Tramadol 50mg capsules

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Tramadol hydrochloride

Saatavilla:

Milpharm Ltd

ATC-koodi:

N02AX02

INN (Kansainvälinen yleisnimi):

Tramadol hydrochloride

Annos:

50mg

Lääkemuoto:

Oral capsule

Antoreitti:

Oral

luokka:

Schedule 3 (CD No Register Exempt Safe Custody)

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 04070200; GTIN: 8901175015061 8901175015078

Pakkausseloste

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 Tramadol is and what it is used for
2.
What you need to know before you take
Tramadol
3.
How to take Tramadol
4.
Possible side effects
5.
How to store Tramadol
6.
Contents of the pack and other
information
1. WHAT TRAMADOL IS AND WHAT IT IS USED
FOR
Tramadol hydrochloride - the active
substance in Tramadol - is a painkiller
belonging to the class of opioids that acts
on the central nervous system. It relieves
pain by acting on specific nerve cells of the
spinal cord and brain.
Tramadol is used for the treatment of
moderate to severe pain.
You must talk to a doctor if you do not feel
better or if you feel worse after number of
days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE TRAMADOL
DO NOT TAKE TRAMADOL
-
if you are allergic to active substance
or any of the other ingredients of this
medicine (listed in section 6).
-
if you are under the influence of alcohol
or sedative drugs including sleeping
pills, other pain-killers or tranquiliser
medicines
-
if you are taking, or have taken in the
last two weeks, certain medicines called
“monoamine oxidase inhibitors” or
MAOIs (used to treat e.g. depression,
and the antibiotic linezolid). The
combination could result in a serious,
potentially life threatening interaction
-
if you have epilepsy that is not controlled
with your current medicine;
-
as a substitute in drug withdrawal.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before
taking Tramadol
-
if you suffer from epilepsy or seizures
(fit

Valmisteyhteenveto

OBJECT 1
Tramadol 50 mg capsules
Summary of Product Characteristics Updated 08-Dec-2021 | Aurobindo
Pharma - Milpharm Ltd.
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Tramadol 50 mg capsules, hard
2. Qualitative and quantitative composition
Each hard capsule contains 50 mg tramadol hydrochloride.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, hard
Green/ Yellow, size '4' hard gelatin capsules filled with white to
off-white powder and imprinted with 'T' on
green cap and '02' on yellow body with black ink.
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.
Unless otherwise prescribed, Tramadol should be administered as
follows:
Adults and children aged 12 years and over
Oral