Active ingredients: Pantoprazole
PANTOPAN 20 mg gastro-resistant tablets
Pantopan package inserts are available for pack sizes:- PANTOPAN 20 mg gastro-resistant tablets
- PANTOPAN 40 mg gastro-resistant tablets
Indications Why is Pantopan used? What is it for?
Pantopan is a 'selective proton pump inhibitor', which is a product that reduces the amount of acid produced in the stomach. It is used for the treatment of acid-related diseases of the stomach and intestines.
Pantopan is used for:
Adults and adolescents aged 12 years or older:
- treatment of symptoms (e.g. heartburn, acid regurgitation, pain when swallowing) associated with gastroesophageal reflux disease caused by acid reflux from the stomach.
- Long-term treatment of reflux esophagitis (inflammation of the esophagus associated with acid reflux from the stomach) and prevention of recurrence.
Adults:
- Prevention of gastric and duodenal ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in patients at risk who require continued NSAID treatment.
Contraindications When Pantopan should not be used
Do not take Pantopan
- If you are allergic (hypersensitive) to pantoprazole or any of the other ingredients of Pantopan (see point 6).
- If you are allergic to medicines containing other proton pump inhibitors.
Precautions for use What you need to know before taking Pantopan
Take special care with Pantopan
- If you have severe liver problems. Tell your doctor if you have ever had liver problems in which case your doctor will require more frequent liver enzyme checks, especially if you are taking Pantopan for long-term therapy. In the event of an increase in liver enzymes, the treatment may be suspended.
- If you need continued treatment with drugs called NSAIDs and take Pantopan as it increases the risk of developing gastric and intestinal complications. The increased risk will be assessed based on your personal risk factors such as age (65 years and over), history of gastric or duodenal ulcer or gastric or intestinal bleeding.
- If you have low body stores or risk factors for reduced vitamin B12 absorption and are on long-term treatment with pantoprazole. Like all products that reduce acid secretion, pantoprazole can reduce the absorption of vitamin B12.
- If you are taking a medicine containing atazanavir (for the treatment of HIV infection) at the same time as pantoprazole, ask your doctor for specific advice.
Tell your doctor immediately if you notice any of the following symptoms:
- unintentional weight loss,
- recurrent vomiting,
- difficulty in swallowing,
- presence of blood in the vomit,
- if you are pale and feel weak (anemia),
- presence of blood in the stool,
- severe or persistent diarrhea, as a slight increase in infectious diarrhea has been observed with Pantopan.
Your doctor may decide that you need to undergo some tests to rule out malignant disease as pantoprazole can relieve the symptoms of cancer and may cause a delay in diagnosis. If your symptoms persist despite treatment, further investigation will be considered.
If you are taking Pantopan for long-term treatment, more than a year, your doctor may have you checked regularly. Whenever you see your doctor, you should report any new or exceptional symptoms and circumstances.
Interactions Which drugs or foods may change the effect of Pantopan
Pantopan can affect the effectiveness of other medicines so tell your doctor if you are taking
- medicines such as ketoconazole, itraconazole and posaconazole (used against fungal infections) or erlotinib (indicated against certain types of cancer) because Pantopan may alter its effectiveness.
- Warfarin and phenprocoumon which affect the thickening or thinning of the blood. You may need further checks.
- Atazanavir (used to treat HIV infection).
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those obtained without a prescription.
Warnings It is important to know that:
Pregnancy and breastfeeding
There are no adequate data on the use of pantoprazole in pregnancy. Passage of the active substance into breast milk has been detected.
If you are pregnant or think you are expecting a baby or if you are breast-feeding, you should only take this medicine if your doctor considers that the benefit for you outweighs the potential risk to the unborn or baby.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
If you experience dizziness or visual disturbances as side effects, do not drive or operate machinery.
Dose, Method and Time of Administration How to use Pantopan: Posology
Always take Pantopan exactly as your doctor has told you. If in doubt, you should consult your doctor or pharmacist.
When and how to take Pantopan
Take the tablets one hour before a meal without chewing or crushing them, but swallow them whole with some water.
Unless your doctor tells you otherwise, the usual dose is:
Adults and adolescents aged 12 and over:
For the treatment of symptoms (e.g. burning, acid regurgitation, pain when swallowing) associated with gastroesophageal reflux disease
The usual dose is one tablet per day. This dose usually brings relief within 2-4 weeks, at most after a further 4 weeks. Your doctor will tell you how long to continue taking the medicine.
After this period, the recurrence of symptoms can be controlled by taking one tablet a day if necessary.
For long-term treatment and prevention of the recurrence of reflux oesophagitis:
The usual dose is one tablet per day.
If the symptom recurs, your doctor may double the dose; in this case you can instead use Pantopan 40 mg tablets, one a day. After healing, the dose can be reduced to one 20 mg tablet per day.
Adults:
for the prevention of duodenal and stomach ulcers in patients requiring continuous NSAID treatment
The usual dose is one tablet per day.
Special patient groups
- If you have severe liver problems, you should not take more than one 20 mg tablet per day
- Children under 12 years old. These tablets are not intended for use in children under 12 years of age.
Overdose What to do if you have taken too much Pantopan
If you take more Pantopan than you should
Tell your doctor or pharmacist: there are no known symptoms of overdose.
If you forget to take Pantopan
Do not take a double dose to make up for a forgotten tablet. Take your next normal dose at the scheduled time.
If you stop taking Pantopan
Do not stop taking these tablets without first talking to your doctor or pharmacist.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Side Effects What are the side effects of Pantopan
Like all medicines, Pantopan can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined according to the following convention:
very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be determined from the available data).
If you notice any of the following side effects, stop using these tablets and tell your doctor immediately or contact the nearest emergency department:
Severe allergic reactions (frequency rare): swelling of the tongue and / or throat, difficulty in swallowing, hives, difficulty in breathing, swelling of the face (Quincke's edema / angioedema), severe dizziness with very fast heart rate and profuse sweating.
Serious skin disorders (frequency not known): blistering and rapid deterioration of general condition, erosion (including slight bleeding) of the eyes, nose, mouth / lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme) and sensitivity to light.
Other serious effects (frequency not known): yellowing of the skin or whites of the eyes (severe damage to liver cells, jaundice) or fever, rash, enlarged kidneys with, sometimes, pain when urinating and pain in the lower back ( severe inflammation of the kidneys).
Other side effects are:
- Uncommon (affecting 1 to 10 users per 1,000) headache; dizziness diarrhea; malaise, vomiting; bloating and flatulence (air); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, rash; itch; feeling weak, tired or generally unwell; sleep disturbances. If you take a proton pump inhibitor such as pantoprazole, especially for longer than a year, you may have a slightly increased risk of hip, wrist or spine fractures. If you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis) consult your doctor.
- Rare (affects 1 to 10 users in 10,000) alteration or loss of taste; visual disturbances such as blurred vision; urticaria; articolar pains; muscular pain; weight changes; rise in body temperature; high fever; swelling of the extremities (peripheral edema); allergic reactions; depression; breast enlargement in males.
- Very Rare (affects less than 1 user in 10,000) disorientation.
- Not known (frequency cannot be determined from the available data) hallucinations, confusion (especially in patients with a history of these symptoms); decrease in the concentration of sodium in the blood.
If you take pantoprazole for more than three months, your blood levels of magnesium may drop. Low magnesium levels can manifest with fatigue, involuntary muscle twitching, disorientation, seizures, dizziness and increased heart rate. If you have any of these symptoms, please consult your doctor immediately. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor should decide whether to check your blood magnesium levels periodically.
Side effects identified through blood tests:
- Uncommon (affects 1 to 10 users in 1,000) increased liver enzymes
- Rare (affects 1 to 10 users in 10,000) increased bilirubin; increased fat in the blood; drastic decrease in circulating granulocytes, associated with high fever.
- Very rare (affects less than 1 user in 10,000) reduction in the number of platelets which can cause bleeding or bruising, more than normal; reduction in the number of white blood cells which can lead to more frequent infections; abnormal reduction in the number of red and white blood cells, as well as platelets.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Expiry and Retention
Keep out of the reach and sight of children
Do not use Pantopan after the expiry date which is stated on the carton and container after EXP.
The expiry date refers to the last day of the month.
HDPE bottles: do not take the tablets 120 days after first opening the bottle
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
What Pantopan contains
- The active ingredient is pantoprazole. One gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).
- The other ingredients are: Core: anhydrous sodium carbonate, mannitol, crospovidone, povidone K90, calcium stearate. Coating: hypromellose, povidone K25, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, methacrylic acid-ethyl acrylate copolymer (1: 1), polysorbate 80, sodium lauryl sulfate, triethyl citrate. Printing ink: shellac, red, black and yellow iron oxide (E172), concentrated ammonia solution.
What Pantopan looks like and contents of the pack
Yellow, oval, biconvex gastro-resistant tablets, marked "P20" on one side.
Packaging: bottles (high density polyethylene container with low density polyethylene closure) and blister (ALU / ALU blister) without or with cardboard reinforcement (blister wallet).
Pantopan is available in the following packs:
Packs with 7, 10, 14, 15, 24, 28, 30, 48, 49, 56, 60, 84, 90, 98, 98 (2x49), 100, 112, 168 gastro-resistant tablets.
Hospital packs with 50, 56, 84, 90, 112, 140, 140 (10x14 or 5x28), 150 (10x15), 280 (20x14 or 10x28), 500, 700 (5x140) gastro-resistant tablets.
Not all pack sizes are marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
PANTOPAN 20 MG FOOD-RESISTANT TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate)
Excipients with known effects:
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Gastro-resistant tablet (tablet)
Yellow, oval biconvex film-coated tablet marked "P20" in brown ink on one side.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Pantopan is indicated in adults and adolescents aged 12 years and over for:
• Symptomatic gastroesophageal reflux disease.
• Long-term treatment and prevention of relapse of reflux oesophagitis.
Pantopan is indicated in adults for:
Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk requiring continued NSAID treatment (see section 4.4).
04.2 Posology and method of administration
Dosage
Adults and adolescents aged 12 and over
Gastroesophageal reflux symptoms
The recommended dose for oral administration is one Pantopan 20 mg tablet per day. Symptom relief is usually achieved within 2-4 weeks. If this period is not sufficient, relief of symptoms will usually be achieved within a further 4 weeks. Once relief of symptoms is achieved, recurrence of symptoms can be controlled by using an on-demand treatment with 20 mg once daily, taking one tablet as needed. In cases where satisfactory symptom control cannot be maintained with on-demand administration, a switch to continued therapy may be considered.
Long-term treatment and prevention of relapse of reflux oesophagitis.
For long-term treatment, a maintenance dose with one Pantopan 20 mg tablet per day is recommended, increasing to 40 mg pantoprazole per day in case of relapse. For these cases, the Pantopan 40 mg tablet is available. After healing of the relapse the dose can be reduced again to one 20 mg tablet of Pantopan.
Adults
Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk who require continued treatment with NSAIDs.
The recommended dose for oral administration is one Pantopan 20 mg tablet per day.
Patients with hepatic impairment
In patients with severe hepatic impairment, a daily dose of 20 mg of pantoprazole should not be exceeded (see section 4.4).
Patients with kidney damage
No dose adjustment is necessary in patients with impaired renal function.
Senior citizens
No dose adjustment is necessary in elderly patients.
Pediatric population
The use of Pantopan is not recommended in children below 12 years of age due to limited data on safety and efficacy in this age group (see section 5.2).
Method of administration
The tablets should not be chewed or crushed and should be swallowed whole with a little water 1 hour before meals.
04.3 Contraindications
Hypersensitivity to the active substance, to substituted benzimidazoles or to any of the excipients listed in section 6.1.
04.4 Special warnings and appropriate precautions for use
Hepatic impairment
In patients with severe hepatic impairment, hepatic enzymes should be monitored regularly during therapy with pantoprazole, especially in long-term use. In the event of an increase in liver enzymes, treatment should be discontinued (see section 4.2).
Co-administration with NSAIDs
The use of pantopan 20 mg in the prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) should be limited to patients who require continued treatment with NSAIDs and who have an increased risk of gastrointestinal complications. risk must be carried out based on the presence of individual risk factors, eg. high age (> 65 years), history of gastric or duodenal ulcer or upper gastrointestinal bleeding.
In the presence of alarming symptoms
In the presence of any alarming symptoms (e.g. significant unintended weight loss, recurrent vomiting, dysphagia, haematemesis, anemia or melaena) and when gastric ulcer is suspected or present, malignancy must be excluded, as the treatment with pantoprazole can relieve symptoms and delay diagnosis.
If symptoms persist despite adequate treatment, further investigation should be considered.
Co-administration with atazanavir
Co-administration of atazanavir with proton pump inhibitors is not recommended (see section 4.5). If the combination of atazanavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring (eg viral load) is recommended in combination with a dose increase of atazanavir to 400 mg with 100 mg of ritonavir. A pantoprazole dose of 20 mg per day should not be exceeded.
Influence on the absorption of vitamin B12
Pantoprazole, like all medicines that inhibit acid secretion, may reduce the absorption of vitamin B12 (cyanocobalamin) as a consequence of hypo- or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced absorption. of vitamin B12 in long-term therapy or when related clinical symptoms are observed.
Long-term treatment
In long-term treatment, especially when a 1 year treatment period is exceeded, patients should be kept under regular surveillance.
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 Pantopan may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella And Campylobacter or C. difficult.
Hypomagnesemia
Proton pump inhibitors (PPIs) such as pantoprazole have been shown to cause severe hypomagnesaemia in patients treated for at least three months and in many cases for one year. Serious symptoms of hypomagnesaemia include fatigue, tetany, delirium, convulsions, dizziness, and ventricular arrhythmia. They can initially manifest insidiously and be neglected. Hypomagnesaemia improves in most patients after taking magnesium and discontinuing the proton pump inhibitor. Healthcare professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment. treatment in patients on therapy for a long time or on digoxin therapy or medicines that can cause hypomagnesaemia (e.g. diuretics).
Bone fractures
Proton pump inhibitors, especially when used in high doses and for prolonged periods (> 1 year), may cause a slightly increased risk of hip, wrist and spine fractures, especially in elderly patients or in the presence of other known risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10% to 40%. This increase may be partly due to other risk factors. Patients at risk of osteoporosis should receive treatment according to current clinical practice guidelines and must take an "adequate amount of vitamin D and calcium.
04.5 Interactions with other medicinal products and other forms of interaction
Effect of pantoprazole on the absorption of other medicinal products
Due to the marked and long-lasting inhibition of gastric acid secretion, pantoprazole can reduce the absorption of drugs whose bioavailability is dependent on gastric pH, eg. some azole antifungals such as ketoconazole, itraconazole, posaconazole and other medicines such as erlotinib.
HIV medicines (atazanavir)
Co-administration of atazanavir and other anti-HIV drugs whose absorption is pH-dependent with proton pump inhibitors may lead to a substantial reduction in the bioavailability of these anti-HIV drugs and may modify the efficacy of these drugs. Therefore, co-administration of proton pump inhibitors with atazanavir is not recommended (see section 4.4).
Coumarin anticoagulants (phenprocoumon or warfarin)
Although no interactions were observed during concomitant treatment with phenprocoumon or warfarin in clinical pharmacokinetic studies, a few isolated cases of International Normalized Ratio (INR) variation during concomitant treatment were observed in the post-marketing period. Thus, in patients treated with coumarin anticoagulants (e.g. phenprocoumon or warfarin), it is recommended to monitor the prothrombin time / INR when starting treatment with pantoprazole, when it is discontinued or when it is administered intermittently.
Methotrexate
Concomitant use of high doses of methotrexate (eg 300 mg) and proton pump inhibitors has been reported to increase methotrexate levels in some patients. Pertando where high doses of methotrexate are administered, eg. for cancer and psoriasis, a temporary withdrawal of pantoprazole should be considered.
Other interaction studies
Pantoprazole is extensively metabolised in the liver by the cytochrome P450 enzyme system. The major route of metabolism is demethylation by CYP2C19 and other metabolic pathways include oxidation by CYP3A4.
Interaction studies with drugs also metabolised through these enzyme systems, such as carbamazepine, diazepam, glibenclamide, nifedipine, and an oral contraceptive containing levonorgestrel and ethinyl estradiol, did not reveal clinically significant interactions.
The results of a series of interaction studies demonstrate that pantoprazole does not affect the metabolism of active substances metabolised by CYP1A2 (such as caffeine, theophylline), CYP2C9 (such as piroxicam, diclofenac, naproxen), CYP2D6 (such as metoprolol), CYP2E1 (such as ethanol) , or does not interfere with p-glycoprotein mediated absorption of digoxin.
There was no evidence of interactions with concomitantly administered antacids.
Interaction studies have also been conducted by concomitantly administering pantoprazole with related antibiotics (clarithromycin, metronidazole, amoxicillin). No clinically relevant interactions were observed.
04.6 Pregnancy and lactation
Pregnancy
There are no adequate data from the use of pantoprazole in pregnant women.Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown Pantopan should not be used during pregnancy unless clearly necessary.
Feeding time
Animal studies have shown excretion of pantoprazole into breast milk. Excretion into human breast milk has been reported. Therefore, a decision must be made whether to discontinue breast-feeding or to discontinue / abstain from Pantopan therapy taking into account the benefit of the drug. breastfeeding for the baby and the benefit of Pantopan therapy for the woman.
04.7 Effects on ability to drive and use machines
Adverse drug reactions such as dizziness and visual disturbances may occur (see section 4.8). In such cases, patients should not drive or operate machinery.
04.8 Undesirable effects
Approximately 5% of patients can be expected to experience adverse drug reactions (ADRs). The most commonly reported ADRs are diarrhea and headache, both of which occur in approximately 1% of patients.
The table below lists the adverse reactions reported with pantoprazole, arranged according to the following frequency classification:
Very common (≥1 / 10); common (≥1 / 100,
For all adverse reactions from post-marketing experience, it is not possible to establish any frequency of Adverse Reaction and therefore they are indicated with a frequency of "not known".
Within each frequency class, adverse reactions are reported in order of decreasing severity.
Table 1 Adverse reactions with pantoprazole in clinical studies and post-marketing experience.
1. Hypocalcemia in association with hypomagnesaemia
2. Muscle spasm as a result of an electrolyte imbalance
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
04.9 Overdose
There are no known symptoms of overdose in humans.
Systemic exposure up to 240 mg administered intravenously over 2 minutes was well tolerated. Since pantoprazole is extensively protein bound, it is not readily dialysable.
In the event of an overdose with clinical signs of intoxication, no specific therapeutic recommendations can be made, with the exception of symptomatic and supportive treatment.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Proton pump inhibitors, ATC code: A02BC02.
Mechanism of action
Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the stomach via a specific blockade of the proton pumps of the parietal cells.
Pantoprazole is converted to its active form in the acidic environment of the parietal cells where it inhibits the enzyme H +, K + -ATPase, which is the final stage in the production of hydrochloric acid in the stomach. This inhibition is dose-dependent and affects both basal and stimulated acid secretion. In most patients, symptoms resolve within 2 weeks. Like other proton pump inhibitors and H2 receptor inhibitors, treatment with pantoprazole reduces stomach acid and consequently increases gastrin in proportion to the reduction in acidity. The increase in gastrin is reversible. Since pantoprazole binds to the enzyme distal to the cell receptor, it can inhibit the secretion of hydrochloric acid regardless of stimulation by other substances (acetylcholine, histamine, gastrin). The effect is the same after oral or intravenous administration of the product.
Pharmacodynamic effects
Fasting gastrin values increase during treatment with pantoprazole. In short-term use, in most cases they do not exceed the upper limit of normal. During long-term treatment, gastrin levels double in most cases. An excessive increase, however, only occurs in isolated cases. As a result, a mild to moderate increase in the number of specific endocrine cells (ECL) in the stomach (simple to adenomatoid hyperplasia) is observed in a minority of cases during long-term treatment. the formation of carcinoid precursors (atypical hyperplasia) or gastric carcinoids as found in animal experiments has not been observed in humans (see section 5.3).
Based on the results of the animal studies, an influence on the endocrine parameters of the thyroid of a long-term treatment with pantoprazole for more than one year cannot be completely excluded.
05.2 "Pharmacokinetic properties
Absorption
Pantoprazole is rapidly absorbed and maximum plasma concentrations are achieved already after a single oral dose of 20 mg. Maximum serum concentrations around 1-1.5 mcg / ml are reached on average about 2.0-2.5 hours after administration, and these values remain constant after repeated administration. Pharmacokinetic characteristics do not change after single or repeated administration. In the dose range of 10 to 80 mg, the plasma kinetics of pantoprazole are linear after both oral and intravenous administration.
The absolute bioavailability of the tablet is approximately 77%. Concomitant food intake does not affect AUC, maximum serum concentration and therefore bioavailability. Only the variability of the lag-time will be increased by the simultaneous food intake.
Distribution
The binding of pantoprazole to serum proteins is approximately 98%. The volume of distribution is approximately 0.15 l / kg.
BiotransformationThe substance is almost exclusively metabolised in the liver. The major metabolic pathway is demethylation by CYP2C19 with subsequent conjugation with sulfate, the other metabolic pathway includes oxidation by CYP3A4.
Elimination
The terminal phase half-life is approximately 1 hour and clearance is around 0.1 l / h / kg. There have been some cases of subjects with slow drug elimination. Due to the specific binding of pantoprazole to the proton pumps of the parietal cells the elimination half-life does not correlate with the longer duration of action (inhibition of acid secretion).
Renal elimination represents the major route of excretion (approximately 80%) for the metabolites of pantoprazole, the remainder is excreted in the faeces. The major metabolite in both serum and urine is desmethylpantoprazole which is conjugated with sulphate. of the main metabolite (approximately 1.5 hours) is not much longer than that of pantoprazole
Special populations
Slow metabolisers
Approximately 3% of the European population have a lack of CYP2C19 enzyme function and are called poor metabolisers. In these individuals the metabolism of pantoprazole is likely to be catalysed primarily by CYP3A4. After a single administration of pantoprazole 40 mg, the area mean under the plasma concentration-time curve was approximately 6-fold higher in poor metabolisers than in subjects who have a functional CYP2C19 enzyme (extensive metabolisers). The mean peak plasma concentrations had increased by approximately 60%. These findings have no implications for the posology of pantoprazole.
Kidney damage
No dose reduction is recommended when pantoprazole is administered to patients with impaired renal function (including dialysis patients). The half-life of pantoprazole is short, as observed in healthy subjects. Only very small amounts of pantoprazole are dialyzed.
Although the half-life of the major metabolite is moderately prolonged (2-3 h), excretion is nevertheless rapid and therefore no accumulation occurs.
Hepatic impairment
Although in patients with liver cirrhosis (Child class A and B) the half-life values increase up to 3-6 hours and the AUC values increase by a factor of 3-5, the maximum serum concentration is only modestly increased by a factor of 1.3 compared to that of healthy subjects.
Senior citizens
A slight increase in AUC and Cmax values observed in elderly volunteers compared to the younger group is also not clinically relevant.
Pediatric population
After administration of single oral doses of 20 or 40 mg of pantoprazole to children aged 5 to 16 years, AUC and Cmax were within the range of corresponding values in adults.
After administration of single i.v. doses of 0.8 or 1.6 mg / kg of pantoprazole to children aged 2-16 years there was no significant association between pantoprazole clearance and age or weight. AUC and volume of distribution were in agreement with the data. detected for adults.
05.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology repeated dose toxicity and genotoxicity.
Neuroendocrine tumors were found in two-year carcinogenicity studies in rats. In addition, squamous cell papillomas were found in the anterior part of the stomach of rats. The mechanism by which benzimidazole derivatives induce the formation of gastric carcinoids has been carefully studied and allows us to conclude that this is a secondary reaction to the marked increase in gastrin which occurs in the rat during chronic treatment with high doses. two years in rodents an increased number of liver tumors was observed in rats and female mice and was attributed to the high metabolism of pantoprazole in the liver.
A slight increase in neoplastic changes of the thyroid was observed in the group of rats treated with the highest dose (200 mg / kg). The onset of these neoplasms is associated with pantoprazole-induced changes in the catabolism of thyroxine in the rat liver. Since the therapeutic dose in humans is low, no harmful effects on the thyroid glands are to be expected.
In animal reproduction studies, signs of mild foetotoxicity were observed at doses above 5 mg / k. Studies have shown no impairment of fertility or teratogenic effects.
Transplacental passage was studied in the rat and it was found to increase as gestation progressed. As a result, the concentration of pantoprazole in the fetus increases just before birth.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Nucleus:
Sodium carbonate, anhydrous
Mannitol (E421)
Crospovidone
Povidone K90
Calcium stearate
Coating:
THEpromellosa
Povidone K25
Titanium dioxide (E171)
Yellow iron oxide (E172)
Propylene glycol
Methacrylic acid-ethyl acrylate copolymer (1: 1)
Polysorbate 80
Sodium lauryl sulfate
Triethyl citrate
Printing ink:
Shellac
Red iron oxide (E172)
Black iron oxide (E172)
Yellow iron oxide (E172)
Concentrated ammonia solution
06.2 Incompatibility
Not relevant.
06.3 Period of validity
Blister packs
3 years.
Bottles
Not open: 3 years
After first opening: 120 days
06.4 Special precautions for storage
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
HDPE bottles with LDPE screw cap).
HDPE bottles with LDPE screw cap.
7 gastro-resistant tablets
10 gastro-resistant tablets
14 gastro-resistant tablets
15 gastro-resistant tablets
24 gastro-resistant tablets
28 gastro-resistant tablets
30 gastro-resistant tablets
48 gastro-resistant tablets
49 gastro-resistant tablets
56 gastro-resistant tablets
60 gastro-resistant tablets
84 gastro-resistant tablets
90 gastro-resistant tablets
98 gastro-resistant tablets
98 (2x49) gastro-resistant tablets
100 gastro-resistant tablets
112 gastro-resistant tablets
168 gastro-resistant tablets
Hospital pack of 50 gastro-resistant tablets
56 gastro-resistant tablets
84 gastro-resistant tablets
90 gastro-resistant tablets
112 gastro-resistant tablets
140 gastro-resistant tablets
140 (10x14) (5x28) gastro-resistant tablets
150 (10x15) gastro-resistant tablets
280 (20x14), (10x28) gastro-resistant tablets
500 gastro-resistant tablets
700 (5x140) gastro-resistant tablets
Blister (ALU / ALU blister) without cardboard reinforcement.
Blister (ALU / ALU blister) with cardboard reinforcement (wallet blister).
7 gastro-resistant tablets
10 gastro-resistant tablets
14 gastro-resistant tablets
15 gastro-resistant tablets
28 gastro-resistant tablets
30 gastro-resistant tablets
49 gastro-resistant tablets
56 gastro-resistant tablets
60 gastro-resistant tablets
84 gastro-resistant tablets
90 gastro-resistant tablets
98 gastro-resistant tablets
98 (2x49) gastro-resistant tablets
100 gastro-resistant tablets
112 gastro-resistant tablets
168 gastro-resistant tablets
Hospital pack of 50 gastro-resistant tablets
56 gastro-resistant tablets
84 gastro-resistant tablets
90 gastro-resistant tablets
112 gastro-resistant tablets
140 gastro-resistant tablets
140 (10x14) (5x28) gastro-resistant tablets
150 (10x15) gastro-resistant tablets
280 (20x14), (10x28) gastro-resistant tablets
500 gastro-resistant tablets
700 (5x140) gastro-resistant tablets
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
No special instructions.
Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Takeda Italia S.p.A., Via Elio Vittorini, 129 - 00144 Rome
08.0 MARKETING AUTHORIZATION NUMBER
Pantopan 20 mg gastro-resistant tablets, 14 tablets in bottle AIC n. 031835097 *
Pantopan 20 mg gastro-resistant tablets, 14 tablets in blister AIC n. 031835022
Pantopan 20 mg gastro-resistant tablets, 15 tablets in blister AIC n. 031835034 *
Pantopan 20 mg gastro-resistant tablets, 28 tablets in blister AIC n. 031835046 *
Pantopan 20 mg gastro-resistant tablets, 30 tablets in blister AIC n. 031835059 *
Pantopan 20 mg gastro-resistant tablets, 56 tablets in blister AIC n. 031835061 *
Pantopan 20 mg gastro-resistant tablets, 60 tablets in blister AIC n. 031835073 *
Pantopan 20 mg gastro-resistant tablets, 100 tablets in blister AIC n. 031835085 *
Pantopan 20 mg gastro-resistant tablets, 15 tablets in bottle AIC n. 031835109 *
Pantopan 20 mg gastro-resistant tablets, 28 tablets in bottle AIC n. 031835111 *
Pantopan 20 mg gastro-resistant tablets, 30 tablets in bottle AIC n. 031835123 *
Pantopan 20 mg gastro-resistant tablets, 56 tablets in bottle AIC n. 031835135 *
Pantopan 20 mg gastro-resistant tablets, 60 tablets in bottle AIC n. 031835147 *
Pantopan 20 mg gastro-resistant tablets, 100 tablets in bottle AIC n. 031835150 *
Pantopan 20 mg gastro-resistant tablets, 140 tablets in blister AIC n. 031835162 *
Pantopan 20 mg gastro-resistant tablets, 140 tablets in 10 blisters AIC n. 031835174 *
Pantopan 20 mg gastro-resistant tablets, 140 tablets in 5 blisters AIC n. 031835186 *
Pantopan 20 mg gastro-resistant tablets, 700 tablets in 5 blisters AIC n. 031835198 *
Pantopan 20 mg gastro-resistant tablets, 280 tablets in 20 blisters AIC n. 031835200 *
Pantopan 20 mg gastro-resistant tablets, 280 tablets in 10 blisters AIC n. 031835212 *
Pantopan 20 mg gastro-resistant tablets, 140 tablets in bottle AIC n. 031835224 *
Pantopan 20 mg gastro-resistant tablets, 140 tablets in 10 bottles AIC n. 031835236 *
Pantopan 20 mg gastro-resistant tablets, 140 tablets in 5 bottles AIC n. 031835248 *
Pantopan 20 mg gastro-resistant tablets, 700 tablets in 5 bottles AIC n. 031835251 *
Pantopan 20 mg gastro-resistant tablets, 280 tablets in 20 bottles AIC n. 031835263 *
Pantopan 20 mg gastro-resistant tablets, 280 tablets in 10 bottles AIC n. 031835275 *
(*) packs not marketed
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 29 May 2000
Date of most recent renewal: 2013
10.0 DATE OF REVISION OF THE TEXT
April 2015
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