What is Suprecur Nasal Spray?

Suprecur Nasal Spray contains buserelin (as buserelin acetate, 150 micrograms in each spray). Other ingredients include citric acid, sodium chloride, sodium citrate, benzalkonium chloride and water. It is a nasal spray; one bottle contains 84 spray doses. A pack of Suprecur Nasal Spray contains two individual cardboard boxes wrapped in a clear plastic outer. Each box contains 1 bottle of solution and a spray pump.

Buserelin is one of a class of medicines called LHRH analogues. It works by decreasing the production of sex hormones.

Why use Suprecur Nasal Spray?

Suprecur Nasal Spray is used to treat endometriosis and also as part of a treatment for infertility.

Before taking your medicine

Tell your doctor:

• if you are pregnant or breast feeding as Suprecur Nasal Spray should not be taken under such circumstances. Take a pregnancy test if there is a possibility that you may be pregnant.
• if you have diabetes or are taking any medication for diabetes. The control of your diabetes may be affected.
• if you have high blood pressure
• if you suffer from depression
• if you are taking any other medicines
• if you have had problems with this or other medicines in the past
• if you suffer from hypersensitivity to any of the ingredients in the product, in particular buserelin, LHRH or benzalkonium chloride
• if you have unusual bleeding between periods
• if you have a tumour (as some types may mean you should not take buserelin)

If you are being treated for endometriosis, tell your doctor if you are using oral contraceptives (the pill). You should change to another (barrier) form of contraceptive during treatment with Suprecur Nasal Spray.

Alongside treatment with Suprecur Nasal Spray, you may be given other hormones called gonadotrophins. This combination may cause an increased risk of Ovarian Hyperstimulation Syndrome (OHSS), compared with the use of gonadotrophins alone. The symptoms of OHSS are listed under 'What undesirable effects may Suprecur Nasal Spray cause?'

If you feel dizzy or drowsy after taking this medicine, do not drive or operate machinery.

This medicine is intended for the use in women, however, there is another dosage which may be used in men. Men should not use either dosage if they have had their testes removed.

How should I use Suprecur Nasal Spray?

Follow your doctor's advice about when and how to use your medicine and read the label and leaflet. Your pharmacist may also help if you are not sure. You should start treatment on the first or second day of your period.

The usual dose for the treatment of endometriosis is two sprays (one into each nostril) three times a day. This is best taken in the morning, at mid-day and in the evening. The usual duration of treatment of endometriosis is six months.

For use as part of infertility treatment the usual dose is one spray (in one nostril only) four times a day for about two to three weeks. Some clinics use higher doses. As part of this treatment, you may also be given gonadotrophins, hCG or progesterone if appropriate.

It is very important to use Suprecur Nasal Spray at regular intervals throughout the waking hours.

You can continue to use Suprecur Nasal Spray if you have a cold. Blow your nose well before using the spray. If you are using a nasal decongestant do not use the decongestant for at least 30minutes after you have used Suprecur Nasal Spray.

If you miss a dose of Suprecur Nasal Spray, take another as soon as you remember unless it is nearly time for your next dose. Never double-up on the next dose to make up for the one you missed.

If you take too much Suprecur Nasal Spray tell your doctor as soon as possible.

Suprecur Nasal Spray is not suitable for children or those who have already been through the menopause or 'change of life'.

How to use the spray bottle.

• 1. Remove spray cap from bottle.
• 2. Remove metered dose nebulizer from transparent plastic container and take off both protective caps.
• 3. Screw nebuliser on to bottle.
• 4. Before first application only, pump 5'8 times, holding bottle vertical, until the solution has filled the system and a uniform spray is emitted. The preliminary pumping is for the purpose of filling the system and testing the spray. It must not be repeated after the first use, in order to avoid wasting the contents.
• 5. Keeping the bottle vertical and bending head over it slightly, spray solution into nose. If necessary the nose should be cleaned before applying the solution.
• 6. After use leave nebulizer on bottle. After replacing protective cap, spray bottle is best stored in its transparent container in an upright position.

What undesirable effects may Suprecur Nasal Spray cause?

Any medicine can have side-effects.

You will probably have a period during the first few weeks of treatment. After this your periods will probably stop, although some people may bleed again.

You may notice symptoms such as hot flushes, sweating or you may have a dry vagina, decreased interest in sex or find intercourse painful.

Cysts (swellings) can sometimes occur in the ovaries during treatment with buserelin but do not interfere with treatment.

You may develop Ovarian Hyperstimulation Syndrome (OHSS). The symptoms of this are back pain, sickness, diarrhoea, difficulty in breathing, reduced urine excretion, pain and/or swelling in the lower abdomen and changes in blood, increasing the likelihood of blood clots.

During long term treatment the amount of calcium in bone may decrease. Most of the calcium is regained when treatment is stopped.

Some people find that the nasal spray irritates the nose and may even cause nosebleeds, make you feel hoarse or disturb your sense of taste and smell. If you have any problems tell your doctor. Long term use of this product could lead to development of pituitary adenoma (a tumour of part of the brain). This does not commonly cause problems but if you have persistent headaches or changes in your vision then consult your doctor.

Other side effects which may also occur include:

• headaches, palpitations, pins and needles, feeling dizzy, tired, nervous, drowsy, depressed, anxious or emotional; have disturbed sleep or lapses in memory or concentration.
• have a problem with hearing or seeing, ringing in ears, dryness of the eyes (possibly with irritation in contact lens users), or have a feeling of pressure behind the eyes
• stomach pain or upsets (eg. feel or be sick, constipation, diarrhoea), feeling thirsty or changes in weight and/or appetite.
• breast tenderness, or changes in the size of the breast, lactation, splitting nails, spots, dry skin or vaginal discharge.
• swelling of the face and extremities (arms and legs)
• discomfort or pain (including shoulder pain or stiffness) in the muscles or skeletal system.
• shortness of breath.
• asthma.
• reddening of the skin, itchy rash or increase or decrease in scalp or body hair.
• increase in blood pressure levels if you already suffer from high blood pressure.
• increase in blood glucose levels if you suffer from diabetes.
• changes in certain components of your blood (lipids or white blood cells and platelets) which may lead to blood test abnormalities and/or bruising.
• increase in the enzymes produced in your liver which may lead to liver test abnormalities.
• you may notice that you are more prone to catching infections which could lead to symptoms such as a cold or sore throat.

If you suffer from any of these symptoms, feel unwell after using the spray, or notice anything unusual or unexpected, tell your doctor.

How should I store Suprecur Nasal Spray?

Store your nasal spray between 2C and 25C. Do not freeze it. Do not use it past the expiry date on the bottle.

One bottle has enough solution to last two weeks if you are being treated for endometriosis at the usual dose. You should stop using a bottle at the end of two weeks and start a new bottle. If you are using Suprecur Nasal Spray as part of an infertility treatment the one bottle can be used for up to five weeks after first opening.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Your medicine could harm them.

If your doctor decides to stop the treatment, return any leftover spray to your pharmacist so that it can be disposed of safely. Only keep it if your doctor tells you to.

Remember this medicine is for you. Only a doctor can prescribe it for you. Never give it to other people. It may harm them, even if they have the same symptoms as you.