ZALDIAR

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

PARACETAMOL; TRAMADOL HYDROCHLORIDE

Fáanlegur frá:

TEC-O-PHARM-LIBRA LTD

ATC númer:

N02BE01

Lyfjaform:

FILM COATED TABLETS

Samsetning:

PARACETAMOL 325 MG; TRAMADOL HYDROCHLORIDE 37.5 MG

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

GRUNENTHAL GMBH, GERMANY

Meðferðarhópur:

PARACETAMOL

Lækningarsvæði:

PARACETAMOL

Ábendingar:

Symptomatic treatment of moderate to severe pain.The use of Zaldiar should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol.

Leyfisdagur:

2022-01-31

Upplýsingar fylgiseðill

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS
(Preparations) – 1986
The medicine is dispensed according to a physician's prescription only
Name of preparation and form:
ZALDIAR
®
film-coated tablets
Active ingredients and quantity:
Tramadol Hydrochloride 37.5 mg
Paracetamol 325 mg
Inactive and allergic ingredients in the medicinal product – see
section 6 and also
"Important information about some ingredients of the medicine" in
section 2.
!
Read the entire leaflet carefully before using the medicine.
This leaflet contains concise information about the medicine. If you
have any further
questions, refer to the physician or the pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It
may harm them, even if it seems like their disease is similar to
yours.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Zaldiar is a combination of two analgesics, tramadol and paracetamol,
which work
together to relieve pain.
Zaldiar is intended for use only by adults and children over the age
of 14.
Therapeutic group:
The preparation contains a combination of tramadol – a pain reliever
from the
opioids group and paracetamol – a pain reliever and fever reducer
from the anilide
group and is intended to treat moderate to severe pain.
2.
BEFORE USING THE MEDICINE:
Do not use the medicine if:

You are sensitive (allergic) to the active ingredients or to any of
the additional
ingredients contained in the medicine (listed in section 6).

In cases of acute alcohol poisoning.

You are taking sleeping pills, pain relievers or medicines that affect
mood and
emotions.

You are also taking medicines called monoamine oxidase inhibitors
(MAOIs)
or have taken MAOIs in the last 14 days before treatment with Zaldiar.
MAOIs
are used in the treatment of depression or Parkinson’s disease.

You have a severe liver disorder.

You have epilepsy that is not adequately controlled by your current
medicine.

In children under the age of 14.
Opioids may cause addiction, e

Vara einkenni

1
Zaldiar
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zaldiar 37.5 mg/325 mg, film coated-tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 37.5 mg tramadol hydrochloride and 325
mg paracetamol.
Excipients: One film coated tablet contains 1.878 mg lactose
monohydrate (= 1.784 mg lactose).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Pale yellow film-coated tablet, marked with the manufacturer‘s logo


on one side and ‘T5’ on the
other side.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Zaldiar tablets are indicated for the symptomatic treatment of
moderate to severe pain.
The use of Zaldiar should be restricted to patients whose moderate to
severe pain is considered to
require a combination of tramadol and paracetamol (see also Section
5.1).
4.2
Posology and method of administration
_Posology_
The use of Zaldiar should be restricted to patients whose moderate to
severe pain is considered
to require a combination of tramadol and paracetamol.
The dose should be individually adjusted according to intensity of
pain and response of the patient.
The lowest effective dose for analgesia should generally be selected.
The total dose of 8 tablets
(equivalent to 300 mg tramadol hydrochloride and 2600 mg paracetamol)
per day should not be
exceeded. The dosing interval should not be less than six hours.
Adults and Adolescents (14 years and older).
An initial dose of two tablets of Zaldiar is recommended Additional
doses can be taken as needed,
not exceeding 8 tablets (equivalent to 300 mg tramadol and 2600 mg
paracetamol) per day.
The dosing interval should not be less than six hours.
Zaldiar should under no circumstances be administered for longer than
is strictly necessary (see
also section 4.4 - Special warnings and precautions for use). If
repeated use or long term treatment
2
with Zaldiar is required as a result of the nature and severity of the
illness, then careful, regular
monitoring should take pl