Benylin Dry Coughs Syrup
*Company:
KenvueStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 29 April 2024
File name
ie-pil-benylin-dry-coughs-2441.pdf
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 29 April 2024
File name
ie-spc v12 Benylin Dry Coughs -2441.pdf
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 21 December 2022
File name
ie-pl-benylin-dry-cough-2100 (1).pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 25 March 2022
File name
ie-spc V10-Benylin Dry Coughs 2100.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
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Updated on 25 March 2022
File name
402554162_Benylin_XXXXXX_EMEA_2021_00028313_002_r0 (1).pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 23 October 2020
File name
ie-pl-benylin-dry-cough-2058.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 19 November 2019
File name
ie leaflet benylin dry coughs 1990.pdf
Reasons for updating
- 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 3 - overdose, missed or forgotten doses
- Change to section 6 - date of revision
Updated on 19 November 2019
File name
ie spc V9 Benylin Dry Coughs 1990.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 30 November 2018
File name
ie-spc V8 Benylin Dry Coughs 1821.pdf
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- Previous version of SPC reinstated
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Updated on 03 October 2018
File name
ie-PIL Benylin Dry Coughs 1821.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 03 October 2018
File name
ie-spc V8 Benylin Dry Coughs 1821.pdf
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
File name
spc.docx
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 08 May 2018
File name
ie-pl Benylin Dry Coughs Syrup April BED02 1634 2018.pdf
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
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 13 January 2017
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
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 09 January 2017
File name
PIL_9041_716.pdf
Reasons for updating
- New PIL for new product
Updated on 09 January 2017
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
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 |
Confusional state^ Insomnia*^ Irritability* Nervousness* Hallucination* |
|
Nervous System Disorders |
Very Common
Not known Not known
Not known Not known
Not known
Not known |
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*
Dyspnoea^ Chest discomfort*
|
|
Gastrointestinal Disorders |
Common Uncommon
Uncommon Uncommon Not known Not known Not known Not known |
Dry Mouth† Gastrointestinal Nausea^ Vomiting^ Abdominal pain^ Constipation* Diarrhoea*^ Dyspepsia* |
|
Skin and Subcutaneous Tissue Disorders |
Not known Not known |
Rash* Pruritus*^ Urticaria*^ |
|
Renal and Urinary Disorders |
Not known
Not known |
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
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 05 April 2013
Reasons for updating
- Change to storage instructions
Updated on 21 July 2011
Reasons for updating
- Change to dosage and administration
Updated on 01 October 2010
Reasons for updating
- Change due to user-testing of patient information
Updated on 14 September 2009
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 08 September 2009
Reasons for updating
- Change to dosage and administration
Updated on 13 November 2008
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
Updated on 25 August 2008
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 19 May 2008
Reasons for updating
- Change to marketing authorisation holder
Updated on 12 September 2005
Reasons for updating
- Change of manufacturer
Updated on 27 September 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 16 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only