You are here: News Patient Information Leaflets in Local Languages Reminder to all pharmaceutical manufacturers and importers NMRA wishes to remind you that the decision to include a patient information leaflet in Sinhala and Tamil languages on the following prescription on

Patient Information Leaflets in Local Languages Reminder to all pharmaceutical manufacturers and importers NMRA wishes to remind you that the decision to include a patient information leaflet in Sinhala and Tamil languages on the following prescription on

Patient Information Leaflets in Local Languages

Reminder to all pharmaceutical manufacturers and importers

NMRA wishes to remind you that the decision to include a patient information leaflet in Sinhala and Tamil languages on the following prescription only medicines on a trial basis will come to effect from 1st March 2018.

  1. Anti-diabetic drugs                             -           Metformin, Insulins
  2. Antihypertensive drugs                       -           Losartan potassium
  3. Statins                                              -           Atorvastatin, Simvastatin
  4. Common antimicrobial drugs               -           Co-amoxiclav, Ciprofloxacin
  5. Antiplatelet drugs                               -           Aspirin

Translation of the entire product information leaflet is not required. Specific information which promotes safe and effective use of medicine should be included in a simple language readily comprehensible to the consumer. The information provided should be scientifically accurate and consistent with the approved product information.

The following information shall be included in the patient information leaflet

(a)    Name of the medicine (generic and brand if applicable), dosage  form, strength and net content of active ingredient(s),

(b)    Any specific age groups for which the medicine is intended to, if applicable

(c)     What is this medicine used for?

(d)    How much and how often should the medicine be taken, and how long the course of treatment will last?

(e)    Any other specific directions about how to use the medicine

(f)      Symptoms of serious or frequent possible adverse effects/undesirable effects and what to do if such effect is experienced

(g)    When this medicine should not be used?

(h)    What other medicines or food should be avoided while taking this medicine

(i)      What should be done, if a dose is missed?

(j)      Any risks to the mother and the fetus or the infant from the use of the medicine during pregnancy or breast-feeding.

(k)     Information for any other special groups of patients, if applicable

(l)      Any other precautions that should be taken while taking this medicine

(m)  Signs and symptoms of overdose and what to do if more than the recommended dose has been taken

(n)    How should the medicine be stored?

(o)    Information on in-use shelf-life after dilution, reconstitution, or first opening, if applicable

(p)    General advices e.g. ‘keep away from children’, as decided by the Authority

(q)    The name and address of the manufacturing site

(r)    The name and address of the marketing authorization holder

The required patient information shall be provided as part of the product information leaflet, a separate package insert, or shall be stated on the label. NMRA welcomes sharing of a common leaflet by the importers & manufacturers.