Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Ritalin 10 tablets.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available.
You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on the medicine. You can also download the most up to date leaflet from www.novartis.com.au.
Those updates may contain important information about the medicine and its use of which you should be aware.
All medicines have risks and benefits. Your doctor has weighed the risks of you or your child taking this medicine against the benefits they expect it will provide.
If you have any concerns about this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.

What Ritalin 10 is used for

Ritalin 10 tablets contain the active ingredient methylphenidate hydrochloride. Methylphenidate hydrochloride is a central nervous system stimulant.
Ritalin 10 tablets have two uses. They are used to treat:

• Attention Deficit Hyperactivity Disorder (ADHD); and

• narcolepsy, a sleep-attack disorder.

ADHD

Narcolepsy

Before you take Ritalin 10

When you must not take it

• periods of severe anxiety, tension or agitation

• Tourette's syndrome (a condition with uncontrolled speech and body movements or tics) or you have a family history of this disorder

• glaucoma (increased pressure in the eye)

• an overactive thyroid or other thyroid problems

• heart problems such as heart attack, irregular heartbeat, chest pain (angina), heart failure, heart disease or if you were born with a heart problem

• very high blood pressure (hypertension) or narrowing of the blood vessels (arterial occlusive disease, which can cause pain in the arms and legs)

• severe depression or other mental illness

• pheochromocytoma (a rare tumour of the adrenal gland, which sits near the kidney)

Before you start to take it

• any heart defects (e.g. structural cardiac abnormality)

• a family history of sudden death or irregular heart beat

• hardening of the arteries

• any other current or previous heart problems

• any disorders of the blood vessels in the brain, e.g. weakening of the blood vessel (aneurysm), stroke, or inflammation of blood vessels (vasculitis)

• severe depression, bipolar disorder or other mental illness

• epilepsy (seizures, convulsions, or fits)

• high blood pressure

• history of alcohol or drug abuse or dependence

• tics (muscle twitching which is usually in the face or shoulders) or if your brothers or sisters have tics

• acute mental disorders that cause abnormal thinking and perceptions (psychosis) or feeling unusually excited, over-active and un-inhibited (acute mania) - your doctor will have told you if you have this

• psychotic symptoms such as seeing or feeling things that are not really there (hallucinations)

• aggressive behaviour

• suicidal thoughts or behaviour

• fingers and toes feeling numb, tingling and changing colour (from white to blue, then red) when cold ('Raynaud's phenomenon').

• have or develop eye problems, including increased pressure in your eye, glaucoma, or problems with your close-up vision (farsightedness).

Taking other medicines

• medicines that increase blood pressure

• alpha 2 agonists like clonidine (used to treat high blood pressure)

• oral anticoagulants or warfarin (medicines used to prevent blood clots)

• some anticonvulsants (medicines used to treat epilepsy or fits)

• medicines used to treat depression, such as tricyclic antidepressants and monoamine oxidase inhibitors (MAO inhibitors)

• phenylbutazone (used to treat pain or fever)

• guanethidine

• anaesthetics

• medicines that influence the level of dopamine in the body (dopaminergic medicines, used to treat Parkinson's disease or psychosis).

• medicines that raise the level of serotonin in the body (serotonergic medicines, for example those used to treat depression like sertraline and venlafaxine).

How to take Ritalin 10

Your doctor will decide on the most suitable dosage according to the individual patient's medical need and response.
Follow all directions given to you by your doctor and pharmacist 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.

How much to take

How to take it

How long to take it

If you forget to take it

If you take too much (overdose)

• vomiting

• agitation

• headache

• tremors

• muscle twitching

• irregular heart beat

• flushing

• fever

• sweating

• dilated pupils

• breathing problems

• confusion

• seizures

• muscle spasms, fever, red-brown urine.

While you are taking Ritalin 10

Things you must do

Things you must not do

Things to be careful of

• hallucinations

• dizziness

• drowsiness

• blurred vision

• other central nervous system side effects which can affect concentration in some people.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Ritalin 10.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by these lists of possible side effects. You may not experience any of them. Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:

• excessive emotional distress or excitement

• nervousness

• feeling anxious, agitated

• feeling jittery

• feeling depressed

• feeling aggressive

• unusually active, depressed mood

• uncontrolled speech and body movements (Tourette's syndrome)

• troubled sleep or restlessness, difficulty falling asleep, sleep disturbance, sleepiness

• nausea (feeling sick)

• dry mouth

• vomiting, stomach pain, upset stomach, indigestion, toothache

• loss of appetite, decreased weight

• excessive sweating

• loss of weight and slower growth in children

• sore throat and runny nose

• headache

• cough

• dizziness

• blurred vision or problems focussing your eyes

• muscle cramps

• fever

• hair loss

• abnormal heart rhythm

• palpitations

• involuntary shaking of the body (sign of tremor)

• skin rash, itchy rash and hives

• joint pain

• excessive teeth grinding

• spasm of the jaw muscles that makes it difficult to open the mouth

• stuttering

• bedwetting in children during the night

• swelling of the face, lips or tongue (severe allergic reaction)

• sudden high fever, severe convulsions

• severe headache or confusion, weakness or paralysis of limbs or face, difficulty speaking

• fast heartbeat, chest pain

• uncontrollable twitching, jerking

• bruising

• muscle twitching or tics

• a sore throat and fever or chills

• uncontrollable writing movements of the limb, face and/ or trunk

• seeing or feeling things that are not really there (hallucination)

• fits (seizures, convulsions, epilepsy)

• skin blisters or itching

• red blotches on the skin

• prolonged erection, causing discomfort of the penis (sign of priapism)

• thoughts or attempts of killing yourself (suicidal ideation or attempt (including completed suicide)).

• fingers and toes feeling numb, feeling cold, tingling and changing colour (from white to blue, then red) when cold (Raynaud’s phenomenon, peripheral coldness).

• abnormal decrease in the levels of all type of blood cells. This is associated with anaemia, decreased platelets, and decreased white blood cells. This can lead to fatigue, increased risk of bleeding, and/or increased risk of infection. This may be serious or life threatening (pancytopenia).

• swelling of the ears (a symptom of allergic reaction);

• stuttering, feeling irritated, mood changes, abnormal behaviour or thinking, anger, excessive awareness of surroundings, feeling over-active and uninhibited (mania), feeling disorientated, changes in sex drive, lack of feeling or emotion, doing things over and over again, being obsessed with one thing, confusion, addiction

• temporary muscle weakness, loss of skin sensation or other functions of the body due to a temporary lack of blood supply to the brain (reversible ischemic neurological deficit), migraine

• double vision, dilated pupils, trouble seeing

• stopped heartbeat, heart attack Sore throat, shortness of breath

• diarrhoea

• constipation

• swelling of face and throat, excessive sweating, redness of the skin, large red blotches on the skin appearing within a few hours of taking the medicine;

• muscle pain, muscle twitching;

• inability to develop or maintain an erection, swelling of the breasts in men

• tiredness

• increased eye pressure (increased intraocular pressure)

• nose bleed

• Blood in the urine

• Chest pain, sudden death of heart origin

• Abnormal sounds from heart.

After taking Ritalin 10

Storage

• Keep your medicine in the original container until it is time to take a dose.

• Store it in a cool dry place.

• Do not store Ritalin 10 or any other medicine in the bathroom or near a sink.

• Do not leave it in the car or on window sills.

Disposal

Product description

What it looks like

Ingredients

• lactose

• calcium phosphate (E341)

• gelatin

• magnesium stearate (E572)

• purified talc (E553b)

• wheat starch

Sponsor

Boxed Warnings

Drug dependence. Ritalin 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

Ritalin 10 contain methylphenidate hydrochloride 10 mg.
Ritalin LA modified release capsules contain 10 mg, 20 mg, 30 mg, 40 mg or 60 mg of methylphenidate hydrochloride.
Ritalin 10 contains lactose, sugars, milk products, lactitol, gluten and sulfur dioxide. Ritalin LA contains sucrose.
For the full list of the excipients, see Section 6.1.

3 Pharmaceutical Form

Ritalin 10 tablets are immediate release white tablets that are scored and marked AB and CG on the reverse.
Ritalin LA are modified release capsules that presented as follows:
10 mg containing white to off-white beads in a light brown opaque hard gelatin capsule with the imprint of NVR on the cap and R10 on a white opaque body in tan-coloured ink.
20 mg containing white to off-white beads in a white opaque hard gelatin capsule with imprint NVR on the cap and R20 on body in tan-coloured ink.
30 mg containing white to off-white beads in a yellow opaque hard gelatin capsule with the imprint NVR on cap and R30 on body in tan-coloured ink.
40 mg containing white to off-white beads in a light brown opaque hard gelatin capsule with the imprint NVR on cap and R40 on body in tan-coloured ink.
60 mg containing white to off-white beads in a light brown opaque cap and a yellow opaque body hard gelatin capsule with imprint NVR on cap and R60 on body in tan-coloured ink. Not all presentations are available.

4 Clinical Particulars

4.9 Overdose

Symptoms. Signs and symptoms of acute overdosage, mainly due to over-stimulation of the central nervous system and from excessive sympathomimetic effects, may include: vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitation, cardiac arrhythmias, hypertension, mydriasis, dryness of mucous membranes and rhabdomyolysis.
Treatment. When treating an overdose, practitioners should bear in mind that a second release of methylphenidate from Ritalin LA capsules occurs at approximately four hours after administration of the capsule.
Treatment consists of appropriate supportive measures and symptomatic treatment of life threatening events, e.g. hypertensive crisis, cardiac arrhythmias, convulsions. For the most current guidance for treatment of symptoms of overdose, the practitioner should consult the Poisons Information Centre on 13 11 26 or current toxicological publication.
The patient must be protected against self injury and against external stimuli that would aggravate overstimulation already present. If the signs and symptoms are not too severe and the patient is conscious, further absorption may be limited by administration of activated charcoal. In cases of marked agitation, intravenous doses of diazepam or haloperidol should be given. Hypertension may be controlled by alpha-adrenergic blocking agents or intravenous sodium nitroprusside.
Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia.
The efficacy of peritoneal dialysis or extracorporeal haemodialysis for methylphenidate overdosage has not been established. Clinical experience with overdose is limited. Patients who have received doses higher than those recommended should be carefully monitored. In the event of overdose leading to clinically significant hypocalcaemia, reversal may be achieved with supplemental oral calcium and/or infusion of calcium gluconate.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Fertility. Methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18 week Continuous Breeding study. The study was conducted at doses up to 160 mg/kg/day, approximately 11-fold the highest recommended human dose of methylphenidate on a mg/m² basis.
Reproductive animal toxicity. Adequate animal reproduction studies to establish safe use of methylphenidate during pregnancy have not been conducted. Oral administration of methylphenidate to rabbits during the period of organogenesis has produced teratogenic effects at systemic exposures (plasma AUC) approximately 3 times clinical exposure at the maximum recommended human dose. The exposure at the no-effect dose was less than human exposure. In rats, teratogenic effects were not seen at systemic exposures (plasma AUC) approximately 12 times clinical exposure at the maximum recommended human dose.
Genotoxicity. Methylphenidate was not mutagenic in assays in vitro (Ames reverse mutation assay and the mouse lymphoma cell forward mutation assay). Methylphenidate showed evidence of a weak clastogenic response in vitro (Chinese hamster ovary cells) but was negative in vivo (mouse bone marrow micronucleus assay).
Carcinogenicity. In a lifetime carcinogenicity study carried out in B6C3F₁ mice, methylphenidate caused an increase in hepatocellular adenomas and, in males only, an increase in hepatoblastomas at a daily dose of approximately 60 mg/kg/day. This dose is approximately 4 times the maximum recommended human dose of methylphenidate on a mg/m² basis. Hepatoblastoma is a relatively rare rodent malignant tumour type. The mouse strain used is sensitive to the development of hepatic tumours, and the significance of these results to humans is unknown.
Methylphenidate did not cause any increases in tumours in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 50 mg/kg/day, which is approximately 7 times the maximum recommended human dose of methylphenidate on a mg/m² basis.
In a 24-week carcinogenicity study in the transgenic mouse strain p53^+/-, there was no evidence of carcinogenicity. Male and female mice were fed diets containing the same concentration of methylphenidate as in the lifetime carcinogenicity study; approximately 60 and 74 mg/kg/day of methylphenidate, respectively, which is approximately 4 and 5 times the maximum recommended human dose of methylphenidate on a mg/m² basis, respectively.
Comment. The US Food and Drug Administration examined data from the Surveillance, Epidemiology and End Results (SEER) database for the years 1973 to 1991 and found that the estimated incidence of hepatoblastoma in the general population was not greater than 1 in 10 million person-years.
A total of 174 cases of hepatoblastoma were reported by the SEER for the period 1973 to 1995. The age-adjusted incidence rate is very low (IR = 0.0382 per 100,000 person-years). The majority of cases (149 out of 174) were diagnosed among the age group 0 to 4 years old, which is in accordance with the natural history of the disease. For the age group 5 to 24 years old the rates of hepatoblastoma are very low with 14 cases reported. For the 0 to 4 years old age group, incidence rates of hepatoblastoma have risen slowly, ranging from 0.3032 per 100,000 in 1973 to 0.4889 per 100,000 in 1995. On the basis of experience since marketing Ritalin 10, there is no evidence that the incidence is higher in patients receiving Ritalin 10.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Active ingredient: Methylphenidate hydrochloride.
Chemical names: methyl (R*, R*)- (±)-α-phenyl-2-piperidine acetate hydrochloride; or 2-piperidineacetic acid, α-phenyl-, methyl ester, hydrochloride; or methyl α-phenyl-2-piperidineacetate hydrochloride.
Molecular formula: C₁₄H₁₉NO₂.HCl.
Molecular weight: 269.8.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMETHHY.gif CAS number. 298-59-9.

7 Medicine Schedule (Poisons Standard)

Controlled Drug (S8).

Summary Table of Changes

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