Maalox for reflux

PACKAGE LEAFLET: INFORMATION FOR THE USER

MAALOX REFLUX 20 mg gastro-resistant tablets

Pantoprazole
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 2 weeks. You must not take MAALOX REFLUX tablets for more than 4 weeks without consulting a doctor.
  Contents of this leaflet:
  1. What MAALOX REFLUX is and what it is used for
  2. What you need to know before taking MAALOX REFLUX
  3. How to take MAALOX REFLUX
  4. Possible side effects
  5. How to store MAALOX REFLUX
  6. Contents of the pack and other information

1. What MAALOX REFLUX is and what it is used for

MAALOX REFLUX contains the active substance pantoprazole, which blocks the acid-producing "pump" in the stomach. As a result, it reduces the amount of acid in your stomach.
MAALOX REFLUX is used for the short-term treatment of reflux symptoms (such as heartburn, acid regurgitation) in adults.
Reflux is the backflow of stomach acid into the esophagus ("food pipe"), which may become inflamed and cause pain. This can lead to symptoms such as a painful burning sensation in the chest rising towards the throat (heartburn) and a sour taste in the mouth (acid regurgitation).
You may experience relief from acid reflux and heartburn symptoms as early as one day after starting treatment with MAALOX REFLUX, but this medicine is not intended to provide immediate relief.
You may need to take the tablets for 2–3 consecutive days before your symptoms improve.
Talk to your doctor if you do not feel better or if you feel worse after 2 weeks.

2. What you should know before taking MAALOX REFLUX

Do not take MAALOX REFLUX if:

• you are allergic to pantoprazole, peanuts, soy, or any of the other ingredients of this medicine (listed in section 6);
• you are taking HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of HIV infection); see “Other medicines and MAALOX REFLUX”.

Warnings and precautions

Talk to your doctor or pharmacist before taking MAALOX REFLUX if:

• you have liver problems or jaundice (yellowing of the skin or eyes);
• you have been treated for heartburn or indigestion continuously for 4 or more weeks;
• you are over 55 years old and take daily treatments for indigestion without a prescription;
• you are over 55 years old and have new or recently changed reflux symptoms;
• you have previously had a gastric ulcer or stomach surgery;
• you regularly see your doctor for serious health conditions;
• you are scheduled for an endoscopy or a breath test called C-urea test;
• you have previously experienced a skin reaction after treatment with a medicine similar to MAALOX REFLUX used to reduce stomach acid;
• you are scheduled for a specific blood test (chromogranin A);
• you are taking HIV protease inhibitors such as atazanavir or nelfinavir (for the treatment of HIV infection) together with pantoprazole; consult your doctor for specific recommendations.

Serious skin problems such as Stevens-Johnson syndrome (SJS), Lyell syndrome, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with pantoprazole use:

• Symptoms of SJS/Lyell syndrome may include blistering, peeling, or bleeding of the skin (including lips, eyes, mouth, nose, genitals, hands, or feet), with or without a rash. You may also experience flu-like symptoms such as fever, chills, or muscle pain.
• Signs and symptoms of DRESS may include flu-like symptoms and widespread rash accompanied by high fever and swollen lymph nodes. Abnormal blood test results may include elevated liver enzymes, increased levels of a type of white blood cells (eosinophilia), and swollen lymph nodes.

If you develop severe skin reactions or any of the above-listed reactions, stop treatment immediately and contact your doctor or a healthcare professional.

If you experience chest pain.

Do not take this medicine for longer than 4 weeks without consulting your doctor. If reflux symptoms (heartburn or acid regurgitation) persist for more than 2 weeks, consult your doctor, who will decide whether long-term use of this medicine is necessary.

Long-term use of MAALOX REFLUX may lead to additional risks such as:

• Reduced absorption of vitamin B12, and vitamin B12 deficiency if your body’s vitamin B12 reserves are already low;
• Fractures of the hip, wrist, or spine, especially if you already have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis);
• Reduced magnesium levels in the blood (possible symptoms: fatigue, involuntary muscle contractions, confusion, seizures, dizziness, rapid heartbeat). Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. Consult your doctor if you have been using this medicine for more than 4 weeks. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

Contact your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be signs of another, more serious condition:

• Unintentional weight loss (not related to diet or exercise program);
• Vomiting, especially if recurrent;
• Blood in vomit; this may appear dark, like coffee grounds;
• Blood in stools, which may appear black or tarry;
• Difficulty swallowing or pain when swallowing;
• Looking pale and feeling weak (anemia);
• Chest pain;
• Stomach ache;
• Severe and/or persistent diarrhea, as this medicine has been associated with a slight increase in infectious diarrhea.

Your doctor may decide that you need further tests.

If you are scheduled for a blood test, tell your doctor that you are taking this medicine.

You may experience relief from acid reflux and heartburn symptoms after only one day of treatment with MAALOX REFLUX, but this medicine is not designed to provide immediate relief. Do not take it as a preventive measure.

If you have suffered from recurrent heartburn or indigestion symptoms for some time, remember to see your doctor regularly.

If you develop a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to stop treatment with MAALOX REFLUX. Remember to also report other side effects such as joint pain.

Children and adolescents

MAALOX REFLUX must not be used in children and adolescents under 18 years of age due to lack of safety data in this younger age group.

Other medicines and MAALOX REFLUX

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. MAALOX REFLUX may interfere with the proper functioning of other medicines. Inform your doctor or pharmacist if you are taking medicines containing any of the following active substances:

• HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of HIV infection). You must not use MAALOX REFLUX if you are taking HIV protease inhibitors. See “Do not take MAALOX REFLUX”.
• Ketoconazole (used for fungal infections);
• Warfarin and phenprocoumon (used to thin the blood and prevent clots). You may need additional blood tests;
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily stop treatment with MAALOX REFLUX, as pantoprazole may increase methotrexate levels in the blood.

Do not take MAALOX REFLUX with other medicines that reduce stomach acid production, such as another proton pump inhibitor (e.g., omeprazole, lansoprazole, or rabeprazole) or an H2 antagonist (e.g., ranitidine, famotidine). However, if necessary, you may take MAALOX REFLUX with antacids (e.g., magnesium hydroxide, alginic acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate, or their combinations).

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or breastfeeding. If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

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

MAALOX REFLUX contains maltitol, soy lecithin, and sodium

If your doctor has told you that you are intolerant to certain sugars, consult your doctor before taking this medicine. MAALOX REFLUX contains soy lecithin. If you are allergic to peanuts or soy, do not use this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially “sodium-free”.

3. How to take MAALOX REFLUX

Take this medicine exactly as described in this leaflet and/or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet per day. Do not exceed this recommended dose of 20 mg of pantoprazole per day.
You should take this medicine for at least 2–3 consecutive days. Stop taking MAALOX REFLUX when your symptoms have resolved. You may experience relief from acid reflux and heartburn symptoms as soon as one day after starting treatment with MAALOX REFLUX; however, this medicine is not designed to provide immediate relief.
If you do not experience any symptom relief after taking this medicine continuously for 2 weeks, consult your doctor. Do not take MAALOX REFLUX for more than 4 weeks without consulting your doctor.
Take the tablet before a meal, at the same time each day. Swallow the tablet whole with some water. Do not chew or break the tablet.
If you take more MAALOX REFLUX than you should
Consult your doctor or pharmacist if you have taken more than the recommended dose. If possible, bring the medicine and this patient information leaflet with you.
If you forget to take MAALOX REFLUX
Do not take a double dose to make up for the missed dose. Take your next normal dose the following day at the usual time.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Consult your doctor immediately or contact the nearest hospital emergency department if you experience any of the following serious side effects. Stop taking this medicine immediately, but bring this leaflet and/or the tablets with you.

• Severe allergic reactions (uncommon frequency: may affect up to 1 in 1,000 people): hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock and angioedema. Typical symptoms are: swelling of the face, lips, mouth, tongue and/or throat, which may cause difficulty in swallowing or breathing, hives, severe dizziness with very rapid heartbeat and profuse sweating.
• Severe skin reactions (frequency not known: frequency cannot be determined from the available data):
• Symptoms of SJS/Lyell syndrome may include blistering, peeling or bleeding of the skin (including lips, eyes, mouth, nose, genitals, hands or feet), with or without a rash. You may also experience flu-like symptoms such as fever, chills or muscle pain. Signs and symptoms of DRESS may include flu-like symptoms and widespread rash accompanied by high body temperature and swollen lymph nodes. Abnormal blood test results may include

elevated liver enzyme levels and increased levels of a type of white blood cells (eosinophilia), as well as swollen lymph nodes.
Other serious side effects (frequency not known: frequency cannot be determined from the available data): yellowing of the skin and eyes (due to severe liver damage), or kidney problems such as pain during urination and lower back pain with fever.
During treatment with the active substance in MAALOX REFLUSSO, the following side effects have been observed:
Common (may affect up to 1 in 10 people)
benign gastric polyps
Uncommon (may affect up to 1 in 100 people)
headache; dizziness; diarrhoea; feeling unwell, vomiting; bloating and flatulence (meteorism); constipation; dry mouth; stomach ache and discomfort; skin rash or hives; itching; feeling of weakness, fatigue or general malaise; sleep disturbances; increased liver enzymes in blood tests; fracture of the hip, wrist or spine.
Rare (may affect up to 1 in 1,000 people):

• altered or complete loss of taste sensation; visual disturbances such as blurred vision; joint pain; muscle pain; weight changes; increased body temperature; swelling of the extremities; allergic reactions; depression; increased levels of bilirubin and fat in the blood (detected in blood tests); breast enlargement in men; high fever and severe decrease in circulating granulocytes (observed in blood tests). Very rare (may affect up to 1 in 10,000 people):
• disorientation; reduced platelet count in the blood, which may lead to increased bleeding or bruising; reduced white blood cell count, which may result in more frequent infections; abnormal concurrent reduction in red blood cells, white blood cells and platelets (observed in blood tests). Frequency not known (frequency cannot be determined from the available data):
• hallucinations, confusion (especially in patients with a history of these symptoms); decreased sodium levels in the blood; decreased magnesium levels in the blood; tingling sensation, prickling, pinpricks, burning or numbness; inflammation of the large intestine causing persistent watery diarrhoea.
• chest pain, which may be a sign of, or a serious allergic reaction called Kounis syndrome. Reporting of side effects If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MAALOX REFLUSSO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the blister, on the bottle, and on the carton. The expiry date refers to the last day of that month.
For tablets packaged in plastic bottles: MAALOX REFLUSSO must be used within three months after first opening the container.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What MAALOX REFLUSSO contains

• The active substance is pantoprazole. Each tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).
• The other components are: Core: maltitol (E965), crospovidone type B, sodium carmellose, anhydrous sodium carbonate, calcium stearate. Coating: Poly(vinyl alcohol), talc, titanium dioxide (E 171), macrogol 3350, soybean lecithin, yellow iron oxide (E 172), anhydrous sodium carbonate, methacrylic acid-ethyl acrylate copolymer (1:1) (dispersion containing polysorbate 80 and sodium lauryl sulfate), triethyl citrate.

Description of the appearance of MAALOX REFLUSSO and pack sizes
Gastro-resistant tablets are yellow and oval, approximately 8.2 x 4.4 mm.
MAALOX REFLUSSO is available in OPA/Alu/PVC-Aluminium blisters or in HDPE bottles. Packs containing 7 or 14 gastro-resistant tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/b
20158 Milano, Italy

Manufacturer
Opella Healthcare Poland Sp. z o.o.
Rzeszów Branch
Ul. Lubelska 52
35-223 Rzeszów, Poland

This medicinal product is authorised in the European Union Member States under the following names:
Belgium: Maalox Control 20 mg gastro-resistant tablets
Estonia: Ipraalox
France: Ipraalox 20 mg gastro-resistant tablets
Italy: Maalox Reflusso 20 mg gastro-resistant tablets
Lithuania: Ipraalox 20 mg skrandyje neirios tabletės
Latvia: Ipraalox 20 mg zarnās šķīstošā tablete
Netherlands: Ipraalox 20 mg maagsapresistente tabletten
Romania: Dicarbocalm Control 20 mg comprimate gastrorezistente

The following lifestyle and dietary recommendations may also help relieve symptoms associated with heartburn and acid reflux:

• Avoid large meals
• Eat slowly
• Stop smoking
• Reduce alcohol and caffeine intake
• Lose weight (if overweight)
• Avoid tight clothing or belts
• Avoid eating at least three hours before going to bed
• Elevate the head of the bed (if symptoms occur at night)
• Reduce consumption of foods that may cause heartburn. These may include: chocolate, peppermint, spearmint, fatty and fried foods, acidic foods, spicy foods, citrus fruits and fruit juices, tomatoes.