Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I taking Tegretol?
Tegretol contains the active ingredient carbamazepine. Tegretol is used to control
epilepsy (fits); sudden repeated attacks of face pain; mania (overactivity, excessive
happiness/irritability); bipolar mood disorder (mania alternating with depression).
For more information, see Section
1. Why am I using Tegretol? in the full CMI.
2. What should I know before I take Tegretol?
Do not use if you have ever had an allergic reaction to carbamazepine, related medicines
or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before I use Tegretol? in the full CMI.
3. What if I am taking other medicines?
4. How do I take Tegretol?
Your doctor will tell you how much Tegretol to take. Tegretol tablets may be taken
during or after meals with a little liquid.
5. What should I know while taking Tegretol?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using Tegretol.
Keep all your doctor's appointments
Tell your doctor if you become pregnant
Tell your doctor if you have thoughts of harming or killing yourself
Protect yourself from the sun - wear protective clothing and sunscreen (at least SPF
15+)
|
|
Things you should not do
|
Do not stop using this medicine suddenly.
Do not lower your dose, without checking with your doctor
Do not give your medicine to anyone else
Do not use Tegretol to treat any other complaints unless your doctor tells you to
|
|
Driving or using machines
|
Be careful before you drive or use any machines or tools until you know how Tegretol
affects you
Children should avoid riding bikes or climbing trees while taking Tegretol
|
|
Drinking alcohol
|
Do not drink alcohol or grapefruit juice
|
|
Looking after your medicine
|
Store below 30°C
Protect from moisture
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6. Are there any side effects?
Swelling in any part of the body, tiredness/sleepiness, weight increase, vomiting,
confusion, hair loss, fever, difficulty breathing, feeling sick, seizures, dry mouth,
fainting/dizziness, less coordination, trouble speaking, muscle weakness/pain, numbness
or tingling, change in sense of taste, hallucinations, depression, agitation, aggression,
eating disorder, restlessness, confusion, blurred vision, double vision, red or swelling
eye/s, vision loss and eyes appear milky, red, itchy skin or any other skin problems.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
carbamazepine
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Tegretol. 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 Tegretol.
Where to find information in this leaflet:
1. Why am I using Tegretol?
Tegretol contains the active ingredient carbamazepine. Tegretol is an anticonvulsant (medicines that prevent or reduce fits).
Tegretol is used to control epilepsy, a condition in which there are repeated seizures
(fits).
Tegretol is also used to control sudden repeated attacks of face pain (known as trigeminal
neuralgia).
Tegretol is used to control mania, a mental condition where overactivity, excessive
happiness or excessive irritability occurs.
Tegretol is also used to control bipolar mood disorder, where periods of mania alternate
with periods of depression.
2. What should I know before I use Tegretol?
Warnings
Do not use Tegretol if:
you are allergic to carbamazepine or related medicines, or any of the ingredients
listed at the end of this leaflet.
you are taking tricyclic antidepressants, which are medicines use to treat depression.
you have a blood disease where there are a low number of red or white blood cells
or platelets.
you have a condition which causes the immune system to attack its own tissues, called
SLE (Systemic lupus erythematosus).
you have an irregular heartbeat caused by a condition called A-V block.
you have hepatic porphyria, a disturbance in the production of porphyrin, a pigment
important for liver function and blood formation
you have severe liver disease
Always check the ingredients to make sure you can use this medicine.
Some symptoms of an allergic reaction may include shortness of breath, wheezing or
difficulty breathing; swelling of the face, lips, eyelids, throat, mouth, tongue or
other parts of the body; rash, itching or hives on the skin.
Check with your doctor if you:
have any other medical conditions such as blood illnesses; heart, liver or kidney
disease; prostate problems
have glaucoma
take any medicines for any other conditions
have problems with your blood caused by other medicines
have mental disorders such as depression or schizophrenia
are allergic to oxcarbazepine, the active ingredient in Trileptal, or phenytoin. These
medicines also treat Epilepsy.
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.
Talk to your doctor if you are breastfeeding or intend to breastfeed. Tegretol passes
into breast milk. If your baby develops a skin rash, becomes sleepy or has any other
unusual symptoms, do not breast feed again until you speak to your doctor.
You should avoid becoming pregnant while using Tegretol and for 2 weeks after you
stop using it.
If you are a female of child-bearing age and are taking hormonal birth control medicines
(the pill), you should use additional or different non-hormonal birth control.
Asian descent, especially Chinese or Thai
Serious skin reactions could occur in patients of Han Chinese or Thai origin.
A blood test may be required before taking Tegretol.
Monoamine oxidase inhibitors (MAOI)
Do not take Tegretol in combination with MAOIs, or within 14 days of taking MAOIs.
Combination of these medicines may cause a sudden increase in body temperature, extremely
high blood pressure and severe convulsions.
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 Tegretol and affect how it works.
Medicines that may
increase
the effect of Tegretol include:
ibuprofen
dextropropoxyphene
danazol
macrolide antibiotics (e.g. erythromycin, troleandomycin, josamycin, clarithromycin),
ciprofloxacin
possibly desipramine, fluoxetine, fluvoxamine, nefazodone, paroxetine, trazodone
vigabatrin
azoles (e.g. itraconazole, ketoconazole, fluconazole, voriconazole)
loratadine, terfenadine
olanzapine, quetiapine
isoniazid
protease inhibitors for HIV treatment (e.g. ritonavir)
acetazolamide
diltiazem, verapamil
possibly cimetidine, omeprazole
oxybutynin, dantrolene
ticlopidine
nicotinamide (in adults, only in high dosage)
levetiracetam
Medicines that may
reduce
the effect of Tegretol include:
oxcarbazepine, phenobarbital, phenytoin, primidone, progabide, clonazepam, valproic
acid or valpromide, brivaracetam
cisplatin or doxorubicin
rifampicin
theophylline, aminophylline
isotretinoin has been reported to alter the bioavailability and/or clearance of carbamazepine
and carbamazepine-10, 11-epoxide
St John's wort
Tegretol may affect how other medicines work, including:
buprenorphine, methadone, paracetamol (long term administration of carbamazepine and
paracetamol may be associated with hepatotoxicity), tramadol
doxycycline, rifabutin
ral anticoagulants (warfarin, phenprocoumon, dicoumarol, acenocoumarol, rivaroxaban,
dabigatran, apixaban, edoxaban)
bupropion, citalopram, mianserin, nefazodone, sertraline, trazodone, tricyclic antidepressants
(e.g. imipramine, amitriptyline, nortriptyline, clomipramine)
aprepitant
clobazam, clonazepam, ethosuximide, lamotrigine, eslicarbazepine, oxcarbazepine, primidone,
tiagabine, topiramate, valproic acid, phenytoin, mephenytoin
Itraconazole, voriconazole
praziquantel, albendazole
imatinib, cyclophosphamide, lapatinib, temsirolimus
clozapine, haloperidol, bromperidol, olanzapine, quetiapine, risperidone, ziprasidone,
aripiprazole, paliperidone
protease inhibitors for HIV treatment, (e.g. indinavir, ritonavir, saquinavir)
alprazolam, midazolam
theophylline
hormonal contraceptives (oestrogens and/or progesterones)
calcium channel blockers (dihydropyridine group), e.g., felodipine, digoxin, simvastatin,
atorvastatin, lovastatin, cerivastatin, ivabradine
corticosteroids (e.g. prednisolone, dexamethasone)
tadalafil
cyclosporin, everolimus, tacrolimus, sirolimus
levothyroxine
isoniazid
lithium or metoclopramide
neuroleptics (haloperidol, thioridazine)
selective serotonin re-uptake inhibitors
diuretics (hydrochlorothiazide, frusemide)
non-depolarising muscle relaxants (e.g. pancuronium)
alcohol
MAO inhibitors
direct acting oral anti-coagulants (rivaroxaban, dabigatran, apixaban, and edoxaban)
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Tegretol.
4. How do I take Tegretol?
How much to take
Your doctor will tell you how much Tegretol to take
Follow the instructions provided and use Tegretol until your doctor tells you to stop.
Tegretol is available as tablets, controlled release tablets (CR) and as a liquid.
How to take Tegretol
Tegretol tablets and Tegretol CR tablets - swallow with a full glass of water.
Tegretol CR tablets - do not crush or chew.
Tegretol liquid - shake the bottle well before measuring the dose.
When to take Tegretol
Take Tegretol during or after a meal.
Tegretol should be taken 2 or 3 times per day, according to your doctor's instructions.
If you forget to use Tegretol
Tegretol should be used regularly at the same time each day. If you miss your dose
at the usual time and it is less than 2 or 3 hours to the next dose, take your dose
as soon as you remember.
If it is almost time for your next dose (less than 2 or 3 hours to your next dose),
skip the dose you missed and take your next dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you use too much Tegretol
If you think that you have used too much Tegretol, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), 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.
5. What should I know while taking Tegretol?
Things you should do
Keep all your doctor's appointments.
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are using Tegretol.
Remind any doctor, dentist or pharmacist you visit that you are using Tegretol.
Call your doctor straight away if you:
become pregnant
have thoughts about harming or killing yourself - all thoughts of suicide should be
taken seriously
Things you should not do
Do not stop using this medicine suddenly. This may worsen your fits.
Do not lower your dose without first checking with your doctor.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not use Tegretol to treat any other complaints unless your doctor tells you to.
Protection from sun
Tegretol makes your skin more sensitive to sunlight. Wear protective clothing and
sunscreen (at least SPF 15+) when outdoors. It may cause a skin rash, itching, redness
or severe sunburn.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Tegretol
affects you.
Tegretol may cause dizziness in some people. Tegretol can make you feel sleepy, cause
you to have blurred vision, double vision or lower your coordination.
Children should avoid riding bikes or climbing trees while taking Tegretol.
Drinking alcohol
Do not drink alcohol while taking Tegretol.
This could cause sleepiness, dizziness or light-headedness.
Drinking grapefruit juice
Do not drink grapefruit juice while taking Tegretol.
Looking after your medicine
Protect from moisture
Store below 30°C
Follow the instructions on the carton on how to take care of your medicine properly.
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 windowsills.
Keep it where young children cannot reach it.
When to discard your medicine
Discard if it has passed the expiry date.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
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
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Less serious side effects
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What to do
|
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General effects:
tiredness/sleepiness
dry mouth
hair loss
loss of appetite
change in sense of taste
Stomach effects:
feeling sick
vomiting
Hormone/gland effects:
swelling/ fluid retention
weight increase
nausea and vomiting, confusion, seizures, or fainting
Spinal cord and brain effects:
reduced muscle coordination/control
sleepiness
headaches
abnormal involuntary movements (e.g. tics, twitching, twisting, squirming)
involuntary eye, mouth or face movements
slurred speech, difficulty speaking
weakness, pain, numbness or tingling
burning or prickling sensation normally in hands, arms, legs, feet
Mood and behaviour effects:
hallucinations
depression
aggression
agitation
eating disorder
restlessness
Eye effects:
blurred vision
conjunctivitis
double vision
vision loss and eyes appearing milky
Hearing effects:
hearing problems
Skin effects:
dermatitis, itchy red skin
skin shedding
acne
skin discolouration
tender red lumps
bleeding
Muscle/bone effects:
muscle weakness, paralysis
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
Serious side effects
Some side effects can only be found when your doctor does tests from time to time
to check your progress. These include:
Higher levels of liver enzymes
Changes to your blood cells count, lipids and electrolytes
Changes to the health of your eyes
Abnormal thyroid function
Heart function changes
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
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Tegretol 100 mg or 200 mg tablets contain
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Active ingredient
(main ingredient)
|
carbamazepine
|
|
Other ingredients
(inactive ingredients)
|
cellulose-microcrystalline
carmellose sodium
silica-colloidal anhydrous
magnesium stearate
|
|
Potential allergens
|
None
|
What Tegretol CR 200 mg or 400 mg tablets contain
|
Active ingredient
(main ingredient)
|
carbamazepine
|
|
Other ingredients
(inactive ingredients)
|
cellulose-microcrystalline
silica-colloidal anhydrous
magnesium stearate
talc
Aquacoat ECD-30
acrylates copolymer
carmellose sodium
hypromellose
polyoxyl 40 hydrogenated castor oil
iron oxide red CI 77491
iron oxide yellow CI 77492
titanium dioxide
|
|
Potential allergens
|
None
|
What Tegretol liquid contains
|
Active ingredient
(main ingredient)
|
carbamazepine
|
|
Other ingredients
(inactive ingredients)
|
methyl hydroxybenzoate
propyl hydroxybenzoate
caramel flavour
propylene glycol
PEG-8 stearate
saccharin sodium
sorbic acid
sorbitol solution (70%)
cellulose-dispersible
hyetellose
purified water
|
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Potential allergens
|
Benzoates (parahydroxybenzoate which can cause allergic reactions)
Sorbitol (changes to fructose which can cause stomach upset and diarrhoea)
|
Do not take this medicine if you are allergic to any of these ingredients.
What Tegretol looks like
Tegretol 100 mg tablets: white tablets marked with a break line and BW on one side,
GEIGY on the other side; packs of 100 tablets. (Aust R 41846).
Tegretol 200 mg tablets: white tablets marked with a break line and GK on one side,
CG on the other side; packs of 100 tablets (Aust R 41848).
Tegretol CR 200 mg tablets: beige-orange capsule shaped tablets with a break line
on both sides, marked H/C on one side and C/G on the other; in PVC/PE/PVDC/Al blister
packs of 100 or 200 tablets (Aust R 42974).*
Tegretol CR 400 mg tablets: brown - orange capsule shaped tablets with a break line
on both sides, marked ENE/ENE on one side and CG/CG on the other; in PVC/PE/PVDC/Al
blister packs of 100 or 200 tablets (Aust R 42944).*
Tegretol liquid: a thick, white, caramel flavoured liquid, packed in 300 mL brown
glass bottles with a child-resistant cap (Aust R 59160).
Who distributes Tegretol
Tegretol is supplied in Australia by:
NOVARTIS Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
Macquarie Park NSW 2113
Telephone 1-800-671-203
® = Registered Trademark
* Not all pack sizes may be available
This leaflet was prepared in December 2023.
tgr051223c_v2 is based on PI tgr051223i.