Product Info Leaflet - Lozenge

Bactidol® Extra Soothing

1.2 mg/600 mcg Lozenge
Antiseptic

PATIENT INFORMATION LEAFLET

Product Description

Honey Lemon flavor
Dichlorobenzyl Alcohol + Amylmetacresol (Bactidol Extra Soothing) 1.2 mg/600 mcg Honey Lemon Flavor Lozenge is a brownish yellow coloured, round, biconvex lozenges having honey lemon flavor with sweet taste.

Orange flavor
Dichlorobenzyl Alcohol + Amylmetacresol (Bactidol Extra Soothing) 1.2 mg/600 mcg Orange Flavor lozenge is an orange coloured, round, biconvex lozenges having orange flavor with sweet taste.

What is in the Medicine and the Strength of the Medicine?

Each Lozenge contains:
2,4-Dichlorobenzyl Alcohol……………………1.2 mg
Amylmetacresol……………………………….600 mcg

What is this Medicine used for?

  • For symptomatic treatment of acute sore throat
  • For symptomatic treatment of acute and chronic pharyngitis, catarrh (irritation or inflammation) of the upper respiratory tract and relief of unpleasant post-operative sensation in the throat

How much and how often should you use this Medicine?

Adults and children 6 years and over:

  • The daily recommended dose is 1 lozenge every 2-3 hours with a maximum daily dose of 8 lozenges.
  • Dissolve one lozenge slowly in the mouth.
  • Do not chew or swallow the lozenge whole.
  • The treatment course duration is 5-7 days.
  • Not to be administered for children below 6 years of age

When should you not take this Medicine?

None known.

Care that should be taken when taking this Medicine

If symptoms persist or worsen, or if new symptoms occur, consult a physician.
Use during pregnancy and lactation:
2,4-Dichlorobenzyl alcohol and Amylmetacresol Combination:
There are no adequate and well-controlled clinical studies in pregnant or breast- feeding women for the combination of dichlorobenzyl alcohol and amylmetacresol but is not expected to contribute increased risk of malformations, spontaneous abortions or decreased birthweight.
It is not known whether 2,4-Dichlorobenzyl alcohol and Amylmetacresol or its metabolites are excreted in breast milk.
This product should not be used during pregnancy or lactation unless the potential benefit of treatment to the mother outweighs the possible risks to the developing fetus or nursing infant. Ask a physician before use if you are pregnant or breastfeeding.
Effects on ability to drive and use machines:
It is not known if the combination of 2,4-Dichlorobenzyl alcohol and Amylmetacresol has an effect on the ability to drive and use machines.

Undesirable Effects of the Medicine

Clinical Trial Data:
Placebo-controlled studies with sufficient adverse event data were not available for the combination of 2,4-Dichlorobenzyl alcohol and amylmetacresol.

Post Marketing Data:
No adverse events were identified from the analysis of the dichlorobenzyl alcohol and amylmetacresol which warrants inclusion in the undesirable effects section.

What other Medicine or Food should be avoided while taking This Medicine?

There are no known drug interactions with 2,4-Dichlorobenzyl alcohol and Amylmetacresol.

What should you do if you miss a dose?

Continue medication based on dosage and/or consult your doctor.

Signs and Symptoms of Overdose

There are no reports found in the literature describing the overdose potential of the combination 2,4-Dichlorobenzyl alcohol and Amylmetacresol.
No adverse events were identified from the analysis of post marketing data for 2,4-Dichlorobenzyl alcohol and Amylmetacresol which warrants inclusion in the Overdose section.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

What to do when you have taken more than the recommended dosage?

Consult your doctor if you have taken more than the recommended dosage.

How should you keep this Medicine?

Store at temperatures not exceeding 30°C.

When should you consult your doctor?

If symptoms persist or worsen, or if new symptoms occur, stop use and consult your doctor.

Imported & Distributed by:

JNTL Consumer Health (Philippines), lnc., KM 14 Edison Road, Merville, Parañaque City. Philippines

Manufactured by:

Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd.) Survey Number 101/2 and 102/1, Daman Industrial Estate, Airport Road, Kadaiya, Daman, 396210, India

Patients must seek medical attention immediately at the first sign of any adverse drug reaction.

For suspected adverse drug reaction, report to the FDA: www. fda.gov.ph.

Registration No.:

Honey Lemon Flavor: DR-XY46810
Orange Flavor: DR-XY46809

Date of First Authorization:

Honey Lemon Flavor: 23 January 2020
Orange Flavor: 23 January 2020
CCDS Version: 24 March 2016