PANPRAZOX 40 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Panprazox, 40 mg, Gastro-Resistant Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Package Leaflet
3. What is Panprazox and what is it used for
4. Important information before taking Panprazox
   1. When not to take Panprazox
   2. Warnings and precautions
   3. Children and Adolescents
   4. Panprazox and other medicines
   5. Pregnancy and Breastfeeding
   6. Driving and using machines
   7. Sodium
5. How to take Panprazox
   1. Method of administration
   2. Recommended dose:
   3. Adults and adolescents aged 12 years and above:
   4. Adults
   5. Patient with kidney problems
   6. Use in children and adolescents
   7. Taking a higher dose of Panprazox than recommended
   8. Missing a dose of Panprazox
   9. Stopping treatment with Panprazox
6. Possible side effects
   1. If you experience any of the following symptoms, stop taking the medicine and contact your doctor or go to the emergency department of your nearest hospital immediately.
   2. Side effects detected in blood tests
   3. Reporting side effects
7. How to store Panprazox
8. Contents of the pack and other information
   1. What Panprazox contains
   2. What Panprazox looks like and contents of the pack
   3. Marketing Authorisation Holder and Manufacturer
   4. Marketing Authorisation Holder
   5. Manufacturer

Package Leaflet: Information for the Patient

Panprazox, 40 mg, Gastro-Resistant Tablets

Pantoprazole

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Panprazox and what is it used for

Panprazox contains the active substance pantoprazole. Panprazox is a selective “proton pump inhibitor”, a medicine that reduces the amount of acid produced in the stomach. Panprazox is used to treat stomach and gut conditions related to acid production.

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

• treatment of reflux oesophagitis (inflammation of the oesophagus caused by acid reflux).

Panprazox is used in adults for:

• treatment of an infection with a bacterium called Helicobacter pyloriin patients with duodenal and stomach ulcers, in combination with two antibiotics (eradication therapy). The goal of treatment is to get rid of the bacteria to reduce the risk of ulcer recurrence.
• treatment of duodenal and stomach ulcers.
• treatment of Zollinger-Ellison syndrome and other conditions related to excessive acid production in the stomach.

2. Important information before taking Panprazox

When not to take Panprazox

• If you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6).
• If you have been diagnosed with an allergy to other proton pump inhibitors.

Warnings and precautions

Before taking Panprazox, discuss it with your doctor or pharmacist.

• If you have severe liver problems. You should tell your doctor if you have ever had liver problems. Your doctor will monitor your liver enzymes more frequently, especially if you are taking Panprazox for a long time. If your liver enzymes increase, you should stop taking the medicine.

In case of increased liver enzymes, treatment should be discontinued.

• If you have a vitamin B12 deficiency or risk factors for low vitamin B12 levels and you are taking pantoprazole for a long time. Like all acid-suppressing medicines, pantoprazole may reduce the absorption of vitamin B12.
• If you are taking HIV protease inhibitors such as atazanavir (used to treat HIV infection), you should consult your doctor.
• Taking a proton pump inhibitor like pantoprazole, especially for more than one year, may slightly increase the risk of hip, wrist, or spine fractures. You should tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
• If you are going to have a specific blood test (chromogranin A).
• If you have ever had a skin reaction with a medicine that reduces acid production like Panprazox.

If you get a rash on your skin, especially in areas exposed to sunlight, you should tell your doctor as soon as possible, as you may need to stop taking Panprazox. You should also tell your doctor about any other side effects, such as joint pain.

You should tell your doctor immediatelybefore or during treatment with Panprazox if you get any of the following symptoms, which could be a sign of a more serious condition:

• unintentional weight loss;
• repeated vomiting;
• bloody vomiting, which may look like coffee grounds;
• blood in your stools, black or tarry stools;
• difficulty swallowing or pain when swallowing;
• pale skin and weakness (anaemia);
• chest pain;
• stomach pain;
• severe diarrhoea and (or) persistent diarrhoea, as taking Panprazox is associated with a small increased risk of infectious diarrhoea.

Your doctor may decide to perform tests to rule out an underlying malignant disease, as treatment with pantoprazole may alleviate the symptoms of the malignant disease and delay its diagnosis. If symptoms persist despite treatment, further tests should be considered.

If you take pantoprazole for more than three months, it is possible that your blood magnesium levels may decrease. Symptoms of low magnesium levels can include fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or rapid heartbeat. If you get any of these symptoms, you should tell your doctor as soon as possible. Low magnesium levels can also lead to low potassium and calcium levels in the blood. Your doctor may order regular blood tests to monitor your magnesium levels.

If you are taking Panprazox for a long time (more than 1 year), your doctor will probably recommend regular monitoring. During each visit to your doctor, you should report any new or unexpected symptoms and the circumstances in which they occurred.

Children and Adolescents

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

Panprazox and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, and about any medicines you plan to take.

Panprazox may affect the effectiveness of other medicines, so you should tell your doctor if you are taking:

• ketokonazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as Panprazox may inhibit the proper functioning of these and other medicines;
• warfarin and phenprocoumon, which affect blood density and prevent blood clots. Further tests may be necessary;
• HIV medicines such as atazanavir;
• methotrexate (used to treat autoimmune diseases or cancer) - if you are taking methotrexate, your doctor may temporarily stop Panprazox, as pantoprazole may increase methotrexate levels in the blood;
• fluvoxamine (used to treat depression and other mental disorders) - if you are taking fluvoxamine, your doctor may order a dose reduction;
• rifampicin (used to treat infections);
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

There is not enough data on the use of pantoprazole in pregnant women. It has been found that the medicine passes into breast milk.

The medicine may be used if your doctor decides that the benefit to the mother outweighs the potential risk to the unborn child or baby.

Driving and using machines

Panprazox has no or negligible influence on the ability to drive and use machines.

Patients who experience side effects such as dizziness and visual disturbances should not drive or operate machinery.

Sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially sodium-free.

3. How to take Panprazox

Take this medicine always as directed by your doctor or pharmacist. If you are not sure, ask 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. If you are taking the medicine twice a day, it is recommended to take the second tablet 30-60 minutes before the evening meal.

Recommended dose:

Adults and adolescents aged 12 years and above:

Treatment of reflux oesophagitis:
The recommended dose is one tablet per day. Your doctor may recommend increasing the dose to two tablets per day. The treatment period for reflux oesophagitis usually lasts from 4 to 8 weeks. Your doctor will decide how long you should take the medicine.

Adults

Treatment of Helicobacter pylori infection in patients with duodenal and stomach ulcers, in combination with two antibiotics (eradication therapy):
The recommended dose is one tablet twice a day plus two tablets of antibacterial medicines: amoxicillin or clarithromycin and metronidazole (or tinidazole) twice a day. 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. You should follow the instructions given by your doctor and read the patient information leaflets in the antibiotic packages. The treatment usually lasts for one to two weeks.

Treatment of stomach and duodenal ulcers:
The recommended dose is one 40 mg tablet per day. After consulting your doctor, the dose may be doubled. Your doctor will decide how long you should take the medicine. The treatment period for stomach ulcers usually lasts 4-8 weeks, and for duodenal ulcers 2-4 weeks.

Long-term treatment of Zollinger-Ellison syndrome and other conditions related to excessive acid production in the stomach:
The initial dose is two 40 mg tablets per day.

You should take two tablets of the medicine 30-60 minutes before the first meal. Your doctor may recommend a different dose, depending on your response to treatment. If your doctor prescribes more than two tablets per day, you should take them in two divided doses.

If your doctor prescribes a daily dose greater than four tablets per day, he will inform you when to stop taking the medicine.

Patient with kidney problems

• in case of kidney problems, you should not take Panprazox for the eradication of Helicobacter pylori.

Patient with liver problems:

• in case of severe liver problems, you should not take more than one 20 mg tablet per day;
• in moderate or severe liver disease, you should not take Panprazox for the eradication of Helicobacter pylori.

Use in children and adolescents

This medicine is not recommended for children and adolescents under 12 years of age.

Taking a higher dose of Panprazox than recommended

Ask 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 forgotten tablet. Take the next planned dose at the usual time.

Stopping treatment with Panprazox

Do not stop taking the tablets without consulting your doctor or pharmacist first.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Panprazox can cause side effects, although not everybody gets them.

If you experience any of the following symptoms, stop taking the medicine and contact your doctor or go to the emergency department of your nearest hospital immediately.

• Severe allergic reactions (rare: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives (nettle rash), difficulty breathing, allergic swelling of the face (Quincke's oedema/angioedema), severe dizziness with very rapid heartbeat and profuse sweating.
• Severe skin reactions (frequency not known: cannot be estimated from the available data): blisters on the skin and rapid worsening of the general condition, erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, polymorphic erythema) and hypersensitivity to light.
• Other severe conditions (frequency not known: cannot be estimated from the available data): yellowing of the skin or the whites of the eyes (severe liver damage, jaundice) or fever, rash, and kidney enlargement, sometimes painful urination and lower back pain (severe kidney inflammation, which can lead to kidney failure).

Other side effects include:

• Common (may affect up to 1 in 10 people)Mild polyps in the stomach.
• Uncommon (may affect up to 1 in 100 people)Headache; dizziness; diarrhoea; nausea; vomiting; bloating and gas; constipation; dry mouth; abdominal pain and discomfort; skin rash, itching; weakness; fatigue or general feeling of being unwell; sleep disorders; fractures of the hip, wrist, or spine.
• Rare (may affect up to 1 in 1,000 people)Taste disorders or complete loss of taste; vision disorders, such as blurred vision; hives; joint pain; muscle pain; weight changes; increased temperature; high fever; swelling of the limbs (peripheral oedema); allergic reactions; depression; breast enlargement in men.
• Very rare (may affect up to 1 in 10,000 people)Disorientation.
• Frequency not known (cannot be estimated from the available data)Hallucinations, confusion (especially in patients who have had these symptoms before); decreased sodium levels in the blood, decreased magnesium levels in the blood (see section 2); decreased calcium levels in the blood (in combination with decreased magnesium levels); decreased potassium levels in the blood; muscle cramps due to electrolyte disturbances, sensation of tingling, prickling, burning, or numbness; rash that may be accompanied by joint pain; inflammatory bowel disease, which can cause persistent watery diarrhoea.

Side effects detected in blood tests

• Uncommon (may affect up to 1 in 100 people)Increased liver enzyme activity.
• Rare (may affect up to 1 in 1,000 people)Increased bilirubin levels; increased fat levels in the blood; significant decrease in white blood cell count (granulocytopenia), associated with high fever.
• Very rare (may affect up to 1 in 10,000 people)Decreased platelet count, which can cause more frequent than usual bleeding or bruising; decreased white blood cell count in the blood, which can lead to more frequent infections; concurrent abnormal decrease in white and red blood cell count, and platelet count.

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the websiteor contact the Marketing Authorisation Holder to report side effects.

5. How to store Panprazox

Keep this medicine out of the sight and reach of children.

Store in a temperature 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 month stated.

The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Panprazox contains

• The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
• The other ingredients are: Tablet core: disodium phosphate anhydrous, mannitol (E421), microcrystalline cellulose, sodium croscarmellose, magnesium stearate (of vegetable origin). Tablet coating: hypromellose, triethyl citrate, sodium carboxymethylcellulose (Type A), methacrylic acid and ethyl acrylate copolymer, yellow iron oxide (E172).

What Panprazox looks like and contents of the pack

Panprazox 40 mg has the form of yellow, oval, gastro-resistant tablets.

Packaging:

bottles (HDPE with a child-resistant polypropylene cap) in a cardboard box or blisters (Aluminum/Aluminum) in a cardboard box.

Panprazox is available in packs containing 14, 15, 28, 30, 60, or 100 gastro-resistant 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

Date of last revision of the leaflet:May 2024