Lansoloc Otc 15 mg Capsules

LANSOLOC OTC 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
LANSOLOC should preferably be taken before a meal. LANSOLOC OTC may be taken once daily at a maximum daily dose of 15 mg (one LANSOLOC OTC capsule) for a maximum treatment period of 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 populations
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 recommended once daily dosage of LANSOLOC OTC should preferably be taken before a meal in the morning. The capsules should be swallowed whole. Do not crush or chew.

LANSOLOC OTC is contraindicated in:
u2022 Patients with hypersensitivity to lansoprazole or to any of the ingredients of LANSOLOC OTC 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 LANSOLOC 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 LANSOLOC. Diagnosis of reflux oesophagitis should be confirmed by endoscopy.

Subacute cutaneous lupus erythematosus (SCLE): Proton pump inhibitors including LANSOLOC OTC has been associated with cases of subacute cutaneous lupus erythematosus (SCLE). If lesions occur, particularly in sunu2013exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly. Treatment with LANSOLOC OTC 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 LANSOLOC OTC 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 LANSOLOC OTC, particularly in patients of middle age or older, who have new or recently changed dyspeptic symptoms.

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

Hypomagnesaemia
In patients treated with LANSOLOC OTC for three months or more severe hypomagnesaemia has been reported. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular dysrhythmia can occur, but they may begin insidiously and be overlooked. Discontinuation of LANSOLOC OTC and magnesium replacement will improve hypomagnesaemia in most affected patients. For patients expected to be on prolonged treatment or who take LANSOLOC OTC with digoxin or medicines that may cause hypomagnesaemia (e.g., diuretics), healthcare professionals should consider measuring magnesium levels before starting LANSOLOC OTC treatment and periodically during treatment.

Bone fractures: Proton pump inhibitors such as LANSOLOC OTC, especially if used in high doses and over extended periods of time (> 1 year), may increase the risk of hip, wrist and spine fracture, mainly in the elderly or where other recognised risk factors are present. Observational studies have suggested that proton pump inhibitors such as LANSOLOC OTC may increase the overall risk of fracture by 10 u2013 40 %. 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.

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 LANSOLOC OTC may lead to an increased risk of gastrointestinal infections, such as with Salmonella and Campylobacter (see section 4.8).

Clostridium difficile-associated diarrhoea: LANSOLOC OTC may also be associated with an increased risk of Clostridium difficile associated diarrhoea (CDAD), especially in hospitalised patients. This diagnosis should be considered for diarrhoea that does not improve.

Tubulointerstitial nephritis: LANSOLOC OTC may increase the risk of subclinical acute or chronic interstitial nephritis which is associated with the use of Proton Pump Inhibitors (PPIs) which 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.

Sucrose
LANSOLOC OTC contains 0,018 g of sucrose per dose. This should be taken into account in patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Since LANSOLOC OTC is metabolised through the cytochrome P450 system, specifically through the CYP3A and CYP2C19 isozymes, the possibility exists for interactions with other medicines that are metabolised via this system. When administering LANSOLOC OTC with the CYP2C19 inhibitor fluvoxamine, a dose reduction should be considered, as plasma concentrations of LANSOLOC OTC increases up to 4-fold. Enzyme inducers affecting CYP2C19 and CYP3A4 such as rifampicin and St Johnu2019s wort (Hypericum perforatum) can significantly reduce the plasma concentrations of LANSOLOC OTC.

Studies have demonstrated that, in healthy subjects, LANSOLOC OTC 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.

When LANSOLOC OTC is co-administered with theophylline (CYP1A2, CYP3A), a minor increase (10 %) in theophylline clearance is observed. This interaction is unlikely to be of clinical concern given the small magnitude and direction of effect on theophylline clearance. Nonetheless, to ensure clinically effective blood levels, individual patients may require additional titration of their theophylline dosage when LANSOLOC OTC is started or stopped.

Concomitant use of proton pump inhibitors such as LANSOLOC OTC 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 LANSOLOC OTC should be considered.

Concomitant use of LANSOLOC OTC and tacrolimus increases the plasma concentrations of tacrolimus (a CYP3A and Pgp substrate). LANSOLOC OTC exposure increases the mean exposure of tacrolimus by up to 81 %. Monitoring of tacrolimus plasma concentrations is advised when concomitant treatment with LANSOLOC OTC is initiated or ended.

Increases in International Normalised Ratio (INR) and prothrombin time have been reported in patients who took proton pump inhibitors, including LANSOLOC OTC, and warfarin concomitantly. Increases in INR and prothrombin time may cause abnormal bleeding and result in death. Patients treated with LANSOLOC OTC and warfarin concomitantly may require monitoring for increases in INR and prothrombin time.

Caution should be exercised when oral contraceptives and carbamazepine are taken concomitantly with LANSOLOC OTC. No clinically significant interaction was seen between LANSOLOC OTC and amoxicillin or non-steroidal anti-inflammatory drugs (NSAIDs).

Sucralfate delays absorption of proton pump inhibitors and reduces the bioavailability of single-dose lansoprazole 30 mg by 17 % when administered concomitantly. Therefore, LANSOLOC OTC should be taken at least 30 minutes before sucralfate. Antacids may reduce the bioavailability of LANSOLOC OTC and should not be taken within 1 hour of LANSOLOC OTC.

LANSOLOC OTC causes a profound and long-lasting inhibition of gastric acid secretion. It is, therefore, theoretically possible that LANSOLOC OTC 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.

Co-administration of LANSOLOC OTC 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 LANSOLOC OTC treatment.

Since a significant reduction in atazanavir or nelfinavir exposure was reported when LANSOLOC OTC was administered concomitantly, LANSOLOC OTC should not be co-administered with atazanavir or nelfinavir (see section 4.3).

LANSOLOC OTC is contraindicated during pregnancy and lactation (section 4.3). Adequate and well-controlled studies in humans have not been done.

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

LANSOLOC OTC 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, 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 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, 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, gum haemorrhage, haematemesis, increased salivation, melaena, mouth ulceration, rectal disorders, rectal haemorrhage, stomatitis, tenesmus, tongue disorders, ulcerative stomatitis. Frequency unknown Sore mouth or throat Hepato-biliary disorders Less frequent Cholelithiasis, elevation of hepatic enzymes, 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. Skin and subcutaneous tissue disorders Frequent Skin rash, pruritus, urticaria. 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 Arthralgia, myalgia, arthritis, bone disorders, joint disorders, leg cramps, musculoskeletal pain, myasthenia, synovitis, fractures of the hip, wrist or spine. 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.

Post-marketing:
MedDRA system organ Class Frequency Side effects Renal and urinary disorders Frequency Unknown Interstitial nephritis (with possible progression to renal failure as it is not necessarily reversed when treatment is discontinued).

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on the SAHPRA website, or to Cipla Medpro (Pty) Ltd at [email protected] or telephone 080 222 6662 (toll free).

(See section 4.4)
In overdose, side effects can be precipitated and/or be of increased severity (see section 4.8). Treatment is symptomatic and supportive.