Tyrozets Lozenges

  • Name:

    Tyrozets Lozenges

  • Company:
    info
  • Active Ingredients:

    Benzocaine, Tyrothricin

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/10/17

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Summary of Product Characteristics last updated on medicines.ie: 18/6/2019

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Johnson & Johnson (Ireland) Ltd

Johnson & Johnson (Ireland) Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name ACTIFED 30 mg/1.25 mg per 5 ml Syrup Active Ingredients Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name ACTIFED 60 mg / 2.5 mg Tablets Active Ingredients Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name Arret 2mg Hard Capsules Active Ingredients Loperamide Hydrochloride
Medicine Name Benylin Children's Chesty Coughs Active Ingredients Guaifenesin
Medicine Name Benylin Children's Dry Coughs Active Ingredients Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Cough Medicine Syrup Active Ingredients Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Day and Night Tablets Active Ingredients Diphenhydramine Hydrochloride, Paracetamol, Pseudoephedrine Hydrochloride
Medicine Name Benylin Dry Coughs Syrup Active Ingredients Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Dual Action Dry Syrup Active Ingredients Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name Benylin Four Flu Tablets Active Ingredients Diphenhydramine Hydrochloride, Paracetamol, Pseudoephedrine Hydrochloride
Medicine Name Benylin Non- Drowsy for Chesty Coughs Active Ingredients Guaifenesin, Levomenthol
Medicine Name BENYLIN Non-Drowsy Dry Coughs, Syrup Active Ingredients Dextromethorphan Hydrobromide
Medicine Name Benylin Phlegm Cough plus Decongestant Syrup Active Ingredients Guaifenesin, Pseudoephedrine Hydrochloride
Medicine Name Benylin Phlegm Cough Syrup Active Ingredients Guaifenesin, Levomenthol
Medicine Name Calpol 120mg/5ml Infant Oral Suspension Active Ingredients Paracetamol
Medicine Name Calpol Infant 120mg/5ml Sugar Free Oral Suspension (bottle) Active Ingredients Paracetamol
Medicine Name Calpol Infant 120mg/5ml Sugar Free Oral Suspension (sachets) Active Ingredients Paracetamol
Medicine Name CALPOL Six Plus 250mg/5ml Oral Suspension Active Ingredients Paracetamol
Medicine Name CALPOL SIX PLUS 250mg/5ml SUGAR/COLOUR FREE ORAL SUSPENSION Active Ingredients Paracetamol
Medicine Name CALPOL Six Plus Fastmelts 250 mg Paracetamol OrodispersibleTablets Active Ingredients Paracetamol
Medicine Name Daktarin 2% w/w Cream Active Ingredients Miconazole nitrate
Medicine Name Daktarin 2% w/w Cutaneous Powder Active Ingredients Miconazole nitrate
Medicine Name DAKTARIN 20mg/g Oral Gel Active Ingredients Miconazole
Medicine Name Imodium 2 mg Capsules Active Ingredients Loperamide Hydrochloride
Medicine Name Imodium Instants 2mg Orodispersible Tablets Active Ingredients Loperamide Hydrochloride
1 - 0 of 65 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 18 June 2019 SmPC

Reasons for updating

  • File format updated to PDF

Legal category: Supply through pharmacy only

Updated on 2 November 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 2 November 2017 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

 

PA Transfer from McNeil Healthcare (Ireland) Ltd to Johnson & Johnson

 

(Ireland) Ltd. Change in PA number. Note the address and contact details remain the same.

 

Updated on 27 October 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 27 October 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 26 April 2017 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Changes made to the text have been highlighted in red, text that has been underlined has been added, and text that has been struck through has been removed:


1. NAME OF THE MEDICINAL PRODUCT

TYROZETS

 

Lozenges

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each lozenge contains:

Tyrothricin 1mg

Benzocaine 5mg

Excipient

 

s with known effect:

 

Sucrose 989.19mg

For

 

a the full list of excipients, see section 6.1.

 

4.2 Posology and method of administration

Adults

 

and children 12 years and older: One lozenge to be dissolved slowly in the

 

mouth every three hours. Do not exceed 8 lozenges in 24 hours.

Children aged 3

 

to 11 years and older: dosage should be reduced in children aged 3-11.

 

Maximum 6 lozenges in 24 hours.

 

Tyrozets are not recommended for children under the

 

age of three years.Do not use this medicine in children less than 3 years of age.

If an adequate response is not evident within two days, consider stopping Tyrozets

lozenges

 

 

. Do not use for longer than five consecutive days.

 

To allow maximum contact with inflamed tissues, Tyrozets

 

lozenges should not be

 

chewed or swallowed whole, but allowed to dissolve slowly in the mouth.

4.3 Contraindications

Hypersensitivity to tyrothricin

 

, or to benzocaine or to any of the excipients listed in

 

section 6.1

 

 

. If evidence of sensitivity occurs during therapy, Tyrozets lozenges should be

 

discontinued.

4.4 Special warnings and precautions for use

The use of antibiotics may cause over-growth of non-susceptible organisms. If new

infections due to bacteria or fungi appear during therapy, Tyrozets

 

lozenges should be

 

stopped and appropriate measures taken.

Topical use of Tyrozets

 

lozenges as an aid to prevention of local infection in no way

 

alters the need for adequate systemic therapy if an infection should develop.

Tyrozets contain sucrose, which may produce dental caries and destabilise otherwise

well-controlled diabetes.

Benzocaine may cause methaemoglobinaemia, a rare but serious condition that must be

treated promptly because it reduces the amount of oxygen carried in the blood. Patients

should stop use and seek immediate medical attention if they develop pale, grey or blue

coloured skin, lips and nail beds; headache; tachycardia; shortness of breath; dizziness or

light-headedness; confusion; fatigue or lack of energy. Symptoms may occur at any time

after using benzocaine.

Those most at risk of developing methaemoglobinaemia are children aged two or

younger, the elderly and patients with certain inborn errors of metabolism such as

glucose-6-phosphodiesterase deficiency, haemoglobin-M disease, NADHmethaemoglobin

reductase (diaphorase 1) deficiency, and pyruvate-kinase deficiency.

Patients who have breathing problems such as asthma, bronchitis, or emphysema,

patients with heart disease, and patients who smoke are at greater risk for complications

related to methaemoglobinaemia. In the most severe cases, methaemoglobinaemia can

result in death.

Due to the local anaesthetic property of

 

Tyrozetsbenzocaine, it may be necessary either

 

to avoid

 

 

food and drink should be avoided directly after taking a lozengewhen

 

anaesthesia is at its maximum, or to rinse the mouth with water after eating

 

 

, to prevent

 

any further trauma to the mucous membranes.

Tyrozets lozenges contain sucrose, which may produce dental caries and destabilise

otherwise well-controlled diabetes.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose

malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

4.6

 

Fertility, pPregnancy and lactation

 

No special precautions.

There are no or limited amount of data from the use of benzocaine and tyrothricin in

pregnant women. It is unknown whether benzocaine or tyrothricin or their metabolites

are excreted in human milk.

This product should not be used during pregnancy and lactation unless the potential

benefit of treatment to the mother outweighs the possible risks to the developing fetus or

nursing infant.

4.9 Overdose

Symptoms

Tyrozets

 

lozenges should only be sucked in the mouth. Insertion into the nasal cavity

 

can damage the sensory epithelium with risk of prolonged loss of smell.

 

Parenteral use

 

of tyrothricin may result in haemolysis, liver and kidney damage.

There are no reports found in the literature describing the overdose potential of the

combination of benzocaine and tyrothricin.

No adverse events were identified from the analysis of post-marketing data for the

combination of benzocaine and tyrothricin.

Parenteral use of tyrothricin may result in haemolysis, liver and kidney damage.

Management

No antidote to either tyrothricin or benzocaine is available. Treatment of overdosage

should be symptomatic and supportive; emesis should be induced or gastric lavage

performed.

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Throat preparations,

 

Antibiotics ATC code: R02A

 

AR02AB02

 

 

.

 

Tyrothricin from

 

Bacillus brevis is a complex mixture of several polypeptides and its

 

main action stems from the content of neutral gramicidins (20%), which neutralise the

phosphorylation of the respiration chains. It is effective mainly against gram positive

bacteria and cocci, against some fungi and some gram negative bacteria.

Benzocaine is a local anaesthetic of the ester type which remains localised for long

periods of time to produce anaesthetic action. It is poorly soluble in water.

6.4 Special precautions for storage

Do not store above 25

 

C. Store in the original package to protect from light.

 

6.6 Special precautions for disposal

 

of a used medicinal product or waste materials

 

derived from such medicinal product and other handling of the product

No special requirements.No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance

with local requirements.

10. DATE OF REVISION OF THE TEXT

July 2015

 

 

13 April 2017






























Updated on 24 April 2017 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 10 August 2015 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 7 August 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Addition of the following text to Section 4.8

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

Updated on 22 May 2009 SmPC

Reasons for updating

  • Change to marketing authorisation holder

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 7

Changed to:

McNeil Healthcare (Ireland) Limited

Airton Road 
Tallaght

Dublin 24

Ireland

Section 8

Changed  to :

PA 823/54/1

Updated on 22 May 2009 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 25 August 2008 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 23 May 2008 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 23 May 2008 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only