Losec

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Losec, 20 mg, enteric-coated hard capsules
Omeprazole

Before taking the medicine, carefully read the contents of the leaflet, 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 specifically for one 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 inform their doctor or pharmacist. 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. Contents of the packaging 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:

• Gastroesophageal 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 called non-steroidal anti-inflammatory drugs (NSAIDs). Losec can also be used to prevent the development of ulcers when taking NSAIDs.
• Excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome).

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

• Gastroesophageal 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 regurgitation of stomach contents into the mouth, vomiting, 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:

Do not take Losec if any of the above points apply to you.
In case of any doubts before starting to take Losec, consult a doctor or pharmacist.

Warnings and precautions

Before taking Losec, consult a 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 any symptoms of these serious skin reactions occur, as described in section 4, stop taking Losec and seek medical attention immediately.
Losec may mask the symptoms of other diseases. For this reason, if any of the following conditions occur before or during treatment with Losec, the doctor should be informed immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting blood or black tarry stools.
• Severe or persistent diarrhea, as omeprazole is associated with a slight increase in the incidence 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 the event 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, all new and unusual symptoms and circumstances should be reported.
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. Patients 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 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. Patients 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. Patients should report such symptoms to their doctor.
This medicine may affect the way the body absorbs vitamin B, especially if it needs to be taken for a long time. Patients 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
• Visual 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

Patients 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 the way some other medicines work, and some other medicines may affect the way Losec works.
Do not take Losec if you are taking a medicine containing nelfinavir (used to treat HIV infection).
Patients 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, the doctor will need to monitor the patient's condition when starting and 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 and 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, the doctor may temporarily stop the patient from taking 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 the 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 she may be pregnant, or plans to become pregnant, she should consult her 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 the 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 they do, do not drive or operate machinery.

Losec in capsule form contains 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 as directed by the doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
The doctor will inform the patient how many capsules to take and for how long. This will depend on the patient's health and age.
Dosing recommendations 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 has been slightly damaged, the recommended dose is 20 mg once a day for 4 to 8 weeks. The doctor may recommend that the patient take a dose of 40 mg for another 8 weeks if the esophagus does not heal
• The recommended dose after healing of the esophagus is 10 mg once a day.
• If the esophagus has not been damaged, the usual dose is 10 mg once a day.

Treatment of duodenal ulcers:

• The recommended dose is 20 mg once a day for 2 weeks. The doctor may recommend taking the same dose for another 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 a day for 4 weeks.

Treatment of gastric ulcers:

• The recommended dose is 20 mg once a day for 4 weeks. The doctor may recommend taking the same dose for another 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 a day for 8 weeks.

Prevention of duodenal and gastric ulcers:

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

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

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

Prevention of duodenal and gastric ulcers during NSAID use:

• The recommended dose is 20 mg once a day.

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

• The recommended dose of Losec is 20 mg twice a day for one week.
• The doctor will also prescribe 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 depends on the child's weight and is determined individually by the doctor.
• The doctor will also prescribe 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. Do not chew or crush the capsules, as they contain enteric-coated pellets, the coating of which prevents the breakdown of the medicine by stomach acid. It is essential not to damage the pellets.

What to do if there are difficulties in swallowing the capsules (in an adult or child)

• If an adult or child has difficulty swallowing the capsules:
• Open the capsule and swallow the contents directly, with a glass of water, or pour the contents into a glass of non-carbonated water, any acidic fruit juice (e.g. apple, orange, or pineapple), or applesauce.
• Always mix the mixture immediately 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, rinse the glass with half a glass of water and drink the liquid. The solid particles contain the medicine - do not chew or crush them.

Taking a higher dose of Losec than recommended

In case of taking a higher dose of Losec than prescribed by the doctor, contact the doctor or pharmacist immediately.

Missing a dose of Losec

In case of missing a dose due to forgetfulness, take the dose as soon as remembered.
If it is time for the next dose, skip the missed dose.
Do not take a double dose to make up for the missed dose.

Stopping treatment with Losec

Do not stop taking Losec without consulting a doctor or pharmacist first.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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, stop taking Losec and contact a 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 mouth, eyes, lips, genitals, and anus 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 symptoms 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 disorders (insomnia).
• Feeling of dizziness, tingling, and drowsiness.
• Feeling of spinning (vertigo).
• Changes in liver function test results.
• Skin rash, urticaria, 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 can lead to weakness, easier bruising, or an increased risk of infection.
• Low sodium levels in the blood. This can lead to weakness, vomiting, and muscle cramps.
• Feeling agitated, confused, or depressed.
• Change in taste.
• Vision problems, such as blurred vision.
• Sudden shortness of breath or wheezing (bronchospasm).
• Dry mouth.
• Inflammation of the mouth.
• Fungal infection, which can affect the intestines
• 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 morphology, 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 encephalopathy.
• Erythema multiforme.
• Muscle weakness.
• Breast enlargement in men.

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

• Colitis (causing diarrhea)
• If Losec has been taken for more than three months, there is a possibility of a decrease in magnesium levels in the blood. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat. If any of these symptoms are observed, the doctor should be informed immediately. Low magnesium levels can lead to low potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.
• 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 symptoms of a local infection, such as sore throat, or difficulty urinating, they should consult their doctor as soon as possible to rule out a possible 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 any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can also be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, 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.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Do not store above 30°C.
Keep the bottle tightly closed to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Losec contains

• The active substance of Losec is omeprazole. Each capsule (enteric-coated hard capsule) contains 20 mg of omeprazole. The other ingredients are: disodium phosphate dihydrate, hydroxypropylcellulose, 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, sodium lauryl sulfate, magnesium stearate, printing ink (contains shellac, ammonium hydroxide, potassium hydroxide, black iron oxide (E 172)), colloidal anhydrous silica, and liquid paraffin. (See section 2: Losec capsules contain lactose)

What Losec looks like and contents of the pack

Losec 20 mg: capsules with a pink body, marked with the number "20" and a red-brown cap marked with A/OM.
Pack sizes:
HDPE bottles containing 14 capsules.
For more detailed information, consult 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
92027 Hlohovec
Slovakia
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 23 – 24
17489 Greifswald
Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warszawa

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warszawa
Authorization number in France, the country of export:34009 340 812 1 7

Parallel import authorization number: 372/24

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: 22.10.2024

[Information about the trademark]