Keral 25mg Tablets

  • Name:

    Keral 25mg Tablets

  • Company:
    info
  • Active Ingredients:

    Dexketoprofen trometamol

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/09/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 5/9/2019

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A. Menarini Pharmaceuticals Ireland Ltd

A

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Medicine Name Brimica Genuair 340 micrograms /12 micrograms inhalation powder Active Ingredients Aclidinium Bromide, Formoterol fumarate dihydrate
Medicine Name Drynol 10 mg orodispersible tablets Active Ingredients Bilastine
Medicine Name Drynol 2.5 mg/ml oral solution Active Ingredients Bilastine
Medicine Name Drynol 20 mg tablets Active Ingredients Bilastine
Medicine Name Eklira Genuair 322 micrograms inhalation powder Active Ingredients Aclidinium Bromide
Medicine Name Fastum 2.5% w/w gel Active Ingredients Ketoprofen
Medicine Name Frovex Active Ingredients Frovatriptan succinate monohydrate
Medicine Name Keral 25 mg granules for oral solution Active Ingredients Dexketoprofen trometamol
Medicine Name Keral 25mg Tablets Active Ingredients Dexketoprofen trometamol
Medicine Name Keral 50 mg/2ml Solution for injection/infusion Active Ingredients Dexketoprofen trometamol
Medicine Name Konverge film-coated tablets Active Ingredients Amlodipine besilate, olmesartan medoxomil
Medicine Name Konverge Plus film-coated tablets Active Ingredients Amlodipine besilate, Hydrochlorothiazide, olmesartan medoxomil
Medicine Name Nebilet Active Ingredients Nebivolol hydrochloride
Medicine Name Nebilet Plus 5 mg / 12.5 mg film-coated tablets Active Ingredients Hydrochlorothiazide, Nebivolol hydrochloride
Medicine Name Nebilet Plus 5 mg / 25 mg film-coated tablets Active Ingredients Hydrochlorothiazide, Nebivolol hydrochloride
Medicine Name Omesar 10mg, 20mg and 40mg Film-Coated Tablets Active Ingredients olmesartan medoxomil
Medicine Name Omesar Plus 20 mg/12.5 mg & 20 mg/25 mg Film-coated tablets Active Ingredients Hydrochlorothiazide, olmesartan medoxomil
Medicine Name Omesar Plus 40 mg/12.5 mg & 40 mg/25 mg film-coated tablets Active Ingredients Hydrochlorothiazide, olmesartan medoxomil
Medicine Name Osteofos D3 Active Ingredients Calcium phosphate, Colecalciferol (Vitamin D3)
Medicine Name Priligy 30 mg and 60 mg film-coated tablets Active Ingredients Dapoxetine hydrochloride
Medicine Name Quofenix 300 mg powder for concentrate for solution for infusion Active Ingredients Delafloxacin Meglumine
Medicine Name Quofenix 450 mg tablets Active Ingredients Delafloxacin Meglumine
Medicine Name Ranexa prolonged-release tablets Active Ingredients Ranolazine
1 - 0 of 31 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 5 September 2019 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose

Free text change information supplied by the pharmaceutical company

Addition of new blister packaging with no special storage conditions.

Updated on 5 September 2019

Reasons for updating

  • 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 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Addition of new blister packaging with a 3 year shelf life and no special storage conditions.

Updated on 1 August 2019 PIL

Reasons for updating

  • XPIL Created

Updated on 1 August 2019

Reasons for updating

  • File format updated to PDF

Free text change information supplied by the pharmaceutical company

File format updated to pdf

Updated on 17 May 2018

Reasons for updating

  • 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
  • Improved presentation of SmPC

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to the SmPC to align to the current QRD template.

Also to update section 4.5 Interactions including updated warning for mifepristone.  Tenofovir, deferasirox and pemetrexed added.

Updated on 13 May 2018 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 19 May 2015

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 19 May 2015 SPC

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 4.6 - 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

The main changes are to update the SmPC as follows:
4.2.       Posology and method of administration
Renal dysfunction: Mild renal dysfunction has changed from "creatinine clearance 50-80 ml/min" to "creatinine clearance 60-89 ml/min"
Moderate to severe renal dysfunction has changed from "creatinine clearance <50 ml/min" to "creatinine clearance <59 ml/min"

4.3.       Contraindications

The following contraindications have been added:
- known photoallergic or phototoxic reactions during treatment with ketoprofen or fibrates
- patients with severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)"
The contraindication in case of history of gastrointestinal ulceration/bleeding is now better specified as "patient with active peptic ulcer/gastrointestinal haemorrhage, or any history of gastrointestinal bleeding, ulceration or perforation";
The levels of severe renal dysfunction have been better specified:
-patients with moderate to severe renal dysfunction is now specified as "creatinine clearance <59ml/min)"

4.4 Special warnings and precautions for use

The paragraph has been organized in sub sections (Gastrointestinal safety, Renal Safety, Liver safety, Cardiovascular and cerebrovascular safety,Skin reactions, Other information; Paediatric population) where the information already present in the previous SmPC have been reported. 
The following information has been added:
Renal Safety
Adequate fluid intake should be ensured during treatment to prevent dehydration and possibly associated increased renal toxicity.
Older patients are more likely to be suffering from impaired renal function (see section 4.2).
Other information
Particular caution is required in patients with:
- congenital disorder of porphyrin metabolism (e.g. acute intermittent porphyria)
- dehydration
- directly after major surgery
If the physician considers long-term dexketoprofen therapy to be necessary, hepatic and renal function and the bloodcount should be regularly checked.
Severe acute hypersensitivity reactions (anaphylactic shock, for example) have been observed on very rare occasions. Treatment must be discontinued at the first signs of severe hypersensitivity reactions following intake of Keral. Depending on the symptoms, any medically required procedures must be initiated by specialist healthcare professionals.
Patients with asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyposis have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs than the rest of the population. Administration of this medicinal product can cause asthma attacks or bronchospasm, particularly in subjects allergic to acetylsalicylic acid or NSAIDs (see section 4.3).
Exceptionally, varicella can be at the origin of serious cutaneous and soft tissues infectious complications. To date, the contributing role of NSAIDs in the worsening of these infections cannot be ruled out. Thus, it is advisable to avoid use of Keral in case of varicella.
KERAL should be administered with caution to patients suffering from haematopoietic disorders, systemic lupus erythematosus or mixed connective tissue disease.
As other NSAIDs, dexketoprofen can mask the symptoms of infectious diseases.

Updated on 19 May 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 May 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 12 August 2011 SPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change to improve clarity and readability
  • Section 4.5 Interactions: information regarding interaction with aminoglycosides has been included.
  • Section 4.8 Undesirable effects: hepatitis, laryngeal oedema and acute renal failure have been included; hepatocellular damage and angioneurotic oedema have been replaced by hepatocellular injury and angioedema, respectively.
  • Minor discrepancies between the SmPC of the film-coated tablets and the solution for injection have been amended.

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company


  • Section 4.5 Interactions: information regarding interaction with aminoglycosides has been included.
  • Section 4.8 Undesirable effects: hepatitis, laryngeal oedema and acute renal failure have been included; hepatocellular damage and angioneurotic oedema have been replaced by hepatocellular injury and angioedema, respectively.
  • Minor discrepancies between the SmPC of the film-coated tablets and the solution for injection have been amended.

Updated on 9 August 2011 PIL

Reasons for updating

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

Updated on 28 September 2009 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 18 November 2008 PIL

Reasons for updating

  • Change due to harmonisation of patient information leaflet
  • Change due to user-testing of patient information

Updated on 12 July 2007 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SmPC changes are to update the cardiovascular, gastrointestinal, skin and fertility warnings.
 Sections 4.2, 4.4, 4.5, 4.8 & 10 have been updated.   

Updated on 12 July 2007 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 20 March 2007 PIL

Reasons for updating

  • Change of active ingredient
  • Change to packaging
  • Change of inactive ingredient
  • Change of contraindications
  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to side-effects

Updated on 20 March 2007 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

The changes have been made following licence renewal.

Updated on 29 March 2005 SPC

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 29 March 2005 PIL

Reasons for updating

  • Change of contraindications
  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to side-effects
  • Change to drug interactions

Updated on 10 August 2004 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 5 August 2004 PIL

Reasons for updating

  • New PIL for new product