RUBIFEN Immediate release tablet, Sustained release tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
Rubifen: Methylphenidate hydrochloride (USP) 5 mg, 10 mg and 20 mg. Rubifen SR: Methylphenidate hydrochloride (USP) 20 mg sustained release tablets.
2. Qualitative and quantitative composition
Each 5mg tablet contains methylphenidate 5mg. Each 10mg tablet contains methylphenidate 10mg. Each 20mg tablet contains methylphenidate 20mg. For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Rubifen immediate release 5, 10 and 20 mg tablets: round white tablet with slightly bevelled edges, marked RU-5, RU-10 or RU-20 containing 5 mg, 10 mg and 20 mg methylphenidate respectively with a score ...
4.1. Therapeutic indications
Attention Deficit/Hyperactivity Disorder (ADHD) ADHD was previously known as attention-deficit disorder or minimal brain dysfunction. Other terms used to describe this behavioural syndrome include: hyperkinetic ...
4.2. Posology and method of administration
Dose titration Careful dose titration is necessary at the start of treatment with methylphenidate. Dose titration should be started at the lowest possible dose. Other strengths of this medicinal product ...
4.3. Contraindications
Hypersensitivity to methylphenidate or to any of the excipients Anxiety, tension Agitation Hyperthyroidism Pre-existing cardiovascular disorders including severe hypertension, angina, arterial occlusive ...
4.4. Special warnings and precautions for use
Treatment with Rubifen is not indicated in all cases of Attention-Deficit/Hyperactivity disorder, and should be considered only after detailed history-taking and evaluation. The decision to prescribe Rubifen ...
4.5. Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions Anti-hypertensive drugs Rubifen may decrease the effectiveness of drugs used to treat hypertension. Use with drugs that elevate blood pressure Rubifen should be used with caution ...
4.6. Fertility, pregnancy and lactation
Pregnancy Methylphenidate is potentially teratogenic in rabbits (see non-clinical safety data). The safety of methylphenidate for use during human pregnancy has not been established. Data from a cohort ...
4.7. Effects on ability to drive and use machines
Rubifen may cause dizziness, drowsiness, blurred vision, hallucinations or other CNS side effects (see Section 4.8). Patients experiencing such side effects should refrain from driving, operating machinery, ...
4.8. Undesirable effects
Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of methylphenidate based on the comprehensive ...
4.9. Overdose
Symptoms Signs and symptoms of acute overdosage, mainly due to overstimulation of the central and sympathetic nervous systems, may include: vomiting, agitation, tremor, hyperreflexia, muscle twitching, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Psychostimulants. Rubifen is a mild CNS stimulant with more prominent effects on mental than on motor activities. Its mode of action in humans is not completely understood, ...
5.2. Pharmacokinetic properties
Absorption Immediate release tablets: After oral administration the active substance (methylphenidate hydrochloride) is rapidly and almost completely absorbed. Owing to extensive first-pass metabolism ...
5.3. Preclinical safety data
Not applicable.
6.1. List of excipients
Rubifen (5 mg, 10 mg and 20 mg) contains calcium hydrogen phosphate dehydrate magnesium stearate, maize starch, and microcrystalline cellulose. Rubifen SR (20 mg) contains cetyl alcohol, ethylcellulose, ...
6.2. Incompatibilities
None known.
6.3. Shelf life
Rubifen (5 mg, 10 mg and 20 mg): 24 months. Rubifen SR (20 mg): 36 month.
6.4. Special precautions for storage
Store at or below 25°C and protect from moisture.
6.5. Nature and contents of container
Rubifen (5 mg, 10 mg and 20 mg): Blister pack, PVC/Al, 30 tablets. Rubifen SR (20 mg): Blister pack, PVC/PVdC AL (10 tbs/blister), 30 tablets.
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
AFT Pharmaceuticals Limited, PO Box 33-203, Takapuna, Auckland 0740, Phone: 0800 423 823
9. Date of first authorization / renewal of the authorization
16/03/2000
10. Date of revision of the text
August 2022
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