Consumer medicine information

1. Why am I using CONCERTA?

CONCERTA contains the active ingredient methylphenidate hydrochloride. CONCERTA is used to treat Attention Deficit Hyperactivity Disorder (ADHD). For more information, see Section 1. Why am I using CONCERTA? in the full CMI.

2. What should I know before I use CONCERTA?

Do not use if you have ever had an allergic reaction to methylphenidate hydrochloride 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 CONCERTA? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with CONCERTA 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 use CONCERTA?

• Children and Adolescents: The starting dose is one CONCERTA 18 mg modified release tablet in the morning.

• Adults: The starting dose is one CONCERTA 18 mg or 36 mg modified release tablet in the morning.

5. What should I know while using CONCERTA?

6. Are there any side effects?

Like all medicines, CONCERTA can cause side effects, although not everybody gets them. Your doctor will discuss potential side effects with you and will explain the risks and benefits of your treatment. Some side effects can be serious, and you may require urgent medical attention.
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.

Boxed Warnings

Drug dependence. Concerta should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behaviour. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

1 Name of Medicine

Methylphenidate hydrochloride.

2 Qualitative and Quantitative Composition

Concerta is available as a modified-release tablet for once-a-day oral administration containing 18, 27, 36 or 54 mg methylphenidate hydrochloride. It is designed to have a 12-hour duration of effect.
Excipient(s) with known effect. Lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Concerta 18 mg are yellow capsule-shaped tablets, with "alza 18" printed in black ink on one side.
Concerta 27 mg are grey capsule-shaped tablets, with "alza 27" printed in black ink on one side.
Concerta 36 mg are white capsule-shaped tablets, with "alza 36" printed in black ink on one side.
Concerta 54 mg are brownish-red capsule-shaped tablets, with "alza 54" printed in black ink on one side.

4 Clinical Particulars

4.9 Overdose

The prolonged release of methylphenidate from Concerta should be considered when treating patients with overdose.
Signs and symptoms. Signs and symptoms of Concerta overdosage, resulting principally from overstimulation of the CNS and from excessive sympathomimetic effects, may include the following: vomiting, agitation, muscle twitching, convulsions, grand mal convulsions, confusional state, hallucinations (auditory and/or visual), hyperhidrosis, headache, pyrexia, tachycardia, palpitations, heart rate increased, sinus arrhythmias, hypertension, mydriasis and dry mouth.
Treatment. Treatment consists of appropriate supportive measures. The patient must be protected against self injury and against external stimuli that would aggravate overstimulation already present. The efficacy of activated charcoal has not been established. Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia.
Efficacy of peritoneal dialysis or extracorporeal haemodialysis for Concerta overdosage has not been established.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Methylphenidate was not mutagenic in the in vitro assays (Ames reverse mutation assay, mouse lymphoma cell forward mutation assay). Methylphenidate was weakly clastogenic in vitro (Chinese hamster ovary cells) but was negative in vivo (mouse bone marrow micronucleus assay). Sister chromatid exchange assay results were positive only at high (cytotoxic) concentrations.
Carcinogenicity. In a lifetime dietary carcinogenicity study carried out in mice, methylphenidate caused an increase in hepatocellular adenomas at a dose of 60-80 mg/kg/day and, in males only, an increase in hepatoblastomas (a relatively rare rodent malignant tumour type) at 60 mg/kg/day. These dose levels are approximately 3 to 8-fold the maximal recommended clinical dose on a mg/m² basis. There was no increase in tumours at 30-40 mg/kg/day (approximately 1 to 4-fold the maximal recommended clinical dose on a mg/m² basis). The mouse strain used is sensitive to the development of hepatic tumours, and the significance of these results to humans is not known. There was no evidence of carcinogenicity in two strains of transgenic mice administered methylphenidate in the diet for 24 weeks at doses up to 60-74 mg/kg/day (approximately 3 to 8-fold the maximal recommended clinical dose on a mg/m² basis) or in a lifetime dietary study in rats at doses up to 50 mg/kg/day (approximately 4 to 10-fold the maximal recommended clinical dose on a mg/m² basis).

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Methylphenidate hydrochloride is the racemic mixture of d,l-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. The d-(R,R)-isomer is pharmacologically more active than the l-(S,S)-isomer. Methylphenidate hydrochloride is a white, odourless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMETHHY.gif C₁₄H₁₉NO₂.HCl.
MW: 269.77.
CAS number. CAS-298-59-9 (methylphenidate hydrochloride).

7 Medicine Schedule (Poisons Standard)

S8 - Controlled Drug.

Summary Table of Changes

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