Ranloc

Package Leaflet: Information for the User

Ranloc, 20 mg, Gastro-Resistant Tablets

Pantoprazole

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 only. 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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Ranloc and what is it used for

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

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

• Treating symptoms (such as heartburn, acid reflux, pain when swallowing) associated with gastroesophageal reflux disease (GORD) caused by acid reflux from the stomach.
• Long-term treatment of reflux oesophagitis (inflammation of the oesophagus caused by acid reflux) and prevention of its recurrence.

Ranloc is used in adults for:

• Preventing gastric and duodenal ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in patients at risk who need to continuously take NSAIDs.

2. Important information before taking Ranloc

When not to take Ranloc

• 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 starting to take Ranloc, inform your doctor, pharmacist, or nurse:

• if you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor may decide to monitor your liver enzymes more frequently, especially if you are taking Ranloc for a long time. If your liver enzymes increase, your doctor may decide to stop your treatment with Ranloc.
• if you have to take NSAIDs continuously and also take Ranloc, due to an increased risk of stomach or gut problems. The increased risk will be assessed according to your individual risk factors, such as age (65 years or older), history of stomach or duodenal ulcers, or bleeding from the stomach or gut.
• if you have a vitamin B12 deficiency or risk factors for a vitamin B12 deficiency, and you are taking pantoprazole long-term. Like all medicines that reduce acid production in the stomach, pantoprazole may lead to reduced vitamin B12 absorption.
• if you are taking HIV protease inhibitors, such as atazanavir (used to treat HIV infection), with pantoprazole, you should ask your doctor for specific advice.
• if you take a proton pump inhibitor like pantoprazole, especially for more than one year, it may slightly increase the risk of hip, wrist, or spine fractures. Inform your doctor if you have osteoporosis (reduced bone density) or if you are taking corticosteroids (which can increase the risk of osteoporosis).
• if you take Ranloc for more than three months, you may experience a decrease in blood magnesium levels, which can lead to fatigue, tetany, confusion, convulsions, dizziness, and cardiac arrhythmias. If you experience any of these symptoms, inform your doctor. Low blood magnesium levels can also lead to low blood potassium and calcium levels. Your doctor may decide to periodically check your blood magnesium levels.
• if you have ever had a skin reaction after taking a medicine that reduces acid production in the stomach. If you experience a skin rash, especially in areas exposed to sunlight, inform your doctor as soon as possible, as you may need to stop taking Ranloc. Also, inform your doctor about any other side effects, such as joint pain.
• about a planned specific blood test (chromogranin A levels).

Inform your doctor immediatelybefore or during treatment with Ranloc if you experience any of the following symptoms, which could be a sign of a more serious condition:

• unintentional weight loss
• vomiting, especially if it is repeated
• blood in your vomit, which may look like coffee grounds
• blood in your stool, black or tar-like stools
• difficulty swallowing or pain when swallowing
• pale skin and weakness (anaemia)
• chest pain
• stomach pain
• severe and/or persistent diarrhoea, as the use of this medicine is associated with a small increased risk of infectious diarrhoea.

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

Children and adolescents

Ranloc is not recommended for use in children, as its use has not been studied in children under 12 years of age.

Ranloc and other medicines

Inform your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, 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 Ranloc may reduce the effectiveness of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting. Additional tests may be necessary.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if you are taking methotrexate, your doctor may temporarily stop your treatment with Ranloc, as pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other mental health conditions) - if you are taking fluvoxamine, your doctor may reduce your dose.
• Rifampicin (used to treat infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy and breastfeeding

Experience with the use of Ranloc in pregnant women is limited. The active substance of the medicine has been detected in human milk.

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.

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

Driving and using machines

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

Do not drive or operate machinery if you experience side effects such as dizziness or blurred vision.

Ranloc contains sodium

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

3. How to take Ranloc

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Method of administration

Take the medicine 1 hour before a meal, without chewing or breaking the tablet. Swallow the tablet whole with water.

Recommended dose

Adults and adolescents aged 12 years and above:

• In the treatment of symptoms (such as heartburn, acid reflux, pain when swallowing) associated with gastroesophageal reflux disease (GORD)The usual dose is one tablet per day. This dose usually provides relief after 2-4 weeks of treatment - at the latest within the next 4 weeks. Your doctor will decide how long you need to take the medicine. Recurring symptoms can be controlled by taking one tablet per day as needed.
• In the long-term treatment and prevention of recurrence of reflux oesophagitisThe usual dose is one tablet per day. If symptoms of the disease return, your doctor may recommend doubling the dose. In this case, one tablet of Ranloc 40 mg per day can be taken. After symptoms have resolved, the dose can be reduced to one tablet (20 mg) per day.

Adults:

• In the prevention of gastric and duodenal ulcers in patients who need to continuously take NSAIDsThe usual dose is one tablet per day.

Patients with liver problems

In the case of severe liver disease, do not take more than one tablet of 20 mg per day.

Use in children and adolescents

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

Taking a higher dose of Ranloc than recommended

Ask your doctor or pharmacist for advice. Symptoms of overdose are not known.

Missing a dose of Ranloc

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

Stopping treatment with Ranloc

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, pharmacist, or nurse.

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 contact your doctor or the nearest hospital immediately:

• Severe allergic reactions (rare: less than 1 in 1000 people):swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, allergic swelling of the face (Quincke's oedema / angioedema), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency not known: cannot be estimated from the available data): blistering of the skin and rapid deterioration of the general condition, erosions (with minor bleeding) of the eyes, nose, mouth/throat, or genitals, or hypersensitivity of the skin/rash, especially in areas of the skin exposed to sunlight. Joint pain or flu-like symptoms, fever, swelling of lymph nodes (e.g. under the arms), and changes in blood test results may also occur (Stevens-Johnson syndrome, Lyell syndrome, polymorphic erythema, subacute cutaneous lupus erythematosus, drug rash with eosinophilia and systemic symptoms (DRESS) and hypersensitivity to light).
• Other severe reactions (frequency not known: cannot be estimated from the available data): yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever, rash, and kidney problems, which may lead to kidney failure.

Other side effects that may occur:

• Common(affecting 1 to 10 people in 100) mild gastric polyps.
• Uncommon(affecting 1 to 10 people in 1,000) headache; dizziness; diarrhoea; nausea, vomiting; feeling of bloating and gas in the abdomen and passing wind; constipation; dry mouth; abdominal pain and discomfort; skin rash, redness, eruptions; itching; weakness, fatigue, or general feeling of being unwell; sleep disturbances, fractures of the hip, wrist, or spine.
• Rare(affecting 1 to 10 people in 10,000) changes in taste or loss of taste; changes in vision, such as blurred vision; hives; joint pain; muscle pain; changes in body weight; increased body temperature; high fever; swelling of limbs (peripheral oedema); allergic reactions; depression; gynaecomastia (breast enlargement in men).
• Very rare(affecting less than 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), feeling of tingling, prickling, burning, or numbness; rash that may be associated with joint pain, infectious colitis (which can cause persistent watery diarrhoea).

Side effects detected by blood tests:

• Uncommon(affecting 1 to 10 people in 100) increased liver enzymes.
• Rare(affecting 1 to 10 people in 10,000) increased bilirubin levels; increased fat levels in the blood; changes in blood cell counts, which may lead to increased risk of infections.
• Very rare(affecting less than 1 in 10,000 people) decreased platelet count, which may lead to increased risk of bleeding and bruising; decreased white blood cell count, which may lead to increased risk of infections; changes in blood cell counts, which may lead to anaemia, infections, and bleeding.
• Frequency not known(cannot be estimated from the available data) decreased sodium, magnesium, calcium, or potassium levels in the blood (see section 2).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309.

Website: https://smz.ezdrowie.gov.pl.

Side effects can also be reported to the marketing authorisation holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ranloc

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Bottle: Ranloc should be used within 100 days of first opening.
• 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 Ranloc contains

The active substance of the medicine is pantoprazole. One gastro-resistant tablet contains 20 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).

The other ingredients are:

Tablet core: anhydrous sodium carbonate, mannitol, crospovidone type A, hydroxypropylcellulose, microcrystalline cellulose, calcium stearate

Tablet coating: Opadry 02H52369 Yellow: hypromellose, propylene glycol, povidone K30, titanium dioxide (E 171), yellow iron oxide (E 172)

Enteric coating: methacrylic acid and ethyl acrylate copolymer (1:1), triethyl citrate, sodium lauryl sulfate, titanium dioxide (E 171), talc

What Ranloc looks like and contents of the pack

The gastro-resistant tablets are white, oval, biconvex, and coated with a protective layer against stomach acid, smooth on both sides.

Ranloc is available in blister packs containing 7, 14, 28, 60, or 90 gastro-resistant tablets.

Ranloc is also available in HDPE bottles containing 60 or 100 gastro-resistant tablets. The bottle contains one sachet of desiccant with silica gel. DO NOT EAT THE CONTENTS OF THE SACHET.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Ranbaxy (Poland) Sp. z o.o.

ul. Idzikowskiego 16

00-710 Warsaw

Manufacturer

Terapia S.A.

124 Fabricii Street, 400632 Cluj-Napoca

Romania

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH, Hoofddorp

Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

France

Pantoprazole CRISTERS PHARMA 20 mg, gastro-resistant tablet

Germany

PANTOPRAZOL BASICS 20 mg, magensaftresistente Tabletten

Italy

Pantoprazolo Sun Pharmaceutical Industries Limited

Spain

Pantoprazol SUN 20mg comprimidos gastrorresistentes EFG

Date of last revision of the leaflet:28.07.2023