Controloc Control · 4.4 Special warnings and precautions for use · 1

HOS-095436 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile Approximately 5% of patients can be expected to experience adverse reactions. Tabulated list of adverse reactions The following adverse reactions have been reported with pantoprazole. Within the following table, adverse reactions are ranked under the MedDRA frequency classification: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 1. Adverse reactions with pantoprazole in clinical trials and post-marketing experience Frequency Common Uncommon Rare Very rare Not known System organ class Blood and Agranulocytosis Thrombocytopenia, lymphatic Leukopenia, system disorders Pancytopenia Immune system Hypersensitivity disorders (incl. anaphylactic reactions and anaphylactic shock) Metabolism and Hyperlipidaemias Hyponatraemia, nutrition and lipid Hypomagnesaemia, disorders increases Hypocalcaemia(1) (triglycerides, Hypokalaemia(1) cholesterol), Weight changes Psychiatric Sleep disorders Depression (and Disorientation (and Hallucination, disorders all aggravations) all aggravations) Confusion (especially in pre-disposed patients, as well as

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095432 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Co-administration of pantoprazole is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir, nelfinavir; due to significant reduction in their bioavailability (see section 4.5).

HOS-095431 · has-indication-information · PDF-Seite 2

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

HOS-095434 · has-interaction-information · PDF-Seite 5

Medicinal products with pH-dependent absorption pharmacokinetics CONTROLOC Control may reduce the absorption of active substances whose bioavailability is dependent on the gastric pH (e.g., ketoconazole). HIV protease inhibitors Co-administration of pantoprazole is contraindicated with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir, nelfinavir; due to significant reduction in their bioavailability (see section 4.3). Coumarin anticoagulants (phenprocoumon or warfarin) Although no interaction during concomitant administration of phenprocoumon or warfarin has been observed in clinical pharmacokinetic studies, a few isolated cases of changes in International Normalised Ratio (INR) have been reported during concomitant treatment in the post-marketing period. Therefore, in patients treated with coumarin anticoagulants (e.g., phenprocoumon or warfarin), monitoring of prothrombin time/INR is recommended after initiation, termination or during irregular use of pantoprazole. Methotrexate Concomitant use of high-dose methotrexate (e.g., 300 mg) and proton pump inhibitors has been reported to increase methotrexate levels in some patients. Therefore, in settings where high-dose methotrexate is used, for example cancer and psoriasis, a temporary withdrawal of pantoprazole may need to be considered. Other interactions studies Pantoprazole is metabolised in the liver via the cytochrome P450 enzyme system. Interaction studies with carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, naproxen, nifedipine, phenytoin, piroxicam, theophylline and an oral contraceptive containing levonorgestrel and ethinyl oestradiol did not reveal clinically significant interactions. However, an interaction of pantoprazole with other substances which are metabolised by the same enzyme system cannot be excluded. There were no interactions with concomitantly administered antacids. Drug-laboratory test interactions There have been reports of false-positive results in some urine screening tests for tetrahydrocannabinol (THC) in patients receiving pantoprazole. An alternative confirmatory method should be considered to verify positive results.

HOS-095435 · has-pregnancy-information · PDF-Seite 5

Pregnancy There are no adequate data from the use of pantoprazole in pregnant women. Studies in animals have shown reproductive toxicity. Preclinical studies revealed no evidence of impaired fertility or teratogenic effects (see section 5.3). The potential risk for humans is unknown. Pantoprazole should not be used during pregnancy. 5 Breast-feeding Pantoprazole/metabolites have been identified in human milk. The effect of pantoprazole on newborns/infants is unknown. CONTROLOC Control should not be used during breast-feeding. Fertility There was no evidence of impaired fertility following the administration of pantoprazole in animal studies (see section 5.3).

HOS-095433 · has-warning-information · PDF-Seite 3

Patients should be instructed to consult a doctor if: • They have unintentional weight loss, anaemia, gastrointestinal bleeding, dysphagia, persistent vomiting or vomiting with blood, since pantoprazole may alleviate symptoms and delay diagnosis of a severe condition. In these cases, malignancy should be excluded. • They have had previous gastric ulcer or gastrointestinal surgery. • They are on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks. • They have jaundice, hepatic impairment, or liver disease. • They have any other serious disease affecting general well-being. • 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. Especially, 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 another proton pump inhibitor or H2 antagonist concomitantly. Patients should consult their doctor before taking this medicinal product if they are due to have an endoscopy or urea breath test. Patients should be advised that the tablets are not intended to provide immediate relief. Patients may start to experience symptomatic relief after approximately one day of treatment with pantoprazole, but it might be necessary to take it for 7 days to achieve complete heartburn control. Patients should not take pantoprazole as a preventive medicinal product. Gastrointestinal infections caused by bacteria 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 medicinal products leads to a slightly increased risk of gastrointestinal infections such as Salmonella, Campylobacter, or Clostridium difficile. Severe cutaneous adverse reactions (SCARs) Severe cutaneous adverse reactions (SCARs) including erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) which can be life-threatening or fatal, have been reported in association with pantoprazole with frequency not known (see section 4.8). Patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear,

Auszug; vollständigen Abschnitt im Original lesen.