Stomadol reflux

Package leaflet: Information for the patient

STOMADOL REFLUSSO 20 mg gastro-resistant tablets

pantoprazole
Generic medicine
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, contact 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.

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

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

STOMADOL 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.
STOMADOL REFLUSSO is used for the short-term treatment of reflux symptoms (for example, heartburn, acid regurgitation) in adults.
Reflux is the return of acid from the stomach into the oesophagus ("food pipe"), which can become inflamed and cause pain. This may cause 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 STOMADOL REFLUSSO, but this medicine is not designed to provide immediate relief. It may be necessary to take the tablets for 2-3 consecutive days to improve symptoms.
Consult your 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 to 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. Inform your doctor if you have ever had liver problems in the past. Your doctor may arrange for more frequent monitoring of your liver enzymes, especially if you are taking STOMADOL REFLUSSO for long-term treatment. If your liver enzymes increase, treatment should be discontinued.

• If you require ongoing treatment with medicines called NSAIDs and are taking STOMADOL REFLUSSO because you are at increased risk of developing gastric or intestinal complications. Your individual risk will be assessed based on personal risk factors such as age (65 years or older), history of gastric or duodenal ulcers, or gastrointestinal bleeding.

• If you have low body reserves or risk factors for vitamin B12 deficiency and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole may lead to reduced absorption of vitamin B12. Contact your doctor if you experience any of the following symptoms, which may indicate low vitamin B12 levels:

• extreme tiredness or lack of energy,

• tingling and numbness,

• 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 treatment of HIV infection), consult your doctor for specific advice.

• Taking a proton pump inhibitor such as pantoprazole, particularly for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis (reduced bone density) or if your doctor has told you that you are at risk of osteoporosis (e.g., if you are taking steroids).

• If you have been taking STOMADOL REFLUSSO for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. Inform your doctor immediately if you experience any of these symptoms. Low magnesium levels may also lead to reduced levels of potassium or calcium 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 gastric acidity.

• If you develop a skin rash, especially in sun-exposed areas, contact your doctor as soon as possible, as it may be necessary to discontinue treatment with STOMADOL REFLUSSO. Remember to report any other adverse effects such as joint pain.

• Serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme have been reported with pantoprazole treatment. Stop taking pantoprazole and contact your doctor immediately if you notice any symptoms related to these serious skin reactions, described in section 4.

• If you are scheduled for a specific blood test (Chromogranin A).

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,
• 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,
• looking pale and feeling weak (anemia),
• chest pain,
• stomach pain,
• 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 certain tests to rule out malignancy, as pantoprazole also relieves symptoms of cancer and could delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered.
If you take STOMADOL REFLUSSO for long-term treatment (over 1 year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms or circumstances each time you see your doctor.

Children and adolescents
STOMADOL REFLUSSO 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 STOMADOL REFLUSSO
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
STOMADOL REFLUSSO may prevent other medicines from working properly, especially medicines containing any of the following active substances:

• atazanavir (used to treat HIV infection),
• ketoconazole, itraconazole, and posaconazole (used for fungal infections) or erlotinib (used for certain types of cancer), as STOMADOL REFLUSSO may prevent these and other medicines from acting correctly,
• 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 discontinue treatment with STOMADOL REFLUSSO, as pantoprazole may increase methotrexate levels in the blood,
• fluvoxamine (used to treat depression and other psychiatric disorders) – 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 are scheduled for a specific urine test (for THC; tetrahydrocannabinol).

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
There are insufficient data on the use of pantoprazole in pregnant women. Excretion in human breast milk has been reported.
You should use this medicine only if your doctor considers the benefit to you greater than the potential risk to the fetus or infant.

Driving and using machines
STOMADOL REFLUSSO does not affect or has a negligible effect on the ability to drive or use machinery.
However, if you experience side effects such as dizziness or vision disturbances, you must not drive or operate machinery.

STOMADOL REFLUSSO contains maltitol
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her 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 exactly as your doctor or pharmacist has told you. If you are unsure, 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 STOMADOL REFLUSSO when your symptoms have resolved. You may experience relief from acid reflux and heartburn symptoms as soon as one day after starting treatment with STOMADOL REFLUSSO; however, this medicine is not designed to provide immediate relief.

If you do not experience symptom relief after taking this medicine continuously for 2 weeks, 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. Swallow the tablet whole with some water. Do not chew or break the tablet.

Patients with liver problems
If you have severe liver problems, you should not take more than one 20 mg tablet per day.

If you take more STOMADOL REFLUSSO than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.

If you forget to take STOMADOL REFLUSSO
Do not take a double dose to make up for the forgotten dose. Take your next dose at the usual time the following day.

If you stop taking STOMADOL REFLUSSO
If you have any doubts about using this medicine, consult 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 will get them.
Consult your doctor immediately or contact the nearest hospital emergency department 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 (Quincke's oedema/angioedema), tongue and/or throat, difficulty swallowing, breathing difficulties, hives, severe dizziness with very rapid heartbeat and profuse sweating.
• Severe skin reactions (frequency not known: frequency cannot be estimated from the available data): appearance of skin blisters, rapid deterioration in general health, skin 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 experience joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arm), and blood tests may show changes in white blood cell count or liver enzymes.
• Reddish, flat, circular or target-shaped spots on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, Lyell syndrome).
• Widespread skin 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 the white of the eye (due to severe liver damage, jaundice), or fever, skin rash, and kidney enlargement sometimes with painful urination and lower back pain (severe kidney inflammation), which may lead to possible kidney failure.

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, exanthema, eruption; itching; weakness, fatigue or general malaise; sleep disorders, hip, wrist or spinal fractures.
• Rare (may affect up to 1 in 1,000 people): altered or complete loss of taste; visual disturbances such as blurred vision; urticaria; 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 people): disorientation.
• Frequency not known (frequency cannot be estimated from the available data): hallucinations, confusion (especially in patients with prior experience of these symptoms); tingling sensation, pins and needles, burning or numbness; erythema, possible joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

Side effects identified through blood tests:

• Uncommon (may affect up to 1 in 100 people): increased liver enzymes.
• Rare (may affect up to 1 in 1,000 people): increased bilirubin; increased blood lipid levels; marked decrease in circulating granulocytes, associated with high fever.
• Very rare (may affect up to 1 in 10,000 people): reduced platelet count, which may cause increased bleeding or bruising; reduced white blood cell count, which may lead to more frequent infections; concomitant abnormal reduction in red and white blood cells as well as platelets.
• Not known (frequency cannot be estimated from the available data): decreased levels of sodium, magnesium, calcium or potassium in the blood (see section 2).

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 the following website: 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 carton and blister after "EXP".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater 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 substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole
  (as sesquihydrate sodium pantoprazole).

• The other components are: Tablet core Maltitol (E 965), crospovidone type B, sodium carmellose, anhydrous sodium carbonate (E 500), calcium stearate
  Tablet coating Polyvinyl alcohol, talc (E 553b), titanium dioxide (E 171), macrogol 3350, soybean lecithin, yellow iron oxide (E 172), anhydrous sodium carbonate (E 500), methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate (E 1505)

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

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharmacare S.r.l.
Via Marghera, 29
20149 Milano - 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 lifestyle and dietary recommendations may also help relieve symptoms related to 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 intake 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.