Equasym XL 10, 20 & 30mg Modified Release Capsules

  • Name:

    Equasym XL 10, 20 & 30mg Modified Release Capsules

  • Company:
    info
  • Active Ingredients:

    Methylphenidate Hydrochloride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/07/20

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Summary of Product Characteristics last updated on medicines.ie: 10/7/2020

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Shire Pharmaceuticals Ireland Limited

Shire Pharmaceuticals Ireland Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Buccolam 2.5mg, 5mg, 7.5mg and 10mg oromucosal solution Active Ingredients Midazolam Hydrochloride
Medicine Name Cinryze 500 IU powder and solvent for solution for injection Active Ingredients C1 inhibitor (human)
Medicine Name Equasym XL 10, 20 & 30mg Modified Release Capsules Active Ingredients Methylphenidate Hydrochloride
Medicine Name Firazyr 30 mg solution for injection in pre-filled syringe Active Ingredients Icatibant Acetate
Medicine Name Foznol 250mg, 500mg, 750mg & 1000mg Chewable Tablets Active Ingredients Lanthanum Carbonate Hydrate
Medicine Name Intuniv 1mg, 2mg, 3mg, 4mg prolonged-release tablets Active Ingredients Guanfacine hydrochloride
Medicine Name Mezavant XL Active Ingredients Mesalazine
Medicine Name Natpar 25, 50, 75, 100 micrograms/dose powder and solvent for solution for injection in pre filled pen Active Ingredients Parathyroid Hormone
Medicine Name Reminyl Oral Solution Active Ingredients Galantamine Hydrobromide
Medicine Name Reminyl XL 8mg, 16mg and 24 mg prolonged release capsules Active Ingredients Galantamine Hydrobromide
Medicine Name Resolor 1 mg film-coated tablets Active Ingredients Prucalopride Succinate
Medicine Name Resolor 2 mg film-coated tablets Active Ingredients Prucalopride Succinate
Medicine Name Tyvense 20mg, 30mg, 40mg, 50mg. 60mg & 70mg Capsules, hard Active Ingredients Lisdexamfetamine dimesylate
Medicine Name Xagrid 0.5mg hard capsule Active Ingredients Anagrelide hydrochloride
1 - 0 of 14 items.Total: Infinity pages

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 10 July 2020 SmPC

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 PIL

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 PIL

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

Section

Changes

1. What Intuniv is used for

Updated:

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.

 

About ADHD

 

People with ADHD find it hard to:

  • sit still
  • concentrate.

 

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.

 

ADHD does not affect the intelligence of a child or young person.

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’.

4. Possible side effects

Addition of 2 AEs:

Common (may affect up to 1 in 10 people)

  • low heart rate
  • blood pressure decreased

 

Removal of HPRA address, email address and telephone number

6. MAH

6. DATE OF REVISION OF THE TEXT

Telephone number updated

June 2020

Updated on 17 October 2019 PIL

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 SmPC

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

Section

Changes

2.            QUALITATIVE AND QUANTITATIVE COMPOSITION

 

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

4.3          Contraindications

 

Updated text:

 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

4.4          Special warnings and precautions for use

 

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.

4.6          Fertility, pregnancy and lactation

 

Updated header:

Breast-feeding

Methylphenidate has been found in the breast-milk of a woman treated with methylphenidate.

8. Undesirable effects

 

Added text:

Not known

priapism, erection increased and prolonged erection*,erectile dysfunction

10.          DATE OF REVISION OF THE TEXT

09 October 2019

Updated on 22 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 22 January 2018 SmPC

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

Change to the address of the Marketing Authorisation Holder, and subsequent update to the date of revision of the text.

Updated on 15 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 December 2017 PIL

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 SmPC

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 6 March 2012 PIL

Reasons for updating

  • Change to side-effects

Updated on 7 November 2011 SmPC

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

Section 4.8

To include; bruxism

Updated on 15 July 2011 SmPC

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

4.9 Overdose

Signs and symptoms - pyychosis has been added.

Updated on 31 May 2011 SmPC

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 SmPC

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 PIL

Reasons for updating

  • Change to storage instructions
  • Change to further information section
  • Change to date of revision

Updated on 25 November 2010 PIL

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 SmPC

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 4.1: Completely updated in lince with article 31 referral
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 PIL

Reasons for updating

  • Change of manufacturer
  • Change to marketing authorisation holder

Updated on 12 August 2009 SmPC

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

Dublin 24

Ireland

 

 

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 PIL

Reasons for updating

  • Addition of manufacturer
  • PIL retired pending re-submission

Updated on 14 November 2007 SmPC

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

Update shelf life to 36 months

Updated on 27 April 2007 PIL

Reasons for updating

  • Change of manufacturer

Updated on 21 February 2007 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 February 2007 SmPC

Reasons for updating

  • New SPC for new product

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