TIPTIPOT NOVIMOL

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

PARACETAMOL

MAH:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

ATC_code:

N02BE01

pharmaceutical_form:

SUSPENSION

composition:

PARACETAMOL 100 MG/ML

administration_route:

PER OS

prescription_type:

Not required

manufactured_by:

CTS CHEMICAL INDUSTRIES LTD

therapeutic_group:

PARACETAMOL

therapeutic_area:

PARACETAMOL

therapeutic_indication:

Analgesic and antipyretic.

authorization_date:

2021-05-31

PIL

LFL 006 03/22
PATIENT LEAFLET IN
ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
This medicine is dispensed without
a doctor's prescription
Suspension
Each 1 ml contains
100 mg paracetamol
Inactive ingredients
and allergens in the
preparation - see section 6 -
“Additional information” and the
“Important information about some
ingredients of the medicine” section.
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 doctor
or the pharmacist.
Use the preparation according to the
instructions in the dosage section of
this leaflet. Consult the pharmacist if
you have further questions.
Refer to the doctor if the fever
persists for more than 3 days or if
the symptoms do not resolve within
5 days despite use of the medicine.
1. What is the medicine intended
for?
The medicine is intended to relieve
pain and reduce fever.
Therapeutic class: analgesic and
antipyretic.
2. Before using the medicine:
Do not use this medicine if:
• There is a known sensitivity to
paracetamol or to any of the
other ingredients the medicine
contains (see section 6).
Special warnings regarding the
use of the medicine:
• If you developed skin side
effects in the past as a result of
taking preparations containing
paracetamol, do not take
preparations containing
paracetamol, so that severe skin
side effects will not recur.
• The preparation contains
paracetamol, which may cause
liver damage when:
○
Given at a higher dosage
than recommended or for a
prolonged period of time.
○
Alcoholic beverages are
consumed during the course of
treatment.
○
Additional medicines which
affect liver function are taken.
• In patients with glutathione
deficiency, use of paracetamol
may increase the risk for
metabolic acidosis.
• Do not use this medicine
frequently without consulting the
doctor.
• Do not take additional antipyretics
and analgesics or cold medicines
without consulting a doctor or a
pharmacist,

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINE
TIPTIPOT NOVIMOL
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
PARACETAMOL 100 MG/ML SUSPENSION
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Pink to red suspension with white particles and a strawberry odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Analgesic and antipyretic.
4.2 DOSE AND METHOD OF ADMINISTRATION
The generally accepted dosage is:
The dosage according to the child’s weight is calculated as 15 mg/kg
of the child’s
weight, per dose. In other words, 0.15 ml for every kg of the
child’s body
weight.
Only if the child’s weight is not known - the dosage will be
determined according to
age, as shown in the age table indicating dosage according to the
child’s age only.
Maximum number of
doses per 24 hours
Dose in ml
Child’s age
Up to 5 times
0.40
0-3 months
Up to 5 times
0.80
4-11 months
Up to 5 times
1.20
1-2 years
Up to 5 times
1.60
2-3 years
Up to 5 times
2.40
4-5 years
Doses should be taken/administered in intervals of at least 4 hours,
as necessary, up
to 5 doses in 24 hours.
Method of use: Shake well before use
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or any of its excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
IDENTIFIED PRECAUTIONS
Contains paracetamol. Do not use with any other paracetamol-
containing products.
The concomitant use with other products containing paracetamol may
lead to an
overdose.
In patients with glutathione depleted states, the use of paracetamol
may increase
the risk of metabolic acidosis.
If symptoms persist, medical advice must be sought.
Keep out of sight and reach of children.
TIPTIPOT NOVIMOL
contains sorbitol. Patients with hereditary fructose intolerance
(HFI) should not take/ be given this medicine.
USE IN HEPATIC IMPAIRMENT
Paracetamol overdose may cause liver failure which may require liver
transplant or
lead to death.
Paracetamol should be used with caution in patients with:

Impaired liver function: Underlyin