Stugeron 25mg

  • Name:

    Stugeron 25mg

  • Company:
    info
  • Active Ingredients:

    Cinnarizine

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/11/19

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Summary of Product Characteristics last updated on medicines.ie: 3/9/2018

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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 Colpermin Gastro-Resistant Capsules Active Ingredients Peppermint Oil
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
1 - 0 of 67 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 21 November 2019 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 3 September 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 3 September 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: Product subject to medical prescription which may not be renewed (A)

Updated on 2 May 2018 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

CCDS updates and QRD

Updated on 26 April 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose

Updated on 12 August 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 12 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: Product subject to medical prescription which may not be renewed (A)

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 7 August 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 21 January 2014 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 4.6 - Pregnancy and lactation
  • Change to section 4.9 - Overdose

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4:

FROM:

As with other antihistamines, Stugeron may cause epigastric discomfort; taking it after meals may diminish gastric irritation.

 

Stugeron has not been found to reduce blood pressure significantly. However, the drug should be used with reasonable caution in hypotensive patients.

 

In patients with Parkinson's disease Stugeron should only be given if the advantages outweigh the possible risk of aggravating this disease.

 

Because of its antihistamine effect, Stugeron may prevent an otherwise positive reaction to dermal reactivity indicators if used within 4 days prior to testing.

 

Use of cinnarizine should be avoided in porphyria.

 

There have been no specific studies in hepatic or renal dysfunction. Stugeron should be used with care in patients with hepatic or renal insufficiency.

 

Patients with rare hereditary problems of fructose or galactose intolerance, LAPP lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency, should not take this medicine because it contains lactose and sucrose.

TO:

As with other antihistamines, Stugeron may cause epigastric upset, which may be diminished if taken after meals.

 

Cinnarizine is a vasodilator.  While it has not been found to reduce blood pressure significantly, it should be used with caution in those with coronary artery disease or in patients with hypotension.

 

In patients with Parkinson's disease, Stugeron should only be given if the advantages outweigh the possible risk of aggravating this disease.

 

Stugeron may cause somnolence, especially at the start of treatment.  Therefore, caution should be taken when alcohol or CNS depressants or tricyclic antidepressants are used concomitantly. (See section 4.5).

 

Diagnostic interference:

Because of its antihistamine effect, Stugeron may prevent otherwise positive reactions to dermal reactivity indicators if used up to 4 days prior to skin testing. (See section 4.5).

 

Use of cinnarizine should be avoided in porphyria.

 

There have been no specific studies in hepatic or renal dysfunction. Stugeron should be used with care in patients with hepatic or renal insufficiency.

 

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

 

Avoid alcoholic drink.

 

Warning:  Do not exceed the stated dose.


Section 4.6:

'Fertility' added to title.

Section 4.9:

Deleted:
Within the first hour after ingestion, gastric lavage may be performed

Section 4.5:

Added:

Diagnostic interference:

Because of its antihistamine effect, Stugeron may prevent otherwise positive reactions to dermal reactivity indicators if used up to 4 days prior to skin testing.



'Fertility' added to title.:Deleted:Added:

Updated on 3 January 2012 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 2 changes:
Previous:
Each tablet contains 25mg cinnarizine.
For excipients, see section 6.1.

Current:
Each tablet contains 25mg cinnarizine.
Excipients: Contains Lactose monohydrate 158.8mg and Sucrose 15.0mg
For a full list of excipients, see section 6.1.



Section 6 changes:
Previous:
List of Excipients
Lactose
Maize starch
Sucrose
Talc
Cotton oil - hydrogenated
Pvidone K90

Current:
List of Excipients
Lactone Monohydrate
Maize starch
Sucrose
Talk
Cotton oil - hydrogenated
Povidone K90

Updated on 23 December 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation
  • Change due to user-testing of patient information

Updated on 21 July 2011 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 18 May 2010 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 25 March 2010 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 6.3: Shelf life changed from 5 to 3 years

Updated on 22 February 2010 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8: Revision based on safety data and presentation of ADRs in a single table.
Section 5.2: Update in line with CCDS
Section 5.3: Update in line with CCDS

Updated on 8 February 2010 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 5.1 -  ATC code added

Updated on 2 February 2010 SmPC

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 7 - Mew MAH - McNeil healthcare (Ire) Ltd.
Section 10 - updated to December 2009

Updated on 9 September 2008 PIL

Reasons for updating

  • Change to marketing authorisation holder address

Updated on 9 September 2008 SmPC

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 7 – Marketing Authorisation Holder

Change of address

Change to section 10 – Date of revision of text

September 2008

Updated on 16 January 2007 PIL

Reasons for updating

  • Change of manufacturer
  • Change to storage instructions
  • Change to date of revision

Updated on 25 April 2006 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 1 February 2006 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 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 20 December 2005 SmPC

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 not be renewed (A)

Updated on 22 November 2005 SmPC

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 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 not be renewed (A)

Updated on 22 November 2005 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change of manufacturer
  • Change to storage instructions
  • Change to date of revision

Updated on 27 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 5 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)