Pantoprazole mercapharm

Package leaflet: Information for the patient

Pantoprazole Mercapharm, 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, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

1. What Pantoprazole Mercapharm is and what it is used for
Pantoprazole Mercapharm is a selective "proton pump inhibitor", a medicine that reduces
gastric acid secretion. It is used in the treatment of stomach and intestinal disorders
associated with hydrochloric acid secretion.
Pantoprazole Mercapharm tablets are used to treat:
Adults and adolescents aged 12 years and above:

• Gastroesophageal reflux disease (GERD). This is inflammation of the oesophagus (the tube connecting the throat to the stomach), accompanied by backflow of stomach acid.

Adults:

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

2. Important information before taking Pantoprazole Mercapharm

When not to take Pantoprazole Mercapharm

• If you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6).
• If you have previously experienced an allergic reaction to medicines containing other proton pump inhibitors.

Warnings and precautions:
Before starting pantoprazole, discuss with your doctor, pharmacist, or nurse:

• If you have severe liver function disorders. Inform your doctor if you have ever had liver problems. Your doctor may recommend more frequent monitoring of liver enzyme activity, especially if long-term treatment with Pantoprazole Mercapharm is required. If liver enzyme activity increases, treatment should be discontinued.
• If you have vitamin B12 deficiency or risk factors suggesting possible reduced vitamin B12 levels, and you are receiving long-term pantoprazole therapy. Like all medicines that reduce (inhibit) gastric acid secretion, pantoprazole may lead to decreased absorption of vitamin B12.
• If you are taking atazanavir (used in the treatment of HIV infection) together with pantoprazole, you should seek detailed advice from your doctor.
• If you have ever experienced a skin reaction after taking a medicine similar to Pantoprazole Mercapharm 40 mg that reduces gastric acid secretion.
• If you have been taking Pantoprazole Mercapharm 40 mg for more than three months, your blood magnesium level may decrease. Symptoms of low magnesium levels may include fatigue, involuntary muscle spasms, confusion, seizures, dizziness, or rapid heartbeat. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium and calcium in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.

If you develop a skin rash, especially in areas exposed to sunlight, inform your doctor as soon as possible, as it may be necessary to discontinue Pantoprazole Mercapharm 40 mg. You should also report any other adverse effects such as joint pain.
If any of the following symptoms occur, inform your doctor immediately:

• Unintentional weight loss
• Recurrent vomiting
• Difficulty swallowing
• Vomiting blood
• Pallor and weakness (anaemia)
• Blood in the stool
• Severe and/or persistent diarrhoea, as use of Pantoprazole Mercapharm is associated with a slightly increased risk of infectious diarrhoea.

Before taking this medicine, inform your doctor:

• If you are scheduled for a specific blood test (chromogranin A levels).

Your doctor may decide that tests are needed to rule out an underlying tumour-related disease, as treatment with pantoprazole may relieve symptoms of tumour disease and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
Taking proton pump inhibitors such as Pantoprazole Mercapharm 40 mg, particularly when used for longer than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
If you are taking Pantoprazole Mercapharm for a prolonged period (over 1 year), you will likely be under continuous medical supervision. In such cases, report any new or unexpected symptoms and their circumstances during every visit to your doctor.

Pantoprazole Mercapharm and other medicines
Pantoprazole Mercapharm may affect the effectiveness of other medicines. Therefore, tell your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, posaconazole (used to treat fungal infections), or erlotinib (used in certain types of cancer), because Pantoprazole Mercapharm may inhibit the proper action of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting. Additional monitoring may be required.
• Atazanavir (used in the treatment of HIV infection).
• Methotrexate (used in high doses as an anticancer chemotherapeutic agent) – your doctor may decide to temporarily discontinue pantoprazole when you are receiving high-dose methotrexate.

Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take.
Pregnancy and breastfeeding
Experience with use in pregnant women is limited. It has been shown that the active substance passes into human breast milk.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Driving and operating machinery
Do not drive or operate machinery if you experience adverse effects such as dizziness or visual disturbances.
Pantoprazole Mercapharm contains lactose and sodium
This medicine contains lactose. If you have been diagnosed with an intolerance to certain sugars, Pantoprazole Mercapharm 40 mg should be taken only after consulting your doctor.
This medicinal product contains 2.68 mg of sodium per dose. This should be taken into account for patients on a low-sodium diet.

3. How to use Pantoprazole Mercapharm

This medicine should always be taken as directed by your doctor. If in doubt,
consult your doctor or pharmacist.
Take this medicine one hour before a meal, without chewing or dividing the tablet. Swallow
the tablet whole with water.
If your doctor has not advised otherwise, the usual recommended dose is:
Adults and adolescents aged 12 years and older:
For the 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 take the medicine.
Adults:
For the treatment of infection with the bacterium called Helicobacter pylori , in patients with duodenal and (or) gastric ulcers, in combination with two antibiotics (eradication therapy).
One tablet twice daily plus two antibiotic tablets: amoxicillin, clarithromycin,
or metronidazole (or tinidazole), each taken twice daily together with a pantoprazole tablet.
The first pantoprazole tablet should be taken one hour before breakfast, and the second pantoprazole tablet one hour before dinner. Follow your doctor's instructions and
read the patient leaflets included in the antibiotic packaging. Treatment is usually given
for one to two weeks.
For the 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 you should take the medicine. 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 medical conditions associated with excessive hydrochloric acid secretion.
The usual initial dose is two tablets per day.
Both tablets should be taken one hour before a meal. Later, the dosage may be adjusted appropriately by your doctor, depending on the amount of hydrochloric acid secreted in the stomach. If more than two tablets per day are prescribed, they should be taken in two divided doses.
If your doctor prescribes a daily dose greater than four tablets, you will be specifically informed when to stop taking the medicine.
Special patient groups:

• In cases of kidney disease, moderate or severe liver impairment, Pantoprazole Mercapharm should not be used for Helicobacter pylori eradication.
• In severe liver disease, no more than one 20 mg pantoprazole tablet per day should be taken (for this purpose, 20 mg pantoprazole tablets are available). Use in children under 12 years of age: Tablets are not recommended for use in children under 12 years of age.

Taking more Pantoprazole Mercapharm than prescribed
Consult your doctor or pharmacist. Symptoms of overdose are not known.
Missing a dose of Pantoprazole Mercapharm
Do not take a double dose to make up for a missed dose. Take the next scheduled dose at the usual time.
Stopping Pantoprazole Mercapharm
Do not stop taking the tablets without first consulting your doctor or pharmacist.
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.

The occurrence of adverse effects is defined according to the following frequency categories:

• very common (more than 1 in 10 patients treated)
• common (1 to 10 in 100 patients treated)
• uncommon (1 to 10 in 1,000 patients treated)
• rare (1 to 10 in 10,000 patients treated)
• very rare (less than 1 in 10,000 patients treated)
• frequency not known (frequency cannot be estimated from the available data)

If any of the following adverse effects occur, contact your doctor immediately or go to the nearest hospital emergency department:

• Severe allergic reactions (rare): swelling of the tongue and/or throat, difficulty swallowing, hives (skin rash resembling nettle burns), breathing difficulties, allergic swelling of the face (angioedema / Quincke's edema / angio-oedema), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency not known): formation of skin blisters and sudden worsening of general condition, erosions (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 not known): yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever, rash and kidney problems manifested by swelling, sometimes with pain during urination and pain in the lower back (severe kidney inflammation).

Other adverse effects occurring:

• Common (1 to 10 in 100 patients treated): benign gastric polyps.
• Uncommon (1 to 10 in 1,000 patients treated): headache; dizziness; diarrhoea; nausea, vomiting; feeling of fullness in the abdomen and bloating with passing wind (flatulence); constipation; dryness of the mouth; abdominal pain and discomfort; skin rash, erythema, skin eruptions; itching of the skin; weakness, exhaustion or general malaise; sleep disturbances; fracture of the hip, wrist or spine (when lansoprazole is used at high doses and for a prolonged period).
• Rare (1 to 10 in 10,000 patients treated): visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; changes in body weight; elevated body temperature; swelling of the limbs (peripheral oedema); allergic reactions; depression; breast enlargement in males; disturbances or complete loss of taste sensation.
• Very rare (less than 1 in 10,000 patients treated): disorientation.
• Frequency not known (cannot be estimated from the available data): hallucinations, confusion (particularly in patients who have previously experienced such symptoms); decreased sodium levels in the blood; muscle cramps; sensations of tingling, pricking, numbness, burning or stinging; inflammation of the large intestine causing persistent watery diarrhoea.

Adverse effects identified by blood tests occurring:

• Uncommon (1 to 10 in 1,000 patients treated): increased liver enzyme activity.
• Rare (1 to 10 in 10,000 patients treated): increased bilirubin levels; increased blood fat levels; marked decrease in white blood cell count (agranulocytosis), which may lead to increased frequency of infections.
• Very rare (less than 1 in 10,000 patients treated): decreased platelet count, which may cause more frequent bleeding and bruising; decreased white blood cell count (leukopenia), which may predispose to more frequent infections; concurrent abnormal reduction in red and white blood cells (pancytopenia).
• Frequency not known (cannot be estimated from the available data): rash possibly associated with joint pain.

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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
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 Pantoprazole Mercapharm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister pack, or bottle (indicated after the EXP mark). The expiry date refers to the last day of the specified month.
Tablet packaging: Expiry date after opening: 90 days.
Storage conditions:
[Tablet packaging:] Do not store above 25°C.
[Blister pack:] Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Pantoprazole Mercapharm contains

• The active substance is pantoprazole. Each tablet contains 40 mg of pantoprazole (as sodium pantoprazole hemi-hydrate).
• Other ingredients are:

Tablet core:
Microcrystalline cellulose (E460i), lactose monohydrate, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
Coloured film-coat:
Polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc (E553b), iron oxide yellow (E172).
Enteric coat:
Methacrylic acid-ethyl acrylate copolymer, sodium lauryl sulfate, polysorbate 80, triethyl citrate (E1505), talc (E553b).

What Pantoprazole Mercapharm looks like and contents of the pack
Pantoprazole Mercapharm 40 mg is an elongated, enteric-coated tablet, pale yellow to ochre in colour.
Pantoprazole Mercapharm 40 mg is available in:
Bottles (HDPE bottles with HDPE or PP caps and a desiccant) containing 7, 14, 28, 30, 50 or 90 enteric-coated tablets.
Blister packs (aluminium/aluminium blisters) containing 7, 14, 28, 30, 56, 90 or 98 enteric-coated tablets.

Marketing Authorisation Holder and Manufacturer
TOWA Pharmaceutical Europe, S.L.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona), Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names: