ZOLEMER 20 mg Tabletka Powlekana

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1. ZOLEMER REFLUSSO 20 mg gastro-resistant tablets
   1. What is ZOLEMER REFLUSSO and what it is used for
   2. What you need to know before taking ZOLEMER REFLUSSO
   3. How to take ZOLEMER REFLUSSO
   4. Possible side effects
   5. How to store ZOLEMER REFLUSSO
   6. Package Contents and Other Information

ZOLEMER REFLUSSO 20 mg gastro-resistant tablets

Pantoprazole

Read this leaflet carefully before 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 you do not feel better or if your symptoms worsen after 2 weeks.
• Do not take ZOLEMER REFLUSSO tablets for more than 4 weeks without consulting your doctor.

Contents of this leaflet:

• 1. What ZOLEMER REFLUSSO is and what it is used for
• 2. What you need to know before you take ZOLEMER REFLUSSO
• 3. How to take ZOLEMER REFLUSSO
• 4. Possible side effects
• 5. How to store ZOLEMER REFLUSSO
• 6. Contents of the pack and other information

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

ZOLEMER REFLUSSO contains the active ingredient pantoprazole, which blocks the ‘pump’ that produces acid in the
stomach. Therefore, it reduces the amount of acid in your stomach.
ZOLEMER REFLUSSO is 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 of symptoms related to acid reflux and heartburn after just one
day of treatment with ZOLEMER REFLUSSO, but this medicine is not studied to provide immediate
relief. You may need to take the tablets for 2-3 consecutive days to improve
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 ZOLEMER REFLUSSO

Do not take ZOLEMERREFLUSSO:

• if you are allergic to pantoprazole, peanuts or soy or to any of the other ingredients of this medicine (listed in section 6);
• if you are taking a medicine containing atazanavir (for the treatment of HIV infection). See “Other medicines and ZOLEMER REFLUSSO”.

Warnings and precautions
Talk to your doctor or pharmacist before taking ZOLEMER REFLUSSO

• if you have been treated for heartburn or indigestion continuously for 4 or more weeks;
• if you are over 55 years old and take indigestion medicines daily without a prescription;
• if you are over 55 years old and experience new or recently changed reflux symptoms;
• if you have previously had a stomach ulcer or operations on the stomach;
• if you have problems with your liver or jaundice (yellowing of the skin or eyes);
• if you regularly visit your doctor for serious health problems or conditions;
• if you are going to undergo an endoscopy or a breath test called a C-urea test;
• if you have ever had a skin reaction after treatment with a medicine similar to ZOLEMER REFLUSSO that reduces stomach acid;
• if you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as you may need to stop treatment with ZOLEMER REFLUSSO. Also remember to report any other undesirable effects such as joint pain;
• if you are going to undergo a specific blood test (Chromogranin A).

Taking ZOLEMER REFLUSSO for prolonged periods may cause additional risks such as:

• reduction of magnesium levels in the blood (possible symptoms: fatigue, involuntary muscle contractions, confusion, convulsions, dizziness, increased heart rate). Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Talk to 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.

Tell your doctor immediately,before or after taking this medicine, if you notice any of the
following symptoms, which may be a sign of another, more serious, disorder:

• an involuntary weight loss (not related to a diet or exercise program);
• vomiting, especially if recurrent;
• presence of blood in the vomit; this may appear dark like coffee grounds;
• presence of blood in the stool; which may appear black or tarry;
• difficulty swallowing or pain when swallowing;
• you appear pale and feel weak (anemia);
• chest pain;
• stomach pain;
• severe and/or persistent diarrhea, because pantoprazole has been associated with a slight increase in infectious diarrhea. Your 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 of symptoms related to acid reflux and heartburn after just
one day of treatment with ZOLEMER 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 for some time, remember to see
your doctor regularly.

Children and adolescents
ZOLEMER REFLUSSO should not be used in children and adolescents under 18 years of age due to
lack of safety information in this younger age group.

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

• atazanavir (used for the treatment of HIV infection). You should not use ZOLEMER REFLUSSO if you are taking atazanavir. See “Do not take ZOLEMER REFLUSSO”;
• ketoconazole (used for fungal infections);
• warfarin and phenprocoumon (used to thin the blood and prevent clots). You may need further blood tests;
• methotrexate (used for the treatment of rheumatoid arthritis, psoriasis and cancer) - if you are taking methotrexate your doctor may temporarily suspend treatment with ZOLEMER REFLUSSO as pantoprazole may increase methotrexate levels in the blood.

Do not take ZOLEMER REFLUSSO with other medicines 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 ZOLEMER REFLUSSO with antacids (e.g. magaldrate, 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 or are planning a
pregnancy, or if you are breastfeeding, 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 use machines.

ZOLEMER REFLUSSO contains maltitol
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this
medicine.

ZOLEMER REFLUSSO contains soy lecithin
If you are allergic to peanuts or soy, do not use this medicine.

ZOLEMER REFLUSSO contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per gastro-resistant tablet, i.e.
essentially ‘sodium-free’.

3. How to take ZOLEMER REFLUSSO

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet a day. Do not exceed this recommended dose of 20 mg of pantoprazole a day.
You must take this medicine for at least 2-3 consecutive days. Stop taking ZOLEMER REFLUSSO when you no longer have any symptoms. You may experience relief of symptoms related to acid reflux and heartburn as early as one day of treatment with ZOLEMER 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 ZOLEMER REFLUSSO for 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 more ZOLEMER REFLUSSO than you should
Consult your doctor or pharmacist immediately if you have taken more than the recommended dose. If possible, bring with you the

If you forget to take ZOLEMER REFLUSSO
Do not take a double dose to make up for a missed dose. Take the next normal dose the next day, at the scheduled time.
If you have any doubts about 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 everybody gets them.

Consult a doctor immediatelyor contact the nearest hospital emergency room if you experience any of the following serious side effects.Stop taking this medicine immediately, but take it with you

• Serious allergic reactions (rare: 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 can cause difficulty swallowing or breathing, urticaria (skin rash), severe dizziness with a very fast and strong heartbeat and profuse sweating.
• Severe skin reactions (frequency not known: frequency cannot be estimated based on available data):skin rash with swelling, appearance of blisters or detachment of the skin, scaling and bleeding around the eyes, nose, mouth or genitals and rapid deterioration of general health conditions, or rash when exposed to the sun.
• Other serious side effects (frequency not known):yellowing of the skin or eyes (due to severe liver damage), or kidney problems such as pain when urinating and lower back pain with fever.

Other side effects include:

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; weakness,
fatigue or general malaise; sleep disorders; increased liver enzymes in blood tests.

Rare (may affect up to 1 in 1,000 people):
alteration or complete loss of taste; visual disturbances such as blurred vision; joint pain; muscle pain; weight changes; increased body temperature; swelling of the
extremities; depression; increased bilirubin and fat levels in the blood (detected in blood tests); breast enlargement in men; high fever and a sharp 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
easily than normal; reduced number of white blood cells, which can lead to more frequent infections; coexisting
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 estimated based on available data):
skin rash, with possible joint pain (subacute cutaneous lupus erythematosus), hallucinations,
confusion (especially in patients who have already experienced these symptoms); decreased levels of sodium in
the blood; decreased level of magnesium in the blood; inflammation of the large intestine, causing
persistent watery diarrhea, a sensation of tingling, prickling, pinpricks, burning or
numbness.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the
national reporting system at https://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 ZOLEMER 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 a plastic bottle: ZOLEMER REFLUSSO must be used within three months
after the first opening of 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 eliminate the
medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What ZOLEMERREFLUSSOcontains

• The active ingredient is pantoprazole. Each tablet contains 20 mg of pantoprazole (as sesquihydrate sodium).
• The other ingredients are: CoreMaltitol (E965), crospovidone type B, sodium carboxymethylcellulose, anhydrous sodium carbonate, calcium stearate. CoatingPolyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350, soybean lecithin, yellow iron oxide (E172), anhydrous sodium carbonate, acrylic acid - ethyl acrylate copolymer (1:1), sodium lauryl sulfate, polysorbate 80, triethyl citrate.

Description of the appearance of ZOLEMER REFLUSSO and contents of the pack
The gastro-resistant tablets are oval, yellow-colored, gastro-resistant tablets.
ZOLEMER REFLUSSO is available in Al/Al blisters or HDPE bottles.
Packs containing 7 or 14 gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan
Sales concessionaire
SO.SE.PHARM SOCIETA’ DI SERVIZIO PER L’INDUSTRIA FARMACEUTICA ED AFFINI S.r.l., Via dei Castelli
Romani, 22 – 00040 Pomezia (Rome)

Manufacturers
Sofarimex–Ind. Quimica e Farmaceutica, S.A., Av. Das Indùstrias, Alto do Colaride 2735-213 Cacém
(Portugal)
Advance Pharma GmbH, Wallenroder Strasse 12-14, 13435 Berlin (Germany)
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel (Germany)
Centrafarm Services B.V., Nieuwe Donk 9, 4879 AC Etten-Leur (Netherlands)
Eurogenerics N.V., Heizel Esplanade B22, 1020 Brussel (Belgium)
Clonmel Healthcare Ltd., Waterford Road Clonmel (Ireland)
PharmaCoDane Aps, Marielundvej 46 A, 2750 Herlev (Denmark)
STADA Arzneimittel GmbH, Muthgasse 36/2 A-1190 Vienna (Austria)

This medicinal product is authorised in the Member States of the European Economic Area under the following
denominations:
Austria: Refluxin 20 mg magensaftresistente Tabletten
Belgium: Refluxine Control 20 mg maagsapresistente tabletten
France: Pantoprazole EG Labo Conseil 20 mg, comprimé gastro-résistant
Ireland: Gastrolief 20 mg gastro-resistant tablets
Italy: Zolemer Reflusso 20 mg gastro-resistant tablets
Luxembourg: Refluxine Control 20 mg comprimés gastro-résistants
Netherlands: Maagzuurtabletten HTP Pantoprazol 20 mg, maagsapresistente tabletten
The following lifestyle and dietary recommendations may also help to
relieve symptoms related to 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 food that may cause heartburn. This may include: chocolate, peppermint, spearmint, fatty and fried foods, acidic foods, spicy foods, citrus fruits and juices, tomatoes.