Zipelor Forte

Zipelor Forte



Joint Stock Company


Full Prescribing Info
Benzydamine hydrochloride.
Each ml of Zipelor Forte contains: Benzydamine Hydrochloride 3 mg/ml.
1 released spray contains 0.51 mg of benzydamine hydrochloride. 15 ml packed in amber glass bottle equipped with a plastic metered-dose pump-dispenser for oral use with a protective cap.
Excipients/Inactive Ingredients: Ethanol 96% - 80 mg/ml, Glycerol, Methyl parahydroxybenzoate (as antimicrobial preservative) - 1.0 mg/ml, Saccharin sodium, Macrogolglycerol hydroxystearate, Mint (flavour), Purified water.
Pharmacology: Pharmacodynamics: The mechanism of anti-inflammatory action of benzydamine is not related to stimulation of the pituitary-adrenal axis. Like other non-steroidal anti-inflammatory agents, benzydamine inhibits the biosynthesis of prostaglandins under certain conditions, but its properties in this respect have not been fully elucidated. The stabilising effect on cellular membranes may also be involved in the mechanism of action.
Benzydamine is an anti-inflammatory analgesic agent structurally unrelated to the steroid group. Benzydamine differs chemically from other non-steroidal anti-inflammatory agents in that it is a base rather than an acid.
Pharmacokinetics: Benzydamine is well absorbed following oral administration. Following topical administration, benzydamine is well absorbed into the inflamed local mucosa where it exerts anti-inflammatory and local anaesthetic actions. Plasma benzydamine levels following use are low and proportionate to the amount actually ingested.
Benzydamine and its metabolites are excreted largely in the urine. Metabolism is largely excreted by oxidative pathways, although dealkylation can be shown.
Benzydamine has been detected in blood and urine following gargling of solution form. Most of the absorbed dose is eliminated in the first 24 hours. Repeated administration for 7 days does not result in accumulation of benzyldamine in plasma.
Zipelor forte is indicated 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.
Dosage/Direction for Use
Do not use Benzydamine Spray in or near the eyes. If any spray gets into the eyes, wash them immediately with cold water.
Spray directly onto the affected area of the mouth or throat as follows: Adults and children over 12 years: 2-4 sprays (1-2 mg) directly onto the sore/inflamed area and swallow gently. Repeat every 1 ½ to 3 hours as necessary.
Children (6-12 years): 2 sprays (1 mg) directly onto sore/inflamed area and swallow gently. Repeat every 1 ½ to 3 hours as necessary.
Children under 6 years: Not recommended.
Uninterrupted treatment should not exceed seven days, unless under medical supervision.
Mode of Administration: Oral.
There are no known cases of overdosage with Zipelor Forte. Adverse CNS effects have been reported following overdosage with high doses of Zipelor Forte. There is no specific antidote for benzydamine. If an excessive quantity is ingested, the treatment should be symptomatic.
Patients with known hypersensitivity to benzydamine or to the other components listed.
Special Precautions
If a sore throat is either caused or complicated by a bacterial infection, appropriate antibacterial therapy should be considered in addition to the use of Zipelor Forte.
Effects on Ability to Drive and Use Machine: When used in the recommended doses, the drug has no effect on the ability to drive and use machines.
Use In Pregnancy & Lactation
The safety of benzydamine hydrochloride has not been established in pregnant patients. If patient is pregnant or breast-feeding, think they may be pregnant or are planning to have a baby, talk to a doctor, dentist or pharmacist before using any medicine.
Adverse Reactions
Zipelor Forte is generally well-tolerated and side effects are minor.
The following adverse reactions have been reported after use of benzydamine hydrochloride in solution form: Local Adverse Reaction: The most commonly reported reaction is oral numbness. Occasional burning or stinging sensation may occur. Other local adverse effects were less common and included dryness or thirst, tingling, warm feeling in mouth and altered sense of taste.
Systemic Adverse Reactions: These were uncommon and consisted mainly of nausea, vomiting, retching, gastrointestinal disorders, dizziness, headache and drowsiness.
Hypersensitivity reactions occur very rarely but may be associated with pruritus, rash, urticaria, photodermatitis and occasionally laryngospasm or bronchospasm.
Drug Interactions
There are no known drug interactions with benzydamine.
Caution For Usage
Incompatibilities: There are no known incompatibilities with benzydamine.
Instructions for use: 1. To use the spray, hold the bottle in an upright position.
2. The first time patient uses the spray, take the transparent cup off. Put the cup with spray arm on the bottle. Point the spray arm away from patient and anyone else. Then press the white plunger down firmly several times until a fine spray appears out of the end of the spray arm. The spray is now ready to use.
3. Point the spray arm at the sore part of throat or mouth and press the white plunger down firmly. One press releases one spray of medicine.
4. Apply the correct number of sprays according to the instruction previously mentioned. Then wipe the end of the spray arm with a clean tissue. This helps to prevent spray blocking.
5. If spray blocks or stops working properly, return it to the pharmacist. Do not push anything into the end of the spray arm to try to clear a blockage.
No additional cleaning is required in use of the product.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines patient no longer use. These measures will help protect the environment.
Store in the original packaging at below 30°С. Do not use this medicine after the expiry date, which is stated on the bottle and carton. After opening, store it below 25°С for 12 months.
Shelf life: Shelf-life of the product is 24 months. After opening, do not keep it more than 12 months.
MIMS Class
Preparations for Oral Ulceration & Inflammation
ATC Classification
R02AX03 - benzydamine ; Belongs to the class of other throat preparations.
Zipelor Forte oromucosal spray 3% w/v
((15 mL)) 1's
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