Ranloc Med

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

The active substance of Ranloc Med is pantoprazole, which blocks the "pump" that produces stomach acid.
This way, the medicine reduces the amount of acid in the stomach.
Ranloc Med is used for short-term treatment of symptoms of gastroesophageal reflux disease (such as heartburn, acid reflux) in adults.
Reflux occurs when stomach acid flows back into the esophagus, which can lead to inflammation of the esophagus and cause pain. Other symptoms may also occur, such as painful burning in the chest that can spread to the throat (heartburn) and a sour taste in the mouth (acid reflux).
Symptoms related to reflux disease and heartburn may improve after the first day of taking pantoprazole, but this medicine is not intended for immediate relief of symptoms. To achieve complete relief of symptoms, it may be necessary to take the tablets for 2-3 consecutive days.
If after 2 weeks there is no improvement or you feel worse, you should contact your doctor.

2. Important information before taking Ranloc Med

When not to take Ranloc Med:

• if you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6),
• if you are taking HIV protease inhibitors such as atazanavir, nelfinavir (used to treat HIV infection). See "Ranloc Med and other medicines".

Warnings and precautions

Before starting to take pantoprazole, you should consult your doctor if:

• you have been treated for heartburn or indigestion continuously for 4 or more weeks
• you are over 55 years old and take over-the-counter indigestion medicines every day
• you are over 55 years old and have noticed new symptoms or a change in the nature of existing symptoms
• you have had stomach ulcers or stomach surgery
• you have liver disease or jaundice (yellowing of the skin or eyes)
• you are under regular medical supervision for other serious conditions or diseases
• you are going to have an endoscopy or urea breath test
• you have ever had a skin reaction after taking a medicine similar to Ranloc Med, which reduces stomach acid production
• you are going to have a specific blood test (chromogranin A levels).
• if you are taking HIV protease inhibitors such as atazanavir or nelfinavir (used to treat HIV infection) at the same time as pantoprazole, you should ask your doctor for specific advice.

You should not take this medicine without consulting your doctor for a period longer than 4 weeks. If the symptoms of reflux disease (heartburn or acid reflux) persist for more than 2 weeks, you should consult your doctor, who will decide whether long-term use of the medicine 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;
• hip, wrist, or spine fractures, especially if you already have osteoporosis (reduced bone density) or if your doctor has determined that you are at risk of osteoporosis (e.g., if you are taking steroids);
• decreased magnesium levels in the blood (possible symptoms: fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat). Low magnesium levels can also lead to decreased potassium and calcium levels in the blood. If you are taking the medicine for more than 4 weeks, you should consult your doctor. Your doctor may order regular blood tests to monitor magnesium levels.

You should immediately inform your doctorbefore or after taking this medicine if you notice the occurrence of the following symptoms, which may be signs of other, more serious diseases:

• unintentional weight loss (not related to diet or exercise)
• vomiting, especially recurring
• vomiting blood; vomiting black material resembling coffee grounds
• blood in stool; black or tarry stools
• difficulty swallowing or pain when swallowing
• pallor and weakness (anemia)
• chest pain
• abdominal pain
• severe and/or persistent diarrhea, as pantoprazole use is associated with a slight increase in the risk of infectious diarrhea. If you experience a skin rash, especially in areas exposed to sunlight, you should tell your doctor as soon as possible, as it may be necessary to discontinue the use of Ranloc Med. You should also tell your doctor about any other side effects, such as joint pain.

Your doctor may decide to perform additional tests.
If you are going to have a blood test, you should inform your doctor that you are taking this medicine.
Symptoms related to reflux disease and heartburn may improve after the first day of taking pantoprazole, but this medicine is not intended for immediate relief of symptoms.
You should not take it as a preventive measure.
If you have been suffering from recurring heartburn or indigestion for some time, you 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 the lack of data on the safety of use of this medicine in this age group.

Ranloc Med and other medicines

You should tell your doctor or pharmacist about all othermedicines you are currently taking or have recently taken, as well as any medicines you plan to take. Ranloc Med may reduce the effectiveness of some other medicines, especially those containing the following active substances:

• HIV protease inhibitors, such as atazanavir, nelfinavir (used to treat HIV infection). You should not take Ranloc Med at the same time as HIV protease inhibitors. See "When not to take Ranloc Med";
• ketokonazole (used to treat fungal infections);
• warfarin and phenprocoumon (used to "thin" the blood and prevent blood clots). Additional blood tests may be necessary;
• methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily discontinue the use of Ranloc Med, as pantoprazole may increase methotrexate levels in the blood.

You should not take Ranloc Med with other medicines that reduce the amount of stomach acid, such as other proton pump inhibitors (omeprazole, lansoprazole, or rabeprazole) or H2 antagonists (e.g., ranitidine, famotidine).
However, Ranloc Med can be taken with antacids (e.g., magaldrate, alginic acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate, or their combinations) if necessary.

Pregnancy, breastfeeding, and fertility

You should not take this medicine if you are pregnant or breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

If you experience side effects such as dizziness or vision disturbances, you should not drive or operate machinery.

Ranloc Med contains sodium

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

3. How to take Ranloc Med

This medicine should always be taken in accordance with the information in this leaflet or as directed by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.
You should take 1 tablet per day. 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 stopped after complete relief of symptoms. It is possible to experience relief of reflux and heartburn symptoms after just one day of taking pantoprazole, but this medicine is not intended for immediate relief of symptoms.
You should consult your doctor if, after taking this medicine continuously for 2 weeks, symptoms do not improve.
You should not take pantoprazole for more than 4 weeks without consulting your doctor.
The tablet should be taken before a meal, at the same time every day. The tablet should be swallowed whole, with water. Do not chew or crush it.

Taking a higher dose of Ranloc Med than recommended

You should immediately consult your doctor or pharmacist if you have taken more than the recommended dose.
If possible, you should bring the medicine and the leaflet with you.

Missing a dose of Ranloc Med

You should not take a double dose to make up for a missed dose. You should take the next scheduled dose the next day, at the usual time.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should immediately inform your doctoror contact the nearest hospital emergency department if you experience any of the following serious side effects. At the same time, you should stop taking this medicine and bring this leaflet and/or the tablets with you.

• Severe allergic reactions (rare: may occur in less than 1 in 1000 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, hives, severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency not known: cannot be estimated from the available data):you may observe the following side effects: rash with swelling, blistering, or peeling of the skin, patchy skin peeling and bleeding from the eyes, nose, mouth, or genitals, and sudden worsening of your general condition or rash, especially in areas of skin exposed to sunlight. You may also experience joint pain or flu-like symptoms, fever, swollen lymph nodes (e.g., under the arm), and changes in white blood cell or liver enzyme levels in blood tests.
• Other severe reactions (frequency not known):yellowing of the skin and whites of the eyes (due to severe liver damage) or fever, rash, and kidney enlargement, sometimes with painful urination, and lower back pain (severe kidney inflammation), which can lead to kidney failure.

Other side effects include:

• common (may occur in less than 1 in 10 people):mild stomach polyps;
• uncommon (may occur in less than 1 in 100 people):headache, dizziness, diarrhea, nausea, vomiting, feeling of fullness in the stomach and bloating with gas, constipation, dry mouth, stomach pain and discomfort, rash or hives, itching, weakness, fatigue, or general feeling of being unwell, sleep disturbances, increased liver enzyme activity in blood tests; hip, wrist, or spine fractures.
• rare (may occur in less than 1 in 1000 people):disturbances or complete loss of taste, vision disturbances, such as blurred vision, joint pain, muscle pain, changes in body weight, increased body temperature, swelling of limbs, allergic reactions, depression, increased bilirubin and lipid levels in the blood (detected in blood tests), breast enlargement in men; high fever and sudden decrease in the number of circulating granulocytes - white blood cells (detected in blood tests).

very rare (may occur in less than 1 in 10,000 people):disturbances of orientation, decreased platelet count, which may cause increased tendency to bleeding and bruising, decreased white blood cell count, which may predispose to more frequent infections, concurrent, abnormal decrease in the number of red and white blood cells, as well as platelets (detected in blood tests).

• frequency not known (frequency cannot be estimated from the available data):hallucinations, confusion (especially in patients who have experienced such symptoms before), decreased sodium, magnesium, calcium, and potassium levels (see section 2); rash that may be associated with joint pain; feeling of tingling, prickling, burning, or numbness, inflammatory bowel disease causing persistent watery diarrhea.

Reporting side effects
If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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 authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ranloc Med

The medicine should be stored 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 month.
There are no special storage requirements.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ranloc Med contains

• The active substance of Ranloc Med is pantoprazole. One gastro-resistant tablet contains 20 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).
• Other ingredients are:

Core of the tablet: anhydrous sodium carbonate, mannitol (E 421), crospovidone type A, hydroxypropylcellulose, microcrystalline cellulose, calcium stearate
Coating of the tablet: 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 Med looks like and contents of the pack

Ranloc Med 20 mg gastro-resistant tablets are white, oval, biconvex, coated with a protective layer against stomach acid, smooth on both sides.
Cold-form blisters: blister packs consist of OPA/Aluminum/PVC/Aluminum.
Ranloc Med is available in blisters, placed in cardboard boxes, containing 7 or 14 gastro-resistant tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego 16
00-710 Warsaw

Manufacturer/importer

S.C. Terapia S.A.
Fabricii Street 124
Cluj Napoca, 400 632
Romania
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH, Hoofddorp
Netherlands
Date of last revision of the leaflet:02.05.2023
The following lifestyle and dietary recommendations may also help alleviate heartburn or other acid-related symptoms:

• Avoiding heavy meals.
• Eating slowly.
• Quitting smoking.
• Limiting alcohol and caffeine consumption.
• Losing weight (if overweight).
• Avoiding tight clothing or belts.
• Avoiding eating meals later than three hours before bedtime.
• Sleeping with your head elevated (if you experience nighttime symptoms).
• Limiting consumption of foods that usually trigger heartburn, such as: chocolate, peppermint, spearmint, fatty and fried foods, acidic, spicy, citrus fruits and juices, tomatoes.