DOLOTRAM PLUS #N/A

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Ranbaxy (SA) (Pty) Ltd

Dosage:

Not Indicated

Pharmaceutical form:

#N/A

Composition:

None

Authorization status:

Registered

Authorization date:

2023-06-05

Patient Information leaflet

Ranbaxy Pharmaceuticals (Pty) Ltd
Dolotram Plus
Reg. No 48/2.9/0698
0005-03/2023
Signed:
Page 1 of 11
PATIENT INFORMATION LEAFLET FOR DOLOTRAM PLUS (CLEAN COPY)
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S5
DOLOTRAM PLUS FILM-COATED TABLETS
Tramadol hydrochloride 37,5 mg and paracetamol 325 mg.
Sugar free.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING DOLOTRAM
PLUS

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor, pharmacist,
nurse or other health care
provider.

DOLOTRAM PLUS 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 DOLOTRAM PLUS is and what it is used for.
2.
What you need to know before you take DOLOTRAM PLUS.
3.
How to take DOLOTRAM PLUS.
4.
Possible side effects.
5.
How to store DOLOTRAM PLUS.
6.
Contents of the pack and other information.
1.
WHAT DOLOTRAM PLUS IS AND WHAT IT IS USED FOR
DOLOTRAM PLUS contains tramadol and paracetamol.
Ranbaxy Pharmaceuticals (Pty) Ltd
Dolotram Plus
Reg. No 48/2.9/0698
0005-03/2023
Signed:
Page 2 of 11
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
belongs to the class of analgesics that acts on the central nervous
system.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOLOTRAM PLUS
DO NOT TAKE DOLOTRAM PLUS:

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 DOLOTRAM PLUS which are
used to treat
depression. These medicines are used to treat dep

Summary of Product characteristics

Ranbaxy Pharmaceuticals (Pty) Ltd
Dolotram Plus
48/2.9/0698
THIS SUBMISSION: COMPLIANT RESPONSE TO CLINICAL EVALUATION
RECOMMENDATION – PVG NOTIFICATION- _OPIOID _
_AGONIST- RISK OF ACUTE PANCREATITIS DATED 31-01-2023 _
_ _
DATE OF THIS SUBMISSION 31/03/2023
APPROVED: 18 JUNE 2023_ _
0005-03/2023
Signed:
Page 1 of 20
PROPOSED CLEAN PROFESSIONAL INFORMATION FOR DOLOTRAM PLUS
SCHEDULING STATUS
S5
1.
NAME OF THE MEDICINE
DOLOTRAM PLUS film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 37,5 mg tramadol (as hydrochloride) and 325 mg
paracetamol.
Sugar free.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Light yellow coloured, film-coated, capsule shaped, biconvex tablets,
debossed with '537' on one
side and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DOLOTRAM PLUS is indicated for the management of moderate to
moderately severe pain in
adults.
DOLOTRAM PLUS is not recommended for minor pain that may be treated
adequately through
lesser means.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
To be used in adults and children over 16 years of age.
DO NOT EXCEED THE RECOMMENDED DOSE.
Ranbaxy Pharmaceuticals (Pty) Ltd
Dolotram Plus
48/2.9/0698
THIS SUBMISSION: COMPLIANT RESPONSE TO CLINICAL EVALUATION
RECOMMENDATION – PVG NOTIFICATION- _OPIOID _
_AGONIST- RISK OF ACUTE PANCREATITIS DATED 31-01-2023 _
_ _
DATE OF THIS SUBMISSION 31/03/2023
APPROVED: 18 JUNE 2023_ _
0005-03/2023
Signed:
Page 2 of 20
_ADULTS: _
For the management of pain, the recommended dose of DOLOTRAM PLUS 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 DOLOTRAM PLUS 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