MXL 30mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Morphine sulfate

Available from:

Napp Pharmaceuticals Ltd

ATC code:

N02AA01

INN (International Name):

Morphine sulfate

Dosage:

30mg

Pharmaceutical form:

Modified-release capsule

Administration route:

Oral

Class:

Schedule 2 (CD)

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 04070200; GTIN: 5012854076518

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_MXL_
_®_ 30 MG, 60 MG, 90 MG, 120 MG, 150 MG AND 200 MG PROLONGED-RELEASE
CAPSULES
Morphine sulfate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What
_MXL _
capsules are and what they are used for
2.
What you need to know before you take
_MXL _
capsules
3.
How to take
_MXL _
capsules
4.
Possible side effects
5.
How to store
_MXL _
capsules
6.
Contents of the pack and other information
1.
WHAT _MXL _CAPSULES ARE AND WHAT THEY ARE USED FOR
These capsules have been prescribed for you by your doctor to relieve
severe pain over a period of 24 hours.
They contain the active ingredient morphine which belongs to a group
of medicines called strong analgesics
or ‘painkillers’.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE _MXL_ CAPSULES
DO NOT TAKE _MXL _CAPSULES IF:
•
you are allergic to morphine or any of the other ingredients of the
capsules (see section 6);
•
you have breathing problems, such as obstructive airways disease,
respiratory depression, or severe
asthma. Your doctor will have told you if you have these conditions.
Symptoms may include
breathlessness, coughing or breathing more slowly or weakly than
expected;
•
you have a head injury that causes a severe headache or makes you feel
sick. This is because the
capsules may make these symptoms worse or hide the extent of the head
injury;
•
you have a condition where the small bowel (part of your gut) does not
work properly (paralytic
ileus), your stomach empties more slowly than it sho

Summary of Product characteristics

OBJECT 1
MXL capsules 30 mg
Summary of Product Characteristics Updated 21-May-2021 | Napp
Pharmaceuticals Limited
•
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
MXL 30 mg 60 mg, 90 mg, 120 mg, 150 mg, 200 mg prolonged release
capsules
2. Qualitative and quantitative composition
Each 30 mg prolonged-release capsule contains Morphine Sulfate 30 mg.
Each 60 mg prolonged-release capsule contains Morphine Sulfate 60 mg
Each 90 mg prolonged-release capsule contains Morphine Sulfate 90 mg
Each 120 mg prolonged-release capsule contains Morphine Sulfate 120 mg
Each 150 mg prolonged-release capsule contains Morphine Sulfate 150 mg
Each 200 mg prolonged-release capsule contains Morphine Sulfate 200 mg
Excipient with known effect:
Each 30 mg prolonged-release capsule contains 0.006 mg of sodium
(sodium dodecyl sulfate)
Each 60 mg prolonged-release capsule contains 0.008 mg of sodium
(sodium dodecyl sulfate)
Each 90 mg prolonged-release capsule contains 0.010 mg of sodium
(sodium do