SPC  Changes to Pantoloc Control 20 mg gastro-resistant tablets – 21 February 2014

Section 4.4

Added subheading “Gastrointestinal infections caused by bacteria”; information remains the same. Under same subheading after “Salmonella, Campylobacter, or” also added “Clostridium”

Section 4.5

Specific interactions between Pantoprazole and methotrexate have been added.

Addition of clarification on the interactions between Pantoprazole metabolised in the liver via P450 enzyme system and other substances by the same enzyme system.

Section 4.6

Under Pregnancy & Breast-feeding subheadings replaced “Pantoloc Control” with “Pantoprazole”

Section 4.7

“Adverse drug” replaced with “ However, adverse” & “operate” replaced with “use”

Section 4.8

Added subheading “Summary of the safety profile” and section slightly reworded.

Added subheading “Tabulated list of adverse reactions” and section slightly reworded.

Replaced “Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.” with “Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.”

The order of the tabulated adverse reactions frequenies has been amended. The information remains the same.

Information on reporting suspected adverse reactions added.

Section 4.9

Deleted: “There are no known symptoms of overdose in man.”

Section 5.1

After “Pharmacotherapeutic group” added: “Drugs for acid related disorders,”

Section 6.5

Deleted “Alu/Alu blisters containing 7 or 14 gastro-resistant tablets or”

After “Alu/Alu blisters with” added “or without”

Section 6.6

Heading renamed.

Deleted: “No special requirements for disposal.”

Section 7

Name “Nycomed” replaced with “Takeda”

Telephone number changed from: “+49-(0)7531-840” to “0800 825332 4”

Telefax number changed from: “+49-(0)7531-842474” to “0800 825332 9”

Section 9

Added: “Date of latest renewal: 12 June 2014”

Section 10

Change of date from 27 May 2013 to 21 February 2014

Section  4.5

Added information about concomitant use of PPIs with methotrexate

Section 4.6

Add  info on fertility

Section 4.7

Added “Pantoloc Control has no or negligible influence on the ability to drive and use machines.”

Section 5.2

Headings renamed

Section 5.3

Delete “Prec linical” add “Non-clinical”

Section 6.6

Add “for disposal.”

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.”

Section 4.1

Add : ‘PANTOLOC Control is indicated for ‘ before ‘short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.’

Section 4.2

Change of heading from ‘Paediatric use’ to ‘Paediatric population’.

Section 4.6

Heading changed from ‘Pregnancy and lactation’ to ‘Fertility, pregnancy and lactation’.

Pregnancy

Final sentence. Change ‘This medicinal product’ to ‘PANTOLOC Control’ before the words ‘should not be used during pregnancy’.

Heading changed from ‘Lactation’ to ‘Breastfeeding’.

Final sentence. Changed ‘This medicinal product’ to ‘PANTOLOC Control’ before the words  ‘should not be used during breast-feeding’.

Section 4.8

Second paragraph.

Wording changed from ‘Within the following table, undesirable effects are ranked under the following frequency classification:’ to ‘Within the following table, undesirable effects are ranked under the MedDRA frequency classification:’.

Changes in Table 1.

Against:

Blood and lymphatic system disorders –

Agranulocytosis added in rare column, Pancytopenia added in very rare column

Nervous system disorders –

Taste disorders added in rare column

Metabolish and nutrition disorders –

Hypomagnesaemia added in Not Known column

Addition of new line in table

Reproducdtive system and breast disorders –

Gynaecomastia added in Rare column

Section 5.3

First sentence. Change from   ‘ ..special hazard to humans...’ to ‘...special hazard for humans.....’.

Section 10

Date change from March 2011 to 7 December 2011

Section 2:

Deletion of : Excipient: contains 1.06 microgram soya lecithin per gastro-resistant tablet.

Section 4.3

Change of wording from : Hypersensitivity to the active substance, to soya or to any of the other excipients

To: Hypersensitivity to the active substance or to any of the excipients

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Section 6.1

Deletion of : Soya lecithin, Titanium dioxide (E171), Antifoam DC 1510

Addition of : Ammonia solution, concentrated

Section 10

Change of date from 12 June 2009 to March 2011.

Addition of words: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.