What is RESELIGO and what it is used for
RESILIGO contains a medicine called goserelin. It belongs to a group of medicines called “LHRH analogues”.
RESELIGO is used to treat prostate cancer. It works by reducing the amount of “testosterone” (hormone) produced by your body. RESELIGO 10.8 mg is a long acting form and is administered every 12 weeks.
2. What you need to know before you are given RESELIGO
You should not be given RESELIGO:
if you are allergic to goserelin or any of the other ingredients of this medicine (listed in section 6);
if you are a woman.
Do not use RESELIGO if any of the above conditions apply to you. If you are not sure, talk to your doctor or pharmacist before using RESELIGO.
Warnings and precautions
Before using RESELIGO, talk to your doctor or nurse if:
you have problems with urination or problems with your waist;
you have diabetes;
you have high blood pressure;
have an illness that affects the strength of your bones, especially if you are an alcoholic, a smoker, have a family history of osteoporosis (a condition affecting bone health), or you are taking anticonvulsants (medicines to treat epilepsy or seizures) or corticosteroids (steroids);
have any heart disease or blood vessel disease including heart rhythm problems (arrhythmia) or are being treated with medicines for these conditions. The risk of heart rhythm problems may increase when using RESELIGO.
There have been reports of depression in patients receiving RESELIGO, which may be severe. If you are taking RESELIGO and develop depressed mood, tell your doctor.
Drugs of this type may cause calcium reduction in the bones (thinning of the bones).
If you go to a hospital, inform the medical staff that you are using RESELIGO.
RESOLIGO should not be given to children.
Other medicines and RESELIGO
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
RESILIGO may interact with some medicines used to treat heart rhythm problems (eg quinidine, procaine, amiodarone and sotalol) or may increase the risk of heart rhythm problems when used with other medicines (eg methadone used to relieve pain and part of the detoxification of drug addiction), moxifloxacin (antibiotic), antipsychotics used in severe mental illnesses).
Driving and using machines
It is unlikely to affect your ability to drive or use tools or machines.
3. How will you be given RESELIGO?
RESULG 10.8 mg implant will be given as a subcutaneous injection into the abdomen every 12 weeks. This will be done by your doctor or nurse.
It is important to keep using RESELIGO even if you feel good. Continue this treatment until your doctor thinks it’s time to stop it.
Your next injection time
RESELIGO should be given every 12 weeks.
Always remind your doctor or nurse to record the next hour for your injection.
If you are given an hour before or 12 weeks after the last injection, please pay attention to your doctor or nurse.
If it has been more than 12 weeks since the last injection, contact your doctor or nurse immediately to get it as soon as possible.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
These side effects are rare. Symptoms may include the sudden onset of:
Skin rash, pruritus or urticaria;
Swelling of the face, lips or tongue or other parts of the body;
Shortness of breath, wheezing or difficulty in breathing.
If this happens, contact your doctor immediately.
Other possible side effects:
Pain in the cross or urinary problems. If this happens, tell your doctor;
Bone pain at the beginning of treatment. If this happens, tell your doctor;
Warm waves and sweat;
Reducing libido and impotence;
Thinning of the bones;
Elevated blood sugar levels;
Numbness of the fingers or legs;
Increase in body weight;
Pain, bruising, bleeding, redness or swelling at the place of administration of goserelin;
Decreased heart function or heart attack;
Changes in blood pressure;
Swelling and soreness of the chest;
Changes in your mood (including depression)
Changes in your blood count
Blood clot in your lungs, causing chest pain or shortness of breath;
Inflammation of the lungs. Symptoms can resemble pneumonia (such as a feeling of shortness of breath and cough);
Psychiatric problems, called psychotic disorders, which can include hallucinations (seeing, feeling or hearing non-existent things), unsettled thoughts and personal changes. This side effect is very rare;
The development of a tumor of the pituitary gland or if you already have a pituitary tumor, goserelin can cause bleeding or a decrease in the tumor. These reactions are very rare. Pituitary tumors can cause severe headache, nausea or vomiting, loss of vision and loss of consciousness;
ECG changes (QT prolongation).
Do not worry about this list of possible side effects. You may not experience any of them.
Reporting of side effects
If any of the side effects gets serious, tell your doctor, pharmacist or nurse.
How to Store RESELIGO
Your doctor may prescribe a prescription so you can buy your medicine from the pharmacy and give it to your doctor when you meet him or her again.
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not store above 30 ° C.
Store in the original package in order to protect from moisture without breaking the seal.
6. Package Contents and Additional Information
What contains RESELIGO
The active substance is goserelin.
One implant contains 10.8 mg goserelin, (as goserelin acetate).
The other ingredients are Poly (D, L-lactide) and Poly (D, L-lactide-co-glycolide) 75:25.
What it looks like and what the package looks like
White to almost white cylindrical rods (approximate dimensions: 1.5 mm in diameter, 13 mm in length, 44 mg in weight) embedded in a biodegradable polymer matrix.
Single-dose syringe-applicator consisting of three main parts: implant-holder body, dandelion and needle. The applicator is packed together with a desiccant capsule in a bag of three laminated layers (on the outside): PEP-film, aluminum layer, PE-film. The bags are then packaged in a cardboard box.
RESILIGO is supplied in cartons of 1 or 3 bags of implants in a pre-filled syringe.
Not all pack sizes may be marketed.