Boots Pharmaceuticals Decongestant 60mg Tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

PSEUDOEPHEDRINE HYDROCHLORIDE

Disponibil de la:

The Boots Company Plc

Codul ATC:

R01BA; R01BA02

INN (nume internaţional):

PSEUDOEPHEDRINE HYDROCHLORIDE

Dozare:

60 milligram(s)

Forma farmaceutică:

Tablet

Tip de prescriptie medicala:

Product not subject to medical prescription

Zonă Terapeutică:

Sympathomimetics; pseudoephedrine

Statutul autorizaţiei:

Marketed

Data de autorizare:

2003-11-04

Prospect

INFORMATION FOR THE USER
Boots Pharmaceuticals Decongestant 60 mg Tablets
Pseudoephedrine Hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription to treat minor
conditions. However, you still
need to take it carefully to get the best results from it.
Keep this leaflet, you may need to read it again
Ask your pharmacist if you need more information or advice
WHAT THIS MEDICINE IS FOR
This medicine contains Pseudoephedrine Hydrochloride, a decongestant,
which acts to
relieve a blocked nose. It can be used to relieve the symptoms of a
blocked nose and
blocked sinuses to help you breathe more easily without causing
drowsiness.
BEFORE YOU TAKE THIS MEDICINE
This medicine can be taken by adults and children of 12 years and
over. However, some
people should not take this medicine or should seek the advice of
their pharmacist or doctor
first.
DO NOT TAKE:
IF YOU ARE ALLERGIC to any of the ingredients (see “What is in this
medicine”)
IF YOU HAVE ANGINA or other heart or circulatory problems
IF YOU HAVE HIGH BLOOD PRESSURE (including that due to a tumour near
your kidney)
IF YOU HAVE severe kidney disease
IF YOU ARE TAKING MONOAMINE OXIDASE INHIBITORS (for depression) or
have taken them
within the last 14 days
IF YOU ARE TAKING other medicines containing pseudoephedrine, or other
decongestants TALK TO YOUR PHARMACIST OR DOCTOR:
If you have diabetes, glaucoma or an overactive thyroid
If you are a man with prostate problems
If you develop a feverish generalised erythema associated with
pustules, stop taking this
medicine and contact your doctor or seek medical attention
immediately. See section
‘Possible side effects’.
Sudden abdominal pain or rectal bleeding may occur with Boots
Decongestant 60 mg
Tablets, due to inflammation of the colon (ischaemic colitis).
Reduction of blood flow to your optic nerve may occur with Boots
Decongestant 60 mg
Tablets. If you develop sudden loss of vision, stop taking this
medicine and contact y

Caracteristicilor produsului

Health Products Regulatory Authority
09 September 2020
CRN009W44
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Boots Pharmaceuticals Decongestant 60mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Pseudoephedrine hydrochloride 60 mg/tablet
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Round white to off-white, flat-faced tablet with a bevelled edge.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief of nasal and sinus congestion.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Adults and children over 12 years: One tablet if necessary, up to four
times daily at intervals of not less than 4 hours.
Children under 12 years: Not recommended.
Elderly: There is no need for dosage reduction in the elderly.
Renal dysfunction: Decongestant Tablets are contraindicated in
patients with severe renal dysfunction.
4.3 CONTRAINDICATIONS
Hypersensitivity to any of the ingredients.
Avoid in patients with angina, coronary artery disease, severe
hypertension, severe renal impairment and phaeochromocytoma.
Should not be taken by patients being treated with monoamine oxidase
inhibitors or within 14 days of stopping such
treatment.
Use in patients who are currently receiving other sympathomimetic
drugs.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Decongestant Tablets should be used with caution in patients with
diabetes mellitus, angle closure glaucoma, hyperthyroidism
and prostatic enlargement.
This product should be used with great care in patients receiving
phenothiazines or tricyclic antidepressants.
Patients with prostatic hypertrophy may have increased difficulty with
micturition.
Health Products Regulatory Authority
09 September 2020
CRN009W44
Page 2 of 5
This product may act as a cerebral stimulant and give rise to
insomnia, nervousness, hyperpyrexia, tremor and epileptiform
convulsions.
Severe Skin reactions
Severe skin reactions such as acute generalized exanthematous
pustulosis (AGEP) may oc