VENTAZOL 20 mg Capsules

Contents of the leaflet

1. Leaflet attached to the packaging: Patient information
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
2. What is Ventazol and what is it used for
3. Important information before taking Ventazol
   1. When not to take Ventazol
   2. Warnings and precautions
   3. Children
   4. Ventazol and other medicines
   5. Ventazol with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Ventazol contains sucrose
   9. Ventazol contains sodium
4. How to take Ventazol
   1. How to take Ventazol
   2. What to do in adults and children in case of difficulty swallowing
   3. What to do if you take more Ventazol than you should
   4. What to do if you miss a dose of Ventazol
   5. What to do if you stop taking Ventazol
5. Possible side effects
   1. If you experience any of the following serious side effects, which may occur in rare (may affect up to 1 in 1000 people) or very rare (may affect up to 1 in 10,000 people) cases, stop taking Ventazol and contact your doctor immediately:
   3. Very rare side effects (may affect less than 1 in 10,000 people):
   4. Frequency not known (frequency cannot be estimated from the available data):
   5. Reporting side effects
6. How to store Ventazol
7. Contents of the pack and other information
   1. What Ventazol contains
   2. What Ventazol looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Netherlands
   8. Austria
   9. Belgium
   10. Denmark
   11. Iceland
   12. Norway
   13. Poland
   14. Portugal
   15. Sweden
   16. United Kingdom

Leaflet attached to the packaging: Patient information

Ventazol, 20 mg, enteric-coated hard capsules, Omeprazolum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What is Ventazol and what is it used for
Important information before taking Ventazol
How to take Ventazol
Possible side effects
How to store Ventazol
Contents of the pack and other information

1. What is Ventazol and what is it used for

Ventazol contains the active substance omeprazole. It belongs to a group of medicines called
“proton pump inhibitors”. These medicines reduce the amount of acid produced in the stomach.
Ventazol is used to treat the following diseases:
Adults:

• Gastroesophageal reflux disease. This occurs when stomach acid flows back into the esophagus (the tube connecting the throat to the stomach) and causes pain, inflammation, and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcer disease) or stomach (gastric ulcer disease).
• Ulcers caused by infection with a bacterium called “Helicobacter pylori”. The doctor may prescribe antibiotics that will fight the infection and help heal the ulcers.
• Ulcers caused by taking non-steroidal anti-inflammatory drugs (NSAIDs). Ventazol may be used to prevent ulcers from forming while taking NSAIDs.
• Excess stomach acid caused by changes in the pancreas (Zollinger-Ellison syndrome).

Children and adolescents:
Children over 1 year of age and weighing ≥ 10 kg

• Gastroesophageal reflux disease. This occurs when stomach acid flows back into the esophagus (the tube connecting the throat to the stomach) and causes pain, inflammation, and heartburn.

In children, symptoms of this disease may also include reflux of stomach contents into the mouth
(regurgitation of acidic stomach contents), nausea (vomiting), and poor weight gain.
Children over 4 years of age and adolescents:

• Ulcers caused by infection with a bacterium called “Helicobacter pylori”. The doctor may prescribe antibiotics that will fight the infection and help heal the ulcers.

2. Important information before taking Ventazol

When not to take Ventazol

• If the patient is allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6).
• If the patient is allergic (hypersensitive) to other medicines in the group of proton pump inhibitors (e.g., pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• If the patient is taking nelfinavir (a medicine used to treat HIV infection) at the same time.

If any of the above situations occur, do not take Ventazol. Consult a doctor. In case of doubts, before taking Ventazol, consult a doctor or pharmacist.

Warnings and precautions

Before starting treatment with Ventazol, discuss it with your doctor or pharmacist.
During treatment with omeprazole, serious skin reactions have been reported, including
Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If the patient experiences any of these symptoms related to serious skin reactions mentioned in section 4, they should stop taking omeprazole and seek medical attention immediately.
Taking Ventazol may mask the symptoms of other diseases. Therefore, if the patient experiences any of the following symptoms before or during treatment with Ventazol, they should inform their doctor immediately:

• Significant, unintentional weight loss and difficulty swallowing.
• Abdominal pain or symptoms of indigestion.
• Vomiting or vomiting with blood.
• Black, tarry stools.
• Severe or persistent diarrhea, as omeprazole may slightly increase the frequency of bacterial diarrhea.
• Severe liver disease.
• If the patient has ever had a skin reaction after taking a medicine that reduces stomach acid.
• A specific blood test (chromogranin A level) is planned.

This medicine may affect the absorption of vitamin B, especially if it needs to be taken for a long time. If the patient experiences any of the following symptoms that may indicate a decrease in vitamin B levels, they should consult a doctor:

• Extreme fatigue or lack of energy
• Feeling of tingling or prickling
• Pain or redness of the tongue, mouth ulcers
• Muscle weakness
• Visual disturbances
• Memory disturbances, confusion, depression

During treatment with omeprazole, kidney inflammation may occur. Signs and symptoms may include
decreased urine output or blood in the urine and (or) hypersensitivity reactions, such as fever, rash, and joint stiffness. Such symptoms should be reported to the attending physician.
If the patient takes Ventazol for a long time (more than 1 year), the doctor will probably perform regular health checks. During follow-up visits, the patient should report all new or unusual symptoms to the doctor.
Taking proton pump inhibitors, such as Ventazol, especially for a period longer than one year, may slightly increase the risk of hip, wrist, or spine fractures. The patient should inform their doctor if they have been diagnosed with osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
If the patient experiences a skin rash, especially in areas exposed to sunlight, they should tell their doctor as soon as possible, as it may be necessary to stop taking Ventazol. The patient should also report any other side effects, such as joint pain.

Children

Some children with chronic diseases may require long-term treatment, but such treatment is not recommended. Do not give this medicine to children under 1 year of age and weighing less than 10 kg.

Ventazol and other medicines

Tell your doctor about all medicines you are taking now or have taken recently, as well as any medicines you plan to take. This includes medicines that are available without a prescription. It is important because Ventazol may change the effect of other medicines or the effect of Ventazol may change if other medicines are taken.
Do not take Ventazol if you are taking a medicine containing nelfinavir(a medicine used to treat HIV infection).
Tell your doctor or pharmacist if you are taking any of the following medicines:

• Ketoconazole, itraconazole, or voriconazole (medicines used to treat fungal infections)
• Digoxin (a medicine used to treat heart conditions)
• Diazepam (a medicine used to treat anxiety, epilepsy, or to relax muscles)
• Phenytoin (a medicine used to treat epilepsy). If you are taking phenytoin, your doctor may order additional tests at the beginning and end of treatment with Ventazol
• Blood-thinning medicines, such as warfarin or other medicines that block the action of vitamin K. Your doctor may order additional tests at the beginning and end of treatment with Ventazol
• Rifampicin (a medicine used to treat tuberculosis)
• Atazanavir (a medicine used to treat HIV infection)
• Tacrolimus (a medicine used to prevent transplant rejection)
• St. John's Wort ( Hypericum perforatum) (a medicine used to treat mild depression)
• Cilostazol (a medicine used to treat intermittent claudication)
• Saquinavir (a medicine used to treat HIV infection)
• Clopidogrel (a medicine used to prevent blood clots)
• Erlotinib (used to treat cancer)
• Methotrexate (a medicine used in high doses in chemotherapy to treat cancer) - if methotrexate is used in high doses, your doctor may temporarily stop taking Ventazol.

If your doctor has prescribed antibiotics, amoxicillin, and clarithromycin to be taken with Ventazol to treat ulcers caused by Helicobacter pyloriinfection, it is very important to tell your doctor about any other medicines you are taking.

Ventazol with food and drink

See section 3.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Omeprazole passes into breast milk, but it is unlikely to affect the baby if taken in therapeutic doses.
Your doctor will decide whether you can take Ventazol while breastfeeding.

Driving and using machines

Ventazol is unlikely to affect your ability to drive or use machines. However, if you experience side effects such as dizziness and visual disturbances (see section 4), do not drive or operate machinery.

Ventazol contains sucrose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Ventazol contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially ‘sodium-free’.

3. How to take Ventazol

Take Ventazol exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The dose and duration of treatment with Ventazol will be determined by your doctor, depending on your disease and age.
Recommended doses:
Adults:

• Treatment of symptoms of gastroesophageal reflux disease, such as heartburn and acid reflux
  into the esophagus:
• If your doctor has found that your esophagus is slightly damaged, the usual dose is 20 mg once a day for 4-8 weeks. In patients who have not healed during this time, the doctor may prescribe a dose of 40 mg for the next 8 weeks.
• The usual dose for patients with healed esophagus is 10 mg once a day.
• If the esophagus is not damaged, the usual dose is 10 mg once a day.

Treatment of duodenal ulcers(duodenal ulcer disease):

• The usual dose is 20 mg once a day for 2 weeks. In patients who have not healed during this time, the doctor may prescribe a dose of 20 mg for the next 2 weeks.
• In patients who have not fully healed, the doctor may prescribe a dose of 40 mg for 4 weeks.

Treatment of gastric ulcers(gastric ulcer disease):

• The usual dose is 20 mg once a day for 4 weeks. In patients who have not healed during this time, the doctor may prescribe a dose of 20 mg for the next 4 weeks.
• In patients who have not fully healed, the doctor may prescribe a dose of 40 mg for 8 weeks.

Preventionof duodenal and gastric ulcers:

• The usual dose is 10 mg or 20 mg once a day. The doctor may also prescribe a higher dose, 40 mg once a day.

Treatment of ulcerscaused by taking non-steroidal anti-inflammatory drugs(NSAIDs):

• The usual dose is 20 mg once a day for 4-8 weeks.

Prevention of duodenal and gastric ulcersduring treatment with non-steroidal anti-inflammatory drugs(NSAIDs) :

• The usual dose is 20 mg once a day.

Treatment and prevention of ulcers associated with Helicobacter pyloriinfection:

• The usual dose is 20 mg twice a day for one week.
• The doctor will also prescribe two antibiotics: amoxicillin and clarithromycin.

Treatment of excess stomach acid caused by changes in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is 60 mg per day.
• The doctor will determine the dose and duration of treatment based on the symptoms.

Use in children and adolescents:
Treatment of symptoms of gastroesophageal reflux disease, such as heartburn and acid reflux
into the esophagus:

• Ventazol can be used in children over 1 year of age and weighing more than 10 kg. The doctor will prescribe a dose based on the child's weight.

Treatment and prevention of ulcers associated with Helicobacter pyloriinfection:

• Ventazol can be used in children over 4 years of age. The doctor will prescribe a dose based on the child's weight.
• The doctor will also prescribe two antibiotics: amoxicillin and clarithromycin.

How to take Ventazol

• It is recommended to take Ventazol in the morning.
• Ventazol can be taken on an empty stomach or with food.
• The capsule should be swallowed whole and washed down with water. The capsule should not be chewed or crushed, as the coating that protects the pellets from stomach acid may be damaged. It is essential not to damage the pellets.

What to do in adults and children in case of difficulty swallowing

• In case of difficulty swallowing capsules:
• Open the capsule, swallow its contents, and wash down with half a glass of water or mix the contents of the capsule with a small amount of yogurt or acidic fruit juice (e.g., apple, orange, or pineapple) or apple sauce.
• Always mix the solution before drinking (the solution will not be clear). The solution should be drunk immediately or within 30 minutes of preparation.
• To ensure that all the medicine is taken, fill the glass with water, stir, and drink.

Undissolved particles contain the medicine; do not chew or crush them.

What to do if you take more Ventazol than you should

If you have taken more Ventazol than you should, contact your doctor or pharmacist immediately.

What to do if you miss a dose of Ventazol

Take the missed dose as soon as possible. If it is almost time for the next dose, do not take the missed dose. Do not take a double dose to make up for the missed dose.

What to do if you stop taking Ventazol

Do not stop taking Ventazol without consulting your doctor or pharmacist first.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ventazol can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, which may occur in rare (may affect up to 1 in 1000 people) or very rare (may affect up to 1 in 10,000 people) cases, stop taking Ventazol and contact your doctor immediately:

• Wheezing, swelling of the lips, tongue, throat, or torso, rash, fainting, or difficulty swallowing (severe hypersensitivity reaction) (rare).
• Redness of the skin with blisters or peeling. Blisters and bleeding may also occur in the mouth, eyes, nose, and genitals. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis (very rare).
• Widespread rash, high fever, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome) (rare).
• Red, peeling 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 feeling tired, which may be signs of liver disease (rare).

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

• Headache.
• Gastrointestinal symptoms: diarrhea, abdominal pain, constipation, bloating with gas.
• Nausea or vomiting.
• Mild stomach polyps.

Uncommon side effects (may affect up to 1 in 100 people):

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, feeling of tingling, numbness, and drowsiness.
• Feeling of spinning (vertigo of labyrinthine origin).
• Changes in liver function tests.
• Rash, urticaria (hives), itching skin.
• General malaise and weakness.

Rare side effects (may affect up to 1 in 1000 people):

• Blood disorders, such as decreased white blood cell or platelet count. They may cause weakness, bruising, and increased susceptibility to infections.
• Allergic reactions, sometimes very severe, including swelling of the lips, tongue, throat, fever, difficulty breathing.
• Low sodium levels in the blood. It may cause weakness, nausea (vomiting), and cramps.
• Feeling agitated, disoriented, or depressed.
• Changes in taste.
• Eye disorders, such as blurred vision.
• Sudden shortness of breath, difficulty breathing (bronchospasm).
• Dryness of the mucous membranes in the mouth.
• Inflammation of the mouth.
• Fungal infection called “thrush”, which may affect the intestines.
• Hair loss.
• Sensitivity to light (sunburn-like rash).
• Joint pain or muscle pain.
• Severe kidney disease (interstitial nephritis).
• Increased sweating.

Very rare side effects (may affect less than 1 in 10,000 people):

• Decreased number of blood cells, including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling, and hearing things that are not there (hallucinations).
• Severe liver disease, including liver failure and hepatitis.
• Stevens-Johnson syndrome.
• Muscle weakness.
• Enlargement of the breasts in men.

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

• Colitis (leading to diarrhea).
• Taking Ventazol for more than three months may cause a decrease in magnesium levels in the blood. Magnesium deficiency may cause symptoms such as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat. If you experience any of these symptoms, tell your doctor immediately. Low magnesium levels may also lead to low potassium or calcium levels in the blood. Your doctor may order regular blood tests to monitor magnesium levels.
• Rash that may be associated with joint pain.

Ventazol can very rarely cause damage to white blood cells, leading to a lack of immunity.
Consult your doctor immediately if you experience an infection with fever and severe deterioration of general condition or fever with signs of local infection, such as neck, throat, or mouth pain, difficulty urinating, as blood tests will be needed to rule out a lack of white blood cells (agranulocytosis). It is essential to inform your doctor about the medicines you are taking.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Ventazol

Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date stated on the carton, bottle, or blister after “EXP”. The expiry date refers to the last day of that month. HDPE bottle: The medicine should be used within 105 days of first opening.
Store in a temperature below 25°C.
Store in the original packaging, and keep the bottle tightly closed to protect from moisture. After use, close the cap tightly.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ventazol contains

• The active substance is omeprazole. One capsule contains 20 mg of omeprazole.
• The other ingredients are:
• Contents of the capsule:sucrose, pellets (sucrose and cornstarch), sodium lauryl sulfate, disodium phosphate, mannitol, hypromellose 6cP, macrogol 6000, talc, polysorbate 80, titanium dioxide (E 171), methacrylic acid - ethyl acrylate copolymer (1:1).
• Capsule shell:gelatin. The 20 mg capsules contain the colorant quinoline yellow (E 104) and titanium dioxide (E 171).

What Ventazol looks like and contents of the pack

Ventazol 20 mg: yellow, opaque capsule, containing spherical pellets in white to off-white color.
Ventazol 20 mg is available in packs of:

• Blister pack - the pack contains 7, 14, 15, 28, 30, 50, 56, 60, 90 capsules.
• HDPE bottle - the pack contains 7, 14, 15, 28, 30, 50, 56, 60, 90 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden

Manufacturer

LABORATORIOS LICONSA, S.A.
Avda. Miralcampo, N°7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), Spain
Sandoz A/S
Edvard Thomsens Vej 14
2300 København S
Denmark

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands

Omeprazol Sandoz capsule 20 mg, maagsapresistente capsule, hard

Austria

Omoquis 20 mg magensaftresistente Hartkapseln

Belgium

Omeprazol AB 20mg, maagsapresistente capsules, hard

Denmark

Omeprazol Sandoz

Iceland

Omeprazol Sandoz 20 mg magasýruþolin hörð hylki

Norway

Omeprazol Sandoz 20 mg enterokapsel, hard

Poland

Ventazol

Portugal

Omoquis

Sweden

Omeprazol Sandoz hårda enterokapslar

United Kingdom

Omeprazole 20 mg gastro-resistant capsules
Date of last revision of the leaflet:24.06.2023