Nexium Control · 4.6 Fertility, pregnancy and lactation · 2

HOS-096470 · has-adverse-reaction-information · PDF-Seite 20

Summary of the safety profile Headache, abdominal pain, diarrhoea and nausea are among those adverse reactions that have been most commonly reported in clinical studies (and also from post-marketing use). In addition, the safety profile is similar for different formulations, treatment indications, age groups and patient populations. No dose-related adverse reactions have been identified. Tabulated list of adverse reactions The following adverse reactions have been identified or suspected in the clinical studies programme for esomeprazole and post-marketing. The reactions are classified according to MedDRA frequency convention: very common (≥ 1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare 20 (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Common Uncommon Rare Very rare Not known Blood and leukopenia, agranulocytosis, lymphatic system thrombocytope- pancytopenia disorders nia Immune system hypersensitivity disorders reactions e.g. fever, angioedema and anaphylactic reaction/shock Metabolism and peripheral hyponatraemia hypomagne- nutrition oedema saemia; disorders severe hypomagne- saemia can correlate with hypocalcae- mia;

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HOS-096464 · has-adverse-reaction-information · PDF-Seite 7

Summary of the safety profile Headache, abdominal pain, diarrhoea and nausea are among those adverse reactions that have been most commonly reported in clinical studies (and also from post-marketing use). In addition, the safety profile is similar for different formulations, treatment indications, age groups and patient populations. No dose-related adverse reactions have been identified. Tabulated list of adverse reactions The following adverse reactions have been identified or suspected in the clinical studies programme for esomeprazole and post-marketing. The reactions are classified according to MedDRA frequency convention: very common (≥ 1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare 7 (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Common Uncommon Rare Very rare Not known Blood and leukopenia, agranulocytosis, lymphatic system thrombocytope- pancytopenia disorders nia Immune system hypersensitivity disorders reactions e.g. fever, angioedema and anaphylactic reaction/shock Metabolism and peripheral hyponatraemia hypomagne- nutrition oedema saemia; disorders severe hypomagne- saemia can correlate with hypocalcae- mia;

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HOS-096460 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipients listed in section 6.1. Esomeprazole must not be used concomitantly with nelfinavir or rilpivirine (see section 4.5).

HOS-096466 · has-contraindication-information · PDF-Seite 16

Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipients listed in section 6.1. Esomeprazole must not be used concomitantly with nelfinavir or rilpivirine (see section 4.5).

HOS-096459 · has-indication-information · PDF-Seite 2

Nexium Control is indicated for the short-term treatment of reflux symptoms (e.g. heartburn and acid regurgitation) in adults.

HOS-096465 · has-indication-information · PDF-Seite 15

Nexium Control is indicated for the short-term treatment of reflux symptoms (e.g. heartburn and acid regurgitation) in adults.

HOS-096468 · has-interaction-information · PDF-Seite 17

Interaction studies have only been performed in adults. Effects of esomeprazole on the pharmacokinetics of other medicinal products As esomeprazole is one enantiomer of omeprazole it is reasonable to advise about interactions reported with omeprazole. 17 Protease inhibitors Omeprazole has been reported to interact with some protease inhibitors. The clinical importance and the mechanisms behind these reported interactions are not always known. Increased gastric pH during omeprazole treatment may change the absorption of the protease inhibitors. Other possible interaction mechanisms are via inhibition of CYP2C19. For atazanavir and nelfinavir, decreased serum levels have been reported when given together with omeprazole and concomitant administration is not recommended. Co-administration of omeprazole (40 mg once daily) with atazanavir 300 mg/ritonavir 100 mg to healthy volunteers resulted in a substantial reduction in atazanavir exposure (approximately 75% decrease in AUC, Cmax, and Cmin). Increasing the atazanavir dose to 400 mg did not compensate for the impact of omeprazole on atazanavir exposure. The co-administration of omeprazole (20 mg once a day) with atazanavir 400 mg/ritonavir 100 mg to healthy volunteers resulted in a decrease of approximately 30% in the atazanavir exposure as compared with the exposure observed with atazanavir 300 mg/ritonavir 100 mg once a day without omeprazole 20 mg once a day. Co-administration of omeprazole (40 mg once a day) reduced mean nelfinavir AUC, Cmax, and Cmin by 36 - 39 % and mean AUC, Cmax, and Cmin for the pharmacologically active metabolite M8 was reduced by 75 - 92%. Due to the similar pharmacodynamic effects and pharmacokinetic properties of omeprazole and esomeprazole, concomitant administration with esomeprazole and atazanavir is not recommended and concomitant administration with esomeprazole and nelfinavir is contraindicated (see section 4.3 and 4.4). For saquinavir (with concomitant ritonavir), increased serum levels (80-100%) have been reported during concomitant omeprazole treatment (40 mg once a day). Treatment with omeprazole 20 mg once a day had no effect on the exposure of darunavir (with concomitant ritonavir) and amprenavir (with concomitant ritonavir). Treatment with esomeprazole 20 mg once a day had no effect on the exposure of amprenavir (with and without concomitant ritonavir). Treatment with omeprazole 40 mg once a day had no effect

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HOS-096462 · has-interaction-information · PDF-Seite 4

Interaction studies have only been performed in adults. Effects of esomeprazole on the pharmacokinetics of other medicinal products As esomeprazole is one enantiomer of omeprazole it is reasonable to advise about interactions reported with omeprazole. 4 Protease inhibitors Omeprazole has been reported to interact with some protease inhibitors. The clinical importance and the mechanisms behind these reported interactions are not always known. Increased gastric pH during omeprazole treatment may change the absorption of the protease inhibitors. Other possible interaction mechanisms are via inhibition of CYP2C19. For atazanavir and nelfinavir, decreased serum levels have been reported when given together with omeprazole and concomitant administration is not recommended. Co-administration of omeprazole (40 mg once daily) with atazanavir 300 mg/ritonavir 100 mg to healthy volunteers resulted in a substantial reduction in atazanavir exposure (approximately 75% decrease in AUC, Cmax and Cmin). Increasing the atazanavir dose to 400 mg did not compensate for the impact of omeprazole on atazanavir exposure. The co-administration of omeprazole (20 mg once a day) with atazanavir 400 mg/ritonavir 100 mg to healthy volunteers resulted in a decrease of approximately 30% in the atazanavir exposure as compared with the exposure observed with atazanavir 300 mg/ritonavir 100 mg once a day without omeprazole 20 mg once a day. Co-administration of omeprazole (40 mg once a day) reduced mean nelfinavir AUC, Cmax and Cmin by 36–39 % and mean AUC, Cmax and Cmin for the pharmacologically active metabolite M8 was reduced by 75-92%. Due to the similar pharmacodynamic effects and pharmacokinetic properties of omeprazole and esomeprazole, concomitant administration with esomeprazole and atazanavir is not recommended and concomitant administration with esomeprazole and nelfinavir is contraindicated (see section 4.3 and 4.4). For saquinavir (with concomitant ritonavir), increased serum levels (80-100%) have been reported during concomitant omeprazole treatment (40 mg once a day). Treatment with omeprazole 20 mg once a day had no effect on the exposure of darunavir (with concomitant ritonavir) and amprenavir (with concomitant ritonavir). Treatment with esomeprazole 20 mg once a day had no effect on the exposure of amprenavir (with and without concomitant ritonavir). Treatment with omeprazole 40 mg once a day had no effect on the exp

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HOS-096469 · has-pregnancy-information · PDF-Seite 20

Pregnancy A moderate amount of data on pregnant women (between 300-1,000 pregnancy outcomes) indicate no malformative or feto/ neonatal toxicity of esomeprazole. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Nexium Control during pregnancy. Breast-feeding Limited information indicates that esomeprazole is excreted in human milk. There is insufficient information on the effects of esomeprazole in newborns/infants. Esomeprazole should not be used during breast-feeding. Fertility Animal studies with the racemic mixture omeprazole, given by oral administration do not indicate effects with respect to fertility.

HOS-096463 · has-pregnancy-information · PDF-Seite 7

Pregnancy A moderate amount of data on pregnant women (between 300-1,000 pregnancy outcomes) indicate no malformative or feto/ neonatal toxicity of esomeprazole. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Nexium Control during pregnancy. Breast-feeding Limited information indicates that esomeprazole is excreted in human milk. There is insufficient information on the effects of esomeprazole in newborns/infants. Esomeprazole should not be used during breast-feeding. Fertility Animal studies with the racemic mixture omeprazole, given by oral administration do not indicate effects with respect to fertility.

HOS-096461 · has-warning-information · PDF-Seite 3

General Patients should be instructed to consult a doctor if: • They have 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 esomeprazole may alleviate symptoms and delay diagnosis. • They have had previous gastric ulcer or gastrointestinal surgery. • They have been on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks. This may be a sign of a more serious condition. • They have frequent wheezing, particularly with heartburn. • They have jaundice or severe liver disease. • They are aged over 55 years with new or recently changed symptoms. Patients with long-term recurrent symptoms of indigestion or heartburn should see their doctor at regular intervals. Patients over 55 years taking any non-prescription indigestion or heartburn remedy on a daily basis should inform their pharmacist or doctor. Patients should not take Nexium Control as a long term preventive medicinal product. Treatment with proton pump inhibitors (PPIs) may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and in hospitalised patients, also possibly Clostridium difficile (see section 5.1). Patients should consult their doctor before taking this medicinal product if they are due to have an endoscopy or urea breath test. Combination with other medicinal products 3 Co-administration of esomeprazole with atazanavir is not recommended (see section 4.5). If the combination of atazanavir with a PPI is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir. Esomeprazole 20 mg should not be exceeded. Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the potential for interactions with medicinal products metabolised through CYP2C19 should be considered. An interaction is observed between clopidogrel and esomeprazole. The clinical relevance of this interaction is uncertain. The use of esomeprazole with clopidogrel should be discouraged (see section 4.5). Patients should not take another PPI or H2 antagonist concomitantly. Interference with laboratory tests Increased Chromogranin A (CgA) level may interfere with investigations for neuroend

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HOS-096467 · has-warning-information · PDF-Seite 16

General Patients should be instructed to consult a doctor if: • They have 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 esomeprazole may alleviate symptoms and delay diagnosis. • They have had previous gastric ulcer or gastrointestinal surgery. • They have been on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks. This may be a sign of a more serious condition. • They have frequent wheezing, particularly with heartburn. • They have jaundice or severe liver disease. • They are aged over 55 years with new or recently changed symptoms. Patients with long-term recurrent symptoms of indigestion or heartburn should see their doctor at regular intervals. Patients over 55 years taking any non-prescription indigestion or heartburn remedy on a daily basis should inform their pharmacist or doctor. Patients should not take Nexium Control as a long term preventive medicinal product. Treatment with proton pump inhibitors (PPIs) may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and in hospitalised patients, also possibly Clostridium difficile (see section 5.1). Patients should consult their doctor before taking this medicinal product if they are due to have an endoscopy or urea breath test. Combination with other medicinal products Co-administration of esomeprazole with atazanavir is not recommended (see section 4.5). If the combination of atazanavir with a PPI is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir. Esomeprazole 20 mg should not be exceeded. 16 Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the potential for interactions with medicinal products metabolised through CYP2C19 should be considered. An interaction is observed between clopidogrel and esomeprazole. The clinical relevance of this interaction is uncertain. The use of esomeprazole with clopidogrel should be discouraged (see section 4.5). Patients should not take another PPI or H2 antagonist concomitantly. Interference with laboratory tests Increased Chromogranin A (CgA) level may interfere with investigations for neuroen

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