Galpseud 60mg tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Pseudoephedrine hydrochloride

Verfügbar ab:

Thornton & Ross Ltd

ATC-Code:

R01BA02

INN (Internationale Bezeichnung):

Pseudoephedrine hydrochloride

Dosierung:

60mg

Darreichungsform:

Oral tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 03100000; GTIN: 5011309876512 5011309872514

Gebrauchsinformation

MHRA HEADER BOX
PCP HEADER BOX
PRODUCT TITLE
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
COLOURS USED
FONTS USED
OPERATOR
ARTWORK NO.
CRN
REASON FOR
CHANGE
SUFFIX
MHRA/IMB
SUBMISSION
REQUIRED
APPROVED BY
DATE
ISSUED BY
DATE
Leaflet
24's
23630405
210 x 148mm
2
18.07.2016
Galpseud Tablets Custom
Yes
B
gill.kennedy
673457
13085
Replace Customer with T&R as
batch release site
Helvetica
Process Black
Keyline (Does not print)
MHRA HEADER BOX
PCP HEADER BOX
PRODUCT TITLE
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
COLOURS USED
FONTS USED
OPERATOR
ARTWORK NO.
CRN
REASON FOR
CHANGE
SUFFIX
MHRA/IMB
SUBMISSION
REQUIRED
APPROVED BY
DATE
ISSUED BY
DATE
Leaflet
24's
23630405
210 x 148mm
2
18.07.2016
Galpseud Tablets Custom
Yes
B
gill.kennedy
673457
13085
Replace Customer with T&R as
batch release site
Helvetica
Process Black
Keyline (Does not print)
GALPSEUD TABLETS
(pseudoephedrine hydrochloride)
IMPORTANT INFORMATION ABOUT GALPSEUD
TABLETS
• This medicine relieves congestion in the nose,
sinus and upper chest.
• It can be used by adults, the elderly and
children over 12 years.
DO NOT GIVE....
• To children under 12 years old.
• To anyone who is allergic to the ingredients
listed. See section 6.
• With other nasal decongestants including
sprays.
NOW READ ALL OF THE LEAFLET BEFORE YOU USE THIS
MEDICINE. IT INCLUDES OTHER INFORMATION WHICH
MIGHT BE ESPECIALLY IMPORTANT FOR YOU.
• Keep this leaflet. You may need to read it
again.
• Ask your pharmacist if you need any more
information or advice.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
1. WHAT THE MEDICINE IS FOR
Galpseud Tablets are for the relief of nose,
sinus and upper chest congestion. The tablets
contain pseudoephedrine which works to
restrict blood vessels, reduces swelling and
production of mucous and so relieves congestion.
2. BEFORE YOU USE THIS
MEDICINE DO NOT USE THE MEDICINE IF YOU
HAVE….
• An ALLERGY to any of the ingredients

Fachinformation

OBJECT 1
GALPSEUD TABLETS
Summary of Product Characteristics Updated 27-Feb-2015 | Thornton &
Ross Ltd
1. Name of the medicinal product
Galpseud Tablets
2. Qualitative and quantitative composition
Active Ingredient:
Pseudoephedrine hydrochloride 60.0mg (Per Tablet).
For full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablets.
Round, curved white tablets embossed with “60“ on one side.
4. Clinical particulars
4.1 Therapeutic indications
Indicated for the relief of nasal, sinus and upper respiratory
congestion.
4.2 Posology and method of administration
For oral administration.
_Adults and children over 12 year_s:
One tablet four times daily.
_Elderly_:
Adult dose is appropriate.
4.3 Contraindications
This product should not be used in patients hypersensitive to
pseudoephedrine or any of the other
ingredients.
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 12 years of age.
Patients with:
• Severe renal impairment
• Phaeochromocytoma
• Diabetes
• Hyperthyroidism
• Closed angle glaucoma.
4.4 Special warnings and precautions for use
Caution should be used when prescribing pseudoephedrine 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, the product should be stopped
• Hallucinations
• Restlessness
• Sleep disturbances.
Patients with rare hereditary problems of galactose intolerance, the
LAPP lactase deficiency or glucose-
galactose malabsorption should not take this medicine.
Do not exceed the stated dose.
Keep out of the sight and reach of children.
4.5 Interaction with other medicinal products and other forms of
interaction
Caution should be exercised with pa