Zolmitriptan (Page 7 of 7)

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.

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 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 they were 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 1(888)721-7115 or visit our website at www.glenmarkpharma-us.com.

What are the ingredients in zolmitriptan tablets?

Zolmitriptan Tablets

Active ingredient: zolmitriptan

Inactive ingredients: anhydrous lactose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 8000, red iron oxide (5 mg tablet), sodium starch glycolate, titanium dioxide and yellow iron oxide (2.5 mg tablet).

Store zolmitriptan tablets at 20° to 25°C (68° F to 77°F); [see USP Controlled Room Temperature].

Protect from light and moisture. Discard when expired.

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

Manufactured by:

Glenmark Pharmaceuticals Limited.

Colvale-Bardez, Goa 403 513, India

For BluePoint Laboratories

Questions? 1 (888)721-7115

Rev 08/19

Package/Label Display Panel

Zolmitriptan Tablets, 2.5 mg

NDC 68001-249-01, 6 Unit Dose Tablets

Zolmitriptan Tablets, 2.5 mg 6 Unit Dose NDC 68001-249-01
(click image for full-size original)

Package/Label Display Panel

Zolmitriptan Tablets, 5 mg

NDC 68001-250-01, 3 Unit Dose Tablets

Zolmitriptan Tablets 5mg NDC 68001-250-01, 3 Unit Dose Tablets
(click image for full-size original)
ZOLMITRIPTAN
zolmitriptan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-249
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZOLMITRIPTAN (ZOLMITRIPTAN) ZOLMITRIPTAN 2.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL 8000
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND (biconvex) Size 7mm
Flavor Imprint Code 497
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-249-01 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68001-249-19)
1 NDC:68001-249-19 6 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (68001-249-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201779 03/13/2014
ZOLMITRIPTAN
zolmitriptan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-250
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZOLMITRIPTAN (ZOLMITRIPTAN) ZOLMITRIPTAN 5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
FERRIC OXIDE RED
POLYETHYLENE GLYCOL 8000
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color PINK Score no score
Shape ROUND (biconvex) Size 9mm
Flavor Imprint Code 498
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-250-01 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68001-250-18)
1 NDC:68001-250-18 3 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (68001-250-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201779 03/13/2014
Labeler — BluePoint Laboratories (985523874)
Establishment
Name Address ID/FEI Operations
Glenmark Generics Ltd. 677318665 ANALYSIS (68001-249), ANALYSIS (68001-250), MANUFACTURE (68001-249), MANUFACTURE (68001-250)

Revised: 01/2020 BluePoint Laboratories

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