Methylphenidate stimulates centres in the brain that are underactive in people with ADHD, such as the bits of the brain involved with concentration. It is not known how methylphenidate may affect plasma concentrations of concomitantly administered medicinal products. Therefore, caution is recommended at combining methylphenidate with other medicinal products, especially those with a narrow therapeutic window.

Because of possible hypertensive crisis, methylphenidate is contraindicated in patients being treated (currently or within the preceding 2 weeks) with non-selective, irreversible MAO-inhibitors (see section 4.3). The daily dose was individually titrated in weekly stages starting with 10 mg a day depending on efficacy and tolerability (study 1) or starting with a dose of 0.5 mg/kg body weight (study 2). A dose of 60 mg a day (study 1) or 1 mg/kg body weight (study 2) should not be exceeded. In the first study, the average dose of methylphenidate at end point was lower, 0.55 mg/kg body weight (administered daily dose min. 10 mg, max. 60 mg) compared with the second study, on average 0.9 mg/kg body weight (administered daily dose min. 20 mg, max. 120 mg). A greater effect size for the whole study population was calculated when administering a higher average dose (0.9 mg/kg body weight), as was the case in the QUMEA study. The clinical studies yielded only limited experience with daily doses of over 80 mg, since only 2 patients were treated with 120 mg/day. The recalculated responder rate was determined as: Responder: Patients with WRAADDS Score 30% reduction or more and without trial discontinuation, Non-Responder: Patients with less reduction in WRAADDS score or early trial discontinuation for every reason, which lead to missing values in week 24 or 8). In the EMMA trial the recalculated responder rate was 128 (53%) in the verum group vs. 44 (37%) in the placebo group (Week 24, fisher's exact test, two-sided, 0.0051). The recalculated responder rate in the QUMEA study in week 8 was 41 (49%) vs. 14 (18%) (verum versus placebo, fisher's exact test, two-sided, p< 0.0001). Medikinet XL is a mild CNS stimulant with more prominent effects on mental than on motor activities. Its mode of action in man is not completely understood but its effects are thought to be due to cortical stimulation and possibly to stimulation of the reticular activating system. It is important not to break or chew the slow-release methylphenidate tablets or capsules. This is because they have a special system in them to deliver the medicine into your body over a few hours, which could be damaged if you chew or break them.Compared to children and adolescents, adult patients may require a higher daily dose, based on the patient's body weight. Light grey opaque capsule body/dark violet opaque capsule cap (15.9 mm) containing white and blue pellets. The results of the first study (EMMA) reveal that gender-specific differences in the response to methylphenidate and the possibility that women could benefit from lower doses cannot be ruled out. This study demonstrated efficacy in men solely in the highest dose range with MPH > 0.7 mg/kg body weight. In women, however, efficacy was demonstrated even in the low (< 0.3 mg/kg body weight) and mid dose range (0.3-0.7 mg/kg body weight). With respect to reduction in symptoms, women in the high dose group showed no significant effect and, with respect to response rate, efficacy was comparable with that in lower dose groups. Remember that methylphenidate has serious side effects. Do not give or sell your tablets to anyone else – they may become very ill.

Do not take methylphenidate if you are trying to get pregnant and use a good method of contraception while taking the drug.

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Owing to extensive first-pass metabolism its systemic availability amounts to approximately 30% (11-51%) of the dose.

Dark violet opaque capsule body/dark violet opaque capsule cap (19.4 mm) containing white and blue pellets. If you or your child is taking other medicines, methylphenidate may affect how well they work or may cause side effects. Tell your doctor if you or your child is taking medicines to treat:has very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs Each modified-release capsule hard contains 30 mg methylphenidate hydrochloride, equivalent to 25.95 mg methylphenidate. You might feel sleepy in the first few days after taking methylphenidate. Do not drive a car, ride a bike or operate machines until you see how this affects you. If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.