Zypelor

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

Composition:

Active ingredient: benzidamine hydrochloride;

1 lozenge contains benzidamine hydrochloride 3 mg, equivalent to 2.68 mg of benzidamine;

Excipients: isomalt (E 953); citric acid, monohydrate; aspartame (E 951); quinoline yellow (E 104); honey flavor; orange flavor; peppermint oil; cochineal red (E 124).

Pharmaceutical form. Lozenges.

Main physicochemical properties: Round, orange-colored lozenges, 19 mm in diameter, with honey and orange flavor.

Pharmacotherapeutic group. Preparations used in throat disorders.

ATC code R02A X03.

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 irritative pathological processes in the oral cavity and pharynx. In addition, benzidamine exerts a moderate-intensity anti-inflammatory and local analgesic effect on the mucous membrane 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. Approximately 2 hours after administration of a 3 mg pastille, the maximum plasma concentration of benzidamine reaches 37.8 ng/mL, and the AUC value is 367 ng/mL×h. However, this is insufficient to produce any systemic pharmacological effect. Excretion occurs primarily via 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 pain, irritation, and inflammation of the oropharynx.

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

No interaction studies have been conducted.

Special precautions for use

In some patients, oral pharyngeal mucosal ulcers may be caused by serious pathological conditions. Therefore, patients whose symptoms worsen or do not improve within 3 days, or who develop fever or other new symptoms, should consult a physician or, where appropriate, a dentist.

Benzydamine is not recommended for patients with hypersensitivity to acetylsalicylic acid or to other nonsteroidal anti-inflammatory drugs.

This medicinal product may cause bronchospasm in patients with bronchial asthma or a history of bronchial asthma. Such patients should use the product with caution.

This medicinal product contains isomalt. If you have been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicinal product.

This medicinal product contains aspartame, a phenylalanine derivative, which may be harmful for patients with phenylketonuria.

This medicinal product contains cochineal red (E 124), which may cause allergic reactions.

Use during pregnancy or breastfeeding

Currently, there are insufficient adequate data on the use of benzydamine in pregnant or breastfeeding women. It is not known whether this product passes into 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.

Effects on ability to drive or operate machinery

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

Dosage and Administration.

The lozenges should be slowly dissolved in the mouth.

Adults and children aged 6 years and older: 1 lozenge 3 times daily.

Do not swallow the lozenges. Do not chew the lozenges.

The duration of treatment should not exceed 7 days.

Children.

This medicinal form is intended for children aged 6 years and older.

Children aged 6–11 years should use this medicinal product under adult supervision.

Overdose.

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

However, it is known that benzidamine, when ingested in large doses (hundreds of times higher than the possible doses of this medicinal form), especially in children, may cause excitation, convulsions, tremor, nausea, excessive sweating, ataxia, and vomiting. Such acute overdose requires immediate gastric lavage, correction of fluid and electrolyte imbalances, symptomatic treatment, and adequate hydration.

Adverse reactions.

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

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

Gastrointestinal disorders:
Rare — burning sensation in the mouth, dry mouth; frequency not known — oral hypoaesthesia.

Immune system disorders:
Rare — hypersensitivity reactions; frequency not known — anaphylactic reactions.

Respiratory, thoracic and mediastinal disorders:
Very rare — laryngospasm.

Skin and subcutaneous tissue disorders:
Uncommon — photosensitivity; very rare — angioneurotic edema.

Shelf life. 3 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 the reach and sight of children.

Packaging. 10 or 12 pastilles in a blister. 1, 2 or 3 blisters in a carton.

Supply classification. Over-the-counter (without prescription).

Manufacturer.

1. Lozy’s Pharmaceuticals S.L., Spain.
2. INFARMADE, S.L., Spain.

Manufacturer's address and place of business.

1. Campus Empresarial, Lekaroz, Navarra, 31795, Spain.
2. Calle De La Torre De Los Herberos 35, Poligono Industrial Carretera De La Isla, Dos Hermanas, 41703, Spain.

Marketing Authorization Holder. JSC "Farmak".

Address of the Marketing Authorization Holder. 63, Kyrylivska Street, Kyiv, Ukraine, 04080.