Pantopraz 40 mg

Package leaflet: Information for the user

Pantopraz 40 mg
40 mg, enteric-coated tablets
Pantoprazolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Pantopraz 40 mg is and what it is used for
2. Important information before taking Pantopraz 40 mg
3. How to take Pantopraz 40 mg
4. Possible side effects
5. How to store Pantopraz 40 mg
6. Contents of the pack and other information

1. What Pantopraz 40 mg is and what it is used for

Pantopraz 40 mg is a selective "proton pump inhibitor", a medicine that reduces the secretion of hydrochloric acid in the stomach. It is used in the treatment of stomach and intestinal disorders associated with hydrochloric acid secretion.

Pantopraz 40 mg is used to treat:
Adults and adolescents aged 12 years and older:

• Gastroesophageal reflux disease (GERD). This is an inflammatory condition of the oesophagus (the tube connecting the throat to the stomach), accompanied by the backflow of hydrochloric acid from the stomach.

Adults:

• Helicobacter pylori infection in patients with gastric and/or duodenal ulcer, in combination with two antibiotics (eradication therapy), to eliminate the bacteria and prevent recurrence of ulcers.
• Gastric and/or duodenal ulcer disease.
• Zollinger-Ellison syndrome and other pathological conditions associated with excessive hydrochloric acid secretion in the stomach.

2. Important information before using Pantopraz 40 mg

When not to use Pantopraz 40 mg

• if the patient is allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6),
• if the patient has previously experienced an allergic reaction to medicines containing other proton pump inhibitors.

Warnings and precautions
Before starting treatment with Pantopraz 40 mg, discuss the following with your doctor:

• if the patient has severe liver function disorders. The patient should inform the doctor if there has ever been any liver problem. The doctor may recommend more frequent monitoring of liver enzyme activity, especially if long-term treatment with Pantopraz 40 mg is required. If liver enzyme activity increases, the medicine should be discontinued.
• if the patient is taking non-steroidal anti-inflammatory drugs (NSAIDs) continuously and also needs to take Pantopraz 40 mg, due to an increased risk of gastrointestinal complications. The level of risk will be assessed according to individual risk factors such as age (65 years or older), history of gastric or duodenal ulcers, or gastrointestinal bleeding.
• if the patient has vitamin B_(12) deficiency or risk factors indicating possible reduced vitamin B_(12) levels and is being treated long-term with pantoprazole. Like all medicines that reduce (inhibit) gastric acid secretion, pantoprazole may lead to reduced absorption of vitamin B_(12).
• if the patient is taking a medicine containing atazanavir (used in the treatment of HIV infection) together with pantoprazole, the patient should seek detailed advice from the doctor.
• if the patient has ever experienced a skin reaction while taking a medicine similar to Pantopraz 40 mg that reduces gastric acid secretion.
• if the patient is scheduled for a specific blood test (chromogranin A levels).
• if the patient has been taking pantoprazole for more than three months, there may be a reduction in blood magnesium levels. Symptoms of low magnesium may include fatigue, involuntary muscle spasms, disorientation, seizures, dizziness, or rapid heartbeat. If any of these symptoms occur, the patient should inform the doctor immediately. Low magnesium levels may also lead to reduced potassium and calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.

If the patient develops a skin rash, especially in areas exposed to sunlight, the patient should inform the doctor as soon as possible, as discontinuation of Pantopraz 40 mg may be necessary. The patient should also report any other adverse effects such as joint pain.
If any of the following symptoms occur, the patient should contact the doctor immediately:

• unintentional weight loss;
• recurrent vomiting;
• difficulty swallowing;
• vomiting blood;
• paleness and weakness (anaemia);
• blood in the stool;
• severe and/or persistent diarrhoea, as treatment with Pantopraz 40 mg is associated with a slightly increased risk of infectious diarrhoea.

The doctor may decide to carry out tests to rule out an underlying tumour, as treatment with pantoprazole may relieve symptoms of tumour-related disease and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
If Pantopraz 40 mg is taken for a prolonged period (more than 1 year), the patient will likely remain under regular medical supervision. In such cases, the patient should report any new or unexpected symptoms and the circumstances of their occurrence during each visit to the doctor.
Taking proton pump inhibitors such as Pantopraz 40 mg, especially for longer than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. The patient should inform the doctor if osteoporosis has been diagnosed or if the patient is taking corticosteroids (which may increase the risk of osteoporosis) – see also section 4.

Children
Pantopraz 40 mg is not recommended for children under 12 years of age due to insufficient data on use in this age group.

Pantopraz 40 mg and other medicines
Inform the doctor or pharmacist about all medicines currently taken or taken recently, as well as any medicines the patient plans to take.
Remember to inform the doctor about treatment with Pantopraz 40 mg if another medicine is prescribed during therapy.
Pantopraz 40 mg may affect the effectiveness of other medicines. Therefore, inform the doctor if the patient is taking:

• medicines such as ketoconazole, itraconazole, or posaconazole (used to treat fungal infections), or erlotinib (used in certain types of cancer), as Pantopraz 40 mg may inhibit the proper action of these and other medicines,
• warfarin or phenprocoumon, which affect blood clotting. Additional tests may be required.
• if the patient is taking atazanavir (used in the treatment of HIV infection).

Pantopraz 40 mg with food and drink
Enteric-coated tablets should be taken whole, without chewing or crushing, one hour before meals, with water.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Experience with the use of this medicine in pregnant women is limited.
It has been shown that the active substance passes into breast milk.
The medicine may be used in pregnant women or women in whom pregnancy cannot be excluded, or in breastfeeding women only if the doctor considers the benefit to the mother to outweigh the potential risk to the unborn child or infant.

Driving and operating machinery
Patients should not drive or operate machinery if they experience adverse effects such as dizziness or visual disturbances.

Pantopraz 40 mg contains lactose (a sugar found in milk).
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Pantopraz 40 mg

This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor or pharmacist.

When and how to take Pantopraz 40 mg
Enteric-coated tablets should be taken whole, one hour before breakfast, without chewing or crushing, with a glass of water.
In combination therapy, a second tablet should be taken one hour before dinner.

Dosage
If your doctor has not advised otherwise, the usual dosage is as follows:
Adults and adolescents aged 12 years and older:

For treatment of reflux esophagitis
The usual dose is one tablet per day. Your doctor may recommend increasing the dose to two tablets per day. The treatment period for reflux esophagitis usually lasts from 4 to 8 weeks. Your doctor will decide how long you should continue treatment.

Adults:

For treatment of infection with the bacterium called Helicobacter pylori , in patients with gastric or duodenal ulcers, in combination with two antibiotics (eradication therapy)
One tablet of Pantopraz 40 mg plus two antibiotic tablets [amoxicillin, clarithromycin or metronidazole (or tinidazole)] twice daily.
The first Pantopraz 40 mg tablet should be taken one hour before breakfast and the second Pantopraz 40 mg tablet one hour before dinner.
Follow your doctor's instructions and read the patient leaflets included in the antibiotic packaging. Treatment usually lasts from one to two weeks.

For treatment of gastric and/or duodenal ulcers
The usual dose is one tablet per day. After consultation with your doctor, the dose may be doubled. Your doctor will decide how long treatment should continue. The treatment period for gastric ulcers usually lasts from 4 to 8 weeks. The treatment period for duodenal ulcers usually lasts from 2 to 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with excessive gastric acid secretion
The usual initial dose is two tablets per day.
Both tablets should be taken one hour before a meal. The dosage may later be adjusted by your doctor depending on the amount of gastric acid secreted. If more than two tablets per day are prescribed, they should be taken in two divided doses.
If your doctor prescribes a daily dose exceeding four tablets, you will be given specific instructions on when to stop taking the medicine.

Special patient groups:

• In patients with renal impairment or moderate to severe liver damage, Pantopraz 40 mg should not be used for Helicobacter pylori eradication.
• In severe liver disease, the dose should not exceed one 20 mg pantoprazole tablet per day (tablets containing 20 mg pantoprazole are available for this purpose).
• Children under 12 years of age: The tablets are not recommended for use in children under 12 years of age.

Taking more Pantopraz 40 mg than recommended
Symptoms of overdose are not known.
If you take more than the recommended dose, contact your doctor or pharmacist immediately.

If you forget to take Pantopraz 40 mg
If you miss a dose, resume treatment with the next scheduled dose.
Do not take a double dose to make up for a missed dose.

Stopping Pantopraz 40 mg
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following adverse effects occur, you should
immediately contact your doctor or go to the nearest hospital emergency department:

• Severe allergic reactions (rare): swelling of the tongue and (or) throat, difficulty swallowing, hives (a rash similar to nettle rash), breathing difficulties, allergic swelling of the face (angioedema / Quincke's oedema / angio-oedema), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency unknown): formation of skin blisters and sudden worsening of general condition, erosion (with slight bleeding) of the eyes, nose, mouth/oral cavity or genital organs (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme), and photosensitivity.
• Other severe reactions (frequency unknown): yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever, rash, and kidney problems manifested by their enlargement, sometimes with pain during urination and pain in the lower back (severe kidney inflammation).

Other adverse effects occurring:

• Common (in 1 to 10 out of 100 treated patients): benign gastric polyps.
• Uncommon (in 1 to 10 out of 1,000 treated patients): headache, dizziness; diarrhoea, nausea, vomiting, feeling of fullness in the abdomen and bloating with passing wind (flatulence), constipation, dry mouth, abdominal pain and discomfort; skin rash, redness, skin eruptions, itching of the skin; fractures of the hip, wrist or spine; weakness, exhaustion or general malaise; sleep disturbances.
• Rare (in 1 to 10 out of 10,000 treated patients): disturbances or complete loss of taste sensation; visual disturbances such as blurred vision; urticaria; joint pain, muscle pain; changes in body weight; elevated body temperature, high fever; swelling of limbs (peripheral oedema); allergic reactions; depression; gynaecomastia (enlargement of breasts in males).
• Very rare (less than 1 in 10,000 treated patients): disorientation.
• Frequency not known (cannot be estimated from available data): hallucinations, confusion (particularly in patients who have previously experienced such symptoms); decreased sodium concentration in blood; rash possibly associated with joint pain; sensations of tingling, pricking, numbness, burning or stinging, colitis causing persistent watery diarrhoea. If a patient takes Pantopraz 40 mg for longer than three months, blood magnesium levels may decrease, which may subsequently lead to fatigue, tetany, delirium, seizures, dizziness and ventricular arrhythmias. If any of these symptoms occur, the patient should inform their doctor. Low magnesium levels in blood may also lead to decreased potassium and calcium levels in blood. The doctor may decide that periodic monitoring of blood magnesium levels is necessary.

Adverse effects identified by blood tests occurring:

• Uncommon (in 1 to 10 out of 1,000 treated patients): increased liver enzyme activity.
• Rare (in 1 to 10 out of 10,000 treated patients): increased bilirubin levels; increased blood lipid levels; sudden decrease in circulating granulocytes – white blood cells associated with high fever, which may lead to more frequent infections.
• Very rare (less than 1 in 10,000 treated patients): decreased platelet count, which may lead to more frequent bleeding and bruising; decreased white blood cell count, which may increase susceptibility to infections; concurrent, abnormal decrease in red blood cells, white blood cells and platelets.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
e-mail: [email protected]
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Pantopraz 40 mg

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Pantopraz 40 mg contains

• The active substance is 40 mg of pantoprazole in the form of pantoprazole sodium sesquihydrate.
• The other ingredients are:
  • microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate;
  • coating Opadry II 85F32029 Yellow: partially hydrolysed polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc, yellow iron oxide (E 172);
  • enteric coating: methacrylic acid-ethyl acrylate copolymer (1:1), dispersion 30%, polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc.

What Pantopraz 40 mg looks like and contents of the pack
Yellow, elongated tablets.
Available pack sizes:
Plastic container containing 14, 28 or 30 enteric-coated tablets in a cardboard box.
Aluminium/Aluminium foil blisters containing 14, 28, 30 or 56 enteric-coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Tel. +48 61 66 51 500

Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Towa Pharmaceutical Europe S.L.
C/ de Sant Martí, 75-97,
Martorelles, 08107 Barcelona
Spain