Zolmitriptan (Page 6 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

The Zolmitriptan Nasal Spray device is a white plastic device, labeled to indicate the nominal dose. Each Zolmitriptan Nasal Spray device administers a single dose of zolmitriptan.

Zolmitriptan Nasal Spray, USP is supplied as a clear to pale yellow solution of zolmitriptan, buffered to a pH 5.0. Each Zolmitriptan Nasal Spray device contains 2.5 mg or 5 mg of zolmitriptan in a 100 μL unit dose aqueous buffered solution containing citric acid, anhydrous, USP, disodium phosphate dodecahydrate USP, benzalkonium chloride solution NF and purified water USP.

2.5 mg Zolmitriptan Nasal Spray is supplied in boxes of 6 single-use nasal spray units. (NDC 45802-606-91)

5 mg Zolmitriptan Nasal Spray is supplied in boxes of 6 single-use nasal spray units. (NDC 45802-711-91)

Each Zolmitriptan Nasal Spray single dose unit spray supplies 2.5 and 5 mg, respectively, of zolmitriptan. The Zolmitriptan Nasal Spray unit must be discarded after use.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Risk of Myocardial Ischemia and/or Infarction, Prinzmetal’s angina, Other Vasospasm-related Events, and Cerebrovascular Events

Inform patients that zolmitriptan may cause serious cardiovascular side effects such as myocardial infarction or stroke, which may result in hospitalization and even death. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms [see Warnings and Precautions (5.1, 5.2, 5.4, 5.5)].

Medication Overuse Headache

Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache, and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) [see Warnings and Precautions (5.6) ].

Serotonin Syndrome

Inform patients about the risk of serotonin syndrome with the use of zolmitriptan or other triptans, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) [see Warnings and Precautions (5.7) ].

Pregnancy

Advise patients to notify their healthcare provider if they are pregnant or plan to become pregnant.

Lactation

Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.2) ].

Handling of Zolmitriptan Nasal Spray device

The Zolmitriptan Nasal Spray device is a white plastic device, labeled to indicate the nominal dose. The device is packaged in individual plastic packs and supplied in boxes of 6 single-use nasal spray devices. Caution patients to not remove the device from the plastic pack prior to dosing. The Zolmitriptan Nasal Spray device is placed in a nostril and actuated to deliver a single dose. Caution patients to avoid spraying the contents of the device in their eyes.

Made in Israel

Manufactured By Perrigo

Yeruham, Israel

Distributed By Perrigo

Allegan, MI 49010

www.perrigorx.com

Rev 11-20

Patient Information

Zolmitriptan (zohl-mi-TRIP-tan)

Nasal Spray

Please read this information before you start taking Zolmitriptan Nasal Spray and each time you renew your prescription just in case anything has changed. Remember, this summary does not take the place of discussions with your doctor. You and your doctor should discuss Zolmitriptan Nasal Spray when you start taking your medication and at regular checkups.

What is Zolmitriptan Nasal Spray?

Zolmitriptan Nasal Spray is a prescription medicine used to treat migraine headaches with or without aura in adults and pediatric patients (12 to 17 years of age).

Zolmitriptan Nasal Spray is not for other types of headaches.

Zolmitriptan Nasal Spray is not for the prevention of migraine headaches.

It is not known if Zolmitriptan Nasal Spray is safe and effective to treat cluster headaches.

Zolmitriptan Nasal Spray is not for people with moderate or severe liver problems (hepatic impairment).

It is not known if Zolmitriptan Nasal Spray is safe and effective in children under 12 years of age.

Who should not use Zolmitriptan Nasal Spray?

Do not use Zolmitriptan Nasal Spray if you have:

•

heart problems, a history of heart problems, or problems with the electrical system of your heart

•

had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation

•

hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider.

•

narrowing of blood vessels to your legs, arms, or stomach (peripheral vascular disease)

•

uncontrolled high blood pressure

•

used certain medicines called 5-HT₁ agonists (“triptans”) such as almotriptan (AXERT®), eletriptan (RELPAX®), frovatriptan (FROVA®), naratriptan (AMERGE®), rizatriptan (MAXALT®), sumatriptan (IMITREX®), sumatriptan/naproxen (TREXIMET®); medicines that contain ergotamine, or ergot medicines such as BELLERGAL-S®, CAFERGOT®, ERGOMAR®, WIGRAINE®; dihydroergotamine like D.H.E. 45® or MIGRANAL®; or methysergide (SANSERT®) in the last 24 hours. Ask your doctor or pharmacist for a list of these medicines if you are not sure.

•

are taking a monoamine oxidase A inhibitor (MAO-A inhibitor) or you stopped taking a MAO-A inhibitor in the last 14 days. Ask your doctor if you are not sure if you take an MAO-A inhibitor such as phenelzine sulfate (NARDIL®) or tranylcypromine sulfate (PARNATE®).

•

are allergic to zolmitriptan or any of the ingredients in Zolmitriptan Nasal Spray.

See the end of this leaflet for a complete list of ingredients in Zolmitriptan Nasal Spray.

What should I tell my doctor before using Zolmitriptan Nasal Spray?

Before using Zolmitriptan Nasal Spray, tell your doctor about all of your medical conditions, including if you:

•

have high blood pressure

•

have high cholesterol

•

have diabetes

•

smoke

•

are overweight

•

are a female who has gone through menopause

•

have heart disease or a family history of heart disease or stroke

•

have liver problems

•

are pregnant or plan to become pregnant. It is not known if Zolmitriptan Nasal Spray will harm your unborn baby.

•

are breastfeeding or plan to breastfeed. It is not known if zolmitriptan passes into your breast milk. Talk to your doctor about the best way to feed your baby while using Zolmitriptan Nasal Spray.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your doctor if you take:

•

medicines used to treat mood disorders, including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs) or monoamine oxidase inhibitors (MAOIs).

•

cimetidine

How should I use Zolmitriptan Nasal Spray?

For detailed instructions, see the step-by-step instructions for using Zolmitriptan Nasal Spray at the end of this Patient Information.

•

Certain people should take their first dose of Zolmitriptan Nasal Spray in their doctor’s office or in another medical setting. Ask your doctor if you should take your first dose in a medical setting.

•

Use Zolmitriptan Nasal Spray exactly as your doctor tells you to use it.

•

Your doctor may change your dose. Do not change your dose without first talking with your doctor.

•

If your headache comes back after using one nasal spray or you only get some relief from your headache, you can use another nasal spray 2 hours after the previous nasal spray.

•

Do not use more than a total of 10 mg of Zolmitriptan Nasal Spray in any 24-hour period.

•

It is not known if it is safe and effective to use Zolmitriptan Nasal Spray for more than 4 headaches in 30 days.

•

Some people who use too much Zolmitriptan Nasal Spray may have worse headaches (medication overuse headaches). If your headaches get worse, your doctor may decide to stop your treatment with Zolmitriptan Nasal Spray.

•

If you use too much Zolmitriptan Nasal Spray, call your doctor or go to the nearest hospital emergency room right away.

•

You should write down when you have headaches and when you take Zolmitriptan Nasal Spray so you can talk to your doctor about how Zolmitriptan Nasal Spray is working for you.

What should I avoid while using Zolmitriptan Nasal Spray?

Zolmitriptan Nasal Spray can cause dizziness, weakness, or drowsiness. If you have these symptoms do not drive a car, use machinery, or do anything that needs you to be alert.

What are the possible side effects of Zolmitriptan Nasal Spray?

Zolmitriptan Nasal Spray can cause serious side effects.

Call your doctor right away if you have any of the following symptoms after using Zolmitriptan Nasal Spray:

•

Heart attack and other heart problems. Heart problems may lead to death. Stop taking Zolmitriptan Nasal Spray and get emergency medical help right away if you have any of the following symptoms of a heart attack or other heart problems:

o

discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back

o

chest pain or chest discomfort that feels like heavy pressure, squeezing, or fullness

o

pain or discomfort in your arms, back, neck, jaw, or stomach

o

shortness of breath with or without chest discomfort

o

breaking out in a cold sweat

o

feeling lightheaded

o

nausea or vomiting with any of the symptoms included above

•

stroke. Symptoms of stroke include face drooping, slurred speech, and unusual weakness or numbness.

•

changes in color or sensation in your fingers and toes (Raynaud’s syndrome)

•

stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include:

o

sudden or severe stomach pain

o

stomach pain after meals

o

weight loss

o

nausea or vomiting

o

constipation or diarrhea

o

bloody diarrhea

o

fever

•

problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include:

o

cramping and pain in your legs or hips

o

feeling of heaviness or tightness in your leg muscles

o

burning or aching pain in your feet or toes while resting

o

numbness, tingling, or weakness in your legs

o

cold feeling or color changes in 1 or both legs or feet

•

serotonin syndrome. Serotonin syndrome is a serious and life-threatening problem that can happen in people using Zolmitriptan Nasal Spray, especially if Zolmitriptan Nasal Spray is used with anti-depressant medicines called selective serotonin reuptake inhibitors (SSRIs) or selective norephinephrine reuptake inhibitors (SNRIs).

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Call your doctor right away if you have any of the following symptoms of serotonin syndrome:

•

mental changes such as seeing things that are not there (hallucinations), agitation, or coma

•

fast heartbeat

•

changes in blood pressure

•

high body temperature

•

tight muscles

•

trouble walking

•

nausea, vomiting, or diarrhea

•

increased blood pressure

•

allergic reactions. Symptoms of an allergic reaction include:

•

rash

•

hives

•

itching

•

swelling of the face, mouth throat, or tongue

•

difficulty breathing

The most common side effects of Zolmitriptan Nasal Spray are:

•

unusual taste

•

numbness

•

dizziness

•

skin sensitivity (hyperparesthesia)

These are not all the possible side effects of Zolmitriptan Nasal Spray. For more information ask your doctor or pharmacist.

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

How should I store Zolmitriptan Nasal Spray?

Store Zolmitriptan Nasal Spray at room temperature between 68°F to 77°F (20°C -25°C).

Keep Zolmitriptan Nasal Spray and all medicines out of the reach of children.

General information about the safe and effective use of Zolmitriptan Nasal Spray.

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use Zolmitriptan Nasal Spray for a condition for which it was not prescribed. Do not give Zolmitriptan Nasal Spray to other people, even if they have the same symptoms that you have. It may harm them.

This leaflet summarizes the most important information about Zolmitriptan Nasal Spray. If you would like more information, talk to your doctor. You can ask your pharmacist or doctor for information about Zolmitriptan Nasal Spray that is written for health professionals.

For more information go to www.perrigorx.com or call 1-866-634-9120.

What are the Ingredients in Zolmitriptan Nasal Spray?

Active ingredient: zolmitriptan

Inactive ingredients: anhydrous citric acid, dibasic sodium phosphate, benzalkonium chloride solution and purified water

The brands listed are the registered trademarks of their respective owners.

Made in Israel

Manufactured By Perrigo

Yeruham, Israel

Distributed By Perrigo

Allegan, MI 49010

www.perrigorx.com

Rev 11-20