Losec

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Losec (Mopral 20 mg), 20 mg, enteric-coated hard capsules
Omeprazole
Losec and Mopral 20 mg are different trade names for the same medicine.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your 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 called omeprazole. It belongs to a group of medicines known as
"proton pump inhibitors". These work by reducing the amount of acid produced in
the stomach.
Losec is used to treat the following conditions:
In adults:

• Gastro-esophageal reflux disease (GERD). This occurs when acid from the stomach flows back into the oesophagus (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 in the stomach (gastric ulcers).
• Ulcers infected with bacteria called "Helicobacter pylori". In such cases, your doctor may also prescribe antibiotics to eradicate the infection and allow ulcers to heal.
• Ulcers caused by medicines known as NSAIDs (non-steroidal anti-inflammatory drugs). Losec may also be used to prevent the development of ulcers during NSAID treatment.
• Excessive acid production due to a pancreatic tumour (Zollinger-Ellison syndrome).

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

• Gastro-esophageal reflux disease (GERD). This occurs when acid from the stomach flows back into the oesophagus, causing pain, inflammation, and heartburn. In children, symptoms may include regurgitation of stomach contents into the mouth (spitting up), vomiting, and poor weight gain.

Children and adolescents aged above 4 years

• Ulcers infected with bacteria called "Helicobacter pylori". If your child has this condition, the doctor may also prescribe antibiotics to eradicate the infection and allow ulcers to heal.

2. Important information before using Losec

When not to use Losec:

• 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 to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole);
• if the patient is taking a medicine containing nelfinavir (used in the treatment of HIV infection).

Do not take Losec if any of the above apply to the patient.
If in doubt, consult a doctor or pharmacist before starting treatment with Losec.
Warnings and precautions
Talk to your doctor or pharmacist before taking Losec.
Severe skin reactions have been reported with treatment using Losec, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP).
If you notice any symptoms related to these severe skin reactions described in section 4, stop taking Losec immediately and seek urgent medical advice.
Losec may mask symptoms of other diseases. Therefore, 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 food or blood.
• Passing black stools (blood-stained faeces).
• Severe or persistent diarrhoea, as omeprazole use is associated with a slightly increased risk of infectious diarrhoea.
• Severe liver problems.
• If the patient has ever had a skin reaction to a medicine similar to Losec that reduces stomach acid secretion.
• Regarding planned specific blood test (chromogranin A levels).

If Losec is used long-term (longer than 1 year), the patient will likely be under close and regular medical supervision. During visits to the doctor, report any new or unusual symptoms and circumstances.
Taking proton pump inhibitors such as Losec, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist or spine. Inform your doctor if you have been diagnosed with osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
If a rash develops, especially in areas exposed to sunlight, inform your doctor as soon as possible, as treatment with Losec may need to be discontinued. Also report any other adverse effects such as joint pain.
Kidney inflammation may occur during omeprazole treatment. Symptoms may include reduced urine output or blood in the urine and/or allergic reactions such as fever, rash, and joint stiffness. These symptoms should be reported to the treating physician.
This medicine may affect how the body absorbs vitamin B12, particularly if taken for a long time. Contact your doctor if you notice any of the following symptoms, which may indicate low vitamin B12 levels:

• Extreme tiredness or lack of energy
• Tingling and numbness
• Sore 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 with body weight < 10 kg.
Losec and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned for use. 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.
Do not take Losec if you are taking a medicine containing nelfinavir (used in the treatment of 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 disorders)
• Diazepam (used to treat anxiety, to reduce muscle tension, or in epilepsy treatment)
• 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 chemotherapeutic agent used in high doses to treat cancer) – if the patient is taking high-dose methotrexate, the doctor may temporarily discontinue Losec.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Losec for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor about any other medicines you are taking.
Losec with food and drink
See section 3.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before starting this medicine.
Omeprazole passes into breast milk, but its effect on the infant is unlikely when used at therapeutic doses. Whether a breastfeeding woman can take Losec will be decided by the doctor.
Driving and using machines
Losec has no influence on the ability to drive or use tools and machines.
However, adverse effects such as dizziness and visual disturbances may occur (see section 4 of this leaflet). If these occur, do not drive or operate machinery.
Losec capsules contain lactose and sodium
Losec capsules contain lactose. If you have been diagnosed with an intolerance to certain sugars, consult your doctor before starting this medicine.
Losec capsules contain less than 1 mmol sodium (23 mg) per capsule; hence, this medicine is considered "sodium-free".

3. How to use Losec

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Your doctor will inform you how many capsules to take and for how long. This will depend on your
medical condition and age.
Dosage recommendations are provided below.

Use in adults:
Treatment of GERD symptoms such as heartburn and acid regurgitation:

• If your doctor has determined that your oesophagus has been slightly damaged, the recommended dose is 20 mg once daily for 4 to 8 weeks. Your doctor may recommend continuing with a dose of 40 mg for an additional 8 weeks if the oesophagus has not healed.
• The recommended dose after healing of the oesophagus is 10 mg once daily.
• If the oesophagus is not damaged, the usual dose is 10 mg once daily.

Treatment of peptic ulcers in the upper part of the small intestine (duodenal ulcers):

• The recommended dose is 20 mg once daily for 2 weeks. Your doctor may recommend continuing with the same dose for another 2 weeks if ulcers have not healed by then.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once daily for 4 weeks.

Treatment of stomach ulcers (gastric ulcers):

• The recommended dose is 20 mg once daily for 4 weeks. Your doctor may recommend continuing with the same dose for another 4 weeks if ulcers have not healed by then.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once daily for 8 weeks.

Prevention of recurrence of duodenal and gastric ulcers:

• The recommended dose is 10 mg or 20 mg once daily. Your 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 recurrence of duodenal and gastric ulcers during treatment with NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is 20 mg once daily.

Treatment of ulcers caused by bacterial infection Helicobacter pylori and prevention of their recurrence:

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

Treatment of excessive acid production caused by a pancreatic tumour (Zollinger-Ellison syndrome):

• The usual dose is 60 mg per day.
• Your doctor will adjust the dose according to individual needs and decide how long treatment with Losec should continue.

Use in children and adolescents
Treatment of GERD symptoms such as heartburn and acid regurgitation:

• Children aged over 1 year and weighing more than 10 kg may take Losec. The dose depends on body weight and will be individually determined by the treating doctor.

Treatment of ulcers caused by bacterial infection Helicobacter pylori and prevention of their recurrence:

• Children aged over 4 years may take Losec. The dose for children depends on body weight and will be individually determined by the treating doctor.
• Your doctor will also prescribe two antibiotics for the child: amoxicillin and clarithromycin.

How to take Losec capsules

• It is recommended to take the capsules in the morning.
• The capsules may 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 coated pellets designed to protect the medicine from breakdown by stomach acid. It is important that the pellets remain intact.

What to do if you have difficulty swallowing capsules (in adults or children)

• If an adult or child has difficulty swallowing capsules:
• Open the capsule and swallow the contents immediately 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 pineapple juice), or with apple puree.
• 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 the patient receives the full dose, rinse the glass thoroughly with half a glass of water and drink this liquid as well. The solid particles contain the medicine – do not chew or crush them.

If you take more Losec than you should
If you take more Losec than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you forget to take Losec
If you forget to take a dose, take it as soon as you remember.
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 dose.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If you notice any of the following rare (may affect 1 in 1,000 people) or very rare (may affect 1 in 10,000 people), but serious adverse reactions, stop taking Losec immediately and contact your doctor without delay:

• Sudden wheezing, swelling of the lips, tongue or throat, rash, fainting or difficulty swallowing (severe allergic reaction). (rare)
• Reddening of the skin with blister formation or peeling. Large blisters and bleeding around the lips, eyes, mouth, nose and genital organs may also occur. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis. (very rare)
• Widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (rare)
• Red, scaly, widespread rash with subcutaneous nodules 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 may be symptoms of liver dysfunction. (rare)

Other adverse reactions include:
Common adverse reactions (may affect 1 in 10 people)

• Headache.
• Effects on stomach or intestines: diarrhoea, abdominal pain, constipation, gas (bloating).
• Nausea or vomiting.
• Benign gastric polyps.

Uncommon adverse reactions (may affect 1 in 100 people)

• Swelling of feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling or pricking sensations, drowsiness.
• Sensation of spinning (vertigo).
• Changes in liver function test results.
• Skin rash, nodular rash (urticaria), and itching.
• General malaise and lack of energy.

Rare adverse reactions (may affect 1 in 1,000 people)

• Blood disorders such as reduced 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 of restlessness, confusion or depression.
• Altered sense of taste.
• Vision problems such as blurred vision.
• Sudden wheezing or shortness of breath (bronchospasm).
• Dryness of the mouth.
• Inflammation of the mucous membrane of the mouth.
• Fungal infection known as "thrush", which may affect the intestines.
• Hair loss (alopecia).
• Skin rash occurring during exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very rare adverse reactions (may affect 1 in 10,000 people)

• Blood count abnormalities including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling or hearing things that are not real (hallucinations).
• Severe liver dysfunction leading to liver failure and encephalopathy.
• Erythema multiforme.
• Muscle weakness.
• Breast enlargement in males.

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

• Inflammation of the intestines (causing diarrhoea).
• If you have taken Losec for longer than three months, there may be a decrease in magnesium levels in the blood. Low magnesium levels may manifest as fatigue, involuntary muscle spasms, disorientation, seizures, dizziness, rapid heartbeat. If any of these symptoms occur, inform your doctor immediately. Low magnesium levels may lead to decreased potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• Rash accompanied by joint pain.

In very rare cases, Losec may affect the number of white blood cells in the blood, leading to immunodeficiency. If a patient develops an infection with symptoms such as fever accompanied by severe deterioration in general condition, or fever with signs of local infection such as pain in the neck, throat or mouth, or difficulty urinating, medical advice should be sought as soon as possible to rule out possible deficiency of white blood cells (agranulocytosis), based on blood test results. It is important that in such a situation the patient informs the doctor or pharmacist about the medicine being taken.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store the medicine Losec

This medicine should be stored in a place inaccessible and out of sight 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 stated month.
Do not store above 30°C.
Keep the bottle tightly closed to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the package and other information

What Losec contains

• The active substance in Losec is omeprazole. Each capsule (enteric hard capsule) contains 20 mg of omeprazole.
  Excipients: Disodium phosphate dihydrate, low-substituted hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, mannitol, methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, microcrystalline cellulose, polyethylene glycol 400, sodium lauryl sulfate.
  Capsule coating: Iron oxide red (E 172), titanium dioxide (E 171), gelatin, sodium lauryl sulfate, magnesium stearate, printing ink (containing shellac, ammonium hydroxide, potassium hydroxide, iron oxide black (E 172)), anhydrous colloidal silicon dioxide, 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 A/OM.
Pack size:
HDPE bottle with PP screw cap containing a desiccant, in a cardboard box, containing 14 capsules.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation 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 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw

Marketing Authorisation Number in France, the country of export: 34009 340 812 1 7
Parallel Import Marketing Authorisation Number: 372/24

This medicinal product is authorised for sale in the European Economic Area and the United Kingdom (Northern Ireland) under the following names: