Larapam SR 100mg tablets

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Tramadol hydrochloride

Tersedia dari:

Sandoz Ltd

Kode ATC:

N02AX02

INN (Nama Internasional):

Tramadol hydrochloride

Dosis:

100mg

Bentuk farmasi:

Modified-release tablet

Rute administrasi :

Oral

Kelas:

Schedule 3 (CD No Register Exempt Safe Custody)

Jenis Resep:

Caution - AMP level prescribing advised

Ringkasan produk:

BNF: 04070200

Selebaran informasi

WHAT IS IN THIS LEAFLET
1.
What Larapam SR Tablets are and what they are
used for
2.
What you need to know before you take Larapam SR Tablets
3.
How to take Larapam SR Tablets
4.
Possible side effects
5.
How to store Larapam SR Tablets
6.
Contents of the pack and other information
Tramadol, the active substance in Larapam SR Tablets, is a
painkiller (analgesic) of the opioid group. Its pain alleviating
effect is due to its influence on specific nerve cells in the spinal
cord and in the brain.
Larapam SR Tablets are used in the treatment of moderate to
severe pain.
DO NOT TAKE LARAPAM SR TABLETS:
•
if you are allergic to tramadol or any of the other ingredients
of this medicine (listed in section 6)
•
in acute poisoning with alcohol, sleeping agents, centrally
acting painkillers, opioids or other psychotropic medicines
(medicines which influence mood, emotional status and
disposition).
•
if you are also taking certain medicines called “monoamine
oxidase inhibitors” or MAOIs (used to treat depression
or Parkinson’s disease) or have taken them in the last
14 days before treatment with Larapam SR Tablets (see
“Other medicines and Larapam SR Tablets”)
•
if you have epilepsy and your fits are not adequately
controlled by treatment
•
as a drug substitute in drug withdrawal treatment
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Larapam SR Tablets if you:
•
think you may already be dependent on other opioid painkillers
•
react sensitively to opiates
•
have a consciousness disturbance (if you feel that you
are going to faint)
•
are in shock (cold sweat can be an indication of this)
•
have difficulty in breathing
•
suffer from increased pressure in the brain (possibly
after a head injury or brain disease)
•
have a liver or kidney disorder
•
suffer from epilepsy or seizures (fits) or have had them
in the past.
If any of the above applies to you, please talk to your doctor
before starting to take this medicine.
Sleep-related breathing disorders: Larapam SR Tablets
contains an

Karakteristik produk

1.
NAME OF THE MEDICINAL PRODUCT
Larapam 100mg SR Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 100 mg tramadol hydrochloride.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Prolonged-release tablet.
Larapam 100 mg SR Tablets are round, biconvex, off white tablets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Treatment of moderate to severe pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose should be adjusted to the intensity of the pain and the
sensitivity of the individual
patient. The lowest effective dose for analgesia should generally be
selected. Daily doses of
400 mg tramadol hydrochloride should not be exceeded, except in
special clinical
circumstances. Unless otherwise prescribed, Larapam SR Tablets should
be given as
follows:
_Adults and adolescents above the age of 12 years_
The usual initial dose is one Larapam 100mg SR Tablet, twice daily, in
the morning and
evening. The dose interval must not be less than 8 hours.
If the pain relief is insufficient, the dose may be increased to:
one Larapam 150mg SR Tablet, twice daily or
one Larapam 200mg SR Tablet, twice daily.
Larapam SR Tablets should under no circumstances be administered for
longer than
absolutely necessary. If long-term pain treatment with tramadol is
necessary in view of the
nature and severity of the illness, then careful and regular
monitoring should be carried out
(if necessary with breaks in treatment) to establish whether, and to
what extent, further
treatment is necessary.
_Paediatric population_
Larapam SR is not suitable for children under the age of 12 years.
_Elderly _
A dose adjustment is not usually necessary in patients up to 75 years
without clinically
manifest hepatic or renal insufficiency. In elderly people over 75
years elimination may be
prolonged. Therefore, if necessary the dose interval is to be extended
according to the
patient's requirements.
_Renal insufficiency/dialysis and hepatic impairment_
In patients with renal and/or hep