Seroxat
Patient Information Leaflet (PIL)
Revisions
Disclaimer
- These are my own notes of changes I've noticed whilst eyeing up the leaflets. These are not definitive and I may have missed changes, misinterpreted a change or misspelled a word. Do not take what I've written as absolute. Please see your doctor or pharmacist if you have any concerns over the contents of your PIL.
- For the definitive list of revisions or to enquire about the revisions if you have any concerns, please see your doctor or pharmacist.
- Online information on revisions to Seroxat PIL can be found http://www.medicines.org.uk/emc/history/3185 but is very thin on what the changes are, hence why I do this blog post.
Changes from PIL dated August 2014
to PIL dated March 2015
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What's been added
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Section 2: What you need to know before you take seroxat
Under "Important
side effects seen with seroxat":
“or neuroleptic
malignant syndrome” added to sentence after “Other patients develop something
called serotonin syndrome …”
“feeling very
agitated or irritable, feeling hot, muscle stiffness” added to list belonging
to sentence which says“... where they have some of all of the following
symptoms”
Under "Other
medicines and seroxat"
“Pravastatin, used to
treat high cholesterol” added to list.
Section 4: Possible
Side Effects
After “Allergic
reactions to Seroxat” ... “(shortness of breath)” has been added after the symptom
“difficulty breathing”
After “Allergic
reactions to Seroxat” the following symptoms have been added ... “and feel weak or
lightheaded resulting in collapse or loss of consciousness”
Section 4: Possible
Side Effects
Under “Frequency
Unknown” section, the following has been added “Some people have
experienced aggression whilst taking seroxat”.
Under “Other
possible side effects during treatment”, under “Uncommon side effects,
likely to affects 1 in every 100 people”, the following has been added “If you
are a diabetic patient you may notice a loss of control of your blood sugar
levels whilst taking seroxat. Please speak to your doctor about adjusting the
dosage of insulin or diabetes medications.”
Under “Other
possible side effects during treatment”, under “Rare side effects,
likely to affects 1 in every 1,000 people”, the following has been added
“Menstrual period disorders (including heavy or irregular periods, bleeding
between periods, and absence or delay of periods.”
Under “Marketing Authorisation Holder and Manufacturer” there are now two manufacturers.
Previously it was just the manufacturer in Romania. Now the “Seroxat 20mg film-coated tablets” are made by manufacturer in Poland and the “Seroxat 10 and 30mg film-coated tablets” are made by the manufacturer in Romania.
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What's been altered
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Section 4: Possible Side Effects
After “Very rare side effects, likely to affect up to 1 in every 10,000 people:” the first bullet point has had the title altered from “Allergic reactions to Seroxat” to “Allergic reactions, which may be severe to seroxat”
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What's been removed
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NONE
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