Kwells 300 microgram Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
08-07-2020
Summary of Product characteristics
(SPC)
19-06-2020
Active ingredient:
Hyoscine hydrobromide
Available from:
Bayer Limited
ATC code:
A04AD; A04AD01
INN (International Name):
Hyoscine hydrobromide
Dosage:
300 microgram(s)
Pharmaceutical form:
Tablet
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Other antiemetics; scopolamine
Authorization status:
Marketed
Authorization date:
1979-04-01
Patient Information leaflet
Patient Information Leaflet
Kwells
300 microgram tablets
Hyoscine Hydrobromide
Read all of this leaflet carefully because it contains important
information for you.
This medicine is available without prescription.
However, you still need to use Kwells 300 microgram tablets carefully
to get the best
results from them.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not
improve.
• If you have any unusual effects after taking this medicine, tell
your doctor or
pharmacist.
IN THIS LEAFLET:
1.
What are Kwells tablets and what are they used for?
2.
Before you take Kwells tablets
3.
How to take Kwells tablets
4.
Possible side effects
5.
How to store Kwells tablets
6.
Further information
1.
WHAT ARE KWELLS® TABLETS AND WHAT ARE THEY USED FOR?
Kwells 300 microgram tablets are used for the fast and effective
prevention and control
of travel sickness. Travel sickness happens when the brain receives
mixed messages.
Visual messages from the eyes inform the brain that the immediate
surroundings are
stationary, but a delicate balancing organ in the ear tells the brain
that you are moving.
This conflicting information triggers the nausea we associate with
travel sickness.
The active substance in Kwells tablets is hyoscine hydrobromide.
Hyoscine hydrobromide
temporarily reduces the effect of movement on the balance organs of
the inner ear and
the nerves responsible for nausea.
Because Kwells tablets melt in the mouth, absorption into the
bloodstream is very rapid
and they can be taken up to 30 minutes before travelling or at the
onset of sickness.
BCH19044
2.
BEFORE YOU TAKE KWELLS® TABLETS
DO NOT take Kwells tablets if you:
• Are allergic (hypersensitive) to hyoscine hydrobromide or any of
the other ingredients
in the tablets (
see Section 6. Further Information
).
• Have glaucoma.
• Blockage of intestines (Paralytic ileus).
• Narrowing of the stomach outlet (Pyloric stenosis).
• Myasthe
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Summary of Product characteristics
Health Products Regulatory Authority
18 June 2020
CRN009P73
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kwells 300 microgram Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hyoscine Hydrobromide 300 microgram
Excipient(s) with know effect
This product contains sodium (as saccharin sodium), please see section
4.4 for further information.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
Small, circular, pink, flat tablet with bevelled edges and a single
scoreline on the surface.
The scoreline is to allow breaking of the tablet into 2 for dosage
purposes and ease of swallowing only.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the prevention of motion 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:
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.
Children under 10: not to be given.
4.3 CONTRAINDICATIONS
Prostatic enlargement, paralytic ileus, pyloric stenosis, glaucoma,
myasthenia gravis and hepatic impairment.
Known hypersensitivity to hyoscine hydrobromide or any other
ingredient in 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.
Health Products Regulatory Authority
18 June 2020
CRN009P73
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