Benylin Dry Coughs Syrup

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Summary of Product Characteristics last updated on medicines.ie: 30/11/2018

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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 30 November 2018 SmPC

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  • Previous version of SmPC reinstated

Legal category: Supply through pharmacy only

Updated on 3 October 2018 PIL

Reasons for updating

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

Updated on 3 October 2018 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

Updated on 14 May 2018 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category: Supply through pharmacy only

Updated on 8 May 2018 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 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains

Updated on 13 January 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 13 January 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

Text that has been highlighted and underlined has been added, text that has been struck through has been removed:

4.4 Special warnings and special

precautions for use

Do not use with any other product containing

diphenhydramine, even one used on skin

This product may cause drowsiness, (See

section 4.8 Undesirable Effects) if affected;

individuals should not drive or operate

machinery.

Caution should be exercised if moderate to

severe renal and/or hepatic impairment is

present, [See Pharmacokinetics].

This product may act as a cerebral stimulant

in children and occasionally in adults.

Patients with the following conditions should

be advised to consult a physician before

using this product:

• Persistent or chronic cough such as occurs

with smoking, asthma or emphysema or

where cough is accompanied by excessive

secretions

• Narrow angle glaucoma.

• Prostate hyperplasia with urinary retention.

If symptoms persist, please consult your

doctor.

Patients who are taking other medication and

/ or under the care of a physician, should

consult their doctor / pharmacist before

taking this product.

Diphenhydramine may enhance the sedative

effects of central nervous system depressants

including alcohol, sedatives, and

tranquilizers. Patients should be advised

while taking this product, to avoid alcoholic

beverages and consult a healthcare

professional prior to taking with central

nervous system depressants (see Section 4.5).

Cases of dextromethorphan abuse have

been reported. Caution is particularly

recommended for adolescents and young

adults as well as in patients with a history

of drug abuse or psychoactive substances.

Dextromethorphan is metabolised by

hepatic cytochrome P450 2D6. The activity

of this enzyme is genetically determined.

About 10% of the general population are

poor metabolisers of CYP2D6. Poor

metabolisers and patients with

concomitant use of CYP2D6 inhibitors

may experience exaggerated and/or

prolonged effects of dextromethorphan.

Caution should therefore be exercised in

patients who are slow metabolizers of

CYP2D6 or use CYP2D6 inhibitors (see

also section 4.5).

This product contains Ponceau 4R (E124) red

colouring which may cause allergic reactions.

This product contains 16.7mg sodium per

5ml. This should be taken into consideration

by those on a controlled sodium diet.

Patients with rare hereditary problems of

fructose intolerance, glucose-galactose

malabsorption or sucrase-isomaltase

insufficiency should not take this medicine.

This medicinal product contains 5 vol %

ethanol (alcohol), i.e. up to 200 mg per 5ml

dose, equivalent to approximately 5 ml beer,

2 ml wine per 5 ml dose. This can be harmful

for those suffering from alcoholism. The

ethanol content should be taken into account

in pregnant or breast-feeding women,

children and high-risk groups such as patients

with liver disease or epilepsy.

Do not exceed the recommended dose

schedule

4.5 Interaction with other medicaments

and other forms of interaction

Dextromethorphan:

MAOIs:

The concomitant use of a

 

dextromethorphan-containing product and

monoamine oxidase inhibitors (including the

antibacterial agent furazolidone), can

occasionally result in serotonin syndrome with

symptoms such as hyperpyrexia,

hallucinations, gross excitation or coma. See

section 4.3

Quinidine

: Dextromethorphan is primarily

 

metabolised by the cytochrome P450

isoenzyme CYP2D6; an interaction with

quinidine (CYP2D6 inhibitor) leading to

increased dextromethorphan plasma

concentrations has been described.

CYP2D6 inhibitors

Dextromethorphan is metabolized by

CYP2D6 and has an extensive first-pass

metabolism. Concomitant use of potent

CYP2D6 enzyme inhibitors can increase

the dextromethorphan concentrations in

the body to levels multifold higher than

normal. This increases the patient's risk

for toxic effects of dextromethorphan

(agitation, confusion, tremor, insomnia,

diarrhoea and respiratory depression) and

development of serotonin syndrome.

Potent CYP2D6 enzyme inhibitors include

fluoxetine, paroxetine, quinidine and

terbinafine. In concomitant use with

quinidine, plasma concentrations of

dextromethorphan have increased up to

20-fold, which has increased the CNS

adverse effects of the agent. Amiodarone,

flecainide and propafenone, sertraline,

bupropion, methadone, cinacalcet,

haloperidol, perphenazine and

thioridazine also have similar effects on

the metabolism of dextromethorphan. If

concomitant use of CYP2D6 inhibitors and

dextromethorphan is necessary, the

patient should be monitored and the

dextromethorphan dose may need to be

reduced.

Diphenhydramine

Alchohol and CNS Depressants:

This product contains diphenhydramine and

therefore may potentiate the effects of

alcohol and other CNS depressants such as

opioid analgesics, anticonvulsants,

antidepressants, antihistamines, antiemetics,

antipsychotics, anxiolytics and hypnotics.

Anticholinergic drugs:

As diphenhydramine

 

possess some anticholinergic activity, the

effects of anticholinergics (e.g. some

psychotrophic drugs and atropine) may be

potentiated by this product. This may result

in tachycardia, mouth dryness,

gastrointestinal disturbances (e.g. colic),

urinary retention and headache.

Menthol

None known.

5.2. Pharmacokinetics

Absorption

Diphenhydramine, dextromethorphan and

menthol are well absorbed from the gut

following oral administration. Peak serum

levels of diphenhydramine following a 50 mg

oral dose are reached at between 2 and 2.5

hrs after an oral dose. Due to individual

differences in the metabolism of

dextromethorphan [See Metabolism &

Elimination], pharmacokinetic values are

highly variable. After the administration of a

20 mg dose of dextromethorphan to healthy

volunteers, the C

max varied from < 1g/l to

 

8g/l, occurring within 2.5 hrs of

administration.

Distribution

Diphenhydramine

Diphenhydramine is widely distributed

throughout the body, including the CNS.

Following a 50 mg oral dose of

diphenhydramine, the volume of distribution

is in the range 3.3 - 6.8 L/kg, and it is some

78% bound to plasma proteins.

Dextromethorphan

Due to extensive pre-systemic metabolism by

the liver, detailed analysis of the distribution of

orally administered dextromethorphan is not

possible.

Metabolism and elimination

Diphenhydramine

Diphenhydramine undergoes extensive first

pass metabolism. Two successive Ndemethylations

occur, with the resultant

amine being oxidised to a carboxylic acid.

Values for plasma clearance of a 50 mg oral

dose of diphenhydramine lie in the range 600

- 1300 ml/min and the terminal elimination

half-life lies in the range 3.4 - 9.3 hours.

Little unchanged drug is excreted in the

urine.

Dextromethorphan

Dextromethorphan undergoes rapid and

extensive first-pass metabolism in the liver

after oral administration. Genetically

controlled O-demethylation is the main

determinant of dextromethorphan

pharmacokinetics in human volunteers. It

appears that there are distinct phenotypes for

this oxidation process resulting in highly

variable pharmacokinetics between subjects.

Unmetabolised dextromethorphan, together

with the three demethylated morphinan

metabolites; dextrorphan (also known as 3-

hydroxy-N-methylmorphinan), 3-

hydroxymorphinan and 3-methoxymorphinan

have been identified as conjugated products in

the urine. Dextrorphan, which also has

antitussive action, is the main metabolite.

Dextromethorphan undergoes rapid and

extensive first-pass metabolism in the liver

after oral administration. Genetically

controlled O-demethylation (CYD2D6) is

the main determinant of

dextromethorphan pharmacokinetics in

human volunteers.

It appears that there are distinct

phenotypes for this oxidation process

resulting in highly variable

pharmacokinetics between subjects.

Unmetabolised dextromethorphan,

together with the three demethylated

morphinan metabolites dextrorphan (also

known as 3-hydroxy-Nmethylmorphinan),

3- hydroxymorphinan

and 3-methoxymorphinan have been

identified as conjugated products in the

urine.

Dextrorphan, which also has antitussive

action, is the main metabolite. In some

individuals metabolism proceeds more

slowly and unchanged dextromethorphan

predominates in the blood and urine.

Menthol

Menthol is hydroxylated in the liver by

microsomal enzymes to p-methane -3,8 diol.

This is then conjugated with glucuronide and

excreted both in urine and bile as the

glucuronide.

Pharmacokinetics in Renal Impairment

The results of a review on the use of

diphenhydramine in renal failure suggest that

in moderate to severe renal failure, the dose

interval should be extended by a period

dependent on the glomerular filtration rate

(GFR).

There have been no specific studies of

BENYLIN Dry Coughs or dextromethorphan

in renal impairment.

Pharmacokinetics in Hepatic Impairment

After intravenous administration of 0.8

mg/kg diphenhydramine, a prolonged halflife

was noted in patients with chronic liver

disease which correlated with the severity of

the disease. However, the mean plasma

clearance and apparent volume of distribution

were not significantly affected.

There have been no specific studies of

BENYLIN Dry Coughs or dextromethorphan

in hepatic impairment.

Pharmacokinetics in the Elderly

Pharmacokinetic studies indicate no major

differences in distribution or elimination of

diphenhydramine compared to younger

adults.

There have been no specific studies of

BENYLIN Dry Coughs or dextromethorphan

in the elderly.

10.  Date of revision

 
23 December 2016



Updated on 9 January 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 9 January 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 14 August 2015 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 2:

Excipients: Each 5ml contains liquid glucose 3.49g, sucrose 1g, ethanol (96%) 0.260 ml and Ponceau 4R (E124) 250 micrograms.

Section 4.2

Posology
Adults and children 12 years and over:

Section 44:

Added:

Do not use with any other product containing diphenhydramine, even one used on skin.

Patients with the following conditions should be advised to consult a physician before using this product:

·         Persistent or chronic cough such as occurs with smoking, asthma or   emphysema or where cough is accompanied by excessive secretions

·         Narrow angle glaucoma.

·         Prostate hyperplasia with urinary retention.

 

Diphenhydramine may enhance the sedative effects of central nervous system depressants including alcohol, sedatives, and tranquilizers. Patients should be advised while taking this product, to avoid alcoholic beverages and consult a healthcare professional prior to taking with central nervous system depressants (see Section 4.5).

This product contains Ponceau 4R (E124) red colouring which may cause allergic reactions.

This product contains 16.7mg sodium per 5ml. This should be taken into consideration by those on a controlled sodium diet.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This medicinal product contains 5 vol % ethanol (alcohol), i.e. up to 200 mg per 5ml dose, equivalent to approximately 5 ml beer, 2 ml wine per 5 ml dose. This can be harmful for those suffering from alcoholism. The ethanol content should be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.

 

Deleted:

 

This product may act as a cerebral stimulant in children and occasionally in adults.

 

Benylin Dry Coughs should only be used under medical supervisions for persistent or chronic cough such as occurs with smoking, asthma or emphysema, or where cough is accompanied by excessive secretions.

Section 4.5:

 

Dextromethorphan:

MAOIs: The concomitant use of a dextromethorphan-containing product and monoamine oxidase inhibitors (including the antibacterial agent furazolidone),             can occasionally result in serotonin syndrome with symptoms such as hyperpyrexia, hallucinations, gross excitation or coma.  See section 4.3

Quinidine: Dextromethorphan is primarily metabolised by the cytochrome P450 isoenzyme CYP2D6; an interaction with quinidine (CYP2D6 inhibitor) leading to increased dextromethorphan plasma concentrations has been described.

 

Diphenhydramine

Alchohol and CNS Depressants:

This product contains diphenhydramine and therefore may potentiate the effects of alcohol and other CNS depressants such as opioid analgesics, anticonvulsants, antidepressants, antihistamines, antiemetics, antipsychotics, anxiolytics and hypnotics.

 

Anticholinergic drugs:

As diphenhydramine possess some anticholinergic activity, the effects of anticholinergics (e.g. some psychotrophic drugs and atropine) may be potentiated by this product. This may result in tachycardia, mouth dryness, gastrointestinal disturbances (e.g. colic), urinary retention and headache.

 

Menthol

None known.    

 

Section 4.6

 

4.6       Fertility, Ppregnancy & Lactation

           

Both diphenhydramine and dextromethorphan have been in widespread use for many years without apparent ill consequence. There are no adequate and well-controlled studies in pregnant or breast-feeding women. However, there is insufficient information on the effects of the administration of dextromethorphan during human pregnancy. In addition, i

It is not known whether dextromethorphan or its metabolites are excreted in breast milk or cross placenta.

 

 Diphenhydramine is known to cross the placenta and has also been detected in breast milk, but levels have not been reported.

 

It is not known whether Menthol or its metabolites cross the placenta. Menthol is excreted in breast milk.

 

Benylin Dry Coughs should not be used during pregnancy or lactation unless the potential benefit of treatment to the mother outweighs the possible risk to the developing foetus or nursing infantconsidered

 

Section 4.8

 

Adverse drug reactions (ADRs) identified during post-marketing experience with Dextromethorphan / Diphenhydramine / Menthol are included in the table below by System Organ Class (SOC). The frequencies are provided according to the following convention:

 

 

Very common ≥1/10

Common ≥1/100 and < 1/10

Uncommon ≥1/1,000 and <1/100

Rare ≥1/10,000 and <1/1,000

Very rare <1/10,000

Not known (cannot be estimated from the available data).


ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as ‘Not known’.

 

Body system (SOC)

Frequency

Adverse Drug Reaction

(Preferred Term)

Immune system disorders

Not known

Angioedema^

 

Psychiatric Disorders

Uncommon

Uncommon

Uncommon

Uncommon

Uncommon

Not known

ExcitationAgitation^*

Confusional state^

Insomnia*^

Irritability*

Nervousness*

Hallucination*

Nervous System

Disorders

Very Common

 

UncommonCommon

Not known

Not known

 

Not known

Not known

 

Not known

 

Not known

Drowsiness Somnolence†

Dizziness†^

Convulsion*

Coordination abnormal*

Headache*

Paraesthesia*

Psychomotor hyperactivity^

Tremor*

Eye Disorders

Not known

Blurred vision*

Ear and Labyrinth

Disorders

Uncommon

Tinnitus*

Cardiac Disorders

Not known

Not known

Palpitations*

Tachycardia*

Vascular Disorders

Not known

Hypotension*

Respiratory, Thoracic

and Mediastinal

Disorders

Common

Uncommon

 

Uncommon

Not known

Not known

Dry throat*

Bronchoconstriction Bronchospasm^

Dyspnoea^

Chest discomfort*

Dry noseNasal dryness*

Gastrointestinal

Disorders

Common

Uncommon

 

Uncommon

Uncommon

Not known

Not known

Not known

Not known

Dry Mouth

Gastrointestinal disturbancedisorder*^

Nausea^

Vomiting^

Abdominal pain^

Constipation*

Diarrhoea*^

Dyspepsia*

Skin and

Subcutaneous Tissue

Disorders

Rarely Uncommon

Not known

Not known

Rash*

Pruritus*^

Urticaria*^

Renal and Urinary

Disorders

Not known

 

Not known

Difficulty in urinationDysuria*

Urinary retention*

General Disorders and

Administration site

Conditions

Common

Asthenia†

† Frequency category based on clinical trials with single‐ingredient Diphenhydramine

* Associated with Diphenhydramine

^ Associated with Dextromethorphan

 

Side effects associated with the use of  Benylin Dry Coughs are uncommon.

 

Diphenhydramine may cause: drowsiness; dizziness; gastrointestinal disturbance; dry mouth, nose and throat; difficulty in urination or blurred vision.  Rarely, a rash may occur.

 

Side-effects attributed to dextromethorphan are uncommon; occasionally             dizziness, confusion, excitation, nausea, vomiting, or gastro-intestinal disturbance, bronoconstriction and dyspnoea may occur.

 

There have been a few reports of abuse of dextromethorphan, but there is no evidence of drug dependence at therapeutic dosages.

 

Adverse reactions to menthol at the low concentration present in Benylin Dry Coughs are not anticipated.

 

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

 

Section 4.9

 

4.9       Overdosage

 

Symptoms and signs

 

The effects of acute toxicity from of Benylin Dry Coughs may include drowsiness, hyperpyrexia, anticholinergic effects, lethargy, nystagmus, ataxia, respiratory depression, nausea, vomiting, hyperactivity, nervousness and tremors. With higher doses, and particularly in children, symptoms of cardiovascular collapse and CNS excitation including hallucinations and epileptiform convulsions may appear; large doses of antihistamines may precipitate attacks in epilepsy with massive doses, coma may follow.

 

Dextromethorphan

Symptoms of overdose may include:

Eye Disorders: Mydriasis

Nervous System Disorders: CNS depression, CNS excitation, Nystagmus, Serotonin syndrome

Respiratory, Thoracic and Mediastinal Disorders: Respiratory depression, Death may occur as a result of respiratory failure.

 

Diphenhydramine

Symptoms of overdose may include:

Mild to Moderate Symptoms: Somnolence, anticholinergic syndrome (mydriasis, flushing, fever, dry mouth, urinary retention, decreased bowel sounds, agitation, confusion and hallucinations), tachycardia, mild hypertension, nausea and vomiting are common after overdose.

 

Severe Symptoms: Effects may include delirium, psychosis, seizures, coma, hypotension, QRS widening, and ventricular dysrhythmias (including torsades de pointes), but are generally only reported in adults after large ingestions.Rhabdomyolysis and renal failure may rarely develop in patients with prolonged agitation, coma or seizures. Death may occur as a result of respiratory failure or circulatory collapse.

 

Menthol

Excessive use of menthol may lead to abdominal pain, vomiting, flushed face, dizziness, weakness, tachycardia, stupor and ataxia.

 

 

Treatment

 

Treatment of overdose should be symptomatic and supportive. Measures to promote rapid gastric emptying (with syrup of ipecac-induced emesis or gastric lavage) and, in cases of acute poisoning, the use of activated charcoal, may be useful. The intravenous use of physostigmine may be efficacious in antagonising severe anticholinergic symptoms. Naloxone has been used successfully as a specific antagonist to dextromethorphan toxicity in children.

 

 

Section 6.6

 

6.6       Instructions for uses/handling Special precautions for disposal and other handling

 

None No special requirements for disposal

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

 

Updated on 11 August 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 5 April 2013 PIL

Reasons for updating

  • Change to storage instructions

Updated on 21 July 2011 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 1 October 2010 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 14 September 2009 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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



Section 4.2:

Indication for use in children under 12 removed.

Section 4.3:

Contraindication not to use in children under 12 added.

Section 10:

Changed to June 2009

Updated on 8 September 2009 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 13 November 2008 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Addition of HDPE plastic cap with PE-Alu-PET wad material.

Updated on 25 August 2008 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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Free text change information supplied by the pharmaceutical company

Change in MAh from Pfizer Consumer Healthcare, Pottery Road, Dun Laoghaire, Co.Dublin to McNeil Healthcare (Ireland) Limited, Airton Road, Tallaght, Dublin 24.

Updated on 19 May 2008 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 12 September 2005 PIL

Reasons for updating

  • Change of manufacturer

Updated on 27 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 16 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only