Zolmitriptan (Page 6 of 7)

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).
Myocardial Ischemia and/or Infarction, Prinzmetal’s Angina, Other Vasospastic Reactions, and Cerebrovascular Events

Inform patients that zolmitriptan may cause serious cardiovascular adverse reactions such as myocardial infarction or stroke, which may result in hospitalization and even death. Although serious cardiovascular reactions can occur without warning symptoms, instruct patients to be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and instruct them to ask for medical advice when observing any indicative sign or symptoms. Instruct patients to seek medical advice if they have symptoms of other vasospastic reactions [see Warnings and Precautions (5.1, 5.2, 5.4, 5.5)].
Medication Overuse Headache

Inform patients that use of drugs to treat acute migraines 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)].

Patient Information

Zolmitriptan Tablets, USP
(zole” mi trip’ tan)

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

What are zolmitriptan tablets?

Zolmitriptan tablets are a prescription medication used to treat migraine headaches in adults. Zolmitriptan tablets are not for other types of headaches. The safety and efficacy of zolmitriptan 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 does zolmitriptan tablets work?

Treatment with zolmitriptan tablets reduces swelling of blood vessels surrounding the brain. This swelling is associated with the headache pain of a migraine attack. Zolmitriptan 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 tablets.

Who should not take zolmitriptan tablets?

Do not take zolmitriptan 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 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 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 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 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 tablets will harm your unborn baby.
Tell your doctor if you are breast feeding or plan to breast feed. 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 tablets.

How should I take zolmitriptan tablets?

• Take zolmitriptan tablets exactly as your doctor tells you to take them. Your doctor will tell you how much zolmitriptan to take and when to take it.
• 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 tablets?

Zolmitriptan tablets are generally well tolerated. As with any medicine, people taking zolmitriptan tablets may have side effects. The side effects are usually mild and do not last long.
The most common side effects of zolmitriptan 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 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 tablets. In particular, this reaction may occur when they use zolmitriptan 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 tablets.

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

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 tablets

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use zolmitriptan tablets for a condition for which it was not prescribed. Do not give zolmitriptan 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 tablets. If you would like more information about zolmitriptan tablets, talk to your doctor. You can ask your doctor or pharmacist for information on zolmitriptan tablets that is written for healthcare professionals. You can also call Rising Pharma Holdings, Inc. at 1(844) 874-7464.

What are the ingredients in zolmitriptan tablets?

Active ingredient: zolmitriptan
Inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. In addition, the 2.5 mg tablets contain yellow iron oxide and the 5 mg tablets contain red iron oxide.

Store zolmitriptan tablets at 20° to 25°C (68° to 77°F) and away from children. Protect from light and moisture. Discard when expired.
The brands listed are trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited. The makers of these brands are not affiliated with and do not endorse Aurobindo Pharma Limited or its products.
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
Made in India
Code: TS/DRUGS/22/2009
Issued: 04/2021