TYMORA OROMUCOSAL SPRAY 0.3% W/V [SIN17050P]
Active ingredients: TYMORA OROMUCOSAL SPRAY 0.3% W/V
Product Info
TYMORA OROMUCOSAL SPRAY 0.3% W/V
[SIN17050P]
Product information
Active Ingredient and Strength | BENZYDAMINE HYDROCHLORIDE - 0.3% W/V |
Dosage Form | SPRAY |
Manufacturer and Country | LABORATORIUM SANITATIS S.L. - SPAIN |
Registration Number | SIN17050P |
Licence Holder | APEX PHARMA MARKETING PTE. LTD. |
Forensic Classification | PHARMACY ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | A01AD02 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
3. WHAT TYMORA OROMUCOSAL SPRAY 0.3% W/V IS USED FOR
Tymora Oromucosal Spray 0.3% w/v is a locally acting analgesic and anti-inflammatory for the temporary relief of painful conditions of the mouth and throat, including tonsillitis, sore throat, radiation mucositis, aphthous ulcers, pharyngitis, swelling, redness, inflammatory conditions, post orosurgical and periodontal procedures.
Dosing
5. HOW TO USE TYMORA OROMUCOSAL SPRAY 0.3% W/V
For oromucosal use only.
Adults and children over 12 years: 2–4 sprays (1–2 mg) directly onto the sore/inflamed area and swallow gently. Repeat every 1 1/2 to 3 hours as necessary.
Children (6–12 years): 2 sprays (1 mg) directly onto sore/inflamed area and swallow gently. Repeat every 1 1/2 to 3 hours as necessary.
Children under 6 years: Not recommended.
Uninterrupted treatment should not exceed seven days, unless under medical supervision.
Instruction for use:

Symptoms And Treatment for Overdosage
Symptoms
Tymora Oromucosal Spray is unlikely to cause adverse systemic effects, even if accidental ingestion should occur. Intoxication is only expected in case of accidental ingestion of large quantities of benzydamine (> 300 mg).
Symptoms associated with overdose of ingested benzydamine are mainly gastrointestinal symptoms and symptoms of the central nervous system. Most frequent gastrointestinal symptoms are nausea, vomiting, abdominal pain and oesophageal irritation. Symptoms of the central nervous system include dizziness, hallucinations, agitation, anxiety and irritability.
Treatment
There is no specific antidote for benzydamine hydrochloride. In acute overdose only symptomatic treatment is possible. Patients should be kept under close observation and supportive treatment should be given. Adequate hydration must be maintained.
Contraindications
4. WHAT YOU NEED TO KNOW BEFORE YOU USE TYMORA OROMUCOSAL SPRAY 0.3% W/V
Do not use Tymora Oromucosal Spray 0.3% w/v
If you are allergic to benzydamine hydrochloride or any of the other ingredients of this medicine.
