BETAFLEX NC TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Adcock Ingram Limited

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS ORPHENADRINE CITRATE 35,0 mg PARACETAMOL 450,0 mg

Authorization status:

Registered

Authorization date:

2001-07-09

Patient Information leaflet

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PATIENT INFORMATION LEAFLET
SCHEDULING STATUS S2
BETAFLEX NC, EACH TABLET CONTAINS: PARACETAMOL 450 MG ORPHENADRINE 35 MG SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
BETAFLEX NC is available without a doctor’s prescription, for you to
treat a mild illness.
Nevertheless, you still need to use BETAFLEX NC carefully to get the
best results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share BETAFLEX NC with any other person.
•
Ask your health care provider or pharmacist if you need more
information or advice.
•
You must see a doctor if your symptoms worsen or do not improve after
10 days.
WHAT IS IN THIS LEAFLET
1. What BETAFLEX NC is and what it is used for
2. What you need to know before you take BETAFLEX NC
3. How to take BETAFLEX NC
4. possible side effects
5. How to store BETAFLEX NC
6. Contents of the pack and other information
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1.WHAT BETAFLEX NC CONTAINS IS AND WHAT IT IS USED FOR
BETAFLEX NC contains paracetamol 450 mg and orphenadrine citrate 35
mg, which belongs to
a group of medicine referred to Analgesic combinations
BETAFLEX NC is used for Generalised pain and the relief of muscle
spasm associated with acute
painful musculo-skeletal conditions.
2.WHAT YOU NEED TO KNOW BEFORE YOU TAKE BETAFLEX NC
DO NOT TAKE
BETAFLEX NC
:
If you are hypersensitive (allergic) to paracetamol and orphenadrine
or any of the other ingredients
of BETAFLEX NC (listed in section 6)
If you suffer from the following:
•
severe liver function
•
enlarged prostate
•
achalasia
(a
failure
of smooth
muscle fibres
to
relax,
which
can
cause
the lower
oesophageal sphincter to remain closed)
•
bladder neck obstruction
•
glaucoma (a condition in which the pressure of fluid in the eye is
high. This can damage
your eyes’ optic nerve)
•
myasthenia gravis (a disorder causing extreme muscle weakness and can
impact a
person’s ability to see, smile, walk, talk and breathe)
•
peptic ulcer (a le

Summary of Product characteristics

_ _
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PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS:
1.
NAME OF MEDICINE
BETAFLEX NC
STRENGTH
Each Tablet contains:
Paracetamol 450 mg
Orphenadrine citrate 35 mg
PHARMACEUTICAL FORM:
Tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Tablet contains:
Paracetamol 450 mg
Orphenadrine 35 mg
Sugar free
For a full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
White, circular, biconvex tablets with a breakbar on one face.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS:
BETAFLEX NC Tablet are indicated generalized pain and the relief of
muscle spasm associated
with acute painful musculo-skeletal conditions.
S2
_ _
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4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults (18 years and older): 2 tablets 3 times a day.
DO NOT EXCEED THE RECOMMENDED DOSAGE
4.3
CONTRAINDICATIONS:
BETAFLEX NC is not recommended for use in patients with
Hypersensitivity to any of the ingredients.
Severe liver function impairment.
Prostatic enlargement, achalasia, bladder neck obstruction, glaucoma,
myasthenia gravis, peptic
ulcer or stenosing and pyloric or duodenal obstruction.
Patients with porphyria.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE:
THIS PRODUCT CONTAINS PARACETAMOL WHICH MAY BE
FATAL IN OVERDOSE. IN THE EVENT OF OVERDOSAGE OR
SUSPECTED
OVERDOSE
AND
NOTWITHSTANDING
THE
FACT THAT THE PERSON MAY BE DOCTOR, HOSPITAL OR
POISON CENTRE MUST BE CONTACTED IMMEDIATELY.
PARACETAMOL:
Dosages in excess of those recommended may cause severe liver damage.
Patients suffering from liver or kidney disease should take BETAFLEX
NC under medical
supervision.
Caution is recommended in patients on other central nervous system
depression-producing
medication as well as patients on anticholinergics or medication with
anticholinergic properties.
_ _
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Use with caution in patients with cardiac disease or arrhythmias,
especially tachycardia.
Do not use continuously for more than 10 days without consulting your
doctor.
4.5 INTERACTION W