Dropizol oral drops, solution prescribing information November 20 20 DRO - PI - 012 Based on SmPC l ast revised 31 st March 2020 from eMC Dropizol® ( opium tincture ) 10 mg/ml oral drops, solution Prescribing Information Please consult the full Summary of Product Characteristics (Sm PC) before prescribing Presentation: 1 ml of oral liquid contains 1 ml of tincture from Papaver somniferum L., succus siccum (Opium, raw) corresponding to 10 mg of morphine. 1 drop contains 50 mg opium tincture corresponding to 0.5 mg (10 mg/ml) anhydrous morphine. 1 ml = 20 drops. Indication: Symptomatic treatment of severe diarrhoea in adults, when use of other anti - diarrhoea treatments have not given sufficient effect. Dos age and a dministration: Treatment should be initiated and supervised by a specialist i.e. oncologist or gastroenterologist. The lowest dose for the shortest treatment period should be used. Taken orally, undiluted or mixed in a glass of water and consumed immediate ly. Adults: Usual starting dose 5 – 10 drops, 2 – 3 times daily . Individual doses should not exceed 1 ml and total daily dose maximum 6 ml. Paediatric population: Dropizol should not be used in children and adolescents aged below 18 years for safety reasons Elderly: Caution should be exercised and initial dosage reduced. Hepatic or r enal impairment : Avoid or reduce dose. Contraindications: Hypersensitivity to the active substance or to any of the excipients , opiate dependency, glaucoma, severe hepatic or rena l impairment, delirium tremens, severe head trauma, risk of paralytic ileus, chronic obstructive pulmonary disease, acute asthma, severe respiratory depression with hypoxia and/or hypercapnia and heart failure secondary to lung disease (Cor pulmonale). Spe cial w arning s and p recaution s : Dropizol should only be used following investigations on the cause of symptoms and when first - line treatment has not given adequate results. Dropizol should be used with caution in the following conditions/for the following patients: The elderly, chronic renal dis ease and/or hepatic disease, alcoholism, biliary colic, cholelithiasis, biliary duct diseases, head injuries or increased intracranial pressure, reduced consciousness, cardiorespiratory shock, monoamine oxidase inhibitors (including moclobemide) or within 2 weeks of withdrawal , adrenocortical deficiency, hypothyroidism, low blood pressure with hypovolaemia, pancreatitis, prostatic hyperplasia and other conditions predisposing to urinary retention, concomitant administration of other antidiarrheal or antiper istaltic drugs, anticholinergics, antihypertensives, convulsive disorders and gastroi ntestinal haemorrhage. A health care professional should be contacted in case of difficulty to urinate. Adjustment of dose may be needed in the elderly, patients with thyro id insufficiency, and patients with mild to moderate renal or hepatic impairment. Avoid use in older adults with a history of falls or fractures as ataxia, impaired psychomotor function and syncope. Anti - diarrheals inhibiting peristalsis should be used with caution in patients with infection or inflammatory bowel diseases. Due to the risk of paralytic ileus, Dropizol is not recommended before a surgical operation or within 24 hours after operation. If paralytic ileu s is suspected treatment with Dropizol must be stopped immediately. Repeated administration may cause dependence and tolerance and the use of opium may lead to addiction to the substance. Particular caution in those predisposed to addiction to narcotics an d alcohol. Concomitant use of Dropizol and sedative medicines may result in sedation, respiratory depression, coma and death, and so should be reserved for patients for whom alternative treatment options are not possible. Patients should be followed closel y and it is strongly recommended that they and their caregivers should be made aware of symptoms of respiratory depression and sedation. Administer at reduced doses and utmost caution in those on other narcotic agents, sedatives, tricylic antidepressants a nd MAO - inhibitors. Should only be used with caution in patients in high - risk groups, such as patients with epilepsy and hepatic disease. Opioids may inhibit the hypothalamic – pituitary – adrenal (HPA) or gonadal axis at multiple levels and is most pronounced after long term use. This may lead to symptoms of adrenal insufficiency. Concomitant use of Dropizol with ethanol, hypnotics, general anaesthetics, MAO inhibitors, tricyclic antidepressants and psychotropic drugs with a sedative action, gabapentin, antieme tic medications , antihistamines and other opioids may result in sedation, respiratory depression, coma or death and thus dose and duration of concomitant use should be limited Dropizol should not be used with other morphine agonists/antagonists. Due to th e ethanol content, Dropizol should not be used concomitantly with disulfiram or metronidazole. Use concurrently with caution with the following medicines; r ifampicin , antihypertensive drugs , zidovudine and fluoxetine. Dropizol may have a major influence on the ability to drive and use machines. For further information on special warnings, precautions and interactions please refer to SmPC. P regnancy and lactation: Dropizol is not recommended during pregnancy unless the benefits clearly outweigh the risks to both mother and child. If used during breastfeeding closely monitor infant for symptoms of resp iratory depression and sedation Undesirable effects: Very common (≥1/10) : Dr owsiness, constipation and dry mouth. Common (≥1/100 to <1/10) : Dizziness, headache, miosis, bronchospasms, cough decreased, nausea, vomiting, loss of appetite, dyspepsia, dysgeusia, urticaria , sweating , urinary retention and asthenia Morphine toxicity symptoms such as miosis, respiratory depression, somnolence, reduced skeletal muscle tone and drop in blood pressure and in severe cases circulatory collapse, stupor, coma, bradycardia and non - cardiogenic lung oedema, hypotension and deat h can occur. Please refer to SmPC for full details Legal category: POM CD Presentation and cost: 1 x 10 ml = £41. Marketing authorisation h older and number : Atnahs Pharma Nordics A/S, Copenhagen Towers, Ørestads Boulevard 108, DK - 2300 Copenhagen S, Denmark. Further information is available from Atnahs Pharma Nordics A/S +45 33 33 76 33 Date of last revision : November 20 2 0 Adverse events should be reported. Healthcare professionals are asked to report any suspected adverse reactions via the Yello w Card Scheme www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events shoul d also be reported to Atnahs Pharma Nordics A/S, Copenhagen Towers, Ørestads Boulevard 108, DK - 2300 Copenhagen S, Denmark or at safety@atnahs.com