STOMADOL 20 mg Enteric-Coated Tablet

Зміст інструкції

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

STOMADOL REFLUSSO 20 mg gastro-resistant tablets

pantoprazole
Generic medicine

Read this leaflet carefully before taking this medicine as it contains important
information for you.

• 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.

Contents of this leaflet
What STOMADOL REFLUSSO is and what it is used for
What you need to know before you take STOMADOL REFLUSSO
How to take STOMADOL REFLUSSO
Possible side effects
How to store STOMADOL REFLUSSO
Contents of the pack and other information.

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

STOMADOL 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.
STOMADOL REFLUSSO is used for the short-term treatment of symptoms of reflux (for example
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 STOMADOL 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
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 STOMADOL REFLUSSO

Do not take STOMADOL REFLUSSO:

• if you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to medicines containing other proton pump inhibitors.
• if you are allergic to peanuts or soy.

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

• If you have severe liver problems. Tell your doctor if you have ever had liver problems in the past. The doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking STOMADOL REFLUSSO for long-term therapy. If liver enzymes increase, treatment should be discontinued.
• If you need continuous treatment with medicines called NSAIDs and are taking STOMADOL REFLUSSO because you have an increased risk of developing gastric and intestinal complications. Each

increased risk will be assessed based on your personal risk factors such as age (65 years and over), a
history of gastric or duodenal ulcers or gastric or intestinal bleeding.

• If you have reduced body stores or risk factors for reduced vitamin B12 and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole can lead to reduced absorption of vitamin B12. Talk to your doctor if you notice any of the following symptoms, which may indicate low levels of vitamin B12:
• extreme fatigue or lack of energy,
• tingling and prickling,
• red or sore tongue, mouth ulcers,
• muscle weakness,
• vision disturbances.
• memory problems, confusion, depression.
• If you are simultaneously taking HIV protease inhibitors such as atazanavir (for the treatment of HIV infection), ask your doctor for specific advice.
• Taking a proton pump inhibitor such as pantoprazole, especially for a period longer than one year, may slightly increase the risk of fractures of the hip, wrist or spine. Tell your doctor if you have osteoporosis (reduced bone density) or if your doctor tells you that you are at risk of osteoporosis (for example, if you are taking steroids).
• If you have been taking STOMADOL REFLUSSO for more than three months, the levels of magnesium in your blood may decrease. Low levels of magnesium can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. Tell your doctor immediately if you experience any of these symptoms. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to STOMADOL 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 it may be necessary to stop therapy with STOMADOL REFLUSSO. Remember to report any other unwanted effects such as joint pain.
• Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and multiforme erythema have been reported in association with treatment with pantoprazole. Stop using pantoprazole and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions, described in section 4.
• If you need to undergo a specific blood test (Chromogranin A).

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
• 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 to rule out a malignancy as
pantoprazole also relieves the symptoms of cancer and may cause a delay in diagnosis. If your symptoms
persist despite treatment, further investigations should be considered.
If you take STOMADOL REFLUSSO for long-term treatment (more than 1 year), your doctor will probably
keep you under regular control. You should report any new or unusual symptom
whenever you meet your doctor.

Children and adolescents
STOMADOL 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 STOMADOL REFLUSSO
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
STOMADOL REFLUSSO can prevent other medicines from working properly. Especially
medicines containing one of the following active ingredients:

• atazanavir (used for the treatment of HIV infection)
• ketoconazole, itraconazole and posaconazole (used for fungal infections) or erlotinib (used for some types of cancer) because STOMADOL REFLUSSO can prevent these and other medicines from working properly
• 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 STOMADOL REFLUSSO as pantoprazole may increase methotrexate levels in the blood
• fluvoxamine (used to treat depression and other psychiatric illnesses) - if you are taking fluvoxamine, your doctor may reduce the dose
• rifampicin (used to treat infections)
• St John's wort ( Hypericum perforatum) (used to treat mild depression).

Talk to your doctor before taking pantoprazole if you need to undergo a specific urine test (for THC;
tetrahydrocannabinol).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
There are no adequate data regarding the use of pantoprazole in pregnant women. Excretion in human breast milk has been reported.
You should only use this medicine if your doctor considers the benefit to you greater than the potential risk
to the fetus or baby.

Driving and using machines
STOMADOL REFLUSSO does not alter or negligibly alters the ability to drive vehicles and use
machinery.
If you experience side effects such as dizziness or visual disturbances, you should not drive or operate machinery.

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

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

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

3. How to take STOMADOL REFLUSSO

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have 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 STOMADOL
REFLUSSO when you no longer have any symptoms. You may experience relief of symptoms related to acid reflux
and heartburn just after one day of treatment with STOMADOL REFLUSSO, but this
medicine is not designed to provide immediate relief.
If you do not experience any relief of symptoms after taking this medicine for 2 weeks continuously,
consult your doctor.
Do not take STOMADOL 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.

Patients with liver problems
If you suffer from severe liver problems, you should not take more than one 20 mg tablet a day.

If you take more STOMADOL REFLUSSO than you should
Consult your doctor or pharmacist. No symptoms of overdose are known.

If you forget to take STOMADOL REFLUSSO
Do not take a double dose to make up for a missed dose. Take the normal next dose,
the next day, at the scheduled time.

If you stop taking STOMADOL REFLUSSO
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
Do not stop treatment with these tablets without first consulting 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 immediatelyor contact the nearest hospital emergency room if you experience any of the following side effects:

• Severe allergic reactions (rare:may affect up to 1 in 1,000 people): swelling of the face (angioedema/Quincke's edema), tongue and/or throat, difficulty swallowing, difficulty breathing, hives, severe dizziness with a very fast and strong heartbeat and heavy sweating.
• Severe skin reactions (frequency not known:the frequency cannot be estimated based on available data ): appearance of skin blisters, rapid deterioration of general health conditions, peeling and bleeding around the eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, particularly in areas of skin exposed to light/sun. You may also have joint pain or flu-like symptoms, fever, swollen glands (e.g. under the armpit) and blood tests may show changes in white blood cell count or liver enzymes.
• Reddish, non-raised, circular or target-shaped spots on the trunk, often with blisters in the center, skin peeling, ulcers on the mouth, throat, nose, genitals and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, Lyell's syndrome).
• Widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Other serious side effects (frequency not known): yellowing of the skin or whites of the eyes (due to severe liver damage, jaundice), or fever, rash, and swelling of the kidneys sometimes with pain when urinating, and lower back pain (severe kidney inflammation), which can lead to possible kidney failure.

Other side effects are:

• Common(may affect up to 1 in 10 people):

Benign polyps in the stomach.

• Uncommon(may affect up to 1 in 100): headache; dizziness; diarrhea; feeling unwell, vomiting; bloating and flatulence; constipation; dry mouth; stomach pain and discomfort; skin rash, exanthema, eruption; itching; weakness, fatigue or general malaise; sleep disorders, hip, wrist or spine fractures.
• Rare(may affect up to 1 in 1,000): alteration or complete loss of the sense of taste; vision disorders such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; swelling of the extremities; depression; breast enlargement in men; high fever, allergic reactions.
• Very rare (may affect up to 1 in 10,000): disorientation.
• Frequency not known(the frequency cannot be estimated based on available data): hallucinations, confusion (especially in patients with a history of these symptoms); tingling, pins and needles, burning or numbness; erythema, possible joint pain, inflammation of the colon, causing persistent watery diarrhea.

Side effects identified through blood tests:

• Uncommon(may affect up to 1 in 100) an increase in liver enzymes.
• Rare(may affect up to 1 in 1,000) an increase in bilirubin; increased levels of fats in the blood; drastic decrease in circulating granulocytes, associated with high fever.
• Very Rare(may affect up to 1 in 10,000) a reduction in the number of platelets, which can cause more bleeding or bruising than normal; a reduction in the 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.
• Not known(the frequency cannot be estimated from available data) Decrease in the level of sodium, magnesium, calcium or potassium in the blood (see section 2).

Reporting of side effects
If 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 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 STOMADOL 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 package and on the blister after “EXP”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What STOMADOL REFLUSSO contains

• The active ingredient is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole

(as pantoprazole sodium sesquihydrate).

• The other ingredients are: Tablet coreMaltitol (E 965), crospovidone type B, sodium carboxymethylcellulose, anhydrous sodium carbonate (E 500), calcium stearate Tablet coatingPolyvinyl alcohol, talc (E 553b), titanium dioxide (E 171), macrogol 3350, soybean lecithin, yellow iron oxide (E 172), anhydrous sodium carbonate (E 500), acrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate (E 1505)

Description of the appearance of STOMADOL REFLUSSO and package contents
The gastro-resistant tablets of STOMADOL REFLUSSO are oval and yellow.
STOMADOL REFLUSSO is available in packs of 7, 14 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Pharmacare S.r.l.
Via Marghera, 29
20149 Milan - Italy

Manufacturer
FINE FOODS & PHARMACEUTICALS N.T.M. S.p.A. - Via Grignano, 43 - 24041 Brembate (Bergamo)
LACHIFARMA s.r.l. Laboratorio Chimico Salentino – S.S. 16 Zona Industriale – 73010 Zollino (Lecce)

The following recommendations regarding lifestyle and dietary changes 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.