Ranloc

Package leaflet: Information for the user

Ranloc, 20 mg, enteric-coated tablets
Pantoprazole
Please read all of 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 as yours.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Ranloc is and what it is used for
2. What you need to know 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 Ranloc is and what it is used for

Ranloc contains the active substance pantoprazole. It is a selective proton pump inhibitor,
a medicine that reduces the production of acid in the stomach. It is used to treat stomach and intestinal disorders
related to hydrochloric acid secretion.
Ranloc is used in adults and adolescents aged 12 years and older for:

• Treating symptoms (e.g. heartburn, acid regurgitation, pain when swallowing) associated with gastro-oesophageal reflux disease (GORD) caused by the backflow of hydrochloric acid from the stomach.
• Long-term treatment of reflux oesophagitis (inflammation of the oesophagus accompanied by regurgitation of gastric acid) and prevention of its recurrence.

Ranloc is used in adults for:

• Prevention of duodenal and gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in patients at risk who require continuous NSAID therapy.

2. Important information before using Ranloc

When not to use Ranloc

• If the patient is allergic to pantoprazole or to 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 Ranloc, inform your doctor, pharmacist, or nurse:

• if the patient has severe liver function impairment. Inform the doctor if there has ever been any liver disorder. The doctor may recommend more frequent monitoring of liver enzyme activity, especially if long-term treatment with Ranloc is required. If increased liver enzyme activity occurs, treatment should be discontinued.
• if the patient is taking non-steroidal anti-inflammatory drugs (NSAIDs) long-term while also taking Ranloc, due to an increased risk of gastrointestinal complications. The level of risk will be assessed according to individual patient risk factors, such as age (65 years or older), history of gastric or duodenal ulcers, or gastrointestinal bleeding.
• if the patient has vitamin B12 deficiency or risk factors indicating possible reduced vitamin B12 levels, particularly during long-term pantoprazole therapy. Like all medicines that reduce (inhibit) gastric acid secretion, pantoprazole may lead to decreased absorption of vitamin B12.
• if the patient is taking protease inhibitors for HIV, such as atazanavir (used in the treatment of HIV infection), the patient should consult the doctor for specific advice.
• 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 (reduced bone density) or is taking corticosteroids (which may increase the risk of osteoporosis).
• if the patient takes Ranloc for longer than three months, there may be a decrease in blood magnesium levels, which may subsequently cause fatigue, tetany, confusion, seizures, dizziness, and ventricular arrhythmias. If any of these symptoms occur, inform the doctor immediately. Low blood magnesium levels may also lead to reduced potassium and calcium levels in the blood. The doctor may decide that periodic monitoring of blood magnesium levels is necessary.
• if the patient has ever had a skin reaction while taking a medicine similar to Ranloc that reduces gastric acid secretion. If a skin rash develops, especially in sun-exposed areas, inform the doctor immediately, as discontinuation of Ranloc may be necessary. Also report any other adverse reactions, such as joint pain.
• about any planned specific blood test (chromogranin A levels).

Contact the doctor immediately before starting or during treatment with Ranloc if any of the following symptoms occur, as they may indicate a more serious underlying condition:

• unintentional weight loss
• vomiting, particularly recurrent
• vomiting blood, which may look like dark coffee grounds
• blood in the stool, black or tarry stools
• difficulty swallowing or pain during swallowing
• paleness and weakness (anaemia)
• chest pain
• abdominal pain
• severe and/or persistent diarrhoea, as use of this medicine is associated with a slightly increased risk of infectious diarrhoea.

The doctor may decide to perform tests to rule out an underlying malignant condition, as treatment with pantoprazole may relieve symptoms of cancer and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
If Ranloc is taken for a prolonged period (over 1 year), the patient will likely be under continuous medical supervision. In such cases, any new or unexpected symptoms and the circumstances of their occurrence should be reported during every visit to the doctor.

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

Ranloc and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including over-the-counter medicines.
Since Ranloc may affect the effectiveness of other medicines, inform the doctor if the patient is taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used in certain types of cancer), because Ranloc may inhibit the proper action of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting and prevent thrombosis. Additional monitoring may be required.
• Medicines used in the treatment of HIV infection, such as atazanavir.
• Methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancer conditions). In such cases, the doctor may temporarily discontinue Ranloc, as pantoprazole may increase methotrexate blood levels.
• Fluvoxamine (used in the treatment of 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 in the treatment of mild depression).

Pregnancy and breastfeeding
Experience with use in pregnant women is limited. It has been shown that the active substance passes into human milk.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
The medicine may be used only if the doctor considers that the benefit outweighs the potential risk to the unborn child or infant.

Driving and operating machinery
Ranloc has no effect or negligible effect on the ability to drive motor vehicles and operate mechanical equipment.
Do not drive motor vehicles or operate mechanical equipment if the patient experiences adverse reactions such as dizziness or visual disturbances.

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

3. How to use Ranloc

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
please consult your doctor or pharmacist.
Method of administration
Take the medicine 1 hour before a meal, without chewing or dividing the tablet. Swallow the tablet whole
with water.
Recommended dose
Adults and adolescents aged 12 years and above:

• For treatment of symptoms (e.g. heartburn, acid regurgitation, pain when swallowing) associated with gastro-oesophageal reflux disease
  The usual dose is one tablet daily. This dose usually provides relief within 2–4 weeks of treatment – and at the latest within the following 4 weeks. Your doctor will decide how long you should continue taking the medicine. Recurrent symptoms may be managed by taking one tablet daily as needed.

• For long-term treatment and prevention of relapse of reflux oesophagitis
  The usual dose is one tablet daily. If symptoms recur, your doctor may recommend doubling the dose. In this case, one tablet of Ranloc 40 mg may be taken daily. After symptoms resolve, the dose may be reduced again to one tablet (20 mg) daily.

Adults:

• For prevention of duodenal and/or gastric ulcers in patients who need to take NSAIDs continuously
  The usual dose is one tablet daily.

Patients with impaired liver function
In case of severe liver disease, do not take more than one 20 mg tablet daily.
Use in children and adolescents
The tablets are not recommended for use in children under 12 years of age.
Taking more Ranloc than recommended
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you miss a dose of Ranloc
Do not take a double dose to make up for the missed dose. Take the next scheduled dose at the usual time.
Stopping Ranloc
Do not stop taking the tablets without first consulting your doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, stop taking the tablets immediately and contact your doctor or go to the nearest hospital emergency department without delay:

• Severe allergic reactions (rare: no more than 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, urticaria (rash resembling nettle stings), breathing difficulties, angioedema of the face (Quincke's edema / angioedema), severe dizziness with rapid heartbeat and profuse sweating.

• Severe skin reactions (frequency unknown: frequency cannot be estimated from available data): formation of skin blisters and sudden worsening of general condition, erosions (with slight bleeding) of the eyes, nose, mouth/oral cavity or genital organs, or skin hypersensitivity/rash, particularly in areas of skin exposed to sunlight. Joint pain or flu-like symptoms may also occur, fever, swollen lymph nodes (e.g. under the arms), and blood tests may show changes in certain white blood cells or liver enzymes (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug rash with eosinophilia and systemic symptoms (DRESS syndrome), and photosensitivity).

• Other severe reactions (frequency unknown: frequency cannot be estimated from available data): yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever, rash, and kidney problems manifested by their enlargement, sometimes with pain during urination and lower back pain (severe kidney inflammation), which may lead to kidney failure.

Other adverse reactions that may occur:

• Common (occurs in 1 to 10 people): benign gastric polyps.
• Uncommon (occurs in 1 to 1,000 people): headache; dizziness; diarrhoea; nausea, vomiting; feeling of fullness in the abdomen and bloating with flatulence (passing wind); constipation; dry mouth; abdominal pain and discomfort; skin rash, erythema, skin eruptions; itching of the skin; weakness, fatigue or general malaise; sleep disturbances, fractures of the hip, wrist or spine.
• Rare (no more than 1 in 1,000 people): disturbances or complete loss of taste sensation; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; changes in body weight; elevated body temperature; high fever; swelling of limbs (peripheral oedema); allergic reactions; depression; gynaecomastia (breast enlargement in men).
• Very rare (no more than 1 in 10,000 people): disorientation.
• Frequency not known (frequency cannot be estimated from available data): hallucinations, confusion (particularly in patients who have previously experienced such symptoms); decreased sodium and magnesium levels in blood (see section 2), sensations of tingling, pricking, burning or numbness, rash possibly accompanied by joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse reactions detected by blood tests that may occur:

• Uncommon (no more than 1 in 100 people): increased liver enzyme activity.
• Rare (no more than 1 in 1,000 people): increased bilirubin levels; increased blood lipid levels; sudden decrease in circulating granulocytes – white blood cells – associated with high fever.
• Very rare (no more than 1 in 10,000 people): decreased platelet count, which may lead to more frequent bleeding and bruising; decreased white blood cell count, which may predispose to more frequent infections; concurrent abnormal decrease in red blood cells, white blood cells, and platelets.
• Frequency not known (frequency cannot be estimated from available data): decreased levels of sodium, magnesium, calcium or potassium in blood (see section 2).

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 of the 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.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Ranloc

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the specified month.
• This medicine does not require any special storage conditions.
• Bottle: Ranloc should be used within 100 days after first opening.
• 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 Ranloc contains
The active substance is pantoprazole. One enteric-coated tablet contains 20 mg of pantoprazole (as
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), iron oxide yellow (E 172)
Enteric coating: methacrylic acid-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 enteric-coated tablets are whitish, oval, biconvex, coated with an acid-protective layer, smooth on both sides.
Ranloc packaging containing blisters: 7, 14, 28, 60, 90 enteric-coated tablets.
Ranloc packaging containing HDPE bottles with a cap and a desiccant: 60 or 100 enteric-coated tablets. DO NOT INGEST the desiccant.
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

Manufacturers
Terapia S.A.
124 Fabricii Street, 400632 Cluj-Napoca
Romania
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH, Hoofddorp,
The Netherlands

This medicinal product is authorised in 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