Fybogel Mebeverine

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.

 

 

 

 

 

 

 

 

 

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

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

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

In Section 10, Updated to September 2013

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

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.