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PRIMPERAN 10mg : metoclopramide scored tablets

PRIMPERAN-10mg-metoclopramide

1. COMPOSITION

Metoctopramde hydrochloride          10.50 mg,

(As anhydrous- metoclopfamde hydrochloride 10.00 mg)

Other inoredients:Lactose monohydrate riser ocrystalhne cellulose, maize starch, colloidal anhydrous silica magnesium stearate, for one scored tablet

2. DOSAGE FORM AND PRESENTATION:

scored tablet Box of 40 (2 x 20 scored tablets)

THERAPEUTIC INDICATIONS

Adult population:

Primperan 10mg is indicated in adults for

– Symptomatic treatment of vomiting and nausea, including acute migraine induced vomiting and nausea

– Prevention of delayed chemotherapy induced vomiting and nausea

– Prevention of radiotherapy induced vomiting and nausea

Paediatric population:

Primperan 10mg is indicated in children aged 15-18 years and weighting over 60 kg for:

Prevention off delayed chemotherapy induced vomiting and nausea as a second tme option

POSOLOGY, METHOD OF ADMINISTRATION

POSOLOGY

Aduilt Patients:

For all indications:

The recommended single dose is 10 mg (1 tablet), repeated up tef three times daily

The maximum recommended daily dost is 30 mg or 0 5 mg/kg body weight

The maximum recommended treatment duration is 5 days Paedutnc patients aged 15-18 years and weighting over 60 kg Prevention of delayed chemotherapy induced vomtmg and nausea

+ The recommended single dose is 10 mg (1 tablet), repeated up to three times daily, or

– The recommended dose is 01 to 015 mg/kg body weight, repeated up to three times daily

. The maximum recommended dally dose is 30 mg or 0 5 mg/kg body weight

+ The maximum recommended treatment duration is 5 days Pnmperan 10 rrg ts not recommended for children aged under 15 year  end weighting up to 00 kg due to unsuitable pharmaceutical form

Special populations:

Elderly patients In elderly patients a doee reduction should be considered, baaed on renal end hepatic function and overall frailty Ranal mparronf in patients wth end stage renal impairment (Creatine deemncc s 15 nt/mn), the daily, doee should be reduced by 75% In patients wth moderate to were renal impairment (Creatinine clearance 15-80 mL/rron). the doee should be reduced by 50%

Hepatic enpewment In patients wth severe hepatic impairment the doee should be reduced by 50%

Chicken Pnmperan 10 mg is not recommended for children aged under 15 years and weighting up to 90 kg due to unsuitable pharmaceutical form

THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU PERSONALLY IN A SPECIFIC SITUATION:

– it is noteuaable m other circumstances do not recommend it to anyone efee

Method of administration Ora! route

How often Primperan 10 mg scored tablets should be taken Allow an interval of at least 0 hours between each dose How long Pnmperan 10 mg scored tablets shoi Id be taken The rmueum recommended treatment durationlays

FOLLOW YOUR DOCTOR S ADVICE:

If you forget to take Pnmperan 10 mg scored tablets Do not take a double dose to make up for a forgotten dose CONTRA-INDICATIONS Never take Primperan 10 mg scored tablets m the following cases

-Hypersensitivity to metoclopraned# or to sny of the excipients

-Gastrointestinal haemorrhage mechanical obstruction, gastrointestinal perforation for which the stimulation of gastrointestinal motility constitutes a risk

-Confirmed or suspected pheochromocytoma due to the risk of severe hypertension episodes.

-History of neuroleptic or metodoprarnde-induced tardive dyskinesia epilepsy (increased crises frequency and intensity),

-Parkinson s disease.

-Combination wth levodopa. or dopamine agonists.

-Knowi history of methemoglobinemia wth metoclopramide or of NADH cytochrome-bS reductase deficiency

children less than 1 year of age due to an increased risk of extrapyramdal disorders.

IF YOU ARE UNSURE OF ANYTHING, IT IS ESSENTIAL THAT YOU ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE

SPECIAL WARNINGS Neurological disorders

Extrapyramdal disorders may occur particularly in children and young adults, and/or when high doses are used These reactions occur usually at the beginning of the treatment and can occur after a single admnistrebon Metoclopramide should be discontinued immediately m the event extrapyramdal symptoms These effects are generally completely reversible after treatment discontinuation, but may require a symptomatic treatment (benzodiazepines in children and/or anticholinergic anti parkinsonian drugs in adults)

The time interval of at least 6 hours between each metoclopramide administration, even in case of vomiting and rejection of the dose. In order to avoid Overdose

Prolonged treatment with metocloppramide may cause tardive dyskinesia potentially irreversible, especially in the elderly Therefore, treatment should not exceed 3 months Treatment must be immediately discontinued if clinical sign of Neuroleptic  Syndrome (NMS) has  been reported metoclopramtio, in combination with neurolepties as well as with monotherapy Metoctopramide immediately discontinued in the event of symptoms of NMS and appropriate treatment should be initiated

Special care should be exercised in patients wth underlying neurological conditions and In patients – being treated with other centrally-acting drugs

Symptoms of Parkinson’s disease may also be exacerbated by metoclopramide

Mathaemoglobinemia

Methaemoglobmema which could be related to NADH cytochrome bS reductase deficiency has been reported In such cases, metoclopramdo should be immediately and permanently discontinued and appropriate measures initiated such as treatment wth methylene blue

There have been reports of serious cardiovascular undesirable effects including cases of circulatory collapse, severe bradycardia, cardiac arrest end QT prolongation following administration of metoclopremde by injection, particularly via the intravenous route Special care should be taken when administering metoclopramide. particularly via the intravenous route to the elderly population, to patients wth cardiac conduction disturbances (including QT prolongation), patents wth uncorrected electrolyte imbalance, bradycardia and those taking other drugs known to prolong QT interval In patients wth renal impairment or wth eeveie hepatic impairment a dose reduction is recommended (see Poeotogj)

You should not use this medicine it you are galactose intolerant oi if you have Lapp lactase deficiency or glucose or galactose malabsorption syndiome (rare hereditary diseases)

IF YOU ARE UNSURE OF ANYTHING. DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE

Pregnancy and breast-feeding A laige amount of data on pregnant women (more than 1000 exposed outcomes) indicates no maltoimativo toxicity nor foetotoxiaty Metodopiamide can be used dunng pregnancy if clinically needed Due to pharmecotopcal properties (as other neuroleptics), in case of metocloppramide administration at the end of pregnancy.

extrapytamdat syndrome tn newborn cannot be excluded Metoclopfamide should be avoided at the end of pregnancy If metoctopferrsde is used neonatal monitoring should be undertaken Breast-feeding

Metoclopfamde is excreted in breast milk at low level Adverse reactions in the breast-fed baby cannot be excluded Therefore metoclopfamide is not recommended during breast-feeding Discontinuation of metoclopramde in breast-feeding women should be considered

AS A GENERAL RULE YOU SHOULD ALWAYS ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE BEFORE TAKING ANY MEDICINE IF YOU ARE PREGNANT OR BREAST-FEEDING

Driving and using machines

Metoclopfamde msy cause drowsiness dizziness, dyskinesia and dystonias wtnch could affect the vision and also interfere with the ability to drive and operate machinery

List of excipient with a specific effect: lactose

DRUG INTERACTIONS AND OTHER INTERACTIONS Contraindicated combination

Metoclopramide is contraindicated with levodopa or dopamine agonists because they have a mutual antagonism

Combination to be avowed

+ Alcohol potentiates the sedative effect of motodoprermde Combinations to ba takanmto consideration Due to the prokmetic effect of metoclopramde, the absorption of certain drugs may be modified

+ Anticholinergics and morphine derivatives. Anticholinergics and morphine derivatives may have both a nutual antagonism with metoclopramde on the digestive tract motility,

+ Central nervous system depressants (morphine derivatives, anxiolytics, neuroleptic, sedative antidepressants, sedative H1 antihistamines barbiturates, c(omdtne and related) Sedative effects of Central Nervous System depressants and metoclopramide are potentiated

Neuroleptics Metoclopramide may have an additive effect wth other neuroleptics on the occurrence of extrapyramdal disorders

–        Serotonergic drugs The use of metoclopramide with serotonergic HRWsiieh as SSRIs mayipfiipase the ssk

–        Digoxin: Metoclopramide may  decrease digoxin bioavaiiabiuty Careful monitoring digoxini plasma concentration is required

–        Cyclosporine Metoctopramfcfe Increases cyclosponoux htoavailabilrty (Cmax by 46% and exposure by 22%) Careful monitoring of cydoeponno plasma concentration is required The clinical consequence Is uncertain

–        Mirvacunum and suxamethonium Metoclopramide injection may prolong the duration of neuromuscular block (through inhibition of plasma cholinesterase)

–        strong CYP206 inhibitors Metoclopfamide exposure levels are increased when co-admmistored with strong CYP206 inhibitors such as fluoxetine and paroxetine Although the clinical significance Is uncertain, patient should be monitored for adverse reactions

+ Metoclopfamide can be used in combination with oral analgesics as a prokmetic to assist absorption of analgesics m acute migraine

ALWAYS INFORM YOUR DOCTOR OR PHARMACIST OF ANY OTHER MEDICINES YOU MAY BE TAKING

POSSIBLE SIDE EFFECTS

which could be related to deficiency, particularly in mainly with concomitant suiphur.releasing medicinal

Like all medicines, 10 mg scored tablets can cause side effects, although not all patients have them Adverse reactions listed by System Organ Class Fiequencies are defined using the following convention very common (51/10), common (51/100, <1/10). uncommon (51/1000, <1/100). rare (51/10000, <1/1000), very rare (<1/10000). not known (cannot be estimated from the available data) Stood

+ Not known Methaemoglobmaemia.

NADH cytochrome b5 reductase  deficency,particularly in neonates Sulfhaemoglobinaemia, mainly with concomitanr administration of high doses of products

States tisyfeg

+ Uncommon Bradycardia, particularly with intravenous formulation

+ Not known Cardiac arrest occurring shortly after injectable use, and which can be subsequent to bradycardia, Atrioventricular block. Sinus arrest particularly with intravenous formulation. Electrocardiogram QT prolonged. Torsade de Pomtee.

Endocrine disorders during prolonged treatment in relation with hyperprolactmaema

+ Uncommon Amenorrhea hyperprotecbnaenia

–        Rare Galactorrhea

–        Not known Gymtecomestta Qastr&ntesbnal dflogto

+ Common Diarrhea Asthenia.

Uncommon Hypersensitivity

Not known Anaphylactic reaction

Nervous system disorders

– Very common Somnolence

– Common Extrapyramdal disorders ( children and young adults and/or when the recommended dose is extent even following administration of Parkinsonism.)

– Uncommon stoma dyskmesia depressed level of consciousness

– Rare Convulsion especially in epileptic patients.

Not known Tardive dysfcmesta which may be persistent during or after prolonged treatment particularly m elderly patients Neuroleptic malignant syndrome

Psychiatric disorders

Common Depression

Uncommon Hallucination

Rare Confustonal state

Vescuter disorders

–        Common Hypotension particularly with miMvenoua formulation

–        Not knovm Shock syncope after injectable use Acute hypertension in patients with pnaeoehromocytoma

The following reactions sometimes associated, occur more frequently when hah doses are used:

+ Extrapyramdal symptoms acute dystonia and dyskinesia, parkinsonian syndrome, akathisra. even following administration of a single dose of the medicinal product particularly in children and young adults

+ Drowsiness decreased level of consciousness, confusion, hallucination

IF YOU NOTICE ANY SIDE EFFECTS PLEASE INFORM YOUR DOCTOR OR PHARMACIST

PHARMACODYNAMIC PROPERTIE:

Pharmacotherapeutic Propulsive

ATCcode A03FA01 ( A limentary tract and metabolism)

Metoclopramide belong to the family dopamine antagonists. it acts on intestinal

PHARMACOKINETIC PROPERTIES

Absorption

Metoclopramide is rapidly absorbed from the gastrointestinal tract. Bioavailability is generally 80%, however this may vary between individuals due to the hepatic first-pass effect

Distribution

Metocloppramide is extensively The volume of distnbubon is 2.2 to 3 4 l/kg Plasma protein binding is low

The drug crosses the placental barrier and is excreted m breastmik

Metabolism

Metoclopramide undergoes slight metabolism

Excretion

Metoclopramide Is mainly excreted  the urine in the unbound or sulfoconjugated form The elimination- half-life is S to 6 hours This value increases in patients with kidney or liver failure

3. OVERDOSE

Symptoms

Extrapyramidal disorders, drowsiness decreased level of consciousness, confusion, hallucination and cardiorespiratory arrest may occur Management

In case of extrapyiansdel symptoms related or not to overdose metoclopramde should be discontinued and the treatment is only symptomatic (benzodiazepines in children and/or anticholinergic antiparkinsonian medicinal products in adults) A symptomatic treatment and a continuous monitoring of the cardiovascular and respiratory functions should be carried out according to dimcal status

STORAGE

Keep out of the reach and sight of children

Do not take Primperan 10mg scored tablets after the expiry date indicated on the box

Store at a temperature no higher than 250C Do not throw away any medicines via wastewater or household wests Ask your pharmacist hot to throw away medicines you no longer use These measures will help protect the environment

Shelf-life: 60 months

Specifications: Manufacturer

Some drugs have composition  metoclopramide : Cirulan , Maxolon , Pliva

Cirulan-metoclopramide

Maxolon-metoclopramide

Pliva-metoclopramide

 

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