Package leaflet: information for the patient

Panprazox, 20 mg, enteric-coated tablets
Pantoprazolum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet for future reference.
If you have any questions, please consult 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 reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

What Panprazox is and what it is used for
Important information before taking Panprazox
How to take Panprazox
Possible side effects
How to store Panprazox
Contents of the pack and other information

1. What Panprazox is and what it is used for

Panprazox contains the active substance pantoprazole. Panprazox is a selective "proton pump inhibitor", a medicine that reduces the amount of hydrochloric acid produced in the stomach. Panprazox is used in the treatment of stomach and intestinal disorders related to hydrochloric acid secretion.
Panprazox is used in adults and adolescents aged 12 years and older for:

treatment of symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated with gastro-oesophageal reflux disease (GORD), caused by the backflow of stomach acid into the oesophagus
long-term treatment and prevention of relapses of reflux oesophagitis (caused by regurgitation of gastric acid).

Panprazox is used in adults for:

prevention of gastric and duodenal ulcers (in the upper part of the small intestine) induced by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in patients at risk who require continuous treatment with NSAIDs.

2. Important information before taking Panprazox

When not to take Panprazox

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 Panprazox, discuss this with your doctor or pharmacist.

If the patient has severe liver problems. Inform the doctor if the patient has ever had liver function disorders. The doctor may order more frequent monitoring of liver enzymes, especially if Panprazox is used long-term. If liver enzyme activity increases, treatment should be discontinued.
If the patient is taking non-steroidal anti-inflammatory drugs (NSAIDs) long-term and is also receiving Panprazox, due to an increased risk of gastrointestinal complications. The level of 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 B_(12) deficiency or risk factors for low vitamin B_(12) levels and is being treated long-term with pantoprazole. As with all medicines that reduce (inhibit) gastric acid secretion, pantoprazole may lead to reduced absorption of vitamin B_(12).
If the patient is taking HIV protease inhibitors, such as atazanavir (used in the treatment of HIV infection), together with pantoprazole, medical advice should be sought.
Use of a proton pump inhibitor such as pantoprazole, especially for more than 1 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 the patient is scheduled for a specific blood test (chromogranin A levels).
If the patient has ever experienced a skin reaction due to taking a medicine similar to Panprazox that reduces gastric acid secretion.

If the patient develops a skin rash, especially in areas exposed to sunlight, inform the doctor immediately, as discontinuation of Panprazox may be necessary. Also report any other adverse reactions, such as joint pain.
Contact your doctor immediately before starting or during treatment if any of the following symptoms occur, as they may indicate another, more serious condition:

Unintentional weight loss;
Recurrent vomiting;
Vomiting blood, which may look like dark coffee grounds;
Blood in the stool, black or tarry stools;
Difficulty swallowing or pain when swallowing;
Pallor and weakness (anaemia);
Chest pain;
Abdominal pain;
Severe diarrhoea and/or persistent diarrhoea, as use of Panprazox is associated with a small increased risk of infectious diarrhoea.

The doctor may decide that further investigations are necessary to rule out an underlying malignant disease, as treatment with pantoprazole may relieve symptoms of cancer and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
If the patient takes pantoprazole for more than three months, it may lead to low magnesium levels in the blood. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or rapid heartbeat. If any of these symptoms occur, inform the doctor immediately. Low magnesium levels may also lead to reduced levels of potassium and calcium in the blood. The doctor may order regular blood tests to monitor magnesium levels.
If Panprazox is taken for a prolonged period (more than 1 year), the doctor will likely recommend regular monitoring. During every visit, report any new or unexpected symptoms and the circumstances under which they occurred.

Children and adolescents
Panprazox is not recommended for use in children and adolescents under 12 years of age, as its safety and efficacy have not been established in this age group.

Panprazox and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Panprazox may affect the effectiveness of other medicines. Therefore, inform the doctor if the patient is taking:

Ketoconazole, itraconazole, posaconazole (used to treat fungal infections), or erlotinib (used to treat certain types of cancer), as Panprazox may interfere with the proper action of these and other drugs;
Warfarin and phenprocoumon, which affect blood clotting. Additional monitoring may be required;
Medicines used to treat HIV infection, such as atazanavir;
Methotrexate (used to treat autoimmune diseases or cancer) – when methotrexate is used, the doctor may temporarily discontinue Panprazox, as pantoprazole may increase methotrexate levels in the blood;
Fluvoxamine (used to treat depression and other psychiatric disorders) – if the patient is taking fluvoxamine, the doctor may recommend a lower dose;
Rifampicin (used to treat infections);
St John’s wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy and breastfeeding
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.
There is insufficient data on the use of pantoprazole in pregnant women. It has been shown that the drug passes into breast milk.
The medicine may be used if the doctor determines that the benefit to the mother outweighs the potential risk to the unborn child or infant.

Driving and operating machinery
Panprazox has no or negligible influence on the ability to drive and operate machinery. However, patients who experience adverse effects such as dizziness or visual disturbances should not drive or operate machinery.

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Panprazox

This medicine should always be taken according to the instructions given by your doctor or pharmacist.
If you are unsure, consult your doctor or pharmacist.
Method of administration
Do not chew or crush the tablets. Swallow the tablets whole with water.
It is recommended to take the tablets (preferably in the morning) 30–60 minutes before the first meal.
Recommended dose:
Adults and adolescents aged 12 years and above:
For treatment of symptoms (e.g. heartburn, acid regurgitation, pain when swallowing) associated
with gastroesophageal reflux disease
The recommended dose is 1 tablet per day.
This dose usually provides relief within 2 to 4 weeks – at the latest within the following 4 weeks.
Your doctor will decide how long you should take the medicine. After that, recurring symptoms can be managed
by taking 1 tablet per day as needed.
For long-term treatment and prevention of relapse of reflux esophagitis
The recommended dose is 1 tablet per day.
If symptoms recur, the dose may be doubled. In such cases, 1 tablet of Panprazox 40 mg per day may be used.
After healing, the dose can be reduced again to 1 tablet of Panprazox 20 mg per day.
Adults:
Prevention of gastric and duodenal ulcers in patients who must continuously take NSAIDs
The recommended dose is 1 tablet per day.
Patients with impaired liver function

In cases of severe liver problems, do not take more than 1 tablet of 20 mg per day.
Use in children and adolescents
This medicine is not recommended for use in children and adolescents under 12 years of age.
Taking more Panprazox than recommended
Consult your doctor or pharmacist. Symptoms of overdose are not known.
Missing a dose of Panprazox
Do not take a double dose to make up for a missed tablet. Take the next scheduled dose at the usual time.
Stopping Panprazox treatment
Do not stop taking the tablets without first consulting your doctor or pharmacist.
If you have any further doubts about using 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.
If any of the following adverse reactions occur, stop taking the medicine immediately and consult a doctor or contact the nearest hospital providing emergency care:

Severe allergic reactions (rare: occur in less than 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, urticaria (rash resembling nettle burn), breathing difficulties, angioedema of the face (Quincke's edema/angioedema), severe central dizziness with very rapid heartbeat and profuse sweating.
Severe skin reactions (frequency unknown: frequency cannot be estimated from available data): skin blisters and sudden deterioration in general health, erosions (including mild bleeding) of the eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme) and photosensitivity.
Other severe conditions (frequency unknown: frequency cannot be estimated from available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, rash and enlarged kidneys, sometimes pain during urination and lower back pain (severe kidney inflammation which may lead to kidney failure).

Other adverse reactions include:

Common (occur in less than 1 in 10 people): benign gastric polyps.
Uncommon (occur in less than 1 in 100 people): headache; central dizziness; diarrhoea; nausea; vomiting; flatulence and gas; constipation; dry mouth; abdominal pain and discomfort; skin rash; hives, skin eruptions; itching; weakness; fatigue or general malaise; sleep disturbances; fracture of the hip, wrist or spine.
Rare (occur in less than 1 in 1,000 people): taste 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; limb swelling (peripheral oedema); allergic reactions; depression; breast enlargement in males.
Very rare (occur in less than 1 in 10,000 people): disorientation.
Frequency not known (frequency cannot be estimated from available data): hallucinations, confusion (particularly in patients who previously experienced such symptoms); decreased sodium levels in blood; decreased magnesium levels in blood (see section 2); decreased calcium levels in blood (in combination with low magnesium levels); decreased potassium levels in blood; muscle spasms resulting from electrolyte disturbances; sensations of tingling, pricking, numbness, burning or stinging; rash possibly accompanied by joint pain; inflammation of the large intestine causing persistent watery diarrhoea.

Adverse reactions identified in blood tests

Uncommon (occur in less than 1 in 100 people): increased liver enzyme activity.
Rare (occur in less than 1 in 1,000 people): increased bilirubin levels; increased blood lipid levels; significant decrease in white blood cell count (granulocytes), associated with high fever.
Very rare (occur in less than 1 in 10,000 people): decreased platelet count, which may result in more frequent bleeding or bruising than usual; decreased white blood cell count, which may lead to more frequent infections; concurrent abnormal decrease in white and red blood cells and platelets.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions 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 181C
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.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Panprazox

Keep this medicine out of sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the stated month.
The marking on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the package and other information

What Panprazox contains

The active substance is pantoprazole. Each enteric-coated tablet contains 20 mg of pantoprazole (as sodium pantoprazole sesquihydrate).
Other components are:
Tablet core: disodium phosphate anhydrous, mannitol (E421), microcrystalline cellulose, sodium croscarmellose, magnesium stearate (of plant origin).
Tablet coating: hypromellose, triethyl citrate, sodium carboxymethyl starch (Type A), methacrylic acid and ethyl acrylate copolymer, iron oxide yellow (E172).

What Panprazox looks like and contents of the pack
Panprazox 20 mg is in the form of yellow, oval enteric-coated tablets.
Packaging:
bottles (HDPE with a child-resistant polpropylene cap) in a cardboard box or blisters (Aluminum/Aluminum) in a cardboard box.
Panprazox is available in the following pack sizes containing:
14, 15, 28, 30, 60 or 100 enteric-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
Teva Pharma, S.L.U,
Poligono Industrial Malpica
calle C, Numero 4
50016 Zaragoza, Spain