Kwells Kids 150microgram tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Hyoscine hydrobromide

Διαθέσιμο από:

Dexcel-Pharma Ltd

Φαρμακολογική κατηγορία (ATC):

N05CM05

INN (Διεθνής Όνομα):

Hyoscine hydrobromide

Δοσολογία:

150microgram

Φαρμακοτεχνική μορφή:

Oral tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 04060000; GTIN: 5010605242045

Αρχείο Π.Χ.Π.

OBJECT 1
KWELLS KIDS
Summary of Product Characteristics Updated 01-May-2018 | Bayer plc
1. Name of the medicinal product
Kwells Kids 150 microgram tablets
2. Qualitative and quantitative composition
Hyoscine Hydrobromide: 150 micrograms
For excipients, see 6.1
3. Pharmaceutical form
Tablet
Small white circular, flat faced tablets with bevelled edges. One face
is bisected by a score line and the
other is plain.
4. Clinical particulars
4.1 Therapeutic indications
For the prevention of travel sickness.
4.2 Posology and method of administration
Tablets to be sucked, chewed or swallowed.
Tablets to be taken up to 30 minutes before the start of the journey
to prevent travel sickness, or at the
onset of nausea.
Adults:
Not applicable.
Elderly persons:
Not applicable.
Children:
Children over 10: 1-2 tablets every 6 hours if required. Do not take
more than 3-6 tablets in 24 hours.
Children 4-10: ½-1 tablet every 6 hours if required. Do not take more
than 1½- 3 tablets in 24 hours.
4.3 Contraindications
Prostatic enlargement, paralytic ileus, pyloric stenosis, glaucoma and
myasthenia gravis.
In addition, Kwells should not be given to patients with a known
sensitivity to hyoscine hydrobromide or
any other component of the product.
4.4 Special warnings and precautions for use
The elderly and patients under medical care (in particular those at
risk of acute urinary retention, or with
cardiovascular, metabolic, gastrointestinal, liver or renal disease,
or suffering from CNS disorders such as
seizures) should consult a doctor before taking this product.
In patients with ulcerative colitis its use may lead to ileus or
megacolon.
Antimuscarinics should be used with caution in persons with Down's
Syndrome.
Caution is advisable in patients with diarrhoea.
Hyperthermia can occur at high ambient temperatures due to decreased
sweating, therefore, Kwells
should be used with caution in patients with fever.
4.5 Interaction with other medicinal products and other forms of
interaction
The effects of hyoscine may be enhanced by other drug