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Valoid Tablets

*
Pharmacy Only: Prescription

  • Company:

    ADVANZ Pharma

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Cyclizine Hydrochloride

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

Updated on 30 June 2021

File name

VALOID - Cyclizine hydrochloride Tablet 50 mg_SPC_IE.pdf

Reasons for updating

  • Change due to harmonisation of SPC

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

Updated on 30 June 2021

File name

VALOID - Cyclizine hydrochloride Tablet 50 mg_PIL_IE.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 May 2015

Reasons for updating

  • New SPC for new product

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

Updated on 04 May 2015

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 - Clinical particulars
  • 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 4.9 - Overdose
  • Change to section 5 - Pharmacological properties
  • 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 - Pharmaceutical particulars
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • 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 8 - MA number
  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

 Update sections 1-4, 4.1- 4.9, 5-5.3, 6-6.6, 7, 8, , 9 & 10 of the SmPC and relevant sections of the PIL

Updated on 04 May 2015

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 - Clinical particulars
  • 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 4.9 - Overdose
  • Change to section 5 - Pharmacological properties
  • 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 - Pharmaceutical particulars
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • 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 8 - MA number
  • Change to section 9 - Date of renewal of authorisation

Free text change information supplied by the pharmaceutical company

 Update sections 1-4, 4.1- 4.9, 5-5.3, 6-6.6, 7, 8, , 9 & 10 of the SmPC and relevant sections of the PIL

Updated on 15 June 2012

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 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - 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 6.5 - 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:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

In section 1 the trade name ‘Valoid Tablets 50mg’ has been added.

 

In section 2 the quantity of the excipient lactose has been added.

 

In section 3 the description of the tablet has been updated. The statement ‘The tablet can be divided into two equal halves’.

 

In section 4.1 the indications have been updated to read:

Valoid is indicated for the prevention and treatment of nausea and vomiting including

•           Motion sickness.

•           Nausea and vomiting caused by narcotic analgesics and by general anaesthetics in the post-operative period.

•           Vomiting associated with radiotherapy especially for breast cancer since Cyclizine does not elevate prolactin levels.

 

In section 4.2 the statement ‘Route of administration – Oral’ has been added.

 

In section 4.4 (special warnings) a caution regarding patients with epilepsy and hepatic disease, severe heart failure, porphyria and neuromuscular disease has been added.  Reports of euphoric/hallucinatory effects and transient paralysis have been added as further cautions.

 

In section 4.6 the details of fertility studies have been removed.

 

In section 4.7 the paragraph has been reworded.

 

In section 4.8 the side effects have been reorganised into system order class. A further warning regarding IV use is mentioned.

 

In section 5.1 the ATCcode and pharmacotherapeutic group has been added.

 

In section 5.2 the pharmacokinetic properties have been updated to reflect the oral formulation.

 

In section 5.3 two sections entitled teratogenicity and fertility have been added with information in each section.

 

In section 6.5 the nature of the container has been updated.

 

In section 6.6 the title of the sub section has been updated to read: ‘Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product’

 

In section 10 the date has been updated to April 2009.

Updated on 15 June 2012

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 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - 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 6.5 - 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

Free text change information supplied by the pharmaceutical company

 

In section 1 the trade name ‘Valoid Tablets 50mg’ has been added.

 

In section 2 the quantity of the excipient lactose has been added.

 

In section 3 the description of the tablet has been updated. The statement ‘The tablet can be divided into two equal halves’.

 

In section 4.1 the indications have been updated to read:

Valoid is indicated for the prevention and treatment of nausea and vomiting including

•           Motion sickness.

•           Nausea and vomiting caused by narcotic analgesics and by general anaesthetics in the post-operative period.

•           Vomiting associated with radiotherapy especially for breast cancer since Cyclizine does not elevate prolactin levels.

 

In section 4.2 the statement ‘Route of administration – Oral’ has been added.

 

In section 4.4 (special warnings) a caution regarding patients with epilepsy and hepatic disease, severe heart failure, porphyria and neuromuscular disease has been added.  Reports of euphoric/hallucinatory effects and transient paralysis have been added as further cautions.

 

In section 4.6 the details of fertility studies have been removed.

 

In section 4.7 the paragraph has been reworded.

 

In section 4.8 the side effects have been reorganised into system order class. A further warning regarding IV use is mentioned.

 

In section 5.1 the ATCcode and pharmacotherapeutic group has been added.

 

In section 5.2 the pharmacokinetic properties have been updated to reflect the oral formulation.

 

In section 5.3 two sections entitled teratogenicity and fertility have been added with information in each section.

 

In section 6.5 the nature of the container has been updated.

 

In section 6.6 the title of the sub section has been updated to read: ‘Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product’

 

In section 10 the date has been updated to April 2009.

Updated on 14 August 2008

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 14 August 2008

Reasons for updating

  • Correction of spelling/typing errors

Updated on 29 August 2007

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 29 August 2007

Reasons for updating

  • Correction of spelling/typing errors

Updated on 04 August 2006

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects
  • 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)

Free text change information supplied by the pharmaceutical company

 

Note: Additional text is shown in red, removed text is shown with strikethrough.

 

 

2.            QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Tablets containing 50 mg cyclizine hydrochloride.

 

For excipients, see 6.1

 

 

4.8            Undesirable effects

 

Urticaria, drug rash, drowsiness, dryness of the mouth, nose and throat, blurred vision, tachycardia, urinary retention, constipation, restlessness, nervousness, insomnia and auditory and visual hallucinations have been reported, particularly when dosage recommendations have been exceeded.  Cholestatic jaundice has occurred in association with cyclizine.

 

Single case reports have been documented of fixed drug eruption, generalized chorea, hypersensitivity hepatitis and agranulocytosis.

 

Other Central Nervous effects which have been reported rarely include dystonia, dyskinesia, extrapyrimidal motor disturbances, tremor, twitching, muscle spasms, convulsions, disorientation, dizziness, decreased consciousness, paraesthesia and transient speech disorders.

 

Rare reports of cholestatic hepatitis and hypersensitivity reactions, including anaphylaxis, angiodema, allergic skin reactions and bronchospasm, have been reported in association with cyclizine.  There have also been a few reports of fixed drug eruption, apnoea, generalized chorea, hypersensitivity hepatitis, hepatic dysfunction and agranulocytosis.

 

9.         DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

 

1st April 1979/ 1st April 1999 2004

 

10.       DATE OF REVISION OF THE TEXT

 

November 2005

 

Updated on 04 August 2006

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

 

Note: Additional text is shown in red, removed text is shown with strikethrough.

 

 

2.            QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Tablets containing 50 mg cyclizine hydrochloride.

 

For excipients, see 6.1

 

 

4.8            Undesirable effects

 

Urticaria, drug rash, drowsiness, dryness of the mouth, nose and throat, blurred vision, tachycardia, urinary retention, constipation, restlessness, nervousness, insomnia and auditory and visual hallucinations have been reported, particularly when dosage recommendations have been exceeded.  Cholestatic jaundice has occurred in association with cyclizine.

 

Single case reports have been documented of fixed drug eruption, generalized chorea, hypersensitivity hepatitis and agranulocytosis.

 

Other Central Nervous effects which have been reported rarely include dystonia, dyskinesia, extrapyrimidal motor disturbances, tremor, twitching, muscle spasms, convulsions, disorientation, dizziness, decreased consciousness, paraesthesia and transient speech disorders.

 

Rare reports of cholestatic hepatitis and hypersensitivity reactions, including anaphylaxis, angiodema, allergic skin reactions and bronchospasm, have been reported in association with cyclizine.  There have also been a few reports of fixed drug eruption, apnoea, generalized chorea, hypersensitivity hepatitis, hepatic dysfunction and agranulocytosis.

 

9.         DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

 

1st April 1979/ 1st April 1999 2004

 

10.       DATE OF REVISION OF THE TEXT

 

November 2005

 

Updated on 10 June 2005

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 10 June 2005

Reasons for updating

  • New SPC for medicines.ie