4.1. Therapeutic indications

Symptomatic and local treatment at the pharynx. Proposed as disinfectant and local pain-killer of sore throat and disorders of the pharynx and mouth accompanied by irritation, the presence of lidocaine causes a quick alleviation of the symptoms.

In case of a bacterial infection accompanied by fever, a supplementary treatment is required.

Covonia Lozenges Lemon is sugar free and can therefore also be used in diabetic patients.

4.2. Posology and method of administration

Posology

Adults: 6 to 10 tablets per day, to melt slowly in the mouth.

Children from 12 years old: half dose.

This medicine is intended as symptomatic treatment and should not be used on a long-term basis. If there is no improvement within 3 to 4 days of treatment, it is advisable to consult a doctor.

Method of administration

Oromucosal use

4.3. Contraindications

Children younger than 12 years old.

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, and in particular to local anaesthetics such as lidocaine.

4.4. Special warnings and precautions for use

Disinfecting substances do not make sterile; they temporarily reduce the number of micro- organisms at the oral cavity and pharynx.

Restrict the use of this medicine to the necessary alleviation of the existing pain and irritation. It must not be administered on a long term basis, in an uninterrupted or repeated manner.

Avoid the use of this medicine in persons with extreme allergic predisposition.

The use of a too high dose (more than 20 tablets per day) can cause a small risk on too great insensitivity of the glottis area, which can cause a diminished control on the swallowing reflex and food aspiration in the airways can occur.

Covonia Lozenges Lemon contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

The additive effect of concomitantly administered products containing sorbitol (fructose) and dietary intake of sorbitol (fructose) should be taken into account.

The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.

Covonia Lozenges Lemon also contains aspartame. This contains a source of phenylalanine and may be harmful for people with phenylketonuria.

Aspartame is hydrolysed in the gastrointestinal tract when orally ingested. One of the major hydrolysis products is phenylalanine.

4.5. Interaction with other medicinal products and other forms of interaction

Due to possible interferences (opposite action or inactivation) the simultaneous or consecutive use of antiseptics should be avoided.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no or limited amount of data from the use of lidocaine and chlorhexidine in pregnant women.

Studies in animals have shown no reproductive toxicity (see section 5.3)

The use of Covonia Lozenges Lemon may be considered during pregnancy, if necessary.

Breast-feeding

Lidocaine is excreted in breast milk but in small quantities that there is generally no risk of the infant being affected at therapeutic dose levels. There is no data on excretion of chlorhexidine in breast milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Covonia Lozenges Lemon therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman

Fertility

There are no relevant data on human fertility available. Animal data with lidocaine does not indicate an effect on male fertility in rats. Animal data with chlorhexidine suggests depression of ovarian activity in mice. The relevance of these finding to humans is not known however are limited given the local exposure to the patient with Covonia Lozenges lemon.

4.7. Effects on ability to drive and use machines

The use of Covonia Lozenges Lemon has no influence on the ability to drive and use machines.

4.8. Undesirable effects

Side effects are classified according to organ system with evaluation of the frequency according to the following convention: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10000, < 1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).

Nervous System Disorders

Common: Oral paraesthesia/hypoaesthesia

Immune system disorders (frequency not known)

It should be taken into account that rare allergic reactions of the skin and mucous membrane, which are caused by contact with anaesthetics of the amide-type, such as lidocaine can occur: cases of dermatitis and rashes, which were caused by this product in other circumstances, have been described.

Anaphylactic reactions may occur.

Taste disorders, and a burning feeling on the tongue may occur.

Prolonged and continuous use of chlorhexidine can cause brown-discoloration of the teeth. However, this brown-discoloration is removable.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for “MHRA Yellow Card” in the Google Play or Apple App Store.

4.9. Overdose

Although this medicine contains only a fraction of the toxic dose and although the foreseen use of this composed medicine is limited to local use, the possibility of an overdose by mistake or carelessness should be taken into account, especially in children.

Symptoms of intoxication:

Lidocaine can cause a systematic intoxication (toxic dose for adults from 0.5 g onwards), which affects the central nervous system and the cardiovascular system.

restlessness, yawning, nervousness, tinnitus, nystagmus, muscle tremor, convulsions, depression, dyspnea.

reduced contractility of the heart muscle, peripheral vasodilation, hypotension, bradycardia, disturbed cardiac rhythm, cardiac arrest.

Chlorhexidine is resorbed in very little amounts from the gastrointestinal tract.

Antidote: none.

Treatment:

Systemic intoxication:

Immediately stop the intake of the medicine.

Hospitalization to ensure the respiration, to counteract dehydration and to maintain the blood circulation.

In case of seizures: diazepam

Choking:

Clear the airways, application of the Heimlich-manoeuvre.

If the obstruction persists, hospitalize the patient.