Reseligo

Package leaflet: information for the patient

Reseligo, 10.8 mg, implant in pre-filled syringe
Goserelinum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist or nurse. See section 4.

Table of contents

1. What Reseligo is and what it is used for
2. Important information before using Reseligo
3. How to use Reseligo
4. Possible side effects
5. How to store Reseligo
6. Contents of the pack and other information

1. What Reseligo is and what it is used for

Reseligo contains an active substance called goserelin. It belongs to a group of medicines known as LHRH analogues.
Please read the section relevant to the patient, depending on whether the patient is a man or a woman.

Use of Reseligo in men
Reseligo is used in the treatment of prostate cancer in men.
The medicine works by reducing the amount of testosterone (a hormone) produced by the patient's body.

Use of Reseligo in women

• Reseligo is used in the treatment of endometriosis. This condition occurs when cells normally found only in the lining of the uterus are present in other parts of the body (usually in nearby structures).
• Reseligo is used in the treatment of uterine fibroids (benign tumours in the uterus).

Administration of Reseligo reduces the amount of estradiol, a hormone produced by the patient's body.

2. Important information before using Reseligo

When not to use Reseligo:

• Reseligo must not be used in children.
• if the patient is allergic to goserelin or to any of the other ingredients of this medicine (listed in section 6).
• if the patient is allergic to other "LHRH analogues", such as buserelin, leuprorelin, and triptorelin.

Do not use Reseligo if any of the above situations apply.
If in doubt, discuss this with your doctor, pharmacist, or
nurse before using Reseligo.
Warnings and precautions
Information for men
Before starting treatment with Reseligo, discuss this with your doctor, pharmacist, or
nurse:

• if the patient has difficulty urinating or back pain;
• if the patient has diabetes;
• if there are any conditions that may weaken bones;
• if the patient has any heart or blood vessel disorders, including heart rhythm disorders (arrhythmia), or if the patient is taking medicines for these conditions. The use of Reseligo may increase the risk of heart rhythm disorders. Cases of depression have been reported during treatment with Reseligo, including severe depression. If the patient develops low mood while taking Reseligo, inform the doctor.

Medicines of this type may cause reduced calcium content in the bones (weakening of bones).
If hospitalised, inform medical staff that the patient is using
Reseligo.
Treatment with Reseligo must only be stopped on the advice of a doctor.
Information for women
Before starting treatment with Reseligo, discuss this with your doctor, pharmacist, or
nurse if:

• the patient is taking oral contraceptives (the pill). Do not use this type of contraception while taking Reseligo.
• Reseligo may cause loss of bone density. After stopping treatment, this problem may partially resolve. Inform the doctor if the patient has another condition affecting bone fragility.

Cases of depression have been reported in women taking Reseligo, which may be severe.
If a woman taking Reseligo develops depression, inform the doctor.
While taking Reseligo, barrier contraception must be used, such as a condom or diaphragm.
If hospitalised, inform medical staff that the patient is using
Reseligo.
Treatment with Reseligo must only be stopped on the advice of a doctor.
Reseligo and other medicines
Tell your doctor, pharmacist, or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including medicines available without a prescription or herbal medicines. This is important because taking several medicines at the same time may sometimes enhance or weaken their effects. The doctor may need to pay special attention to the patient.
Reseligo may affect the action of certain medicines used to treat heart rhythm disorders
(such as quinidine, procainamide, amiodarone, or sotalol) or increase the risk of heart rhythm disorders when used together with certain other medicines (e.g.
methadone (a medicine used to treat pain or as part of detoxification in people addicted to narcotics), moxifloxacin (an antibiotic), antipsychotic medicines used to treat severe mental disorders, or medicines used to reduce blood clotting).
Pregnancy, breastfeeding and fertility
Do not take Reseligo if the patient is pregnant or breastfeeding. If the patient is pregnant, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
It is unlikely that Reseligo will affect the ability to drive or
operate any devices or machinery.

3. How to use Reseligo

• The Reseligo 10.8 mg implant will be injected under the skin of the abdomen every twelve weeks. The injection will be administered by a doctor or nurse. The doctor will pay particular attention to very thin patients.
• It is important to continue treatment with Reseligo even if the patient's condition improves.
• Treatment should be continued until the doctor decides that it can be discontinued.

Next appointment:

• Reseligo should be administered as an injection every 12 weeks.
• Always remind your doctor or nurse to schedule an appointment for your next injection.
• If your scheduled appointment is earlier or later than 12 weeks after the last injection, inform your doctor or nurse.
• If more than 12 weeks have passed since the last injection, contact your doctor or nurse to receive the next injection as soon as possible.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Allergic reactions
These effects are rare. The following symptoms may occur suddenly:

• rash, itching or hives
• swelling of the face, lips, tongue or other parts of the body
• shortness of breath, wheezing or difficulty breathing. If any of these symptoms occur, seek immediate medical advice.
  Injury at the injection site (including damage to blood vessels within the abdominal cavity) after goserelin injection, very rarely leading to severe bleeding.

Contact a doctor immediately if any of the following symptoms are observed:

• abdominal pain
• abdominal bloating
• shallow breathing
• dizziness
• decreased blood pressure and (or) any disturbances in consciousness

If the doctor needs to surgically remove the implant, they may determine its exact location using ultrasound.
Other possible adverse effects:
Very common (may affect more than 1 in 10 patients)

• hot flushes and sweating. Occasionally, this adverse effect may persist for some time (even up to several months) after discontinuation of goserelin
• reduced libido.

Common (may affect 1 in 10 patients)

• loss of bone mass
• tingling in fingers and toes
• skin rashes
• increased body weight
• changes in blood pressure
• mood changes; depression has been frequently reported. Very rare (may affect more than 1 in 10,000 patients)
• psychiatric disorders known as psychotic disorders, including possible hallucinations (seeing, feeling or hearing things that are not real), thought disorders and personality changes. These symptoms are very rare
• development of a pituitary tumour or, (if the patient previously had a pituitary tumour): goserelin may cause bleeding from the tumour or tumour collapse. These effects are very rare. Pituitary tumours may cause severe headaches, nausea or vomiting, vision loss and loss of consciousness. Frequency unknown (frequency cannot be estimated from available data)
• blood-related changes
• liver disorders
• pulmonary embolism, causing chest pain or shortness of breath
• pneumonia. Symptoms may be typical of pneumonia (such as shortness of breath and cough).

Information for men
The following adverse effects may occur in men:
Very common (may affect more than 1 in 10 patients)

• impotence.

Common (may affect 1 in 10 patients)

• bone pain at the beginning of treatment. If these symptoms occur, discuss them with your doctor
• numbness, pain, weakness and loss of control over the bowels and bladder (symptoms of spinal cord compression). If these symptoms occur, discuss them with your doctor
• reduced heart function or heart attack
• breast swelling
• elevated blood glucose levels
• pain, bruising, bleeding, redness or swelling at the Reseligo injection site.

Uncommon (may affect 1 in 100 patients)

• joint pain
• lower back pain or difficulty urinating. If these symptoms occur, discuss them with your doctor
• breast tenderness.

Frequency unknown (frequency cannot be estimated from available data)

• changes in ECG (prolongation of QT interval)
• hair loss.

Information for women
The following adverse effects may occur in women:
Very common (may affect more than 1 in 10 patients)

• vaginal dryness
• change in breast size
• acne, which has been very frequently reported (often within one month of starting treatment)
• pain, bruising, bleeding, redness or swelling at the Reseligo injection site.

Common (may affect 1 in 10 patients)

• headaches
• hair loss (usually mild, but sometimes severe)
• joint pain
• tumour flare syndrome (sudden worsening related to the tumour), tumour pain.

Rare (may affect 1 in 100 patients)

• small ovarian cysts (swellings), which may cause pain. These usually resolve without treatment.

Frequency unknown (frequency cannot be estimated from available data)

• vaginal bleeding. This is most likely to occur within the first month after starting Reseligo and should resolve spontaneously. However, if it does not resolve or causes discomfort, contact your doctor.
• slight worsening of fibroid symptoms, such as pain.

When Reseligo is used in the treatment of uterine fibroids or endometriosis, the following symptoms may occur:

• slight worsening of fibroid symptoms, such as pain. This is usually short-lived and resolves with continued treatment with Reseligo. However, if symptoms persist or cause discomfort, discuss them with your doctor.

The list of possible adverse effects provided should not cause undue concern. It is possible that none of them will occur.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Reseligo medicine

• The medicine may be prescribed to the patient by a doctor. The prescription should be dispensed at a pharmacy, and the medicine should be brought to the next visit.
• Keep the medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and sachet following "EXP". The expiry date refers to the last day of the specified month.
• Do not store above 30°C.
• Store in the original packaging to protect from moisture. Do not open the foil pouch.
• Medicines must not be disposed of via sewage systems or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Reseligo contains

• The active substance is goserelin. One implant contains 10.8 mg goserelin (as goserelin acetate).
• The other ingredients are DL-lactide polymer and DL-lactide and glycolide copolymer (75:25).

What Reseligo looks like and contents of the pack
White or almost white cylindrical rods (approximate dimensions: diameter 1.5 mm, length 13 mm,
mass 44 mg) embedded in a biodegradable polymer matrix.
The single-dose applicator syringe consists of three main parts: the body with the implant chamber, the plunger, and the needle. The applicator, together with a moisture-absorbing capsule, is placed in a pouch made of three laminated layers (from the outside): PETP film, aluminium layer, PE film. The pouches are placed in a cardboard box.
Reseligo is available in cardboard boxes containing 1 or 3 pouches with the implant in a pre-filled syringe.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer:
AMW GmbH Arzneimittelwerk Warngau
Birkerfeld 11, Warngau
Germany

For further information, contact the representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00
(logo of the Marketing Authorisation Holder)