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Reseligo 3.6 mg. 1 seringe

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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".

Use RESELIGO in men
RESELIGO is used to treat prostate cancer. It works by reducing the amount of "testosterone" (hormone) produced by your body.

Using RESELIGO in women
RESELIGO is used to:

Treatment of breast cancer;
Treatment of a condition called "endometriosis". A condition where cells normally found only in the lining of the uterus are also found elsewhere in your body (usually in organs adjacent to the uterus);
Treatment of benign neoplasms in the uterus, called "uterine myomas";
Thinning of the uterine lining before surgery of the uterus;
For help in the treatment of infertility (in combination with other medicines). Helps control oocyte release from the ovaries.
In women, RESELIGO works by reducing the amount of "estrogen" (hormone) produced by your body.

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 pregnant or breast-feeding (see the "Pregnancy and Breastfeeding" section below).
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
If you go to a hospital, inform the medical staff that you are using RESELIGO.

Before using RESELIGO, talk to your doctor or nurse if:

you have high blood pressure;
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.

Information about men
Before using RESELIGO, talk to your doctor or nurse if:

you have problems with urination or problems with your waist;
you have diabetes;
have a family history of osteoporosis (a disease that affects bone health), or you are taking anticonvulsants (medicines to treat epilepsy or seizures) or corticosteroids (steroids).
Drugs of this type may cause calcium reduction in the bones (thinning of the bones).

Information about women
Before using RESELIGO, talk to your doctor or nurse if:

have a family history of osteoporosis (a disease that affects bone health), have irregular nutrition, or are taking anticonvulsants (medicines to treat epilepsy or seizures) or corticosteroids (steroids).
Drugs of this type may cause calcium reduction in the bones (thinning of the bones). This can be improved when treatment is stopped.

If you are taking RESELIGO for endometriosis treatment, your doctor may reduce bone thinning by prescribing other medicines.

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).

Pregnancy and Lactation:
Do not use RESELIGO if you are pregnant or breast-feeding.
Do not use RESELIGO if you are trying to get pregnant (unless RESELIGO is used as part of infertility treatment).
Do not use oral contraceptives during treatment with RESELIGO. Use barrier contraceptive methods such as a condom or diaphragm (hat).

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?
RESOLF 3.6 mg implant will be given as a subcutaneous injection into the abdomen every 4 weeks (28 days). 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
Your next injection time

RESELIGO should be given every 28 days.
Always remind your doctor or nurse to record the next hour for your injection.
If you are given an hour before or after the 28th day after the last injection, please pay attention to your doctor or nurse.
If more than 28 days have elapsed since your last injection, contact your doctor or nurse immediately to get it as soon as possible.
Information about women
If you are receiving RESULTS for uterine fibroids and have anemia (low levels of red blood cells or hemoglobin), your doctor may prescribe an iron supplement.

The duration of your treatment depends on what you have been told about:

For treatment of uterine fibroids, you should use RESELIGO for no more than three months.
For treatment of endometriosis, you should use RESELIGO for not more than six months.
To thin the uterine lining before surgery on the uterus, you should use RESELIGO no more than one or two months (four or eight weeks).
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.

The following side effects may occur in men or women:
Allergic reactions:
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:

Warm waves and sweat;
Reducing libido;
Thinning of the bones;
Numbness of the fingers or legs;
Skin rashes;
Hair loss;
Increase body weight;
Joint pain;
Changes in blood pressure;
Pain, bruising, bleeding, redness or swelling at the site of RESELIGO;
Changes in your mood (including depression)
Changes in your blood count
Hepatic problems;
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).
Information about men
The following undesirable effects may occur in men:

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;
Decreased heart function or heart attack;
Swelling and soreness of the chest;
Elevated blood sugar levels.
Information about women
The following undesirable effects may occur in women:

Changes in blood calcium levels. Signs of this may include a feeling of stomach upset, nausea, or a strong thirst. If this happens, tell your doctor because he or she may need to do blood tests;
Vaginal bleeding. This usually occurs in the first month after initiation of goserelin treatment and is expected to stop spontaneously. However, if you continue or feel unwell, tell your doctor;
Dryness of the vagina;
Changing the size of the chest;
Small cysts (swelling) of the ovaries that can cause pain. They usually disappear without treatment.
Some women may get into menopause earlier during goserelin treatment and their menstrual cycle is not resumed after discontinuation of goserelin therapy;
Acne has been reported very commonly (often within one month of starting treatment).
When goserelin is used to treat endometriosis, uterine fibroids, infertility or thinning of the lining of the uterus, the following side effects may also occur:

Changes in body hair;
Dry skin;
Weight gain;
Increased levels of fatty substance known as cholesterol in the blood. This will be seen in a blood test;
Inflammation of the vagina and secretion from the vagina;
Sleep disturbances and fatigue;
Swelling of legs and ankles;
Muscle pain;
Sudden painful clamping of the muscles (cramps) on your legs;
Gastric complaints, nausea or vomiting, diarrhea and constipation;
Changes in your voice
When used to treat uterine fibroids, a slight increase in the symptoms of myomas, such as pain, may occur.
When goserelin is used to treat breast cancer, the following may occur:

Worsening of breast cancer symptoms at the beginning of treatment. This may include an increase in pain or an increase in the size of the affected tissue. These reactions usually do not last long and resolve with continued treatment with goserelin. However, if the symptoms persist or you feel unwell, tell your doctor.
When goserelin is used to treat infertility in combination with another medicine called gonadotrophin, the following may occur:

The effect on your ovaries may be too strong. You may notice stomach pain, abdominal swelling and a feeling of stomach upset or nausea. If this happens, tell your doctor immediately.
Do not worry about this list of possible side effects. You may not experience any of them.
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 and the bag 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 3.6 mg of gosereliri, in the form of goserelin acetate.
The other ingredient is Poly (D, L-lactide-co-glycolide) 50:50.

What it looks like and what the package looks like
White to almost white cylindrical rods (approximate dimensions: 1.2 mm in diameter, 13 mm in length, 18 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.



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