Reseligo

Package Leaflet: Information for the Patient

Reseligo, 10.8 mg, implant in a prefilled syringe

Goserelin

Read all of this leaflet carefully before using this medicine because it contains important information for you.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 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 the active substance goserelin. It belongs to a group of medicines called LHRH analogues.
Reseligo is used to treat prostate cancer in men.
The medicine works by reducing the amount of testosterone - a hormone produced by the patient's body.
Reseligo 10.8 mg implant in a prefilled syringe is a long-acting form, given every 12 weeks, of Reseligo 3.6 mg.

2. Important information before using Reseligo

When not to use Reseligo:

• if you are allergic to goserelin or any of the other ingredients of this medicine (listed in section 6);
• in women.

Do not use Reseligo if any of the above applies to you.
If you are not sure, talk to your doctor, pharmacist, or nurse before using Reseligo.

Warnings and precautions

Before starting treatment with Reseligo, talk to your doctor, pharmacist, or nurse:

• if you have difficulty urinating or back pain;
• if you have diabetes;
• if you have high blood pressure;
• if you have any conditions that may weaken your bones, especially if you drink a lot of alcohol, smoke, have a family history of osteoporosis (a condition that weakens bones), or are taking anti-epileptic medicines (used to treat epilepsy or seizures) or corticosteroids (steroids);
• if you have any heart or blood vessel disease, including irregular heart rhythm (arrhythmia), or are taking medicines for these conditions. Reseligo may increase the risk of irregular heart rhythm.

There have been reports of depression during treatment with Reseligo, including severe depression. If you experience low mood while using Reseligo, tell your doctor.
Medicines like this one can cause a decrease in bone density (weakening of bones).
If you are admitted to hospital, tell the medical staff that you are using Reseligo.

Children

Reseligo should not be used in children.

Reseligo and other medicines

Tell your doctor, pharmacist, or nurse about all medicines you are taking, or have recently taken, and any you plan to take, including those obtained without a prescription and herbal medicines.
Reseligo may affect the way some medicines work, especially those used to treat irregular heart rhythm (such as quinidine, procainamide, amiodarone, or sotalol), or increase the risk of irregular heart rhythm when taken with certain other medicines (such as methadone, moxifloxacin, or antipsychotic medicines used to treat severe mental disorders).

Driving and using machines

It is unlikely that Reseligo will affect your ability to drive or use machines.

3. How to use Reseligo

Reseligo 10.8 mg implant will be injected under the skin of your stomach every 12 weeks.
The injection will be given by a doctor or nurse.
It is important to continue treatment with Reseligo even if you feel better.

• Continue treatment until your doctor decides to stop it.

Next appointment:

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

4. Possible side effects

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

Allergic reactions

These effects are rare. The following symptoms may occur suddenly:

• rash, itching, or hives
• swelling of the face, lips, or tongue or other parts of the body
• difficulty breathing, wheezing, or shortness of breath. If you experience any of these symptoms, seek medical attention immediately.

Injury at the injection site (including blood vessel damage in the abdominal cavity) after goserelin injection, in very rare cases leading to severe bleeding.
Seek medical attention immediatelyif you notice any of the following symptoms:

• abdominal pain
• abdominal swelling
• shortness of breath
• dizziness
• decreased blood pressure and/or any changes in consciousness

Other possible side effects:

Very common (may affect more than 1 in 10 people)

• hot flashes and sweating. Occasionally, this side effect may persist for some time (even up to several months) after stopping goserelin treatment.
• decreased sex drive and impotence

Common (may affect up to 1 in 10 people)

• back pain or difficulty urinating. If you experience these symptoms, talk to your doctor.
• bone pain at the start of treatment. If you experience these symptoms, talk to your doctor.
• bone density loss
• increased blood sugar levels
• tingling in fingers and toes
• skin rash
• weight gain
• pain, bruising, bleeding, redness, or swelling at the injection site
• heart problems or heart attack
• changes in blood pressure
• breast tenderness or swelling
• mood changes (including depression)

Uncommon (may affect up to 1 in 100 people)

• joint pain

Very rare (may affect up to 1 in 10,000 people)

• psychotic disorders, including hallucinations (seeing, feeling, or hearing things that are not there), disordered thinking, and personality changes. These symptoms are very rare.
• pituitary tumors or, if you have had a pituitary tumor: goserelin may cause bleeding from the tumor or pituitary apoplexy. These effects are very rare. Pituitary tumors can cause severe headaches, nausea, vomiting, loss of vision, and loss of consciousness

Frequency not known (cannot be estimated from the available data)

• hair loss
• blood disorders
• liver problems
• blood clots in the lungs, causing chest pain or shortness of breath
• pneumonia. Symptoms may be typical of pneumonia (such as shortness of breath and cough).
• changes in ECG (prolonged QT interval)

The list of possible side effects should not cause undue concern.
It is possible that none of them will occur.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.
Side effects can be reported directly to the Department of Pharmacovigilance, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Aleje Jerozolimskie 181C, 02-222 Warsaw,
Phone: +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 Reseligo

• The medicine may be prescribed by your doctor. You should collect the prescription from the pharmacy and bring the medicine with you to your next appointment.
• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
• Do not store above 30°C.
• Store in the original package to protect from moisture. Do not open the blister pack.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Reseligo contains

• The active substance is goserelin. One implant contains 10.8 mg of goserelin (as goserelin acetate).
• The other ingredients are DL-lactic acid polymer and a copolymer of DL-lactic acid and glycolic acid (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 syringe applicator consists of three main parts: the body with the implant chamber, the plunger, and the needle. The applicator with a desiccant capsule is placed in a pouch, which consists of three laminated layers (from the outside): PETP film, aluminum layer, PE film. The pouches are placed in a cardboard box.
Reseligo is available in cardboard boxes containing 1 or 3 pouches with an implant in a prefilled syringe.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
Manufacturer:
AMW GmbH Arzneimittelwerk Warngau
Birkerfeld 11, Warngau
83627
Germany

For further information about this medicine and its authorized names in the European Economic Area, please contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
phone: +48 22 375 92 00

Date of last revision of the leaflet:

(logo of the marketing authorization holder)