Pantoprazole mercapharm

Patient Information Leaflet

Pantoprazole Mercapharm, 20 mg
Enteric-coated tablets
Pantoprazole
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, 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.

Leaflet Contents:

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 the production of acid in the stomach. It is used in the treatment of stomach and intestinal disorders related to hydrochloric acid secretion.
Pantoprazole Mercapharm is used for:
Adults and adolescents aged 12 years and above:

• Treatment of symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated with gastroesophageal reflux disease caused by backflow of stomach acid
• Long-term treatment of reflux esophagitis (inflammation of the oesophagus accompanied by regurgitation of gastric acid) and prevention of its recurrence.

Adults:

• Prevention of duodenal and/or gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in patients at risk who require continuous NSAID therapy.

2. Important information before using Pantoprazole Mercapharm

When not to use Pantoprazole Mercapharm

• 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 pantoprazole, discuss this with your doctor, pharmacist, or
nurse:

• if the patient has severe liver impairment. Inform the doctor if there has ever been any history of liver problems. The doctor may recommend more frequent monitoring of liver enzyme activity, especially during long-term treatment with Pantoprazole Mercapharm. If liver enzyme activity increases, treatment with this medicine should be discontinued.
• if the patient is required to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously while also taking Pantoprazole Mercapharm, due to an increased risk of gastrointestinal complications. This increased risk will be assessed according to individual patient risk factors, such as age (65 years or older), history of gastric or duodenal ulcers, or gastrointestinal bleeding.
• if the patient has vitamin B12 deficiency or risk factors indicating possible reduced vitamin B12 levels, and is undergoing long-term treatment with pantoprazole. As with all medicines that reduce (inhibit) gastric hydrochloric acid secretion, pantoprazole may lead to reduced absorption of vitamin B12.
• if the patient is taking a medicine containing atazanavir (used in the treatment of HIV infection) concomitantly with pantoprazole, the patient should seek detailed advice from the doctor.
• if the patient has previously experienced a skin reaction while taking a medicine similar to Pantoprazole Mercapharm 20 mg that reduces gastric acid secretion.
• if the patient has been taking Pantoprazole Mercapharm 20 mg for more than three months, there may be a reduction in blood magnesium levels. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, confusion, 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, particularly in areas exposed to sunlight, the patient should inform the doctor as soon as possible, as discontinuation of Pantoprazole Mercapharm 20 mg may be necessary. The patient should also report any other adverse effects, such as joint pain.
The doctor should be informed immediately if any of the following symptoms occur:

• unintentional weight loss
• recurrent vomiting
• difficulty swallowing
• vomiting blood
• pallor and weakness (anaemia)
• blood in 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 the doctor:

• about any planned specific blood test (chromogranin A levels).

The doctor may decide that tests are necessary to rule out an underlying tumour-related disease, as treatment with pantoprazole may alleviate symptoms of tumour disease and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
Use of proton pump inhibitors such as Pantoprazole Mercapharm 20 mg, particularly when used for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform the doctor if the patient has osteoporosis or is taking corticosteroids (which may increase the risk of osteoporosis).
If Pantoprazole Mercapharm is taken for a prolonged period (over 1 year), the patient will likely be under continuous medical supervision. In such cases, any new or unexpected symptoms and their circumstances should be reported during every visit to the doctor.

Pantoprazole Mercapharm and other medicines
Pantoprazole Mercapharm may affect the effectiveness of other medicines. Therefore, inform the doctor if the patient is taking:

• Medicines such as ketoconazole, itraconazole, posaconazole (used to treat fungal infections), or erlotinib (used in certain types of cancer), because Pantoprazole Mercapharm may interfere with 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) – the doctor may decide to temporarily discontinue pantoprazole when the patient is receiving high-dose methotrexate.

Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans 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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
Do not drive or operate machinery if the patient experiences adverse effects such as dizziness or visual disturbances.

Pantoprazole Mercapharm contains lactose and sodium
This medicine contains lactose. If the patient has been diagnosed with an intolerance to certain sugars, Pantoprazole Mercapharm 20 mg should be taken only after consultation with a doctor.
This medicinal product contains 1.34 mg of sodium per dose. This should be taken into consideration 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 the medicine 1 hour before a meal. Do not chew or divide the tablet. Swallow
whole with water.
If your doctor has not advised otherwise, the usual recommended dose is:
Adults and adolescents aged 12 years and above:
For treatment of symptoms (e.g. heartburn, acid regurgitation, pain when swallowing) associated with gastro-oesophageal reflux disease
The usual dose is one tablet per day. This dose usually provides relief within 2–4 weeks of treatment – at the latest within the following 4 weeks. Your doctor will decide how long you should continue taking the medicine. Recurrent symptoms may be managed by taking one tablet per day when necessary.
For long-term treatment and prevention of relapse of reflux oesophagitis.
The usual dose is one tablet per day. If symptoms return, your doctor may recommend doubling the dose. In such a case, one tablet per day of Pantoprazole Mercapharm 40 mg may be used. After symptoms have subsided, the dose may be reduced again to one tablet (20 mg) per day.
Adults:
For prevention of duodenal and/or gastric ulcers in patients who must continuously take NSAIDs.
The usual dose is one tablet per day.
Special patient groups:
• In case of severe liver function impairment, do not take more than one 20 mg tablet per day.
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 recommended
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 treatment
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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The occurrence of adverse reactions 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 reactions 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, urticaria (a rash resembling nettle stings), breathing difficulties, angioedema of the face (Quincke's edema/angioedema), severe dizziness with rapid heartbeat and profuse sweating.
• Severe skin reactions (frequency not known): formation of skin blisters and sudden deterioration in general condition; erosions (with slight bleeding) of the eyes, nose, oral cavity/mouth, 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 kidney enlargement, sometimes with pain during urination and lower back pain (severe kidney inflammation).

Other adverse reactions 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; bloating and flatulence (passing wind); constipation; dry mouth; abdominal pain and discomfort; skin rash, erythema, skin eruptions; itching of the skin; fatigue, exhaustion, or general malaise; sleep disturbances; fracture of the hip, wrist, or spine (when lansoprazole is used in high doses and for a prolonged period).
• Rare (1 to 10 in 10,000 patients treated): Vision disturbances such as blurred vision; urticaria; joint pain; muscle pain; changes in body weight; increased body temperature; swelling of the limbs (peripheral oedema); allergic reactions; depression; gynaecomastia (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 reactions 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 lipid 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 reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

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 symbol). 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 your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Pantoprazole Mercapharm contains

• The active substance is pantoprazole. Each tablet contains 20 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
• Other ingredients are:

Tablet core:
Microcrystalline cellulose (E460i), lactose monohydrate, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
Coloured coating:
Polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc (E553b), iron oxide yellow (E172), quinoline yellow aluminium lake (E104).
Enteric coating:
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 20 mg is a yellow to ochre-coloured, elongated, coated tablet.
Pantoprazole Mercapharm 20 mg is available in:
Bottle packs (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 European Economic Area countries under the following names: