Patient Information

Zolmitriptan (ZOLE-mi-TRIP-tan)
Orally Disintegrating Tablets, USP

Please read this information before you start taking zolmitriptan orally disintegrating tablets 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 orally disintegrating tablets when you start taking your medication and at regular checkups.

What are zolmitriptan orally disintegrating tablets?

Zolmitriptan orally disintegrating tablets are a prescription medication used to treat migraine headaches in adults. Zolmitriptan orally disintegrating tablets are not for other types of headaches. The safety and efficacy of zolmitriptan orally disintegrating tablets in patients under 18 have not been established.

What is a Migraine Headache?

Migraine is an intense, throbbing headache. You may have pain on one or both sides of your head. You may have nausea and vomiting, and be sensitive to light and noise. The pain and symptoms of a migraine headache can be worse than a common headache. Some women get migraines around the time of their menstrual period. Some people have visual symptoms before the headache, such as flashing lights or wavy lines, called an aura.

How do zolmitriptan orally disintegrating tablets work?

Treatment with zolmitriptan orally disintegrating tablets reduces swelling of blood vessels surrounding the brain. This swelling is associated with the headache pain of a migraine attack. Zolmitriptan orally disintegrating tablets block the release of substances from nerve endings that cause more pain and other symptoms like nausea, and sensitivity to light and sound. It is thought that these actions contribute to relief of your symptoms by zolmitriptan orally disintegrating tablets.

Who should not take zolmitriptan orally disintegrating tablets?

Do not take zolmitriptan orally disintegrating tablets if you:

• •Have heart disease or a history of heart disease
• •Have uncontrolled high blood pressure
• •Have hemiplegic or basilar migraine (if you are not sure about this, ask your doctor)
• •Have or had a stroke or problems with your blood circulation
• • Have serious liver problems
• • Have taken any of the following medicines in the last 24 hours: other “triptans” like almotriptan (AXERT®), eletriptan (RELPAX®), frovatriptan (FROVA®), naratriptan (AMERGE®), rizatriptan (MAXALT®), sumatriptan (IMITREX®), sumatriptan/naproxen (TREXIMET); ergotamines like BELLERGAL-S® , CAFERGOT® , ERGOMAR® , WIGRAINE®; dihydroergotamine like D.H.E. 45® or MIGRANAL®; or methysergide (SANSERT®). These medications have side effects similar to zolmitriptan orally disintegrating tablets.
• • Have taken monoamine oxidase (MAO) inhibitors such as phenelzine sulfate (NARDIL®) or tranylcypromine sulfate (PARNATE®) for depression or other conditions within the last 2 weeks.
• •Are allergic to zolmitriptan orally disintegrating tablets or any of its ingredients. The active ingredient is zolmitriptan. The inactive ingredients are listed at the end of this leaflet.

Tell your doctor about all the medicines you take or plan to take, including prescription and non-prescription medicines, supplements, and herbal remedies.

Tell your doctor if you are sensitive to phenylalanine, which can be found in the artificial sweetener aspartame. Zolmitriptan orally disintegrating tablets contain phenylalanine.

Tell your doctor if you are taking selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), two types of drugs for depression or other disorders. Common SSRIs are CELEXA® (citalopram HBr), LEXAPRO® (escitalopram oxalate), PAXIL® (paroxetine), PROZAC® (fluoxetine), SYMBYAX® (olanzapine/fluoxetine), ZOLOFT® (sertraline), SARAFEM® (fluoxetine) and LUVOX® (fluvoxamine). Common SNRIs are CYMBALTA® (duloxetine) and EFFEXOR® (venlafaxine). Your doctor will decide if you can take zolmitriptan orally disintegrating tablets with your other medicines.

Tell your doctor if you know that you have any of the following: risk factors for heart disease like high cholesterol, diabetes, smoking, obesity (overweight), menopause, or a family history of heart disease or stroke.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if zolmitriptan will harm your unborn baby.

Tell your doctor if you 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 orally disintegrating tablets.

How should I take zolmitriptan orally disintegrating tablets?

• •Take zolmitriptan orally disintegrating tablets exactly as your doctor tells you to take it. Your doctor will tell you how many zolmitriptan orally disintegrating tablets to take and when to take them.
• •If you take zolmitriptan orally disintegrating tablets, do not remove the tablet from the blister pack until you are ready to take your medicine.
• •You do not need to take any liquids with your zolmitriptan orally disintegrating tablets.
• •Take zolmitriptan orally disintegrating tablets whole.
• •Place zolmitriptan orally disintegrating tablets on your tongue, where it will dissolve.
• •Safely throw away any unused tablets or pieces of tablets that have been removed from the blister packaging.
• •If your headache comes back after your first dose, you may take a second dose any time after 2 hours of taking the first dose. For any attack where the first dose did not work, do not take a second dose without talking with your doctor. Do not take more than a total of 10 mg of zolmitriptan (tablets or spray combined) in any 24 hour period. If you take too much medicine, contact your doctor, hospital emergency department, or poison control center right away.

What are the possible side effects of zolmitriptan orally disintegrating tablets?

Zolmitriptan orally disintegrating tablets are generally well tolerated. As with any medicine, people taking zolmitriptan orally disintegrating tablets may have side effects. The side effects are usually mild and do not last long.

The most common side effects of zolmitriptan orally disintegrating tablets are:

• •pain, pressure or tightness in the neck, throat or jaw
• •dizziness
• •tingling or other abnormal sensations
• •tiredness
• •drowsiness
• •feeling warm or cold
• •nausea
• •feeling of tightness or heaviness in other areas of the body
• •dry mouth

In very rare cases, patients taking triptans may experience serious side effects, such as heart attacks, high blood pressure, stroke, or serious allergic reactions. Extremely rarely, patients have died. Call your doctor right away if you have any of the following problems after taking zolmitriptan orally disintegrating tablets:

• •severe tightness, pain, pressure or heaviness in your chest, throat, neck, or jaw
• •shortness of breath or wheezing
• •sudden or severe stomach pain
• •hives; tongue, mouth, or throat swelling
• •problems seeing
• •unusual weakness or numbness

Some people may have a reaction called serotonin syndrome, which can be life-threatening, when they use zolmitriptan orally disintegrating tablets. In particular, this reaction may occur when they use zolmitriptan orally disintegrating tablets together with certain types of antidepressants known as SSRIs or SNRIs. Symptoms may include mental changes (hallucinations, agitation, coma), fast heartbeat, changes in blood pressure, high body temperature or sweating, tight muscles, trouble walking, nausea, vomiting, and diarrhea. Call your doctor immediately if you have any of these symptoms after taking zolmitriptan orally disintegrating tablets.

This is not a complete list of side effects. Talk to your doctor if you develop any symptoms that concern you.

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

What to do in case of an overdose?

Call your doctor or poison control center or go to the nearest hospital emergency room.

General advice about zolmitriptan orally disintegrating tablets

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use zolmitriptan orally disintegrating tablets for a condition for which they were not prescribed. Do not give zolmitriptan orally disintegrating tablets to other people, even if they have the same symptoms as you. People may be harmed if they take medicines that have not been prescribed for them.

This leaflet summarizes the most important information about zolmitriptan orally disintegrating tablets. If you would like more information about zolmitriptan orally disintegrating tablets, talk to your doctor. You can ask your doctor or pharmacist for information on zolmitriptan orally disintegrating tablets that is written for healthcare professionals.

You can also call 1 (888) 721-7115 or visit our website at www.glenmarkpharma-us.com.

What are the ingredients in zolmitriptan orally disintegrating tablets?

Active ingredient: zolmitriptan

Inactive ingredients: aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor and talc. The peppermint flavor contains corn starch.

Store zolmitriptan orally disintegrating tablets at 20°C to 25°C (68°F to 77°F); [see USP Controlled Room Temperature] and away from children.

Protect from light and moisture. Discard when expired.

Other brands mentioned are trademarks of their respective owners and are not trademarks of Glenmark Pharmaceuticals Limited. The makers of these brands are not affiliated with Glenmark Pharmaceuticals Limited or its products.

Distributed by:

Glenmark Pharmaceuticals Inc., USA

Elmwood Park, NJ 07407

Questions? 1 (888) 721-7115

www.glenmarkpharma-us.com

June 2025