TEVA - COLD CAPLETS

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

CAFFEINE; CHLORPHENIRAMINE MALEATE; PARACETAMOL; PHENYLEPHRINE HYDROCHLORIDE

Disponible desde:

TEVA ISRAEL LTD

Código ATC:

R01BA53

formulario farmacéutico:

CAPLETS

Composición:

PARACETAMOL 300 MG; CHLORPHENIRAMINE MALEATE 2 MG; PHENYLEPHRINE HYDROCHLORIDE 10 MG; CAFFEINE 30 MG

Vía de administración:

PER OS

tipo de receta:

Not required

Fabricado por:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Grupo terapéutico:

PHENYLEPHRINE, COMBINATIONS

Área terapéutica:

PHENYLEPHRINE, COMBINATIONS

indicaciones terapéuticas:

Symptomatic relief of common cold, congestion associated with sinusitis, allergic rhinitis accompanied by fever and pain.

Fecha de autorización:

2023-02-28

Información para el usuario

PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed without a
doctor’s prescription
TEVA-COLD
TABLETS
TEVA-COLD
CAPLETS
The active ingredients and their
quantities in each tablet/caplet:
Paracetamol
300 mg
Caffeine anhydrous
30 mg
Phenylephrine hydrochloride
10 mg
Chlorpheniramine maleate
2 mg
For information on the inactive and
allergenic ingredients in the preparation,
see section 2 – “Important information
regarding some of the ingredients of
the medicine” and section 6 – “Further
Information”.
READ THE LEAFLET CAREFULLY IN ITS
ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information
about the medicine. If you have further
questions, refer to the doctor or
pharmacist.
Take the medicine according to the
instructions given in this leaflet )section 3(
in the section on dosage. Consult
the pharmacist if you need further
information.
Refer to the doctor if the symptoms
of the illness worsen or if there is no
improvement after 3-5 days.
1. WHAT
IS
THE
MEDICINE
INTENDED FOR?
The medicine is intended to relieve
cold symptoms, sinus congestion and
allergic rhinitis accompanied by fever
and pain.
THERAPEUTIC GROUP:
• Paracetamol – analgesic and
antipyretic.
•
Caffeine anhydrous – xanthine alkaloid,
central nervous system stimulant.
• Phenylephrine hydrochloride –
sympathomimetic, decongestant for
the nose and ears.
• Chlorpheniramine
maleate
–
antihistamine.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• You are sensitive )allergic(
to
paracetamol,
caffeine,
phenylephrine, chlorpheniramine or
to any of the additional ingredients
contained in the medicine.
• In the past you developed an allergic
reaction after using antihistamines.
• You suffer from problems of the
kidneys, liver, from hyperthyroidism,
from diabetes, from high blood
pressure or from heart disease.
• You suffer from pheochromocytoma
or from glaucoma.
• You
are
taking
tricyclic
antidepressants )for example,
imipram

Ficha técnica

Teva‐Cold Tablets/Caplets New SPC SZ 8.2022
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Teva-Cold Tablets
Teva-Cold Caplets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet/caplet contains:
Paracetamol 300 mg
Caffeine anhydrous 30 mg
Phenylephrine Hydrochloride 10 mg
Chlorpheniramine maleate 2 mg
Excipients with known effect:
Lactose.
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablets and Caplets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The product is recommended for symptomatic relief of common cold,
congestion
associated with sinusitis, allergic rhinitis accompanied by fever and
pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
One tablet/caplet every 4 hours as required.
Children of 6-12 years old:
One tablet/caplet, up to 3 times a day.
Do not exceed the stated dose. Use the lowest amount needed to achieve
benefit for the
shortest duration of treatment.
If the disease symptoms worsen or do not improve after 3-5 days,
patients should consult a
doctor.
Teva‐Cold Tablets/Caplets New SPC SZ 8.2022
4.3 CONTRAINDICATIONS

Known hypersensitivity to paracetamol, caffeine, phenylephrine,
chlorpheniramine
or any of the other constituents of the medicine.

Concomitant use of other sympathomimetic decongestants or paracetamol
medicine

Phaeochromocytoma

Closed angle glaucoma

Hepatic or severe renal impairment,

Hypertension and heart disease.

hyperthyroidism, diabetes.

Patients taking tricyclic antidepressants, or beta-blocking drugs

Patients taking or who have taken within the last two weeks monoamine
oxidase
inhibitors (MAOIs) (see section 4.5).

Hypersensitivity to antihistamines
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Contains paracetamol. Patients should be advised not to take other
paracetamol-
containing products concurrently. The concomitant use with other
products
containing paracetamol may lead to an overdose. Paracetamol overdose
may cause
liver failure which may require liver transplant o