Dilantin

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

STORAGE AND HANDLING

SPL MEDGUIDE

• ●Skin rash and blisters, hives (raised bumps), fever or itching

• ●Swelling of your face, mouth, lips, gums, tongue or neck

• ●Trouble breathing

• ●Like other antiepileptic drugs, DILANTIN, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

• ●attempts to commit suicide

• ●new or worse depression

• ●new or worse anxiety

• ●feeling agitated or restless

• ●panic attacks

• ●trouble sleeping (insomnia)

• ●new or worse irritability

• ●acting aggressive, being angry, or violent

• ●acting on dangerous impulses

• ●an extreme increase activity and talking (mania)

• ●other unusual changes in behavior or mood

• ●If you have suicidal thoughts or actions, do not stop DILANTIN 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?

• ●Keep all follow-up visits with your healthcare provider as scheduled.

• ●Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

• ●Do not stop taking DILANTIN without first talking to your healthcare provider. Stopping DILANTIN suddenly can increase the possibility of side effects including increased seizure frequency.

• ●Have or had porphyria (a blood disorder)

• ●Have or had diabetes

• ●Are pregnant or plan to become pregnant. Because of the potential harm to your developing baby, DILANTIN should not be taken during pregnancy unless you are told otherwise by your healthcare provider. If you discover you are pregnant, do not suddenly stop taking DILANTIN because this may lead to serious consequences for you and your baby. If you become pregnant, you should talk to your healthcare provider immediately. You should also consider enrolling in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This registry is collecting information about the safety of the use of all antiepileptic drugs during pregnancy. To enroll, call the toll free number 1-888-233-2334.

• ●Are breast feeding. Taking DILANTIN while breast feeding it is not recommended.

• ●Consume alcohol. Alcohol drinking can increase or decrease the DILANTIN level in your blood.

• ●Have or had Vitamin D deficiency or any other condition that causes thinning of the bones.

• ●Receive nutrition through a feeding tube. Patients who are receiving nutrition through a feeding tube may have lower-than-expected blood levels of DILANTIN. Do not administer DILANTIN at the same time as the feeding preparation.

• ●How should I take DILANTIN?

• ●Try to take DILANTIN at the same times each day to avoid missing any doses. If you miss a dose of DILANTIN, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of DILANTIN at the same time.

• ●Tell your healthcare provider of any clinical condition (such as surgery) during which it is not possible to take DILANTIN orally as prescribed.

• ●In adults whose seizures are well controlled with divided doses of three 100-mg capsules daily, once-a-day dosing may be considered. You should discuss this possibility with your healthcare provider.

• ●Do not take capsules that are discolored.

• ●Do not stop taking DILANTIN unless your healthcare provider tells you to do so. If your treatment is stopped, it should be done gradually. If you stop taking DILANTIN suddenly or before your healthcare provider tells you, there is an increased risk of seizures.

• ●OVERDOSE

• ●The fatal dose in children is unknown.

• ●What should I avoid while taking DILANTIN?

• ●Some patients taking DILANTIN may develop a rare drug-induced syndrome called Anticonvulsant Hypersensitivity Syndrome (AHS) which is characterized by fever and along with involvement of other organs such as the lymph nodes or liver. You may have a higher risk of developing AHS if you or your family member have had experienced this syndrome in the past, if you are of black ancestry, or if your immune system is suppressed.

• ●Mood changes, distressing thoughts, or feelings about suicide.

• ●If any of the common side effects listed below become serious, or if you notice any side effects not listed in this Medication Guide, please tell your healthcare provider or pharmacist.

• ●lack of coordination

• ●slurred speech

• ●mental confusion

• ●nausea

• ●vomiting

• ●constipation

• ●rash

• ●Tell your healthcare provider about any side effect that bothers you or that does not go away.

• ●Store DILANTIN Capsules at room temperature between 68(20and 77(25in tight, light-resistant containers. Protect from moisture.

• ●General information about DILANTIN

INACTIVE INGREDIENT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION