What is the most important information I should know about Ritalin/Ritalin LA?

Ritalin/Ritalin LA may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Ritalin/Ritalin LA with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do NOT take more than the recommended dose without checking with your doctor. If you are taking Ritalin/Ritalin LA for an attention deficit disorder, it should be used as a part of a treatment program that includes a variety of treatment measures (eg, psychological, educational, social). If your condition does not get better within 1 month or if it gets worse, check with your doctor. Serious effects, including heart attack, stroke, and sudden death, have occurred with the use of stimulant medicines in patients with heart defects or other serious heart problems. If you have a heart defect or another serious problem, talk with your doctor about other therapies to treat your condition. Ritalin/Ritalin LA may cause a prolonged (more than 4 hours) or painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens. Ritalin/Ritalin LA may cause circulation problems in the hands and feet. Tell your doctor if you have any numbness, pain, tingling, cold feeling, or skin color change (eg, from pale to blue or red) in your hands or feet. Call your doctor right away if you have any unexplained sores or wounds on your fingers or toes. Tell your doctor or dentist that you take Ritalin/Ritalin LA before you receive any medical or dental care, emergency care, or surgery. Before you start any new medicine, check the label to see if it has a decongestant in it. If it does or if you are not sure, check with your doctor or pharmacist. Lab tests, including blood pressure, heart function, complete blood cell counts, and platelet counts, may be performed while you use Ritalin/Ritalin LA. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Ritalin/Ritalin LA may affect growth rate and weight gain in CHILDREN and teenagers in some cases. They may need regular growth and weight checks while they take Ritalin/Ritalin LA. Caution is advised when using Ritalin/Ritalin LA in CHILDREN; they may be more sensitive to its effects, especially loss of appetite, stomach pain, weight loss, trouble sleeping, and fast heartbeat. Ritalin/Ritalin LA should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ritalin/Ritalin LA while you are pregnant. It is not known if Ritalin/Ritalin LA is found in breast milk. If you are or will be breast-feeding while you use Ritalin/Ritalin LA, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, Ritalin/Ritalin LA may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Ritalin/Ritalin LA stops working well. Do not take more than prescribed.

Some people who use Ritalin/Ritalin LA for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. Do not suddenly stop taking Ritalin/Ritalin LA. If you do, you may have WITHDRAWAL symptoms. These may include depression or other mental problems. If you need to stop Ritalin/Ritalin LA, your doctor will lower your dose over time.

Side effects of Ritalin/Ritalin LA in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few drugs minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the drug, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. The below-mentioned list are the side effects of Ritalin/Ritalin LA. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.

Adverse Effects Reported during Clinical Trials: Children: A randomised, double-blind, placebo-controlled parallel group clinical study (Protocol 07) was conducted to evaluate the efficacy and safety of Ritalin/Ritalin LA LA in children aged 6-12 years with ADHD. In the double-blind treatment phase of this study, Ritalin/Ritalin LA LA was administered once daily for up to two weeks at individually titrated doses in the 10-40 mg range. The incidence of treatment-emergent adverse events reported during the double-blind treatment phase is summarised in Table 6. Adverse events reported with an incidence ≥2% in all treated subjects in Protocol 07 (including adverse events during the titration period and placebo-washout period) are included in Table 7.

Adults: Ritalin/Ritalin LA LA was evaluated in a randomized, double-blind, placebo-controlled, multicentre core study (D2302) in the treatment of 725 adult patients (395 male and 330 female) diagnosed with ADHD. Maintenance of effect of Ritalin/Ritalin LA LA was evaluated in a 6-month maintenance study (D2302E1) in 298 patients. The incidence of adverse events reported during the core study and extension studies are summarised in Table 8 and Table 9 respectively.

The AE profile seen in the maintenance period was similar to that observed in the core study. No unexpected SAEs or AEs were observed in this extension study and the commonly observed AEs were expected and driven by the pharmacologic activity.

The most frequently affected primary SOCs (≥10% in all extension patients) starting in the extension study were infections and infestations, nervous system disorders, psychiatric disorders, and gastrointestinal disorders. There was no evidence of toxicity to any organ system. The most commonly reported individual AEs (≥5.0% in any dose group) during the extension study were nasopharyngitis (19.1%), headache (14.1%), decreased appetite (7.7%), dry mouth (6.7%) and nausea (5.0%).

Post-Marketing Experience: Nervousness and insomnia are very common adverse reactions which occur at the beginning of Ritalin/Ritalin/Ritalin LA LA treatment and are usually controlled by reducing the dosage and omitting the drug in the afternoon or evening.

Loss of appetite is very common but usually transient. Abdominal pain, insomnia and tachycardia are common, usually at the beginning of treatment and may be alleviated by concomitant food intake.

Tabulated Summary of Adverse Reactions: Adverse drug reactions listed in Table 10 are listed by MedDRA system organ class. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): Very common ≥10%; common ≥1% to <10%; uncommon ≥0.1% to <1%; rare ≥0.01% to <0.1%; very rare <0.01%.

Very rare reports of poorly documented neuroleptic malignant syndrome (NMS) have been received. In most of these reports, patients were also receiving other medications. It is uncertain what role Ritalin/Ritalin LA played in these cases.

Adverse events reported since market introduction in patients taking Ritalin/Ritalin LA include suicide, suicide attempt and suicidal ideation. No causal relationship between Ritalin/Ritalin LA and these events has been established.

Additional Adverse Reactions Reported with Other Methylphenidate-Containing Products: The list below shows adverse reactions not listed for Ritalin/Ritalin LA that have been reported with other methylphenidate-containing products based on clinical trials data and post-market spontaneous reports.

What are the possible side effects of Ritalin/Ritalin LA?

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Aggressive and violent behavior arm, back, or jaw pain black, tarry stools blistering, peeling, or loosening of the skin blood in the urine bloody nose chest pain or discomfort chest tightness or heaviness chills cold confusion cough or hoarseness cracks in the skin crying depersonalization diarrhea dizziness dysphoria euphoria fainting fast, pounding, or irregular heartbeat or pulse fever flu-like symptoms heavier menstrual periods joint or muscle pain loss of heat from the body nausea nervousness paranoia pinpoint red spots on the skin quick to react or overreact emotionally rapidly changing moods red, irritated eyes red, swollen skin scaly skin seeing, hearing, or feeling things that are not there severe or sudden headache skin rash or itching sore throat sores, ulcers, or white spots in the mouth or on the lips sudden loss of coordination sudden slurring of speech sweating twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs unusual bleeding or bruising unusual tiredness or weakness

Rare

Convulsions difficulty with breathing high fever increased sweating loss of bladder control severe muscle stiffness tiredness uncontrolled vocal outbursts or tics (uncontrolled repeated body movements) unusually pale skin

Incidence not known

Blistering, burning, crusting, dryness, or flaking of the skin chest pain difficulty with swallowing hives, itching, scaling, severe redness, soreness, or swelling of the skin large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs painful or difficult urination pale skin paleness or cold feeling in the fingertips and toes puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue swollen glands tingling or pain in the fingers or toes when exposed to cold troubled breathing with exertion

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Confusion as to time, place, or person false or unusual sense of well-being holding false beliefs that cannot be changed by fact muscle twitching overactive reflexes sweating unusual excitement, nervousness, or restlessness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abdominal or stomach pain decreased weight difficulty with moving drowsiness headache hives or welts loss of appetite muscle pain or stiffness redness of the skin trouble sleeping vomiting

Less common

Decreased appetite stuffy or runny nose weight loss

Incidence not known

Bigger, dilated, or enlarged pupils (black part of the eye) bleeding, bruising, burning, itching, redness, skin rash, swelling, or soreness at the application site blurred or loss of vision disturbed color perception double vision hair loss halos around lights increased sensitivity of the eyes to light night blindness overbright appearance of lights thinning of the hair tunnel vision

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Copyright 2016 Truven Health Analytics, Inc. All Rights Reserved.