Tramulief SR 100mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Tramadol hydrochloride

Διαθέσιμο από:

Advanz Pharma

Φαρμακολογική κατηγορία (ATC):

N02AX02

INN (Διεθνής Όνομα):

Tramadol hydrochloride

Δοσολογία:

100mg

Φαρμακοτεχνική μορφή:

Modified-release tablet

Οδός χορήγησης:

Oral

Kατηγορία:

Schedule 3 (CD No Register Exempt Safe Custody)

Τρόπος διάθεσης:

Caution - AMP level prescribing advised

Περίληψη προϊόντος:

BNF: 04070200; GTIN: 5021730020637

Φύλλο οδηγιών χρήσης

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 Tramulief SR is and what it is used for
2.
What you need to know before you take Tramulief SR
3.
How to take Tramulief SR Tablets
4.
Possible side effects
5.
How to store Tramulief SR
6.
Contents of the pack and other information
1.
WHAT TRAMULIEF SR IS AND WHAT IT IS USED FOR
Tramadol, the active substance in Tramulief SR, is a pain killer
belonging
to the class of opioids that acts on the central nervous system. It
relieves
pain by acting on specific nerve cells of the brain and spinal cord.
Tramulief SR is used for the treatment of moderate to severe pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMULIEF SR
DO NOT TAKE TRAMULIEF SR:
-
if you are allergic to tramadol hydrochloride or any of the other
ingredients of this medicine (listed in section 6);
-
in acute poisoning with alcohol, sleeping pills, pain relievers, or
other
psychotropic medicines (medicines that affect mood and emotions);
-
if you are also taking monoamine oxidase inhibitors (MAOIs) (certain
medicines used for the treatment of depression) or have taken them in
the last 14 days before treatment with Tramulief SR (see “Other
medicines and Tramulief SR”);
-
if you are an epileptic and your fits are not adequately controlled by
treatment;
-
as a substitute in drug withdrawal.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Tramulief SR if:
-
you think that you are addicted to other pain relievers (opioids);
-
you suffer from consciousness disorders (i

Αρχείο Π.Χ.Π.

OBJECT 1
TRAMULIEF SR 100MG TABLETS
Summary of Product Characteristics Updated 26-Jul-2018 | ADVANZ Pharma
•
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
Tramulief SR 100 mg prolonged-release tablets
2. Qualitative and quantitative composition
One prolonged-release tablet contains 100 mg tramadol hydrochloride.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablet
Tramulief SR 100 mg prolonged-release tablets are off white, round
biconvex tablets, 9.1 mm diameter.
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, Tramulief SR prolonged-release tablets
should be given as follows:
Adults and adolescents older than 12 years:
The usual initial