Equoral

Leaflet accompanying the packaging: patient information

Equoral, 25 mg, soft capsules

Equoral, 50 mg, soft capsules

Equoral, 100 mg, soft capsules

Ciclosporin

You should carefully read the contents of the leaflet before taking 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 or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Equoral and what is it used for

What is Equoral

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

What is Equoral used for and how does Equoral work

• In patients after organ, bone marrow, and stem cell transplantation, Equoral works by controlling the immune system. Equoral 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, Equoral stops this immune response. These diseases include eye diseases that threaten vision loss (endogenous uveitis, including uveitis in Behçet's disease), severe cases of certain skin diseases (atopic dermatitis or eczema and psoriasis), severe rheumatoid arthritis, and a kidney disease called nephrotic syndrome.

2. Important information before taking Equoral

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

When not to take Equoral

• if the patient is allergic (hypersensitive) to ciclosporin or any of the other ingredients of the 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 bosentanand aliskiren(used to lower blood pressure).

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

Warnings and precautions

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

• the patient experiences any signs of infection (such as fever or sore throat). Equoral 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 low magnesium level. 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 potassium level in the blood;
• the patient has gout;
• the patient needs to be vaccinated.

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

Protection from sunlight and sun exposure

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

• wearing protective clothing;
• frequently applying sunscreens with a high protection factor.

You should talk to your doctor before taking Equoral if:

• the patient has or has had problems with alcohol;
• the patient has epilepsy;
• the patient has any liver disease;
• the patient is pregnant;
• the patient is breastfeeding;
• this medicine has been prescribed for a child. If any of these situations apply to you (or you are not sure), tell your doctorbefore taking Equoral. This is because the medicine contains alcohol (see also below "Equoral contains ethanol").

Monitoring during Equoral treatment

The doctor will monitor the following parameters:

• ciclosporin 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 how Equoral works or why it has been prescribed for you, ask your doctor.

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

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

• the patient has kidney disease (except for nephrotic syndrome);
• the patient has uncontrollable infections;
• the patient has any malignant tumor;
• the patient has uncontrolled high blood pressure. If high blood pressure develops during treatment and cannot be controlled with medication, the doctor should stop Equoral treatment.

Do not take Equoral if any of these situations apply to you. If in doubt, consult your doctor or pharmacist before taking Equoral. In patients treated for uveitis in Behçet's disease, the doctor will closely monitor the patient's condition, especially if they experience neurological symptoms (such as 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 mobility of the eyeballs).

The doctor will closely monitor treatment in elderly patients and those treated for psoriasis or atopic dermatitis. If Equoral has been prescribed for the treatment of psoriasis or atopic dermatitis, the patient should not be exposed to UVB radiation or undergo phototherapy during treatment.

Hepatitis C

Tell your doctor if you have hepatitis C. During treatment for viral hepatitis C, liver function may change, which may affect ciclosporin blood levels. Close monitoring by the doctor of ciclosporin blood levels and dose adjustment after starting hepatitis C treatment may be necessary.

Children and adolescents

Equoral should not be given to children for non-transplant-related diseases, except for the treatment of nephrotic syndrome.

Elderly patients (65 years and older)

Experience with Equoral 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 Equoral if their disease is particularly severe.

Other medicines and Equoral

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. In particular, tell your doctor or pharmacist if you are taking any of the following medicines before or during Equoral treatment:

• Medicines that may affect potassium levels. These include potassium-containing medicines, potassium supplements, diuretics (diuretics that spare potassium), 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 ciclosporin (the active substance of Equoral) blood levels. The doctor may recommend monitoring ciclosporin blood levels when starting or stopping other medicines.
• Medicines that may increase ciclosporin 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 problems), 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), cannabidiol (used to treat seizures).
• Medicines that may decrease ciclosporin 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), certain blood pressure-lowering medicines (bosentan), and terbinafine (an antifungal medicine used to treat fungal infections of the toes and fingernails).
• 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 (proton pump inhibitors), tacrolimus, painkillers (non-steroidal anti-inflammatory medicines such as diclofenac), medicines containing fibric acid (used to lower blood lipid levels, fibrates).
• Nifedipine. A medicine used to treat high blood pressure and chest pain. Taking nifedipine during ciclosporin treatment may cause gum swelling and overgrowth around the teeth.
• Digoxin (used to treat heart diseases), cholesterol-lowering medicines (HMG-CoA reductase inhibitors, also called statins), prednisolone, etoposide (used to treat cancer), repaglinide (an antidiabetic medicine), immunosuppressive medicines (everolimus, sirolimus), ambrisentan, and specific anticancer medicines called anthracyclines (such as doxorubicin).
• Mycophenolate sodium or mycophenolate mofetil (an immunosuppressive medicine) and eltrombopag (used to treat bleeding disorders).

If any of these situations apply to you (or you are not sure), talk to your doctoror pharmacist before taking Equoral.

Equoral with food and drink

Do not take Equoral with grapefruit or grapefruit juice, as they may affect the way Equoral works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Before taking this medicine, talk to your doctoror pharmacist.

• Tell your doctor if you are pregnant or plan to become pregnant.Experience with Equoral during pregnancy is limited. Equoral should not be taken during pregnancy unless necessary. If you need to take this medicine, your doctor will discuss the benefits and risks of taking it during pregnancy.
• Tell your doctor if you are breastfeeding. If you are taking Equoral, you should not breastfeedbecause ciclosporin, the active substance of Equoral, passes into breast milk. This may affect your baby.

Driving and using machines

Drowsiness, disorientation, or blurred vision may occur after taking Equoral. Be careful when driving or operating machinery while taking Equoral until you know how it affects you.

Equoral contains ethanol

Equoral contains approximately 18.8% (by volume) ethanol (alcohol), which is equivalent to a maximum of 798 mg per dose in transplant patients. This is equivalent to almost 20 ml of beer (5%) or 8.3 ml of wine (12%) per dose. The alcohol in this medicine may affect the way other medicines work. If you are taking other medicines, ask your doctoror pharmacist. If you are addicted to alcohol, ask your doctoror pharmacist before taking this medicine. Alcohol may be harmful to patients with alcohol dependence, epilepsy, brain damage, liver disease, or pregnant or breastfeeding women. It may also be harmful if this medicine is given to children.

Equoral contains sorbitol

Equoral 25 mg contains 8.6 mg of sorbitol per capsule. Equoral 50 mg contains 20.20 mg of sorbitol per capsule. Equoral 100 mg contains 28.70 mg of sorbitol per capsule. Sorbitol is a source of fructose. If you or your child have been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the body does not break down fructose, talk to your doctorbefore taking this medicine or giving it to your child.

Equoral contains castor oil (hydrogenated macrogolglycerides)

The medicine contains castor oil, which may cause stomach upset and diarrhea.

3. How to take Equoral

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor. Do not take more medicine than prescribed. The doctor will carefully adjust the dose of this medicine to your individual needs. Taking too much medicine may affect kidney function. You will have regular blood tests and hospital visits, especially after transplantation. This will be an opportunity to discuss your treatment and any problems you may have.

How much Equoral to take

The doctor will adjust the correct dose of Equoral for you. It depends on your body weight and the reason why you are taking this medicine. The doctor will also tell you how often to take it.

• For adults:

Organ, bone marrow, or stem cell transplantation

The total daily dose usually ranges from 2 mg to 15 mg per kilogram of body weight. It is divided into two doses. Higher doses are usually used before and immediately after transplantation. Lower 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 you. This may require blood tests.

Endogenous uveitis

The total daily dose usually ranges from 5 mg to 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 usually ranges from 3 mg to 5 mg per kilogram of body weight. It is divided into two doses.

Psoriasis and atopic dermatitis

The total daily dose usually ranges from 2.5 mg to 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. You should carefully follow the doctor's instructions and never change the dose yourself, even if you feel well.

Switching from another oral ciclosporin medicine to Equoral soft capsules

In patients who are already taking another oral ciclosporin medicine, the doctor may decide to switch to Equoral soft capsules. All these medicines contain ciclosporin as the active substance. Equoral is a different, improved formulation of ciclosporin. Ciclosporin is better absorbed into the blood from Equoral, and there is less likelihood that absorption will depend on food intake. This means that ciclosporin blood levels will remain more stable during Equoral treatment.

If your doctor changes one oral ciclosporin medicine to another:

Do not take the previous medicine again unless your doctor tells you to. After the change, the doctor will closely monitor your condition for a short time. This is because of the change in ciclosporin absorption into the blood. The doctor will check that you are receiving the correct dose for your needs. You may experience some side effects. If this happens, tell your doctoror pharmacist. It may be necessary to reduce the dose of the medicine. Never reduce the dose yourself unless your doctor tells you to.

When to take Equoral

Take Equoral every day at the same time. This is very important in transplant patients.

How to take Equoral

Always take the daily dose in 2 divided doses. Remove the capsules from the blister pack. Swallow the capsules whole, with a glass of water.

How long to take Equoral

The doctor will tell you how long to take Equoral. It depends on whether you are 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 rash, treatment usually lasts 8 weeks. You should continue taking Equoral for as long as your doctor has prescribed. If you have any questions about how long to take Equoral, talk to your doctoror pharmacist.

Taking more Equoral than prescribed

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

Missing a dose of Equoral

If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose. Then take your medicine as you normally would. Do not take a double dose to make up for a missed dose.

Stopping Equoral treatment

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

4. Possible side effects

Like all medicines, Equoral 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, ciclosporin 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 are saying, 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 in the neck, loss of coordination with (or without) speech or eye movement disorders.
• Swelling of the back of the eye. This may be associated with 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, nausea, loss of appetite, dark urine, or without these symptoms.
• Kidney disorders that can significantly reduce the amount of urine produced.
• Low red blood cell or platelet count. Symptoms of these disorders include pale skin, feeling tired, shortness of breath, dark urine, breakdown of red blood cells, bruising or bleeding without obvious cause, feeling confused, feeling disoriented, decreased alertness, and kidney problems.

Other side effects include:

Very common side effects:may affect more than 1 in 10 people.

• Kidney function disorders.
• High blood pressure.
• Headache.
• Uncontrollable shaking of the body.
• Excessive hair growth on the body and face.
• High blood lipid levels.

Common side effects:may affect 1 to 10 people in 100.

• Seizures (convulsions).
• Liver function disorders.
• High blood sugar levels.
• Fatigue.
• Loss of appetite.
• Nausea, vomiting, discomfort, and/or abdominal pain, diarrhea.
• Excessive hair growth.
• Acne, flushing.
• Fever.
• Low white blood cell count.
• Numbness or tingling.
• Muscle pain, muscle spasms.
• Stomach ulcers.
• Gum overgrowth covering the teeth.
• High blood levels of uric acid and potassium, low blood levels of magnesium.

Uncommon side effects:may affect 1 to 10 people in 1,000.

• Brain disorders, including sudden seizures, confusion, insomnia, disorientation, vision disturbances, loss of consciousness, weakness in the limbs, movement disorders.
• Rash.
• General swelling.
• Weight gain.
• Low red blood cell or platelet count, which may increase the risk of bleeding.

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, muscle weakness.
• Destruction of red blood cells, 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.

Very rare side effects:may affect 1 to 10 people in 100,000.

• Swelling of the back of the eye, which may be associated with increased pressure in the head and vision disturbances.

Other side effects with unknown frequency:frequency cannot be estimated from the available data.

• Severe liver disorders with yellowing of the eyes or skin, nausea, loss of appetite, dark urine, or without these symptoms.
• Bleeding under the skin or purple spots on the skin, sudden bleeding without obvious cause.
• Migraine or severe headache, often with nausea or vomiting and sensitivity to light.
• Hearing loss.
• Pain in the legs and feet.

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctoror pharmacist.

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 any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of the 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 be reported directly 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 Equoral

Keep this medicine out of the sight and reach of children. Store in a temperature below 25°C, in the original packaging. Do not store in the refrigerator, do not freeze. Store the capsules in the original packaging until use to protect from light. After opening the blister pack, a characteristic smell is noticeable. This is normal and does not mean that the capsules are not suitable for use. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Equoral contains

• The active substanceis ciclosporin.
• Equoral 25 mg, each capsule contains 25 mg of ciclosporin.
• Equoral 50 mg, each capsule contains 50 mg of ciclosporin.
• Equoral 100 mg, each capsule contains 100 mg of ciclosporin.
• Other ingredients:anhydrous ethanol, unsaturated fatty acid esters and polyglycerol (n = 3), unsaturated fatty acid esters and polyglycerol (n = 10), hydrogenated macrogolglycerides, D,L-(alpha) tocopherol. Capsule ingredients: gelatin, glycerol, non-crystallizing sorbitol, glycine, iron oxide, titanium dioxide.

What Equoral looks like and contents of the pack

Equoral 25 mg: soft gelatin capsules, oval, 12.5 x 8 mm in size, yellow in color, containing a yellowish to yellowish-brown oily liquid. Equoral 50 mg: soft gelatin capsules, elongated, 21 x 8 mm in size, yellow ochre in color, containing a yellowish to yellowish-brown oily liquid. Equoral 100 mg: soft gelatin capsules, elongated, 26 x 8 mm in size, brown in color, containing a yellowish to yellowish-brown oily liquid. The pack contains 50 capsules in blisters, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel.: (22) 345 93 00

Manufacturer

Teva Czech Industries s.r.o., Ostravská 29, 747 70 Opava-Komarov, Czech Republic; Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków

Date of last revision of the leaflet: