Details for: SYNAREL
Company: PFIZER CANADA ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02188783 | SYNAREL | NAFARELIN (NAFARELIN ACETATE) | 200 MCG / ACT | METERED-DOSE AEROSOL | NASAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
SYNAREL is used in the treatment of endometriosis, including pain relief and reduction of endometriosis lesions. The treatment is recommended for a period of 6 months only.
What it does
SYNAREL temporarily reduces estrogen in the body, thereby temporarily relieving the symptoms of endometriosis.
When it should not be used
Do not take SYNAREL if you:
- are allergic to nafarelin acetate, or any similar gonadotropin-releasing hormone (GnRH) analogue, or any of the ingredients in SYNAREL.
- are pregnant or think that you are pregnant;
- are planning to become pregnant;
- have abnormal vaginal bleeding of unknown cause;
- are breastfeeding.
What the medicinal ingredient is
Nafarelin acetate.
What the non-medicinal ingredients are
Benzalkonium chloride, glacial acetic acid, hydrochloric acid, sorbitol, sodium hydroxide, purified water.
What dosage form it comes in
Each 8 mL bottle of SYNAREL (nafarelin acetate) contains
nafarelin acetate nasal solution 2 mg/mL. Each bottle is
supplied with a metered spray pump.
The 8 mL bottle contains enough solution for 60 sprays,
enough to last 30 days using two sprays per day. After the
stated number of sprays has been delivered a small amount of
liquid may be left in the bottle. Do not try to use up that
leftover amount because you might get too low a dose, which
could interfere with the effectiveness of your treatment.
Dispose of the bottle and do not reuse
Warnings and precautions
Signs and symptoms of endometriosis can worsen at the
beginning of therapy with SYNAREL.
Menstruation should stop with use of SYNAREL. During the
first 2 months of SYNAREL use, vaginal bleeding (often
called breakthrough bleeding) may occur. This may also
occur if you miss one or more doses of SYNAREL. You
should advise your doctor or pharmacist, if regular
menstruation persists.
You must use a non-hormonal method of birth control while taking SYNAREL to prevent pregnancy. You should discuss effective non-hormonal methods of birth control with your doctor. If you think you are pregnant while taking SYNAREL, you should stop using the drug and contact your doctor immediately. SYNAREL may hurt the unborn baby.
SYNAREL is not recommended for use in a patient younger than 18 years of age.
BEFORE you use SYNAREL talk to your doctor or
pharmacist if:
- you are pregnant or think that you are pregnant
- you are planning to become pregnant
- you are breastfeeding
- you have or have family history of osteoporosis, or use drug that can reduce bone mass such as anticonvulsants, corticosteroid, or use alcohol and/or tobacco. SYNAREL can cause thinning of the bone.
Interactions with this medication
Tell your doctor and pharmacist if you are taking, have
been taking, or are planning to take any other medicines,
including non-prescription drugs.
You may use a nasal decongestant spray while you are being
treated with SYNAREL if you follow these simple rules. Use
SYNAREL first. Wait at least 30 minutes after using
SYNAREL before you use the decongestant spray.
Proper use of this medication
REMEMBER: This medication is for YOU. Never give it
to others. It may harm them even if their symptoms are
the same as yours.
Take SYNAREL as instructed by your doctor.
Usual Dose
1 spray (200mcg) in one nostril the morning and 1 spray (200
mcg) in the other nostril in the evening, about 12 hours apart.
HOW TO USE YOUR SYNAREL NASAL SPRAY UNIT
To Prime the Pump:
CAUTION: Avoid breathing in the spray during priming.
Before you use a bottle of SYNAREL nasal spray for the
first time, you have to prime the spray pump. Follow these
steps:
- Remove the safety clip and the plastic dust cover from the
spray bottle.
- Put two fingers on the "shoulders" of the spray bottle and
put your thumb on the bottom of the bottle.
- Point the tip of the bottle away from you and push the bottle -- quickly and firmly 7-10 times -- with your thumb, until a fine spray appears. Usually the spray will appear after about 7 pumps.
-
Gently blow your nose to clear both nostrils before you
use SYNAREL nasal spray.
- Remove the safety clip and plastic dust cover from the
spray bottle.
-
Bend your head forward a little and put the spray tip into
one nostril. (The tip should not reach too far into your
nose). Aim the tip toward the BACK and OUTER SIDE
of your nose.
- Close the other nostril with your finger.
- Applying pressure EVENLY to the “shoulder”,
QUICKLY AND FIRMLY pump the sprayer ONE
TIME, at the same time as you sniff in gently.
- Remove the sprayer from your nose and tilt your head backwards for a few seconds. This lets the spray spread over the back of your nose.
- Wipe tip of pump with a soft cloth or tissue after each
use. Replace the safety clip and plastic dust cover on the
spray bottle.
- Be sure to clean the spray tip after every use. Failure to do so may result in a clogged tip that could cause improper dose delivery.
- Hold bottle in horizontal position. Rinse spray tip with warm water while wiping the tip with your finger or soft cloth for 15 seconds.
- Wipe spray tip with a soft cloth or tissue to dry. Replace the safety clip and plastic dust cover on the spray bottle.
- DO NOT ATTEMPT TO CLEAN SPRAY TIP USING A POINTED OBJECT. DO NOT ATTEMPT TO DISASSEMBLE PUMP.
Overdose
Missed Dose
TREATMENT WITH SYNAREL MUST BE
UNINTERRRUPTED – WITH NO MISSED DOSES
Here are some suggestions to help you remember:
- Keep your SYNAREL in a place where you will be reminded to use it each morning and each evening;
- Keep track of each dose on a calendar;
- Make a note on your calendar on the day you start a new bottle of SYNAREL.
Side effects and what to do about them
Signs and symptoms of endometriosis can worsen at the
beginning of therapy with SYNAREL.
Your menstrual flow will decrease at the beginning of treatment,
then stop altogether later when the body’s production of
estrogens decreases.
Very common side effects are hot flashes, decreased interest
in sex, headache, vaginal dryness, mood changes, acne,
muscle pain, irritation of the tissues inside the nose, and
reduction in breast size. Common side effects are
nervousness, insomnia, dandruff, weight gain, swelling,
gastrointestinal fullness, nausea, altered taste, breast pain,
depression, excessive hair growth, dry skin, dizziness,
vertigo, pain during or after intercourse, weight loss, joint
pain, increased appetite, loss of appetite, nose bleed,
conjunctivitis, weakness, and increased interest in sex.
Uncommon side effects are incoordination, neurosis,
increased sweating, hair loss, skin discolouration, flat red
rash, enlarged breasts, herpes simplex, menstrual disorder,
cystitis, painful or difficultly urinating, loss of bladder
control, vaginal bleeding, muscle weakness, constipation,
diarrhea, gastritis, vomiting, dry nose, sinusitis, voice
alteration, ear pain, eye pain, mucous membrane disorder,
palpitation.
Ovarian hyperstimulation syndrome (excessive stimulation of
egg production in the ovaries) has also been observed.
Check with your doctor or pharmacist right away if you have
any bothersome or unusual effects while taking SYNAREL.
| Symptom / effect | Talk with your doctor or pharmacist only if severe | Talk with your doctor or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Uncommon | |||
| Drug sensitivity (shortness of breath, chest pain, urticaria, rash and pruritus) | ✔ | ✔ | |
| Vaginal hemorrhage | ✔ | ✔ | |
| Ovarian hyperstimula tion syndrome (excessive stimulation of egg production in the ovaries. Symptoms can include abdominal bloating, pain in the abdomen, weight gain, nausea, vomiting, diarrhea) | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking SYNAREL, stop taking the drug and contact your doctor or pharmacist.
How to store
Store upright between 15 - 25ºC. Protect from light and
freezing.
You should not use your medication after the expiration date
printed on the carton and label.
Keep all medications out of the reach of children. This
medication could harm them.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full Product Monograph, prepared for
Health Professionals can be found at:
http://www.pfizer.ca
or by contacting the sponsor, Pfizer Canada Inc., at 1-800-
463-6001.
This leaflet was prepared by Pfizer Canada Inc.
Last revised: 19 January 2016