Panprazox

Package Leaflet: Information for the Patient

Panprazox, 20 mg, Gastro-Resistant Tablets

Pantoprazolum

Read the package leaflet carefully before taking the medicine, 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, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the 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 hydrochloric acid produced in the stomach. Panprazox is used to treat stomach and intestinal diseases associated with hydrochloric acid production.
Panprazox is used in adults and adolescents aged 12 years and above for:

• treatment of symptoms (e.g. heartburn, acid reflux, pain when swallowing) associated with gastroesophageal reflux disease (GERD) caused by stomach acid flowing back into the esophagus
• long-term treatment and prevention of relapse of reflux esophagitis (associated with stomach acid reflux).

Panprazox is used in adults for:

• prevention of stomach and duodenal ulcers caused 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 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 proton pump inhibitors.

Warnings and precautions

Before starting treatment with Panprazox, discuss it with your doctor or pharmacist.

• If you have severe liver problems. Tell your doctor if you have ever had liver function disorders. Your doctor will prescribe more frequent monitoring of liver enzymes, especially if you are taking Panprazox for a long time. If liver enzyme levels increase, treatment should be discontinued.

In case of long-term use of Panprazox (more than 1 year), your doctor will probably recommend regular monitoring. During each visit to the doctor, report any new and unexpected symptoms and circumstances of their occurrence.

Children and adolescents

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

Panprazox and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Panprazox may affect the efficacy of other medicines, so tell your doctor if you are taking:

• ketokonazol, itrakonazol and pozakonazol (used to treat fungal infections) or erlotynib (used to treat certain types of cancer), as Panprazox may inhibit the proper functioning of these and other medicines;
• warfarin and fenprokumon, which affect blood density. Further tests may be necessary;
• medicines used to treat HIV infection, such as atazanawir;
• metotreksat (used to treat autoimmune diseases or cancer) - if you are taking metotreksat, your doctor may temporarily discontinue Panprazox, as pantoprazole may increase metotreksat levels in the blood;
• fluwoksamina (used to treat depression and other mental disorders) - if you are taking fluwoksamina, your doctor may prescribe a dose reduction;
• ryfampicynę (used to treat infections);
• Hypericum perforatum (used to treat mild depression).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There is limited data on the use of pantoprazole in pregnant women. It has been found that the medicine passes into breast milk in nursing women.
The medicine may be used if the doctor considers that the benefit to the mother outweighs the potential risk to the unborn child or infant.

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.
Recommended dose:

Adults and adolescents aged 12 years and above:

In the treatment of symptoms (e.g. heartburn, acid reflux, pain when swallowing) associated with gastroesophageal reflux disease
(GERD)
The recommended dose is one tablet per day.
This dose usually provides relief within 2 to 4 weeks - at the latest after another 4 weeks.
Your doctor will decide how long you should take the medicine. Then, recurring symptoms can be controlled by taking one tablet per dayas needed.
In the long-term treatment and prevention of relapse of reflux esophagitis
The recommended dose is one 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 may be reduced to 1 tablet of Panprazox 20 mg per day.

Adults:

Prevention of stomach and duodenal ulcers in patients who must take NSAIDs continuously
The recommended dose is one tablet per day.

Patient with liver impairment

• In case 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 a higher dose of Panprazox than recommended

Consult a 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 scheduled 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 medicine, 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 side effects, stop taking the medicine and contact your doctor or the nearest hospital with an emergency service:

• 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 edema/anaphylactic shock), 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 deterioration of general health, ulcers (including mild bleeding) of the eyes, nose, mouth/throat or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme) and hypersensitivity to light.
• Other severe conditions (frequency not known: cannot be estimated from the available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, rash and enlarged kidneys, sometimes pain when urinating and pain in the lower back (severe kidney inflammation, which can lead to kidney failure).

Other side effects include:

• Common (may affect up to 1 in 10 people)Mild stomach polyps.
• Uncommon (may affect up to 1 in 100 people)Headache; dizziness; diarrhea; 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)Disturbances of taste or complete loss of taste; visual disturbances such as blurred vision; hives; joint pain; muscle pain; changes in body weight; increased body temperature; high fever; swelling of the limbs (peripheral edema); allergic reactions; depression; breast enlargement in men.
• Very rare (may affect up to 1 in 10,000 people)Disorientation.
• Not known (frequency 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 associated with joint pain, inflammatory bowel disease causing persistent watery diarrhea.

Side effects identified 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 may cause more frequent than usual bleeding or bruising; decreased white blood cell count in the blood, which may lead to more frequent infections, concurrent abnormal decrease in white and red blood cell count, and platelet count.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

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. This 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 20 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 carboxymethyl cellulose (Type A), methacrylic acid and ethyl acrylate copolymer, yellow iron oxide (E172).

What Panprazox looks like and contents of the pack

Panprazox 20 mg is a yellow, oval, gastro-resistant tablet.
Packaging:
HDPE bottles 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 authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +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