Xoolam for reflux

Package leaflet: Information for the patient

Xoolam reflux 20 mg gastro-resistant tablets

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 told 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, including those not listed in this leaflet, 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.

Contents of this leaflet:

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

1. What Xoolam Reflux is and what it is used for

Xoolam Reflux contains the active substance pantoprazole. Xoolam Reflux is a selective "proton pump inhibitor", a medicine that reduces the amount of acid produced in the stomach. Xoolam Reflux is used for the short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation).

2. What you should know before taking Xoolam reflux

Do not take Xoolam reflux

• If you are allergic to the active substance 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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Xoolam reflux. In particular:

• If you have severe liver problems. Inform your doctor if you have previously had liver problems. Your doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking Xoolam reflux for long-term treatment. If liver enzymes increase, treatment must be discontinued.
• If you require ongoing treatment with NSAIDs and are taking Xoolam reflux because you have an increased risk of developing gastric or intestinal complications. Any increased risk will be assessed based on your individual 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.
• If you are taking protease inhibitors for HIV, such as atazanavir (for the treatment of HIV infection), ask your doctor for specific advice.
• If you are taking multiple daily doses of proton pump inhibitors for a prolonged period (one year or more), you may have an increased risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).
• If you have been taking Xoolam reflux for more than 3 months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or increased heart rate. Inform your doctor immediately if you experience any of these symptoms. Low magnesium levels can also lead to reduced 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 Xoolam reflux that reduces stomach acid.
• If you notice the appearance of a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Xoolam reflux. Remember to also report any other adverse effects such as joint pain.
• If you need to undergo a specific blood test (Chromogranin A).

Inform your doctor immediately before or after taking this medicine if you experience any of the following symptoms, which could be signs of a more serious underlying condition:

• Unintentional weight loss
• Recurrent vomiting
• Presence of blood in vomit, which may appear as dark, coffee-ground-like material
• Looking pale and feeling weak (anemia)
• Blood in stools, which may appear dark or tarry
• Difficulty swallowing or pain when swallowing
• 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 further tests to rule out malignancy, as pantoprazole may also relieve symptoms of cancer and could delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered.

If you are taking Xoolam reflux for long-term treatment (more than 1 year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms or circumstances whenever you see your doctor.

Children
The use of Xoolam reflux is not recommended in children.

Other medicines and Xoolam reflux
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Xoolam reflux may affect the effectiveness of other medicines, so inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as Xoolam reflux may prevent these and other medicines from working properly.
• Warfarin and fenprocoumon, which affect blood clotting. You may need additional monitoring.
• Medicines used to treat HIV, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily discontinue treatment with Xoolam reflux because 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).

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription.

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

Driving and using machines
Xoolam reflux does not affect or has a negligible effect on the ability to drive vehicles or operate machinery.
However, if you experience adverse effects such as dizziness or visual disturbances, you should not drive or operate machinery.

3. How to take Xoolam reflux

Take this medicine exactly as stated in this leaflet or as instructed by your
doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Take the tablets 1 hour before a meal, without chewing or crushing them, and swallow them whole with a little
water.
The recommended dose is one tablet per day. Do not exceed the recommended dose.
It may be necessary to take the tablets for 2–3 consecutive days to achieve an improvement
in symptoms. Once symptoms have completely resolved, treatment should be discontinued.
Treatment must not last longer than 4 weeks without consulting your doctor.
If there is no improvement in symptoms after 2 weeks of continuous treatment, the patient should
consult their doctor.
Once symptom relief has been achieved, recurrence of symptoms can be managed by taking one
tablet per day, as needed.

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

Use in children and adolescents
Children: These tablets are not recommended for use in children.

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

If you forget to take Xoolam reflux
Do not take a double dose to make up for the missed dose. Take your next dose at the scheduled time.

If you stop taking Xoolam reflux
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.
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 experiences them.
If you experience any of the following side effects, stop treatment with these tablets immediately and
consult your doctor or contact the emergency department of the nearest hospital:

• Serious allergic reactions (rare frequency: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, facial allergic swelling (Quincke's oedema / angioedema), severe dizziness with rapid heartbeat and profuse sweating.
• Serious skin disorders (frequency not known: frequency cannot be estimated from the available data): appearance of skin blisters and rapid deterioration of your general condition, erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme), and light sensitivity.
• Other serious disorders (frequency not known: frequency cannot be estimated from the available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, skin rash, and kidney enlargement sometimes with pain during urination or lower back pain (severe kidney inflammation) which may lead to possible kidney failure.

Other side effects include:

• Uncommon (may affect up to 1 in 100 people): headache; dizziness; diarrhoea; nausea, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; skin rash, exanthema, rash; itching; feeling of weakness, fatigue or general malaise; sleep disorders, hip, wrist or spinal fractures.
• Common (may affect up to 1 in 10 people): benign polyps in the stomach.
• Rare (may affect up to 1 in 1,000 people): visual disturbances such as blurred vision; altered or complete loss of taste sensation; hives; joint pain; muscle pain; weight changes; increased body temperature; swelling of the extremities (peripheral oedema); allergic reactions; depression; breast enlargement in men.
• Very rare (may affect up to 1 in 10,000 people): disorientation.
• Not known (frequency cannot be estimated from the available data): hallucinations, confusion (especially in patients with prior experience of these symptoms); decreased sodium levels in the blood, decreased magnesium levels in the blood (see section 2), 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 lipids; 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.

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: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xoolam reflux

Keep Xoolam reflux out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
No special storage precautions required.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Xoolam Reflux contains
The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as
sodium sesquihydrate).
The other components are:
Tablet core: sodium carbonate, mannitol (E421), crospovidone, pregelatinized maize starch, calcium
stearate.
Intermediate film coating: hypromellose, triacetin, titanium dioxide (E171).
Gastro-resistant film coating: methacrylic acid-ethyl acrylate copolymer 1:1, sodium lauryl sulfate, polysorbate 80,
triethyl citrate, talc, titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).
Description of the appearance of Xoolam Reflux 20 mg gastro-resistant tablets and contents of the
pack
Xoolam Reflux 20 mg tablets are film-coated, light yellow, gastro-resistant, round, biconvex tablets.
Packaged in Poliamide/Alu/PVC blisters with an aluminum foil lid, containing 12 gastro-resistant tablets.
Marketing Authorization Holder and Manufacturer
LABORATORI ALTER S.r.l.
Via Egadi 7
20144 – Milan
Manufacturer responsible for batch release:
Laboratorios Alter, S.A.
Calle de Mateo Inurria, 30
28036 Madrid - Spain