Zypelor

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

Composition:

Active substance: benzydamine;

1 ml of spray contains benzydamine hydrochloride 1.5 mg;

Excipients: ethanol 96%, glycerol, methylparaben (E 218), sodium saccharin, sodium hydrogen carbonate, polysorbate 20, peppermint flavor, purified water.

Pharmaceutical form. Oral spray.

Main physicochemical properties: clear, colorless liquid with a characteristic minty odor.

Pharmacotherapeutic group.
Agents for use in dentistry. Other agents for local application 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 mainly via the urine, primarily 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/gingival mucosa 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 dentist.

Benzydamine is not recommended for 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, including those with a history of asthma. Such patients must be warned accordingly.

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

For athletes: the use of medicinal products containing ethyl alcohol may result in a positive 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 data available on the use of benzydamine in pregnant or breastfeeding women. The ability of this product to pass into breast milk has not been studied. Animal studies are insufficient to draw any 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.

Effect on ability to drive and use machines.

When used at the recommended doses, this medicinal product does not affect the ability to drive or operate machinery.

Method of administration and dosage.

Set the spray pump to the working position.

Pressing the pump produces an aerosol containing 1 spray dose – 0.17 ml, corresponding to 0.255 mg of benzidamine hydrochloride.

Dosing

Adults: 4–8 sprays 2–6 times daily.

Children (6–12 years): 4 sprays 2–6 times daily.

Children (4–6 years): 1 spray per every 4 kg of body weight. The maximum dose is equivalent to 4 sprays 2–6 times daily.

Do not exceed the recommended doses.

Children.

The drug can be used in children aged 4 years and older.

Overdose.

There have been no reports of overdose with benzidamine when used topically.

In case of accidental ingestion of a large amount of benzidamine (> 300 mg), especially in children, poisoning may occur. Characteristic signs of overdose after ingestion include gastrointestinal symptoms (most commonly nausea, vomiting, abdominal pain, esophageal irritation) and central nervous system symptoms (dizziness, hallucinations, excitement, convulsions, tremor, excessive sweating, ataxia, anxiety, and irritability).

Such acute overdose requires immediate gastric lavage, treatment of water-electrolyte imbalances, symptomatic therapy, and adequate hydration.

Side effects.

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

Adverse reactions are classified according to their frequency of occurrence: very common (≥ 1/10); common (from ≥ 1/100 to < 1/10); uncommon (from ≥ 1/1000 to < 1/100); rare (from ≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); frequency not known (cannot be estimated from 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 alteration.

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 edema; frequency not known – rash, itching, 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.

15 ml or 30 ml in a bottle. 1 bottle in a box.

Release category.

Over-the-counter.

Manufacturer.

JSC "Farmak".

Manufacturer's address and location of activity.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.