Ranloc

DE/H/0866/IB/059/G

Package leaflet: Information for the user

Ranloc, 40 mg, enteric-coated tablets
Pantoprazole
Please read the entire leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents:

1. What Ranloc is and what it is 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 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 stomach acid. 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 the treatment of:

• Gastroesophageal reflux disease (GERD). This condition involves inflammation of the oesophagus (the tube connecting the throat to the stomach) accompanied by the backflow of hydrochloric acid from the stomach.

Ranloc is used in adults for:

• Helicobacter pylori infection in patients with gastric and/or duodenal ulcer, in combination with two antibiotics (eradication therapy), to eliminate the bacteria and prevent recurrence of ulcers.
• Gastric and/or duodenal ulcer disease.
• Zollinger-Ellison syndrome and other conditions associated with excessive production of hydrochloric acid in the stomach.

2. Important information before taking Ranloc

When not to take Ranloc

• If the patient is allergic to pantoprazole or 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
DE/H/0866/IB/059/G
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 liver enzyme activity increases, the medicine should be discontinued.
• If the patient has vitamin B deficiency or risk factors indicating possible reduced vitamin B levels, and is receiving long-term pantoprazole therapy. Like all medicines that reduce (inhibit) gastric acid secretion, pantoprazole may lead to reduced absorption of vitamin B.
• If the patient is taking HIV protease inhibitors such as atazanavir (used in the treatment of HIV infection) concomitantly with pantoprazole, the patient should consult the doctor for detailed advice.
• Use of a proton pump inhibitor such as pantoprazole, especially for periods longer 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 if corticosteroids are being used (which may increase the risk of osteoporosis).
• If the patient takes Ranloc for longer than three months, magnesium levels in the blood may decrease, which could lead to fatigue, tetany, confusion, seizures, dizziness, and ventricular arrhythmias. If any of these symptoms occur, inform the doctor immediately. Low 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 experienced a skin reaction due to taking a medicine similar to Ranloc that reduces gastric acid secretion. If a skin rash develops, particularly 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.
• Regarding planned specific blood tests (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 another, more serious condition:

• Unintentional weight loss
• Vomiting, especially recurrent
• Vomiting blood, which may look like dark coffee grounds
• Blood in stool, black or tarry stools
• Difficulty swallowing or pain when swallowing
• Pallor 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 disease, as treatment with pantoprazole may relieve symptoms of malignancy 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 their circumstances should be reported during each 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 or has recently taken, including medicines obtained without a prescription, as well as any medicines the patient plans to take.

Since Ranloc may affect the effectiveness of other medicines, inform the doctor if the patient is taking:

• Medicines such as ketoconazole, itraconazole, posaconazole (used to treat fungal infections), or erlotinib (used in certain types of cancer), because Ranloc may impair the proper action of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting and help 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). In case of methotrexate use, 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 reducing the dose).
• 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 become pregnant, 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 or negligible influence on the ability to drive mechanical vehicles or operate machinery.
Do not drive or operate machinery if the patient experiences adverse effects such as dizziness or visual disturbances.

Ranloc contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
DE/H/0866/IB/059/G

3. How to take Ranloc

This medicine should always be taken as directed by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
Instructions for use
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 reflux esophagitis
  The usual dose is one tablet daily. Your doctor may recommend increasing the dose to two tablets daily. Treatment for reflux esophagitis usually lasts 4 to 8 weeks. Your doctor will decide how long you should take the medicine.

Adults

• For treatment of infection with a bacterium called Helicobacter pylori, in patients with duodenal and/or gastric ulcers, in combination with two antibiotics (eradication therapy)
  One tablet twice daily plus two antibiotic tablets: amoxicillin, clarithromycin or metronidazole (or tinidazole), each taken twice daily together with a pantoprazole tablet. The first pantoprazole tablet should be taken 1 hour before breakfast and the second pantoprazole tablet 1 hour before dinner. Follow your doctor's instructions and read the patient leaflets provided in the antibiotic packaging. Treatment usually lasts for one to two weeks.
• For treatment of gastric and/or duodenal ulcers
  The usual dose is one tablet daily. After consultation with your doctor, the dose may be doubled. Your doctor will decide how long you should continue treatment. Treatment for gastric ulcers usually lasts 4 to 8 weeks. Treatment for duodenal ulcers usually lasts 2 to 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with
excessive hydrochloric acid secretion in the stomach
The usual initial dose is two tablets daily.
Both tablets should be taken 1 hour before a meal. The dosage may later be adjusted by your doctor depending on the amount of hydrochloric acid secreted in the stomach. If more than two tablets per day are prescribed, they should be taken in two divided doses.
If your doctor prescribes a daily dose exceeding four tablets, they will provide specific instructions on when to stop taking the medicine.

Patients with impaired kidney function
Ranloc should not be used for Helicobacter pylori eradication in patients with kidney problems.

Patients with impaired liver function
In severe liver disease, no more than one 20 mg tablet of pantoprazole per day should be taken (tablets containing 20 mg pantoprazole are available for this purpose).
In moderate or severe liver disease, Ranloc should not be used for Helicobacter pylori eradication.

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 forget to take 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.
DE/H/0866/IB/059/G

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 medicine immediately and contact your doctor or go to the nearest 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, hives (rash with stinging sensation like nettle rash), difficulty breathing, angioedema (Quincke's oedema/angioedema), severe dizziness with rapid heartbeat and profuse sweating.
• Severe skin reactions (frequency unknown: frequency cannot be estimated from the available data): formation of skin blisters and sudden deterioration in general condition, erosion (with slight bleeding) of the eyes, nose, oral cavity/mouth or genital organs, or skin hypersensitivity/rash, particularly in areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, and swollen lymph nodes (e.g. under the arms) may also occur, 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 the available data): yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever, rash, and kidney problems manifested by kidney enlargement, sometimes with pain during urination and pain in the lower back (severe kidney inflammation which may lead to kidney failure).

Other adverse reactions occur:

• Frequently (occur in 1 out of 10 people): benign gastric polyps.
• Uncommonly (occur in 1 out of 1,000 patients):

DE/H/0866/IB/059/G
headache; dizziness; diarrhoea; nausea, vomiting; feeling of fullness in the abdomen and
bloating with passing wind; constipation; dry mouth; pain and discomfort in the abdomen;
skin rash, erythema, skin eruptions; itching of the skin; weakness, exhaustion, or general
malaise; sleep disturbances; fractures of the hip, wrist, or spine.

• Rarely (occur in 1 out of 10,000 patients): taste 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; breast enlargement in men.
• Very rarely (no more than 1 in 10,000 people): disorientation.
• Frequency unknown (frequency cannot be estimated from the available data): hallucinations, confusion (particularly in patients who have previously experienced such symptoms); decreased sodium levels in blood, decreased 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 identified by blood tests:

• Uncommonly (no more than 1 in 100 people): increased liver enzyme activity.
• Rarely (no more than 1 in 1,000 people): increased bilirubin levels; increased blood lipid levels; fever-related, sudden decrease in circulating granulocytes – white blood cells.
• Very rarely (no more than 1 in 10,000 people): decreased platelet count, which may lead to increased bleeding and bruising; decreased white blood cell count, which may increase susceptibility to infections; concurrent abnormal decrease in red blood cells, white blood cells, and platelets.
• Frequency unknown (frequency cannot be estimated from the 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 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 authorisation holder. Reporting adverse reactions helps provide more information on the safety of this 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 cardboard box and blister pack. The expiry date refers to the last day of the specified month.

DE/H/0866/IB/059/G

• This medicine does not require any special storage conditions.
• Bottle: Ranloc should be used within 100 days after first opening.
• Medicines should 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 40 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, iron oxide yellow (E 172)

What Ranloc looks like and contents of the pack
The enteric-coated tablets are yellow, oval-shaped, biconvex, coated with an acid-resistant protective layer, smooth on both sides.
Ranloc pack sizes containing blisters: 7, 14, 28, 60, 90 enteric-coated tablets.
Ranloc pack sizes containing HDPE bottles with cap and 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.
Idzikowskiego Street 16
00-710 Warsaw
Poland

Manufacturer
Terapia S.A.
124 Fabricii Street, 400632 Cluj-Napoca
Romania
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH, Hoofddorp,
The Netherlands
Alkaloida Chemical Company Zrt.
H-4440, Tiszavasvári,
Kabay János u. 29.
Hungary

This medicinal product is authorised in the European Economic Area member states under the following names:
Germany PANTOPRAZOL BASICS 40 mg magensaftresistente Tabletten
Italy Pantoprazolo Sun Pharmaceutical Industries Limited
Spain Pantoprazol SUN 40mg comprimidos gastrorresistentes EFG