TIPTIPOT AFALPI

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

PSEUDOEPHEDRINE AS HYDROCHLORIDE

Tilgængelig fra:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

ATC-kode:

R01BA02

Lægemiddelform:

DROPS

Sammensætning:

PSEUDOEPHEDRINE AS HYDROCHLORIDE 15 MG/ML

Indgivelsesvej:

PER OS

Recept type:

Not required

Fremstillet af:

CTS CHEMICAL INDUSTRIES LTD

Terapeutisk gruppe:

PSEUDOEPHEDRINE

Terapeutisk område:

PSEUDOEPHEDRINE

Terapeutiske indikationer:

Symptomatic treatment of nasal congestion, to relief eustachian tube congestion.

Autorisation dato:

2021-01-31

Indlægsseddel

PATIENT LEAFLET IN ACCORDANCE
WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
This medicine is dispensed without a
doctor's prescription
ORAL DROPS
The active ingredient and its
concentration
Pseudoephedrine (as hydrochloride)
15 mg/ml
Each drop contains 1 mg of
pseudoephedrine.
Inactive ingredients and allergens in the
preparation - see section 6 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.
The medicine is not intended for babies
under 1 year of age.
For children 1 to 6 years old, the
medicine is dispensed with a doctor’s
prescription only.
Take the product according to the
instructions in the dosage section of this
leaflet. Consult the pharmacist if you
have further questions. Refer to the
doctor if signs of the ailment (symptoms)
worsen or do not improve, or if fever
develops after 7 days.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for relief of
nasal congestion and middle ear
congestion.
Therapeutic class: the active ingredient
belongs to the class of sympathomimetic
agents.
The active ingredient pseudoephedrine
is a decongestant which acts to constrict
blood vessels and to reduce swelling
and mucous production, and thus
relieves congestion.
2. BEFORE USING THE MEDICINE:
DO NOT USE THIS MEDICINE IF:
• You are sensitive (allergic) to the
active ingredient or any of the
additional components the medicine
contains.
• You are currently treated with
medicines of the monoamine
oxidase inhibitors group (for
depression) or you have stopped
using such medicines less than 14
days ago.
• You are suffering from a severe
problem in your kidneys, heart
disease, circulation problems,
hypertension, diabetes, overactive
thyroid gland, glaucoma,
pheochromocytoma (a tumor in the
adrenal gland).
• You are pregnant or breastfeeding.
• You are taking medicin

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
TIPTIPOT AFALPI
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients:
PSEUDOEPHEDRINE (AS HYDROCHLORIDE) 15 MG/ML
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Drops.
A clear, yellowish liquid with strawberry smell.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of nasal congestion, to relief eustachian tube
congestion..
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
The generally accepted dosage is:
For children 6-12 years old: one drop per kg body weight per dose, up
to 4 doses
per 24 hours (a maximum of 30 drops per dose).
For children 1 to 6 years old, the medicine should be dispensed with a
doctor’s
prescription only.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to pseudoephedrine or to any of the excipients listed
in
section 6.1.
•
Patients receiving monoamine oxidase inhibitors or who have
received these agents in the last two weeks. Patients using other
sympathomimetic decongestants or beta-blockers. (See Section 4.5).
•
Patients with cardiovascular disease including ischaemic heart
disease, occlusive vascular disease and hypertension.
•
Children under 1 year of age.
•
Patients with:
o
Severe renal impairment
o
Phaeochromocytoma
o
Diabetes
o
Hyperthyroidism
o
Closed angle glaucoma.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution should be used in prescribing Tiptipot Afalpi for patients
with
prostatic enlargement or bladder dysfunction.
Also use with caution in patients with severe hepatic impairment, or
with mild
to moderate renal impairment.
If any of the following occur, Tiptipot Afalpi should be stopped
o
Hallucinations
o
Restlessness
o
Sleep disturbances.
Excipients with known effect:
Tiptipot Afalpi contains Sorbitol. Patients with hereditary fructose
intolerance
(HFI) should not take/be given this medicinal product.
Severe Skin reactions
Severe skin reactions such as acute generalized exanthematous
pustulosis
(AGEP) may occur with pseudoephedrin