MCR 30

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

MORPHINE SULFATE

Available from:

RAFA LABORATORIES LTD

ATC code:

N02AA01

Pharmaceutical form:

TABLETS CONTROLLED RELEASE

Composition:

MORPHINE SULFATE 30 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

RAFA LABORATORIES LTD, JERUSALEM

Therapeutic group:

MORPHINE

Therapeutic area:

MORPHINE

Therapeutic indications:

Prolonged relief of severe pain.

Authorization date:

2012-06-30

Patient Information leaflet

PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is sold with a doctor’s prescription only
MCR
® 10, MCR
® 30, MCR
® 100
MORPHINE TABLETS IN A CONTROLLED RELEASE SYSTEM
ACTIVE INGREDIENT:
Each tablet of MCR 10 contains: 10 mg Morphine sulphate
Each tablet of MCR 30 contains: 30 mg Morphine sulphate
Each tablet of MCR 100 contains: 100 mg Morphine sulphate
For a list of inactive ingredients, please see section 6.
Also refer to ‘Important information about some of the medicine's
ingredients’ in section 2.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further questions,
please refer to your doctor or pharmacist.
This medicine has been prescribed for the treatment of your disease.
Do not pass it on to
others. It may harm them even if it seems to you that their disease is
similar to yours. This is
especially important while using a medicine of this kind, prescribed
to you after careful
evaluation of the benefit versus the risk of its unneeded use.
Medicines of the opioids group may cause addiction, especially with
prolonged use and they
have a potential for misuse and overdose. A reaction to an overdose,
may be manifested by slow
breathing and may even cause death. Make sure you know the name of the
medicine, the
dosage that you take, how often you take it, the duration of
treatment, potential side effects and
risks.
Additional information regarding the risk of dependence and addiction
can be found at the
following link:
https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/risk/DocLib/opioids_en.pdf
Taking this medicine along with medicines from the benzodiazepines
group, other medicines which
depress the central nervous system (including drugs) or alcohol may
cause a feeling of profound
drowsiness, breathing difficulties (respiratory depression), coma and
death.
1. WHAT IS THIS MEDICINE INTENDED FOR?
The medicine is intended for the relief of severe and prolonged pains.
TH

Summary of Product characteristics

1
MCR-DL-April 2021-06
1.
NAME OF THE MEDICINAL PRODUCT
MCR
®
10, MCR
®
30, MCR
®
100
Controlled release tablets.
For oral use.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
MCR 10: Morphine Sulfate 10 mg
MCR 30: Morphine Sulfate 30 mg
MCR 100: Morphine Sulfate 100 mg
Excipients with known effect:
MCR 10 and MCR 30 tablets contain Lactose.
MCR 30 tablets contain sunset yellow (E110).
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Controlled-release tablets
MCR 10 tablets are brown round coated tablets.
MCR 30 tablets are purple round coated tablets.
MCR 100 tablets are grey round coated tablets.
4.
CLINICAL PARTICULARS
WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
Concomitant use of opioids with benzodiazepines or other central
nervous system (CNS) depressants, including alcohol,
may result in profound sedation, respiratory depression, coma, and
death [see sections 4.4, 4.5].
Reserve concomitant prescribing of these drugs for use in patients for
whom alternative treatment options are
inadequate.
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and
sedation.
4.1
THERAPEUTIC INDICATIONS
Prolonged relief of severe pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For the correct and effective use of morphine it is critical to adjust
the dosing regimen for each patient individually. The
following dosage recommendations are, therefore, only suggested
approaches to what is actually a series of clinical
decisions in the management of the pain of an individual patient.
The dosage of morphine is individualized according to the severity of
the pain, the patient's age and metabolism, previous
history of analgesic therapy, and response to morphine.
The correct dosage for any individual patient is that which is
sufficient to control pain with no, or tolerable, side effects for a
full 12 hours.
MCR should be taken on a regular 12-hourly schedule, at the minimum
dose required to