Buserelin 1 mg/ml solution for injection

Buserelin 1 mg/ml solution for injection

buserelin acetate

The name of your medicine is Buserelin Injection. It contains a medicine called buserelin. This belongs to a group of medicines called gonadotropin releasing hormone analogues. This is a synthetic version of a hormone that occurs naturally in the body. It works by lowering the production of sex hormones.

It can be used to treat infertility. It works by stopping the natural production of hormones that control ovulation. Synthetic hormones are then used to artificially stimulate ovulation. Your doctor should give you more information about how your treatment works.

Do not use Buserelin Injection:

• if you are allergic to buserelin acetate or any other ingredients of this medicine (listed in section 6).
  Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• if you have abnormal menstrual bleeding.
• if you are pregnant or breast-feeding.
• This medicine is for use in women only. However, there is another form of this medicine that can be used in men. Men should not use either form of this medicine if they have had their testicles removed.

Do not have this medicine if any of the above apply to you. If you are not sure, talk to your doctor or nurse before having Buserelin Injection.

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Posology

Your doctor will start treatment on day 1 or day 21 of your menstrual cycle.

The recommended daily dose is 200 to 500 micrograms given as a single daily injection or 500 micrograms twice a day.

You will be given daily injections until blood tests show that levels of sex hormones are lowered. This usually takes one to three weeks. You will then be given other hormones as well as Buserelin Injection. Your doctor will tell you how long you are to continue having these medicines.

Method of administration

Buserelin Injection is normally given by a doctor or nurse. This is because it needs to be given as an injection underneath the skin (subcutaneous injection).

The doctor or nurse will usually give you the first injections. You may then be trained how to give the injections to yourself. Your doctor or nurse will show you how to do this. Do not try to inject yourself if you have not been trained how to do so. If you are not sure what to do, talk to your doctor or nurse immediately.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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

Stop using Buserelin Injection and see a doctor or go to a hospital straight away:

• if you have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. You may also have pain or a skin rash in the area you were injected with Buserelin Injection.
• if you have diarrhoea, pain, swelling or a feeling of tension in your stomach, feel sick or are sick, have gained weight, are having difficulty breathing or are short of breath or are passing less urine. These could be signs of a serious side effect called ‘Ovarian Hyperstimulation Syndrome’. This is more likely if you are taking other hormones as well as Buserelin Injection (buserelin) as part of a treatment for infertility.

Tell your doctor straight away if you notice any of the following serious side effects:

• You bruise more easily than usual. This could be because of a blood problem called ‘thrombocytopenia’.
• You get a lot of infections. Signs include fever, sore throat or mouth ulcers. These could be signs of a blood problem called leukopenia.
• You have severe headaches and eyesight problems. This is very rare but if it happens it could be due to tumours on the pituitary gland. This gland is found at the base of the brain.
• Your blood pressure becomes higher. This is very rare but if it happens you may get symptoms such as crushing chest pain, confusion, problems with your eyesight, tiredness and an uneven heartbeat.

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:

• Menopausal-like symptoms and withdrawal bleeding.
• Some weeks after starting treatment you may get signs such as hot flushes, increased sweating, dry vagina, painful sexual intercourse or loss of sex drive (libido). These may be severe in some cases. Breakthrough bleeding or spotting may also occur.
• Pain, discomfort or swelling in the lower part of the stomach, changes to your periods, constipation, diarrhoea or needing the toilet more often. These symptoms could be a sign of ovarian cysts.
• Bone or muscle discomfort such as shoulder pain or stiffness. Bones may become less dense during long-term treatment, due to a lowering in the amount of bone mineral. This effect is reversible when treatment is stopped. If Buserelin Injection is used for a long period of time, it may increase the risk of you getting a condition called ‘osteoporosis’. This is when your bones are more likely to break.
• Lowered tolerance to glucose which may lead to worsening of existing diabetes.
• Changes in body weight, changes in appetite and increased thirst.
• Mood changes such as feeling depressed or worsening of depression and feeling anxious.
  • Frequency: Long term use: common
    Short term use: Uncommon
• Feeling nervous, dizzy, tired or drowsy.
• Headache (which may be like a migraine) and disturbed sleep.
• Problems with memory and concentration.
• Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin. This can feel like ‘pins and needles’ (usually in the arms and legs) and is called paraesthesia.
• Dry eyes (possibly leading to eye irritation in people who wear contact lenses), blurred eyesight, feeling of pressure behind the eyes.
• Hearing problems such as ringing in the ears (tinnitus).
• Very fast, uneven or forceful heartbeat (palpitations).
• Facial swelling (puffiness) due to water retention which may also cause swollen arms or legs.
• Feeling or being sick, stomach ache, pain in the lower abdomen, diarrhoea or constipation.
• Dry skin or acne.
• Hair grows more than normal (including body and facial hair).
• Hair loss (including body or facial hair).
• Splitting of nails.
• Vaginal discharge, changes in breast size, breast tenderness or milk production.
• Changes in the level of liver enzymes, fats (lipids) and a substance called ‘bilirubin’ in the blood shown up in blood tests.
• Worsening of your condition if you have uterine fibroids.
• Frequency not known: changes in ECG (QT prolongation).

Keep this 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 label. The expiry date refers to the last day of that month.

Once opened use within 15 days.

Do not store above 25 °C. Do not freeze.

Keep the vials in the outer carton in order to protect from light.

Discoloured or cloudy solution should not be used.

Each vial contains enough solution for ten doses. After finishing a course of treatment the vial should be disposed of and a new vial started for the next treatment.

Do not throw away any medicines via wastewater or household waste. If you are using this medicine at home you will be given a container (a sharps bin) to use for disposal. Return the sharps bin or any used or unused syringes to your doctor or nurse or pharmacist for disposal. These measures will help to protect the environment.

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.