DILANTIN^®

Active ingredient(s): Phenytoin sodium or Phenytoin

This leaflet provides important information about using DILANTIN. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about taking DILANTIN.

Where to find information in this leaflet:

1. Why am I taking DILANTIN?
2. What should I know before I take DILANTIN?
3. What if I am taking other medicines?
4. How do I take DILANTIN?
5. What should I know while taking DILANTIN?
6. Are there any side effects?
7. Product details

DILANTIN contains the active ingredient phenytoin sodium or phenytoin. DILANTIN belongs to a group of medicines called anticonvulsants. These drugs are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen.

DILANTIN is used to control epilepsy. Epilepsy is a condition where you have repeated seizures (fits). There are many different types of seizures, ranging from mild to severe.

DILANTIN is also used to help prevent seizures occurring during or after brain surgery. DILANTIN may be used alone, or in combination with other medicines, to treat your condition. Your doctor may have prescribed DILANTIN for another reason. Ask your doctor if you have any questions about why DILANTIN has been prescribed for you. There is no evidence that DILANTIN is addictive.

Warnings

Do not take DILANTIN if:

• you have an allergy to:
  - phenytoin sodium or phenytoin, the active ingredients in DILANTIN or other hydantoin medicines
  - methylphenobarbitone or any other barbiturate medicines
  - other medicines used to treat fits and convulsions
  - any of the ingredients listed at the end of this leaflet.
  Symptoms of an allergic reaction to DILANTIN may include:
  - shortness of breath, wheezing or difficulty breathing
  - swelling of the face, lips, tongue or other parts of the body
  - rash, itching or hives on the skin.
• you are taking delavirdine, a medicine used in the treatment of HIV infection.
• packaging is torn or shows signs of tampering.

Always check the ingredients to make sure you can take this medicine.

If you are not sure whether you should start taking DILANTIN, talk to your doctor or pharmacist.

Check with your doctor if you:

• have allergies to any other medicines, especially barbiturates or any other anticonvulsant medicines, any other substances such as foods, preservatives or dyes.
• have any other medical conditions
  - liver problems
  - heart problems
  - diabetes
  - high blood sugar levels
  - lymphadenopathy, a condition of the lymph glands
  - Systemic Lupus Erythematosus
  - porphyria, a rare blood pigment disorder
  - hypoalbuminaemia, a decrease in serum albumin in the blood, causing water retention
  - hypersensitivity syndrome, which results in fever, rash, blood disorders and hepatitis
  - a severe skin disorder called Stevens Johnson syndrome
  - toxic epidermal necrolysis, a severe skin reaction with painful red areas, which blister and peel.
• take any medicines for any other condition

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant. It is very important to control your fits while you are pregnant. Your doctor can help you decide if it is necessary for you to take DILANTIN during pregnancy. DILANTIN has been known to cause abnormalities and malignancies in the newborns, delaying their growth and causing other harmful side effects.

Talk to your doctor if you are breastfeeding or intend to breastfeed. It is not recommended to breastfeed while taking DILANTIN, as it may pass through breast milk and affect your baby. If you do breastfeed, watch your baby carefully. If your baby develops a skin rash, becomes difficult to wake or has unusual symptoms, don't breastfeed again until you speak to your doctor.

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking DILANTIN.

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with DILANTIN and affect how it works. These include:

• disulfiram, a medicine used to treat alcoholism
• other medicines used to treat fits and convulsions
• warfarin, a medicine used to prevent blood clots
• some pain relievers, such as salicylates and tramadol
• benzodiazepines, medicines used as sleeping tablets, sedatives, tranquillisers, or to treat anxiety and panic attacks
• medicines used to treat mental illness such as clozapine, phenothiazines
• medicines used to treat depression
• medicines used to lower cholesterol
• corticosteroids such as cortisone and prednisolone
• ciclosporin, a medicine used to prevent organ transplant rejection and to treat severe rheumatoid arthritis and some severe skin conditions
• some medicines used to treat cancer
• some medicines used to treat heart problems
• some antibiotics and antifungal medicines used to treat infections
• isoniazid, a medicine used to prevent and treat tuberculosis (TB)
• antiretrovirals, used in the treatment of HIV infection
• medicines used to treat parasitic worm infections
• furosemide, a diuretic (fluid tablet), which is used to reduce water retention and high blood pressure
• some medicines used to treat stomach or duodenal ulcers, such as omeprazole, sucralfate and cimetidine
• general anaesthetics and muscle relaxants, medicines used during an operation
• methadone, a medicine used to control severe pain and to treat heroin addiction
• methylphenidate, a medicine used to treat Attention Deficit Disorder
• St John's wort (Hypericum perforatum), an ingredient used in herbal medicines to treat anxiety and depression
• some medicines used to control diabetes, such as tolbutamide, glibenclamide, chlorpropamide and diazoxide
• some vitamins such as folic acid and Vitamin D
• theophylline, a medicine used to treat asthma
• estrogens, a hormone used in oral contraceptives (birth control pills) and in hormone replacement therapy. Your doctor may advise you to use an additional method of contraception while taking DILANTIN.

These medicines may be affected by DILANTIN or may affect how well it works. Your doctor will tell you if you need different amounts of your medicine, or if you need to take different medicines.

Your doctor and pharmacist may have more information on medicines to be careful with or to avoid while taking DILANTIN.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect DILANTIN.

How much to take

• Your doctor will tell you how much medicine to take each day. This may depend on your age, your condition and whether or not you are taking any other medicines.
• Your doctor may recommend that you start with a low dose of DILANTIN and slowly increase the dose to the lowest amount needed to control your epilepsy/convulsions.
• Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.
• If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

When to take DILANTIN

• DILANTIN should be taken at about the same time each day. Taking DILANTIN at the same time each day will have the best effect. It will also help you remember when to take your medicine.
• Take DILANTIN during or immediately after a meal. This will help prevent stomach upset.

How to take DILANTIN

• Capsules: swallow whole with at least half a glass of water.
  Infatabs: chew before swallowing.
  Suspension: shake the bottle well and accurately measure the dose with a medicine measure before taking it. Shaking the bottle and using a medicine measure will make sure that you get the correct dose. You can get a medicine measure from your pharmacist.
• Continue taking DILANTIN for as long as your doctor tells you to. DILANTIN helps control your condition but does not cure it. Therefore, you must take your medicine every day, even if you feel well.
• Do not stop taking DILANTIN, or lower the dosage, without checking with your doctor. Do not let yourself run out of medicine over the weekend or on holidays.
• Stopping DILANTIN suddenly may cause unwanted effects or make your condition worse. Your doctor will slowly reduce your dose before you can stop taking it completely.

If you forget to take DILANTIN

DILANTIN should be taken regularly at the same time each day.

If you miss your dose at the usual time and it is almost time for your next dose (within 4 hours), skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose you missed.

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much DILANTIN

If you think that you or anyone else may have taken too much DILANTIN, urgent medical attention may be needed.

You should immediately:

• phone the Poisons Information Centre
  (Australia telephone 13 11 26) for advice, or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

Things you should do

• Tell any other doctors, dentists, and pharmacists who are treating you that you are taking DILANTIN.
• If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking DILANTIN.
• Before you have any surgery or emergency treatment, tell your doctor or dentist that you are taking DILANTIN.
• Tell your doctor if you feel DILANTIN is not helping your condition. Your doctor may need to change your medicine.
• Tell your doctor if, for any reason, you have not taken DILANTIN exactly as prescribed. Otherwise, your doctor may change your treatment unnecessarily.
• Tell your doctor if you want to take oral contraceptives while taking DILANTIN. You may need a higher dose of oral contraceptives than usual to prevent pregnancy, or you may need to consider other forms of contraception.
• If you need to have any medical tests while you are taking DILANTIN, tell your doctor. DILANTIN may affect the results of some tests including test for thyroid function.
• Be sure to keep all of your doctor's appointments so that your progress can be checked. Your doctor will check your progress and may want to take some tests from time to time. This helps to prevent unwanted side effects.

Call your doctor straight away if you:

• Notice any of the following
  - increase in seizures (fits)
  - yellowing of the skin and/or eyes
  - swelling of the face
  - strong stomach pains
  - generally feeling unwell with tiredness, weakness and vomiting.
  These symptoms may mean that you have a serious condition affecting your liver. You may need urgent medical attention.
• If you become pregnant while taking DILANTIN
• if you have any thoughts about suicide or self-harm, any unusual changes in mood or behaviour, or you show signs of depression.
  Some people being treated with anti-epileptics such as DILANTIN have thoughts of harming or killing themselves.
  Patients and caregivers should be alert and monitor for these effects. Signs and symptoms of suicide include:
  - thoughts or talk of death or suicide.
  - thoughts or talk of self-harm or harm to others
  - any recent attempts of self-harm
  - new or increase in aggressive behaviour, irritability or agitation
  - feelings of depression.
  Mention of suicide or violence must be taken seriously. If you or someone you know is demonstrating these warning signs of suicide while taking DILANTIN, contact your doctor or a mental health professional right away.

Remind any doctor, dentist or pharmacist you visit that you are taking DILANTIN.

Things you should not do

• Do not give DILANTIN to anyone else, even if their symptoms seem similar to yours or they have the same condition as you.
• Do not take DILANTIN to treat any other complaints unless your doctor tells you to.
• Do not stop taking it unless your doctor tells you to.

Things to be careful of

Driving or using machines

Be careful before you drive or use any machines or tools until you know how DILANTIN affects you.

As with other anticonvulsant medicines, DILANTIN may cause dizziness, light-headedness, weakness, tiredness, and decreased coordination in some people.

Children should not ride a bike, climb trees or do anything else that could be dangerous if they are feeling drowsy or sleepy.

DILANTIN may cause drowsiness, dizziness or sleepiness in some people and affect alertness.

Drinking alcohol

Tell your doctor if you drink alcohol.

Be careful when drinking alcohol while taking DILANTIN.

Combining DILANTIN and alcohol can make you more sleepy, dizzy or lightheaded. Your doctor may suggest you avoid alcohol while you are being treated with DILANTIN.

Looking after your medicine

• Keep your tablets and capsules in the bottle until it is time to take them. If you take the tablets or capsules out of the bottle they will not keep well.
• Keep your medicine in a cool dry place where the temperature stays:
  - below 30°C (tablets/capsules)
  - below 25°C(syrup)

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Getting rid of any unwanted medicine.

If your doctor or pharmacist tells you to stop taking DILANTIN and you no longer need it or it is out of date, take it to any pharmacy for safe disposal.

Do not take this medicine after the expiry date (EXP) printed on the pack.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking DILANTIN.

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. Sometimes they are serious, most of the time they are not. However, some side effects may need medical attention.

If you are over 65 years of age you may have an increased chance of getting side effects.

If you get any side effects, do not stop taking DILANTIN without first talking to your doctor or pharmacist.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

If you are of African or Chinese descent or are immune-deficient you may be at a higher risk of developing some of the above mentioned serious side effects. If you belong to this portion of the population, your doctor will discuss the risks versus the benefits with you.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed above may happen in some people. Some of these side effects (for example, changes in thyroid function, structure of bones, high cholesterol or blood pressure) can only be found when your doctor does blood tests from time to time to check your progress.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

This medicine is only available with a doctor's prescription.

What DILANTIN contains

DILANTIN 100 mg capsule

DILANTIN 30 mg capsule

DILANTIN Infatab 50 mg chewable tablet

DILANTIN Paediatric Suspension 30 mg/5 mL oral liquid

Do not take this medicine if you are allergic to any of these ingredients.

What DILANTIN looks like

DILANTIN capsules 100 mg - white and orange capsules that are marked PARKE DAVIS on one side and P-D 100 on the other side. They are available in bottles of 200 capsules. (AUST R 295265)

DILANTIN Capsules 30 mg - white capsules marked PARKE DAVIS on one side and P-D 30 on the other side. They are available in bottles of 200 capsules. (AUST R 295264)

DILANTIN Infatabs 50 mg - yellow, chewable, spearmint-flavoured triangular tablets. They are marked P-D 007 on one side and a break bar on the other side. They are available in bottles of 200 tablets. (AUST R 297268) (new formulation)

DILANTIN Paediatric Suspension - a reddish-pink suspension which is available in a 500 mL bottle
(AUST R 14309)

Who distributes DILANTIN

Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

This leaflet was prepared in November 2022.

DILANTIN^® is a Viatris company trade mark

DILANTIN_cmi\Nov22/00

Published by MIMS January 2023