Synarel

• Before you start this treatment, read the manufacturer's printed information leaflet from inside your pack. The leaflet will give you more information about nafarelin spray, and a full list of side-effects which you may experience from using it.
• Your doctor will tell you how many sprays to use, and whether you should use it in one or both nostrils. This will depend upon the reason why you are using it, so follow the instructions you are given. If you are unsure about how or when to use the spray, ask your pharmacist to explain it to you again.
• You will be asked to start using the spray on a set day - this is often (but not always) day two of your menstrual cycle.
• It is important that you use this medicine regularly and space the doses out evenly throughout the day.
• If you sneeze straight after using the spray, the medicine may not be absorbed and work as it should. If this happens, repeat your dose.
• If you forget a dose, take it as soon as you remember unless it is almost time for your next dose; in which case, skip the missed dose and take your next dose when it is due. Do not take two doses together to make up for a forgotten dose.

How to use the spray

1. Read the instructions in the manufacturer's printed leaflet that comes with your medicine.
2. Remove the plastic cap, and the safety clip under the nozzle.
3. Before you use the spray for the first time, you must 'prime' the pump. This is so you get the right amount of medicine in each spray. Hold the bottle so that the nozzle is between two fingers, and your thumb is on the bottom of the bottle. Then aim the nozzle away from you and press your thumb upwards several times until a fine spray appears. You only need to do this the first time you use a new bottle.
4. Then, gently blow your nose to clear it. Do not be too concerned if you have a cold, as the medicine will still be absorbed. Bend your head forward a little, and put the nozzle into one of your nostrils. Hold your other nostril closed with a finger.
5. Breathe in through your open nostril and at the same time press the bottle once to release a spray. Try to aim the spray towards the back and outer side of your nostril.
6. Remove the spray and bend your head backwards for a few seconds to allow the spray to spread over the back of your nose.
7. If you have been told to use the spray in both nostrils at the same time of day, repeat steps 3 and 4 in your other nostril. If not, next time you use the spray, remember to use it in your other nostril.
8. Clean the nozzle by holding it under warm running water and gently wiping with your finger.
9. Wipe the nozzle with a clean tissue and replace the plastic cap and clip.

Synarel is part of the drug class:

• Gonadorelin

If you take too much Synarel, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Nafarelin nasal can harm an unborn baby or cause birth defects. Do not use if you are pregnant.

Do not breast-feed while using this medication.

If you are a woman, you should not use nafarelin nasal if you have abnormal vaginal bleeding that has not been checked by a doctor.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of nafarelin nasal spray in children. Nafarelin will stop having an effect on a child treated for central precocious puberty soon after the child stops using it, and puberty will advance normally.

Appropriate studies have not been performed on the relationship of age to the effects of nafarelin nasal spray for the treatment of endometriosis in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of nafarelin nasal spray in geriatric patients.

Pregnancy

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amifampridine
• Amisulpride
• Bepridil
• Cisapride
• Dronedarone
• Mesoridazine
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfuzosin
• Amiodarone
• Amitriptyline
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Delamanid
• Desipramine
• Deutetrabenazine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Eribulin
• Erythromycin
• Escitalopram
• Famotidine
• Felbamate
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Granisetron
• Halofantrine
• Haloperidol
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Itraconazole
• Ivabradine
• Ketoconazole
• Lapatinib
• Levofloxacin
• Lumefantrine
• Mefloquine
• Methadone
• Metronidazole
• Mifepristone
• Mizolastine
• Moxifloxacin
• Nelfinavir
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Pimavanserin
• Pipamperone
• Pitolisant
• Posaconazole
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Ribociclib
• Rilpivirine
• Risperidone
• Ritonavir
• Sertindole
• Sevoflurane
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tizanidine
• Tolterodine
• Toremifene
• Trazodone
• Trimipramine
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voriconazole
• Vorinostat
• Zuclopenthixol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding—Should not be used in patients with this condition.

• Alcohol abuse or
• Cigarette smoking or
• Conditions that increase the chances of developing thinning bones or
• Osteoporosis (brittle bones), or history of—Increases your risk of developing osteoporosis.

• Brain tumors, history of or
• Seizures or epilepsy, history of or—Use with caution. May increase risk for seizures.

• Depression, history of or
• Mental problems, history of or
• Polycystic ovarian disease (PCOD) or
• Pituitary gland problem or
• Rhinitis (swelling or irritation of the nose)—Use with caution. May make these conditions worse.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Breast enlargement
• light vaginal bleeding between regular menstrual periods, called spotting
• longer or heavier menstrual periods
• vaginal bleeding between regular menstrual periods, called breakthrough bleeding

• Body odor
• growth of pubic hair

• Body odor
• breast enlargement
• growth of pubic hair
• light vaginal bleeding between regular menstrual periods, called spotting
• longer or heavier menstrual periods
• vaginal bleeding between regular menstrual periods, called breakthrough bleeding

• Chest pain
• rash, hives or welts, itching
• redness of the skin

• Fast or irregular heartbeat
• numbness or tingling of the hands or feet
• pain in the eyes or joints
• patchy brown or dark brown discoloration of the skin
• pelvic bloating or tenderness
• unexpected or excess milk flow from the breasts
• unusual tiredness or weakness

• Cough
• difficulty with speaking
• dizziness or lightheadedness
• double vision
• fainting
• fast heartbeat
• inability to move the arms, legs, or facial muscles
• inability to speak
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• pain, redness, or swelling in the arm or leg
• slow speech
• sweating
• troubled breathing
• vomiting
• yellow eyes or skin

• Anxiety or mental depression
• changes in vision
• cold, clammy, or pale skin
• confusion
• convulsions
• headache
• irregular heartbeats
• nightmares or unusually vivid dreams
• slow heart rate
• vomiting
• weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acne
• dandruff
• hot flashes
• increase or decrease in sexual desire
• increased hair growth, often abnormally distributed
• mood swings
• muscle pain
• oily skin
• pain during sexual intercourse
• rapid weight gain
• reduced breast size
• stopping of menstrual periods
• swelling of the feet or lower legs
• vaginal dryness

• Acne
• dandruff
• mood swings
• oily skin

• Acne
• dandruff
• hot flashes
• mood swings
• oily skin

• Breast pain
• headache (mild and transient)
• irritated or runny nose
• mental depression (mild and transient)

• Irritated or runny nose

• Irritated or runny nose
• white or brownish vaginal discharge

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Synarel.
• It may take 2 months to see the full effect.
• This medicine may cause weak bones (osteoporosis) with long-term use. Talk with your doctor to see if you have a higher chance of weak bones or if you have any questions.
• Use care if you have risks for soft, brittle bones (osteoporosis). Some of these risks include drinking alcohol, smoking, taking steroids, taking drugs to treat seizures, or having family members with osteoporosis. Talk with your doctor about your risks of osteoporosis.
• Have a bone density test as you have been told by your doctor. Talk with your doctor.
• Do not use a nose decongestant spray within 2 hours after using this medicine.
• Ovarian cysts may rarely happen in the first 2 months of therapy.
• Most of the time, Synarel stops you from having a period (menstrual bleeding). This is not a method of birth control. Use a non-hormone type of birth control like condoms to prevent pregnancy while taking this medicine.
• If you miss doses of Synarel, bleeding between cycles can happen. There may also be a chance of getting pregnant if you miss doses of this medicine. Talk with your doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking Synarel, call your doctor right away.

1. Hypersensitivity to GnRH, GnRH agonist analogs or any of the excipients in Synarel;
2. Undiagnosed abnormal vaginal bleeding;
3. Use in pregnancy or in women who may become pregnant while receiving the drug. Synarel may cause fetal harm when administered to a pregnant woman. Major fetal abnormalities were observed in rats, but not in mice or rabbits after administration of Synarel during the period of organogenesis. There was a dose-related increase in fetal mortality and a decrease in fetal weight in rats [see Pregnancy]. The effects on rat fetal mortality are expected consequences of the alterations in hormonal levels brought about by the drug. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, she should be apprised of the potential hazard to the fetus;
4. Use in women who are breast-feeding [see Nursing Mothers].

Applies to nafarelin: nasal spray

Along with its needed effects, nafarelin (the active ingredient contained in Synarel) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking nafarelin:

• Breast enlargement
• light vaginal bleeding between regular menstrual periods, called spotting
• longer or heavier menstrual periods
• vaginal bleeding between regular menstrual periods, called breakthrough bleeding

• Body odor
• growth of pubic hair

• Body odor
• breast enlargement
• growth of pubic hair
• light vaginal bleeding between regular menstrual periods, called spotting
• longer or heavier menstrual periods
• vaginal bleeding between regular menstrual periods, called breakthrough bleeding

• Chest pain
• rash, hives or welts, itching
• redness of the skin

• Fast or irregular heartbeat
• numbness or tingling of the hands or feet
• pain in the eyes or joints
• patchy brown or dark brown discoloration of the skin
• pelvic bloating or tenderness
• unexpected or excess milk flow from the breasts
• unusual tiredness or weakness

• Cough
• difficulty with speaking
• dizziness or lightheadedness
• double vision
• fainting
• fast heartbeat
• inability to move the arms, legs, or facial muscles
• inability to speak
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• pain, redness, or swelling in the arm or leg
• slow speech
• sweating
• troubled breathing
• vomiting
• yellow eyes or skin

• Anxiety or mental depression
• changes in vision
• cold, clammy, or pale skin
• confusion
• convulsions
• headache
• irregular heartbeats
• nightmares or unusually vivid dreams
• slow heart rate
• vomiting
• weakness

Some side effects of nafarelin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acne
• dandruff
• hot flashes
• increase or decrease in sexual desire
• increased hair growth, often abnormally distributed
• mood swings
• muscle pain
• oily skin
• pain during sexual intercourse
• rapid weight gain
• reduced breast size
• stopping of menstrual periods
• swelling of the feet or lower legs
• vaginal dryness

• Acne
• dandruff
• mood swings
• oily skin

• Acne
• dandruff
• hot flashes
• mood swings
• oily skin

• Breast pain
• headache (mild and transient)
• irritated or runny nose
• mental depression (mild and transient)

• Irritated or runny nose

• Irritated or runny nose
• white or brownish vaginal discharge