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Laxido® OrangeZemtard® XLSaline SteripoulesFlotros®

Laxido® Orange

Laxido Orange, powder for oral solution: Please refer to the Summary of Product Characteristics (SPC) before prescribing.
Abbreviated Prescribing Information.

Presentation: Single-dose sachet, each containing a free flowing white powder composed of: Macrogol 3350 13.125g, sodium chloride 350.7mg, sodium hydrogen carbonate 178.5mg, and potassium chloride 46.6mg. Indications:Treatment of chronic constipation and faecal impaction. Dosage: Chronic constipation:A course of treatment for chronic constipation with Laxido Orange does not normally exceed 2 weeks, although this can be repeated if required. Extended use may be necessary in the care of patients with severe chronic or resistant constipation, secondary to multiple sclerosis or Parkinson’s Disease, or induced by regular constipating medication in particular opioids and antimuscarinics. Adults, adolescents and the elderly:1-3 sachets daily in divided doses, according to individual response. For extended use, the dose can be adjusted down to 1 or 2 sachets daily. Children below 12 years old: Not recommended. Faecal Impaction: A course of treatment for faecal impaction with Laxido Orange does not normally exceed 3 days. Adults, adolescents and the elderly: 8 sachets daily, all of which should be consumed within a 6 hour period. Children below 12 years old: Not recommended. Patients with impaired cardiovascular function: For the treatment of faecal impaction the dose should be divided so that not more than 2 sachets are taken in any one hour. Administration: Each sachet should be dissolved in 125 ml water. For use in faecal impaction, 8 sachets may be dissolved in 1 litre of water. The reconstituted solution should be stored covered in a refrigerator (2°C to 8°C), for up to six hours. Contraindications: Intestinal obstruction or perforation caused by functional or structural disorder of the gut wall, ileus and in patients with severe inflammatory conditions of the intestinal tract (e.g. ulcerative colitis, Crohn’s disease and toxic megacolon). Hypersensitivity to the active substances or any of the excipients contained in Laxido Orange. Warnings and Precautions: The faecal impaction diagnosis should be confirmed by appropriate physical or radiological examination of the rectum and abdomen. If patients develop any symptoms indicating shifts of fluids/electrolytes, Laxido Orange should be stopped immediately. The absorption of other medicinal products could transiently be reduced due to an increase in gastrointestinal transit induced by Laxido Orange. Interactions: It is a theoretical possibility that absorption of other medicinal products could be reduced transiently during concomitant use with Laxido Orange. There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products e.g. anti-epileptics. Therefore, other medicines should not be taken orally for one hour before and for one hour after taking Laxido Orange. Fertility, pregnancy and lactation: Studies in animals have shown indirect reproductive toxicity. There are limited data from the use of Laxido Orange in pregnant women. Clinically, no effects during pregnancy are anticipated, since systemic exposure to macrogol 3350 is negligible. Laxido Orange can be used during pregnancy. Laxido Orange can be used during breast-feeding. There are no data on the effects of Laxido Orange on fertility in humans. Effects on ability to drive and use machines: Laxido Orange has no influence on the ability to drive and use machines. Undesirable effects: Reactions related to the gastrointestinal tract are the most common and include: abdominal pain, vomiting, nausea, dyspepsia, abdominal distension, borborygmi, flatulence and anal discomfort. Diarrhoea may also occur, mild cases of which usually respond to dose reduction. Allergic reactions including anaphylaxis, angioedema, dyspnoea and skin reactions can occur. Other effects can include electrolyte disturbances, headache and peripheral oedema. Overdose:Refer to SPC. Legal Category: P. NHS Price: Cartons of 20 sachets: £2.85; 30 sachets: £4.27. MA Number: PL 27827/0026. Full prescribing information available from the MA Holder: Galen Limited, Seagoe Industrial Estate, Craigavon, BT63 5UA, United Kingdom. Date of Preparation: June 2014..

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Galen Limited on 028 3833 4974 and select the customer services option, or e-mail customer.services@galen-pharma.com.
Medical information enquiries should also be directed to Galen Limited.

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Zemtard® XL

Zemtard XL Prescribing Information

Please refer to the Summary of Product Characteristics (SPC) before prescribing Zemtard XL. Presentation: All presentations of Zemtard XL are hard gelatin capsules containing prolonged release diltiazem hydrochloride beads for oral use. Zemtard 120 XL: Brownish-red and orange capsules marked "DIL 120", each containing 120mg diltiazem hydrochloride. Zemtard 180 XL: Pink and grey capsules marked "DIL 180", each containing 180mg diltiazem hydrochloride. Zemtard 240 XL: Light blue capsules marked "DIL 240", each containing 240mg diltiazem hydrochloride. Zemtard 300 XL: Light blue and white capsules marked "DIL 300", each containing 300mg diltiazem hydrochloride. Indications: Treatment of mild to moderate hypertension. Prophylaxis and treatment of angina pectoris. Dosage and administration: Capsules should be swallowed whole (not chewed) with half a glass of fluid. Adults: The recommended dose is between 180 and 300mg given once daily. Doses of up to 360mg/day in hypertension and 480 mg/day in angina may be of benefit in some patients. Elderly and patients with impaired renal or hepatic function: Recommended starting dose of 120 mg daily. The dose should not be increased if the heart rate falls below 50bpm. Children: Not recommended. Contra-indications: Hypersensitivity to diltiazem or any of the excipients; patients with marked bradycardia, sick sinus syndrome, left ventricular failure with stasis or second or third degree AV block, except in the presence of a functioning pacemaker; pregnancy, women of childbearing potential and while breastfeeding; Due to the risk of ventricular fibrillation, diltiazem should not be given with dantrolene infusion. Warnings and Precautions: Caution required in patients with heart failure or reduced left ventricular function, mild bradycardia, first degree AV block or prolonged PR interval. Reduced starting dose in elderly patients and in renal or hepatic impairment. Sudden withdrawal of diltiazem might be associated with an exacerbation of angina. Interactions: Caution should be exercised when combining Zemtard XL with alpha-blockers, barbiturates, beta-blockers, cardiac glycosides, antidepressants, anxiolytics and hypnotics, corticosteroids, nitrate derivatives, amiodarone, itraconazole and mefloquine. Plasma concentrations of carbamazepine, phenytoin, ciclosporin, cilostazol (avoid concomitant use), sirolimus, tacrolimus, theophylline, atorvastatin, simvastatin and lovastatin may be increased by diltiazem. Plasma concentrations of diltiazem may be reduced by rifampicin, and increased by ulcer-healing drugs, atazanavir and ritonavir. The effect of diltiazem can be reduced by phenytoin and probably by primidone. Plasma concentrations of both drugs may increase when diltiazem is given with nifedipine. Neurotoxicity may occur when diltiazem is given with lithium without an increase in the plasma concentration of lithium. In common with other calcium antagonists, when diltiazem is used with drugs that may induce bradycardia or with anti-arrhythmic drugs or other antihypertensive drugs, the possibility of an additive effect should be borne in mind. Enhanced hypotensive effect when calcium-channel blockers are given with general anaesthetics. Lethal ventricular fibrillation is constantly observed in animals following intravenous verapamil and dantrolene administered concomitantly (see Contra-indications). Pregnancy and lactation: Diltiazem should not be used in pregnancy or in women of childbearing potential. If use of the drug is considered essential in nursing mothers, an alternative method of feeding should be instituted, since diltiazem is excreted in breast milk. Effects on ability to drive and use machines: Diltiazem may cause hypotension and dizziness. Patients should be warned not to drive or operate machinery until the effect of diltiazem has been established. Undesirable effects: Adverse effects are most commonly related to the vasodilatory action of the drug, are generally mild and transient, dose-dependent and more frequent in the elderly. Reported adverse effects include lower limb oedema, headache, hypotension, dizziness, flushing, asthenia/fatigue, palpitations, malaise, nausea and other gastro-intestinal disturbances; skin rashes, usually localised and limited to erythema and urticaria, but may also include desquamative erythema, erythema multiforme, exfoliative dermatitis and acute generalised exanthematous pustulosis (AGEP); photosensitivity (namely, photodistributed hyperpigmentation); gynaecomastia, gum hyperplasia, extrapyramidal symptoms, depression; transient elevation of liver transaminases, isolated cases of clinical hepatitis. Overdose: Please refer to SPC. Basic NHS cost: Blister packs of 28 capsules. Zemtard 120mg XL: £5.19. Zemtard 180mg XL: £5.27. Zemtard 240 XL: £5.36. Zemtard 300 XL: £5.70. Legal classification: POM. Marketing Authorisation Holder: Galen Limited, Seagoe Industrial Estate, Craigavon, Northern Ireland, BT63 5UA. Marketing Authorisation Number: Zemtard 120 XL: PL 27827/0033. Zemtard 180 XL: PL 27827/0034. Zemtard 240 XL: PL 27827/0035. Zemtard 300 XL: PL 27827/0036. Full prescribing information available from: Galen Limited, Seagoe Industrial Estate, Craigavon, Northern Ireland, BT63 5UA. Date of Preparation: January 2014.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Galen Limited on 028 3833 4974 and select the customer services option, or e-mail customer.services@galen-pharma.com.
Medical information enquiries should also be directed to Galen Limited.

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Saline Steripoules

Saline Steripoules 2.5ml Prescribing Information

Please refer to the Summary of Product Characteristics (SPC) before prescribing Saline Steripoules 2.5ml. Presentation: Nebuliser solution (2.5ml) in plastic ampoules, containing sodium chloride 0.9%. Indications: For the dilution of solutions for nebulisation. Dosage and administration: As directed by the physician; by inhalation from a suitable nebuliser. Contraindications: The solution should not be injected or administered orally. Warnings and Precautions: Do not use unless the product is clear and the pack intact. Discard any surplus after use. Saline Steripoules 2.5ml should be used with a nebuliser, only under the direction of a physician. Patients using nebuliser solutions at home should be warned that if the usual relief is diminished or the usual duration of action reduced, they should consult their doctor. Interactions: None known. Pregnancy and lactation: As with all medication, particular caution must be exercised during the first trimester of pregnancy. Effects on ability to drive and use machines: None known. Undesirable effects: Saline Steripoules are not expected to cause any undesirable effects in normal use. Overdose: Substantial oral ingestion may require the use of a diuretic to remove excess sodium. Basic NHS Cost: £13.50 per carton containing 20 Steripoules. Legal Classification: POM. Marketing Authorisation Number: PL 27827/0020. Marketing Authorisation Holder: Galen Limited, Seagoe Industrial Estate, Craigavon, Northern Ireland, BT63 5UA, UK. Full Prescribing information available from: Galen Limited, Seagoe Industrial Estate, Craigavon, Northern Ireland, BT63 5UA, UK. Date of Preparation: July 2010.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Galen Limited on 028 3833 4974 and select the customer services option, or e-mail customer.services@galen-pharma.com.
Medical information enquiries should also be directed to Galen Limited.

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Flotros®

Flotros 20mg tablets Prescribing Information

Please refer to the Summary of Product Characteristics (SPC) before prescribing Flotros 20mg tablets. Presentation: Round, white, film-coated tablets each containing 20mg trospium chloride. Indications: Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder (e.g. idiopathic or neurologic detrusor overactivity). Dosage: Adults: 20mg twice daily, except in patients with severe renal impairment where 20mg once daily or every second day is recommended. Tablets should be swallowed whole with a glass of water before meals on an empty stomach. Review treatment at intervals of 3-6 months. Children under 12 years: Not recommended. Contra-indications: Urinary retention, severe gastro-intestinal conditions (including toxic megacolon), myasthenia gravis, narrow-angle glaucoma, tachyarrhythmia and hypersensitivity to trospium chloride or any of the excipients. Warnings and Precautions: Gastro-intestinal obstructive conditions, urinary flow obstruction with risk of urinary retention, autonomic neuropathy, hiatus hernia, reflux oesophagitis, those in whom fast heart rates are undesirable (e.g. in hyperthyroidism, coronary artery disease, and congestive heart failure), renal impairment. Caution should also be exercised in patients with mild to moderate hepatic impairment. Use of Flotros 20mg tablets in cases of severe hepatic impairment is not recommended. Organic causes of frequency, urgency and urge incontinence should be considered before beginning treatment. Flotros 20mg tablets contain lactose; patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this product. Interactions: Potentiation of the therapeutic effect of other drugs that possess anticholinergic properties; enhancement of the tachycardic action of ߟ-sympathomimetics; decrease in the efficacy of pro-kinetic agents. Alterations to the absorption of drugs administered concurrently cannot be excluded. Medications containing guar, colestyramine and colestipol may inhibit the absorption of Flotros 20mg tablets, so simultaneous administration is not recommended. Metabolic drug interactions are not expected with Flotros 20mg tablets. Pregnancy and lactation: Caution should be exercised with the use of Flotros 20mg tablets during pregnancy and lactation. Effects on ability to drive and use machines: Ability to operate a motor vehicle or machinery may be impaired by disturbance of visual accommodation. Side effects: Very common (> 10%): dry mouth; common (> 1%): dyspepsia, constipation, abdominal pain, nausea; uncommon (< 1%): flatulence, diarrhoea; rare (< 0.1%): micturition disorders, urinary retention, tachycardia, disorders of accommodation, dyspnoea, rash, asthenia, chest pain; very rare (< 0.01%): tachyarrhythmia, myalgia, arthralgia, angioedema, mild to moderate increase in serum transaminase levels, anaphylaxis, headache, dizziness. Overdose: Please refer to SPC. Basic NHS cost: £15.47 per 60 tablets. Legal classification: POM. Marketing Authorisation Holder: Galen Limited, Seagoe Industrial Estate, Craigavon, Northern Ireland, BT63 5UA. Marketing Authorisation Number: PL 27827/0025. Full prescribing information available from: Galen Limited, Seagoe Industrial Estate, Craigavon, Northern Ireland, BT63 5UA. Date of Preparation: January 2014.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Galen Limited on 028 3833 4974 and select the customer services option, or e-mail customer.services@galen-pharma.com.
Medical information enquiries should also be directed to Galen Limited.

Download as PDF