Gastroschoum for reflux

Package leaflet: Information for the user

GastroSchoum Reflux 20 mg hard capsules

omeprazole
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 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 side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Talk to your doctor if you do not notice any improvement or if your symptoms worsen after 14 days.
Contents of this leaflet:

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

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

Schoum gastroprotect contains the active substance omeprazole. It belongs to a group of medicines called "proton pump inhibitors". These medicines work by reducing the amount of acid produced by the stomach.
This medicine is used in adults for the short-term treatment of reflux symptoms (for example, heartburn and acid regurgitation).
Reflux is the backflow of acid from the stomach into the esophagus ("food pipe"), which can become inflamed and painful. This may cause symptoms such as a painful burning sensation in the chest rising up 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 feeling better.

2. What you need to know before taking GASTROSCHOUM REFLUX

Do not take GastroSchoum Reflux

• 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 (for example pantoprazole, lansoprazole, rabeprazole, esomeprazole). If you are taking a medicine containing nelfinavir (used for HIV infections).

Do not take Schoum gastroprotect if any of the above apply to you. If you are unsure,
speak with 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 experience
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), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with treatment with GastroSchoum Reflux. Discontinue
use of GastroSchoum Reflux and contact your doctor immediately if you notice any of the
symptoms related to these severe skin reactions described in section 4.
During treatment with 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,
skin rash, and joint stiffness. Inform your doctor if you experience any of these symptoms.
This medicine may mask symptoms of other diseases. Therefore, if any of the following
conditions occur before taking GastroSchoum Reflux or develop while taking it, speak
immediately with your doctor if:

• You lose a lot of weight without reason and have difficulty swallowing.
• You experience stomach pain or indigestion.
• You start vomiting food or blood.
• You pass black stools (blood-stained stools).
• You develop severe or persistent diarrhoea, as omeprazole has been associated with a slightly increased risk of infectious diarrhoea.
• You have previously had a gastric ulcer or undergone stomach surgery.
• You have been 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 had new or recently changed reflux symptoms.
• You have ever had a skin reaction after treatment with a medicine similar to Schoum gastroprotect that reduces gastric acidity.
• You need to undergo a specific blood test (chromogranin A).

Patients should not take omeprazole as a preventive medicine.
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 Schoum
gastroprotect. Remember to also report any other adverse effects such as joint pain.
Children and adolescents
The use of GastroSchoum Reflux is not recommended in children and adolescents under
18 years of age due to insufficient safety and efficacy data.
Other medicines and GastroSchoum Reflux
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines. This also applies to medicines you can buy without a prescription.
This is because GastroSchoum Reflux can affect the action of some medicines and some
medicines may affect GastroSchoum Reflux.
Do not take GastroSchoum Reflux if you are taking medicines containing nelfinavir (used to
treat HIV infections).
You must specifically inform your doctor or pharmacist if you are taking clopidogrel (used to
prevent blood clots (thrombi)).
Talk to your doctor or pharmacist if you are taking any of the following 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 starting or stopping GastroSchoum Reflux.
• Medicines used to thin the blood such as warfarin or other vitamin K antagonists. Your doctor will need to monitor your condition when starting or stopping GastroSchoum Reflux.
• 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 cancer treatment).
• Methotrexate (a chemotherapeutic medicine used at high doses for cancer treatment) – if you are taking a high dose of methotrexate, your doctor may ask you to temporarily stop treatment with GastroSchoum Reflux.

Schoum gastroprotect with food and drinks
See section 3 “How to take GastroSchoum Reflux”.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Omeprazole is excreted in breast milk but is unlikely to affect the infant when therapeutic doses are used. Your doctor will decide whether you can take Schoum gastroprotect while
breastfeeding.
Driving and using machines
It is unlikely that GastroSchoum Reflux affects the ability to drive or use tools
or machinery. Undesirable effects such as dizziness and visual disturbances may occur (see section 4). If these occur, you must not drive or use machinery.
GastroSchoum Reflux contains sodium
This medicine contains 225 mg of sodium (the main component of table salt) per
capsule. This corresponds to 11.2% of the maximum recommended daily dietary intake of 2
g of sodium for an adult.

3. How to take GASTROSCHOUM REFLUX

Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one capsule (20 mg) once daily for up to 14 days. Contact your doctor if your symptoms have not resolved after this period.
You may need to take the capsules for 2 or 3 consecutive days before symptoms improve. Most patients achieve complete symptom relief within 7 days.
Once symptoms have completely resolved, you should stop taking Schoum gastroprotect.

Administration of 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 the last meal (for example, in the morning before breakfast). The medicine contains the excipient sodium hydrogen carbonate, which protects the active substance omeprazole from acid degradation in the stomach. If the medicine is taken with food, the protective effect of sodium bicarbonate may be reduced and the medicine may not work fully.
• Swallow the capsule whole with half a glass of water. Do not chew or open the capsules, as this may prevent them from working properly.

If you take more GastroSchoum Reflux than you should
If you take more GastroSchoum Reflux than recommended, speak with your doctor or pharmacist immediately.

If you forget to take GastroSchoum Reflux
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for 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 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 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, throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction). (rare)
• Skin redness with blisters or peeling. Severe blisters and bleeding of the lips, eyes, mouth, nose and genitals may also occur. These symptoms could be signs of “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”. (very rare)
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (rare)
• Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (generalized pustular eruption). (rare)
• Yellowing of the skin, dark urine and fatigue, which may be symptoms of liver problems. (rare)

GastroSchoum Reflusso may very rarely affect white blood cells, leading to immunodeficiency. If you develop an infection with symptoms such as fever accompanied by severe deterioration in your general health, or fever with signs of local infection such as neck, throat or mouth pain, or difficulty urinating, you must consult your doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) by means of 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.
• Stomach or intestinal problems: diarrhoea, stomach pain, constipation, gas in the intestine (flatulence).
• Feeling unwell (nausea) or being unwell (vomiting).
• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation like “pins and needles”, feeling drowsy.
• Feeling of dizziness (vertigo).
• Changes in blood tests assessing liver function.
• Skin redness (erythema), skin rash with hives (urticaria) and skin itching.
• Feeling generally unwell and weak.

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

• Blood problems such as reduced white blood cells or platelets. This may cause weakness, bruising or increased susceptibility to infections.
• Low levels of sodium in the blood. This may cause weakness, feeling unwell (vomiting) and cramps.
• Feeling restless, confused or depressed.
• Altered taste.
• Vision problems such as blurred vision.
• Suddenly feeling breathless or short of breath (bronchospasm).
• Dry mouth.
• Inflammation of the inner part of the mouth.
• A fungal infection called “thrush” that may affect the intestine.
• Hair loss (alopecia).
• Skin rash upon 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 count including agranulocytosis (lack of white blood cells).
• Aggressive behaviour.
• Seeing, feeling or hearing things that are not real (hallucinations).
• Serious liver problems leading to liver failure and brain inflammation.
• Erythema multiforme.
• Muscle weakness.
• Gynaecomastia in men.

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

• Inflammation of the intestine (which may lead to diarrhoea).
• Hypomagnesaemia (low magnesium levels in the blood).
• Erythema, possible joint pain.

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 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 stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
Store below 25°C. Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine 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 GastroSchoum Reflux contains
The active substance is omeprazole. Each hard capsule contains 20 mg of omeprazole.
The other components are sodium hydrogen carbonate (E500i), sodium starch glycolate (type A), sodium stearyl fumarate (E485), in gelatin capsules (E441), iron oxide red (E 172) and titanium dioxide (E171).

Description of the appearance of GastroSchoum Reflux and package contents
GastroSchoum Reflux is a white to almost white powder in hard capsules with an opaque white body and red cap, without printing.
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 Authorization Holder and Manufacturer
Marketing Authorization Holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milan
Italy

Manufacturers
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 authorized in the European Economic Area countries under the following names:
Czech Republic Helicid Neo
Bulgaria Helicid Rapid 20 mg hard capsules (Хелицид Рапид 20 mg твърди капсули)
Poland Helicid Rapid
Hungary Helant 20mg kemény kapszula
Slovakia Helicid Neo
Romania Helant 20 mg capsule
Italy GastroSchoum Reflusso
Estonia Omeprazole Zentiva
Latvia Omeprazole Zentiva 20 mg cietās kapsulas
Lithuania Omeprazole Zentiva 20 mg kietosios kapsulės
Sweden Omeprazol Zentiva