Burnloc 15mg Capsule

BURNLOC is indicated in the short-term symptomatic relief of heartburn and hyperacidity at a maximum daily dose of 15 mg for a maximum period of 14 days.

Posology
BURNLOC should preferably be taken before a meal.
Heartburn and hyperacidity: One BURNLOC (15 mg) capsule daily for up to 14 days. Patients should be advised to consult their doctor in the event of symptoms persisting, getting worse or continuing for 14 days (see section 4.3).

Special population
Elderly: No dose adjustment is necessary.
Renal impairment: No dose adjustment is necessary in renal failure u2013 this also applies to patients on dialysis.
Paediatric population
Safety and efficacy in children have not been established.

Method of administration
The capsule should be taken orally, preferably in the morning before meals (see section 5.2).

BURNLOC is contraindicated in:
u2022 Patients with hypersensitivity to lansoprazole or to any of the ingredients of BURNLOC listed in section 6.1.
u2022 Pregnancy and lactation (see section 4.6).
u2022 Patients with liver impairment.
u2022 Conjunction with atazanavir or nelfinavir, due to a significant reduction in atazanavir or nelfinavir exposure (see section 4.5).

Safety and efficacy in children have not been established. Treatment with BURNLOC may alleviate the symptoms of malignant ulcers and can delay diagnosis. Therefore, the possibility of malignancy of gastric ulcer or a malignant disease of the oesophagus should be excluded prior to treatment with BURNLOC. Diagnosis of reflux oesophagitis should be confirmed by endoscopy.

Contains sucrose: Patients with rare hereditary conditions such as fructose intolerance, glucose-galactose mal-absorption or sucrose-isomaltase insufficiency should not take BURNLOC.

Contains mannitol: May have a mild laxative effect.

Contains sodium (as in sodium laurilsulfate): This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially u2018sodium-freeu2019.

Effects related to acid inhibition: During long-term treatment, gastric glandular cysts have been reported in increased frequency. These physiological changes result from pronounced inhibition of gastric acid secretion. Decreased gastric acidity increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with BURNLOC may lead to an increased risk of gastrointestinal infections such as Salmonella and Campylobacter.

In the presence of symptoms such as, significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, or melaena, and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with BURNLOC may alleviate symptoms and delay diagnosis.

Clostridium difficile-associated diarrhoea: Proton pump inhibitor (PPI) therapy, including BURNLOC, may be associated with an increased risk of Clostridium difficile-associated diarrhoea (CDAD). This diagnosis should be considered for diarrhoea that does not improve.

Hypomagnesaemia: Severe hypomagnesaemia has been reported in patients treated with PPIs like Lansoprazole, as in BURNLOC, for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness, and ventricular dysrhythmia can occur, but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the Lansoprazole, as in BURNLOC. For patients expected to be on prolonged treatment or who take BURNLOC with digoxin or medicines that may cause hypomagnesaemia (e.g., diuretics), healthcare professionals should consider measuring magnesium levels before starting BURNLOC treatment and periodically during treatment.

Subacute cutaneous lupus erythematosus (SCLE): Proton pump inhibitors have been associated with cases of subacute cutaneous lupus erythematosus (SCLE). If lesions occur, particularly in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly. Treatment with BURNLOC may increase the risk of SCLE with other proton pump inhibitors.

In the presence of symptoms such as significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena, and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with BURNLOC may alleviate symptoms and delay diagnosis. Therefore, the possibility of malignancy of gastric ulcer or a malignant disease of the oesophagus should be excluded prior to treatment with BURNLOC, particularly in patients of middle age or older, who have new or recently changed dyspeptic symptoms. Diagnosis of reflux oesophagitis should be confirmed by endoscopy.

BURNLOC is not indicated for mild gastrointestinal complaints, such as nervous dyspepsia.

Bone fractures: Proton pump inhibitors including BURNLOC may increase the risk of hip, wrist and spine fracture, mainly in the elderly or where other recognised risk factors are present, especially if used in high doses and over extended periods of time (> 1 year). Patients who are at risk of osteoporosis should have a sufficient intake of vitamin D and calcium and receive care according to current clinical guidelines.

Tubulointerstitial nephritis: BURNLOC may increase the risk of subclinical acute or chronic interstitial nephritis which is associated with the use of Proton Pump Inhibitors (PPIs). This may lead to chronic renal inflammation and reduced renal function that may also progress to renal failure as it is not necessarily reversed when treatment is discontinued (see section 4.8).

Acute or chronic interstitial nephritis: PPIs may trigger acute or chronic interstitial nephritis which is commonly associated with acute kidney injury (AKI). Hence, PPIs should be used carefully. Patients on PPIs should be closely monitored for signs or symptoms of acute interstitial nephritis. These may range from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function e.g. malaise, nausea and anorexia.

u2022 Since BURNLOC is metabolised through the cytochrome P450 system, specifically through the CYP3A and CYP2C19 isozymes, the possibility exists for interactions with medicines that are metabolised via this system.

u2022 When administering BURNLOC with the CYP2C19 inhibitor fluvoxamine, a dose reduction should be considered, as plasma concentrations of BURNLOC increases up to 4-fold.

u2022 Enzyme inducers: enzyme inducers affecting CYP2C19 and CYP3A4 such as rifampicin and St Johnu2019s wort (Hypericum perforatum) can significantly reduce the plasma concentrations of BURNLOC.

u2022 Studies have demonstrated that lansoprazole (as seen in BURNLOC) does not have clinically significant interactions with other medicines metabolised by the cytochrome P450 system, such as phenazone, clarithromycin, diazepam, indomethacin, ibuprofen, phenytoin, propranolol, or prednisone. These medicines are metabolised through various cytochrome P450 isozymes, including CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A.

u2022 Theophylline: co-administration of BURNLOC with theophylline may result in a minor increase in theophylline clearance. This interaction is unlikely to be of clinical concern considering the small magnitude and direction of effect on theophylline clearance. However, to ensure clinically effective blood levels, individual patients may require additional titration of their theophylline dosage when BURNLOC is started or stopped.

u2022 Concomitant use of proton pump inhibitors such as BURNLOC may elevate and prolong serum levels of methotrexate and/or its metabolites, possibly leading to methotrexate toxicities. It is recommended that in high-dose methotrexate administration, temporary withdrawal of BURNLOC should be considered.

u2022 Tacrolimus: concomitant use of BURNLOC and tacrolimus may increase the plasma concentrations of tacrolimus (a CYP3A and Pgp substrate). Lansoprazole, as in BURNLOC, exposure increases the exposure of tacrolimus. Monitoring of tacrolimus plasma concentrations is advised when concomitant treatment with BURNLOC is initiated or ended.

u2022 Warfarin: monitoring of patients receiving concomitant warfarin is recommended, since a minor reduction in the concentration of warfarin may occur. Increases in International Normalised Ratio (INR) and prothrombin time have been reported in patients who took proton pump inhibitors and warfarin concomitantly. Increases in INR and prothrombin time may cause abnormal bleeding and result in death. Patients treated with BURNLOC and warfarin concomitantly may require monitoring for increases in INR and prothrombin time.

u2022 Oral contraceptives and carbamazepine: caution should be exercised when oral contraceptives and carbamazepine are taken concomitantly with BURNLOC.

u2022 No clinically significant interaction was seen between BURNLOC and amoxicillin or non-steroidal anti-inflammatory drugs (NSAIDs).

u2022 Methotrexate: concomitant use of proton pump inhibitors such as BURNLOC may elevate and prolong serum levels of methotrexate and/or its metabolites, possibly leading to methotrexate toxicities. It is recommended that in high-dose methotrexate administration, temporary withdrawal of BURNLOC should be considered.

u2022 Sucralfate: Sucralfate delays absorption of proton pump inhibitors and reduces the bioavailability of proton pump inhibitors when administered concomitantly. BURNLOC must be taken at least 30 minutes before sucralfate.

u2022 Antacids: may reduce the bioavailability of BURNLOC and should not be taken within 1 hour of BURNLOC.

u2022 Lansoprazole causes a profound and long-lasting inhibition of gastric acid secretion. It is, therefore, possible that BURNLOC may interfere with the absorption of medicines where gastric pH is an important determinant of bioavailability (e.g. ketoconazole, itraconazole, voriconazole, ampicillin esters, iron salts, digoxin, and dasatinib). With voriconazole, the plasma concentration of both medicines may be increased.

u2022 Digoxin: Co-administration of BURNLOC and digoxin may lead to increased plasma levels of digoxin. Therefore, the plasma levels of digoxin should be monitored and the dose of digoxin adjusted if necessary when initiating and ending BURNLOC treatment.

u2022 A significant reduction in atazanavir or nelfinavir exposure was reported when lansoprazole was administered concomitantly, BURNLOC should not be co-administered with atazanavir or nelfinavir (see section 4.3).

BURNLOC is contraindicated during pregnancy and lactation (see section 4.3).

Pregnancy
Adequate and well-controlled studies in humans have not been done.

Breastfeeding
It is not known whether lansoprazole is distributed into breast milk. However, lansoprazole or its metabolites are distributed into the milk of rats and lansoprazole has been shown to cause tumorigenic effects in animals. Mothers on BURNLOC should not breastfeed their infants.

BURNLOC may lead to visual disturbances, drowsiness and impaired concentration that may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants (see section 4.8). Patients should be advised, particularly at the initiation of therapy, against taking charge of vehicles or machinery or performing potentially hazardous tasks where visual disturbances or loss of concentration could lead to accidents.

Tabulated summary of adverse reactions
The following adverse reactions have been classified according to the following categories, frequent, less frequent and frequency unknown.

MedDRA system organ class
Frequency
Side effects
Infections and infestations
Less Frequent
Candidiasis, infection, oral moniliasis, pneumonia, upper respiratory infection, urinary tract infection, otitis media.
Frequency unknown
Clostridium difficile associated diarrhoea.
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Less frequent
Carcinoma, laryngeal neoplasia, skin carcinoma.
Blood and lymphatic system disorders (Haematological)
Less frequent
Thrombocytopenia, anaemia, leukopenia, neutropenia, eosinophilia, haemolysis, lymphadenopathy, agranulocytosis, pancytopenia. Bruising, purpura, petechiae.
Immune system disorders
Less frequent
Allergic reaction. Frequency unknown
Bruising, purpura, petechiae.
Endocrine disorders
Less frequent
Diabetes mellitus, goitre, hypothyroidism, gynaecomastia, galactorrhoea.
Metabolism and nutrition disorders
Less frequent
Anorexia, increased appetite, thirst, gout, dehydration, hyperglycaemia or hypoglycaemia, weight gain or loss. Hypomagnesaemia. Severe hypomagnesaemia may result in hypocalcaemia. Hypomagnesaemia may also be associated with hypokalaemia. Frequency unknown
Hyponatraemia, hypomagnesaemia.
Psychiatric disorders
Less frequent
Insomnia, somnolence, abnormal dreams, agitation, anxiety, apathy, depersonalisation, depression, emotional lability, hallucinations, aggravated hostility, increased or decreased libido, nervousness, neurosis, sleep disorders, thought-abnormalities.
Nervous system disorders
Frequent
Headache
Less frequent
Cerebral infarction, migraine, amnesia, confusion, convulsion, hemiplegia, hyperkinesia, hyperaesthesia, paraesthesia, parosmia, taste loss, taste perversion, dizziness, tremor, somnolence, insomnia.
Eye disorders
Less frequent
Blurred vision, diplopia, abnormal vision, conjunctivitis, dry eyes, eye pain, photophobia, retinal degeneration, visual field defects.
Ear and labyrinth disorders
Less frequent
Vertigo, deafness, ear disorder, tinnitus.
Cardiac disorders
Less frequent
Angina, myocardial infarction, dysrhythmia, bradycardia, palpitations, tachycardia, syncope, oedema.
Vascular disorders
Less frequent
Hypertension, hypotension, shock (circulatory failure), vasodilation, peripheral oedema, cerebrovascular accident.
Respiratory, thoracic and mediastinal disorders
Less frequent
Asthma, bronchitis, increased cough, dyspnoea, epistaxis, haemoptysis, hiccups, pharyngitis, pleural disorder, respiratory disorder, upper respiratory inflammation, rhinitis, sinusitis, stridor.
Gastrointestinal disorders
Frequent
Diarrhoea, nausea, vomiting, constipation, abdominal pain.
Less Frequent
Dry mouth, glossitis, ulcerative colitis, gynaecomastia, galactorrhoea, enlarged abdomen, halitosis, abnormal stools, bezoar, cardiospasm (oesophageal pain), colitis, dyspepsia, dysphagia, enteritis, eructation, oesophageal stenosis, oesophageal ulcer, oesophagitis, faecal discolouration, flatulence, gastric nodules or fundic gland polyps, gastritis, gastroenteritis, gastrointestinal anomalies, gastrointestinal disorders, gastrointestinal haemorrhage, haematemesis, increased salivation, melaena, mouth ulceration, rectal disorders, rectal haemorrhage, stomatitis, tenesmus, taste abnormalities, ulcerative stomatitis.
Frequency unknown
Sore mouth or throat.
Hepato-biliary disorders
Less frequent
Elevation of hepatic enzymes, Cholelithiasis, jaundice [mostly in association with liver injury (an increase in up to twice the upper limit of the normal range of hepatic enzymes)], hyperbilirubinaemia, hepatitis.
Frequency unknown
Hepatic failure, hepatic encephalopathy.
Frequent
Skin rash, pruritus, urticaria.
Skin and subcutaneous tissue disorders
Less frequent
Alopecia, acne, contact dermatitis, dry skin, fixed eruption, hair disorders, maculopapular rash, nail disorders, skin disorders, sweating, Stevens-Johnson syndrome, or toxic epidermal necrolysis.
Frequency unknown
Erythematous or bullous rashes, including erythema multiforme, hair thinning, photosensitivity.
Musculoskeletal and connective tissue disorders
Less frequent
Asthenia, arthralgia, myalgia, arthritis, bone disorders, joint disorders, leg cramps, musculoskeletal pain, myasthenia, synovitis, fractures of the hip, wrist or spine.
Renal and urinary disorders
Frequency Unknown
Interstitial nephritis (with possible progression to renal failure as it is not necessarily reversed when treatment is discontinued).
Renal and urinary disorders
Less frequent
Dysuria, kidney calculus, kidney pain, polyuria, urethral pain, urinary frequency, urinary urgency, urination impaired, interstitial nephritis (with possible progression to renal failure).

Reproductive system and breast disorders
Less frequent
Gynaecomastia, galactorrhoea, abnormal menses, breast enlargement, breast pain, breast tenderness, dysmenorrhoea, impotence, leucorrhoea, menorrhagia, menstrual disorders, penis disorders, testis disorders, vaginitis.
General disorders and administration site conditions
Less frequent
Asthenia, fever, back pain, chest pain, chills, flu syndrome, malaise, neck pain, neck rigidity, pain, pelvic pain.
Frequency unknown
Fatigue.

(See section 4.4) Treatment is symptomatic and supportive.