Patient Information Leaflet

Panprazox, 40 mg, enteric-coated tablets
Pantoprazole
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet. 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 them, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Panprazox is and what it is used for
What you need to know 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 to treat stomach and intestinal disorders related to hydrochloric acid secretion.

Panprazox is used in adults and adolescents aged 12 years and older for:

Treatment of reflux esophagitis (associated with stomach acid regurgitation).

Panprazox is used in adults for:

Treatment of infection with a bacterium called Helicobacter pylori in patients with duodenal and gastric ulcers, in combination with two antibiotics (eradication therapy). The aim of treatment is to eliminate the bacteria to reduce the risk of recurrence of ulcer disease.
Treatment of duodenal and gastric ulcer.
Treatment of Zollinger-Ellison syndrome and other conditions associated with excessive hydrochloric acid secretion in the stomach.

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.
Treatment should be discontinued if liver enzyme activity increases.
If the patient has vitamin B deficiency or risk factors for low vitamin B levels and is receiving long-term pantoprazole therapy. Like all drugs 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.
The 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 if corticosteroids are being taken (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 effects occurring, such as joint pain.
Contact the doctor immediately before starting or during treatment with this medicine if any of the following symptoms occur, as they may indicate another, more serious illness:

Unintentional weight loss;
Repeated vomiting;
Vomiting blood, which may look like dark coffee grounds;
Blood in 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 treatment with Panprazox is associated with a small increased risk of infectious diarrhoea.

The doctor may decide that tests are needed to rule out an underlying tumour disease, because treatment with pantoprazole may relieve symptoms of cancer and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
If the patient has been taking pantoprazole for more than three months, blood magnesium levels may decrease. 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 potassium and calcium levels in the blood. The doctor may order regular blood tests to monitor magnesium levels.
If Panprazox is taken for a prolonged period (over 1 year), the doctor will likely recommend regular monitoring. During every visit to the doctor, report any new or unexpected symptoms and the circumstances of their occurrence.

Children and adolescents
Panprazox is not recommended for children and adolescents under 12 years of age, as its effects have not been studied in this age group.

Panprazox with other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Panprazox may affect the effectiveness of other medicines, so 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), because Panprazox may inhibit the proper action of these and other drugs;
Warfarin and phenprocoumon, which affect blood clotting and prevent thrombosis. 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 blood levels;
Fluvoxamine (used to treat depression and other psychiatric disorders) – if the patient is taking fluvoxamine, the doctor may recommend a dose reduction;
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 plans to become pregnant, she should consult a 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 only 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 effect or negligible effect on the ability to drive and operate machinery.
Patients who experience adverse effects such as dizziness or visual disturbances should not drive or operate machinery.

Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, 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 in doubt, consult your doctor or pharmacist.
Instructions for use
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. If the medicine is taken twice daily, it is recommended to take the second tablet 30–60 minutes before the evening meal.
Recommended dose:
Adults and adolescents aged 12 years and older:
Treatment of reflux esophagitis:
The recommended dose is 1 tablet per day. Your doctor may recommend increasing the dose to 2 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 taking the medicine.
Adults
Treatment of infection with a bacterium called Helicobacter pylori in patients with duodenal and gastric ulcers, in combination with two antibiotics (eradication therapy):
The recommended dose is 1 tablet twice daily, plus 2 antibacterial tablets: amoxicillin or clarithromycin and metronidazole (or tinidazole), taken twice daily. The first pantoprazole tablet should be taken 30–60 minutes before the first meal, and the second pantoprazole tablet 30–60 minutes before the evening meal. Follow your doctor's instructions and read the patient leaflets included in the antibiotic packaging. Treatment usually lasts from one to two weeks.
Treatment of gastric and duodenal ulcers:
The recommended dose is one 40 mg tablet per day. After consultation with your doctor, the dose may be doubled. Your doctor will decide how long you should continue taking the medicine. The treatment duration for gastric ulcers usually lasts 4–8 weeks, whereas for duodenal ulcers it is 2–4 weeks.
Long-term treatment of Zollinger-Ellison syndrome and other conditions associated with excessive hydrochloric acid secretion in the stomach:
The initial dose is 2 tablets of 40 mg per day.
Take 2 tablets 30–60 minutes before the first meal. Your doctor may recommend a different dose depending on your body's response to treatment. If your doctor prescribes more than 2 tablets per day, they should be taken in two divided doses.
If your doctor prescribes a daily dose exceeding four tablets, you will be specifically informed when to discontinue the medicine.
Patients with renal impairment:

Patients with kidney problems should not take Panprazox for Helicobacter pylori eradication.

Patients with hepatic impairment:

In case of severe liver problems, do not take more than one 20 mg tablet per day.
Panprazox should not be used for Helicobacter pylori eradication in patients with moderate or severe liver disease.

Use in children and adolescents
This medicine is not recommended for use in children and adolescents under 12 years of age.
If you take more Panprazox than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take Panprazox
Do not take a double dose to make up for the missed tablet. Take the next scheduled dose at the usual time.
Stopping Panprazox
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 everybody will experience them.
If any of the symptoms listed below occur, stop taking the medicine immediately and consult a doctor or go to the Accident and Emergency Department of your nearest hospital.

Severe allergic reactions (uncommon: occurs in less than 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, urticaria (rash resembling nettle rash), difficulty breathing, angioedema of the face (Quincke's oedema/angio-oedema), severe central dizziness with very rapid heartbeat and profuse sweating.
Severe skin reactions (frequency unknown: frequency cannot be estimated from available data): skin blistering and sudden deterioration in general health, erosion (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 kidney enlargement, sometimes with pain during urination and lower back pain (severe kidney inflammation which may lead to kidney failure).

Other adverse reactions include:

Common (affects less than 1 in 10 people): Benign gastric polyps.
Uncommon (affects less than 1 in 100 people): Headache; central dizziness; diarrhoea; nausea; vomiting; flatulence and wind; constipation; dryness of the mouth; abdominal pain and discomfort; skin rash; urticaria, skin eruptions; itching; weakness; fatigue or general malaise; sleep disturbances; fracture of the hip, wrist or spine.
Rare (affects 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 temperature; high fever; limb swelling (peripheral oedema); allergic reactions; depression; breast enlargement in males.
Very rare (affects less than 1 in 10,000 people): Disorientation.
Not known (frequency cannot be estimated from available data): Hallucinations, confusion (particularly in patients who have 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 due to electrolyte disturbances, sensations of tingling, pricking, numbness, burning or pins and needles, painful rash, colitis causing persistent watery diarrhoea.

Adverse reactions identified in blood tests

Uncommon (affects less than 1 in 100 people): Increased liver enzyme activity.
Rare (affects less than 1 in 1,000 people): Increased bilirubin levels; increased blood lipid levels, marked decrease in white blood cells (granulocytes) associated with high fever.
Very rare (affects less than 1 in 10,000 people): Decreased platelet count, which may lead to 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 reactions occur, including any adverse reactions 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, 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 authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store 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 no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Panprazox contains

The active substance is pantoprazole. Each enteric-coated tablet contains 40 mg of pantoprazole (as sodium pantoprazole sesquihydrate).
The other ingredients 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-ethyl acrylate copolymer, yellow iron oxide (E172).

What Panprazox looks like and contents of the pack
Panprazox 40 mg is yellow, oval-shaped, enteric-coated tablets.
Packaging:
bottles (HDPE with child-resistant polpropylene cap) in a cardboard box or blisters (Aluminum/Aluminum) in a cardboard box.
Panprazox is available in 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