Celevac 500 mg tablets
- Name:
Celevac 500 mg tablets
- Company:
ADVANZ Pharma
- Active Ingredients:
- Legal Category:
Supply through pharmacy only

Print ViewKeyword Search SPC
1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
ADVANZ Pharma

Company Products
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 7 August 2015 PIL
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- 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 5.3 - 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
Free text change information supplied by the pharmaceutical company
Updated on 7 August 2015 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- 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 5.3 - 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
Updated on 7 August 2015 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only
Updated on 15 June 2012 PIL
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 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 2 (QUANTITATIVE AND QUALITATIVE COMPOSITION), the following statements have been added:
Excipient: Each tablet also contains 110.467 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
In section 3 (PHARMACEUTICAL FORM), the following statement has been added:
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses
In section 4 (Therapeutic indications), the following wording has been removed:
Route of administration
Oral
In section 4.2 (Posology and method of administration), the following statements have been added:
Route of administration
Oral
In Section 6.6 the heading has been changed to:
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 (DATE OF PARTIAL REVISION OF THE TEXT) the following date has been added:
October 2008
Updated on 15 June 2012 SPC
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 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 2 (QUANTITATIVE AND QUALITATIVE COMPOSITION), the following statements have been added:
Excipient: Each tablet also contains 110.467 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
In section 3 (PHARMACEUTICAL FORM), the following statement has been added:
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses
In section 4 (Therapeutic indications), the following wording has been removed:
Route of administration
Oral
In section 4.2 (Posology and method of administration), the following statements have been added:
Route of administration
Oral
In Section 6.6 the heading has been changed to:
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 (DATE OF PARTIAL REVISION OF THE TEXT) the following date has been added:
October 2008
Updated on 27 August 2008 PIL
Reasons for updating
- New SPC for new product
Updated on 27 August 2008 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only