PRESENT SPC

PROPOSED SPC

4.8 UNDESIRABLE EFFECTS

4.8 UNDESIRABLE EFFECTS

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (>1/l0), common (>1/100 and <1/10), uncommon (>1/1000 and <1/100), rare (> 1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports, not known (cannot be estimated from the available data).

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (>1/l0), common (>1/100 and <1/10), uncommon (>1/1000 and <1/100), rare (> 1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports, not known (cannot be estimated from the available data).

Immune system disorders

Very rare: Hypersensitivity reactions including anaphylaxis

Immune system disorders

Very rare: Hypersensitivity reactions including anaphylaxis

Eye disorders

Rare: Colour vision disturbances, retinal/artery occlusion

Eye disorders

Rare: Colour vision disturbances, retinal/artery occlusion

Vascular disorders

Rare: Thromboembolic events

Very rare: Arterial or venous thrombosis at any sites

Vascular disorders

Rare: Thromboembolic events

Very rare: Arterial or venous thrombosis at any sites

Gastro-intestinal disorders

Very rare: Digestive effects such as nausea, vomiting and diarrhoea, may occur but disappear when the dosage is reduced.

Gastro-intestinal disorders

Very rare: Digestive effects such as nausea, vomiting and diarrhoea, may occur but disappear when the dosage is reduced.

Skin and subcutaneous tissue disorders

Skin and subcutaneous tissue disorders

Rare: Allergic skin reactions

Rare: Allergic skin reactions Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

10. DATE OF REVISION OF THE TEXT

10. DATE OF REVISION OF THE TEXT

4th July 2013

26^th November 2013

PRESENT PIL

PROPOSED PIL

4. Possible side effects

4. Possible side effects

Like all medicines Cyklokapron can cause side effects, although not everybody gets them.

Like all medicines Cyklokapron can cause side effects, although not everybody gets them.

Eye disorders

Rare (affects 1 to 10 users in 1,000)

-    Problems with your eyesight, especially your colour vision.

-    A blood clot in your eye. This may cause bleeding in the eye, or a loss of vision

Eye disorders

Rare (affects 1 to 10 users in 1,000)

-    Problems with your eyesight, especially your colour vision.

-    A blood clot in your eye. This may cause bleeding in the eye, or a loss of vision

Immune system disorders

Very rare (affects less than 1 user in 10,000)

- this includes allergic reactions which cause difficulty in breathing or dizziness.

Immune system disorders

Very rare (affects less than 1 user in 10,000)

- this includes allergic reactions which cause difficulty in breathing or dizziness.

Vascular disorders

Vascular disorders

Very rare (affects less than 1 user in 10,000)

- A blood clot in your blood vessels (called a 'thrombosis’).

Very rare (affects less than 1 user in 10,000)

- A blood clot in your blood vessels (called a 'thrombosis’).

Gastrointestinal disorders

Very rare (affects less than 1 user in 10,000)

-    Feeling sick

-    Being sick

-    Diarrhoea

Gastrointestinal disorders

Very rare (affects less than 1 user in 10,000)

-    Feeling sick

-    Being sick

-    Diarrhoea

These are usually mild and pass very quickly, but if they continue, tell your doctor or pharmacist.

These are usually mild and pass very quickly, but if they continue, tell your doctor or pharmacist.

Skin and subcutaneous tissue disorders

Rare (affects 1 to 10 users in 1,000)

- Itchy, red or swollen skin

Skin and subcutaneous tissue disorders

Rare (affects 1 to 10 users in 1,000)

- Itchy, red or swollen skin

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

6. Further information

6. Further information

This leaflet was last updated in 03/2011.

This leaflet was last updated in November 2013.