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KWELLS 300 MICROGRAM TABLETS

Active substance(s): HYOSCINE HYDROBROMIDE / HYOSCINE HYDROBROMIDE / HYOSCINE HYDROBROMIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

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 effects of hyoscine may be enhanced by other drugs with anticholinergic
properties (including amantadine, some antihistamines, phenothiazine
antipsychotics and tricyclic antidepressants), therefore, combining these drugs
with hyoscine should be avoided.
There may be an increased risk of side effects when given with MAOIs due to
inhibition of drug-metabolising enzymes.
The sedative effect of Kwells may be enhanced with alcohol or CNS
depressants.
The reduction in gastric motility caused by Kwells may also affect the
absorption of other drugs. There is an antagonism of effect of domperidone
and metoclopramide on gastro-intestinal activity.
There could be a reduced effect of sublingual nitrate tablets due to the failure
to dissolve properly under the tongue owing to dry mouth.

4.6

Fertility, pregnancy and lactation
The safety of this medicine in pregnancy has not been established. It should
only be used during pregnancy, particularly in the first trimester, if the
expected benefit to the mother outweighs any potential risk to the developing
foetus.
Caution is required during lactation as small amounts of this medicine may
pass into breast milk.

4.7

Effects on ability to drive and use machines
May cause drowsiness. If affected do not drive or operate machinery.

4.8

Undesirable effects

The listed adverse drug reactions are based on spontaneous reports, thus an organization
according to CIOMS II categories of frequency is not pertinent.
General: hyperthermia at high temperatures due to decreased sweating.
Eye disorders: blurred vision, mydriasis.
Gastrointestinal disorders: dry mouth.
Immune system disorders: allergic reaction and anaphylactic reaction. Hypersensitivity
reactions with respective laboratory and clinical manifestations, including asthma
syndrome, mild to moderate reactions affecting skin, respiratory tract, gastrointestinal
tract, and cardiovascular system, and symptoms such as rash, urticaria, oedema, pruritus,
cardio-respiratory distress, have been reported.
Nervous system disorders: drowsiness, dizziness, sedation and somnolence are commonly
reported. Central nervous system stimulation including restlessness, hallucinations and
confusion, have been less frequently reported following the administration of hyoscine.
There have been rare reports of an increase in seizure frequency in epileptic patients (the
same caution for this patient population is included in Section 4.4).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9

Overdose
The symptoms of overdosage are tachycardia, arrhythmia, blurring of vision and
photophobia, urinary retention. Drowsiness is usual but paradoxical stimulation
with hallucinations may occur. Treatment: gastric lavage or induced emesis and
symptomatic treatment.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Hyoscine hydrobromide is thought to act as an anticholinergic agent by both
cutting off stimuli to the vestibular apparatus and also by acting directly on the
vomiting centre.

5.2

Pharmacokinetic properties
Hyoscine hydrobromide is readily absorbed from the gastro-intestinal tract,
and in circulation is bound to plasma proteins. Clinical studies have shown
that oral hyoscine hydrobromide is effective in preventing motion sickness at
plasma concentration of 50pg/ml (equivalent to 0.17nmol/l). This
concentration is reached within 30 minutes following oral/buccal
administration of 0.3 mg hyoscine hydrobromide and it is effective for about 4
hours. Hyoscine hydrobromide is almost entirely metabolised in the body.

5.3

Preclinical safety data
Not applicable.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Mannitol
Potato Starch
Gelatin Powder
Aluminium Stearate
Saccharin Sodium
Ferric Oxide
Purified Water (not detectable)

6.2

Incompatibilities
None known.

6.3

Shelf life
60 months.

6.4

Special precautions for storage
Do not store above 25°C.

6.5

Nature and contents of container
1. Strip packs formed from 0.03mm soft-tempered aluminium coated with
polyethylene.
a. Two strips of six tablets in cardboard carton.
b. One strip of twelve tablets in cardboard carton.
c. Strip of two tablets stapled into a cardboard cover.
2. Blister packs formed from 20μm hard-tempered aluminium foil and 250um
opaque, white PVC or 250μm opaque, white PVC coated with 40 gsm PVDC.
a. Two strips of six tablets in cardboard carton.
b. One strip of twelve tablets in cardboard carton
c. Strip of two tablets stapled into a cardboard covercarton.
Pack sizes: 12, 2.

6.6

Instructions for use and handling
No special precautions necessary.

7

MARKETING AUTHORISATION HOLDER
Bayer plc, Consumer Care Division
Bayer House
Strawberry Hill
Newbury
Berkshire, RG14 1JA, UK

8.

MARKETING AUTHORISATION NUMBER(S)
PL 00010/0329

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
12/10/2005

10

DATE OF REVISION OF THE TEXT
16/07/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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