Losec

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Losec, 20 mg, gastro-resistant hard capsules, Omeprazole

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a 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

• 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 pack 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 produced 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 that connects 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 NSAIDs (non-steroidal anti-inflammatory drugs). 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

• Gastroesophageal reflux disease (GERD). This is when stomach acid flows back into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms of this disorder may include reflux of stomach contents into the mouth (regurgitation), 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:

• if the patient has been diagnosed with an allergy to omeprazole or any of the other ingredients of this medicine (listed in section 6);
• if the patient has been diagnosed with an allergy to medicines containing other proton pump inhibitors (e.g., pantoprazole, lansoprazole, rabeprazole, esomeprazole);
• if the patient is taking a medicine containing nelfinavir (used to treat HIV infection).

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.
With Losec treatment, 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, stop taking Losec and seek medical help 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, inform your doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting blood or black tarry stools.
• Severe or persistent diarrhea, as omeprazole use 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 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, 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.
Inform your doctor if you 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. The patient should also report any other side effects, such as joint pain.
While taking omeprazole, 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 the way the body absorbs vitamin B12, especially if it needs to be taken for a long time. If the patient notices any of the following symptoms, which may indicate a low level of vitamin B12, they should contact their doctor:

• 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. Do not give this medicine to children under 1 year of age or weighing less than 10 kg.

Losec and other medicines

Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or 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).
Inform 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 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 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 in high doses 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 the bacterium Helicobacter pylori, 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 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 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 may occur (see section 4 of this leaflet). If they do occur, do 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 consult 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 your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The doctor will inform you how many capsules to take and for how long. This will depend on your 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(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(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 duodenal and gastric ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is 20 mg once a day 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 a day.

Treatment of ulcers caused by bacterial infection with Helicobacter pyloriand 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 it is necessary 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 over 10 kg. The dose depends on the child's weight and is determined individually by the doctor.

Treatment of ulcers caused by bacterial infection with Helicobacter pyloriand 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.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules, as they contain enteric-coated pellets that prevent the medicine from being broken down by stomach acid. It is essential not to damage the pellets.

What to do if you have 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 applesauce.
• Always mix the mixture immediately before drinking (the mixture will not be clear). 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

If you have taken a higher dose of Losec than prescribed by your doctor, contact your doctor or pharmacist immediately.

Missing a dose of Losec

If you miss a dose, take it as soon as you remember.
If it is time for your next dose, skip the missed dose.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Losec

Do not stop taking Losec without consulting your doctor or pharmacist first.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

If you notice 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 your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, or 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 and blisters, accompanied by fever, which usually appears at the beginning of treatment (acute generalized exanthematous pustulosis). (rare)
• Yellowing of the skin, dark urine, and fatigue, which may 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, or 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, easy bruising, or an 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.
• Fungal infection, which can affect the intestines and is caused by fungi
• Hair loss (alopecia).
• Skin rash during sun exposure.
• 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 inflammation.
• Polymorphic erythema.
• Muscle weakness.
• Breast enlargement in men.

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

• Colitis (causing diarrhea)
• If you have 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 you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may lead to low potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• Rash that may be associated with 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 local infection symptoms, 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 blood test results. It is essential for the patient to inform their doctor or pharmacist about the medicine they are taking.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Losec

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or label after EXP. The expiry date refers to the last day of that 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 your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Losec contains

• The active substance of Losec is omeprazole. Each gastro-resistant hard capsule contains 20 mg of omeprazole. The other ingredients are: disodium phosphate dihydrate, hydroxypropylcellulose low-substituted, hypromellose, lactose anhydrous, magnesium stearate, mannitol, methacrylic acid
• copolymer type C (1:1) dispersion 30 percent, microcrystalline cellulose, macrogol (polyethylene glycol 400), sodium lauryl sulfate, iron oxide E172, titanium dioxide E171, gelatin, printing ink (contains shellac, ammonia solution, potassium hydroxide, iron oxide black E172), colloidal silica anhydrous, 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.

Package sizes:
HDPE bottles containing 14 capsules.

Marketing authorization holder

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald, Germany

Manufacturer

Saneca Pharmaceuticals a.s.
Nitrianska 100
SK-920 27 Hlohovec
Slovakia
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 23 – 24
17489 Greifswald
Germany
To obtain more detailed information, please contact:
Komtur Polska Sp. z o.o.
phv@komtur.com

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 last revision of the leaflet: August 2023.

Other sources of information

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products