LOSEC 20 mg Capsules

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.
3. Losec (Mopral 20 mg), 20 mg gastro-resistant hard capsules
   1. The patient should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Losec and what is it used for
5. Important information before taking Losec
   1. When not to take Losec:
   2. Warnings and precautions
   3. Children
   4. Losec and other medicines
   5. Losec with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Losec capsules contain lactose and sodium
6. How to take Losec
   1. Use in adults:
   2. Prevention of duodenal and gastric ulcers:
   3. Use in children and adolescents
   4. How to take Losec
   5. What to do if the patient has difficulty swallowing the capsules (in adults or children)
   6. Taking a higher dose of Losec than recommended
   7. Missing a dose of Losec
   8. Stopping treatment with Losec
7. Possible side effects
   1. In case of 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, the patient should stop taking Losec and contact their doctor immediately:
   3. Common side effects (may affect up to 1 in 10 people)
   4. Uncommon side effects (may affect up to 1 in 100 people)
   5. Rare side effects (may affect up to 1 in 1,000 people)
   6. Very rare side effects (may affect up to 1 in 10,000 people)
   7. Frequency not known (frequency cannot be estimated from the available data)
   8. Reporting side effects
8. How to store Losec
9. Package contents and other information
   1. What Losec contains
   2. What Losec looks like and contents of the pack
   3. Marketing authorization holder in France, the country of export:
   4. Manufacturer:
   5. Parallel importer:
   6. Repackaged by:
   7. Parallel import authorization number: 159/24
   8. This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
   9. Date of leaflet approval: 22.04.2024

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Losec (Mopral 20 mg), 20 mg gastro-resistant hard capsules

Omeprazole
Losec and Mopral 20 mg are different trade names for the same medicine.

The patient should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Losec and what is it used for
• 2. Important information before taking Losec
• 3. How to take Losec
• 4. Possible side effects
• 5. How to store Losec
• 6. Package contents and other information

1. What is Losec and what is it used for

Losec contains the active substance omeprazole. It belongs to a group of medicines called
“proton pump inhibitors”. Their action is to reduce the amount of acid secreted in the
stomach.
Losec is used to treat the following diseases and disorders:
In adults:

• Gastro-esophageal reflux disease (GERD). This is when stomach acid flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the small intestine (duodenal ulcers) or stomach (gastric ulcers).
• Ulcers infected with bacteria called “Helicobacter pylori”. In such cases, the doctor may also prescribe antibiotics to cure the infection and allow the ulcers to heal.
• Ulcers caused by drugs known as non-steroidal anti-inflammatory drugs (NSAIDs). Losec can also be used to prevent the development of ulcers when taking NSAIDs.
• Excessive stomach acid due to a tumor in the pancreas (Zollinger-Ellison syndrome).

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

• Gastro-esophageal reflux disease (GERD). This is when stomach acid flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.

In children, symptoms of this disorder may include spitting up or vomiting food, and poor weight gain.
Children and adolescents over 4 years of age

• Ulcers infected with bacteria called “Helicobacter pylori”. If a child has this disease, the doctor may also prescribe antibiotics to cure the infection and allow the ulcers to heal.

2. Important information before taking Losec

When not to take Losec:

The patient should not take Losec if any of the above points apply to them. In case of any doubts before starting to take Losec, the patient should talk to their doctor or pharmacist.

Warnings and precautions

Before taking Losec, the patient should talk to their doctor or pharmacist.
During treatment with Losec, 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 notices any symptoms related to these serious skin reactions described in section 4, they should stop taking Losec and seek medical help immediately.
Losec may mask the symptoms of other diseases. For this reason, if the patient experiences any of the following conditions before or during treatment with Losec, they should immediately inform their doctor:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting blood or food.
• Passing black stools (stool discolored with blood).
• Severe or persistent diarrhea, as omeprazole is associated with a slight increase in the frequency of infectious diarrhea.
• Severe liver problems.
• If the patient has ever had a skin reaction after taking a medicine that reduces stomach acid.
• About a planned specific blood test (chromogranin A levels).

In case of long-term use of Losec (longer than 1 year), the patient will most likely remain under close and regular medical supervision. During visits to the doctor, the patient should report any new or unusual symptoms and circumstances.
When taking proton pump inhibitors like Losec, especially for a period longer than one year, the risk of hip, wrist, or spine fractures may increase slightly. The patient should inform their doctor if they have been diagnosed with osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).
If the patient experiences a rash, especially in areas exposed to sunlight, they should tell their doctor as soon as possible, as it may be necessary to stop taking Losec. The patient should also report any other side effects, such as joint pain.
During omeprazole treatment, kidney inflammation may occur. Symptoms may include decreased urine output or blood in the urine and (or) hypersensitivity reactions, such as fever, rash, and joint stiffness. The patient should report such symptoms to their doctor.
This medicine may affect how the body absorbs vitamin B, especially if it needs to be taken for a long time. The patient should contact their doctor if they notice any of the following symptoms, which may indicate a low level of vitamin B:

• Extreme fatigue or lack of energy
• Numbness and tingling
• Painful or red tongue, mouth ulcers
• Muscle weakness
• Vision disturbances
• Memory problems, confusion, depression

Children

Some children with chronic diseases may require long-term treatment, although this is not recommended. This medicine should not be given to children under 1 year of age or weighing less than 10 kg.

Losec and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking, have recently taken, and plan to take. This includes medicines available without a prescription. This is important because Losec may affect how some other medicines work, and some other medicines may affect how Losec works.
The patient should not take Losec if they are taking a medicine containing nelfinavir (used to treat HIV infection).
The patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• Ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections)
• Digoxin (used to treat heart rhythm disorders)
• Diazepam (used to treat anxiety, to reduce muscle tension, or to treat epilepsy).
• Phenytoin (used to treat epilepsy). If the patient is taking phenytoin, their doctor will need to monitor their condition when starting or stopping Losec.
• Medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. The doctor will need to monitor the patient's condition when starting or stopping Losec.
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (used in organ transplantation)
• 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)
• Erlotinib (used to treat cancer)
• Methotrexate (a chemotherapy medicine used to treat cancer) - if the patient is taking high doses of methotrexate, their doctor may temporarily stop Losec.

If the doctor has prescribed the patient antibiotics amoxicillin and clarithromycin and Losec to treat ulcers caused by Helicobacter pylori infection, it is very important for the patient to inform their doctor about any other medicines they are taking.

Losec with food and drink

See section 3.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, thinks they may be pregnant, or plans to become pregnant, they should consult their doctor or pharmacist before taking this medicine.
Omeprazole passes into breast milk, but its effect on the baby is unlikely if the medicine is used at therapeutic doses. Whether a breastfeeding patient can take Losec will be decided by their doctor.

Driving and using machines

Losec does not affect the ability to drive or use machines.
However, side effects such as dizziness and blurred vision (see section 4 of this leaflet) may occur. If these occur, the patient should not drive or operate machinery.

Losec capsules contain lactose and sodium

Losec capsules contain lactose. If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.
Losec capsules contain less than 1 mmol of sodium (23 mg) per capsule, which means the medicine is essentially 'sodium-free'.

3. How to take Losec

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient is unsure, they should consult their doctor or pharmacist.
The doctor will tell the patient how many capsules to take and for how long. This will depend on the patient's health and age.
The recommended doses are presented below.

Use in adults:

Treatment of GERD symptoms, such as heartburn and acid reflux:

• If the doctor has found that the patient's esophagus is slightly damaged, the recommended dose is 20 mg once daily for 4 to 8 weeks. The doctor may recommend that the patient take a dose of 40 mg for a further 8 weeks if the esophagus does not heal
• The recommended dose after healing of the esophagus is 10 mg once daily.
• If the esophagus is not damaged, the usual dose is 10 mg once daily.

Treatment of duodenal ulcers:

• The recommended dose is 20 mg once daily for 2 weeks. The doctor may recommend that the patient take the same dose for a further 2 weeks if the ulcers do not heal within this time.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once daily for 4 weeks.

Treatment of gastric ulcers:

• The recommended dose is 20 mg once daily for 4 weeks. The doctor may recommend that the patient take the same dose for a further 4 weeks if the ulcers do not heal within this time.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once daily for 8 weeks.

Prevention of duodenal and gastric ulcers:

• The recommended dose is 10 mg or 20 mg once daily. The doctor may increase the dose to 40 mg once daily.

Treatment of duodenal and gastric ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is 20 mg once daily for 4 to 8 weeks.

Prevention of duodenal and gastric ulcers during NSAID (non-steroidal anti-inflammatory drug) use:

• The recommended dose is 20 mg once daily.

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of their recurrence:

• The recommended dose of Losec is 20 mg twice daily for one week.
• The doctor will also prescribe the patient two antibiotics: amoxicillin and clarithromycin.

Treatment of excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome):

• The usual dose is 60 mg per day.
• The doctor will adjust the dose according to the individual needs of the patient and decide how long the patient needs to take Losec.

Use in children and adolescents

Treatment of GERD symptoms, such as heartburn and acid reflux:

• Losec can be taken by children over 1 year of age and weighing more than 10 kg. The dose depends on the child's weight and is determined individually by the doctor.

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of their recurrence:

• Children over 4 years of age can take Losec. The dose for children is based on the child's weight and is determined individually by the doctor.
• The doctor will also prescribe the child two antibiotics: amoxicillin and clarithromycin.

How to take Losec

• It is recommended to take the capsules in the morning.
• The capsules can be taken with or without food.
• The capsules should be swallowed whole with half a glass of water. The capsules should not be chewed or crushed, as they contain enteric-coated pellets, whose coating prevents the breakdown of the medicine by stomach acid. It is essential not to damage the pellets.

What to do if the patient has difficulty swallowing the capsules (in adults or children)

• If the patient has difficulty swallowing the capsules:
• Open the capsule and swallow the contents directly, washing it down with a glass of water or mix the contents with a glass of non-carbonated water, any acidic fruit juice (e.g., apple, orange, or grapefruit), or apple sauce.
• Always mix the mixture just before drinking (the mixture will not be clear). Then drink the mixture immediately after preparation or within 30 minutes.
• To ensure that the patient has taken the entire dose, the glass should be rinsed with half a glass of water and the rinse swallowed. The solid particles contain the medicine - they should not be chewed or crushed.

Taking a higher dose of Losec than recommended

If the patient has taken a higher dose of Losec than prescribed by their doctor, they should contact their doctor or pharmacist immediately.

Missing a dose of Losec

If the patient misses a dose, they should take it as soon as they remember.
If it is time for the next dose, the patient should skip the missed dose.
The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Losec

The patient should not stop taking Losec without consulting their doctor or pharmacist first.
If the patient has any further questions about the use of this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

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

In case of 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, the patient should stop taking Losec and contact their doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, and throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction). (rare)
• Redness of the skin with blistering or peeling. Large blisters and bleeding in the lips, eyes, mouth, nose, and genitals may also occur. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis. (very rare)
• Widespread rash, high fever, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome). (rare)
• Red, scaly, widespread rash with small 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 can be signs of liver problems. (rare)

Other side effects include:

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

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, gas (bloating).
• 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).
• Feeling of dizziness, tingling, and drowsiness.
• Feeling of spinning (vertigo).
• Changes in liver function test results.
• Skin rash, hives, and itching.
• General feeling of being unwell and lack of energy.

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

• Blood problems, such as a decreased number of white blood cells or platelets. This may lead to weakness, easier bruising, or increased risk of infection.
• Low sodium levels in the blood. This may lead to weakness, vomiting, and muscle cramps
• Feeling agitated, confused, or depressed.
• Changes in taste.
• Vision problems, such as blurred vision.
• Sudden shortness of breath or wheezing (bronchospasm).
• Dry mouth.
• Mouth inflammation.
• A fungal infection called “thrush”, which can affect the intestines and is caused by yeast
• Hair loss (alopecia).
• Skin rash in areas exposed to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

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

• Changes in blood cell counts, including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems leading to liver failure and brain damage.
• Multi-form erythema.
• Muscle weakness.
• Breast enlargement in men.

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

• Colitis (causing diarrhea)
• If the patient has taken Losec for more than three months, there is a possibility of decreased magnesium levels in the blood. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat. If the patient experiences any of these symptoms, they should inform their doctor immediately. Low magnesium levels may lead to low potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.
• A rash that may be accompanied by joint pain.

In very rare cases, Losec may affect the number of white blood cells in the blood, leading to a lack of immunity. If the patient experiences an infection with symptoms such as fever with a serious deterioration in general health or fever with signs of a local infection, such as a sore throat, or difficulty urinating, they should consult their doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) based on a blood test result. It is essential for the patient to inform their doctor or pharmacist about the medicine they are taking.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Losec

This medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The patient should not store the medicine at temperatures above 30°C. The bottle should be kept tightly closed to protect it from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What Losec contains

The active substance of Losec is omeprazole. Each capsule (gastro-resistant hard capsule) contains 20 mg of omeprazole. The other ingredients are: disodium phosphate dihydrate, hydroxypropylcellulose low-substituted, hypromellose, lactose, magnesium stearate, mannitol, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%, microcrystalline cellulose, macrogol 400, sodium lauryl sulfate; capsule shell: red iron oxide (E 172), titanium dioxide (E 171), gelatin, magnesium stearate, sodium lauryl sulfate, printing ink (contains shellac, ammonium hydroxide, potassium hydroxide, black iron oxide (E 172), colloidal silica anhydrous, and liquid paraffin.
(See section 2: Losec capsules contain lactose).

What Losec looks like and contents of the pack

Pink body and red-brown cap, marked with the number "20" and A/OM, respectively.
Pack size:
HDPE bottles with PP caps containing a desiccant in a cardboard box, containing 14 capsules.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in France, the country of export:

CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany

Manufacturer:

Saneca Pharmaceuticals a.s., Nitrianska 100, 920 27 Hlohovec, Slovakia
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 23-24, 17489 Greifswald, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Authorization number in France, the country of export: 3400934081217

Parallel import authorization number: 159/24

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of leaflet approval: 22.04.2024

[Information about the trademark]