Drug Registration Number: 2A 21/68

SUMMARY OF PRODUCT CHARACTERISTICS 
1. Name of the medicinal product 
VIKNOX THROAT ORANGE 
2. Qualitative and Quantitative Composition 
Each lozenge contains: 
  o 2,4-Dichlorobenzyl Alcohol. 1.2 mg 
  o Amylmetacresol 0.6 mg 
For the full list of excipients, see section 5.1 
3. Pharmaceutical Form 
Orange-round compressed lozenge 
4. Clinical Particulars 
4.1 Therapeutic indications 
For relief symptom of sore throat. 
4.2 Posology and method of administration 
Adults and children over 6 years old: One lozenge to be dissolved slowly in the mouth every 2-3 hours up to a maximum of 12 lozenges in 24 hours 
Method of Administration: For oral administration. To be dissolved slowly in the mouth. 
4.3 Contraindications 
Hypersensitivity to any of the ingredients. 
4.4 Special warnings and precautions for use 
If symptoms persist, have not improved, or have worsened after 2 days, consult a doctor or pharmacist. Pregnant and breastfeeding women should consult a doctor or pharmacist before using medicine. Shouldn’t be used in children under 6 years. 
4.5 Interaction with other medicinal products and other forms of interaction 
No clinically significant interactions are known 
4.6 Fertility, Pregnancy and lactation

• Fertility: No data are available regarding the effects on fertility.
• Pregnancy: There are no or limited amount of data from the use of amylmetacresol and 2,4-dichlorbenzyl alcohol. As with all medicines care should be taken when using this product in pregnancy and medical advice sought if necessary.
• Lactation: It is unknown whether 2,4-Dichlorobenzyl alcohol, amylmetacresol or metabolites are excreted in human milk. A risk to the newborns / infants cannot be excluded.

4.7 Effects on ability to drive and use machines. 
No or negligible influence on the ability to drive and use machines. 
4.8 Undesirable effects 
The list of the following adverse effects relates to those experienced with 2,4-dichlorobenzyl alcohol and amymetacresol at Low risk medicidine doses, in short term use. 
Adverse events which have been associated with 2,4-Dichlorobenzyl alcohol and amylmetacresol are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (<1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

*2,4-Dichlorobenzyl alcohol and amylmetacresol 
** Hypersensitivity reactions may include rash, urticaria and angioedema, which may include swelling of the face, neck, throat or tongue that could affect breathing. 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Health Product Vigilance Center; HPVC. 
5. Pharmaceutical particulars 
5.1 List of excipients 
Sorbitol, Maltodextrin, Magnesium stearate, Calcium hydroxide, Menthol crystal, Orange flavor, Sunset yellow lake 
5.2 Incompatibilities 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. 
5.3 Shelf life 
1 year 
5.4 Special precautions for storage 
Store at a temperature not exceeding 30°C. Store the drug in a dry place. Keep out of reach of children. 
5.5 Nature and contents of container 
A blister push through pack consisting of hard temper aluminium foil heat sealed to a light resistance PVC/PVDC blister. The tray contains an appropriate number of lozenges to give a pack size of 8 lozenges, 10 blisters packed into a cardboard box. 
6. Marketing authorisation Holder 
TPI Biopharmaceuticals Co., Ltd. (Thailand) 
299/99 Moo 5, Tumbon Thap Kwang, Kaeng Khoi District, Saraburi 18260, Thailand

This drug information is a summary. 
If you have any questions, please consult your doctor or pharmacist.