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CYKLOKAPRON 500 MG FILM-COATED TABLETS

Active substance(s): TRANEXAMIC ACID

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Meda Pharmaceuticals Ltd
Cyklokapron 500 mg Film-coated Tablets

1-2-form-present-and-proposed-table

National Type IA-C.I.z Variation
to implement statuatory wording concerning reporting suspected adverse reactions
Cyklokapron 500 mg Film-coated Tablets
PL 15142/0130
Module 1.2 PRESENT AND PROPOSED TABLE
PRESENT SPC
4.8 UNDESIRABLE EFFECTS

PROPOSED SPC
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
Gastro-intestinal disorders
Very rare: Digestive effects such as nausea, vomiting and diarrhoea, may Very rare: Digestive effects such as nausea, vomiting and diarrhoea, may
occur but disappear when the dosage is reduced.
occur but disappear when the dosage is reduced.
Skin and subcutaneous tissue disorders

Skin and subcutaneous tissue disorders
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November 2013

Meda Pharmaceuticals Ltd
Cyklokapron 500 mg Film-coated Tablets

Rare: Allergic skin reactions

1-2-form-present-and-proposed-table

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

26th November 2013

PRESENT PIL
4. Possible side effects

PROPOSED PIL
4. Possible side effects

Like all medicines Cyklokapron can cause side effects, although not Like all medicines Cyklokapron can cause side effects, although not
everybody gets them.
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
Immune system disorders
Very rare (affects less than 1 user in 10,000)
Very rare (affects less than 1 user in 10,000)
- this includes allergic reactions which cause difficulty in breathing or - this includes allergic reactions which cause difficulty in breathing or
dizziness.
dizziness.
Vascular disorders

Vascular disorders
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November 2013

Meda Pharmaceuticals Ltd
Cyklokapron 500 mg Film-coated Tablets

1-2-form-present-and-proposed-table

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 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.
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

This leaflet was last updated in 03/2011.

6.

Further information

This leaflet was last updated in November 2013.

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November 2013

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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