Panrazol

Package Leaflet: Information for the Patient

Panrazol, 20 mg, Gastro-Resistant Tablets

pantoprazole

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Panrazol and what is it used for

Panrazol contains the active substance pantoprazole.
Panrazol is a selective proton pump inhibitor, a medicine that reduces the amount of acid produced in the stomach. It is used for the treatment of conditions where the stomach produces too much acid, such as gastroesophageal reflux disease.

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

• symptoms (such as heartburn, acid regurgitation, pain on swallowing) associated with gastroesophageal reflux disease (GERD), caused by reflux of acid from the stomach.
• long-term treatment of GERD and prevention of relapse.

Panrazol is used in adults for:

• prevention of gastric and duodenal ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk who need continuous NSAID treatment.

2. Important information before taking Panrazol

When not to take Panrazol

• If you are allergic to pantoprazole or any of the other ingredients of this medicine.
• If you are allergic to other proton pump inhibitors.

Warnings and precautions

Before taking Panrazol, tell your doctor or pharmacist if:

• You have severe liver problems. You should tell your doctor if you have ever had problems with your liver in the past. Your doctor may need to monitor your liver function more closely while you are taking this medicine.
• You have to take a medicine containing atazanavir (for the treatment of HIV) at the same time as pantoprazole. Atazanavir is not recommended for use in combination with Panrazol.
• You have reduced body stores or risk factors for reduced vitamin B12 and are taking pantoprazole long-term. As with all acid-reducing medicines, pantoprazole may lead to a reduced absorption of vitamin B12.
• You are due to have a specific blood test (Chromogranin A).

If you get any of the following side effects, you should contact your doctor immediately:

• severe skin reactions, including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS);
• unintentional weight loss, vomiting, especially when vomiting blood, black or tar-like stools, difficulty swallowing, or abdominal (stomach) pain;
• blurred vision, or loss of vision, or eye pain, or eye discomfort;

Children and adolescents

Panrazol is not recommended for use in children below 12 years of age.

Panrazol with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

• medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as Panrazol may interfere with their action;
• warfarin or phenprocoumon (used to thin the blood), as your doctor may need to monitor your blood more closely;
• atazanavir (used to treat HIV);
• methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer);
• fluvoxamine (used to treat depression and other psychiatric diseases);
• rifampicin (used to treat tuberculosis);
• St. John's Wort (Hypericum perforatum) (used to treat mild depression);

Pregnancy and breastfeeding

There is limited experience with the use of pantoprazole during pregnancy. 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.

Driving and using machines

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

Panrazol contains sodium

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

3. How to take Panrazol

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration

Do not chew or crush the tablets. Swallow the tablets whole with a glass of water, 1 hour before a meal.

Adults and adolescents aged 12 years and above:

Treatment of symptoms related to gastroesophageal reflux disease (such as heartburn, acid regurgitation, pain on swallowing)

The recommended dose is one tablet per day. This dose usually provides relief within 2-4 weeks - at the latest after another 4 weeks. Your doctor will tell you how long to take the medicine.

Long-term treatment and prevention of relapse of GERD

The recommended dose is one tablet per day. If symptoms return, your doctor may increase the dose to 2 tablets per day.

Adults:

Prevention of gastric and duodenal ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs)

The recommended dose is one tablet per day.

Patients with liver problems

If you have severe liver problems, you should not take more than one 20 mg tablet per day.

Use in children and adolescents

Tablets are not recommended for use in children below 12 years of age.

If you take more Panrazol than you should

Inform your doctor or pharmacist. There are no known symptoms of overdose.

If you forget to take Panrazol

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.

If you stop taking Panrazol

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

4. Possible side effects

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

If you experience any of the following side effects, stop taking the tablets and tell your doctor immediately or contact the casualty department of your nearest hospital:

• Severe allergic reactions (rare:may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, anaphylactic shock, severe dizziness with rapid heartbeat and profuse sweating.
• Severe skin reactions (frequency not known:cannot be estimated from the available data): you may notice one or more of the following symptoms
• blisters on the skin and/or mucous membranes, rapid deterioration of your general health, eye, nose, mouth, or genital areas, or skin rash, especially on areas exposed to the sun. You may also have fever, joint pain, or flu-like symptoms, swollen lymph nodes, and changes in blood tests, including eosinophilia.
• red, non-raised, target-like, or circular patches on the trunk, often with blisters in the center, peeling of the skin, mouth ulcers, genital ulcers, and eye inflammation. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread skin rash, high fever, and enlarged lymph nodes (DRESS or drug hypersensitivity reaction).
• Other severe reactions (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 swollen kidneys, sometimes with painful urination and lower back pain (severe kidney problems), which may lead to kidney failure.

Other side effects include:

• Common(may affect up to 1 in 10 people) mild gastrointestinal 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, or hives; feeling weak, fatigued, or generally unwell; sleep disorders; fractures of the hip, wrist, or spine.
• Rare(may affect up to 1 in 1,000 people) changes in taste; changes in vision, such as blurred vision; hives; joint pain; muscle pain; changes in body weight; increased body temperature; high fever; swelling of the extremities (peripheral edema); allergic reactions; depression; breast enlargement in men (gynaecomastia).
• Very rare(may affect up to 1 in 10,000 people) disorientation (especially in older people).
• Frequency not known(cannot be estimated from the available data)

hallucinations, confusion (especially in people who have had these symptoms before); feeling of tingling, prickling, burning, or numbness; muscle cramps due to electrolyte disturbances (changes in the levels of salts in the body); inflammation of the colon (colonopathy) leading to persistent watery diarrhea.

Side effects identified from blood tests:

• Uncommon(may affect up to 1 in 100 people) increased liver enzymes.
• Rare(may affect up to 1 in 1,000 people) increased bilirubin; increased fat levels in the blood; sudden reduction in the number of blood platelets, which may cause you to bruise or bleed more easily than normal.
• Very rare(may affect up to 1 in 10,000 people) reduction in the number of white blood cells, which may lead to increased risk of infection; low levels of sodium, magnesium, calcium, or potassium in the blood (see section 2).
• Frequency not known(cannot be estimated from the available data)

Reporting of 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.

5. How to store Panrazol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Panrazol 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: mannitol, sodium carbonate, croscarmellose sodium (Type A), methacrylic acid - ethyl acrylate copolymer (1:1) (Eudragit L100-55), calcium stearate. Coating: hypromellose 3 cP, titanium dioxide (E171), talc, macrogol 400, sodium lauryl sulfate.

Enteric coating: methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%, propylene glycol, yellow iron oxide (E172), titanium dioxide (E171), talc.

What Panrazol looks like and contents of the pack

Panrazol 20 mg: light yellow, elliptical, biconvex, gastro-resistant tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer

Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
For further information on this medicine, contact the Marketing Authorisation Holder.

Date of last revision of the package leaflet:December 2023