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Self-care advice for customers11-13

PI

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Kwells 300 mcg Tablets

Pharmaceutical Form: Tablets. Indications: For the prevention of travel sickness. Active Ingredient: Hyoscine Hydrobromide. Posology: 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. Method of Administration: Tablets to be taken up to 30 minutes before the start of the journey to prevent travel sickness, or at the onset of nausea. Tablets to be sucked, chewed or swallowed. 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. 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. 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 gastrointestinal 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. 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. Effects on ability to drive and use machines: May cause drowsiness. If affected do not drive or operate machinery. 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. 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. Legal Category: P. Price: £3.99 Product Licence Number and Holder: PL 14017/0299 Dexcel® Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire NN11 8PB, UK. Date of Preparation: February 2021.

Kwells Kids 150 mcg Tablets

Pharmaceutical Form: Tablets. Indications: For the prevention of travel sickness. Active Ingredient: Hyoscine Hydrobromide. Posology: Adults: Not applicable. Elderly persons: Not applicable. 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 1 ½ -3 tablets in 24 hours. Method of Administration: Tablets to be taken up to 30 minutes before the start of the journey to prevent travel sickness, or at the onset of nausea. Tablets to be sucked, chewed or swallowed. 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. 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. 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. 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. Effects on ability to drive and use machines: May cause drowsiness. If affected do not drive or operate machinery. 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). 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. Legal Category: P. Price: £3.99. Product Licence Number and Holder: PL 14017/0300 Dexcel® Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire NN11 8PB, UK. Date of Preparation: February 2021.

Adverse event reporting

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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard, or search for the MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Dexcel Pharma on: 01748 828 784.