Reseligo

Package Leaflet: Information for the Patient

Reseligo, 3.6 mg, Implant in a Prefilled Syringe

Goserelin

Read the Package Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.

• Keep this package 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. 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 package leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Reseligo and What is it 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 Package and Other Information

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

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

1. What is Reseligo and What is it Used For

Reseligo contains the active substance goserelin, which belongs to a group of medicines called LHRH analogues.

Use of Reseligo in Men

In men, Reseligo is used to treat 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:

• to treat breast cancer;
• to treat a condition called endometriosis. In endometriosis, cells that normally occur only in the lining of the uterus are also found in other parts of the body (usually in structures near the uterus);
• to treat benign tumors of the uterus, called uterine fibroids;
• to thin the lining of the uterus before a planned uterine surgery;
• as an adjunct in the treatment of infertility (in combination 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. 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);
• if you are pregnant or breastfeeding (see section "Pregnancy and Breastfeeding" below).

Do not use Reseligo if any of the above situations apply. If you are unsure, consult your doctor, pharmacist, or nurse before using Reseligo.

Warnings and Precautions

In case of hospitalization, inform the medical staff that you are using Reseligo.

Before starting treatment with Reseligo, discuss it with your doctor, pharmacist, or nurse:

• if you have high blood pressure;
• if you have any heart or blood vessel diseases, including rhythm disorders (arrhythmia), or if you are taking medicines for these conditions. During treatment with Reseligo, the risk of rhythm disorders may increase.

Depression has been reported during treatment with Reseligo, including severe depression. If you experience low mood while using Reseligo, inform your doctor.

Information for Men

Before starting treatment with Reseligo, discuss it with your doctor, pharmacist, or nurse:

• if you have difficulty urinating or back pain;
• if you have diabetes;
• if you have any conditions that may weaken your bones, especially if you drink large amounts of alcohol, smoke, or have a family history of osteoporosis (a disease that weakens bones) or if you are taking antiepileptic medicines (used to treat epilepsy or seizures) or corticosteroids (steroids). These types of medicines can cause a decrease in bone calcium (bone weakening).

Information for Women

Before starting treatment with Reseligo, discuss it with your doctor, pharmacist, or nurse:

• if you have any conditions that may weaken your bones, especially if you drink large amounts of alcohol, smoke, or have a family history of osteoporosis (a disease that weakens bones) or if you are taking antiepileptic medicines (used to treat epilepsy or seizures) or corticosteroids (steroids). These types of medicines can cause a decrease in bone calcium (bone weakening). This may improve after stopping treatment.

If you are using Reseligo for endometriosis, your doctor may recommend using other medicines that reduce bone loss.

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, as well as any medicines you plan to take.

Reseligo may affect the action of some medicines used to treat rhythm disorders (such as quinidine, procainamide, amiodarone, or sotalol) or increase the risk of rhythm disorders when used 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), or antipsychotic medicines used to treat severe mental disorders).

Pregnancy, Breastfeeding, and Fertility

• Do not use Reseligo if you are pregnant or breastfeeding.
• Do not use Reseligo if you plan 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 a diaphragm.

Driving and Using Machines

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

3. How to Use Reseligo

• Reseligo 3.6 mg implant will be injected under the skin of your abdomen every four weeks (28 days). The injection will be administered by a doctor or nurse.
• It is essential to continue treatment with Reseligo, even if you feel better.
• Continue treatment until your doctor decides it can be stopped.

Next Appointment:

• Reseligo should be used as an injection every 28 days.
• Always remind your doctor or nurse to schedule an appointment for the next injection.
• If the scheduled appointment is 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 you are receiving Reseligo for uterine fibroids and have anemia (low red blood cell count or low hemoglobin), your doctor may recommend taking iron supplements.
• The duration of treatment will depend on the reason for using Reseligo:
• for uterine fibroids, Reseligo should be used for no more than three months.
• for endometriosis, Reseligo should be used for no more than six months.
• to thin the uterine lining before surgery, Reseligo should be used for one or two months (four or eight weeks).

4. Possible Side Effects

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

The Following Side Effects May Occur in Men and Women

Allergic Reactions

These reactions 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 breathing problems. If you experience any of these symptoms, seek medical attention immediately.

Injury at the injection site (including vascular injury in the abdominal cavity) after goserelin injection, in very rare cases leading to severe bleeding.

Seek medical attention immediatelyif you observe any of the following symptoms:

• abdominal pain
• abdominal distension
• 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 patients)

• hot flashes and sweating. Occasionally, this side effect may persist for some time (even up to several months) after stopping goserelin.
• decreased sexual desire
• pain, bruising, bleeding, redness, or swelling at the injection site.

Common (may affect 1 in 10 patients)

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

Very rare (may affect 1 in 10,000 patients)

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

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

• blood changes
• liver disorders
• blood clots in the lungs, causing chest pain or difficulty breathing
• pneumonia. Symptoms may be typical of pneumonia (such as difficulty breathing and coughing).
• changes in ECG (prolonged QT interval).

Information for Men

The following side effects may occur in men:

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

• impotence

Common (may affect 1 in 10 patients)

• back pain or difficulty urinating. If you experience these symptoms, discuss them with your doctor.
• bone pain at the start of treatment. If you experience these symptoms, discuss them with your doctor.
• heart failure or heart attack
• breast tenderness or swelling
• increased blood sugar levels.

Information for Women

The following side effects may occur in women:

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

• vaginal dryness
• breast changes
• acne, often within a month of starting treatment

Common (may affect 1 in 10 patients)

• headaches

Rare (may affect 1 in 1000 patients)

• small ovarian cysts, which may cause pain. They usually resolve without additional treatment.
• in some women, early menopause may occur during goserelin treatment, and menstrual periods may not return after stopping treatment

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

• vaginal bleeding. This usually occurs in the first month after starting treatment and should resolve on its own. If symptoms persist or bother you, discuss them with your doctor.
• mild worsening of uterine fibroid symptoms, such as pain

If Goserelin is Used to Treat Endometriosis, Uterine Fibroids, Infertility, or to Thin the Uterine Lining Before Surgery, the Following Side Effects May Also Occur:

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

If Goserelin is Used to Treat Breast Cancer, the Following Side Effects May Occur:

• worsening of breast cancer symptoms at the start of treatment. This may cause increased pain or tumor growth. These symptoms usually do not last long and 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 severe thirst. If you experience these symptoms, discuss them with your doctor. Your doctor may order a blood test.

If Goserelin is Used to Treat Infertility,in combination with another medicine called gonadotropin, the following side effects may occur:

• overstimulation of the ovaries. You may experience abdominal pain, bloating, nausea, or vomiting. If you experience these symptoms, inform your doctor immediately.

The list of possible side effects should not cause undue concern.

It is possible that none of them will occur.

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety 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 also be reported to the marketing authorization holder.

Reporting side effects will help gather more information on the safety of this medicine.

5. How to Store Reseligo

• The medicine may be prescribed to you by a doctor. Have the prescription filled at a pharmacy and bring the medicine with you to your next appointment.
• Store the medicine out of sight and reach of children.
• Do not use this medicine after the expiration date stated on the carton and blister pack after "EXP". The expiration date refers to the last day of the month stated.
• 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. 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 3.6 mg of goserelin (as goserelin acetate).
• The other ingredient is a copolymer of DL-lactic and glycolic acid (50:50).

What Reseligo Looks Like and What the Package Contains

White or almost white cylindrical rods (approximate dimensions: diameter 1.2 mm, length 13 mm, weight 18 mg), embedded in a biodegradable polymer matrix.

The single-dose prefilled 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 blister pack, which consists of three laminated layers (from the outside): PETP film, aluminum layer, and PE film. The blister packs are placed in a cardboard box.

Reseligo is available in cardboard boxes containing 1 or 3 blister packs 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 More Information on the Medicinal Product and its Names in the Member States of 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

Tel.: +48 22 375 92 00

Date of Last Revision of the Package Leaflet:

(logo of the marketing authorization holder)