Bayer Limited

Kwells 300 microgram tablets

Hyoscine Hydrobromide 300 microgram

For a full list of excipients, see section 6.1

Tablet

Small, circular, pink, flat tablets 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.

For the prevention of motion sickness.

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.

Prostatic enlargement, paralytic ileus, pyloric stenosis, glaucoma, myasthenia gravis and hepatic impairment.

Known hypersensitivity to hyoscine hydrobromide or any other ingredient in the product.

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.

May cause drowsiness. Children taking this medicine should not be left unattended.

Avoid alcoholic drink.

In patients with hepatic impairment an increase of the bioavailability of scopolamine hydrobromide could theoretically occur as hepatic metabolism appears to be the primary route of metabolism. In theory, this could lead to a greater potential for, or prolongation of, undesirable effects.

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 failure to dissolve properly under the tongue owing to dry mouth.

In a study in healthy volunteers, the administration of hyoscine with grapefruit juice, an inhibitor of CYP3A, increased the AUC_0-24h and prolonged the time to peak concentration, resulting in a higher drug bioavailability.

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 and on advice of a physician.

Caution is required during lactation as small amounts of this medicine may pass into breast milk.

This product may cause drowsiness and patients receiving it should not drive or operate machinery unless it has been shown that their physical and mental capacity remain unaffected.

The listed adverse drug reactions are based on spontaneous reports, thus an organisation according to CIOMS II categories of frequency is not pertinent.

General: hyperthermia at high temperatures due to decreased sweating.

Eye disorders: blured 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, has been less frequently reported following the administration of hyoscine hydrobromide. 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).

The symptoms of overdosage are tachycardia, arrhythmia, blurring of vision and photophobia, urinary retention. Drowsiness is usual but paradoxical stimulation with hallucinations may occur. Overdosage (relative or absolute) may produce flushing, dilated pupils and symptoms of CNS stimulation.

Treatment: gastric lavage or induced emesis and symptomatic treatment.

Pharmacotherapeutic group: antiemetics and antinauseants, scopolamine

ATC code: A04 AD01

Hyoscine hydrobromide competitively inhibits muscarinic receptors for acetylcholine and acts as a nonselective muscarinic antagonist, producing both peripheral antimuscarinic properties and central sedative, antiemetic, and amnestic effects.

Hyoscine hydrobromide is absorbed rapidly, but variably and incompletely from the gastrointestinal tract. The mean time to peak drug concentration is approximately 24 mintues following administration. The oral bioavailability has been reported to be only 13%. Pharmacological effects on the GI tract (decreased motility and decreased gastric secretion), and intestinal metabolism (see below) may also contribute to the limited oral bioavailability. Approximately 30% of hyoscine in the plasma is bound to protein. The elimination half life is estimated at approximately 1 hour.

Limited human data regarding the metabolism of hyoscine are available, however, since only a small proportion (2.6%) of pharmacologically active drug is excreted in the urine, a first pass metabolism is theorized. While the metabolic profile has not been fully elucidated, it is suggested that glucuronide and/or sulfate conjugation are significant metabolic pathways. In addition, it appears that oxidative demethylation of the drug via CYP3A, probably occuring in the intestinal mucosa, is also involved.

Non-clinical studies reveal no unexpected clinically relevant findings and no evidence of carcinogenicity.

Mannitol (E421)

Potato Starch

Gelatin Powder

Aluminium Stearate

Saccharin Sodium (E954)

Ferric Oxide (E172)

None known.

5 years.

Do not store above 25 °C.

Blister packs formed from 20μm hard-tempered aluminium foil and 250μm opaque, white PVC.

Pack size: 12 tablets.

Not all pack sizes may be marketed.

No special requirements.

Bayer Ltd

The Atrium

Blackthorn Road

Dublin 18

Ireland

PA 1410/48/2

Date of first authorisation: 01 April 1979

Date of last renewal: 01 April 2009

February 2010