XOOLAM 20 mg Enteric-Coated Tablet

Содержание инструкции

1. Xoolam reflusso 20 mg gastro-resistant tablets
   1. What is Xoolam reflusso and what is it used for
   2. What you need to know before you take Xoolam reflusso
   3. How to take Xoolam reflusso
   4. Possible side effects
   5. How to store Xoolam reflusso
   6. Contents of the pack and other information

Xoolam reflusso 20 mg gastro-resistant tablets

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 would like more information or advice, ask your pharmacist.

If any side effects occur, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

• Contact your doctor if you do not feel any improvement or if your symptoms worsen after 2 weeks. Contents of this leaflet:
• 1. What Xoolam reflusso is and what it is used for
• 2. What you need to know before you take Xoolam reflusso
• 3. How to take Xoolam reflusso
• 4. Possible side effects
• 5. How to store Xoolam reflusso
• 6. Contents of the pack and other information

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

Xoolam reflusso contains the active ingredient pantoprazole. Xoolam reflusso is a selective “proton pump
inhibitor”, a medicine that reduces the amount of acid produced in the stomach. Xoolam reflusso is
used for the short-term treatment of reflux symptoms (for example, heartburn, acid regurgitation).

2. What you need to know before you take Xoolam reflusso

Do not take Xoolam reflusso

• If you are allergic to the active ingredient 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 reflusso. In particular:

• If you have severe liver problems. Tell your doctor if you have had liver problems in the past. Your doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking Xoolam reflusso for long-term therapy. If liver enzymes increase, treatment should be discontinued.
• If you need continuous treatment with NSAIDs and are taking Xoolam reflusso because you have an increased risk of developing gastric and intestinal complications. Any 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 gastrointestinal 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.
• If you are simultaneously taking HIV protease inhibitors such as atazanavir (for the treatment of HIV infection), ask your doctor for specific advice.
• If you take multiple daily doses of proton pump inhibitors for a long period of time (one year or more) you may have an increased risk of fractures of the hip, wrist or spine. Tell your doctor if you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).
• If you have been taking Xoolam reflusso for more than 3 months, magnesium levels in the blood may decrease. Low levels of magnesium can cause fatigue, involuntary muscle contractions, confusion, 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 Xoolam 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 Xoolam reflusso. Also remember to report any other unwanted effects such as joint pain.
• If you are to undergo a specific blood test (Chromogranin A).

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

• an involuntary weight loss
• recurrent vomiting
• presence of blood in the vomit, which may appear as dark coffee grounds in the vomit
• you appear pale and feel weak (anemia)
• presence of blood in the stool 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 modest increase in infectious diarrhea. Your doctor may decide that you need to undergo some tests to rule out malignancy as pantoprazole also relieves the symptoms of cancer and could cause a delay in diagnosis. If your symptoms persist despite treatment, further investigations should be considered.

If you take Xoolam reflusso for long-term treatment (more than 1 year) your doctor will probably
monitor you regularly. You should report any new or unusual symptom or circumstance
whenever you see your doctor.

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

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

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for some types of cancer) because Xoolam reflusso may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect the thickening, or thinning of the blood. You may need further checks.
• 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 stop treatment with Xoolam reflusso because pantoprazole can increase methotrexate levels in the blood;
• Fluvoxamine (used to treat depression and other mental 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).

Tell 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 no adequate data regarding the use of pantoprazole in pregnant women. Excretion in human
breast milk has been reported.
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
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
Xoolam reflusso does not alter or alters negligibly the ability to drive vehicles and use machines.
If you experience side effects such as dizziness or vision disturbances, you should not drive vehicles or operate
machinery.

3. How to take Xoolam reflusso

Take this medicine following exactly the instructions in this leaflet or as indicated by your
doctor or pharmacist. If you have any doubts, 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 a day. Do not exceed the recommended dose.
It may be necessary to take the tablets for 2-3 consecutive days to obtain an improvement
of symptoms. Once complete relief of symptoms is achieved, treatment should be discontinued.
Treatment should not exceed 4 weeks without consulting your doctor.
If no improvement of symptoms is observed after 2 weeks of continuous treatment, the patient should
consult their doctor.
Once relief of symptoms is obtained, you can monitor the recurrence of symptoms by taking one
tablet a day, as needed.

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

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

If you take more Xoolam reflussothan you should
Consult your doctor or pharmacist. No symptoms of overdose are known.

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

If you stop taking Xoolam reflusso
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.
If you have any further questions 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.

If you experience any of the following side effects, stop treatment with these tablets and
consult a doctor immediately, or contact the nearest hospital emergency room:

• Serious allergic reactions (rare frequency:may affect up to 1 in 1,000 people):swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic facial swelling (angioedema / Quincke's edema), severe dizziness with a very fast heartbeat and profuse sweating.
• Serious skin conditions (frequency not known:the frequency cannot be defined based on 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's syndrome, erythema multiforme) and light sensitivity.
• Other serious conditions (frequency not known:the frequency cannot be defined based on available data):yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, rash, and enlargement of the kidneys sometimes with pain when urinating or lower back pain (severe kidney inflammation) which may lead to possible kidney failure.

Other side effects are:

• Not Common(may affect up to 1 in 100 people) headache; dizziness; diarrhea; feeling of nausea, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; rash, exanthema, rash; itching; feeling of weakness, fatigue or general malaise; sleep disorders, hip, wrist or spine 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; alteration or complete loss of the sense of taste; hives; joint pain; muscle pain; weight changes; increased body temperature; swelling of the extremities (peripheral edema); allergic reactions; depression; increased breast volume in men.
• Very Rare(may affect up to 1 in 10,000 people) disorientation.
• Not known(the frequency cannot be defined based on available data) hallucinations, confusion (especially in patients with a history of these symptoms); decreased levels of sodium in the blood, decreased levels of magnesium in the blood (see section 2), sensation of tingling, pins and needles, burning sensation or numbness, erythema, possible joint pain, inflammation of the large intestine causing persistent watery diarrhea.

Side effects identified through blood tests:

• Not Common(may affect up to 1 in 100 people) an increase in liver enzymes.
• Rare(may affect up to 1 in 1,000 people) an increase in bilirubin; increased fats in the blood; drastic decrease in circulating granulocytes, associated with high fever.
• Very Rare(may affect up to 1 in 10,000 people)

a reduction in the number of platelets, which may cause more bleeding or bruising than normal;
a reduction in the number of white blood cells, which may lead to more frequent infections; coexisting
abnormal reduction in the number of red blood cells and white blood cells, as well as platelets.

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 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 reflusso

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

6. Contents of the pack and other information

What Xoolam reflusso contains
The active ingredient is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as
sodium sesquihydrate).
The other ingredients are:
Tablet core: sodium carbonate, mannitol (E421), crospovidone, pregelatinized starch, calcium
stearate.
Intermediate coating film: hypromellose, triacetin, titanium dioxide (E171).
Gastro-resistant film: 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 reflusso 20 mg gastro-resistant tablets and pack contents
The tablets of Xoolam reflusso 20 mg are film-coated, light yellow, with a gastro-resistant coating, round, biconvex.
Pack in Polyamide/Alu/PVC blister and an aluminum foil containing 12 gastro-resistant tablets.

Marketing Authorisation 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