Fybogel Mebeverine

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/05/17

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Summary of Product Characteristics last updated on medicines.ie: 13/4/2017
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Reckitt Benckiser Ireland Limited

Reckitt Benckiser Ireland Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Bonjela Oromucosal Gel Active Ingredients Cetalkonium Chloride, Choline Salicylate
Medicine Name Bonjela Teething Gel Oromucosal Gel Active Ingredients Cetalkonium Chloride, Choline Salicylate
Medicine Name Dettol Antiseptic Disinfectant 4.8 % w/v Concentrate for Cutaneous Solution Active Ingredients Chloroxylenol
Medicine Name Disprin Active Ingredients Acetylsalicylic acid (Aspirin)
Medicine Name Disprin Direct 300mg Orodispersible Tablets Active Ingredients Aspirin
Medicine Name Disprin Extra Strength Active Ingredients Acetylsalicylic Acid
Medicine Name E45 Cream Active Ingredients Anhydrous Lanolin, Light Liquid Paraffin, White Soft Paraffin
Medicine Name Fybogel Citrus Active Ingredients Ispaghula Husk
Medicine Name Fybogel Mebeverine Active Ingredients Ispaghula Husk, Mebeverine Hydochloride
Medicine Name Fybogel Orange 3.5g Granules Active Ingredients Ispaghula Husk
Medicine Name Gaviscon Advance Oral Suspension Active Ingredients Potassium hydrogen carbonate, Sodium Alginate
Medicine Name Gaviscon Advance Tablets Active Ingredients Potassium Bicarbonate, Sodium Alginate
Medicine Name Gaviscon Extra Chewable Tablets Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Extra Oral Suspension Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Extra Oral Suspension 300ml Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Infant Active Ingredients Magnesium Alginate, Sodium Alginate
Medicine Name Gaviscon Liquid - Peppermint Flavour Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Liquid Aniseed Flavour Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Oral Suspension Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Peppermint Chewable Tablets Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Hydrogen Carbonate
Medicine Name Gaviscon Suspension Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Hc45 Hydrocortisone Acetate 1% w/w Cream Active Ingredients Hydrocortisone Acetate
Medicine Name Lemsip Chesty Cough 50 mg/5 ml Oral Solution Active Ingredients Guaifenesin
Medicine Name Lemsip Cold & Flu Capsules with Caffeine Active Ingredients Caffeine, Paracetamol
Medicine Name Lemsip Cold & Flu Headcold 500mg Powder for Oral Solution Active Ingredients Paracetamol
1 - 0 of 71 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 22 May 2017 PIL

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 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains

Updated on 22 May 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 13 April 2017 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 4.3 - 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 4.8 – 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 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Changes to the following sections have been made:
Section 2. Qualitative and Quantitative Composition

Addition of text “Excipients with known effect”

 

Section 4.2 Posology and method of administration

Addition of posology for Elderly & children below 12 years of age

Amendment of method of administration to include water quantity

Addition of text regarding preparation & when the product should be taken

 

Section 4.3 Contraindications

Addition of the following contraindications:

·         Patients suffering from abnormal constrictions in the GI tract & diseases of the oesophagus and cardia

 

·         Patients with a sudden change in bowel habit

 

·         Undiagnosed rectal bleeding

 

·         Failure to defecate

 

 

Section 4.4 Special warnings and precautions for use

Addition of the following text:

 

·         Change of diet should be considered before pharmacological management of IBS

 

·         A doctor should be consulted if new symptoms develop or if symptoms worsen

 

·         Product should be mixed with 240ml water before use & adequate fluid intake should be maintained

 

·         When taken with inadequate fluid amounts, bulk forming agents can cause obstruction of the throat and oesophagus

 

·         Ispaghula husk should not be used by patients with symptoms such as abdominal pain, nausea and vomiting

 

·         If abdominal pain occurs, or in cases of any irregularity of faeces, the use of ispaghula husk should be discontinued

 

·         The treatment of debilitated patients and / or elderly patients requires medical supervision.

 

·         In order to decrease the risk of gastrointestinal obstruction ispaghula husk should not be used together with medicinal products known to inhibit peristaltic movement

 

·         Warning on hypersensitivity reactions

 

·         It is recommended to assess clinically the possible sensitisation of individuals at risk and, if justified, to perform specific diagnostic tests.

 

·         In case of proven sensitisation leading to hypersensitivity reactions, exposure to the product should be stopped immediately and avoided in the future (See 4.3).

 

·         This medicinal product contains 2.50 mmol of potassium per dose. 

 

·         This medicinal product contains 2.57 mmol of sodium per dose. 

 

·         This medicinal product contains aspartame (E951), a source of phenylalanine.  May be harmful for people with phenylketonuria.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


Section 4.5 Interaction with other medicinal products and other forms of interaction

Addition of interaction information regarding Ispaghula husk and:

Cardiac glycosides, coumarin derivaitives, lithium, carbamazepine, vitamins & minerals, diabetic patients, thyroid hormines and medicines know to inhibit peristaltic movement (e.g. opioids).

 

Section 4.6 Fertility, pregnancy and lactation

Additional text added in relation to pregnancy, breast-feeding & fertility

 

Section 4.7 Effects on ability to drive and use machines

Addition of the text “This product has no or negligible influence on the ability to drive & use machines

 

Section 4.8 Undesirable effects

Addition of medDRA table detailing system organ class, frequency & adverse events

Addition of paragraph regarding Reporting of Suspected Adverse Reactions

 

Section 4.9 Overdose

Change in text regarding symptoms

Addition of text regarding management

 

Section 5.1 Pharmacodynamic properties

Addition of Pharmacotherapeutic Group & ATC code

Additional information added regarding the pharmacological properties of both Ispaghula husk & Mebeverine hydrochloride

 

Section 5.2 Pharmacokinetic properties

Additional information added regarding the pharmacokinetic properties of both Ispaghula husk & Mebeverine hydrochloride

 

Section 5.3 Preclinical safety data

Additional information added regarding the preclinical safety data of both Ispaghula husk & Mebeverine hydrochloride

 Section 6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

Amendment of text The contents of one sachet should be stirred into a glass of cold water (240mls) and taken immediately.

 

Section 10. Date of Revision of the text

 

 Amendment of text January 2017.

 

 

 

 

 

 

 

 

 

Updated on 13 April 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 10 February 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to how the medicine works
  • Change to date of revision

Updated on 20 December 2013 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.2 Posology and Method of Administration – Added: “The product should not be taken immediately before going to sleep.

 

Section 4.3 Contraindications – Added: Natural or drug-induced reduction in gut motility

 

Section 4.8 Undesirable effects – Added: Contact information and instructions for reporting suspected adverse reactions to the IMB


Section 10 Date of Revision of the Text - October 2013

Updated on 11 September 2013 SmPC

Reasons for updating

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

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 4.2 - Updated posology to be more specific

In section 4.3 - Added paralytic ileus, and colonic atony as cases of contraindication

In section 4.4 - Added additional warnings 

In section 4.8 - Added additional warning such as flatulence and bloating, anaphylactic reaction, Urticaria, Rash, hypersensitvity

In section 6.5 - Added "Not all pack sizes may be marketed"

In Section 10 - Changed dated of revision of the text to September 2013

Updated on 9 September 2013 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients
  • 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

In Section 6.1, changed Eudragit E100 to Basic Butylated Methacrylate Copolymer

In Section 10, Updated to September 2013

Updated on 14 March 2012 SmPC

Reasons for updating

  • 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 4.8 - Undesirable effects
  • 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 4.2:
Included the following text:  When preparing the product for administration, it is important to try to avoid inhaling any of the powder in order to minimize the risk of sensitization to the active ingredient

Section 4.3:
Included the following text: 
Hypersensitivity to the active substance ispaghula husk, or to any of the excipients listed on section 6.1 (see 4.4 Special warnings and precautions for use)

Section 4.4:
Included the following text: Warning on hypersensitivity reactions In individuals with continued occupational contact to powder of Plantago ovata seeds (i.e. healthcare workers, caregivers) allergic sensitization may occur due to inhalation, this is more frequent in atopic individuals. This sensitization usually leads to hypersensitivity reactions which could be serious (see 4.8 Undesirable effects).It is recommended to assess clinically the possible sensitization of individuals at risk and, if justified, to perform specific diagnostic tests.In case of proven sensitization leading to hypersensitivity reactions, exposure to the product should be stopped immediately and avoided in the future (see 4.3 Contraindications).”

 

Section 4.8
Included the following text:  Ispaghula/psyllium husk contains potent allergens. The exposure to these allergens is possible through oral administration, contact with the skin and, in the case of powder formulations, also by inhalation.

As a consequence to this allergic potential, individuals exposed to the product can develop hypersensitivity reactions such as rhinitis, conjunctivitis, bronchospasm and in some cases, anaphylaxia. Cutaneous symptoms as exanthema and/or pruritus have also been reported. Special attention should be given to individuals manipulating the powder formulations routinely (see 4.4 Special warnings and precautions for use).

Section 6.6: 
Included the following text:  See section 4.2

Updated on 13 March 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change due to user-testing of patient information

Updated on 23 October 2007 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 3 October 2007 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 2: Addition of excipients Aspartame, potassium and sodium
 
Section 4: Update sodium, potassium and aspartame warnings

Updated on 10 May 2007 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 6.1 - List of excipients
  • 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: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

SECTION 1:  Update of name of product to 'Fybogel Mebeverine Granules for Oral Suspension'.
 
SECTION 6.1:  Excipient of beta-carotene content changed to 10% CWS/S and content changed to include; beta-carotene, All-rac-alpha-tocopherol, Maize oil refined, Maize starch, and Modified food starch.  Additional excipient of riboflavin sodium phosphate included.
 
SECTION 7:  Change of address of Marketing Authorisation Holder to - 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland.
 
SECTION 9:  Updated to amend last renewal date to 14th March 2006.
 

Updated on 4 August 2006 SmPC

Reasons for updating

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

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.4 updated to add :Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.  Patients allergic to peanut or soya should not take this medicine.

Updated on 28 October 2005 SmPC

Reasons for updating

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

Legal category: Supply through pharmacy only

Updated on 30 June 2005 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through pharmacy only

Updated on 16 May 2005 SmPC

Reasons for updating

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

Legal category: Supply through pharmacy only

Updated on 11 August 2004 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through pharmacy only

Updated on 16 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only