TRAMAL RETARD 100

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

TRAMADOL HYDROCHLORIDE

Disponibil de la:

TEC-O-PHARM-LIBRA LTD

Codul ATC:

N02AX02

Forma farmaceutică:

TABLETS EXTENDED RELEASE

Compoziție:

TRAMADOL HYDROCHLORIDE 100 MG

Calea de administrare:

PER OS

Tip de prescriptie medicala:

Required

Produs de:

GRUNENTHAL GMBH, GERMANY

Grupul Terapeutică:

TRAMADOL

Zonă Terapeutică:

TRAMADOL

Indicații terapeutice:

Moderate to severe pain.

Data de autorizare:

2022-08-31

Prospect

PATIENT LEAFLET ACCORDING TO THE PHARMACISTS’
Regulations (Preparations) – 1986
The medicine is dispensed with a physician’s prescription only
Tramal Retard 100
Tramal Retard 50
The active ingredient and its quantity:
Tramadol hydrochloride 100 or 50 mg
Inactive ingredients and allergens: See under ‘Important information
about some of
this medicine’s ingredients, and section 6 ‘Additional
information’.
Read the entire leaflet carefully before using the medicine. This
leaflet contains concise
information about the medicine. If you have any other questions, refer
to the physician or the
pharmacist.
This medicine has been prescribed for the treatment of your illness.
Do not pass it on to
others. It may harm them even if it seems to you that their medical
condition is similar.
This medicine is not intended for children under the age of 14 years.
1.
What is the medicine intended for?
Tramadol - the active ingredient in Tramal Retard - 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.
Tramal Retard is intended for the treatment of moderate to severe
pain.
Therapeutic group: opioids.
2.
Before using the medicine
Do not take the medicine:

if you are sensitive (allergic) to the active ingredient 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 taking MAO inhibitors (certain medicines to treat
depression) or have taken
them in the last 14 days before treatment with Tramal Retard (see
section "Other
medicines and Tramal Retard").

if you are an epileptic and your fits are not adequately controlled by
your treatment.

as a substitute in drug withdrawal.
Opioid medicines can cause addiction (mainly with prolonged use), and
potential
abuse and overdose are possible. The reaction to overdose can be slow
bre

Caracteristicilor produsului

TRAMAL RETARD 100 TRAMAL RETARD 50
1.
NAME OF THE MEDICINAL PRODUCT
TRAMAL RETARD 100, TRAMAL RETARD 50MG
extended-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each extended-release tablet contains 100 or 50 mg tramadol
hydrochloride.
Excipient with known effect: Each prolonged-release tablet contains
2.5 mg lactose
monohydrate (see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Extended-release tablet
Tramal Retard 100: Round, biconvex, white coloured film-coated
tablets, marked with
the manufacturer‘s logo on one side, marked T1 on the other side.
Tramal Retard 50: Pale yellow coloured, round, biconvex, film-coated
tablets, marked
with the manufacturer's logo on one side and T0 on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Moderate to severe pain
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Prior to starting treatment with opioids, a discussion should be held
with patients to
put in place a strategy for ending treatment with tramadol in order to
minimise the risk
of addiction and drug withdrawal syndrome (see section 4.4).
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. The total daily dose of 400 mg active substance should not
be exceeded,
except in special circumstances.
Unless otherwise prescribed, Tramal Retard should be administered as
follows:
_Adults and adolescents above the age of 14 years: _
The usual initial dose is 50-100 mg tramadol hydrochloride twice
daily, morning and
evening. If pain relief is insufficient, the dose may be titrated
upwards to 150 mg or
200 mg tramadol hydrochloride twice daily (see section 5.1).
_Children: _
Tramal Retard is not suitable for children below the age of 14 years.
_Geriatric patients_
:
A dose adjustment is not usually necessary in patients up to 75 years
without
clinically manifest hepatic or renal insufficiency. In elderly
patients over 75 years
elimina