Cipramil 20mg tablets *

  • Company:

    Lundbeck (Ireland) Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

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 05 May 2021

File name

IE-Cipramil 20mg fct-SPC_1620203148.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Addition of:

4.4. Special warnings and precautions for use
SSRIs/SNRIs may increase the risk of postpartum haemorrhage (see sections 4.6, 4.8).


4.6. Fertility, pregnancy and lactation
Observational data indicate an increased risk (less than 2-fold) of postpartum haemorrhage following SSRI/SNRI exposure within the month prior to birth (see sections 4.4, 4.8).

 

4.8. Undesirable effects
Reproductive system and breast disorders: postpartum haemorrhage*; frequency not known
* This event has been reported for the therapeutic class of SSRIs/SNRIs (see sections 4.4, 4.6).

Updated on 05 May 2021

File name

IE-Cipramil 10, 20mg fct-PIL_1620203088.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Section 2 warnings and precautions - Addition of:
• History of bleeding disorders […], or if you are pregnant (see ‘Pregnancy’2)
Pregnancy2
If you take Cipramil near the end of your pregnancy there may be an increased risk of heavy vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Cipramil so they can advise you.

 

Section 4 possible side effects - Addition of:
Frequency not known
• Heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see Pregnancy2 in section 2 for more information

Updated on 16 November 2020

File name

REG_013051_1605527258.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 8 - Marketing authorisation number(s)

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 16 November 2020

File name

REG_013057_1605527202.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 25 May 2020

File name

1-3-1 IE Cipramil 20mg Tablets SPC_1590412950.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 25 May 2020

File name

1-3-1 IE Cipramil tablets 10mg & 20mg PL_1590412865.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect

Updated on 18 October 2019

File name

Cipramil 20 mg film-coated tablets. spc_1571406358.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change in section 4.4. Special warnings and precautions for use

Selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors
(SNRIs) may cause symptoms of sexual dysfunction (see section 4.8). There have been reports
of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation
of SSRIs/SNRI.

Updated on 18 October 2019

File name

Cipramil 10 and 20 mg film-coated tablets pl_1571406157.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Free text change information supplied by the pharmaceutical company

Change in section 2. Warnings and precautions

Medicines like Cipralex (so called SSRIs/SNRIs) may cause symptoms of
sexual dysfunction (see section 4). In some cases, these symptoms have
continued after stopping treatment.

Updated on 11 September 2019

File name

1-3-1 SPC IE 20mg Tablets_1568184092.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 11 September 2019

File name

1-3-1 IE Cipramil tablets 10mg & 20mg PL_3_1568183368.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 May 2019

File name

1-3-1 SPC IE 20mg Tablets_1557234334.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 06 March 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)