DBL™ Phenytoin Injection

DBL™ Phenytoin Injection

Active ingredient(s): phenytoin (FEN-i-toyn)

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Consumer Medicine Information (CMI)

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

Where to find information in this leaflet:

1. Why am I being treated with DBL Phenytoin Injection?
2. What should I know before treatment with DBL Phenytoin Injection?
3. What if I am taking other medicines?
4. How is DBL Phenytoin Injection given?
5. What should I know during treatment with DBL Phenytoin Injection?
6. Are there any side effects?
7. Product details

1. Why am I being treated with DBL Phenytoin Injection?

DBL Phenytoin Injection contains the active ingredient phenytoin. DBL Phenytoin Injection 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.

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

DBL Phenytoin Injection is also used to help prevent seizures during or after brain surgery.

It may also be used to treat a rapid or irregular heartbeat.

Your doctor may have prescribed it for another reason.

Ask your doctor if you have any questions about why it has been prescribed for you.

There is no evidence that DBL Phenytoin Injection is addictive.

2. What should I know before treatment with DBL Phenytoin Injection?

Warnings

You must not be given DBL Phenytoin Injection if:

1. you are allergic to phenytoin, or to a group of medicines called hydantoins or any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction 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.

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

2. you have or have had certain types of irregular heartbeat conditions.
3. you are taking delavirdine, a medicine used in the treatment of HIV infection.

If you are not sure whether you should be given DBL Phenytoin Injection, talk to your doctor or pharmacist.

Check with your doctor if you:

• have allergies to:
  – any other medicines, especially any other anticonvulsant medicines
  – any other substances, such as foods, preservatives or dyes.
• have or have had any other medical conditions, especially the following:
  – depression
  – a lowered resistance to disease
  – thoughts of suicide or self-harm
  – liver problems
  – heart problems
  – low blood pressure
  – diabetes
  – kidney problems
  – a rare blood pigment disorder called porphyria
  – lymphadenopathy, a condition of the lymph glands
  – hypoalbuminaemia, a decrease in albumin in the blood, causing water retention
  – a severe skin disorder called Stevens Johnson syndrome
  – toxic epidermal necrolysis, a severe skin reaction with painful red areas which blister and peel
  – anticonvulsant hypersensitivity syndrome, which results in fever, rash and hepatitis.
• take any medicines for any other condition

If you have not told your doctor about any of the above, tell them before you are given this medicine.

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.

DBL Phenytoin Injection may affect your developing baby if you are given it during pregnancy. However, it is very important to control your fits while you are pregnant. If it is necessary for you to be given this medicine, your doctor can help you decide whether or not you should be given it during pregnancy. Phenytoin 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.

DBL Phenytoin Injection passes into breast milk; therefore, there is a possibility that the breastfeed baby may be affected.

If there is a need to consider using this medicine while you are breastfeeding, your doctor will discuss with you the benefits and risks of you being given it.

3. What if I am taking other medicines?

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 DBL Phenytoin Injection and affect how it works. These include:

• medicines used to treat infections such as amphotericin B, chloramphenicol, doxycycline, erythromycin, fluoroquinolones (such as ciprofloxacin), isoniazid, praziquantel, rifampicin, sulfadiazine, sulfamethoxazole-trimethoprim, tetracycline, fluconazole, voriconazole, posaconazole, albendazole, itraconazole, ketoconazole and miconazole
• medicines used to treat HIV infection including delavirdine, amprenavir, efavirenz, lopinavir/ritonavir, indinavir, nelfinavir, ritonavir, saquinavir, and fosamprenavir
• medicines used to prevent blood clots such as warfarin, apixaban, dabigatran, edoxaban, rivaroxaban and ticagrelor
• disulfiram, a medicine used to treat alcohol dependency
• benzodiazepines, medicines used as sedatives or to treat mental disorders such as anxiety (e.g. chlordiazepoxide and diazepam)
• medicines used to treat mental disorders such as clozapine, haloperidol, phenothiazines and thiothixene
• methylphenidate used to treat ADHD (Attention Deficit Hyperactivity Disorder)
• anticonvulsants, medicines used to treat epilepsy such as barbiturates, carbamazepine, phenobarbital, ethosuximide, lamotrigine, primidone, topiramate, oxcarbazepine, valproate, valproic acid, lacosamide and vigabatrin
• medicines used to treat depression such as tricyclic antidepressants, MAO inhibitors, trazodone and serotonin reuptake inhibitors (such as fluoxetine, sertraline and paroxetine)
• hormones such as oestrogens in hormone replacement therapy and oral contraceptives
  Your doctor may advise you to use an additional method of contraception while you are given DBL Phenytoin Injection. You should use effective contraception advised by your doctor during treatment and for one month after stopping treatment.
• muscle relaxants or general anaesthetics (e.g. halothane, cisatracurium and rocuronium), medicines used during an operation
• medicines used to manage heart and blood pressure problems such as, beta blockers, calcium channel blockers, diazoxide, digoxin, disopyramide, dopamine, lignocaine, mexiletine, amiodarone, diltiazem, nifedipine, ticlopidine, nimodipine, quinidine and verapamil
• medicines used to treat cancer such as bleomycin, carboplatin, carmustine, cisplatin, dacarbazine, methotrexate, vinblastine, calcium folinate, doxorubicin, fluorouracil and capecitabine
• some vitamins such as folic acid and vitamin D
• medicines used to treat cholesterol levels such as atorvastatin, simvastatin and fluvastatin
• medicines used to treat stomach ulcers such as cimetidine, omeprazole, ranitidine and sucralfate
• theophylline a medicine used to treat asthma
• medicines used to treat immune conditions such as ciclosporin and corticosteroids
• some pain relievers such as salicylates, azapropazone and phenylbutazone
• L-dopa, a medicine used to treat Parkinson’s disease
• frusemide, a medicine used to treat fluid retention
• medicines used to treat diabetes, such as tolbutamide and glibenclamide
• methadone, a medicine used to control severe pain or treat opioid dependence
• St John’s Wort (hypericum perforatum)
• medicines used in organ transplant such as tacrolimus.

These medicines may be affected by DBL Phenytoin Injection or may affect how well it works. You may need different amounts of your medicine, or you may need to take/use different medicines. Your doctor or pharmacist will advise you.

Your doctor and pharmacist may have more information on medicines to be careful with or avoid while you are being given this medicine.

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

4. How is DBL Phenytoin Injection given?

How much is given

Your doctor will decide what dose you will receive. This depends on your condition and other factors, such as your weight.

How it is given

DBL Phenytoin Injection is given as a slow injection into a vein. It must only be given by a doctor or nurse.

How many injections will you need

This medicine helps control epilepsy, but will not cure it. Therefore, you may need regular injections. Your doctor will decide how long you should continue to be given DBL Phenytoin Injection.

Treatment with phenytoin should not be stopped suddenly.

If you are given too much DBL Phenytoin Injection

As DBL Phenytoin Injection is given to you under the supervision of your doctor, it is very unlikely that you will receive too much.

However, if you think that you have been given too much DBL Phenytoin Injection and/or if you experience severe side effects, you should immediately:

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

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

Symptoms of an overdose include the side effects listed below in Section 6. Are there any side effects? but are usually of a more severe nature.

Ask your doctor or pharmacist if you have any concerns.

5. What should I know during treatment with DBL Phenytoin Injection?

Things you should do

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.

• have any thoughts of suicide or self harm, or other mental/mood changes
  Antiepileptic drugs, including phenytoin increase the risk of suicidal thoughts or behaviour in patients taking these drugs. You should be careful of worsening depression, suicidal thoughts or behaviour, and/or any unusual changes in mood or behaviour.

You should use effective contraception advised by your doctor during treatment and for one month after stopping treatment.

Call your doctor straight away if you become pregnant or think you may be pregnant.

Your doctor will check your progress and may want to take some tests from time to time. This helps to prevent unwanted side effects.

Remind any doctor, nurse, pharmacist or dentist you visit that you are using DBL Phenytoin Injection.

Things you should not do

Do not stop treatment of this medicine suddenly without checking with your doctor.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how DBL Phenytoin Injection affects you.

As with other anticonvulsant medicines, DBL Phenytoin Injection may cause dizziness, lightheadedness and tiredness in some people. Make sure you know how you react to this medicine before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed. If this occurs do not drive. If you drink alcohol, dizziness or lightheadedness may be worse.

Drinking alcohol

Tell your doctor if you drink alcohol.

Your doctor may suggest you avoid alcohol while you are being treated with this medicine.

Drinking alcohol while using this medicine can make you more sleepy, dizzy or light-headed.

6. Are there any side effects?

This medicine helps most people with epilepsy, but it may have unwanted side effects in a few people. All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. Many of the side effects occur only with long term treatment with phenytoin. 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.

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

Side effects

Side effects

What to do

Administration site reactions pain or redness at the injection site Nervous system related issues drowsiness or feeling tired sleeplessness dizziness or light-headedness headache weakness, unsteadiness when walking, reduced coordination muscle twitching trembling hands confusion slurred speech Changes in behaviour, thinking or mood nervousness, excitement, irritability or stuttering Gastrointestinal-related issues stomach pain nausea or vomiting loss of appetite loss of weight loss of taste difficulty in swallowing constipation Changes in skin, hair and mouth bleeding, tender or enlarged gums enlargement of facial features including thickening of lips raised, red, skin discoloration or rash excessive hairiness Eye-related issues uncontrollable jerky eye movements blurred vision Reproductive system issues sexual disturbances, such as painful erection breast enlargement in males

Speak to your doctor if you have any of these side effects and they worry you. These side effects are usually mild.

Serious side effects

Serious side effects

What to do

Administration site reactions swelling, discolouration and pain below the injection site Changes in behaviour thinking or mood depression thoughts of suicide or self-harm unusual changes in mood or behaviour Nervous system-related issues sudden onset of uncontrollable muscle spasms affecting the eyes, head, neck and body numbness or weakness of the arms or legs Liver problems persistent nausea or vomiting loss of appetite, generally feeling unwell itching yellowing of the skin and/or eyes dark coloured urine, light coloured bowel motions, pain in the abdomen Sudden allergic reaction symptoms rash, itching or hives swelling of the face, lips tongue or other parts of the body shortness of breath, wheezing or difficulty breathing Severe skin reaction symptoms severe skin rash, itching, hives, blisters or peeling skin, which may be accompanied by: – fever, chills, headache, swollen glands, stomach pain, sore mouth, inflammation of the eye or penis, hayfever, aching joints and muscles swelling and redness of the skin with small pus-filled spots or painful lumps under the skin with a fast heartbeat, fever and weight loss Respiratory-related issues difficulty breathing, wheezing, chest congestion, cough and phlegm Heart and blood-related issues changes in heartbeat, sometimes with fainting low blood pressure shortness of breath, swelling of feet and ankles and face, weight increase due to fluid build-up tiredness, headache, shortness of breath when exercising, chest discomfort, dizziness, lethargy or pale skin fever, sore throat, swollen glands, mouth ulcers, unusual bleeding or bruising under the skin Bone-related issues bone fracture

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

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

Other side effects not listed here may occur in some people.

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 treatment with any of your medicines.

7. Product details

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

What DBL Phenytoin Injection contains

Active ingredient (main ingredient)	Phenytoin sodium
Other ingredients (inactive ingredients)	Propylene glycol Ethanol absolute Water for injections Sodium hydroxide Hydrochloric acid

DBL Phenytoin Injection does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

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

What DBL Phenytoin Injection looks like

DBL Phenytoin Injection is available in 2 strengths:

• 100 mg/2 mL, 5 x 2 mL ampoules (AUST R 46942)
• 250 mg/5 mL, 5 x 5 mL ampoules (AUST R 46943)

How is DBL Phenytoin Injection stored

DBL Phenytoin Injection will be stored in the pharmacy or on the ward. The injection is kept in a cool dry place, protected from light, where the temperature stays below 25°C.

Who distributes DBL Phenytoin Injection

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizermedinfo.com.au

This leaflet was prepared in July 2023.

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© Pfizer Australia Pty Ltd 2023