MUSCOL

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ORPHENADRINE (CITRATE); PARACETAMOL

Available from:

TEVA ISRAEL LTD

ATC code:

M03BC51

Pharmaceutical form:

TABLETS

Composition:

PARACETAMOL 500 MG; ORPHENADRINE (CITRATE) 30 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

TEVA ISRAEL LTD, ISRAEL

Therapeutic group:

ORPHENADRINE, COMBINATIONS

Therapeutic area:

ORPHENADRINE, COMBINATIONS

Therapeutic indications:

Relief of mild to moderate pain of acute musculoskeletal disorders.

Authorization date:

2021-06-30

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s
prescription only
Muscol
Tablets
Each tablet contains:
Paracetamol 500 mg
Orphenadrine citrate 30 mg
For information regarding inactive ingredients, see section 2 –
“Important information about some of the ingredients of the
medicine” and section 6 – “Additional information”.
Read the entire leaflet carefully before using the medicine.
This leaflet contains concise information about the medicine.
If you have additional questions, refer to the doctor or the
pharmacist.
This medicine has been prescribed for you. Do not pass it on
to others. It may harm them even if it seems to you that their
medical condition is similar.
This medicine is not intended for use in children under 12 years
of age.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended to relieve muscle pain.
Therapeutic class:
Paracetamol – analgesic and antipyretic.
Orphenadrine citrate – a skeletal muscle relaxant, which acts
in the central nervous system to produce a reaction of muscle
relaxation.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
•
You
are
sensitive
(allergic)
to
the
active
ingredients
(paracetamol or orphenadrine citrate) or to any of the
other ingredients this medicine contains (see section 6 –
“Additional information”). Always check the ingredients to
make sure you can use this medicine.
•
You have glaucoma (high intra-ocular pressure).
•
You have an intestinal obstruction or esophageal disease.
•
You have an enlarged prostate or urinary tract obstruction.
•
You
have
a
muscle
weakness
disease
(myasthenia
gravis).
Special warnings regarding the use of the medicine
•
If you have developed skin side effects in the past as a result
of taking preparations containing paracetamol, do not take
preparations containing paracetamol, so that severe skin
side effects will not recur.
•
The preparation contains paracetamol, which may cause
liver damage when:
○
G

Summary of Product characteristics

1
Muscol-Tablet_update-SPC_Notification-05-2021_NS
SUMMARY OF PRODUCT CHARACTERISTICS
MUSCOL
®
TABLETS
1.
NAME OF THE MEDICINE
Muscol Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Orphenadrine citrate 30 mg and paracetamol 500
mg.
For the full list of excipients, see Section 6.1 - "List of
excipients".
3.
PHARMACEUTICAL FORM
Tablets.
Light pink, round flat tablet with beveled edges, scored in half on
one side and engraved "IKA" on the
other side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Relief of mild to moderate pain of acute musculoskeletal disorders.
4.2.
DOSE AND METHOD OF ADMINISTRATION
Adults
2 tablets, three times daily.
4.3.
CONTRAINDICATIONS

Hypersensitivity to the active substances (paracetamol or orphenadrine
citrate) or to any of the
expients listed in section 6.1 - "List of excipients".

Glaucoma

Prostatic hypertrophy or obstruction at the bladder neck,

Myasthenia gravis

Oesophageal spasm and pyloric or duodenal obstruction.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
IDENTIFIED PRECAUTIONS
Concomitant treatment with other medicines that contain orphenadrine
or paracetamol is not
recommended.
Safety of continuous long-term therapy with orphenadrine has not been
established. Therefore if
orphenadrine is prescribed for prolonged use, periodic monitoring of
blood, urine and liver function is
recommended.
2
Muscol-Tablet_update-SPC_Notification-05-2021_NS
ORPHENADRINE CITRATE
Orphenadrine citrate should be used with caution in patients with
tachycardia, cardiac decompensation,
coronary insufficiency or cardiac arrhythmias.
PARACETAMOL
Paracetamol should be used with caution in patients with hepatic or
renal dysfunction.
_ _
Paracetamol has been associated with a risk of rare but serious skin
reactions. These skin reactions,
known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis
(TEN), and acute generalized
exanthematous pustulosi