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Lansoprazole 30mg Gastro-resistant Capsules

Last Updated on eMC 21-Sep-2017 View document  | Zentiva Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 21-Sep-2017 and displayed until Current

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation

Date of revision of text on the SPC: 11-Sep-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 2 - Qualitative and Quantitative Composition 

Updated:-

Excipient(s) with known effect

Also contains sucrose.

Section 4 – Clinical Particulars

Posology – deleted

 

4.2

For optimal effect lansoprazole should be taken once daily in the morning, except when used for H. pylori eradication when treatment should be twice a day, once in the morning and once in the evening. Lansoprazole should be taken at least 30 minutes before food (see section 5.2). Capsules should be swallowed whole with water. 

4.3

Impaired hepatic or function

Added:-

Hepatic impairment

Paediatric population

Method of Administration

For optimal effect lansoprazole should be taken once daily in the morning, except when used for H. pylori eradication when treatment should be twice a day, once in the morning and once in the evening. Lansoprazole should be taken at least 30 minutes before food (see section 5.2). Capsules should be swallowed whole with water. 

Added:-

listed in section 6.1.

Deleted:-

Lansoprazole should not be administered with atazanavir (see section 4.5).

4.4

Added:-

Lansoprazole, like all proton pump inhibitors (PPIs), might increase the counts of bacteria normally present in the gastrointestinal tract. This may increase the risk of gastrointestinal infections caused by bacteria such as Salmonella, Campylobacter and, especially in hospitalized patients, Clostridium difficile.

Co-administration of lansoprazole is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH, such as atazanavir and nelfinavir, due to significant reduction in their bioavailability (see section 4.5). If co-administration of lansoprazole with HIV protease inhibitors is unavoidable, close clinical monitoring is recommended.

Daily treatment with any acid-suppressing medications over a prolonged period of time (several years) may lead to malabsorption of cyanocobalamin (vitamin B12) caused by hypo- or achlorhydria. Cyanocobalamin deficiency should be considered in patients with Zollinger-Ellison syndrome and other pathological hypersecretory conditions requiring long-term treatment, individuals with reduced body stores or risk factors for reduced vitamin B12 absorption (such as the elderly) on long-term therapy or if relevant clinical symptoms are observed.

See Section 4.8

4.5

Added:-

Medicinal products, removed drugs

HIV Protease Inhibitors:

Co-administration of lansoprazole is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH, such as atazanavir and nelfinavir, due to significant reduction in their bioavailability (see section 4.4).

Deleted:-

Atazanavir

Lansoprazole should not be co administered with atazanavir (see section 4.3)

Added:-

Warfarin:

There have been reports of increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with lansoprazole and warfarin concomitantly may need to be monitored for increase in INR and prothrombin time.

 

Patient monitoring should be taken in

co-administration of lansoprazole with theophylline.

Deleted:-

Caution is advised when combining the two drugs

Added:-

Medicinal products and drugs removed

Methotrexate:

Concomitant use with high-dose methotrexate may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities.

4.6

Added:-

Breast-feeding and Lactation removed

Fertility:

No human data on the effect of lansoprazole on fertility are available. Reproductive studies in pregnant rats and rabbits revealed no lansoprazole-related impairment of fertility.

4.8

Minor adjustments to graph

5.3

Added:-

Non-clinical and Preclinical removed

6.6

Added:-

and other handling

10

Revision date change

Updated on 01-Jun-2017 and displayed until 21-Sep-2017

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling

Date of revision of text on the SPC: 18-May-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Type IB-C.I.2.a- To update sections 2, 4.2, 4.4, 4.5, 4.6, 5.1 and 6.6 of the SPC in line with the reference product. Consequentially the PIL has been updated.

Updated on 11-Apr-2017 and displayed until 01-Jun-2017

Reasons for adding or updating:

  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC: 01-Mar-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Type IAIN C.I.z variation to update the Summary of Product Characteristics and Patient Information Leaflet to implement a PRAC recommendation – Fundic gland polyps.

Updated on 15-Dec-2016 and displayed until 11-Apr-2017

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

Date of revision of text on the SPC: 09-Dec-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

update sections 4.4 (special warnings) and 5.1 (pharmacodynamics) of the SmPC in line with the PRAC recommendations on signals regarding Proton pump inhibitors (PPIs) and associated elevated circulating levels of Chromogranin A. Consequently the PIL has been updated

Updated on 04-Nov-2016 and displayed until 15-Dec-2016

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 14-Oct-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Innovator update

Updated on 05-Jan-2016 and displayed until 04-Nov-2016

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC: 05-Dec-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update to section s4.4 and 4.8 inline with PRAC recommendation regarding subacute cutaneous lupus erythematosus,

Updated on 05-May-2015 and displayed until 05-Jan-2016

Reasons for adding or updating:

  • Change to section 6.3 - Shelf life

Date of revision of text on the SPC: 21-Apr-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Shelf life reduction  24months

Updated on 04-Apr-2014 and displayed until 05-May-2015

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 20-Jan-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4. CLINICAL PARTICULARS    

                       

4.1 Therapeutic indications

           

• Treatment of duodenal and gastric ulcer

• Treatment of reflux oesophagitis

• Prophylaxis of reflux oesophagitis

• Eradication of Helicobacter pylori (H. pylori) concurrently given with appropriate antibiotic therapy for treatment of H.pylori-associated ulcers

• Treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment

• Prophylaxis of NSAID-associated gastric ulcers and duodenal ulcers in patients at risk (see section 4.2) requiring continued therapy

• Symptomatic gastroesophageal reflux disease

• Zollinger-Ellison syndrome.

 

           

4.2 Posology and method of administration           

 

For optimal effect lansoprazole should be taken once daily in the morning, except when used for H. pylori eradication when treatment should be twice a day, once in the morning and once in the evening. Lansoprazole should be taken at least 30 minutes before food (see section 5.2). Capsules should be swallowed whole with liquid. 

 

Treatment of duodenal ulcer:

The recommended dose is 30mg once daily for 2 weeks. In patients not fully healed within this time, the medication is continued at the same dose for another two weeks.

 

Treatment of gastric ulcer:

The recommended dose is 30mg once daily for 4 weeks. The ulcer usually heals within 4 weeks, but in patients not fully healed within this time, the medication may be continued at the same dose for another 4 weeks.

 

Reflux oesophagitis:

The recommended dose is 30mg once daily for 4 weeks. In patients not fully healed within this time, the treatment may be continued at the same dose for another 4 weeks.

 

Prophylaxis of reflux oesophagitis:

15mg once daily. The dose may be increased up to 30mg daily as necessary.

 

Eradication of Helicobacter pylori:

When selecting appropriate combination therapy consideration should be given to official local guidance regarding bacterial resistance, duration of treatment, (most commonly 7 days but sometimes up to 14 days), and appropriate use of antibacterial agents.

 

The recommended dose is 30 mg of lansoprazole twice daily for 7 days in combination with one of the following:

 

clarithromycin 250-500 mg twice daily + amoxicillin 1 g twice daily

 

clarithromycin 250 mg twice daily + metronidazole 400-500 mg twice daily

 

The H. pylori eradication results obtained when clarithromycin is combined with either amoxicillin or metronidazole give rates of up to 90%, when used in combination with lansoprazole.

 

Six months after successful eradication treatment, the risk of re infection is low and relapse is therefore unlikely.

 

Use of a regimen including lansoprazole 30 mg twice daily, amoxicillin 1 g twice daily and metronidazole 400-500 mg twice daily has also been examined. Lower eradication rates were seen using this combination than in regimens involving clarithromycin. It may be suitable for those who are unable to take clarithromycin as part of an eradication therapy, when local resistance rates to metronidazole are low.

 

Treatment of NSAID associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment:

 

30mg once daily for four weeks. In patients not fully healed the treatment may be continued for another four weeks. For patients at risk or with ulcers that are difficult to heal, a longer course of treatment and/or a higher dose should probably be used.

 

Prophylaxis of NSAID associated gastric and duodenal ulcers in patients at risk (such as age  65 or history of gastric or duodenal ulcer) requiring prolonged NSAID treatment:

15mg once daily. If the treatment fails the dose 30mg once daily should be used.

 

Symptomatic gastro-oesophageal reflux disease:

The recommended dose is 15mg or 30mg daily. Relief of symptoms is obtained rapidly. Individual adjustment of dosage should be considered. If the symptoms are not relieved within 4 weeks with a daily dose of 30mg, further examinations are recommended.

 

Zollinger-Ellison syndrome:

The recommended initial dose is 60mg once daily. The dose should be individually adjusted and the treatment should be continued for as long as necessary. Daily doses of up to 180mg have been used. If the required daily dose exceeds 120mg, it should be given in two divided doses.

 

Impaired hepatic or renal function:

There is no need for a dose adjustment in patients with impaired renal function.

Patients with moderate or severe liver disease should be kept under regular supervision and a 50% reduction of the daily dose is recommended (see section 4.4 and 5.2).

 

Elderly:

 

Due to reduced clearance of lansoprazole in the elderly an adjustment of dose may be necessary based on individual requirements. A daily dose of 30mg should not be exceeded in the elderly unless there are compelling clinical indications.

 

Children:

 

The use of lansoprazole is not recommended in children as clinical data are limited (see also section 5.2). 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.


4.4 Special warnings and precautions for use       

 

In common with other anti-ulcer therapies, the possibility of malignant gastric tumour should be excluded when treating a gastric ulcer with lansoprazole because lansoprazole can mask the symptoms and delay the diagnosis.

 

Lansoprazole should be used with caution in patients with moderate and severe hepatic dysfunction (see sections 4.2 and 5.2).

 

Decreased gastric acidity due to lansoprazole might be expected to increase gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with lansoprazole may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.

 

In patients suffering from gastro-duodenal ulcers, the possibility of H.pylori infection as an etiological factor should be considered.

 

If lansoprazole is used in combination with antibiotics for eradication therapy of H.pylori, then the instructions for the use of these antibiotics should also be followed.

 

Because of limited safety data for patieants on maintenance treatment for longer than 1 year, regular review of the treatment and a thorough risk/benefit assessment should be regularly performed in these patieants.

 

Very rarely cases of colitis have been reported in patients taking lansoprazole. Therefore, in the case of severe and/or persistent diarrhoea, discontinuation of therapy should be considered.

 

The treatment for the prevention of peptic ulceration of patients in need of continuous NSAID treatment should be restricted to high risk patients (e.g. previous gastrointestinal bleeding, perforation or ulcer, advanced age, concomitant use of medication known to increase the likelihood of upper GI adverse events [e.g. corticosteroids or anticoagulants], the presence of a serious co-morbidity factor or the prolonged use of NSAID maximum recommended doses).

 

Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10–40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.

 

Hypomagnesaemia

Severe hypomagnesaemia has been reported in patients treated with PPIs like pantoprazole 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 arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI.

For patients expected to be on prolonged treatment or who take PPIs with digoxin or drugs that may cause hypomagnesaemia (e.g., diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.

 

 

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


4.8 Undesirable effects

 

Frequencies are defined as common ( > 1/100, < 1/10); uncommon ( > 1/1,000, < 1/100); rare ( >1/10,000, <1/1,000); very rare ( <1/10,000); not known (frequency cannot be estimated from the available data)


Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

10. DATE OF REVISION OF THE TEXT          

           

05/07/12

 




Updated on 25-Jul-2012 and displayed until 04-Apr-2014

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC: 05-Jul-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



To update sections 4.4 and 4.8 of the SPC in line with the agreed PhVWP and CMDh wording on the effects of proton pump inhibitors on magnesium blood levels in long term users and on the increased risk of fractures of the hip, wrist and spine.  As a consequence, the PIL has been updated.



This text has been added to section 4.4:

Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10–40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.

 

Hypomagnesaemia

Severe hypomagnesaemia has been reported in patients treated with PPIs like pantoprazole 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 arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI.

For patients expected to be on prolonged treatment or who take PPIs with digoxin or drugs that may cause hypomagnesaemia (e.g., diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.

This text has been changed in section 4.8 (shown in red):

Frequencies are defined as common ( > 1/100, < 1/10); uncommon ( > 1/1,000, < 1/100); rare ( >1/10,000, <1/1,000); very rare ( <1/10,000); not known (frequency cannot be estimated from the available data)

 

Common

Uncommon

Rare

Very rare

Not Known

Blood and lymphatic system disorders

 

Thrombocytopenia, eosinophilia, leucopenia

Anaemia

Agranulocytosis,

pancytopenia

 

Metabolism and nutritional disorders

 

 

 

 

Hypomagnesaemia (see section 4.4)

Musculoskeletal and connective tissue disorders

 

Arthralgia, myalgia

Fracture of the hip, wrist or spine (see section 4.4)

 

 

 

Updated on 20-Mar-2012 and displayed until 25-Jul-2012

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Legal Category:POM

Black Triangle (CHM): NO

Company contact details

Zentiva

Company image
Address

One Onslow Street, Guildford, Surrey, GU1 4YS

Fax

+44 (0) 1483 554831

Medical Information e-mail
Telephone

+44 (0)1483 505 515

Medical Information Direct Line

+44 (0)845 372 7101

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

lansoprazole

Legal categories

POM - Prescription Only Medicine

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