Reseligo

Package leaflet: Information for the patient

Reseligo, 3.6 mg, implant in pre-filled syringe
Goserelinum
Please read all of this leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult 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 adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

Most of the information in this leaflet applies to both men and women.

• If information applies only to men, it is indicated under the heading: Information for men.
• If information applies only to women, it is indicated under the heading: Information for women.

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.

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

Use of Reseligo in women
In women, Reseligo is used:

• in the treatment of breast cancer;
• in the treatment of a condition called endometriosis. In endometriosis, cells normally found only in the lining of the uterus are also found in other parts of the body (usually in nearby structures close to the uterus);
• in the treatment of benign uterine tumours known as fibroids;
• to thin the lining of the uterus before planned uterine surgery;
• as an adjunct in infertility treatment (together with other medicines). This medicine helps control the release of eggs from the ovaries.

In women, Reseligo works by reducing the amount of estrogen – a hormone produced by the patient's body.

2. Information before using Reseligo

When not to use Reseligo:

• if the patient is allergic to goserelin or any of the other ingredients of this medicine (listed in section 6);
• if the patient is pregnant or breastfeeding (see section "Pregnancy and breastfeeding" below).

Do not use Reseligo if any of the above situations apply.
If in doubt, discuss with your doctor, pharmacist, or nurse before using Reseligo.
Warnings and precautions
If admitted to hospital, inform medical staff that you are using Reseligo.
Before starting treatment with Reseligo, discuss with your doctor, pharmacist, or nurse:

• if the patient has high blood pressure;
• 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 developing heart rhythm disturbances.

Cases of depression, including severe depression, have been reported during treatment with Reseligo. If the patient experiences low mood while taking Reseligo, inform the doctor.
Information for men
Before starting treatment with Reseligo, discuss with your doctor, pharmacist, or nurse:

• if there are difficulties with passing urine or back pain;
• if the patient has diabetes;
• if there are any conditions that may weaken bones, especially if the patient drinks large amounts of alcohol, smokes, has a family history of osteoporosis (a disease that weakens bones), or if the patient is taking anticonvulsant medicines (used for epilepsy or seizures) or corticosteroids (steroids). These types of medicines may cause reduced calcium in the bones (weakening of bones).

Information for women
Before starting treatment with Reseligo, discuss with your doctor, pharmacist, or nurse:

• if there are any conditions that may weaken bones, especially if the patient drinks large amounts of alcohol, smokes, has a family history of osteoporosis (a disease that weakens bones), or if the patient is taking anticonvulsant medicines (used for epilepsy or seizures) or corticosteroids (steroids). These types of medicines may cause reduced calcium in the bones (weakening of bones). This may improve after stopping treatment.

If Reseligo is used for the treatment of endometriosis, the doctor may recommend also using other medicines to reduce bone mass loss.
Children
Reseligo must not be used in children.
Other medicines and Reseligo
Tell your doctor, pharmacist, or nurse about all medicines the patient is currently taking, has recently taken, or might take in the future.
Reseligo may affect the action of certain medicines used to treat heart rhythm disorders (such as quinidine, procainamide, amiodarone, or sotalol) or may increase the risk of heart rhythm disturbances when used together with certain other medicines (e.g. methadone (a medicine used to treat pain or as part of detoxification in drug-dependent individuals), moxifloxacin (an antibiotic), or antipsychotic medicines used to treat severe mental disorders).
Pregnancy, breastfeeding and fertility

• Do not use Reseligo if the patient is pregnant or breastfeeding.
• Do not use Reseligo if the patient plans to become pregnant (unless Reseligo is used as part of infertility treatment).
• Do not take "the pill" (oral contraceptives) while using Reseligo. Use mechanical methods of contraception, such as condoms or diaphragm.

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 3.6 mg implant will be injected under the skin of the abdomen every four weeks (28 days). The injection will be administered by a doctor or nurse.
• 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 stopped.

Next appointment:

• Reseligo should be administered as an injection every 28 days.
• Always remind your doctor or nurse to schedule the next appointment for your following injection.
• If the scheduled appointment occurs earlier or later than 28 days after the last injection, inform your doctor or nurse.
• If more than 28 days have passed since the last injection, contact your doctor or nurse to receive the next injection as soon as possible.

Information for women:

• If a patient is receiving Reseligo for uterine fibroids and has anaemia (low red blood cell count or low haemoglobin levels), the doctor may recommend taking iron supplements.
• The duration of treatment will depend on the reason for using Reseligo:
• for the treatment of uterine fibroids, Reseligo should be used for up to three months only.
• for the treatment of endometriosis, Reseligo should be used for up to six months only.
• to thin the endometrial lining before surgery, Reseligo should be used for only one or two months (four or eight weeks).

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.

The following adverse effects may occur in both men and women

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 medical advice immediately.

Injury at the injection site (including damage to blood vessels within the abdominal cavity)
after goserelin injection, very rarely leading to severe bleeding.
Contact your doctor immediately if you observe any of the following symptoms:

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

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 stopping goserelin.
• decreased libido
• pain, bruising, bleeding, redness or swelling at the injection site of Reseligo.

Common (may affect 1 in 10 patients)

• loss of bone mass
• tingling in fingers and toes
• skin rashes
• hair loss
• weight gain
• joint pain
• changes in blood pressure
• mood changes (including depression)

Very rare (may affect 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 apoplexy. These effects are very rare. Pituitary tumours may cause severe headaches, nausea or vomiting, vision loss and loss of consciousness.

Frequency unknown (cannot be estimated from available data)

• blood-related changes
• liver disorders
• pulmonary blood clot causing chest pain or shortness of breath
• pneumonia. Symptoms may be typical of pneumonia (such as shortness of breath and cough).
• changes in ECG (prolongation of QT interval).

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)

• lower back pain or difficulty urinating. If these symptoms occur, discuss them with your doctor.
• bone pain at the beginning of treatment. If these symptoms occur, discuss them with your doctor.
• impaired heart function or heart attack
• breast tenderness and swelling
• increased blood sugar levels

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

• vaginal dryness
• changes in breast size
• acne, observed very commonly (often within one month after starting treatment)

Common (may affect 1 in 10 patients)

• headaches

Rare (may affect 1 in 1000 patients)

• small ovarian cysts, which may cause pain. These usually resolve without additional treatment.
• in some women, early menopause occurs during goserelin treatment, and menstruation does not return after stopping treatment.

Frequency unknown (cannot be estimated from available data)

• vaginal bleeding. This most commonly occurs in the first month after starting treatment and should resolve spontaneously. If symptoms persist or are bothersome, discuss them with your doctor.
• slight worsening of fibroid-related symptoms, such as pain.

When goserelin is used in the treatment of endometriosis, uterine fibroids, infertility
or to thin the endometrial lining before surgery, the following adverse effects may also occur:

• changes in body hair
• dry skin
• weight gain
• increased blood levels of fat (cholesterol). This can be detected in a blood test.
• vaginal inflammation and discharge
• nervousness
• sleep disturbances and fatigue
• swelling of feet and ankles
• muscle pain
• sudden, painful leg muscle cramps
• gastrointestinal symptoms such as nausea or vomiting, diarrhoea and constipation
• changes in voice quality
• in the treatment of uterine fibroids, slight worsening of fibroid-related symptoms, such as pain.

When goserelin is used in the treatment of breast cancer, the following adverse effects may occur:

• worsening of breast cancer symptoms at the beginning of treatment. There may be an increase in pain or tumour lesions. These symptoms usually do not last long and typically resolve during treatment. However, if symptoms persist or cause discomfort, discuss them with your doctor.
• changes in blood calcium levels. Symptoms may include severe nausea, persistent vomiting or excessive thirst. If these symptoms occur, discuss them with your doctor. Your doctor may order a blood test.

When goserelin is used in the treatment of infertility, in combination with another medicine called gonadotropin, the following adverse effects may occur:

• excessive ovarian stimulation. The patient may experience abdominal pain, bloating, nausea or vomiting. If these symptoms occur, inform your doctor immediately.

The above list of possible adverse effects 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, tell your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 provide more information on the safety of this 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 the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and foil pack after "EXP". The expiry date refers to the last day of the stated month.
• Do not store above 30°C.
• Store in the original packaging to protect from moisture. Do not open the foil packaging.
• Medicines must 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 Reseligo contains

• The active substance is goserelin. One implant contains 3.6 mg goserelin (as goserelin acetate).
• The other ingredient is a copolymer of DL-lactide and glycolide (50:50).

What Reseligo looks like and contents of the pack
White or almost white cylindrical rods (approximate dimensions: diameter 1.2 mm, length 13 mm,
mass 18 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 desiccant 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
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 about this medicinal product and its names in the Member States of the European Economic Area, please contact the local 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)