PRIMPERAN 10MG SUPPOSITORIES

Ülke: Malezya

Dil: İngilizce

Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktif bileşen:

METOCLOPRAMIDE HYDROCHLORIDE

Mevcut itibaren:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (International Adı):

METOCLOPRAMIDE HYDROCHLORIDE

Paketteki üniteler:

10Units Units

Tarafından üretildi:

Unither Liquid Manufacturing

Bilgilendirme broşürü

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1
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_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
PRIMPERAN
® SUPPOSITORY
_ _
Metoclopramide (10mg)
_ _
WHAT IS IN THIS LEAFLET
1. What Primperan Suppository is
used for
2. How Primperan Suppository works
3. Before you use Primperan
Suppository
4. How to use Primperan Suppository
5. While you are using it
6. Side effects
7. Storage and Disposal of Primperan
Suppository
8. Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
WHAT PRIMPERAN SUPPOSITORY IS USED
FOR
Primperan Suppository is used to
prevent nausea and vomiting induced
by chemotherapy or radiotherapy in
adult.
HOW PRIMPERAN SUPPOSITORY WORK
Primperan Suppository contains active
substance metoclopramide which
belongs to a group of medicines called
antiemetics. It works by blocking the
action of a chemical in the brain and
prevent vomiting.
BEFORE YOU USE PRIMPERAN
SUPPOSITORY
_- When you must not use it _
Do not use Primperan Suppository if:
• You are allergic (hypersensitive) to
metoclopramide or to any of the other
ingredients of this medicine (listed in
Ingredients at the end of the leaflet).
• You are a child who under 18 years of
age.
• You have gastrointestinal bleeding,
obstruction or perforation.
• You have had rectal bleeding or
inflammation of the lining of rectum
(proctitis)
• You have a tumour on the adrenal
gland causing severe high blood
pressure called ‘pheochromocytoma’
• You have had heamoglobin
abnormalities related to
metoclopramide
(methemoglobinemia) or a hereditary
disease affecting the red blood cells
due to an enzyme deficiency in the
past.
• You have already presented with
abnormal movement (tardive
dyskinesia) during treatment with
neuroleptics or metoclopramide.
• You have epilepsy.
• You have parkinson’s disease
(rigidity, tremor)
Do not use this medicine if any of the
above apply to you. If you are not sure,
talk to your doctor or pharmacist
before using Primperan Suppository.
_- Before you start to use it _
Check with your doctor before using
Primperan

Ürün özellikleri

NAME OF THE MEDICINAL PRODUCT Primperan ® 10 mg scored suppositories QUALITATIVE AND QUANTITATIVE COMPOSITION Metoclopramide............................................................................................................... ................. ..........0.01 g for one scored suppository. For the complete list of excipients, see list of excipients. PHARMACEUTICAL FORM Scored suppository. CLINICAL PARTICULARS Therapeutic indications Adult spopulation : Primperan ® 10 mg scored suppositories is indicated in adults for: Symptomatic treatment of nausea and vomiting - Prevention of d elayed chemotherapy induced nausea and vomiting (CINV) - Prevention of radiotherapy induced nausea and vomiting (RINV) . Posology and method of administration For us e in adults only. Rectal use. 1 suppository contains 10 mg of metoclopramide. The suppositories are scored. All Indications (adults) The recommended dosage is 10mg per dose, 1 to 3 times daily. The maximum recommended daily dose is 30mg or 0.5mg/kg. Delayed nausea and vomiting not induced by antimitotic agents : ½ to 1 suppository per dose, 3 times daily, before meals, allowing an inter val of at least 6 hours between doses. Delayed nausea and vomiting induced by antimitotic agents : 0.5 mg/kg/dose, 4 times daily, i.e. 1 suppository per 20 kg body weight per dose, allowing an interval of at least 6 hours between doses. Treatment for periods of more than 3 months should be avoided. The maximum recommended treatment duration is 5 days. Method of admini stration : A minimum interval of 6 hours between two administrations is to be respected, even if vomiting or rejection of the dose occurs (see Special warnings and precautions for use). Special populations Elderly subjects In elderly subjects, a dose red uction should be considered, based on kidney and liver function, and overall frailty. Kidney failure In patients with end -stage kidney failure (creatinine clearance ≤ 15 ml/min), the daily dose should be reduced by 75%. In patients with moderate to severe kidney fa