Equasym XL 10, 20 & 30mg Modified Release Capsules
*Company:
Takeda Products Ireland LtdStatus:
No Recent UpdateLegal 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
Updated on 15 February 2024
File name
ie-pl-equasym XL 10 20 30mg cap-contusion CCDS-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 15 February 2024
File name
ie-spc-equasym XL 10 20 30mg cap -contusion-ccds-clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 February 2024
File name
ie-spc-equasym XL 10 20 30mg cap -contusion-ccds-clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 November 2022
File name
ie-spc-equasym XL 10 20 30mg cap -Epistaxis-clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 November 2022
File name
ie-pl-equasym XL 10 20 30mg cap-Epistaxis- clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 30 November 2021
File name
ie-pl-equasym XL 10 20 30mg cap -MAT-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 30 November 2021
File name
ie-spc-equasym XL 10 20 30mg cap MAT-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 September 2021
File name
ie-spc-equasym XL 10 20 30mg cap TIB-77-clean- Mar 21.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The Date of revision of the text has been updated to 24 August 2021.
No other changes have been made to the SmPC.
Updated on 11 May 2021
File name
ie-spc-equasym XL 10 20 30mg cap TIA-77-clean- Mar 21.pdf
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
6.6 Special precautions for disposal
No special requirements
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Updated on 23 December 2020
File name
ie-pl-equasym XL 10 20 30mg cap TIAIN-074-clean-Oct20.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 23 December 2020
File name
ie-spc-equasym XL 10 20 30mg cap TIAIN-074-clean-16Dec20.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 December 2020
File name
ie-pl-equasym XL 10 20 30mg cap TIB-072-March2020-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Correction of spelling/typing errors
Updated on 23 December 2020
File name
ie-pl-equasym XL 10 20 30mg cap TIB-072-March2020-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Correction of spelling/typing errors
Updated on 10 July 2020
File name
ie-spc-equasym XL 10 20 30mg cap TIB-072-27May2020-clean.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
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.4 Special warnings and precautions for use
Excipients
This medicinal product contains sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
4.6 Fertility, pregnancy and lactation
Pregnancy
Data from a cohort study of in total approximately 3,400 pregnancies exposed in the first trimester do not suggest an increased risk of overall birth defects. There was a small increased occurrence of cardiac malformations (pooled adjusted relative risk, 1.3; 95 % CI, 1.0-1.6) corresponding to 3 additional infants born with congenital cardiac malformations for every 1000 women who receive methylphenidate during the first trimester of pregnancy, compared with non-exposed pregnancies.
4.8. Undesirable effects
Trismus and incontinence added
10. Date of revision of text
27th May 2020
Updated on 10 July 2020
File name
ie-pl-equasym XL 10 20 30mg cap TIB-072-March2020-clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 10 July 2020
File name
Intuniv-UK-IE-PIL-Renewal-June 2020-Clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to MA holder contact details
Free text change information supplied by the pharmaceutical company
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Section |
Changes |
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1. What Intuniv is used for |
Updated:
About ADHD
People with ADHD find it hard to:
ADHD can cause problems with everyday life. Children and young people with ADHD may have difficulty learning and doing homework. They can find it hard to behave well at home, at school or in other places.
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2. What you need to know before you take Intuniv |
Addition of: You should talk to your doctor if you do not feel better or if you feel worse and very sleepy or drowsy after taking this medicine for around 6 weeks. Your doctor may want to review your treatment.
Intuniv contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. |
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4. Possible side effects |
Addition of 2 AEs: Common (may affect up to 1 in 10 people)
Removal of HPRA address, email address and telephone number |
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6. MAH 6. DATE OF REVISION OF THE TEXT |
Telephone number updated June 2020 |
Updated on 17 October 2019
File name
IE-PIL Equasym XL 10 20 30mg modified release hard capsule - Jul 19-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 4 - possible side effects
Updated on 17 October 2019
File name
IE-SmPC, Equasym XL, 10, 20, 30mg, modified release hard capsule - Oct 19-clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- 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
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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Section |
Changes |
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2. QUALITATIVE AND QUANTITATIVE COMPOSITION
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Updated text: Each capsule contains 10 mg methylphenidate hydrochloride corresponding to 8.65 mg methylphenidate. Each capsule contains 20 mg methylphenidate hydrochloride corresponding to 17.30 mg methylphenidate. Each capsule contains 30 mg methylphenidate hydrochloride corresponding to 25.94 mg methylphenidate. Excipients with known effect 45 mg sucrose/capsule for Equasym XL 10 mg 90 mg sucrose/capsule for Equasym XL 20 mg 135 mg sucrose/capsule for Equasym XL 30 mg |
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4.3 Contraindications
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Updated text:
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 |
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4.4 Special warnings and precautions for use
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Added text: Priapism Prolonged and painful erections have been reported in association with methylphenidate products, mainly in association with a change in the methylphenidate treatment regimen. Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention. |
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4.6 Fertility, pregnancy and lactation
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Updated header: Breast-feeding Methylphenidate has been found in the breast-milk of a woman treated with methylphenidate. |
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8. Undesirable effects
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Added text: Not known priapism, erection increased and prolonged erection*,erectile dysfunction |
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10. DATE OF REVISION OF THE TEXT |
09 October 2019 |
Updated on 22 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 January 2018
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 15 December 2017
File name
PIL_11853_668.pdf
Reasons for updating
- New PIL for new product
Updated on 15 December 2017
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 27 September 2016
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Logorrhea and erectile dysfunction have been added as undesirable effects of unknown frequency.
Other minor changes have been made in line with changes to the template SPCs
Update to date of revision of the text
Updated on 06 March 2012
Reasons for updating
- Change to side-effects
Updated on 07 November 2011
Reasons for updating
- 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
To include; bruxism
Updated on 15 July 2011
Reasons for updating
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Signs and symptoms - pyychosis has been added.
Updated on 31 May 2011
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.2 Posology and method of administration
Equasym XL should not be taken too late in the morning as it may cause disturbances in sleep. If the effect of the medicinal product wears off too early in the late afternoon or evening, disturbed behaviour and/or inability to go to sleep may recur. A small dose of an immediate-release methylphenidate hydrochloride tablet late in the day may help to solve this problem. In that case, it could be considered that adequate symptom control might be achieved with a twice daily immediate release methylphenidate regimen. The pros and cons of a small evening dose of immediate-release methylphenidate versus disturbances in falling asleep should be considered.
4.4 Special warnings and precautions for use
Aggressive or hostile behaviour
Physicians should evaluate the need for adjustment of the treatment regimen in patients experiencing behaviour changes bearing in mind that upwards or downwards titration may be appropriate. Treatment interruption can be considered.
4.8 Undesirable effects – updated in line with SPC Guideline
4.9 Overdose
When treating patients with overdose, allowances must be made for the delayed release of methylphenidate from formulations with extended durations of action.
10. DATE OF REVISION OF THE TEXT
19 May 2011
Updated on 16 February 2011
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 3. Pharmaceutical Form
Change in capsule logo from 'UCB' to 'S544'
6.4 Special precautions for storage
Change in storage conditions from 'Store below 30°C' to 'Store below 25°C'.
10. Date of Revision of Text
05/2010 to 02/2011
Updated on 14 February 2011
Reasons for updating
- Change to storage instructions
- Change to further information section
- Change to date of revision
Updated on 25 November 2010
Reasons for updating
- Change of trade or active ingredient name
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change of contraindications
- Change to instructions about missed dose
- Change to instructions about overdose
- Change to side-effects
- Change to drug interactions
- Change to information about drinking alcohol
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to how the medicine works
- Change to further information section
- Change to date of revision
- Change to improve clarity and readability
- Change due to harmonisation of patient information leaflet
Updated on 10 June 2010
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- Change to section 7 - Marketing authorisation holder
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Addition of legal category
- Change to section 4.7 - Effects on ability to drive and use machines
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2: Completely updated in lince with article 31 referral
Section 4.3: Completely updated in lince with article 31 referral
Section 4.4: Completely updated in lince with article 31 referral
Section 4.5: Completely updated in lince with article 31 referral
Section 4.6: Completely updated in lince with article 31 referral
Section 4.7: Completely updated in lince with article 31 referral
Section 4.8: Completely updated in lince with article 31 referral
Section 4.9: Completely updated in lince with article 31 referral
Section 5.1: Table has been reformatted and replacement of noradrenaline for norepinephrine in the 2nd sentence of the last paragraph
Section 5.3: Completely updated in lince with article 31 referral
Section 6.3: 36 months replaced with 3 years in line with the QRD template
Section 6.5: Updated to list only the pack size available in Ireland
Section 7: MAH telephone number and e-mail address added
Section 9: Information corrected
Section 9: Information corrected
Legal category added
Updated on 17 August 2009
Reasons for updating
- Change of manufacturer
- Change to marketing authorisation holder
Updated on 12 August 2009
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
7. MARKETING AUTHORISATION HOLDER
Shire Pharmaceuticals Ireland Limited
5 Riverwalk
Citywest Business Campus
8. MARKETING AUTHORISATION NUMBER(S)
PA 1575/1/1, 2, 3
10. DATE OF REVISION OF THE TEXT
12 June 2009
Updated on 26 August 2008
Reasons for updating
- Addition of manufacturer
- PIL retired pending re-submission
Updated on 14 November 2007
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 27 April 2007
Reasons for updating
- Change of manufacturer
Updated on 21 February 2007
Reasons for updating
- New PIL for new product
Updated on 19 February 2007
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)