PHENYTOIN SODIUM - phenytoin sodium capsule, extended release
Unichem Pharmaceuticals (USA), Inc.
----------
MEDICATION GUIDE
Extended Phenytoin Sodium Capsules USP (fen' i toin soe' dee um) |
|||||||
What is the most important information I should know about extended phenytoin sodium capsules?
1. Do not stop taking extended phenytoin sodium capsules without first talking to your healthcare provider.
|
|||||||
|
|
|
|
||||
Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. How can I watch for early symptoms of suicidal thoughts and actions?
|
|||||||
|
|
|
|||||
Call your healthcare provider even if the symptoms are mild or if you have been taking extended phenytoin sodium capsules for an extended period of time. These symptoms can be a sign of a serious allergic reaction. 4. Extended phenytoin sodium capsules ca n cause problems with your heart, including a slow heartbeat. Let your healthcare provider know right away if you have any of these symptoms:
|
|||||||
What are extended phenytoin sodium capsules?
Extended phenytoin sodium capsules are prescription medicine used to treat certain types of seizures called tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. |
|||||||
Do not take extended phenytoin sodium capsules if you:
|
|||||||
Before taking extended phenytoin sodium capsules, tell your healthcare provider about all of your medical conditions, including if you:
If you become pregnant while taking extended phenytoin sodium capsules, the level of extended phenytoin sodium capsules in your blood may decrease, causing your seizures to become worse. Your healthcare provider may change your dose of extended phenytoin sodium capsules. If you take extended phenytoin sodium capsules during pregnancy, your baby is also at risk for bleeding problems right after birth. Your healthcare provider may give you and your baby medicine to prevent this. All women of child-bearing age should talk to their healthcare provider about using other possible treatments instead of extended phenytoin sodium capsules. If you are of childbearing age and are not planning on getting pregnant, you should use effective birth control (contraception) while taking extended phenytoin sodium capsules. Pregnancy Registry: If you become pregnant while taking extended phenytoin sodium capsules, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
Taking extended phenytoin sodium capsules with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. |
|||||||
How should I take extended phenytoin sodium capsules?
|
|||||||
What should I avoid while taking extended phenytoin sodium capsules?
|
|||||||
What are the possible side effects of extended phenytoin sodium capsules?
See " What is the most important information I should know about extended phenytoin sodium capsules?" Extended phenytoin sodium capsules may cause other serious side effects including:
The most common side effects of extended phenytoin sodium capsules include: |
|||||||
|
|
|
|||||
Extended phenytoin sodium capsules can cause overgrowth of your gums. Brushing and flossing your teeth and seeing a dentist regularly while taking extended phenytoin sodium capsules can help prevent this from happening. These are not all of the possible side effects of extended phenytoin sodium capsules. 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 extended phenytoin sodium capsules?
|
|||||||
General information about the safe and effective use of extended phenytoin sodium capsules.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use extended phenytoin sodium capsules for a condition for which it was not prescribed. Do not give extended phenytoin sodium capsules to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about extended phenytoin sodium capsules that is written for health professionals. |
|||||||
What are the ingredients in extended phenytoin sodium capsules?
Extended phenytoin sodium capsules 10 0 mg: Active ingredient: phenytoin sodium Inactive ingredients: anhydrous lactose, confectioner's sugar, talc, and magnesium stearate. The empty hard gelatin capsule shells also contain gelatin, sodium lauryl sulphate, and titanium dioxide. The capsules are imprinted with edible ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac. Manufactured by: UNICHEM LABORATORIES LTD. Ind. Area, Meerut Road, Ghaziabad – 201 003, India Manufactured for: |
|||||||
East Brunswick, NJ 08816. 05-R/10/2022 13014206 For more information about extended phenytoin sodium capsules, call Unichem Pharmaceuticals (USA) Inc. at 1-866-562-4616. |
|||||||
This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 10/2022 |