Zypelor

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ZIPELOR® (ZIPELOR)

Composition:

Active substance: benzydamine;

1 ml of solution contains benzidamine hydrochloride 1.5 mg;

Excipients: ethanol 96%, glycerol, methylparaben (E 218), sodium saccharin, sodium bicarbonate, polysorbate 20, peppermint flavoring, quinoline yellow 70% (E 104), patent blue V (E 131), purified water.

Pharmaceutical form. Oral solution.

Main physicochemical properties: clear green liquid with a characteristic peppermint odor.

Pharmacotherapeutic group. Agents for use in dentistry. Other agents for local use in the oral cavity.

ATC code A01AD02.

Pharmacological properties.

Pharmacodynamics.

Benzidamine is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-exudative properties.

Clinical studies have demonstrated that benzidamine is effective in relieving symptoms associated with localized inflammatory conditions of the oral cavity and pharynx. In addition, benzidamine exerts anti-inflammatory and local analgesic effects on the mucous membranes of the oral cavity.

Pharmacokinetics.

Absorption through the mucous membranes of the oral cavity and pharynx has been confirmed by the presence of measurable amounts of benzidamine in human plasma. However, these concentrations are insufficient to produce any systemic pharmacological effect. Excretion occurs primarily via the urine, mainly in the form of inactive metabolites or conjugated compounds.

It has been shown that topical application leads to accumulation of an effective concentration of benzidamine in inflamed tissues due to its ability to penetrate through the mucous membrane.

Clinical characteristics.

Indications.

Symptomatic treatment of irritations and inflammations of the oropharynx; pain caused by gingivitis, stomatitis, pharyngitis; in dentistry, used after tooth extraction or for prophylactic purposes.

Contraindications.

Hypersensitivity to the active substance or to other components of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Studies on interaction have not been conducted.

Special precautions for use

If sensitivity occurs during prolonged use, treatment should be discontinued and a physician should be consulted for appropriate management.

In some patients, ulcers of the buccal mucosa/throat may be caused by serious underlying pathological conditions. Therefore, patients whose symptoms worsen or do not improve within 3 days, or who develop fever or other new symptoms, should seek medical advice from a physician or, where appropriate, a dentist.

Benzidamine should not be used in patients with hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs).

The use of this medicinal product may cause bronchospasm in patients with bronchial asthma or a history of bronchial asthma. Such patients must be warned accordingly.

This medicinal product contains a small amount of ethanol (alcohol), less than 100 mg per dose.

For athletes: the use of medicinal products containing ethyl alcohol may result in a positive anti-doping test.

This medicinal product contains methylparaben (E 218), which may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding

There are currently insufficient adequate data on the use of benzidamine in pregnant or breastfeeding women. It is not known whether this product is excreted in breast milk. Animal studies are insufficient to allow conclusions regarding the effects of this product during pregnancy or breastfeeding. The potential risk to humans is unknown.

Zipelor® should not be used during pregnancy or breastfeeding.

Ability to influence reaction speed when driving or operating machinery

When used at the recommended doses, this medicinal product has no effect on the ability to drive or operate machinery.

Method of Administration and Dosage

Measure 15 ml of Zipelor® solution from the bottle using the provided measuring cup and rinse the oral cavity with the undiluted solution or diluted solution (15 ml of the solution can be diluted with 15 ml of water). Rinse 2–3 times daily. Do not exceed the recommended dose.

Children

The product must not be used in children under 12 years of age due to the risk of accidentally swallowing the solution during mouth rinsing.

Overdose

There have been no reports of benzidamine overdose with topical administration.

In case of accidental ingestion of a large amount of benzidamine (> 300 mg), poisoning may occur. Characteristic signs of overdose following oral ingestion include gastrointestinal symptoms (most commonly nausea, vomiting, abdominal pain, esophageal irritation) and central nervous system effects (dizziness, hallucinations, excitement, anxiety, and irritability).

Very rarely, ingestion of high doses of benzidamine by children (hundreds of times higher than the recommended doses for this dosage form) has been associated with excitement, seizures, tremor, nausea, excessive sweating, ataxia, and vomiting. Such acute overdose requires immediate gastric lavage, treatment of fluid and electrolyte imbalances, symptomatic therapy, and adequate hydration.

Adverse reactions.

Within each frequency group, adverse effects are listed in order of decreasing occurrence.

Adverse reactions are classified by frequency of occurrence: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000); very rare (< 1/10000); frequency not known (cannot be estimated based on available data).

Gastrointestinal disorders: rare − burning sensation in the mouth, dry mouth; frequency not known − oral hypoaesthesia, nausea, vomiting, swelling and discoloration of the tongue, taste alterations.

Immune system disorders: rare − hypersensitivity reaction; frequency not known − anaphylactic reaction.

Respiratory, thoracic and mediastinal disorders: very rare − laryngospasm; frequency not known − bronchospasm.

Skin and subcutaneous tissue disorders: uncommon − photosensitivity; very rare − angioneurotic oedema; frequency not known − rash, pruritus, urticaria.

Nervous system disorders: frequency not known − dizziness, headache.

Shelf life. 2 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

100 ml in a bottle. 1 bottle per carton.

Pharmaceutical category.

Over-the-counter.

Manufacturer.

JSC "Farmak".

Manufacturer's address and location of its business activity.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.