Package leaflet: Information for the user

ZOLEMER REFLUX 20 mg gastro-resistant tablets

Pantoprazole
Please read all of 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 to do.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any of the side effects listed in this leaflet, or any not listed, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen after 2 weeks.
You must not take ZOLEMER REFLUX tablets for more than 4 weeks without consulting your doctor.

Contents of this leaflet:

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

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

ZOLEMER REFLUSSO contains the active substance 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 reflux symptoms (for example, heartburn, acid
regurgitation) in adults.
Reflux is the backflow of acid from the stomach into the oesophagus ("food pipe"), which can 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 soon as one day after starting treatment with ZOLEMER REFLUSSO; however, this medicine is not studied to provide immediate relief. You may need to take the tablets for 2-3 consecutive days to improve symptoms.
Speak to your doctor if you do not feel better or if you feel worse after 2 weeks.

2. What you need to know before taking ZOLEMER REFLUX

Do not take ZOLEMER REFLUX:

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 REFLUX".

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

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 have recently developed new or changed reflux symptoms;
if you have previously had a stomach ulcer or stomach surgery;
if you have liver problems or jaundice (yellowing of the skin or eyes);
if you regularly visit your doctor for serious health conditions;
if you are scheduled for an endoscopy or a breath test called the C-urea test;
if you have ever had a skin reaction after treatment with a medicine similar to ZOLEMER REFLUX that reduces stomach acid;
if you develop a skin rash, especially in sun-exposed areas, contact your doctor as soon as possible, as treatment with ZOLEMER REFLUX may need to be stopped. Remember to also report any other side effects such as joint pain;
if you are scheduled for a specific blood test (Chromogranin A).

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

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. Contact 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 your 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, particularly if recurrent;
presence of blood in vomit; this may appear dark, like ground coffee;
presence of blood in stools; stools may appear black or tarry;
difficulty swallowing or pain when swallowing;
you look pale and feel weak (anemia);
chest pain;
stomach pain;
severe and/or persistent diarrhea, as pantoprazole has been associated with a slight increase in infectious diarrhea. Your doctor may decide that you need further tests.

If you are having a blood test, tell your doctor that you are taking this medicine.
You may experience relief from acid reflux and heartburn symptoms as early as one day after starting treatment with ZOLEMER 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 for some time, remember to see your doctor regularly.

Children and adolescents
ZOLEMER 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 ZOLEMER REFLUX
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. ZOLEMER REFLUX may prevent other medicines from working properly.
Especially medicines containing any of the following active substances:

atazanavir (used to treat HIV infection). Do not use ZOLEMER REFLUX if you are taking atazanavir. See "Do not take ZOLEMER REFLUX";
ketoconazole (used for fungal infections);
warfarin and fenprocoumon (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 ZOLEMER REFLUX, as pantoprazole may increase methotrexate levels in the blood.

Do not take ZOLEMER 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 ZOLEMER REFLUX with antacids (e.g., magaldrate, alginic acid, sodium bicarbonate, aluminium 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, plan to become pregnant, or are 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.

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

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

ZOLEMER REFLUX 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 REFLUX

Take this medicine exactly as stated 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 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 ZOLEMER
REFLUX when you no longer have any symptoms. You may experience relief from acid reflux and heartburn symptoms as soon as one day after starting treatment with ZOLEMER REFLUX, but 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 ZOLEMER 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 ZOLEMER REFLUX than you should
Consult your doctor or pharmacist immediately if you have taken more than the recommended dose. If possible, bring the medicine and this leaflet with you.
If you forget to take ZOLEMER REFLUX
Do not take a double dose to make up for the missed dose. Take your next normal dose at the usual time the following day.
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 everyone 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 (rare: may affect up to 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, hives (skin rash), severe dizziness with very rapid heartbeat and profuse sweating.
Severe skin reactions (frequency not known: frequency cannot be estimated from the available data): skin rash with swelling, appearance of blisters or skin peeling, desquamation and bleeding around the eyes, nose, mouth or genitals, rapid worsening of general health, or skin rash when exposed to sunlight.
Other serious side effects (frequency not known): yellowing of the skin or eyes (due to severe liver damage), or kidney problems such as pain during urination and lower back pain with fever.

Other side effects include:
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 malaise; skin rash or hives; itching; weakness, fatigue or general malaise; sleep disturbances; increased liver enzymes in blood tests.
Rare (may affect up to 1 in 1,000 people):
altered or complete loss of taste; visual disturbances such as blurred vision; joint pain; muscle pain; weight changes; increased body temperature; swelling of extremities; depression; increased bilirubin and blood fat levels (detected in blood tests); breast enlargement in men; high fever and severe reduction 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 may cause increased bleeding or bruising; reduced number of white blood cells, which may lead to more frequent infections; concomitant abnormal reduction in red blood cells, white blood cells and platelets (observed in blood tests).
Frequency not known (frequency cannot be estimated from the available data):
skin rash, possibly with joint pain (subacute cutaneous lupus erythematosus); hallucinations; confusion (especially in patients who have previously experienced these symptoms); decreased sodium levels in the blood; decreased magnesium levels in the blood; inflammation of the large intestine causing persistent watery diarrhoea; tingling sensation, itching, prickling, burning or numbness.

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 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 stated on the blister, bottle, or outer carton. The expiry date refers to the last day of that month.
For tablets packed in plastic bottles: ZOLEMER REFLUSSO must be used within three months after first opening the container.
Do not store above 25°C.
Do not dispose of medicines 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 ZOLEMER 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 Polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350, soybean lecithin, yellow iron oxide (E172), anhydrous sodium carbonate, methacrylic acid - ethyl acrylate copolymer (1:1), sodium lauryl sulfate, polysorbate 80, triethyl citrate.

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

Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milano
Marketing Authorization Holder's Distributor
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 (The 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 authorized in the Member States of the European Economic Area under the following names:
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 compresse gastroresistenti
Luxembourg: Refluxine Control 20 mg comprimés gastro-résistants
The Netherlands: Maagzuurtabletten HTP Pantoprazol 20 mg, maagsapresistente tabletten

The following recommendations regarding changes in lifestyle and diet may also help relieve symptoms related to heartburn and acid reflux:

Avoid large meals
Eat slowly
Stop smoking
Reduce alcohol and caffeine intake
Reduce 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 include: chocolate, peppermint, mint, fatty and fried foods, acidic foods, spicy foods, citrus fruits and fruit juices, tomatoes