Package leaflet: Information for the user

Ranloc Med, 20 mg, enteric-coated tablets
Pantoprazole
Please read all of this leaflet carefully before taking this medicine, because it contains important information for you.
This medicine should always be used exactly as described in this patient information leaflet or as directed by your doctor or pharmacist.

Keep this leaflet. You may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 2 weeks, or if you feel worse, contact your doctor.
Do not take Ranloc Med for longer than 4 weeks without consulting your doctor.

Contents of the leaflet

What Ranloc Med is and what it is used for
What you need to know before taking Ranloc Med
How to take Ranloc Med
Possible side effects
How to store Ranloc Med
Contents of the pack and other information

1. What Ranloc Med is and what it is used for

The active substance in Ranloc Med is pantoprazole, which blocks the acid-producing "pump" in the stomach.
This reduces the amount of acid produced in the stomach.
Ranloc Med is used for short-term treatment of symptoms of gastroesophageal reflux disease (GERD) (such as heartburn, acid regurgitation) in adults.
Reflux refers to the backflow of stomach acid into the oesophagus, which may lead to inflammation of the oesophagus and cause pain. Other symptoms may include a burning discomfort in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).
Symptoms associated with reflux and heartburn may improve within the first day of taking pantoprazole; however, this medicine is not intended for immediate relief of symptoms. Complete relief of symptoms may require taking the tablets for 2 to 3 consecutive days.
If there is no improvement after 2 weeks, or if you feel worse, consult your doctor.

2. Important information before using Ranloc Med

When not to use Ranloc Med:

if the patient is allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6),
if the patient is taking HIV protease inhibitors such as atazanavir, nelfinavir (used in the treatment of HIV infection). See "Ranloc Med with other medicines".

Warnings and precautions
Before starting treatment with pantoprazole, consult a doctor if:

the patient has been treated for heartburn or indigestion continuously for 4 or more weeks,
the patient is over 55 years old and takes over-the-counter antacids daily,
the patient is over 55 years old and has noticed new symptoms or a change in the nature of existing symptoms,
the patient has a history of peptic ulcer disease or has undergone stomach surgery,
the patient has liver disease or jaundice (yellowing of the skin or eyes),
the patient is under continuous medical care due to other serious conditions or diseases,
the patient is scheduled for an endoscopic examination or urease breath test,
the patient has ever experienced a skin reaction due to taking a medicine similar to Ranloc Med that reduces gastric acid secretion,
the patient is planning a specific blood test (chromogranin A level),
if the patient is taking HIV protease inhibitors such as atazanavir or nelfinavir (used in the treatment of HIV infection) concomitantly with pantoprazole, the patient should ask the doctor for detailed advice.

This medicine should not be taken for longer than 4 weeks without consulting a doctor. If symptoms of reflux disease (heartburn or acid regurgitation) persist for more than 2 weeks, the patient should consult a doctor, who will decide whether long-term treatment is necessary.
Long-term use of Ranloc Med may be associated with additional risks, such as:

reduced absorption of vitamin B and vitamin B deficiency in case of low vitamin B levels in the body;
fractures of the hip, wrist, or spine, especially if the patient already has osteoporosis (reduced bone density) or if the doctor has determined that there is a risk of developing osteoporosis (e.g. if the patient is taking steroids);
decreased magnesium levels in the blood (possible symptoms: fatigue, involuntary muscle spasms, disorientation, seizures, dizziness, rapid heartbeat). Low magnesium levels may also lead to decreased potassium and calcium levels in the blood. If the medicine is used for longer than 4 weeks, the patient should consult a doctor. The doctor may order regular blood tests to monitor magnesium levels.

The patient should immediately inform the doctor before or after using this medicine if any of the following symptoms appear, which may indicate other, more serious conditions:

unintentional weight loss (not related to diet or physical exercise),
vomiting, especially recurrent,
vomiting blood; vomiting black material resembling coffee grounds,
blood in 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 the use of pantoprazole is associated with a slightly increased risk of infectious diarrhoea. If the patient develops a skin rash, especially in areas exposed to sunlight, they should inform the doctor as soon as possible, as discontinuation of Ranloc Med may be necessary. The patient should also report any other adverse reactions, such as joint pain.

The doctor may decide that additional tests are necessary.
If the patient is to have blood tests performed, they should inform the doctor about taking this medicine.
Symptoms related to reflux disease and heartburn may improve as early as on the first day of pantoprazole treatment; however, this medicine is not intended for immediate symptom relief.
It should not be used preventively.
If the patient has been suffering from recurrent heartburn or indigestion symptoms for some time, they should remain under regular medical supervision.

Children and adolescents
Ranloc Med should not be used in children and adolescents under 18 years of age due to lack of data on safety and efficacy in this age group.

Ranloc Med with other medicines
Tell your doctor or pharmacist about all other medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Ranloc Med may reduce the effectiveness of certain other medicines, especially those containing one of the following active substances:

HIV protease inhibitors, such as atazanavir, nelfinavir (used in the treatment of HIV infection). Ranloc Med must not be used concomitantly with HIV protease inhibitors. See "When not to use Ranloc Med";
ketoconazole (used in fungal infections);
warfarin and phenprocoumon (used to "thin" the blood and prevent blood clots). Additional blood tests may be required;
methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancer diseases). When methotrexate is used, the doctor may temporarily discontinue Ranloc Med, as pantoprazole may increase methotrexate levels in the blood.

Ranloc Med should not be used together with other medicines that reduce the amount of acid produced in the stomach, such as other proton pump inhibitors (omeprazole, lansoprazole, or rabeprazole) or H₂ antagonists (e.g. ranitidine, famotidine).
However, Ranloc Med may be used if necessary together with acid-neutralizing agents (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or their combinations).

Pregnancy, breastfeeding and fertility
This medicine should not be used if the patient is pregnant or breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
If the patient experiences adverse effects such as dizziness or visual disturbances, they should not drive or operate machinery.

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

3. How to use Ranloc Med

This medicine should always be used according to the information contained in this leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Take 1 tablet daily. Do not exceed the recommended daily dose of pantoprazole, which is 20 mg.
The medicine should be taken for at least 2-3 consecutive days. Treatment should be discontinued after symptoms have completely resolved. Relief of reflux and heartburn symptoms may occur as early as one day after starting pantoprazole; however, this medicine is not intended for immediate relief of symptoms.
Consult a doctor if symptoms do not improve after 2 weeks of continuous use of this medicine.
Do not take pantoprazole for longer than 4 weeks without consulting a doctor.
Take the tablet before a meal, at the same time each day. Swallow the tablet whole with water. Do not chew or crush the tablet.
Use of a higher than recommended dose of Ranloc Med
Seek immediate advice from a doctor or pharmacist if an overdose has occurred.
If possible, bring the medicine and this leaflet with you.
Missed dose of Ranloc Med
Do not take a double dose to make up for a missed dose. Take the next scheduled dose at the usual time the following day.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must immediately inform your doctor or contact the nearest hospital emergency department if any of the following serious adverse reactions occur. At the same time,
you should immediately stop taking this medicine and bring this leaflet and/or the tablets with you.

Severe allergic reactions (frequency: rare – may occur in no more than 1 in 1,000 people): hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock, and angioedema. Typical symptoms include: swelling of the face, lips, mouth, tongue, and/or throat, which may cause difficulty swallowing or breathing, urticaria (hives), severe dizziness with rapid heartbeat and profuse sweating.
Severe skin reactions (frequency unknown: cannot be estimated from available data): the patient may experience the following adverse reactions: rash with swelling, formation of skin blisters or skin peeling, exfoliative dermatitis, bleeding from the eyes, nose, mouth, or genital organs, sudden worsening of general condition, or rash particularly in sun-exposed areas of skin. Joint pain or flu-like symptoms, fever, swollen lymph nodes (e.g. under the arm) may also occur, and blood tests may show changes in white blood cell count or liver enzymes.
Other severe reactions (frequency unknown): yellowing of the skin and whites of the eyes (due to severe liver damage), or fever, rash, and kidney enlargement sometimes accompanied by painful urination and lower back pain (severe kidney inflammation), which may lead to kidney failure.

Other adverse reactions include:

Common (may occur in no more than 1 in 10 people): benign gastric polyps;
Uncommon (may occur in no more than 1 in 100 people): headache, dizziness, diarrhoea, nausea, vomiting, feeling of fullness in the abdomen and bloating with flatulence, constipation, dry mouth, abdominal pain and discomfort, rash or urticaria, itching of the skin, weakness, fatigue or general malaise, sleep disturbances, increased liver enzyme activity detected in blood tests; fracture of the hip, wrist, or spine.
Rare (may occur in no more than 1 in 1,000 people): disturbances or complete loss of taste sensation, visual disturbances such as blurred vision, joint pain, muscle pain, changes in body weight, elevated body temperature, swelling of limbs, allergic reactions, depression, increased levels of bilirubin and lipids in blood (detected in blood tests), breast enlargement in males; high fever and sudden decrease in circulating granulocytes – white blood cells (detected in blood tests).
Very rare (may occur in no more than 1 in 10,000 people): disturbances in orientation, decreased platelet count, which may lead to increased tendency to bleeding and development of skin petechiae (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 (detected in blood tests).
Frequency unknown (frequency cannot be estimated from available data): hallucinations, confusion (particularly in patients who have previously experienced such symptoms), decreased sodium, magnesium, calcium, and potassium levels (see section 2); rash possibly accompanied by joint pain; sensations of tingling, pricking, burning, or numbness; inflammation of the large intestine causing persistent watery diarrhoea.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 Med

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. The expiry date refers to the last day of the stated month.
There are no special storage instructions.
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 Med contains

The active substance is pantoprazole. One enteric-coated tablet contains 20 mg of pantoprazole (as sodium pantoprazole hemihydrate).
The other ingredients are:

Tablet core: anhydrous sodium carbonate, mannitol (E 421), crospovidone type A,
hydroxypropylcellulose, microcrystalline cellulose, calcium stearate
Tablet coating: 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 Med looks like and contents of the pack
Ranloc Med 20 mg enteric-coated tablets are whitish, oval, biconvex, coated with an acid-protective layer, smooth on both sides.
Cold-form blister packs: blister packs consist of OPA/Aluminium/PVC/Aluminium.
Ranloc Med is available in blister packs contained in cardboard boxes of 7 or 14 enteric-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warszawa
Poland

Manufacturer/Importer
S.C. Terapia S.A.
Str. Fabricii nr.124
Cluj Napoca, 400 632
Romania
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH, Hoofddorp
The Netherlands

The following lifestyle recommendations and dietary changes may also help alleviate heartburn or other symptoms related to gastric acid:

Avoid large meals.
Eat slowly.
Stop smoking.
Limit alcohol and caffeine intake.
Reduce body weight (in case of overweight).
Avoid tight clothing or belts.
Avoid eating meals less than three hours before lying down.
Sleep with the head elevated (in case of nocturnal symptoms).
Limit consumption of foods that commonly trigger heartburn, such as: chocolate, peppermint, spearmint, fatty and fried foods, acidic or spicy foods, citrus fruits and fruit juices, tomatoes.