Galpseud Plus linctus

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Prenos Navodilo za uporabo (PIL)
05-01-2023
Prenos Lastnosti izdelka (SPC)
10-09-2020

Aktivna sestavina:

Pseudoephedrine hydrochloride; Chlorphenamine maleate

Dostopno od:

Thornton & Ross Ltd

Koda artikla:

R01BA52

INN (mednarodno ime):

Pseudoephedrine hydrochloride; Chlorphenamine maleate

Odmerek:

6mg/1ml ; 400microgram/1ml

Farmacevtska oblika:

Oral solution

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 03100000; GTIN: 5011309872316

Navodilo za uporabo

                                GALPSEUD
Linctus
PLUS
POM
500ml
Pseudoephedrine hydrochloride,
chlorphenamine maleate
READ ALL THE LABEL BEFORE USE.
1. WHAT THE MEDICINE IS FOR
Galpseud Plus Linctus contains pseudoephedrine to reduce
congestion and chlorphenamine, an antihistamine, to
control the symptoms of allergies. It is for relief of allergic
rhinitis caused by hay fever and other allergies.
2. BEFORE YOU USE THE MEDICINE….
✗ DO NOT USE THE MEDICINE IF YOU HAVE….
•
An ALLERGY to any of the ingredients listed. • Epilepsy
• Taken MAOIS (MONOAMINE OXIDASE INHIBITORS) for
depression within the last two weeks • HIGH BLOOD
PRESSURE or are TAKING MEDICINE FOR HIGH BLOOD PRESSURE
• Or give to children UNDER 2 YEARS OLD.
!
TALK TO YOUR DOCTOR IF YOU HAVE….
•
Asthma • Kidney or liver problems • Heart disease •
Diabetes • An overactive thyroid gland • Glaucoma (raised
eyeball pressure) • Bladder problems including difficulty
passing water • 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 4.
Sudden abdominal pain or rectal bleeding may occur
with Galpseud Plus Linctus, due to inflammation of the
colon (ischaemic colitis). If you develop these
gastro-intestinal symptoms, stop taking Galpseud Plus
Linctus and contact your doctor or seek medical
attention immediately. See section 4. Reduction of
blood flow to your optic nerve may occur with this
medicine. If you develop sudden loss of vision, stop
taking this medicine and contact your doctor or seek
medical attention immediately. See section 4.
!
TALK TO YOUR DOCTOR IF YOU ARE TAKING….
• Other decongestants • Medicines to reduce your
appetite • Medicines which stimulate the nervous
system (amphetamines) • Medicines which lower your
blood pressure • Beta blockers for a heart condition
• The antibiotic Furazolidone • Cardiac glycosides for
heart problems • Any tranquillisers, antidepressants,
sedatives or sleepin
                                
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Lastnosti izdelka

                                OBJECT 1
GALPSEUD PLUS LINCTUS
Summary of Product Characteristics Updated 07-Oct-2020 | Thornton &
Ross Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Galpseud Plus Linctus
2. Qualitative and quantitative composition
Active Ingredients:
Per 5ml Dose:
Pseudoephedrine hydrochloride 30mg
Chlorphenamine maleate
2.0mg
Excipient(s) with known effect:
Per 5ml Dose:
Ethanol (96%)
80mg
Sodium parahydroxybenzoates (E215, E217, E219)
7.5mg
Amaranth (E123)
0.25mg
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Oral liquid.
4. Clinical particulars
4.1 Therapeutic indications
For the relief of allergic rhinitis.
4.2 Posology and method of administration
For oral administration.
Adults:
Two 5ml spoonfuls three times daily.
Children:
Under 2 years: Not recommended.
2 – 6 years: 2.5ml three times daily.
6 – 12 years: 5ml three times daily.
Not more than 3 doses should be given in any 24 hours.
4.3 Contraindications
Contra-indicated in patients with a known hypersensit
                                
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