Consumer medicine information

1. Why am I using 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 use 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?

Some medicines may interfere with Tegretol and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

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?

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.

1 Name of Medicine

Australian Approved Name: carbamazepine.

2 Qualitative and Quantitative Composition

Tegretol tablets containing 100 mg or 200 mg of carbamazepine.
Tegretol controlled release (CR) tablets containing 200 mg or 400 mg of carbamazepine.
Tegretol liquid containing 100 mg of carbamazepine per 5 mL.
Carbamazepine is a white or yellowish-white almost odourless crystalline powder, tasteless or with a slightly bitter taste; melting point: 189 to 193°C. The powder is slightly soluble in water and ether; soluble 1 in 10 of alcohol and 1 in 10 of chloroform; soluble in acetone.
Excipients with known effect. Tegretol liquid contains hydroxybenzoates, saccharin, sorbates, sorbitol and traces of benzoates. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Tablets. 100 mg. White, scored, marked BW, GEIGY on reverse.
200 mg. White, scored, marked GK, CG on reverse.
200 mg CR. Beige-orange, ovaloid, scored, marked H/C and C/G.
400 mg CR. Brown-orange, ovaloid, scored, marked ENE/ENE and CG/CG.
Liquid. White, viscous, caramel-flavoured suspension.

4 Clinical Particulars

4.9 Overdose

Signs and symptoms. The presenting signs and symptoms of overdosage develop within 1 to 3 hours of ingestion and usually involve the central nervous, cardiovascular, respiratory systems, and the adverse drug reactions mentioned under Section 4.8 Adverse Effects (Undesirable Effects). Relapse and aggravation of symptoms on the 2nd and 3rd day after overdose may occur. This is thought to be due to delayed absorption, possibly due to production of a gastric mass of tablets. In the case of the CR tablet, there is the theoretical possibility that this may be accentuated. However, there is limited clinical experience to support this.
Central nervous system. CNS depression: disorientation, depressed level of consciousness, somnolence, agitation, hallucination, coma; blurred vision, slurred speech, dysarthria, nystagmus, ataxia, dyskinesia, initially hyperreflexia, later hyporeflexia, convulsions (especially in small children), psychomotor disturbances, myoclonus, hypothermia, mydriasis.
Respiratory system. Respiratory depression, pulmonary oedema.
Cardiovascular system. Tachycardia, hypotension, at times hypertension, conduction disturbance with widening of QRS complex, syncope in association with cardiac arrest.
Gastrointestinal system. Vomiting, delayed gastric emptying, reduced bowel motility.
Musculoskeletal system. Rhabdomyolysis.
Renal function. Retention of urine, oliguria or anuria, fluid retention, water intoxication due to an ADH-like effect of carbamazepine.
Laboratory findings. Hyponatraemia (see Management), leukocytosis, leukopenia, hypokalaemia, metabolic acidosis, hyperglycaemia, glycosuria, acetonuria, increased muscle creatine phosphokinase.
Management. Contact the Poisons Information Centre on 131 126 for advice on management.
There is no specific antidote. Management should be guided initially by the patient's clinical condition. All patients suspected of serious overdose should be admitted to hospital and the plasma carbamazepine concentration measured to confirm carbamazepine poisoning and to ascertain the size of the overdose.
Administration of activated charcoal. If the patient's level of consciousness is impaired, intubation may be necessary to protect the airway. Supportive medical care in an intensive care unit with cardiac monitoring and careful correction of electrolyte imbalance.
Hyponatraemia is not usually a problem in acute overdosage. However, in chronic intoxication it may be managed by fluid restriction and slow and careful intravenous infusion of NaCl 0.9%. These measures may be useful in preventing brain damage.
Special recommendations. Hypotension. Intravenous fluid replacement. If the patient fails to respond, consider intravenous dopamine or dobutamine.
Disturbances of cardiac rhythm. There are no data regarding drug treatment of carbamazepine induced arrhythmias. These should, therefore, be handled according to the circumstances in each patient.
Convulsions. Initially, administer a benzodiazepine (e.g. diazepam) if seizures occur. If seizures recur, another anticonvulsant, e.g. phenobarbitone (with caution because of increased respiratory depression), may be considered.
Charcoal haemoperfusion has been recommended. Forced diuresis, haemodialysis and peritoneal dialysis have been reported to not be effective.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Bacterial and mammalian mutagenicity studies yielded negative results.
Carcinogenicity. In rats treated with oral carbamazepine at doses of 25, 75 and 250 mg/kg/day for 2 years, the incidence of hepatocellular tumours was dose-dependently increased in females, and aspermatogenesis and testicular atrophy were observed at all doses (see Section 4.6 Fertility, Pregnancy and Lactation, Effects on fertility). This dose range is 0.2 to 2 times the maximum recommended clinical dose of 1200 mg/day, on a surface area basis. The significance of the carcinogenicity findings relative to the use of carbamazepine in humans is not known.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCARBAM.gif Chemical name: 5H-dibenzo[b,f]azepine-5-carboxamide.
Empirical formula: C₁₅H₁₂N₂O.
Molecular weight: 236.3.
CAS number. 298-46-4.

7 Medicine Schedule (Poisons Standard)

Prescription Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/TEGRETST.gif