ciprofloxacin, amphotericin B, trimethoprim (used to treat urinary tract infections), melphalan (used to treat cancer), non-steroidal anti-inflammatory medicines (such as diclofenac), and fibrates (used to lower blood lipid levels).
• Nifedipine. This medicine is used to treat high blood pressure and chest pain. Taking nifedipine with cyclosporin may cause gum overgrowth.
• Digoxin (used to treat heart conditions), cholesterol-lowering medicines (HMG-CoA reductase inhibitors, also known as statins), prednisolone, etoposide (used to treat cancer), repaglinide (an antidiabetic medicine), immunosuppressants (everolimus, sirolimus), ambrisentan, and specific anticancer medicines called anthracyclines (such as doxorubicin). If any of these situations apply to you (or you are not sure), consult your doctor or pharmacist before taking Cyclaid.

Cyclaid with food and drink

Do not take Cyclaid with grapefruit or grapefruit juice, as they may affect the action of Cyclaid.

Pregnancy and breastfeeding

Before taking any medicine, consult your doctor or pharmacist. Your doctor will discuss the risks of taking Cyclaid during pregnancy with you.

Tell your doctor if you are pregnant or planning to become pregnant.

Experience with Cyclaid during pregnancy is limited. Cyclaid should not be used during pregnancy unless necessary. If it is necessary to take this medicine, your doctor will discuss the benefits and risks of taking it during pregnancy with you.
Tell your doctor if you are 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

Tell your doctor if you have hepatitis C. Liver function may change during hepatitis C treatment, which may affect cyclosporin blood levels. Close monitoring of cyclosporin blood levels by your doctor and dose adjustment after starting hepatitis C treatment may be necessary.

Driving and using machines

Cyclaid contains alcohol, which may impair your ability to drive or operate machinery.
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) per 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.
A 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 per 25 mg capsule.
The medicine contains 79 mg of propylene glycol per 50 mg capsule.
The medicine contains 136.5 mg of propylene glycol per 100 mg capsule.
Before administering the medicine to a child under 4 weeks of age, consult your doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.

3. How to take Cyclaid

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Do not take more than the recommended dose.
Your doctor will adjust the dose of this medicine to your condition. Taking too much medicine may affect kidney function. You will have regular blood tests and hospital visits, especially after transplantation. You will be able to discuss your treatment and any problems with your doctor.

How much Cyclaid to take

Your doctor will adjust the dose of Cyclaid for you. The dose depends on your body weight and the reason for taking the medicine. Your doctor will also tell you 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 given before and immediately after transplantation. Smaller doses are given after the transplanted organ or bone marrow has stabilized.
• Your doctor will adjust the dose of Cyclaid to be optimal for you. This may involve 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 is usually 5 mg per kilogram of body weight. It is divided into two doses. In patients with kidney disease, the first dose given 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 is usually 6 mg per kilogram of body weight. It is divided into two doses. In patients with kidney disease, the first dose given each day should not be more than 2.5 mg per kilogram of body weight. You must carefully follow your doctor's instructions and never change the dose of the medicine yourself, even if you feel well.

If your doctor changes one oral cyclosporin medicine to another

After changing from one oral cyclosporin formulation to another:
Your doctor will closely monitor your condition for a short time.
You may experience some side effects. If this happens, tell your doctor or pharmacist. A dose change may be necessary. Never change the dose yourself unless your doctor tells you to.

When to take Cyclaid

Take Cyclaid every day at the same time. This is especially important for transplant patients.

How to take Cyclaid

Always take the daily dose in two divided doses. Remove the capsules from the blister pack.
Swallow the capsules whole with water.

How long to take Cyclaid

Your doctor will tell you how long to take Cyclaid. This depends on whether you are taking the medicine after transplantation or for severe skin diseases, rheumatoid arthritis, uveitis, or nephrotic syndrome. For severe psoriasis, treatment usually lasts 8 weeks.
Continue taking Cyclaid for as long as your doctor tells you.
If you have questions about how long to take Cyclaid, ask your doctor or pharmacist.

Taking more Cyclaid than prescribed

If you accidentally take more than the prescribed dose, tell your doctor immediatelyor go to the emergency room of your nearest hospital. You may need medical attention.

Missing a dose of Cyclaid

If you forget to take a dose, take it as soon as possible.
If it is almost time for your next dose, skip the missed dose.
Then take your medicine as before.
Do not take a double dose to make up for a forgotten dose.

Stopping Cyclaid treatment

Do not stop taking Cyclaid unless your doctor tells you to.
Continue taking Cyclaid even if you feel well. Stopping Cyclaid treatment may increase the risk of rejecting the transplanted organ.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Some side effects can be serious

Tell your doctor immediatelyif you notice 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 of the skin. Signs of infection may include fever or sore throat.
Changes in vision, loss of coordination, difficulty speaking or understanding speech, memory loss, difficulty walking, headache with nausea and vomiting or without, vision disturbances, including limited eye movement.
Brain disorders with symptoms such as seizures, confusion, disorientation, decreased responsiveness, personality changes, agitation, insomnia, vision changes, blindness, coma, paralysis of part or all of the body, stiff 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, nausea, loss of appetite, dark urine, swelling of the face, hands, feet, and (or) whole body.
Kidney disorders that can significantly reduce the amount of urine produced.
Low red blood cell or platelet count. Symptoms include pale skin, feeling tired, shortness of breath, dark urine (sign of red blood cell breakdown), bruising or bleeding without obvious cause, feeling confused, feeling disoriented, decreased sensitivity, and kidney disorders.

Other side effects include:

Very common side effects:may affect more than 1 in 10 people.
Kidney problems.
High blood pressure.
Headache.
Uncontrolled shaking of the body.
Excessive hair growth on the body and face.
High blood lipid levels.
Tell your doctorif you experience any of these symptoms.
Common side effects:may affect 1 to 10 people in 100.
Seizures (fits).
Liver problems.
High blood sugar levels.
Fatigue.
Lack of appetite.
Nausea, vomiting, stomach pain, constipation, diarrhea.
Excessive hair growth.
Acne, 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 levels of magnesium in the blood.
Tell your doctorif you experience any of these symptoms.
Uncommon side effects:may affect 1 to 10 people in 1,000.
Brain disorders with symptoms such as seizures, confusion, insomnia, disorientation, vision changes, 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.
Tell your doctorif you experience any of these symptoms.
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 stomach pain.
Muscle weakness, loss of muscle strength, muscle pain in the legs or arms or other muscles of the body.
Destruction of red blood cells, including kidney disorders with symptoms such as swelling of the face, abdomen, hands, and (or) feet, decreased urine production, difficulty breathing, chest pain, seizures, loss of consciousness.
Changes in menstrual cycle, breast enlargement in men.
Tell your doctorif you experience any of these symptoms.
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.
Tell your doctorif you experience any of these symptoms.
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, 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 obvious cause.
Migraine or severe headache often with nausea and vomiting and sensitivity to light.
Pain in the legs and feet.
Hearing loss.
Tell your doctorif you experience any of these symptoms.

Additional 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 side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Medicines 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, you can help provide more information on the safety of this medicine.

5. How to store Cyclaid

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Store in the original packaging to protect from light and moisture.
Store the capsules in the blister packs. Remove the packaging immediately before taking the medicine.
Do not use this medicine 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 may 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Cyclaid contains

The active substance is cyclosporin. Each soft capsule contains 25 mg, 50 mg, or 100 mg of cyclosporin.
The other ingredients are:
Capsule contents: ethanol anhydrous, 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.
50 mg: soft capsule, white.
100 mg: soft capsule, gray.
The pack 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