Equasym XL 20mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Methylphenidate hydrochloride

Available from:

Takeda UK Ltd

ATC code:

N06BA04

INN (International Name):

Methylphenidate hydrochloride

Dosage:

20mg

Pharmaceutical form:

Modified-release capsule

Administration route:

Oral

Class:

Schedule 2 (CD)

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 04040000; GTIN: 5015313011884

Patient Information leaflet

04 Oct 2011
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EQUASYM
® XL 10 MG, 20 MG AND 30 MG MODIFIED-RELEASE CAPSULES, HARD
methylphenidate hydrochloride
The name of your medicine is Equasym XL, it contains the active
substance ‘methylphenidate
hydrochloride’. The name ‘methylphenidate’ will also be used in
this leaflet.
IMPORTANT THINGS YOU NEED TO KNOW ABOUT YOUR MEDICINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
THIS MEDICINE IS USED TO TREAT ADHD:
-
The full name for ADHD is ‘Attention Deficit Hyperactivity
Disorder’.
-
The medicine helps with your brain activity. It can help improve your
attention, help you concentrate,
and make you less impulsive.
-
You need to have other treatments for ADHD as well as this medicine.
Read Section 1 for more information.
BEFORE YOU TAKE THIS MEDICINE, TALK TO YOUR DOCTOR IF:
-
You have heart, circulation, or mental health problems - you may not
be able to take this medicine.
-
You are taking any other medicines - this is because methylphenidate
can affect how other medicines
work.
Read Section 2 for more information.
WHILE TAKING THIS MEDICINE:
-
See your doctor regularly. This is because your doctor will want to
check how the medicine is
working.
-
Do not stop taking the medicine without first talking to your doctor.
-
Your doctor may stop your medicine to see if it is still needed, if
you take it for more than a year.
-
The most common side effects are feeling nervous, not being able to
sleep or having a headache.
Read Sections 3 and 4 for more information.
TALK TO YOUR DOCTOR STRAIGHT AWAY IF ANY OF THE FOLLOWING HAPPEN:
-
Your mood and how you feel changes.
-
You feel any problems with your heart.
Read Section 4 for more information.
THE REST OF THIS LEAFLET INCLUDES MORE DETAIL AND OTHER IMPORTANT
INFORMATION ON THE SAFE AND EFFECTIVE
USE OF THIS MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
T

Summary of Product characteristics

OBJECT 1
EQUASYM XL 20 MG CAPSULES
Summary of Product Characteristics Updated 11-Nov-2022 | Takeda UK Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Equasym XL 10 mg modified-release capsules, hard
Equasym XL 20 mg modified-release capsules, hard
Equasym XL 30 mg modified-release capsules, hard
2. Qualitative and quantitative composition
Each capsule contains 10 mg methylphenidate hydrochloride
corresponding to 8.65 mg methylphenidate.
Excipient: 45 mg sucrose/capsule for Equasym XL 10 mg
Each capsule contains 20 mg methylphenidate hydrochloride
corresponding to 17.30 mg methylphenidate.
Excipient: 90 mg sucrose/capsule for Equasym XL 20 mg
Each capsule contains 30 mg methylphenidate hydrochloride
corresponding to 25.94 mg methylphenidate.
Excipient: 135 mg sucrose/capsule for Equasym XL 30 mg
For the full list of excipients, see Section 6.1
3. Pharmaceutical form
Modified release capsule, hard.
Equasym XL 10 mg capsule: The capsule has a dark green opaque cap
impri