Elements for a Public Summary

Transcription

1 VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Gastro-oesophageal reflux disease (GERD), reflux oesophagitis: GERD is defined by the presence of symptoms resulting from abnormal exposure of the oesophageal mucosa to refluxed acid gastric contents when these symptoms are sufficient to impair quality of life of patients. Most common symptoms of GERD include heartburn or burning pain in the chest associated or not with epigastric pain, nausea after eating, and regurgitations. The criteria usually admitted for GERD clinical diagnosis is the occurrence of heartburn or acid regurgitation at least once a week. Reflux oesophagitis is an inflammation of oesophageal mucosa caused by acid reflux from the stomach, and may be associated with GERD. The prevalence of GERD in the western world usually ranges between 10 and 20 %. Risk factors include genetic factors, behavioural factors such as smoking, alcohol consumption, or dietary factors, comorbidity factors (obesity, peptic ulcer disease, irritable bowel syndrome) and pregnancy. Ulcers induced by non-selective NSAIDs By inhibiting COX, NSAIDs decrease the production of prostaglandins in the stomach thereby impairing its protective role on mucosal integrity and promoting gastric inflammation. Use of NSAIDs promotes gastrointestinal adverse effects such as gastric and duodenal ulcers. The major risk factors for NSAID-induced gastric ulcer are: high NSAID regimen, age over 65 years, a history of gastric or duodenal ulcer or gastrointestinal bleeding, heavy use of alcohol or tobacco, concomitant treatment with corticosteroids, antiplatelet drugs and anticoagulants, antidepressants (SSRI). VI.2.2 Summary of treatment benefits Gastro-oesophageal reflux disease (GERD) treatment: The standard treatment of GERD is a symptomatic treatment: short term therapy to relieve occasional symptoms (frequency below once a week) includes antiacids, alginates or anti-h2 (cimetidine, ranitidine). long-term therapy for frequent symptoms (above once a week): PPI is the choice of treatment to reduce the amount of acid produced in the stomach when symptoms frequency increases : prescription of PPI at half dose for 4 weeks. In case of relapse, a maintenance treatment with PPI at the minimal efficient dose is recommended. Reflux oesophagitis treatment: IPP are recommended at half-dose for non severe oesophagitis, and at full dose for severe oesophagitis. In case of relapse, a maintenance treatment with PPI at the minimal efficient dose is recommended. For GERD as well as for reflux oesophagitis, PPI therapy is the standard curative treatment. Ulcers induced by non-selective NSAIDs in patients at risk with a need for continuous NSAID treatment.

2 The standard treatment for AINS-induced ulcer prophylaxis consists of administration of PPI for 4 weeks (for duodenal ulcer) and for 8 weeks (gastric ulcer). If there is no alternative to NSAID treatment, the association with a PPI usually allows NSAID continuation. The association of PPI with NSAID is the standard prophylaxis for gastric and duodenal ulcers. VI.2.3 Unknowns relating to treatment benefits Not Applicable VI.2.4 Summary of safety concerns Important identified risks Jaundice (icterus) Damages to the liver An elevation of hepatic enzymes (transaminases, GT) in blood can be found in patients treated with pantoprazole. More rarely, hepatic damages can be observed. Hepatic symptoms usually resolve or improve upon discontinuation of therapy. - Monitoring of liver enzymes (ASAT/ALAT, GT) in patients with liver problems and /or in patients on long-term treatment - dose 20 mg should not be exceeded in patients with severe hepatic impairment Metabolic changes (Low level of magnesium ) Severe Skin reactions Muscular and bone disorders (bone fractures, joint pain, muscular pain) Long-term treatment with pantoprazole may result in decreased level of magnesium in blood which can lead to fatigue, involuntary muscle contractions, dizziness or convulsions. Similarly Skin reactions such as rash, eruption and pruritus are the most common reactions. Severe reactions such as blistering, erosion of skin and mucosae could also occur. Pantoprazole should be discontinued immediately in case of skin reaction. - Long-term treatment with pantoprazole may result in increased risk of bone fracture, particularly in elderly and patient at risk of osteoporosis Monitoring of magnesium blood levels Avoid administration in patients who have previously experienced skin reaction with PPI Adequate calcium and vitamin d intake should be monitored in patients at risk or on long-term treatment

3 Renal problems Gastrointestinal infections In few cases, pantoprazole induced severe kidney inflammation Pantoprazole, like all proton pump inhibitors (PPIs), might be expected to increase the counts of bacteria normally present in the upper gastrointestinal tract. Treatment with /.../ may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter. No No Important potential risks Interaction with methotrexate Pantoprazole, like all proton pump inhibitors (PPIs), might increase methotrexate toxicity. Yes Precaution of use in patients treated with methotrexate Important missing information Use during pregnancy and lactation There are no adequate data from the use of pantoprazole in pregnant women. Excretion into human milk has been reported. If you are pregnant, or think you may be pregnant, or if you are breast-feeding, you should use this medicine only if your doctor considers the benefit for you greater than the potential risk for your unborn child or baby. VI.2.5 Summary of risk minimisation measures by safety concern All medicines have a Summary of Product Characteristics (SmPC) which provides physicians, pharmacists and other health care professionals with details on how to use the medicine, the risks and recommendations

4 for minimising them. An abbreviated version of this in lay language is provided in the form of the package leaflet (PL). The measures in these documents are known as routine risk minimisation measures. The Summary of Product Characteristics and the Package leaflet for PANTOPRAZOLE MAYOLY SPINDLER 20 mg can be found in the PANTOPRAZOLE MAYOLY SPINDLER 20 mg s EPAR page. This medicine has no additional risk minimisation measures. VI.2.6 Planned post authorisation development plan No post-authorisation safety or efficacy studies are ongoing or are planned to be conducted for PANTOPRAZOLE MAYOLY SPINDLER 20 mg. VI.2.7 Summary of changes to the Risk Management Plan over time Table 1. Major changes to the Risk Management Plan over time Version Date Safety Concerns Comment Version 2 14/01/2014 Identified Risks - Jaundice, hepatocellular injury, hepatocellular failure - Hypersensitivity, anaphylactic reaction, anaphylactic shock - Hypomagnesaemia, hyperlipidemia, hyponatraemia - Bone fracture, arthralgia, myalgia - Interstitial nephritis - angioedema, severe cutaneous adverse events Potential risks Interaction with methotrexate Missing data Use during pregnancy and lactation

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