Hrf 100mcg (Powder For Reconstitution For Injection)
HRF 100 mcg (Powder for Reconstitution for Injection), PL 17509/0005
leaflet text 23/12/2013
PATIENT INFORMATION LEAFLET
HRF* 100 micrograms powder for solution for injection
Gonadorelin
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What HRF is and what it is used for
2. Before you take HRF
3. How to take HRF
4. Possible side effects
5. How to store HRF
6. Further information
1. WHAT HRF IS AND WHAT IT IS USED FOR
This product’s full name is HRF* 100 micrograms powder for injection. In this leaflet it is referred to as HRF.
The powder in the vial contains 100 micrograms of the active ingredient gonadorelin as gonadorelin hydrochloride and lactose monohydrate.The powder is dissolved in 1 ml of sterile water for injections before use.
Gonadorelin is a synthetically produced hormone which is the same as a naturally occurring hormone (LH/FSH-RH).
HRF is used to help check whether the hormones called luteinising hormone (LH) and follicle-stimulating hormone (FSH), which occur naturally within the human body, are being produced and released at the correct levels.
LH stimulates egg production (ovulation) from the ovary in the female, and the hormone testosterone from the testicle, in the male. FSH stimulates the ovaries to release eggs, and the testicles to produce sperm.
2. BEFORE YOU TAKE HRF Do not take HRF if you:
• are allergic (hypersensitive) to HRF, similar medicines, or to lactose.
• are, or suspect you may be, pregnant
• are breast-feeding
Take special care with HRF
If you are in the early part of your menstrual cycle, adequate contraceptive measures should be taken.
HRF may provoke early ovulation in women. If you rely on the timing of your menstrual cycle to avoid pregnancy, then you need to be aware of this risk.
HRF injection is not recommended if you have a brain tumour called a pituitary adenoma.
Taking other medicines
You should tell your doctor if you are taking or have taken any of the following medicines:
• spironolactone (diuretic)
• steroids (such as glucocorticoids)
• oestrogens, progestogens, androgens or oral contraceptives (hormones)
• phenothiazines (psychiatric medicine)
• levodopa (Parkinson’s medicine)
• dopamine antagonist (schizophrenia medicine)
• digoxin (heart medicine)
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
If you are pregnant, likely to become pregnant or are breast-feeding, you should not receive HRF. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
HRF should not affect your ability to drive or operate machinery.
3. HOW TO TAKE HRF
HRF should be given in a hospital under the supervision of an appropriate healthcare professional. Dosage
The powder is dissolved in 1 ml of sterile water for injections before use.
HRF is given by means of a small injection under the surface of the skin or into a vein.
The doctor or nurse will take several blood samples before and after you receive the HRF injection to monitor hormone levels.
In women, the HRF injection should be given in the first week of the menstrual cycle.
If you take more HRF than you should
This is unlikely, since you will be given HRF by a healthcare professional. Large doses do not seem to produce any unwanted effects which are not seen at normal doses.
If you forget to take HRF
This is unlikely, since you will be given HRF by a healthcare professional. If you suspect that you have not been given HRF correctly then contact your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, HRF can cause side effects, although not everybody gets them.
Allergic reaction
Allergic reactions have occurred on rare occasions after several doses. These may produce a wheezing cough, a rapid heartbeat, flushing, rash, swelling, itching, redness of face, eyelids and lips, or a hard lump at the injection site.
Menstrual cycle changes
HRF may interfere with women’s menstrual cycles, causing early ovulation. If you are practising the rhythm method of contraception you should employ a barrier method of contraception for the period of treatment, or take other steps to avoid unwanted pregnancy.
HRF may cause heavy and/or prolonged menstrual periods (menorrhagia).
Rare side effects
Headaches, nausea, lightheadedness, stomach discomfort or hot flushes.
Local side effects
Occasionally, swelling, with or without pain and a rash, may occur at the point where the injection was given.
A skin rash at the point where the injection was given, or covering a wider area of skin, has sometimes been seen in situations where the injection has been given repeatedly over a long period of time.
Very rarely, pain underneath and inflammation around the site of injection with accompanying feverishness has been reported.
Reporting side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE HRF
Keep out of the reach and sight of children.
Do not use HRF after the expiry date, which is stated on the labels and carton.
Store the unopened pack below 25C.
Store the reconstituted solution in a refrigerator (2C - 8C). If unused after 24 hours it must be discarded.
Do not use HRF if you notice that the reconstituted solution is discoloured.
6. FURTHER INFORMATION
Marketing authorisation holder and manufacturer
Intrapharm Laboratories Ltd, The Courtyard Barns, Choke Lane, Cookham Dean, Maidenhead, Berkshire SL6 6PT, United Kingdom.
This leaflet was last revised in December 2013.