GASTROSCHOUM REFLUSSO 20 mg Hard capsules

Зміст інструкції

1. GastroSchoum Reflusso 20 mg hard capsules
   1. What is GASTROSCHOUM REFLUSSO and what is it used for
   2. What you need to know before taking GASTROSCHOUM REFLUSSO
   3. How to take GASTROSCHOUM REFLUSSO
   4. Possible side effects
   5. How to store GastroSchoum Reflusso
   6. Contents of the pack and other information

GastroSchoum Reflusso 20 mg hard capsules

omeprazole

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 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, tell your doctor or pharmacist. See section 4.
Talk to your doctor if you do not feel better or if your symptoms get worse after 14 days.

Contents of this leaflet:

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

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

Schoum gastroprotect contains the active ingredient omeprazole. It belongs to a group of medicines
called “proton pump inhibitors”. These medicines work by reducing the amount of acid that
your stomach produces.
This medicine is used in adults for the short-term treatment of reflux symptoms
(for example, heartburn and acid regurgitation).
Reflux is the return of acid from the stomach into the esophagus “food pipe”, which can become
inflamed and painful. 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 need to take the capsules for 2-3 consecutive days before you start to feel better.

2. What you need to know before taking GASTROSCHOUM REFLUSSO

Do not take GastroSchoum Reflusso

• If you are allergic to omeprazole, 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 (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole). If you are taking a medicine containing nelfinavir (used for HIV infections).

Do not take Schoum gastroprotect if you fall into any of the above cases. If you are not sure,
talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions
Do not take Schoum gastroprotect for more than 14 days without consulting your doctor. If you do not feel
relief, or if your symptoms worsen, consult your doctor.
Severe skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis
(AGEP), have been reported in association with treatment with GastroSchoum Reflusso. Stop
using GastroSchoum Reflusso and contact your doctor immediately if you notice any of the
symptoms related to these severe skin reactions described in section 4.
During the intake of omeprazole, inflammation of the kidneys may occur. Signs and symptoms may
include decreased urine volume or blood in the urine and/or allergic reactions such as fever,
rash and joint stiffness. Inform your doctor if you experience any of these symptoms.
This medicine may mask the symptoms of other diseases. Therefore, if one of the following
conditions occurs before taking GastroSchoum Reflusso or occurs while you are taking it, talk
immediately to your doctor if:

• You lose a lot of weight for no reason and have difficulty swallowing.
• You experience stomach pain or have indigestion.
• You start vomiting food or blood.
• You pass black stools (stools stained with blood).
• You experience severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• You have previously had a gastric ulcer or have undergone stomach surgery.
• You are continuously treated for 4 or more weeks for reflux or heartburn.
• You continuously suffer from indigestion or heartburn for 4 or more weeks.
• You have jaundice or serious liver problems.
• You are over 55 years old and have new or recently changed reflux symptoms.
• You have ever had a skin reaction after treatment with a medicine similar to Schoum gastroprotect that reduces stomach acid.
• You need to undergo a specific blood test (chromogranin A).

Patients should not take omeprazole as a preventative medicine.
If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact
your doctor as soon as possible, as you may need to stop therapy with Schoum
gastroprotect. Remember to also report any other side effects such as joint pain.

Children and adolescents
The use of GastroSchoum Reflusso is not recommended in children and adolescents under the age of
18 years due to insufficient safety and efficacy data.

Other medicines and GastroSchoum Reflusso
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This includes medicines you can buy without a prescription.
This is because GastroSchoum Reflusso can affect the action of some medicines and some
medicines can have effects on GastroSchoum Reflusso.
Do not take GastroSchoum Reflusso if you are taking medicines containing nelfinavir(used for
treating HIV infections).
You must specifically inform your doctor or pharmacist if you are taking clopidogrel (used for
preventing blood clots (thrombi)).
Talk to your doctor or pharmacist if you are taking any of these medicines:

• Ketoconazole, itraconazole, posaconazole or voriconazole (used to treat fungal infections).
• Digoxin (used to treat heart problems).
• Diazepam (used to treat anxiety, to relax muscles or in epilepsy).
• Phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor will need to monitor your condition when you start or stop taking GastroSchoum Reflusso.
• Medicines that are used to thin the blood such as warfarin or other vitamin K blockers. Your doctor will need to monitor your condition when you start or stop taking GastroSchoum Reflusso.
• Rifampicin (used to treat tuberculosis).
• Atazanavir (used to treat HIV infections).
• Tacrolimus (used in organ transplants).
• St. John's Wort ( Hypericum perforatum) (used to treat mild depression).
• Cilostazol (used to treat intermittent claudication).
• Saquinavir (used to treat HIV infection).
• Clopidogrel (used to prevent blood clots (thrombi)).
• Erlotinib (used in the treatment of cancer).
• Methotrexate (a chemotherapeutic medicine used at high doses for the treatment of cancer) - if you are taking a high dose of methotrexate, your doctor may ask you to temporarily stop treatment with GastroSchoum Reflusso.

Schoum gastroprotect with food and drink
See section 3 “How to take GastroSchoum Reflusso”.

Pregnancy and breastfeeding
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.
Omeprazole is excreted in breast milk but is unlikely to have effects on the baby when
therapeutic doses are used. The doctor will decide whether you can take Schoum gastroprotect if you
are breastfeeding.

Driving and using machines
It is unlikely that GastroSchoum Reflusso will affect your ability to drive or operate tools
or machinery. Side effects such as dizziness and visual disturbances may occur (see section
4). If these occur, you should not drive or operate machinery.

GastroSchoum Reflussocontains sodium
This medicine contains 225 mg of sodium (the main component of table salt) in
each capsule. This is equivalent to 11.2% of the recommended maximum daily intake of 2
g of sodium for an adult.

3. How to take GASTROSCHOUM REFLUSSO

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended doses are one capsule (20 mg) once a day for up to 14 days. Contact your
doctor if you have not been relieved of your symptoms after this period.
You may need to take the capsules for 2 or 3 consecutive days before your symptoms
improve. Most patients achieve complete symptom relief within 7 days.
Once you are completely free from symptoms, you should stop taking Schoum gastroprotect.

Taking the medicine

• Take your capsule on an empty stomach, at the same time each day. An empty stomach means at least 30 minutes before a meal and at least 2 hours after your last meal (for example in the morning before breakfast). The medicine contains the excipient sodium hydrogen carbonate which protects the active ingredient omeprazole from degradation by acids in the stomach. If the medicine is taken with food, the protective effect of sodium bicarbonate is reduced and the medicine may not have its full effect.
• Swallow the capsule whole with half a glass of water. Do not chew or open the capsules as this may prevent them from working correctly.

If you take more GastroSchoum Reflussothan you should
If you take more GastroSchoum Reflusso than recommended, talk to your doctor or pharmacist
immediately.

If you forget to take Gastroschoum reflusso
If you forget to take a dose, take it as soon as you remember. However, if it is almost time to take
your next dose, skip the missed dose. Do not take a double dose to make up for a
forgotten capsule.
If you have any doubts about using 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 rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious side effects, stop taking GastroSchoum Reflusso and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue and throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction). (rare)
• Redness of the skin with blisters or peeling. Severe blisters and bleeding of the lips, eyes, mouth, nose and genitals may also occur. These manifestations could be signs of “Stevens-Johnson” syndrome or “toxic epidermal necrolysis”. (very rare)
• Widespread skin rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (rare)
• Widespread, red and scaly skin rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). (rare)
• Yellowing of the skin, dark urine and fatigue, which may be symptoms of liver problems. (rare)

GastroSchoum Reflusso can very rarely affect white blood cells, leading to immunodeficiency. If you experience an infection with symptoms such as fever with severedeterioration of general health or fever with symptoms of local infection such as sore throat, or difficulty urinating, you should consult a doctor as soon as possiblein order to rule out a lack of white blood cells (agranulocytosis) by performing a blood test. In this case it is important that you inform your doctor about the medicine you are taking.

Other side effects:
Common (may affect up to 1 in 10 people)

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, gas in the intestines (flatulence).
• Feeling unwell (nausea) or feeling sick (vomiting).
• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling sensation like “pins and needles”, feeling sleepy.
• Feeling of spinning (vertigo).
• Changes in blood tests that assess how the liver is working.
• Skin redness, rash with hives (urticaria) and itching of the skin.
• Feeling generally unwell and weak.

Rare (may affect up to 1 in 1,000 people)

• Blood problems such as a decrease in white blood cells or platelets. This can cause weakness, bruising or increased susceptibility to infections.
• Low levels of sodium in the blood. This can cause weakness, feeling unwell (vomiting) and cramps.
• Feeling agitated, confused or depressed.
• Altered taste.
• Vision problems such as blurred vision
• Suddenly feeling short of breath or wheezing (bronchospasm).
• Dry mouth.
• Inflammation of the inside of the mouth.
• An infection called “thrush” that can affect the intestines and is caused by a fungus.
• Hair loss (alopecia).
• Skin rash during exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Serious kidney problems (interstitial nephritis).
• Increased sweating.

Very rare (may affect up to 1 in 10,000 people)

• Changes in blood counts including agranulocytosis (lack of white blood cells).
• Aggressive behavior.
• Seeing, feeling or hearing things that are not there (hallucinations).
• Serious liver problems leading to liver failure and brain inflammation.
• Erythema multiforme.
• Muscle weakness.
• Gynecomastia in men.

Frequency not known (the frequency cannot be estimated from the available data):

• Inflammation of the intestine (which can lead to diarrhea).
• Hypomagnesemia (magnesium deficiency in the blood).
• Erythema, possible joint pain.

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 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 GastroSchoum 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.
Store at a temperature below 25°C. Store in the original package to protect the
medicine from humidity.
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 GastroSchoum Reflusso contains
The active ingredient is omeprazole. Each hard capsule contains 20 mg of omeprazole.
The other ingredients are sodium hydrogen carbonate (E500i), sodium starch glycolate (type A), sodium
stearylfumarate (E485) in gelatin capsules (E441), red iron oxide (E 172) and titanium dioxide
(E171).

Description of the appearance of GastroSchoum Reflusso and contents of the pack
GastroSchoum Reflusso is a powder from white to almost white in capsules with an opaque white body and
red cap without writing.
The hard capsules are packaged in PVC/PVDC/Alu blisters.
Pack sizes: 7 and 14 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano
Manufacturer
Zentiva k.s.
U Kabelovny 130
Dolní Měcholupy
102 37 Praha-Dolní Měcholupy
Czech Republic
and
Labormed-Pharma S.A.
Bd. Theodor Pallady nr. 44B, sector 3, cod 032266 Bucharest
Romania

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Czech Republic Helicid Neo
Bulgaria Helicid Rapid 20 mg hard capsules (Хелицид Рапид 20 mg твърди капсули)
Poland Helicid Rapid
Hungary Helant 20mg hard capsule
Slovakia Helicid Neo
Romania Helant 20 mg capsules
Italy GastroSchoum Reflusso
Estonia Omeprazole Zentiva
Latvia Omeprazole Zentiva 20 mg cietās kapsulas
Lithuania Omeprazole Zentiva 20 mg kietosios kapsulės
Sweden Omeprazol Zentiva