Kwells 300microgram tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hyoscine hydrobromide

Available from:

Dexcel-Pharma Ltd

ATC code:

N05CM05

INN (International Name):

Hyoscine hydrobromide

Dosage:

300microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04060000; GTIN: 5010605242144

Summary of Product characteristics

OBJECT 1
KWELLS 300 MICROGRAM TABLETS
Summary of Product Characteristics Updated 01-May-2018 | Bayer plc
1. Name of the medicinal product
Kwells 300 microgram tablets
2. Qualitative and quantitative composition
Hyoscine Hydrobromide 300 microgram
For excipients, see section 6.1
3. Pharmaceutical form
Tablet
Small pink 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.
Adults:
1 tablet every 6 hours if required. Do not take more than 3 tablets in
24 hours.
Elderly:
There is no special dosage regimen for the elderly and as such caution
should be exercised
Children:
Children over 10: ½-1 tablet every 6 hours if required. Do not take
more than 1½-3 tablets in 24 hours.
Tablets to be taken up to 30 minutes before the start of the journey
to prevent travel sickness, or at the
onset of nausea.
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 ef