CinnaFact®

What is it?

What is CinnaFact^®?

CinnaFact^® is the brand name of buserelin. It is a synthetic peptide analog of the natural GnRH with enhanced biological activity. After repeated administration of CinnaFact^®, the secretion of gonadotropin release and gonadal steroids is significantly inhibited. Each CinnaFact^® vial contains 5.5 mg of buserelin acetate as ready-to-use solution.

Indications

What is CinnaFact^® used for?

In adult women, CinnaFact^® can be used for the following:

• Treatment of endometriosis (an illness where some of the tissues that line the womb are found elsewhere in the body).
• As part of a treatment for infertility. It works by stopping the natural production of hormones that control ovulation. Synthetic hormones are then used to stimulate ovulation artificially.

In adult men, CinnaFact^® is used to treat prostate cancer by lowering the amount of testosterone.

Contraindications

Who should not use CinnaFact^®?

Do not use CinnaFact^® if:

• you are allergic (hypersensitive) to buserelin or other similar medicines such as goserelin, or any of the other ingredients of CinnaFact^®.
• you have a tumor that is not affected by changes in hormone levels
• you are a woman with abnormal menstrual bleeding
• you are a man who has had an operation to remove his testicles

Important information

What should you know about taking CinnaFact^®?

Tell your healthcare provider if you have any of the following:

Any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions. The risk of heart rhythm problems may be increased when using CinnaFact^®.

What other drugs could affect CinnaFact^®?

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because CinnaFact^® can affect the way some other medications work. Also, some medicines can change the way CinnaFact^® works.

In particular, tell your doctor or pharmacist if you are taking the following:

• Medicines for diabetes
• Oral contraceptives (the Pill or mini Pill). If you have endometriosis and are taking oral contraceptives your doctor will ask you to change to another form of contraception

CinnaFact^® might interfere with some medicines used to treat heart rhythm problems (e.g., quinidine, procainamide, amiodarone, and sotalol) or might increase the risk of heart rhythm problems when used with some other drugs (e.g., methadone, moxifloxacin, antipsychotics used for serious mental illnesses).

How to use CinnaFact^®?

Your healthcare provider will prescribe the dose that is right for you.

Is CinnaFact^® safe during pregnancy and breastfeeding?

Do not have this medicine if:

• you are pregnant, might become pregnant or think you may be pregnant. This is because CinnaFact^® may be harmful to the developing baby. Women must have a pregnancy test to make sure they are not pregnant before being given this medicine. CinnaFact^® will be stopped before you are given the hormones used to stimulate ovulation.
• you are breast-feeding or planning to breastfeed. This is because small amounts may pass into mothers’ milk

If you get pregnant during treatment, stop having this medicine and tell your healthcare provider immediately.

What happens if you miss a dose?

If you think you have missed a dose, tell your doctor or nurse. If you are injecting this medicine yourself and you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

What happens if you overdose?

If you give yourself more CinnaFact^® injection than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.

How should CinnaFact^® be used?

CinnaFact^® is injected under the skin (subcutaneous). Read the detailed Instructions for Use.

Side Effects

What are some side effects of CinnaFact^®?

Like all medicines, CinnaFact^® can cause side effects, although not everybody gets them. Tell your healthcare provider or get medical help right away if you have any of the following signs or symptoms:

Headache, decreased libido, hot flash, vaginal dryness, menorrhagia (in women), impotence (in men), back pain, and weakness.

These are not all the possible side effects of CinnaFact^®.

Storage

How to store CinnaFact^®?

• Keep CinnaFact^® out of the reach of children.
• Do not permit the product to freeze and do not expose it to sources of heat.
• Keep CinnaFact^® away from direct light.
• Do not use if the solution is cloudy, leaking, or has particles.
• CinnaFact^® should be kept at a temperature between 2°C and 25°C (36°F to 77°F).
• Do not use CinnaFact^® after the expiration date printed on the carton and the vial.
• The product can be kept up to 20 days after the first opening when stored at room temperature.