ANGAL MENTHOL 2mg/ml + 0.5mg/ml spray 30ml
BRIEF CHARACTERISTICS OF THE MEDICINAL PRODUCT
- NAME OF THE MEDICINAL PRODUCT
Angal Menthol 2 mg/ml+0.5 mg/ml, spray for oral mucosa, solution
Angal Menthol 2 mg/ml+0.5 mg/ml, oromucosal spray, solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 2 mg of chlorhexidine digluconate and 0.5 mg of lidocaine hydrochloride.
Excipients with known effect: ethanol.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Oral mucosal spray, solution.
Angal Menthol is a clear, colorless solution.
4. CLINICAL DATA
4.1 Therapeutic indications
Angal Menthol is indicated for symptomatic and local treatment of diseases of the pharynx. It acts as a disinfectant and local anesthetic for sore throats and conditions of the pharynx and oral cavity accompanied by irritation and painful swallowing, such as pharyngitis, gingivitis, stomatitis and aphthae. The presence of lidocaine in the composition leads to rapid relief of symptoms.
In cases of bacterial infection accompanied by high fever, additional treatment is required.
Angal Menthol does not contain sugar and can be used by diabetics.
4.2 Dosage and method of administration
Dosage :
Adults and children over 12 years of age: 3 to 5 sprays, 6 to 10 times a day.
Children over 6 years : 2 to 3 injections, 3 to 5 times a day.
Angal Menthol should not be used in children under 6 years of age.
This medicinal product is intended for symptomatic treatment and should not be used long-term.
If there is no improvement after 3-4 days of treatment and the patient has a bacterial infection with fever, a doctor's consultation is recommended and treatment of the infection is necessary.
Application method
Oropharyngeal administration.
Before use, the patient should hold the applicator perpendicular to the bottle.
The patient should open his mouth wide, point the applicator towards the pharynx and press the button. During the application, you should hold your breath.
In case the spray will not be used for a period of time, it is recommended to clean the applicator after the last use using the following procedure:
- The spray should be turned back and the button should be pressed until the solution in the applicator is removed (the applicator no longer sprays solution).
- The applicator should be detached from the bottle and placed in warm water for a few minutes.
- Remove the applicator from the water and wait for it to dry.
- To block the mechanism of the bottle, the dry applicator should be placed on it so that it points down.
Angal Menthol Spray should not be used immediately before or during a meal.
- Contraindications
-
- Hypersensitivity to the active substances or to any of the excipients listed in point 6.1.
- Children under 6 years of age.
- Alcohol dependence
- Children with a history of muscle cramps (including febrile seizures) as this product contains levomenthol
Angal Menthol is not compatible with some substances commonly found in toothpastes. For this reason, there should be an interval of at least 30 minutes between the use of Angal Menthol spray and toothpaste.
4.4 Special warnings and precautions for use
In bacterial infections accompanied by elevated body temperature, chlorhexidine/lidocaine is used only as an additional therapy.
When used by patients with heart failure, impaired liver function and those treated with lidocaine analogues (class I antiarrhythmics), caution is required, as the adverse effects of lidocaine may increase.
Caution is advised when using chlorhexidine/lidocaine in patients prone to hypersensitivity reactions.
Use of this medicinal product should be limited to relief of pain and irritation. The use of this medicinal product should not be long-term and continuous.
If no improvement occurs after 3-4 days of treatment, it is necessary to prescribe additional treatment.
Avoid contact with eyes. If the spray accidentally gets into the eyes, they should be immediately flushed with clean water or an eyewash solution for at least 15 minutes, with the eyes open.
There is a small risk of insensitivity of the glottis area and reduced control of the swallowing reflex leading to aspiration of food into the respiratory tract when using very high doses (more than 1 pack per day).
After application, do not take food or drink or brush your teeth.
Angal Menthol contains sodium and ethanol.
This medicine contains less than 1 mmol sodium (23 mg) per 100 ml, i.e. it can be said to be practically sodium-free.
This medicinal product contains small amounts of ethanol (alcohol) up to 180 mg for 5 puffs, equivalent to 4.5 ml of beer or 2 ml of wine for 5 puffs.
Harmful for people suffering from alcoholism. To be considered in pregnant or women,
who are breastfeeding, children and high-risk groups such as patients with liver disease or
epilepsy.
Pediatric population
Angal Menthol spray is contraindicated in children under 6 years of age.
4.5 Interaction with other medicinal products and other forms of interaction
Lidocaine is a known inhibitor of the liver enzyme CYP1A2 and, to a lesser extent, isoenzymes 2D6 and 3A4, but interactions with substrates of these enzymes when administered according to recommendations are of no clinical significance.
Patients should not co-administer chlorhexidine/lidocaine with cholinesterase inhibitors (eg, neostigmine, distigmine, pyridostigmine) or with other medicinal products for the treatment of myasthenia gravis.
During treatment with chlorhexidine/lidocaine, patients should not simultaneously apply other local antiseptics to disinfect the throat. This does not apply to other medicinal products containing chlorhexidine/lidocaine due to the same composition. When combining spray with lozenges, the recommended daily dose should not be exceeded.
Chlorhexidine is incompatible with anionic substances (eg, sodium lauchyl sulfate) and certain other substances (eg, alginates, tragacanth) that are often used with toothpastes. For this reason, there should be at least 30 minutes between using the toothpaste and chlorhexidine/lidocaine.
Pediatric population
The combination of spray and lozenges should not be used in children.
4.6 Fertility, pregnancy and lactation
Pregnant women and those who are breastfeeding should note that Angal Menthol contains 44.4% alcohol.
This medicinal product is intended for local treatment. If the listed warnings and restrictions on use are taken into account, this medicinal product can be used during pregnancy and breastfeeding. Female patients should be advised to inform their treating physician.
4.7 Effects on the ability to drive and use machines
No studies have been conducted on the effects of chlorhexidine/lidocaine on the ability to drive and use machines.
- Adverse drug reactions
Good tolerability has been observed with local application in the mouth and pharynx, for short periods of time, at the recommended doses.
Adverse drug reactions are listed by system organ class and based on the following frequency convention:
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (frequency cannot be estimated from the available data)
Disorder of the immune system
Common: skin hypersensitivity reactions
Rare: severe hypersensitivity reactions, including anaphylactic shock
Very rare : urticaria
With an unknown frequency: delayed hypersensitivity reaction (contact allergy, photosensitivity) or other local skin reaction or tooth reaction.
Psychiatric disorders
With unknown frequency: anxiety, nervousness, euphoria
Disorders of the nervous system
Not known: drowsiness, dizziness, disorientation, confusion (including slurred speech), vertigo, tremor, psychosis, nervousness, paresthesia, tingling, convulsions, loss of consciousness, coma
Eye disorders
Not known: visual disturbances, including blurred or double vision
Disorder of the ear and labyrinth
With an unknown frequency: tinnitus
Respiratory, thoracic or mediastinal disorders
Not known: asthma, dyspnoea, respiratory distress syndrome, respiratory depression, respiratory arrest
Gastrointestinal disorders
Common: nausea, vomiting, abdominal pain
With an unknown frequency: difficulty swallowing, aphthae
Disorder of the skin and subcutaneous tissue
Rare: contact dermatitis
With an unknown frequency: peeling of the skin, swelling of the parotid gland
Musculoskeletal and connective tissue disorders
Not known: muscle twitching or tremors
General violation and violations at the place of application
With an unknown frequency: asthenia, transient taste disturbances or burning sensation of the tongue, sensation of hot or cold
Disorder of the blood and lymphatic systems
With an unknown frequency: methemoglobinemia
With long-term use of chlorhexidine (on the entire surface of the oral cavity), it is possible that a transient brown discoloration of the teeth may appear. This staining can be cleaned. No staining was reported when the drug was applied to the pharyngeal area.
Pediatric population
The frequency and severity of adverse reactions in children is expected to be the same as in adults.
Reporting of suspected adverse reactions
Post-marketing reporting of suspected adverse reactions is important. This allows continued monitoring of the benefit/risk ratio of the medicinal product. Medical professionals are required to report any suspected adverse reaction through the national reporting system to the Medicines Executive Agency, 8 Damyan Gruev Street, 1303 Sofia, phone: +359 2 8903417, website: www.bda.bg.
- Overdose
Although this medicinal product is intended for topical use, there is a possibility of overdose due to error or carelessness, especially in children.
Chlorhexidine is absorbed in a very small amount from the gastrointestinal tract. Lidocaine is absorbed faster, but its bioavailability is only 35%. The toxic effects of lidocaine occur at plasma concentrations higher than 6 mg/l.
After the administration of excessive doses (more than 20 lozenges per day), swallowing disorders (decreased control of the swallowing reflex) may occur exceptionally.
Systemic intoxication is the result of affecting the central nervous system and the cardiovascular system. The first effects of overdose are disorders of the central nervous system.
Based on the data on acute, subacute and chronic toxicity of the two active substances, when used correctly and in the recommended spray doses, the risk of strong systemic effects of lidocaine is very low and mainly related to improper use.
Symptoms of intoxication:
Lidocaine can cause systemic intoxication (the toxic dose for adults is over 0.5 g), affecting the central nervous system and the cardiovascular system.
The symptoms are:
- headache, hallucinations, dizziness, drowsiness, restlessness, paraesthesia, speech or hearing disorders, numbness around the mouth, metabolic acidosis, psychosis, epileptic coma, depressed consciousness, fatigue, yawning, nervousness, tinnitus, nystagmus, muscle tremors, convulsions , depression, dyspnea.
- decreased contractility of the heart muscle, peripheral vasodilatation, hypotension, bradycardia, disturbed heart rhythm (sinus arrest, tachyarrhythmia), cardiac arrest, circulatory collapse.
In addition to these symptoms, isolated cases of chlorhexidine overdose with the following symptoms are known: pharyngeal edema, necrotic lesions of the esophagus, increased levels of serum transaminases (30 times higher than normal), vomiting, gastric and duodenal erosions with active atrophic gastritis, euphoria, visual disturbances and complete loss of taste (which lasts 8 hours).
Treatment:
Systemic intoxication:
- Immediately stop using the medicinal product;
- Anionic substances are applied;
- Hospitalization to ensure recovery of breathing, control of dehydration and maintenance of blood circulation;
- In cases of seizures: diazepam.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: throat preparations, ATC code: R02AA05
Lidocaine hydrochloride is a local, peripherally acting anesthetic of the amide group, which has a superficial analgesic effect without affecting motor function at the site of application. It acts locally in the form of a non-ionized base. Lidocaine has a favorable efficacy/toxicity ratio and very rarely can cause allergic reactions.
Chlorhexidine is considered an excellent oral antiseptic. One of its main advantages, in addition to its powerful antimicrobial action, is its ability to bind to a variety of substrates, retaining its antibacterial activity, and to be gradually released, resulting in long-term maintenance of effective concentrations. This property is called substantiality (surface activity).
Chlorhexidine is a cation-active antiseptic agent. It has a strong bactericidal effect against both gram-positive and gram-negative bacteria (eg Micrococcus sp., Staphylococcus sp., Streptococcus sp., Bacillus sp., Clostridium sp., Corynebacterium sp. ). It also has an antimycotic effect against dermatophytes and yeasts, and appears to exhibit an antiviral effect against some viruses ( in vitro activity against influenza, HSV-1, HSV-2 ).
Chlorhexidine has a strong positive charge; therefore, it binds to the negatively charged bacterial cell wall and extracellular structures. Adsorption is specific and affects the phosphate-containing parts of the bacterial cell wall.
Chlorhexidine binds to the negatively charged surfaces of the oral mucosa, teeth and intra-oral plaque, which contributes to the long-term availability of chlorhexidine in the oral cavity. In a human study, it was found that solutions containing 0.2% chlorhexidine retained their antibacterial effect for up to 7 hours after administration.
5.2 Pharmacokinetic properties
Small amounts may reach the digestive system when small amounts of Angal Menthol are swallowed or via saliva. Chlorhexidine is not absorbed in the gastrointestinal tract. After topical application to healthy skin, chlorhexidine is adsorbed into the upper layer of the skin, resulting in a long-lasting antibacterial effect on the skin. In pharmacokinetic studies, it was found that about 30% of chlorhexidine is retained in the oral cavity after rinsing, which is then gradually released into the saliva.
Resorption of the local anesthetic lidocaine can be observed from the oral and pharyngeal mucosa. However, most of it is degraded before reaching the systemic circulation. The anesthetic effect with local application of lidocaine manifests itself from the second minute and lasts from 30 to 45 minutes. The anesthesia is superficial and does not cover the submucosal structures.
5.3 Preclinical safety data
Published nonclinical data indicate that chlorhexidine and lidocaine are well tolerated.
6. PHARMACEUTICAL DATA
6.1 List of excipients
Ethanol
Glycerol
Anhydrous citric acid
Levomenthol
Cineol
Saccharin-sodium
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Expiry Date
30 months
6.4 Special storage conditions
To be stored in a place inaccessible to children. To be stored below 25 o C. Do not use Angal Menthol after the expiry date, which is stated on the box/label after the inscription "Expired by:". The first two characters mean the month, the next two or four characters the year. The expiration date corresponds to the last day of the specified month. Angal Menthol can be used up to 3 months after first opening.
- Type and contents of packaging
Spray pump bottle containing 30 ml of oral mucosal spray.
6.6 Special precautions for disposal and handling
There are no special requirements.
7. HOLDER OF THE USE AUTHORIZATION
Sandoz dd
Verovškova 57,
1000 Ljubljana
Slovenia
8. USE AUTHORIZATION NUMBER(S).
Reg. No: 20160318
9. DATE OF FIRST AUTHORIZATION/RENEWAL OF THE MARKETING AUTHORIZATION
Date of first authorization: November 2016
10. TEXT UPDATE DATE
04/2019
