Valtrex™ 250 mg film-coated tablets

  • Name:

    Valtrex™ 250 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Valaciclovir hydrochloride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/07/15

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Summary of Product Characteristics last updated on medicines.ie: 15/7/2015
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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

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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 15 July 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 15 July 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 July 2015 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 - change to Ireland MAH address

Updated on 15 July 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 24 March 2015 SmPC

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8 - Update to the HPRA reporting details

Updated on 23 March 2015 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 10 June 2014 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Section 4.1 - amended to specify that the treatment and suppression of recurrent ocular HSV infections is for immunocompetent adults and adolescents, and immunocompromised adults.
Section 4.3 - Reference to listing in section 6.1
Section 4.8 - Update to reporting adverse reactions

Updated on 9 June 2014 PIL

Reasons for updating

  • Change to instructions about overdose
  • Change to storage instructions
  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 12 April 2012 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • 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

5.       PHARMACOLOGICAL PROPERTIES

 

5.1     Pharmacodynamic properties

 

Antivirals for systemic use.

 

Pharmacotherapeutic group: Nucleosides and nucleotides excluding reverse transcriptase inhibitors, ATC code: J05AB11.

 

6.       PHARMACEUTICAL PARTICULARS

 

6.1         List of excipients

 

Tablet core

Microcrystalline cellulose

Crospovidone

Povidone

Magnesium stearate

Silica colloidal anhydrousColloidal silicon dioxide

 

Film coat

Hypromellose

Titanium dioxide

Polyethylene glycolMacrogol 400Macrogol

Polysorbate 80 (500 and 1000 mg tablets only)

Carnauba wax

 

 

 

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

[To be completed nationally]2011-12-15

 

10.     DATE OF REVISION OF THE TEXT

 

2012-01-202011-07-12

Updated on 10 April 2012 PIL

Reasons for updating

  • Change of inactive ingredient

Updated on 3 November 2011 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications

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

Free text change information supplied by the pharmaceutical company

3.              pharmaceutical form

 

Film-coated tablets.

White film-coated tablet, biconvex, elongated tablet with a white to off-white core,. Biconvex, elongated, unscored, marked branded “GX CE7” in blue ink on one side by engraving.

 

 

4.                            clinical particulars

 

4.1            Therapeutic Indications

 

Varicella zoster virus (VZV) infections – herpes zoster

 

Valtrex is indicated for the treatment of herpes zoster (shingles) and ophthalmic zoster in immunocompetent adults (see section 4.4).

 

Valtrex is indicated for the treatment of herpes zoster in adult patients with mild or moderate immunosuppression (see section 4.4).

 

Herpes simplex virus (HSV) infections

 

Valtrex is indicated

·         for the treatment and suppression of HSV infections of the skin and mucous membranes including

o   treatment of first-episode of genital herpes in immunocompetent adults and adolescents and in immunocompromised adults

 

o   treatment of recurrences of genital herpes in immunocompetent adults and adolescents, and in immunocompromised adults

 

o   Treatment and suppression of recurrent ocular HSV infections (see section 4.4)

o   suppression of recurrent genital herpes in immunocompetent adults and adolescents and in immunocompromised adults.

 

·         Treatment and suppression of recurrent ocular HSV infections (see section 4.4)

 

Clinical studies have not been conducted in HSV-infected patients immunocompromised for other causes than HIV-infection (see section 5.1).

 

Cytomegalovirus (CMV) infections:

 

Valtrex is indicated for the prophylaxis of CMV infection and disease following solid organ transplantation in adults and adolescents (see section 4.4).

 

Updated on 4 October 2011 PIL

Reasons for updating

  • Change to side-effects

Updated on 23 September 2011 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

4.8                        Undesirable Effects


The most common adverse reactions (ARs) reported in at least one indication by patients treated with Valtrex in clinical trials were headache and nausea. More serious ARs such as thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome, acute renal failure and neurological disorders are discussed in greater detail in other sections of the label.

 

Undesirable effects are listed below by body system organ class and by frequency.

 

The following frequency categories are used for classification of adverse effects:

Very common             ³ 1/10,

Common                     ³ 1/100 and < 1/10,

Uncommon                 ³ 1/1,000 and < 1/100,

Rare                            ³ 1/10,000 and < 1/1,000,

Very rare                     < 1/10,000.

 

Clinical trial data have been used to assign frequency categories to ARs if, in the trials, there was evidence of an association with valaciclovir.

 

For ARs identified from postmarketing experience, but not observed in clinical trials, the most conservative value of point estimate (‘rule of three’) has been used to assign the AR frequency category. For ARs identified as associated with valaciclovir from post-marketing experience, and observed in clinical trials, study incidence has been used to assign the AR frequency category. The clinical trial safety database is based on 5855 subjects to valaciclovir in clinical trials covering multiple indications (treatment of herpes zoster, treatment/suppression of genital herpes & treatment of cold sores).

 

Clinical Trial Data

 

Nervous system disorders

Very common:                 Headache.

 

Gastrointestinal disorders

Common:         Nausea.

 

Post Marketing Data

 

Blood and lymphatic system disorders

Uncommon:     Leucopenia, thrombocytopenia.

Leucopenia is mainly reported in immunocompromised patients.

 

Immune system disorders

Rare:    Anaphylaxis.

 

Psychiatric and nervous system disorders

Common:        Dizziness

Uncommon:    confusion, hallucinations, decreased consciousness, tremor, agitation.

Rare:                ataxia, dysarthria, convulsions, encephalopathy, coma, psychotic symptoms, delirium.

 

Neurological disorders, sometimes severe, may be linked to encephalopathy and include confusion, agitation, convulsions, hallucinations, coma. These events are generally reversible and usually seen in patients with renal impairment or with other predisposing factors (see section 4.4). In organ transplant patients receiving high doses (8000 mg daily) of Valtrex for CMV prophylaxis, neurological reactions occurred more frequently compared with lower doses used for other indications.

 

Respiratory, thoracic and mediastinal disorders

Uncommon:     Dyspnoea.

 

Gastrointestinal disorders

Common:        vomiting, diarrhoea

Uncommon:    Abdominal discomfort

 

Hepato-biliary disorders

Uncommon:     Reversible increases in liver function tests (e.g. bilirubin, liver enzymes).

 

Skin and subcutaneous tissue disorders

Common:         Rashes including photosensitivity, pruritus

Uncommon:     Urticaria,

Rare:                angioedema.

 

Renal and urinary disorders

Uncommon:                 Renal Pain, haematuria (often associated with other renal events).

Rare:                            Renal impairment, acute renal failure (especially in elderly patients or in patients with renal impairment receiving higher than the recommended doses).

Renal pain may be associated with renal failure.

 

Intratubular precipitation of aciclovir crystals in the kidney has also been reported. Adequate fluid intake should be ensured during treatment (see section 4.4).

 

 

Additional information on special populations

There have been reports of renal insufficiency, microangiopathic haemolytic anaemia and thrombocytopenia (sometimes in combination) in severely immunocompromised adult patients, particularly those with advanced HIV disease, receiving high doses (8000 mg daily) of valaciclovir for prolonged periods in clinical trials. These findings have been observed in patients not treated with valaciclovir who have the same underlying or concurrent conditions.

Updated on 21 February 2011 PIL

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 4 January 2011 SmPC

Reasons for updating

  • 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 4.3 - 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 5.1 - 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 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

There are changes throughout the SPC but the most significant are:

·         The doses of Valtrex should be reduced in patients with impaired kidney function.

·         The addition of the indication for treatment of herpes zoster and the expansion of the indication to include treatment of ophtalmic zoster, treatment and supression of herpes simplex virus in immunocompetent adults and adolescents and in immunocompromised adults, and treatment and suppression of recurrent ocular HSV infections.

·         The introduction of dose instructions for treatment of herpes zoster and the revision of dose instructions in HSV infections of the skin and mucous membranes in immunocompetent and immunocompromised patients, including the addition of a dose instruction for the treatment of herpes labialis (cold sores).

·         The sections regarding warnings and precautions, interactions, fertility, pregnancy and lactation, side effects, overdose and pharmacological properties have also been revised further to the review of updated clinical data.

 

Updated on 3 December 2010 PIL

Reasons for updating

  • New PIL for new product
  • New PIL for medicines.ie

Updated on 21 October 2010 SmPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided