TRAMADEX DROPS

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

TRAMADOL HYDROCHLORIDE

متاح من:

DEXCEL LTD, ISRAEL

ATC رمز:

N02AX02

الشكل الصيدلاني:

DROPS

تركيب:

TRAMADOL HYDROCHLORIDE 100 MG/ML

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

DEXCEL LTD, ISRAEL

المجموعة العلاجية:

TRAMADOL

المجال العلاجي:

TRAMADOL

الخصائص العلاجية:

Short to medium term treatment of moderate to severe pain.

تاريخ الترخيص:

2013-06-30

نشرة المعلومات

PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine can be sold with a physician’s prescription only
TRAMADEX
®
DROPS, 100 MG/ML
Each 1 ml (40 drops) contains Tramadol hydrochloride 100 mg.
Inactive ingredients and allergens in the medicine – see section 6
"Additional information"
and in section 2 "Important information about some of the ingredients
of the medicine".
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains
concise information about the medicine. If you have any further
questions, ask the doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if you think that their medical condition is the same as yours.
THIS MEDICINE IS NOT INTENDED FOR CHILDREN UNDER THE AGE OF 14 YEARS.
OPIOID MEDICINES CAN CAUSE ADDICTION (MAINLY WITH PROLONGED USE), AND
POTENTIAL
ABUSE AND OVERDOSE ARE POSSIBLE. THE REACTION TO OVERDOSE CAN BE SLOW
BREATHING
AND EVEN DEATH.
MAKE SURE THAT YOU KNOW THE NAME OF THE MEDICINE, THE DOSAGE YOU ARE
TAKING, HOW
OFTEN YOU TAKE IT, THE DURATION OF TREATMENT, AND ITS SIDE EFFECTS AND
POTENTIAL RISKS.
ADDITIONAL INFORMATION ABOUT THE RISK OF DEPENDENCE AND ADDICTION CAN
BE FOUND AT:
_HTTPS://WWW.HEALTH.GOV.IL/UNITSOFFICE/HD/MTI/DRUGS/RISK/DOCLIB/OPIOIDS_EN.PDF_
1.
WHAT IS THE MEDICINE INTENDED FOR?
TRAMADEX DROPS is intended for the treatment of moderate to severe
pain.
THERAPEUTIC GROUP: opioids.
Tramadol, the active substance in TRAMADEX DROPS, is a painkiller
belonging to the class of
medicines called opioids and it acts on the central nervous system. It
relieves pain by acting
on specific nerve cells of the spinal cord and brain.
2.
BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE:

if you are hypersensitive (allergic) to the active ingredient
(tramadol hydrochloride)
or to any of the other ingredients this medicine contains (see section
6).

in a state of acute poisoning with alcohol, sleeping pills, pain
relievers or other
psychotropic

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Tramadex drops
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml (=40 drops) of Tramadex drops contains 100 mg of Tramadol
hydrochloride.
Excipient with known effect:
Each 1ml of Tramadex drops contains 200 mg sucrose and 150 mg
propylene glycol (see section 4.4).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Drops, oral solution.
Clear, transparent to light yellow solution, slightly viscous.
WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
Concomitant use of opioids with benzodiazepines or other central
nervous system (CNS) depressants, including alcohol,
may result in profound sedation, respiratory depression, coma, and
death [see sections 4.4 and 4.5].
Reserve concomitant prescribing of these drugs for use in patients for
whom alternative treatment options are inadequate.
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and
sedation.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short to medium term treatment of moderate to severe pain
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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, Tramadex drops should be administered as
follows:
Adults and adolescents above the age of 14 years:
50 to 100 mg tramadol hydrochloride (20 to 40 drops), 4-6 hourly.
The lowest analgesically effective dose should generally be selected.
Daily doses of 400 mg active substance should not be exceeded, except
in special clinical circumstances.
Elderly patients:
A dose adjustment is not usually necessary in elderly patients (up to
75 years) without clinically manifest hepatic or renal
insufficiency. In elderly patients (over 75 years) the elimination may
be prolonged. Therefore, if necessary, the dosage
interval is to be extended according to