Lansoprazole 30mg Gastro-resistant Capsules

Each capsule contains 30mg of Lansoprazole.

Each capsule contains 161mg sucrose.

For a full list of excipients, see section 6.1

Gastro-resistant capsule, hard

White capsules (size no. 1) filled with a white to light brown or slightly pink coloured pellets.

Uses

Lansoprazole is effective in the treatment of acid-related disorders of the upper gastro-intestinal tract, with the benefit of rapid symptom relief. Lansoprazole is also effective in combination with antibiotics in the eradication of Helicobacter pylori (H. pylori).

Indications

Healing and long term management of Gastro Oesophageal Reflux Disease (GORD).

Healing and maintenance therapy for patients with duodenal ulcer.

Relief of reflux-like symptoms (e.g. heartburn) and/or ulcer-like symptoms (e.g. upper epigastric pain) associated with acid-related dyspepsia.

Healing of benign gastric ulcer.

Treatment and prophylaxis of NSAID-associated benign gastric ulcers, duodenal ulcers and relief of symptoms in patients requiring continued NSAID treatment.

Long term management of pathological hypersecretory conditions including Zollinger-Ellison syndrome.

Lansoprazole is also effective in patients with benign peptic lesions, including reflux oesophagitis, unresponsive to H2 receptor antagonists.

Eradication of H. pylori from the upper gastrointestinal tract when used in combination with appropriate antibiotics in patients with gastritis or duodenal ulcer leading to the healing and prevention of relapse of the ulcer.

Dosage:

Gastro Oesophageal Reflux Disease: Lansoprazole 30mg once daily for 4 weeks. The majority of patients will be healed after the first course. For those patients not fully healed at this time, a further 4 weeks treatment at the same dosage should be given.

For long term management, a maintenance dose of Lansoprazole 15mg or 30mg once daily can be used dependant upon patient response.

Duodenal ulcer: Lansoprazole 30mg once daily for 4 weeks.

For prevention of relapse, the recommended maintenance dose is Lansoprazole 15mg once daily.

Acid-related dyspepsia: Intermittent courses, as required, of Lansoprazole 15 mg or 30 mg once daily for 2-4 weeks depending on the severity and persistence of symptoms. Patients who do not respond after 4 weeks, or who relapse shortly afterwards, should be investigated.

Benign gastric ulcer: Lansoprazole 30mg once daily for 8 weeks.

Treatment of NSAID-associated benign gastric and duodenal ulcers and relief of symptoms: Lansoprazole 15mg or 30mg once daily for 4 or 8 weeks. Most patients will be healed after 4 weeks; for those patients not fully healed, a further 4 weeks treatment can be given.

For patients at particular risk or with ulcers that may be difficult to heal, the higher dose and/or the longer treatment duration should be used.

Prophylaxis of NSAID-associated benign gastric ulcers, duodenal ulcers and symptoms: Lansoprazole 15mg or 30mg once daily.

Hypersecretory conditions: The initial dose should be Lansoprazole 60mg once daily. The dosage should then be adjusted individually. Treatment should be continued for as long as clinically indicated.

For patients who require 120mg or more per day, the dose should be divided and administered twice daily.

Eradication of H. pylori: The following combinations have been shown to be effective when given for 7 days:

Lansoprazole 30mg twice daily plus clarithromycin 250-500mg twice daily and amoxycillin 1g twice daily, or

Lansoprazole 30mg twice daily plus clarithromycin 250-500mg twice daily and metronidazole 400mg twice daily, or

Lansoprazole 30mg twice daily plus amoxycillin 1g twice daily and metronidazole 400mg twice daily.

The best eradication results are obtained when clarithromycin is combined with either amoxycillin or metronidazole. When used in combination with the recommended antibiotics, Lansoprazole is associated with H. pylori-eradication rates of up to 90%.

Eradication of H. pylori with any one of the above regimens has been shown to result in the healing of duodenal ulcers, without the need for continued anti-ulcer drug therapy. The risk of reinfection is low and relapse following successful eradication is, therefore, unlikely.

To achieve the optimal acid inhibitory effect, and hence most rapid healing and symptom relief, Lansoprazole 'once daily' should be administered in the morning before food. Lansoprazole 'twice daily' should be administered once in the morning before food, and once in the evening.

The capsules should be swallowed whole. Do not crush or chew.

Elderly: Dose adjustment is not required in the elderly. The normal daily dosage should be given.

Children: The use of lansoprazole is not recommended in children as clinical data are limited. Treatment of small children below one year of age should be avoided as available data have not shown beneficial effects in the treatment of gastro-oesophageal reflux disease.

Impaired Hepatic and Renal Function:

Lansoprazole is metabolised substantially by the liver. Clinical trials in patients with liver disease indicate that metabolism of lansoprazole is prolonged when daily doses of 30mg are administered to patients with severe hepatic impairment. It is therefore recommended that the daily dose for patients with severe liver disease is individually adjusted to 15mg or 30mg. These patients should be kept under regular supervision and a daily dosage of 30mg should not be exceeded.

There is no need to alter the dosage in patients with mild to moderate impairment of hepatic function or impaired renal function.

The use of Lansoprazole is contra-indicated in patients with a history of hypersensitivity to any of the ingredients of Lansoprazole capsules

In common with other anti-ulcer therapies, the possibility of malignancy should be excluded when gastric ulcer is suspected, as symptoms may be alleviated and diagnosis delayed. Similarly, the possibility of serious underlying disease such as malignancy should be excluded before treatment for dyspepsia commences, particularly in patients of middle age or older who have new or recently changed dyspeptic symptoms.

Before using Lansoprazole with antibiotics to eradicate H. pylori, prescribers should refer to the full prescribing information of the respective antibiotics for guidance.

Lansoprazole should be used with caution in patients with severe hepatic dysfunction. These patients should be kept under regular supervision and a daily dosage of 30mg should not be exceeded (See Section 4.2 Posology and Method of Administration).

Decreased gastric acidity due to any means, including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with acid-reducing drugs may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.

Special warnings about the other ingredients

Each Lansoprazole 30mg Capsule contains 161 mg sucrose, therefore the drug is not suitable for patients with inborn fructose intolerance, with glucose/galactose malabsorption syndrome or sucrose isomaltase deficiency.

Lansoprazole is hepatically metabolised and studies indicate that it is a weak inducer of Cytochrome P450. There is the possibility of interaction with drugs which are metabolised by the liver. Caution should be exercised when oral contraceptives and preparations such as phenytoin, carbamazepine, theophylline, or warfarin are taken concomitantly with the administration of Lansoprazole.

No clinically significant effects on NSAIDs or diazepam have been found.

Antacids and sucralfate may reduce the bioavailability of lansoprazole and should, therefore, not be taken within an hour of Lansoprazole.

There is insufficient experience to recommend the use of Lansoprazole in pregnancy. Animal studies do not reveal any teratogenic effect. Reproduction studies indicate slightly reduced litter survival and weights in rats and rabbits given very high doses of lansoprazole. The use of Lansoprazole in pregnancy should be avoided.

Animal studies indicate that lansoprazole is secreted in breast milk. There is no information on the secretion of lansoprazole into breast milk in humans. The use of Lansoprazole during breast feeding should be avoided unless considered essential

Lansoprazole is not known to affect ability to drive or operate machines.

Lansoprazole is well-tolerated, with adverse events generally being mild and transient.

The most commonly reported adverse events are headache, dizziness, fatigue and malaise.

Gastrointestinal effects include diarrhoea, constipation, abdominal pain, nausea, vomiting, flatulence and dry or sore mouth or throat.

As with other PPIs, very rarely, cases of colitis have been reported. In severe and/or protracted cases of diarrhoea, discontinuation of therapy should be considered. In the majority of cases symptoms resolve on discontinuation of therapy.

Alterations in liver function test values and, rarely, jaundice or hepatitis, have been reported.

Dermatological reactions include skin rashes, urticaria and pruritus. These generally resolve on discontinuation of drug therapy. Serious dermatological reactions are rare but there have been occasional reports of Stevens-Johnson

Syndrome, toxic epidermal necrolysis and erythematous or bullous rashes including erythema multiforme. Cases of hair thinning and photosensitivity have also been reported.

Other hypersensitivity reactions include angioedema, wheezing, and very rarely, anaphylaxis. Cases of interstitial nephritis have been reported which have sometimes resulted in renal failure.

Haematological effects (thrombocytopenia, agranulocytosis, eosinophilia, leucopenia and pancytopenia) have occurred rarely. Bruising, purpura and petechiae have also been reported.

Other reactions include arthralgia, myalgia, depression, peripheral oedema and, rarely, paraesthesia, blurred vision, taste disturbances, vertigo, confusion and hallucinations.

Gynaecomastia and impotence have been reported rarely.

There is no information on the effect of overdosage. However, Lansoprazole has been given at doses up to 120mg/day without significant adverse effects. Symptomatic and supportive therapy should be given as appropriate.

Lansoprazole is a member of a class of drugs called proton pump inhibitors. Its mode of action is to inhibit specifically the H+ / K+ ATPase (proton pump) of the parietal cell in the stomach, the terminal step in acid production, thus reducing gastric acidity, a key requirement for healing of acid-related disorders such as gastric ulcer, duodenal ulcer and reflux oesophagitis. It is believed that the parent drug is biotransformed into its active form(s) in the acidic environment of the parietal cell, whereupon it reacts with the sulphydryl group of the H+ / K+ ATPase causing inhibition. This inhibition is reversible in vitro by intrinsic and extrinsic reducing agents. Lansoprazole's mode of action differs significantly from the H2 antagonists which inhibit one of the three pathways involved in stimulation of acid production. A single dose of 30mg inhibits pentagastrin-stimulated acid secretion by approximately 80%, indicating effective acid inhibition from the first day of dosing.

Lansoprazole has a prolonged pharmacological action providing effective acid suppression over 24 hours, thereby promoting rapid healing and symptom relief.

By reducing gastric acidity, Lansoprazole creates an environment in which appropriate antibiotics can be effective against H. pylori. In vitro studies have shown that lansoprazole has a direct antimicrobial effect on H. pylori.

Lansoprazole exhibits high (80-90%) bioavailability with a single dose. As a result, effective acid inhibition is achieved rapidly. Peak plasma levels occurred within 1.5 to 2.0 hours. The plasma elimination half-life ranges from 1 to 2 hours following single or multiple doses in healthy subjects. There is no evidence of accumulation following multiple doses in healthy subjects. The plasma protein binding is 97%.

Following absorption, lansoprazole is extensively metabolised and is excreted by both the renal and biliary route. A study with ¹⁴C-labelled lansoprazole indicated that up to 50% of the dose was excreted in the urine. Lansoprazole is metabolised substantially by the liver.

Gastric tumours have been observed in life-long studies in rats.

An increased incidence of spontaneous retinal atrophy has been observed in life-long studies in rats. These lesions which are common to albino laboratory rats have not been observed in monkeys or dogs or life-long studies in mice. They are considered to be rat specific. No such treatment related changes have been observed in patients treated continuously for long periods.

Sugar spheres (sucrose and maize starch)

Povidone

Disodium hydrogen phosphate dihydrate (E339)

Sucrose

Sodium Laurisulfate

Methacrylic Acid – Ethyl Acrylate Copolymer (1:1) dispersion 30%

Macrogol 6000 (E1521)

Titanium Dioxide (E171)

Polysorbate 80 (E 433)

Talc (E553b)

Capsule Shell:

Not applicable

3 Years

In-Use Shelf life (plastic containers)

3 Months

Blisters: Do not store above 30°C. Store in the original package, in order to protect from moisture.

Plastic containers: Do not store above 25°C. Store in the original package.

Keep the container (bottle) tightly closed, in order to protect from moisture.

High density polyethylene plastic container with polypropylene cap containing 2g silica gel desiccant capsule.

Pack sizes of 14, 28, 56 and 98. Container with 98 capsules contains two (2x1g) silica gel desiccants.

Not all pack sizes may be marketed

Blister (laminated OPA/Al/PVC foil - aluminium foil)

Pack sizes of 2, 7, 14, 15, 28, 30, 50, 42 and 56.

Not all pack sizes may be marketed.

No special requirements.

Actavis Group PTC ehf

Reykjavikurvegur 76-78

220 Hafnarfjordur

Iceland

PL 30306/0258

06/10/2009

04/07/2011

IF APPLICABLE

IF APPLICABLE