M.I.R. 15

Valsts: Izraēla

Valoda: angļu

Klimata pārmaiņas: Ministry of Health

Aktīvā sastāvdaļa:

MORPHINE SULFATE

Pieejams no:

RAFA LABORATORIES LTD

ATĶ kods:

N02AA01

Zāļu forma:

TABLETS

Kompozīcija:

MORPHINE SULFATE 15 MG

Ievadīšanas:

PER OS

Receptes veids:

Required

Ražojis:

RAFA LABORATORIES LTD, JERUSALEM

Ārstniecības grupa:

MORPHINE

Ārstniecības joma:

MORPHINE

Ārstēšanas norādes:

For the relief of moderate to severe pain.

Autorizācija datums:

2023-05-31

Lietošanas instrukcija

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
M.I.R. 15
M.I.R. 30
Tablets
Active ingredient:
Each tablet of M.I.R. 15 contains: Morphine sulfate 15 mg
Each tablet of M.I.R. 30 contains: Morphine sulfate 30 mg
For the list of the additional ingredients, see section 6.
See also 'Important information about some of the medicine's
ingredients' in section 2.
Read the entire leaflet carefully before using the medicine.
This leaflet contains concise information about the medicine. If you
have any further questions,
please refer to the doctor or pharmacist.
This medicine has been prescribed to treat your condition. Do not pass
it on to others. It may
harm them, even if it seems to you that their medical condition is
similar to yours. This is
particularly important when using a medicine of this kind, which was
prescribed for you after
meticulous evaluation of the benefit versus risk of using it
unnecessarily.
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 in 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 the medicine intended for?
The medicine is intended for relief of moderate to severe pain.
Therapeutic Group:
Opioid analgesics
.
The medicine has been prescribed for you only and

Produkta apraksts

DL-M.I.R-SPC-SEP 2023-notif_05
Summary of Product Characteristics
1. NAME OF THE MEDICINAL PRODUCT
M.I.R. 15
M.I.R. 30
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
M.I.R. 15: Each tablet contains Morphine Sulfate 15 mg
M.I.R. 30: Each tablet contains Morphine Sulfate 30 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Immediate release tablets
M.I.R. 15
Blue, scored tablets
M.I.R. 30
Pink, scored 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
M.I.R. tablets are indicated for the relief of moderate to severe
pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration
Oral.
Posology
Prior to starting treatment with opioids, a discussion should be held
with patients to put in place a
strategy for ending treatment with morphine in order to minimise the
risk of addiction and drug
withdrawal syndrome (see section 4.4).
Ϯ
Adults and children over 12 years
:
The dosage of M.I.R. tablets is dependent on the severity of pain and
the patient's previous history of
analgesic requirements. One tablet to be taken every four to six hours
or as directed by a physician.
Increasing severity of pain or tolerance to morphine will require
increased dosage of M.I.R. tablets alone
or in combination to achieve the desired relief.
Patients receiving M.I.R. tablets in place of parenteral morphine
should be given a sufficiently increased
dosage to compensate for any reduction in analgesic effects associated
with oral administration.