200 micrograms/dose nasal spray, solution
nafarelin
What Synarela is and what it is used for
Nafarelin works in the body like the gonadotropin-releasing hormone that is found naturally in the body, i.e. GnRH. GnRH is formed in the brain and stimulates the pituitary gland to produce hormone er, which in turn stimulates the ovaries to produce the female sex hormones estrogen and progesterone.
Correspondingly, Synarela stimulates the ovaries to produce the female sex hormones at the beginning of the treatment, but within 2-3 weeks the production of the sex hormones ceases.
This is used in endometriosis when the endometrium has spread outside the uterus. These endometriosis foci are dependent on estrogen and progesterone and treatment with Synarela causes the endometriosis tissue to disappear or decrease. Menstruation stops temporarily but returns when the treatment ends. Treatment of endometriosis should not exceed 6 months.
Synarela is also used in connection with in vitro fertilization. Then the inhibitory effect on the ovaries is used. In this way, spontaneous ovulation and a premature formation of the corpus luteum are avoided.
What you need to know before you use Synarela
Do not use Synarela
- if you are allergic to nafarelin, GnRH, GnRH -like substances, or any other ingredient in this medicine (listed in section 6)
- if you are pregnant
- if you have abdominal bleeding and the cause has not been investigated.
Warnings and precautions
Talk to your doctor or pharmacist before using Synarela.
During treatment, you must use a non-hormonal contraceptive (condom, pessary ) to prevent pregnancy. This may seem strange if you are being treated to get pregnant but the intention is to achieve pregnancy only when treatment with Synarela is finished. Your doctor can tell you more about this.
Depression, which can be severe, has been reported in patients taking Synarela. Tell your doctor if you feel down/depressed while taking Synarela.
Using Synarela in combination with gonadotropins to treat infertility can sometimes lead to an overreaction of your ovaries (ovarian hyperstimulation syndrome, OHSS). You may have stomach pains, distended abdomen, and feel sick or vomit. If this happens, talk to a doctor. See also section 4 “Potential side effects”.
Other medicines and Synarela
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those without a prescription.
If you use mucosal decongestant nasal drops or nasal spray, e.g. for a cold or allergy, you must take these at least half an hour after spraying Synarela.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Limited experience of use during pregnancy. There is a risk that the fetus will be affected. Synarela should therefore not be used during pregnancy.
It is unknown whether Synarela passes into breast milk.
Driving ability and use of machinery
No effects have been observed.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects . Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
How to use Synarela
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The dose is determined by the doctor, who adjusts it individually for you.
Never change the prescribed dose yourself without consulting your doctor.
If you sneeze during or immediately after spraying with Synarela, the dose may be too low. You should therefore spray an additional dose in these cases for safety reasons.
Endometriosis: Treatment begins on the 2nd or 4th day of the menstrual cycle. The recommended dose is 1 spray in one nostril in the morning and 1 spray in the other nostril in the evening, i.e. a total of 2 sprays per day, for 6 months.
Pretreatment for in vitro fertilization: Recommended dose is 1 spray in each nostril morning and evening, i.e. a total of 4 sprays per day.
Important advice when using Synarela spray bottle
- The pump should produce a fine spray cloud, which can only happen through a quick and firm pressure. It is normal to see some larger liquid droplets in the fine cloud. But if the spray dose comes out as a thin jet of liquid instead of a fine cloud, the spray is not working and you should contact the pharmacy for help.
- Make sure to clean the spray tip after activation (at the time of first use). The spray tip must then be cleaned before and after each use. If the tip is not cleaned, it can cause it to become clogged, which may mean that you do not receive the correct amount of the medicine prescribed for you. Always replace the safety clip and protective cap on the spray tip after use to prevent tip clogging.
- The pump is designed to deliver only a predetermined amount of medication, no matter how hard you push.
- Avoid making the small hole in the spray tip larger. If the hole in the spray tip is made larger, an incorrect dose of Synarela will be delivered.
Activate the spray pump: Before using a Synarela bottle for the first time, you must activate the spray bottle. You only need to do this once, before taking the first dose .
1. Remove and save the safety clip and protective cap to expose the spray tip. Hold the bottle upright, pointing away from you with two fingers on the “shoulders” and the thumb against the bottom of the bottle.
2. Activate the pump by pressing several times strongly and evenly until the spray dose comes as a fine, even jet. This usually requires 5-7 pushes. It is not necessary to activate the pump again at the next use. You will waste your medicine if you activate the pump every time you use it.
3. Clean the spray tip after activation:
Hold the bottle horizontally and rinse the spray tip with warm water while rubbing it with your finger or a clean, soft cloth for 15 seconds.
Do not clean the spray tip with any sharp object. This can cause the pump to deliver an incorrect dose of the spray. Do not remove the pump from the bottle as the necessary pressure in the bottle is released.
Wipe the spray tip with a clean, soft cloth or tissue.
Use:
1. Pinch gently to clear nostrils.
2. Remove and save protective cap and safety clip. Hold the bottle shown earlier.
3. Clean the spray tip. Hold the bottle horizontally and rinse the spray tip with warm water
while rubbing it with your finger or a clean, soft cloth for 15 seconds.
Do not clean the spray tip with any sharp object. This can cause the pump to deliver an incorrect dose of the spray. Do not remove the pump from the bottle as the necessary pressure in the bottle is released.
Wipe the spray tip with a clean, soft cloth or tissue.
4. Bend your head slightly forward. Hold one nostril and insert the spray tip into the other. Aim the spray tip backwards and towards the outer side of the nose.
5. Press the bottle firmly upwards between the thumb and fingers once while breathing in gently through the nostril. If your doctor has told you to take 4 sprays every day, now spray into the other nostril.
6. Remove the spray bottle from the nostril. Bend your head back for a few seconds so that the liquid spreads over the nasal mucosa.
7. Clean the spray tip. Hold the bottle horizontally and rinse the spray tip with warm water while rubbing it with your finger or a clean, soft cloth for 15 seconds.
Do not clean the spray tip with any sharp object. This can cause the pump to deliver an incorrect dose of the spray. Do not remove the pump from the bottle as the necessary pressure in the bottle is released.
Dry the spray tip with a soft towel or tissue.
It is important to clean the spray tip before and after use to prevent it from becoming clogged, which could otherwise result in you receiving an incorrect dose of the medicine.
8. Replace the safety clip and protective cap on the spray tip. This is important to prevent the spray tip from clogging.
If you have used too much Synarela
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Synarela
If you forget to take a dose at the usual time, take it as soon as you remember and then continue to take Synarela at the usual times. Do not take a double dose to make up for a missed dose .
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
Most of the side effects are a consequence of reduced hormone production.
Very common (may affect more than 1 in 10 users):
Weight gain, rapid mood swings, decreased sexual desire, headaches, hot flashes, rhinitis, acne , muscle pain, dry mucous membranes in the abdomen, reduced breast size, eczema ( seborrhea ) and edema (swelling).
Common (may affect up to 1 in 10 users):
Insomnia, weight loss, osteoporosis (usually returns to normal about 6 months after stopping treatment), irritated mucous membranes in the nose, depression (long-term treatment), emotional instability (long-term treatment), estrogen deficiency, reduction in the size of the mammary glands, increased sexual desire, hypersensitivity reactions (such as chest pains, breathing difficulties, hives , skin rashes and itching ), paresthesias (ant crawls), increase in blood pressure, decrease in blood pressure, premature menopause, bleeding from the uterus and increased hair growth ( hirsutism ).
Uncommon (may affect up to 1 in 100 users):
Depression (short-term treatment), emotional instability (short-term treatment), breast enlargement, ovarian cysts, hair loss ( alopecia ) and joint pain.
Rare (may affect up to 1 in 1,000 users):
Visual impairment and joint inflammation.
Has been reported (occurring in an unknown number of users):
Overproduction of the ovaries (ovarian hyperstimulation syndrome, OHSS) which can cause symptoms such as abdominal pain (mild to moderate), bloating (including fluid retention), shortness of breath, nausea, vomiting and diarrhoea.
Pneumonia and pulmonary fibrosis have been reported but the relationship with treatment with Synarela has not been demonstrated.
How to store Synarela
Always put on safety clip and protective cap after use.
Store the bottle upright at a maximum of 25 ºC.
The bottle is stored in the outer carton. Do not freeze.
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is nafarelin acetate corresponding to nafarelin 2 mg/ml.
- Other ingredients are sorbitol (stabilizer) and benzalkonium chloride ( preservative ), acetic acid, sodium hydroxide and/or hydrochloric acid (for pH adjustment) and purified water.
Appearance and package sizes of the medicine
The solution is clear, colorless to slightly yellow.
Packaging sizes: Spray bottles with dose pump of 4 ml (30 doses ), 2 x 4 ml (2 x 30 doses ) and 8 ml (60 doses ).
Pfizer AB
191 90 Sollentuna
Phone: 08-550 520 00
Email: eumedinfo@pfizer.com