Unigesic (35 + 450) mg tablets

দেশ: মাল্টা

ভাষা: ইংরেজি

সূত্র: Medicines Authority

থেকে পাওয়া:

Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. 14th Km National Road Athens - Lamia 1, GR-145 64 Kifissia, Greece

এটিসি কোড:

M03BC51

INN (আন্তর্জাতিক নাম):

ORPHENADRINE CITRATE 35 mg PARACETAMOL 450 mg

ফার্মাসিউটিকাল ফর্ম:

TABLET

রচনা:

ORPHENADRINE CITRATE 35 mg PARACETAMOL 450 mg

প্রেসক্রিপশন টাইপ:

POM

থেরাপিউটিক এলাকা:

MUSCLE RELAXANTS

পণ্য সারাংশ:

Licence number in the source country: NOT APPLICAPABLE

অনুমোদন অবস্থা:

Authorised

অনুমোদন তারিখ:

2022-05-25

তথ্য লিফলেট

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PACKAGE LEAFLET: INFORMATION FOR THE USER
UNIGESIC (35+450) MG/TAB TABLETS
orphenadrine citrate and paracetamol
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 Unigesic is and what it is used for
2.
What you need to know before you take Unigesic
3.
How to take Unigesic
4.
Possible side effects
5.
How to store Unigesic
6.
Contents of the pack and other information
1.
WHAT UNIGESIC IS AND WHAT IT IS USED FOR
Unigesic contains orphenadrine citrate that is a muscle relaxant and
paracetamol that is an analgesic.
Unigesic is used for:
-
Painful muscle disorders after injuries.
-
Muscle contractions caused by sudden movements of the body.
-
Sprains.
-
Extra-articular rheumatism accompanied by muscle spasm (inflammation
of the connective
tissues (fibrositis), inflammation of the muscles (myositis) and
muscle pain (myalgia)).
-
Acute or chronic pain in the back (lumbar region).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE UNIGESIC
DO NOT TAKE UNIGESIC
-
if you are allergic to orphenadrine citrate or paracetamol or any of
the other ingredients of this
medicine (listed in section 6).
-
if you have glaucoma.
-
if you have urinary retention e.g. prostatic hyperplasia or bladder
obstruction.
-
if you suffer from a disease that causes muscle weakness (severe
myasthenia (myasthenia
Gravis)).
-
if you suffer from liver and kidney failure.
-
if you have stomach and bowel obstruction.
-
if you are breast-feeding.
Unigesic is contraindicated in children under 12 years of age.
WARNINGS AND PRECAUTIONS
Talk t

পণ্য বৈশিষ্ট্য

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Unigesic (35 + 450) mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 35 mg of orphenadrine citrate and 450 mg of
paracetamol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
White, standard convex bisect two-layer tablets with a diameter of
12.0 mm ± 0.6%.
The tablets can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Unigesic is indicated for:
•
Painful post-traumatic muscle syndromes.
•
Muscle contractions caused by sudden body movements.
•
Sprains.
•
Extra-articular rheumatism accompanied by muscle spasm (fibrositis,
myositis, myalgia).
•
Acute or chronic low back pain (lumbago).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
1-2 tablets 3 times daily or as determined depending on the
patient’s condition.
_Elderly _
The dose in patients over 65 years of age should not exceed 3 tablets
daily (105 mg orphenadrine
citrate daily). The usual dose is ½-1 tablet 3 times daily (see
section 4.4).
_Paediatric population _
No data available. The safety and efficacy of Unigesic in children 0
to 12 years of age have not yet
been established.
Treatment duration
The duration of treatment will generally vary to a maximum of 10 days,
depending on the patient’s
condition.
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Method of administration
The tablets can be divided into two equal doses. The tablets should be
swallowed with a glass of
water. The tablets can be taken with or without food.
4.3.
CONTRAINDICATIONS
Unigesic is contraindicated in:
•
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
•
Glaucoma, urinary retention (e.g. prostatic hyperplasia or bladder
neck obstruction), severe
myasthenia (myasthenia Gravis) or gastrointestinal obstruction, e.g.
pyloric and duodenal
stenosis,
stenosing
peptic
ulcer,
megaesophagus,
due
to
the
parasympatholytic
action
of
orphenadrine.
•
Severe hepatic and severe renal i