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Imodium 2 mg Capsules

*
Pharmacy Only: Prescription

  • Company:

    Kenvue

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

  • Active Ingredient(s):

    Loperamide Hydrochloride

    *Additional information is available within the SPC or upon request to the company

Updated on 17 March 2024

File name

ie-spc v16-imodium capsules-2380.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:Product subject to medical prescription which may be renewed (B)

Updated on 17 March 2024

File name

ie-pl-imodium-capsules-2380.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 07 June 2023

File name

ie-spc-clean-pa-330-45-2-bv2181.pdf

Reasons for updating

  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 25 January 2023

File name

ie-mockup-pl-clean-pa-330-45-2-bv2257 and 2261 revised.pdf

Reasons for updating

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

Updated on 19 December 2022

File name

ie-mockup-pl-clean-330-45-2-bv2257 and bv2261.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 19 December 2022

File name

ie-mockup-pl-clean-bv2257-PA 330-45-2.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 25 May 2022

File name

ie-spc-clean-pa-330-45-2-bv2213.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 25 May 2022

File name

ie-mockup-pl-clean-pa-330-45-2-bv2213.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 06 July 2020

File name

ie-mockup-pl-clean-330-45-2-bv2039.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 06 July 2020

File name

ie-spc-clean-330-45-2-bv2039.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 09 August 2019

File name

IMH02 BV 1939 SPC v12.0.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 07 May 2019

File name

ie-spc-clean-pa 330-45-2-bv1863.pdf

Reasons for updating

  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 20 August 2018

File name

ie-mockup-pl-clean-imo-330-45-2-bv1741.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 20 August 2018

File name

ie-spc-clean-imodium-330-45-2-bv1741.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 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 27 December 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 27 December 2017

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:Product subject to medical prescription which may be renewed (B)

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 20 December 2017

File name

PIL_8489_746.pdf

Reasons for updating

  • New PIL for new product

Updated on 20 December 2017

Reasons for updating

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

Updated on 12 July 2017

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Added text has been highlighted and underlined, removed text has been struck through:


4.2. Posology and Method of

Administration

For oral administration. The capsules should

be taken with water.

i) As an adjunct in the management of

acute diarrhoea

Adults and children 9-12 years

1 to 2 capsules (2 to 4 mg) is the usual initial

dose, followed by 1 capsule (2 mg) three

times daily. The maximum daily dose should

not exceed 10 mg.

Children 4-8 years

A total maximum daily dose of 4 mg in

divided doses (see 4.4 Special warnings and

precautions for use).

Under 4 years

Not recommended.

Use in elderly

No dose adjustment is required for the

elderly.

Renal impairment

No dose adjustment is required for patients

with renal impairment.

Hepatic impairment

Although no pharmacokinetic data are

available in patients with hepatic impairment,

Imodium should be used with caution in such

patients because of reduced first pass

metabolism (see 4.4 Special warning and

precautions for use).

ii) For the symptomatic treatment of

diarrhoea associated with chronic bowel

 

disorders

Adults only

Studies have shown that patients may need

differing amounts of loperamide. The

starting dosage should be between 4 to 8 mg

(2 to 4 capsules) per day in divided doses

depending on severity. If required, this dose

can be adjusted according to response.

Having established the patient’s daily

maintenance dose, the capsules may be

administered on a twice daily regimen.


4.4. Special Warnings and Precautions

for Use

Treatment of diarrhoea with loperamide HCl

is only symptomatic. Whenever an

underlying etiology can be determined,

specific treatment should be given when

appropriate.

The necessity for specific therapy, such as

anti-infectives, should be borne in mind,

particularly should treatment be required for

a period longer than three days.

Loperamide should be used with caution

when hepatic function, necessary for the

drug’s metabolism, is defective, as this may

result in relative overdose leading to CNS

toxicity.

Patients with AIDS treated with Imodium for

diarrhoea should have therapy stopped at the

earliest signs of abdominal distension. There

have been isolated reports of toxic

megacolon in AIDS patients with infectious

colitis from both viral and bacterial

pathogens treated with loperamide

hydrochloride.

Antimotility agents such as loperamide may

precipitate ileus and toxic megacolon in

patients with ulcerative colitis, and should be

avoided in severe acute attacks. It may be

used cautiously in mild or less severe attacks

as an adjunct to other measures, but should

be discontinued promptly should abdominal

distension or other untoward symptoms

occur.

The stated dose should not be exceeded.

Patients with rare hereditary problems of

galactose intolerance, the Lapp lactase

deficiency or glucose-galactose

malabsorption should not take this medicine

because it contains lactose.

Cardiac events including QT prolongation

and Torsades de Pointes have been reported

in association with overdose. Some cases had

a fatal outcome (see section 4.9). Patients

should not exceed the recommended dose

and/or the recommended duration of

treatment. Abuse and misuse of loperamide,

as an opioid substitute, have been described

in individuals with opioid addiction (see

section 4.9 Overdose).

Swallowing of capsules may be difficult for

young children who should be carefully

supervised to avoid any potential risk of

choking.


4.9. Overdose

Signs and symptoms:

In case of overdose (including relative

overdose due to hepatic dysfunction), CNS

depression (stupor, coordination abnormality,

somnolence, miosis, muscular hypertonia and

respiratory depression), constipation, urinary

retention and ileus may occur. Children, and

patients with hepatic dysfunction, may be

more sensitive to CNS effects.

In individuals who have ingested overdoses

of loperamide HCl, cardiac events such as

QT interval prolongation, Torsades de

Pointes, other serious ventricular

arrhythmias, cardiac arrest and syncope have

been observed (see section 4.4). Fatal cases

have also been reported. In individuals who

have intentionally ingested overdoses

(reported in doses from 40 mg up to 792 mg

per day) of loperamide HCl, QT interval

prolongation and or serious ventricular

arrhythmias, have been observed (see section

4.4 Warnings and Precautions). Fatal cases

have also been reported.

Treatment:

In cases of overdose, ECG monitoring for QT

interval prolongation should be initiated.

If CNS symptoms of overdose occur,

naloxone may be given as an antidote. Since

the duration of action of loperamide is longer

than that of naloxone 1 to 3 hrs), repeated

treatment with naloxone might be indicated.

Therefore, the patient should be monitored

closely for at least 48 hours in order to detect

possible CNS depression.


5.3. Preclinical Safety Data

Non-clinical in vitro and in vivo evaluation

of loperamide indicates no significant cardiac

electrophysiological effects within its

therapeutically relevant concentration range

and at significant multiples of this range (up

to 47-fold). However, at extremely high

concentrations associated with overdoses (see

section 4.4 Warnings and Precautions),

loperamide has cardiac electrophysiological

actions consisting of inhibition of potassium

(hERG) and sodium currents, and

arrhythmias. Within its therapeutically

relevant concentration range and at

significant multiples of this range (up to 47-

fold), loperamide has no significant cardiac

electrophysiological effects. However, at

extremely high concentrations associated

with intentional overdose (see section 4.4

Warnings and Precautions), loperamide has

cardiac electrophysiological actions

consisting of inhibition of potassium (hERG)

and sodium currents, and arrhythmias in in

vitro and in vivo animal models.


6.6. Special precautions for

disposalInstructions for Use/Handling

No special requirements.

9. Date of First

Authorisation/Renewal of Authorisation

14 April 19797 / 30 January 2009
















































































Updated on 03 July 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 24 November 2016

Reasons for updating

  • 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 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Added text has been underlined and highlighted in blue, text that has been removed has been struck through:

4.4 Special warnings and precautions for use

Treatment of diarrhoea with loperamide HCl is only symptomatic. Whenever an underlying etiology can be determined, specific treatment should be given when appropriate.

The necessity for specific therapy, such as anti-infectives, should be borne in mind, particularly should treatment be required for a period longer than three days.

Loperamide should be used with caution when hepatic function, necessary for the drug’s metabolism, is defective, as this may result in relative overdose leading to CNS toxicity.

Patients with AIDS treated with Imodium for diarrhoea should have therapy stopped at the earliest signs of abdominal distension.  There have been isolated reports of toxic megacolon in AIDS patients with infectious colitis from both viral and bacterial pathogens treated with loperamide hydrochloride.

Antimotility agents such as loperamide may precipitate ileus and toxic megacolon in patients with ulcerative colitis, and should be avoided in severe acute attacks.  It may be used cautiously in mild or less severe attacks as an adjunct to other measures, but should be discontinued promptly should abdominal distension or other untoward symptoms occur.

The stated dose should not be exceeded.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine because it contains lactose.

Abuse and misuse of loperamide, as an opioid substitute, have been described in individuals with opioid addiction (see section 4.9 Overdose).

4.6 Fertility, pPregnancy and lactation

 

Pregnancy

The safety of Imodium in human pregnancy has not been established.

 

Breast-Feeding

Small amounts of loperamide may appear in human breast milk.  Therefore, Imodium is not recommended during breast feeding.

 

Women who are pregnant or breast feeding infants should therefore be advised to consult their doctor for appropriate treatment.

 

Fertility

The effect on human fertility has not been evaluated.


4.9.      Overdose

Signs and symptoms:

Overdose (relative or absolute) may lead to constipation, urinary retention, ileus and central nervous system depression (miosis, muscular hypertonia, somnolence and bradypnoea).  Naloxone may be given as an antidote, repeated as necessary over an observation period of at least 48 hours.

In case of overdose (including relative overdose due to hepatic dysfunction), CNS depression (stupor, coordination abnormality, somnolence, miosis, muscular hypertonia and respiratory depression), constipation, urinary retention and ileus may occur. Children, and patients with hepatic dysfunction, may be more sensitive to CNS effects.

 

In individuals who have intentionally ingested overdoses (reported in doses from 40 mg up to 792 mg per day) of loperamide HCl, QT interval prolongation and or serious ventricular arrhythmias, have been observed (see section 4.4 Warnings and Precautions). Fatal cases have also been reported.

 

Treatment:

In cases of overdose, ECG monitoring for QT interval prolongation should be initiated. If CNS symptoms of overdose occur, naloxone may be given as an antidote.  Since the duration of action of loperamide is longer than that of naloxone 1 to 3 hrs), repeated treatment with naloxone might be indicated. Therefore, the patient should be monitored closely for at least 48 hours in order to detect possible CNS depression.


5.2.      Pharmacokinetic properties

 

The half-life of loperamide in man is 10.8 hours with a range of 9 to 14 hours.  Studies on distribution in rats show high affinity for the gut wall with preference for binding to the receptors in the longitudinal muscle layer.  Loperamide is well absorbed from the gut, but is almost completely extracted and metabolised by the liver where it is conjugated and excreted via the bile.  Due to its high affinity for the gut wall and its high first pass metabolism, very little loperamide reaches the systemic circulation.

Absorption:  Most ingested loperamide is absorbed from the gut, but as a result of significant first pass metabolism, systemic bioavailability is only approximately 0.3%.

 

Distribution: Studies on distribution in rats show a high affinity for the gut wall with a preference for binding to receptors of the longitudinal muscle layer.  The plasma protein binding of loperamide is 95%, mainly to albumin.  Non-clinical data have shown that loperamide is a P-glycoprotein substrate.

 

Metabolism: Loperamide is almost completely extracted by the liver, where it is predominantly metabolized, conjugated and excreted via the bile.  Oxidative N-demethylation is the main metabolic pathway for loperamide, and is mediated mainly through CYP3A4 and CYP2C8.  Due to this very high first pass effect, plasma concentrations of unchanged drug remain extremely low.

 

Elimination: The half-life of loperamide in man is about 11 hours with a range of 9-14 hours.  Excretion of the unchanged loperamide and the metabolites mainly occurs through the faeces.


5.3.  Preclinical safety data

Not applicable.

Within its therapeutically relevant concentration range and at significant multiples of this range (up to 47-fold), loperamide has no significant cardiac electrophysiological effects. However, at extremely high concentrations associated with intentional overdose (see section 4.4 Warnings and Precautions), loperamide has cardiac electrophysiological actions consisting of inhibition of potassium (hERG) and sodium currents, and arrhythmias in in vitro and in vivo animal models.


10.       Date of (Partial) Revision of the Text

 

16 November 2016


Updated on 24 November 2016

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 6 - date of revision

Updated on 12 October 2015

Reasons for updating

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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Addition of Adverse Event Reporting details to Section 4.8 of the SPC
SNAS 1415

Updated on 12 October 2015

Reasons for updating

  • Addition of separate PILs covering individual presentations
  • Addition of information on reporting a side effect.

Updated on 06 September 2012

Reasons for updating

  • Change due to user-testing of patient information

Updated on 02 March 2012

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 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4 of the SPC has been updated in line with the Core Data Sheet.

Updated on 05 November 2009

Reasons for updating

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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 7: New PA Holder: McNeil Healthcare (Ireland) Ltd., Airton Road, Tallaght, Dublin 24, Ireland
Section 8: New PA number: 823/56/3

Updated on 02 November 2009

Reasons for updating

  • Change of licence holder
  • Change to date of revision

Updated on 06 July 2009

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

1.

NAME OF THE MEDICINAL PRODUCT

Strength added

 

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Quantitative composition of an excipient added

 

4.4

Special Warnings and Precautions for Use

Lactose warning added

5.1

Pharmacodynamic properties

ATC code added

 

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Renewal date changed

 

10.

DATE OF REVISION OF THE TEXT

 

Changed to 12 June 2009

Updated on 30 June 2009

Reasons for updating

  • Change of trade or active ingredient name
  • Change to storage instructions

Updated on 17 October 2008

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to Section:

 

IPHA – Fragments submitted to IMB

7.

MARKETING AUTHORISATION HOLDER

Changed to: Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG, UK

10.

DATE OF REVISION OF THE TEXT

 

Changed to 9 October 2008

 

Updated on 19 September 2008

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 4.8 – Undesirable effects

Update to MedDRA and addition of ‘Very rare: Loss of consciousness, depressed level of consciousness’

Change to section 10 – Date of revision of text

August 2008

Updated on 28 August 2008

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 2 – quantitative and qualitative composition

Update QRD

Change to section 4.1 – Therapeutic Indications

Update QRD

Change to section 4.2 – Posology and |Method of Administration

Update QRD

Change to section 4.3 – Contra-indications

Update QRD Lactose

Change to section 4.4 – Special Warnings and Precautions for Use

Update QRD

Change to section 4.5 –Interaction with other medicinal products and other forms of interaction

Update QRD

Change to section 4.6 – Pregnancy and Lactation

Update QRD

Change to section 4.7 - Effects on Ability to Drive and Use Machines

Update QRD

Change to section 4.8 – Undesirable effects

Update to MedDRA and Loss of consciousness, depressed level of consciousness,

Change to section 5.1 - Pharmacodynamic properties

ATC code

Change to section 5.2 - Pharmacokinetic properties

Update to QRD

Change to section 5.3 - Preclinical Safety Data

Update to QRD

Change to section 6.1 – List of Excipients

Update to QRD

Change to section 6.6 –  Instructions for use, handling and disposal

Update to QRD

Change to section 10 – Date of revision of text

August 2008

Updated on 18 August 2006

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 27 August 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 24 August 2004

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 06 August 2004

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 11 November 2003

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 06 November 2003

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 17 September 2003

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 05 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)