MARTACET TABLET

Država: Južnoafrička Republika

Jezik: engleski

Izvor: South African Health Products Regulatory Authority (SAHPRA)

Aktivni sastojci:

Tramadol Hydrochloride & Paracetamol

Dostupno od:

Novagen Pharma (Pty) Ltd

Doziranje:

See ingredients

Farmaceutski oblik:

TABLET

Sastav:

Each Film- coated Tablet contains: Tramadol Hydrochloride37,5 mg; Paracetamol 325,0 mg

Status autorizacije:

Registered

Datum autorizacije:

2023-02-06

Uputa o lijeku

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PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
MARTACET
TRAMADOL HYDROCHLORIDE 37,5 MG AND PARACETAMOL 325 MG.
SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING MARTACET.
-
KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN.
-
IF YOU HAVE FURTHER QUESTIONS, PLEASE ASK YOUR DOCTOR, PHARMACIST,
NURSE OR OTHER HEALTHCARE
PROVIDER.
-
MARTACET HAS BEEN PRESCRIBED FOR YOU PERSONALLY AND YOU SHOULD NOT
SHARE YOUR MEDICINE WITH
OTHER PEOPLE. IT MAY HARM THEM, EVEN IF THEIR SYMPTOMS ARE THE SAME AS
YOURS.
WHAT IS IN THIS LEAFLET:
1. What Martacet is and what it is used for
2. What you need to know before you use Martacet
3. How to use Martacet
4. Possible side effects
5. How to store Martacet
6. Contents of the pack and other information
1. WHAT MARTACET IS AND WHAT IT IS USED FOR
Martacet contains tramadol and paracetamol.
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Tramadol is a painkiller belonging to the class of the opioids that
acts on the central nervous system. It is used
for the management of moderate to moderately severe pain.
Paracetamol, the other active substance, has centrally acting
analgesic effects.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MARTACET
DO NOT TAKE MARTACET
:
•
If you are allergic to tramadol, paracetamol, any of the other
ingredients mentioned in section 6.1, or other
opioids such as codeine.
•
If you are suffering from acute alcohol poisoning.
•
If you are taking sleeping pills, pain relievers or medicines that
affect mood and emotions.
•
If you are also taking medicines such as tranylcypromine and
moclobemide or have taken them in the last
14 days before treatment with Martacet which are used to treat
depression. These medicines are used to
treat depression and belong to a group called monoamine oxidase
inhibitors (MAOIs).
•
If you have a severe liver disorder
•
Martacet must not be used for narcotic (an addictive substance)
withdrawal treatment.
•
You should not take Martacet if you suffer from severe breathing
problems.
•
You should not take Martacet if you are sufferin

Svojstava lijeka

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PROPOSED CLEAN PROFESSIONAL INFORMATION
SCHEDULING STATUS
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1. NAME OF THE MEDICINE
Martacet 37,5 mg/ 325 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 37,5 mg tramadol hydrochloride and
325 mg paracetamol.
Martacet is sugar free.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets
Light yellow, oblong shaped biconvex film-coated tablets debossed with
“I 03” on one side and plain on
the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Martacet is indicated for the management of moderate to moderately
severe pain in adults.
Martacet is not recommended for minor pain that may be treated
adequately through lesser means.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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POSOLOGY
To be used in adults and children over 16 years of age.
DO NOT EXCEED THE RECOMMENDED
DOSE.
ADULTS
For the management of pain, the recommended dose of Martacet is 1 or 2
tablets every 4 to 6 hours as
needed for pain relief up to a maximum of 8 tablets per day.
As with all analgesic medicines, a titration period of several days
with gradual dose increases at the
initiation of Martacet therapy may be beneficial for some patients.
Clinical studies with tramadol in patients with moderate to moderately
severe chronic pain indicated that
the tolerability of tramadol can be improved by starting at a lower
dose with gradual upward titration to
reach doses that provide sufficient pain relief.
SPECIAL POPULATIONS
RENAL IMPAIRMENT:
For patients with creatinine clearance < 30 mL/min, the dosing
interval of Martacet should be increased
not to exceed 2 tablets every to 12 hours.
METHOD OF ADMINISTRATION
For Oral use
Tablets must be swallowed whole, with a sufficient quantity of liquid.
They must not be broken or chewed.
4.3
CONTRAINDICATIONS
•
Martacet is contraindicated in patients with a known hypersensitivity
to tramadol, paracetamol, or any
of the other ingredients mentioned in section 6.1 or other opioids
such as codei