Tumsigon Otc 20 mg Capsules

TUMSIGON OTC is indicated in:

• the temporary short-term relief of heartburn and hyperacidity.

Posology

Short term relief of heartburn and hyperacidity

The maximum dose is 20 mg per day and the treatment is for a maximum period of 14 days. If no symptom relief is obtained within 2 weeks of continuous treatment, further investigation is recommended, and the patient must be advised to consult a doctor.

Special populations

Elderly

Dose reductions are not necessary in elderly patients. The long-term safety of TUMSIGON OTC in patients with renal and hepatic impairment has not been established (see sections 4.8 and 5.2).

Impaired renal function

Dose reductions are not necessary in renal impairment (see sections 4.4 and 5.2).

Impaired hepatic function

Bioavailability and plasma half-life of TUMSIGON OTC are increased in patients with impaired hepatic function, therefore a daily dose of 10 u2013 20 mg is generally sufficient (see sections 4.4, 4.8 and 5.2).

Paediatric population

There is very limited experience with the use of TUMSIGON OTC in children (see sections 4.4, 4.8 and 5.2). TUMSIGON OTC should not be used in children under 1 year of age or < 10 kg.

Method of administration

TUMSIGON OTC is recommended to be given in the morning and swallowed whole with a half glass of liquid. The capsule should not be chewed or crushed.

• Hypersensitivity to omeprazole or to any of the excipients listed in section 6.1.
• Known hypersensitivity to substituted benzimidazoles.
• Safety in pregnancy and lactation has not been established (see section 4.6).
• TUMSIGON OTC must not be used concomitantly with nelfinavir (see sections 4.4 and 4.5).
• Co-administration of atazanavir with TUMSIGON OTC is not recommended (see sections 4.4 and 4.5).

Gastric malignancy

Prior to treatment or in the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, or melaena), the possibility of malignancy or gastric ulcer or a malignant disease of the oesophagus should be excluded as the treatment with TUMSIGON OTC may alleviate the symptoms of malignant ulcers and can thus delay diagnosis.

Clostridium difficile -associated diarrhoea

Proton pump inhibitor (PPI) therapy like TUMSIGON OTC may 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 (see section 4.8). Patients should use the lowest dose and shortest duration of TUMSIGON OTC therapy appropriate to the condition being treated.

Acute interstitial nephritis (AIN) leading to acute kidney injury (AKI) and/or chronic kidney disease

TUMSIGON OTC may increase the risk of subclinical acute interstitial nephritis (AIN) associated with proton pump inhibitors (PPIs) leading to chronic renal inflammation and reduced renal function (tubular injury being u201ctubulointerstitial nephritisu201d also called u201cAcute interstitial nephritis (AIN)u201d) (see section 4.8).

AIN has been observed in patients taking PPIs, such as TUMSIGON OTC, and may occur at any point during PPI therapy. AIN is characterised by an inflammatory reaction within the tubulointerstitial space of the kidney. Acute interstitial inflammatory reactions are associated with damage to the tubulointerstitium and can progress to acute kidney injury (AKI) (acute renal failure). AIN may be drug-related, infectious, systemic, autoimmune, genetic, and idiopathic with the most common cause being related to a medicine or drug exposure. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decrease renal function (e.g., malaise, nausea, anorexia). A delay in diagnosis and continued use of the PPI can lead to chronic renal failure. Patients on treatment with PPIs must be frequently monitored for renal function and the urine checked for haematuria and/or proteinuria. Patients should be advised to report any decrease in urine volumes or if they suspect that there is blood in their urine. Treatment with PPIs should be discontinued in patients with AIN.

Concomitant administration with nelfinavir and atazanavir

The plasma levels of nelfinavir and atazanavir are decreased in case of co-administration with omeprazole. Concomitant administration of proton pump inhibitors such as omeprazole as in TUMSIGON OTC with nelfinavir is contraindicated and with atazanavir is not recommended (see sections 4.3 and 4.5).

If the combination of atazanavir with TUMSIGON OTC is judged unavoidable, close clinical monitoring (e.g. virus load) is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; omeprazole 20 mg should not be exceeded.

Hepatic and renal impairment

The long-term safety of TUMSIGON OTC in patients with renal and/or hepatic impairment has not been established. Hepatic impairment may require a reduction in dose (see sections 4.2 and 5.2).

Interaction with clopidogrel

Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by use with concomitant medicines, such as TUMSIGON OTC, that interfere with CYP2C19 activity. Avoid concomitant use of clopidogrel and TUMSIGON OTC. Concomitant use of clopidogrel with 80 mg omeprazole, reduced the pharmacological activity of clopidogrel even when administered 12 hours apart. When using TUMSIGON OTC, consider alternative anti-platelet therapy (see section 4.5).

The clinical relevance of this interaction is uncertain. As a precaution, concomitant use of TUMSIGON OTC and clopidogrel should be discouraged.

Subacute cutaneous lupus erythematosus (SCLE)

Proton pump inhibitor (PPI) therapy like TUMSIGON OTC is associated with very infrequent cases of SCLE (see section 4.8). If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping TUMSIGON OTC. SCLE after previous treatment with TUMSIGON OTC may increase the risk of SCLE with other proton pump inhibitors.

Gastrointestinal infections

Decreased gastric acidity increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with TUMSIGON OTC may lead to slightly increased risk of gastrointestinal infections, such as Salmonella and Campylobacter (see section 4.8).

Interactions with diagnostic investigations for neuroendocrine tumours

Serum chromogranin A (CgA) levels increase secondary to medicine-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumours. To avoid this interference, TUMSIGON OTC treatment should be stopped for at least 5 days before CgA measurements. If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of TUMSIGON OTC treatment.

Concomitant administration with methotrexate

Concomitant use of PPIs such as TUMSIGON OTC with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration a temporary withdrawal of TUMSIGON OTC may be considered in some patients (see section 4.5).

Concomitant use with St Johnu2019s Wort or rifampicin

Medicines which induce CYP2C19 or CYP3A4 (such as St Johnu2019s Wort or rifampicin) can substantially decrease omeprazole concentrations. Avoid concomitant use of TUMSIGON OTC with St Johnu2019s Wort or rifampicin.

Excipient sucrose

TUMSIGON OTC contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Excipient lactose

TUMSIGON OTC contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Excipient mannitol

TUMSIGON OTC contains mannitol which, on rare occasions, may cause hypersensitivity reactions and may have a laxative effect.

Pregnancy

Safety in pregnancy has not been established (see section 4.3).

Breastfeeding

Safety lactation has not been established (see section 4.3).

Fertility

Animal studies with the racemic mixture omeprazole, given by oral administration do not indicate effects with respect to fertility.

TUMSIGON OTC may lead to drowsiness and impaired concentration that may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Adverse drug reactions such as dizziness, visual disturbances and vertigo may occur (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 loss of concentration could lead to accidents.

a) Summary of the safety profile

It is reported that the most common side effects (1 u2013 10 %) are headache, abdominal pain, constipation, diarrhoea, flatulence and nausea/vomiting.

b) Tabulated list of adverse reactions

The table below shows all adverse drug reactions (ADRs) observed during clinical trials and postmarket spontaneous reports with omeprazole.

System Organ Class Frequency Frequent Less Frequent Not known Infections and infestations Clostridium difficile -associated diarrhoea Blood and lymphatic system disorders leukopenia, thrombocytopenia, agranulocytosis, pancytopenia Immune system disorders hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock Metabolism and nutrition disorders hyponatraemia hypomagnesaemia; severe hypomagnesaemia may result in hypocalcaemia; hypomagnesaemia may also be associated with hypokalaemia. Psychiatric disorders insomnia agitation, confusion, depression, aggression, hallucinations Nervous system disorders headache, dizziness, paraesthesia, somnolence taste disturbance Eye disorders blurred vision Ear and labyrinth disorders vertigo Respiratory, thoracic and mediastinal disorders bronchospasm Gastrointestinal disorders abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting, fundic gland polyps (benign) dry mouth, stomatitis, gastrointestinal candidiasis microscopic colitis Hepatobiliary disorders increased liver enzymes hepatitis with or without jaundice, hepatic failure, encephalopathy in patients with pre-existing liver disease Skin and subcutaneous tissue disorders dermatitis, pruritus, rash, urticaria alopecia, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN) subacute cutaneous lupus erythematosus (see section 4.4) Musculoskeletal and connective tissue disorders fracture of the hip, wrist or spine arthralgia, myalgia, muscular weakness Renal and urinary disorders interstitial nephritis (see section 4.4) Reproductive system and breast disorders gynaecomastia General disorders and administration site conditions malaise, peripheral oedema increased sweating

d. Paediatric population

The adverse event profile was generally the same in children as for adults in short- as well as in long-term treatment for acid-related disease. There are no long-term data regarding the effects of omeprazole treatment on puberty and growth. (see sections 4.2, 4.4 and 5.2).

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. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

Blurred vision, confusion, diaphoresis, flushing, headache, malaise, nausea, and tachycardia have been reported from over-dosage with omeprazole. There is no specific antidote for overdose with omeprazole. TREATMENT IS SYMPTOMATIC AND SUPPORTIVE. Due to extensive protein binding, omeprazole is not readily dialysable. Patients in whom overdose is confirmed or suspected should be referred for medical practitioner / doctor consultation.