Futapan   Enteric Coated Tablets

 Pantoprazole 40mg

 

Usage and indications:

Adults and adolescents 12 years of age and above:

• Reflux oesophagitis.

Adults:

• Eradication of Helicobacter pylori (H. pylori) in combination with appropriate antibiotic therapy in patients with H. pylori associated ulcers.

• Gastric and duodenal ulcer.

• Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions.

Dosage and administration:

 Method of administration.

 Futapan tablets should not be chewed or crushed, and should be swallowed whole 1 hour before a meal with some water.                                        

Recommended dose:

Adults and adolescents 12 years of age and above:

Reflux oesophagitis

one tablet of Futapan per day. In individual cases the dose may be doubled (increase to 2 tablets Futapan daily) especially when there has been no response to other treatment.

A 4-week period is usually required for the treatment of reflux oesophagitis. If this is not sufficient, healing will usually be achieved within a further 4 weeks. 

Adults

Eradication of H. pylori in combination with two appropriate antibiotics

In H. pylori positive patients with gastric and duodenal ulcers, eradication of the germ

by a combination therapy should be achieved. Considerations should be given to official local guidance (e.g. national recommendations) regarding bacterial resistance and the appropriate use and prescription of antibacterial agents.

Depending upon the resistance pattern, the following combinations can be recommended for the eradication of H. pylori:

a) Twice daily one tablet Futapan

+ Twice daily 1000mg amoxicillin

+ Twice daily 500mg clarithromycin

b) Twice daily one tablet Futapan

+ Twice daily 400 - 500mg metronidazole (or 500mg tinidazole)

+ Twice daily 250 - 500mg clarithromycin

c) Twice daily one tablet Futapan

+ Twice daily 1000mg amoxicillin

+ Twice daily 400 - 500mg metronidazole (or 500mg tinidazole)

In combination therapy for eradication of H. pylori infection, the second Futapan tablet should be taken 1 hour before the evening meal. The combination therapy is implemented for 7 days in general and can be prolonged for a further 7 days to a total duration of up to two weeks.

If, to ensure healing of the ulcers, further treatment with Futapan is indicated, the dose recommendations for duodenal and gastric ulcers should be considered.

If combination therapy is not an option, e.g. if the patient has tested negative for H. pylori, the following dose guidelines apply for Futapan tablets monotherapy:

Treatment of gastric ulcer

One tablet of Futapan per day. In individual cases the dose may be doubled (increase to 2 tablets Futapan daily) especially when there has been no response to other treatment. A 4-week period is usually required for the treatment of gastric ulcers. If this is not sufficient, healing will usually be achieved within a further 4 weeks.

Treatment of duodenal ulcer

One tablet of Futapan per day. In individual cases the dose may be doubled (increase to 2 tablets Futapan daily) especially when there has been no response to other treatment. A duodenal ulcer generally heals within 2 weeks. If a 2-week period of treatment is not sufficient, healing will be achieved in almost all cases within a further 2 weeks.

Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions

For the long-term management of Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions patients should start their treatment with a daily dose of 80mg (2 tablets of Futapan 40mg). Thereafter, the dose can be titrated up or down as needed using measurements of gastric acid secretion to guide. With doses above 80mg daily, the dose should be divided and given twice daily. A temporary increase of the dose above 160mg pantoprazole is possible but should not be applied longer than required for adequate acid control.

Treatment duration in Zollinger-Ellison syndrome and other pathological hypersecretory conditions is not limited and should be adapted according to clinical needs.

Undesirable effects:

Blood and lymphatic system:

Rare: Agranulocytosis

Very rare: Thrombocytopenia; leukopenia; pancytopenia.

Immune system disorders:

Rare: Hypersensitivity (including anaphylactic reactions and anaphylactic shock).

Metabolism and nutritional disorders:

Rare: Hyperlipidaemias and lipid increases (triglycerides, cholesterol); weight changes.

Not known: Hyponatraemia; hypomagnesaemia.

Psychiatric disorders:

Uncommon: Sleep disorders.

Rare: Depression (and all aggravations).

Very rare: Disorientation (and all aggravations).

Not known: Hallucination; Confusion (especially in pre-disposed patients, as well as the aggravation of these symptoms in case of pre-existence).

Nervous system disorders:

Uncommon: Headache; dizziness.

Rare: Taste disorders.

Eye disorders:

Rare: Disturbances in vision/ blurred vision.

Gastrointestinal Disorders:

Uncommon: Diarrhoea; nausea /vomiting; abdominal distension and bloating; constipation; dry mouth; abdominal pain and discomfort.

Hepatobiliary disorders:

Uncommon: Liver enzymes increased (transaminases, γ-GT).

Rare: Bilirubin increased.

Not known: Hepatocellular injury; jaundice; hepatocellular failure.

Skin and sub-cutaneous tissue disorders:

Uncommon: Rash / exanthema / eruption; pruritus.

Rare: Urticaria; angioedema.

Not known: Stevens-Johnson syndrome; Lyell syndrome; erythema multiforme; photosensitivity.

Musculoskeletal, connective tissue disorders:

Uncommon: Fracture of the hip, wrist or spine.

Rare: Arthralgia; myalgia.

Renal and urinary disorders:

Not known: Interstitial nephritis.

Reproductive system and breast disorders:

Rare: Gynaecomastia.

General disorders and administration site conditions:

Uncommon: Asthenia, fatigue and malaise.

Rare: Body temperature increased; peripheral edema.

Warnings and precautions:

Prescription of proton pump inhibitor (PPI) drugs may cause lowering of serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year); magnesium supplementation alone does not improve low serum magnesium levels and the PPI have to be discontinued.

  • Low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heartbeats (arrhythmias), and convulsions (seizures); however, patients do not always get these symptoms. Treatment of hypomagnesemia generally requires magnesium supplements. Treatment in patients taking a PPI and who have hypomagnesemia may also require stopping the PPI.
  • Bone Fracture: Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long term PPI therapy (a year or longer).          Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk of osteoporosis-related fractures should be managed according to the established treatment guidelines.
  • Use caution when administering high-dose methotrexate to patients receiving proton pump inhibitor (PPI) therapy.

Case reports and published population pharmacokinetic studies suggest that concomitant use of some PPIs, such as omeprazole, esomeprazole, and pantoprazole, with methotrexate (primarily at high dose), may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities.

 In two of these cases, delayed methotrexate elimination was observed when high-dose methotrexate was co-administered with PPIs, but was not observed when methotrexate was co-administered with ranitidine. However, no formal drug interaction studies of methotrexate with ranitidine have been conducted.

Hepatic Impairment

In patients with severe liver impairment, particularly those on long-term use, liver enzymes should be monitored regularly during treatment with pantoprazole. In the case of a rise in liver enzymes, Futapan 40mg enteric coated tablets should be discontinued.

Combination therapy: In the case of combination therapy, the summaries of product characteristics of the respective medicinal products should be observed.

In presence of alarm symptoms

In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with pantoprazole may alleviate symptoms and delay diagnosis.

Further investigation is to be considered if symptoms persist despite adequate treatment.

Co-administration with atazanavir

Co-administration of atazanavir with proton pump inhibitors is not recommended. If the combination of atazanavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring (e.g. virus load) is recommended in combination with an increase in the dose of atazanavir to 400mg with 100mg of ritonavir. A pantoprazole dose of 20mg per day should not be exceeded.

Influence on vitamin B12 absorption

In patients with Zollinger-Ellison syndrome and other pathological hypersecretory conditions requiring long-term treatment, pantoprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy or if respective clinical symptoms are observed.

Long term treatment

In long-term treatment, especially when exceeding a treatment period of 1 year, patients should be kept under regular surveillance.

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 recognized 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.

Gastrointestinal infections caused by bacteria

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 pantoprazole may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter.

Risk of hip, wrist and spine fracture

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. 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.

Pack: Carton box containing (HDPE) plastic jar, silica gel sealed with Al foil, closed with (HDPE) plastic cap and contains 14 enteric coated tablets.

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