Zeptaloz Lemon 0,6 mg & 1,2 mg Lozenge
PDF Leaflet Revision Date: 29 August 2023
Clinical Summary
Quick overview from the medicine insert
Indication
Relief of minor mouth and throat infections.
Dosage (summary)
Dissolve 1 lozenge every 2-3 hours, max 12 lozenges/24 hours. No dosage reduction for elderly.
Special Populations
- Children under 6 years
Pregnancy & Breastfeeding
Limited data in pregnancy; caution advised. Unknown if excreted in breast milk.
Contraindications
- Hypersensitivity to ingredients
- Children under 6 years
Common side effects
- Hypersensitivity reactions
- Glossodynia
- Oral discomfort
Counselling Points
- Use the lowest effective dose for the shortest duration
- Contains sugar; caution in diabetics
Serious warnings
- Consult doctor if sore throat persists for more than two days
- Choking hazard for young children
Important Disclaimer
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
ZEPTALOZ: is used for the relief of minor mouth and throat infections.
4.2 Posology and method of administration
Posology
Unless otherwise prescribed by your doctor, the standard dose is:
Adults and children over 6 years
u2022 The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.
u2022 Dissolve one lozenge slowly in the mouth every 2 to 3 hours.
u2022 Do not exceed 12 lozenges in any 24-hour period.
Elderly
There is no need for dosage reduction in the elderly.
Paediatric population
ZEPTALOZ is not suitable for children under 6 years (see section 4.3)
Method of administration
For oral administration
To be dissolved slowly in the mouth
4.3 Contraindications
- Hypersensitivity to 2,4-dichlorobenzyl alcohol, amylmetacresol or to any of the excipients in ZEPTALOZ (see section 6.1)
- Children under 6 years of age
4.4 Special warnings and precautions for use
When a sore throat persists for more than two days, consult your doctor.
Excipient warning
ZEPTALOZ contains glucose and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltose insufficiency should not take ZEPTALOZ.
Paediatric population
Not to be given to children under 6 years (see section 4.3).
Remember young children can choke on lozenges.
4.5 Interaction with other medicines and other forms of interaction
No clinically significant interactions are known.
4.6 Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of amylmetacresol and 2,4-dichlorbenzyl alcohol in pregnancy. Care should be taken when using this product in pregnancy and medical advice sought if necessary.
Breastfeeding
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.
Fertility
No data available
4.7 Effects on ability to drive and use machines
ZEPTALOZ has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
Immune System Disorders
Frequency unknown: Hypersensitivity ab1
Gastrointestinal Disorders
Frequency unknown: Glossodynia ab , oral discomfort ab
a 2,4-dichlorobenzyl alcohol, b amylmetacresol
1 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 authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8
4.9 Overdose
Overdosage should not present a problem other than gastrointestinal discomfort. Treatment should be symptomatic.
