MAALOX 20 mg Enteric-Coated Tablet

Зміст інструкції

1. MAALOX REFLUSSO 20 mg gastro-resistant tablets
   1. What MAALOX REFLUSSO is and what it is used for
   2. What you need to know before taking MAALOX REFLUSSO
   3. How to take MAALOX REFLUSSO
   4. Possible side effects
   5. How to store MAALOX REFLUSSO
   6. Contents of the pack and other information

MAALOX REFLUSSO 20 mg gastro-resistant tablets

Pantoprazole

Read this leaflet carefully before you start taking this medicine as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

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

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

MAALOX REFLUSSOcontains the active ingredient pantoprazole, which blocks the ‘pump’ that
produces acid in the stomach. Therefore, it reduces the amount of acid in your stomach.

MAALOX REFLUSSOis used for the short-term treatment of symptoms of reflux (such
as heartburn, acid regurgitation) in adults.
Reflux is the return of acid from the stomach into the esophagus (“food pipe”), which can
become inflamed and cause pain. This can cause symptoms such as a painful burning
sensation in the chest that rises towards the throat (heartburn) and an acidic taste in the mouth
(acid regurgitation).
You may experience relief from symptoms related to acid reflux and heartburn as early as
one day after treatment with MAALOX REFLUSSO, but this medicine is not designed to
provide immediate relief.
You may need to take the tablets for 2-3 consecutive days to improve your
symptoms.
See a doctor if you do not feel better or if you feel worse after 2 weeks.

2. What you need to know before taking MAALOX REFLUSSO

Do not takeMAALOXREFLUSSO:
if you are allergic to pantoprazole, peanuts, soy or any other of the ingredients
of this medicine (listed in section 6);
if you are taking HIV protease inhibitors such as atazanavir, nelfinavir (for the
treatment of HIV infection), see “Other medicines and MAALOX REFLUSSO”

Warnings and precautions
Talk to your doctor or pharmacist before taking MAALOX REFLUSSO
If you have problems with your liver or jaundice (yellowing of the skin or eyes).
If you have been treated for heartburn or indigestion continuously for 4 or more
weeks.
If you are over 55 years old and take daily treatments for indigestion without a prescription.
If you are over 55 years old and have new symptoms of reflux or that have recently changed.
If you have previously had a stomach ulcer or operations on the stomach.
If you regularly see a doctor for serious health problems or conditions.
If you are going to have an endoscopy or a breath test called a C-urea test.
If you have had a skin reaction after treatment with a medicine similar to MAALOX
REFLUSSO to reduce stomach acid.
If you are going to have a specific blood test (Chromogranin A).
If you are taking HIV protease inhibitors such as atazanavir, nelfinavir (for the
treatment of HIV infection) at the same time as pantoprazole, talk to your
doctor for specific recommendations.
Serious skin problems such as Stevens-Johnson syndrome (SJS), Lyell's syndrome and drug reaction with eosinophilia
and systemic symptoms (DRESS) have been reported with the use of pantoprazole:
o The symptoms of SJS/Lyell's syndrome may include blistering, peeling or bleeding on any part 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 aches.
o The 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 increased
levels of liver enzymes and an increase in a type of white blood cells (eosinophilia) and
swollen lymph nodes.
If you develop severe skin reactions or any of the reactions listed above, stop
treatment immediately and contact your doctor or healthcare professional.
If you experience chest pain.
Do not take this medicine for more than 4 weeks without consulting your doctor. If your symptoms of
reflux (heartburn or acid regurgitation) persist for more than 2 weeks, see your
doctor who will decide if you need to take this medicine long term.
Taking MAALOX REFLUSSOfor prolonged periods may cause additional risks
such as:
Reduced absorption of vitamin B12, and vitamin B12 deficiency if your body's stores of vitamin B12 are already reduced.
Fracture of the hip, wrist or spine, especially if you already suffer from
osteoporosis or are taking corticosteroids (which can increase the risk of
osteoporosis).
Reduction of magnesium levels in the blood (possible symptoms: fatigue, involuntary muscle contractions, confusion, convulsions, dizziness, rapid heartbeat). Low levels of magnesium can also lead to a reduction in levels of
potassium or calcium in the blood. See your doctor if you are using this medicine
for more than 4 weeks. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

Immediately tell your doctor, before or after taking this medicine, if you notice
any of the following symptoms, which may be a sign of another, more serious, disorder:
Unintentional weight loss (not related to a diet or exercise program).
Vomiting, especially if recurrent.
Presence of blood in the vomit; this may appear dark in color like coffee grounds.
Presence of blood in the stool, which may appear black or like tar.
Difficulty swallowing or pain when swallowing.
You appear pale and feel weak (anemia).
Chest pain.
Stomach pain.
Severe and/or persistent diarrhea, because this medicine has been associated with a slight
increase in infectious diarrhea.
The doctor may decide that you need some tests.
If you are going to have a blood test, tell your doctor that you are taking this medicine.
You may experience relief from symptoms of acid reflux and heartburn after only one day of
treatment with MAALOX REFLUSSO, but this medicine is not designed to provide
immediate relief. You should not take it as a preventative 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 areas exposed to the sun, consult your
doctor as soon as possible, as you may need to stop treatment with
MAALOX REFLUSSO. Remember to also mention other negative effects such as joint pain.

Children and adolescents
MAALOX REFLUSSO should not be used by children and adolescents under 18 years
of age due to the lack of safety data in this younger age group.

Other medicines and MAALOX REFLUSSO
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. MAALOX REFLUSSOmay prevent other medicines from
working properly. Tell your doctor or pharmacist if you are taking medicines
containing any of the following active ingredients:

• HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of HIV infection). You should not use MAALOX REFLUSSO if you are taking HIV protease inhibitors. See “Do not take MAALOX REFLUSSO”.
• Ketoconazole (used for fungal infections).
• Warfarin and phenprocoumone (used to thin the blood and prevent clots). You may need further blood tests.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis and cancer) - if you are taking methotrexate your doctor may temporarily stop treatment with MAALOX REFLUSSO because pantoprazole can increase methotrexate levels in the blood. Do not take MAALOX REFLUSSOwith other drugs that limit the amount of acid produced in the stomach, such as another proton pump inhibitor (omeprazole, lansoprazole or rabeprazole) or an H2 antagonist (e.g. ranitidine, famotidine). However, if necessary, you can take MAALOX REFLUSSOwith antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate, or their combinations). Pregnancy and breastfeedingDo not take this medicine if you are pregnant or breastfeeding. If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machinesIf you experience side effects such as dizziness or vision disturbances, you should not drive or operate machinery. MAALOX REFLUSSOcontains maltitol, soy lecithin and sodiumIf your doctor has told you that you are intolerant to some sugars, contact your doctor before taking this medicine. MAALOX REFLUSSOcontains 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, which is
essentially “sodium-free”.

3. How to take MAALOX REFLUSSO

Take this medicine following exactly the instructions in this leaflet and/or the instructions of 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 must take this medicine for at least 2-3 consecutive days. Stop taking MAALOX

REFLUSSOwhen you no longer have any symptoms. You may experience relief from symptoms related to
acid reflux and heartburn as early as one day of treatment with MAALOX

REFLUSSO, but this medicine is not designed to provide immediate relief.
If you do not experience any relief of symptoms after taking this medicine continuously for 2 weeks, consult your doctor. Do not take MAALOX REFLUSSOfor more than 4 weeks without
consulting your doctor.
Take the tablet before a meal, at the same time each day. You must swallow the
tablet whole with a little water. Do not chew or break the tablet.

If you take moreMAALOX REFLUSSOthan you should
Consult your doctor or pharmacist if you have taken more than the recommended dose. If possible, bring with

If you forget to takeMAALOX REFLUSSO
Do not take a double dose to make up for a missed dose. Take the normal
dose next day, at the scheduled time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Consult your doctor immediatelyor contact the nearest hospital emergency room if you experience any of the following serious side effects. Stop taking it immediately

• Serious allergic reactions (rare frequency:can 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 can cause difficulty swallowing or breathing, urticaria, severe dizziness with a very fast heartbeat and profuse sweating.
• Severe skin reactions (frequency not known:frequency cannot be defined based on available data):
• The symptoms of SJS/Lyell syndrome may include the appearance of blisters, peeling or bleeding on any part 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 aches. The signs and symptoms of DRESS may include flu-like symptoms and widespread rash accompanied by high body temperature and enlarged lymph nodes. Abnormal blood test results may include

an increase in liver enzyme levels and an increase in a type of white blood cells (eosinophilia) and enlarged lymph nodes.

Other serious side effects (frequency not known:frequency cannot be defined based on available data): yellowing of the skin and eyes (due to severe liver damage), or kidney problems such as pain when urinating and lower back pain with fever. During treatment with the active substance of MAALOX REFLUSSO, the following side effects have been observed:

Common(may affect up to 1 in 10 people)
benign polyps in the stomach

Uncommon(may affect up to 1 in 100 people)
headache; dizziness; diarrhea; feeling unwell, vomiting; bloating and flatulence (meteorism); constipation; dry mouth; stomach pain and discomfort; skin rash or urticaria; itching; feeling weak, tired or generally unwell; sleep disturbances; increased liver enzymes in blood tests hip, wrist or spine fracture.

Rare(may affect up to 1 in 1,000 people):

• alteration or complete loss of sense of taste; vision disorders 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 number of platelets in the blood, which can cause bleeding or bruising more frequently than normal; reduced number of white blood cells, which can lead to more frequent infections; simultaneous abnormal reduction in the number of red blood cells and white blood cells, as well as platelets (observed in blood tests). Frequency not known(frequency cannot be defined based on available data):
• hallucinations, confusion (especially in patients with a history of these symptoms); decreased levels of sodium in the blood; decreased level of magnesium in the blood, sensation of tingling, prickling, pinpricks, burning or numbness; inflammation of the colon, causing persistent watery diarrhea.
• chest pain, which may be a sign of a serious allergic reaction called Kounis syndrome. Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 or the bottle and
on the packaging. The expiry date refers to the last day of that month.
For tablets packaged in plastic bottles: MAALOX REFLUSSOmust be
used within three months of first opening the container.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What the medicine containsMAALOX REFLUSSO

• The active ingredient is pantoprazole. Each tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).
• The other ingredients are: Core:maltitol (E965), crospovidone type B, sodium carboxymethylcellulose, 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, ethyl-acrylate copolymer acidic methacrylate (1:1), (dispersion containing polysorbate 80 and sodium lauryl sulfate), triethyl citrate. Description of the appearance ofMAALOX REFLUSSOand contents of the packThe gastro-resistant tablets are yellow and oval, approximately 8.2 x 4.4 mm. MAALOX REFLUSSOis 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 Authorisation HolderOpella Healthcare Italy S.r.l. Viale L. Bodio, 37/b 20158 Milano ManufacturerOpella Healthcare Poland Sp. z o. o. Oddział w Rzeszowie Ul. Lubelska 52 35-223 Rzeszów, Poland

This medicinal product is authorised in the Member States of the European Community with 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 gastro-resistant tablets
The following recommendations regarding lifestyle and dietary changes
can also help relieve symptoms associated with heartburn and acidity.

• 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 bedtime
• Raise the head of the bed (if symptoms occur at night)
• Reduce the intake of foods that can cause heartburn. These may include: chocolate, peppermint, spearmint, fatty and fried foods, acidic foods, spicy foods, citrus fruits and juices, tomatoes.