Consumer medicine information

Pramin 10 mg Tablets

Metoclopramide hydrochloride

BRAND INFORMATION

Brand name

Pramin

Active ingredient

Metoclopramide hydrochloride

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Pramin 10 mg Tablets.

1. Why am I taking PRAMIN?


PRAMIN contains the active ingredient metoclopramide hydrochloride. PRAMIN is used to manage nausea and vomiting.
For more information, see Section 1. Why am I taking PRAMIN? in the full CMI.

2. What should I know before I take PRAMIN?


Do not take if you are allergic to medicines containing metoclopramide hydrochloride or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I take PRAMIN? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with PRAMIN and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take PRAMIN?

  • Adults 20 years and over - 1 tablet every 8 hours.
  • Adolescents: 15 to 19 years - ½ to 1 tablet every 8 hours.
  • The dose varies with the age of the patient and reason for use. Children and adolescents are very sensitive to the effects of PRAMIN. Your doctor will normally start the treatment at the lower dose.

More instructions can be found in Section 4. How do I take PRAMIN? in the full CMI.

5. What should I know while taking PRAMIN?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are taking PRAMIN.
  • Tell your doctor if nausea and vomiting persist.
  • Tell your doctor if you become pregnant while taking PRAMIN.
  • If you are going to have surgery, tell the surgeon or anaesthetist you are taking PRAMIN.
Things you should not do
  • Do not exceed the recommended dose.
  • Do not give this medicine to anyone else, even if they have the same condition as you.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how PRAMIN affects you.
  • PRAMIN may cause dizziness, light-headedness, tiredness or drowsiness in some people.
Drinking alcohol
  • Drinking alcohol whilst taking PRAMIN may make you sleepy.
Looking after your medicine
  • Store in a cool dry place where the temperature stays below 30°C.
  • Keep your tablets in the original container until it is time to take them.

For more information, see Section 5. What should I know while taking PRAMIN? in the full CMI.

6. Are there any side effects?


Less serious side effects include drowsiness, tiredness, restlessness, dizziness, headache, bowel irregularities, insomnia, anxiety and agitation.
Some of the more serious side effects include uncontrolled or repeated movements, (e.g., sucking or smacking of the lips, darting of the tongue, chewing movements, uncontrolled movements of the arms or legs), fast or irregular heartbeat, depression, and swelling of hands, ankles or feet.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Pramin

Active ingredient

Metoclopramide hydrochloride

Schedule

S4

 

1 Name of Medicine

Metoclopramide hydrochloride monohydrate.

2 Qualitative and Quantitative Composition

Each Pramin tablet contains metoclopramide hydrochloride monohydrate as the active ingredient, equivalent to 10 mg of metoclopramide hydrochloride.
Excipients with known effect. Contains sugars as lactose and trace amounts of sulfites.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Pramin 10 mg tablet. White, normal convex, marked "ME" over "10" on one side, G on reverse.

4 Clinical Particulars

4.9 Overdose

Clinical features. Overdose of metoclopramide may be expected to produce effects that are extensions of common adverse reactions: drowsiness, disorientation and extrapyramidal reactions have been the principal effects reported. Other reported effects associated with metoclopramide overdose have included feelings of anxiety or restlessness, headache, vertigo, nausea, vomiting, constipation, weakness, hypotension and xerostomia. A-V block has been observed very rarely.
Management. Treatment of metoclopramide overdosage generally involves symptomatic and supportive care. Extrapyramidal reactions may be controlled by antiparkinsonian agents such as benztropine, or antihistamines with anticholinergic action such as diphenhydramine. Appropriate therapy should be instituted if hypotension or excessive sedation occurs. Methaemoglobinaemia should be treated with methylene blue. Haemodialysis and continuous ambulatory peritoneal dialysis appears ineffective in removing metoclopramide.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Chemical name: 4-amino- 5-chloro-N-(2-diethylaminoethyl)- 2-methoxybenzamide hydrochloride monohydrate.
Structural formula:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMETMON.gif Molecular formula: C14H22ClN3O2,HCl,H2O. Molecular weight: 354.3.
Metoclopramide hydrochloride is a white or almost white, crystalline powder; odourless or almost odourless. It is soluble in 0.7 parts of water, in 3 parts of ethanol (96%) and in 55 parts of chloroform. It is practically insoluble in ether.
CAS number. 54143-57-6.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes

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