Decongestant with Paracetamol tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Osta kohe

Laadi alla Infovoldik (PIL)
12-06-2018
Laadi alla Toote omadused (SPC)
12-06-2018

Toimeaine:

Paracetamol; Pseudoephedrine hydrochloride

Saadav alates:

The Boots Company Plc

ATC kood:

R01BA52

INN (Rahvusvaheline Nimetus):

Paracetamol; Pseudoephedrine hydrochloride

Annus:

500mg ; 60mg

Ravimvorm:

Oral tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Never Valid To Prescribe As A VMP

Toote kokkuvõte:

BNF: 03100000

Infovoldik

                                INFORMATION FOR THE USER
Decongestant with Pain Relief Tablets
(Paracetamol, 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 Paracetamol, an analgesic, which acts to
relieve pain and reduce
fever. It also contains Pseudoephedrine, a decongestant, which acts to
relieve a blocked
nose.
It can be used to relieve the symptoms of colds and flu, including
aches and pains,
headache, blocked nose and sinuses and to reduce fever.
For children, simple treatments should be tried first before you give
this medicine. Further
information on “TREATING COUGHS AND COLDS IN CHILDREN” is provided
at the end of this
leaflet.
BEFORE YOU TAKE THIS MEDICINE
This medicine can be taken by adults and children of 6 years and over.
However, some
people should not take this medicine or should seek the advice of
their pharmacist or doctor
first.
X DO NOT TAKE:

IF YOU ARE ALLERGIC to any of the ingredients in this medicine (see
“What is in this medicine”)

IF YOU ARE ALLERGIC TO OTHER DECONGESTANTS

IF YOU HAVE SEVERE LIVER OR KIDNEY PROBLEMS

IF YOU HAVE HEART OR BLOOD VESSEL DISEASE, including poor circulation
in your hands or feet

IF YOU HAVE HIGH BLOOD PRESSURE (including that due to a tumour near
your kidney)

IF YOU HAVE DIABETES

IF YOU HAVE AN OVERACTIVE THYROID

IF YOU HAVE GLAUCOMA or you have been told you have raised pressure in
the eye

IF YOU ARE TAKING ANY OF THESE MEDICINES:
- Monoamine oxidase inhibitors or moclobemide (for depression), or
have taken them within
the last 14 days
- Medicines called beta-blockers (normally for heart problems)
- Other decongestants

IF YOU ARE PREGNANT
! TALK TO YOUR PHARMACIST
                                
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Toote omadused

                                OBJECT 1
BOOTS DECONGESTANT TABLETS
Summary of Product Characteristics Updated 04-Apr-2018 | THE BOOTS
COMPANY PLC
1. Name of the medicinal product
Decongestant Tablets
2. Qualitative and quantitative composition
Active ingredient
Pseudoephedrine hydrochloride
60mg/tablet
3. Pharmaceutical form
Tablets
4. Clinical particulars
4.1 Therapeutic indications
For the relief of nasal and sinus congestion without causing
drowsiness.
For oral administration.
4.2 Posology and method of 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.
4.3 Contraindications
Hypersensitivity to any of the ingredients. Avoid in patients with
cardiovascular disease, hypertension,
severe renal impairment, diabetes mellitus, closed angle glaucoma,
hyperthyroidism, prostatic
enlargement and phaeochromocytoma.
4.4 Special warnings and precautions for use
If symptoms are not controlled by Boots Decongestant Tablets, medical
advice should be sought.
Keep all medicines out of the reach of children.
Warning: Do not exceed the stated dose.
4.5 Interaction with other medicinal products and other forms of
interaction
Should not be given to patients being treated with monoamine oxidase
inhibitors or within 14 days of
stopping such treatment. May enhance the effects of anticholinergic
drugs such as tricyclic
antidepressants. May increase the possibility of arrhythmias in
digitalised patients. May increase the
vasoconstrictor effects of ergot alkaloids.
4.6 Pregnancy and lactation
The safety of decongestant tablets during pregnancy and lactation has
not been established but in view of
a possible association of foetal abnormalities with first trimester
exposure to pseudoephedrine, the use of
the product during pregnancy should be avoided. The amounts of
pseudoephedrine secreted into breast
milk are considered to be too small to be harmful.
4.7 Effects on ability to driv
                                
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