LOSEC 20 mg HARD GASTRORESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Losec 20mg gastro-resistant hard capsules

Omeprazole

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Losec and what is it used for
2. What you need to know before you take Losec
3. How to take Losec
4. Possible side effects
   1. Storing Losec

1. Contents of the pack and further 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’. These medicines work by reducing the amount of acid produced by the stomach.

Losec is used to treat the following conditions:

In adults:

• ‘Gastro-oesophageal reflux disease’ (GORD). In this condition, acid from the stomach escapes into the gullet (the tube which carries food from the mouth to the stomach) causing pain and inflammation.
• Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer).
• Ulcers which are infected with bacteria called ‘Helicobacter pylori’. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Losec can also be used to stop ulcers from forming if you are taking NSAIDs.
• Too much acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and = 10 kg

• ‘Gastro-oesophageal reflux disease’ (GORD). In this condition, acid from the stomach escapes into the gullet (the tube which carries food from the mouth to the stomach) causing pain and inflammation. In children, the symptoms of the disease can include the return of stomach contents into the mouth (regurgitation), vomiting and insufficient weight gain.

Children over 4 years of age and adolescents

• Ulcers caused by bacteria called ‘Helicobacter pylori’. If your child has this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before you take Losec

Do not take Losec:

• If you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• If you are taking a medicine containing nelfinavir (used to treat HIV infection).

Do not take Losec if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Losec.

Warnings and precautions

Talk to your doctor or pharmacist before taking Losec.

Serious skin reactions have been reported with Losec in association with the treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). Stop taking Losec and contact your doctor immediately if you experience any of these symptoms.

Losec may hide the symptoms of other diseases. Therefore, if you experience any of the following before or while taking Losec, consult your doctor immediately:

• Losing a lot of weight without reason and having trouble swallowing.
• Having stomach pain or indigestion.
• Starting to vomit food or vomit blood.
• Having black stools (faeces) that look like tar.
• Having severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
• Having severe liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to Losec to reduce stomach acid.
• If you are due to have a specific blood test (Chromogranin A).

If you take Losec for a long period of time (more than 1 year) your doctor will probably keep you under regular surveillance. You should report any new and unusual symptoms to your doctor, especially if you have been taking Losec for a long time.

Taking a proton pump inhibitor like Losec, especially over a period of more than one year, may slightly increase the risk of fracture of the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you get a rash on your skin, especially in areas exposed to the sun, you should contact your doctor as soon as possible as you may need to stop your treatment with Losec. Remember to also mention any other symptoms that you may have such as joint pain.

When taking omeprazole, kidney inflammation can occur. The signs and symptoms may include decrease in urine volume or blood in the urine and/or hypersensitivity reactions such as fever, rash and joint pain. You should inform your doctor of these signs.

This medicine may affect the way your body absorbs vitamin B12. If you are taking this medicine for a long time, you should talk to your doctor, as you may need to have your vitamin B12 levels checked. If you have low levels of vitamin B12, you may experience symptoms such as:

• Extreme tiredness or lack of energy
• Numbness or tingling
• Pain in the tongue or mouth, or mouth ulcers
• Muscle weakness
• Changes in vision
• Memory problems, confusion or depression

Children

Some children with long-term illnesses 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.

Other medicines and Losec

Taking Losec with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you can buy without a prescription. This is because Losec can affect the way some medicines work and some medicines can affect the way Losec works.

Do not take Losec if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Tell 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 for heart problems)
• Diazepam (used for anxiety, relax muscles or in epilepsy)
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Losec
• Medicines used to prevent blood clots, such as warfarin or other vitamin K blockers. Your doctor will need to monitor you when you start or stop taking Losec
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (in cases of 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 (thrombi))
• Erlotinib (used to treat cancer)
• Methotrexate (a chemotherapy medicine used in high doses to treat cancer) - if you are taking high-dose methotrexate, your doctor may need to temporarily stop your treatment with Losec.

If your doctor has also prescribed the antibiotics amoxicillin and clarithromycin for you to take with Losec to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.

Taking Losec with food and drink

See section 3.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning 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 when used in recommended doses. Your doctor will decide whether you can take Losec if you are breast-feeding.

Driving and using machines

Losec is unlikely to affect your ability to drive or use any tools or machines. Side effects such as dizziness and visual disturbances (see section 4) may occur. If affected, you should not drive or operate machinery.

Losec capsules contain lactose and sodium

Losec capsules contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Losec capsules contain less than 23 mg of sodium (1 mmol) per capsule; this is essentially ‘sodium-free’.

3. How to take Losec

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Your doctor will tell you how many capsules to take and for how long. This will depend on your condition and age.

The recommended dose is as follows:

Use in adults

Treatment of symptoms of GORD, such as heartburn and acid regurgitation:

• If your doctor finds that you have mild oesophageal damage, the recommended dose is 20 mg once a day for 4 to 8 weeks. Your doctor may tell you to take a dose of 40 mg once a day for a further 8 weeks if your oesophagus has not yet healed.

• The recommended dose once the oesophagus has healed is 10 mg once a day.
• If your oesophagus 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. Your doctor may tell you to take the same dose for a further 2 weeks if the ulcer has not yet healed.
• If the ulcer does not heal after this time, 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. Your doctor may tell you to take the same dose for a further 4 weeks if the ulcer has not yet healed.
• If the ulcer does not heal after this time, the dose may be increased to 40 mg once a day for 8 weeks.

Preventionof duodenal and gastric ulcers:

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

Treatment of ulcerscaused by NSAIDs:

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

Prevention of ulcerscaused by NSAIDs:

• The recommended dose is 20 mg once a day

Treatment of ulcerscaused by Helicobacter pyloriinfectionand preventionof relapse:

• The recommended dose is 20 mg of Losec twice a day for one week.

• Your doctor will also tell you to take two antibiotics among amoxicillin, clarithromycin and metronidazole.

Treatment of Zollinger-Ellison syndrome:

• The recommended dose is 60 mg daily.
• Your doctor will adjust the dose depending on your needs and also decide how long you need to take the medicine for.

Use in children and adolescents

Treatment of symptoms of GORD, such as heartburn and acid regurgitation

• Children over 1 year of age and weighing more than 10 kg can take Losec. The dose for children is based on their weight and your doctor will decide the correct dose.

Treatment of ulcerscaused by Helicobacter pyloriinfectionand preventionof relapse:

• Children over 4 years of age can take Losec. The dose for children is based on their weight and your doctor will decide the correct dose.
• Your doctor will also prescribe two antibiotics, amoxicillin and clarithromycin, for your child to take.

How to take this medicine

• It is recommended to take the capsules in the morning.
• You can take your capsules with food or on an empty stomach.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules, as they contain coated granules which stop the medicine from being broken down by the acid in the stomach. It is important not to damage the granules.

What to do if you or your child have trouble swallowing the capsules

• If you or your child have trouble swallowing the capsules:
• • Open the capsules and swallow the contents directly with half a glass of water or pour the contents into a glass of water, non-carbonated fruit juice (e.g. apple, orange or grapefruit) or apple sauce.
  • Always stir the mixture just before drinking it (the mixture will not be clear). Drink the mixture immediately or within 30 minutes.
  • To make sure that you have taken all the medicine, refill the glass with water, rinse the glass and drink it.

If you take more Losec than you should

If you have taken more Losec than you should, talk to a doctor or pharmacist immediately. You can also contact the national poison centre, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Losec

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

If you stop taking Losec

Do not stop taking Losec without first talking to your doctor or pharmacist.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from 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 adverse effects, stop taking Losec and consult your doctor immediately:

• Sudden whistling when breathing (sudden wheezing), swelling of the lips, tongue, and throat or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction). (rare)
• Redness of the skin with blistering or peeling. Intense blisters and bleeding may also appear on the lips, eyes, mouth, nose, and genitals. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis". (very rare)
• Widespread rash, high body temperature, and inflammation of the lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (rare)
• A red, scaly, and widespread rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis). (rare)
• Yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver problems. (rare)

Other adverse effects are:

Frequent adverse effects (may affect up to 1 in 10 people)

• Headache.
• Effects on the stomach or intestine: diarrhea, stomach pain, constipation, and gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach.

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

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Feeling that everything is spinning (vertigo).
• Abnormal liver function tests.
• Skin rash, hives, and itching.
• Feeling of general discomfort and lack of energy.

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

• Blood problems, such as a decrease in white blood cells or platelets. This can cause weakness or bruising and increase the risk of infection.
• Low sodium levels in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Taste disturbances.
• Visual problems, such as blurred vision.
• Sudden difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation of the mouth.
• Infection called "candidiasis" that can affect the intestine and is caused by a fungus.
• Hair loss (alopecia).
• Skin rash when exposed to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

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

• Abnormal blood counts, such as agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems that can cause liver failure and brain inflammation.
• Erythema multiforme.
• Muscle weakness.
• Increased breast size in males.

Frequency not known (cannot be estimated from available data)

• Inflammation of the intestine (causing diarrhea).

• If you are being treated with Losec for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can manifest as fatigue, muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform periodic tests to monitor your magnesium levels.
• Rash, possibly with joint pain.

In very rare cases, Losec can affect the white blood cells in the blood and cause immunodeficiency. If you have an infection with symptoms such as fever with a severely deteriorated general condition or fever with symptoms of local infection, such as neck, throat, or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to perform a blood test and rule out a lack of white blood cells (agranulocytosis). It is essential that you provide information about the medication you are taking at that time.

Reporting adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that do not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Losec

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging or blister after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Keep this medicine in its original packaging (blister) to protect it from moisture.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Losec composition

• The active ingredient is omeprazole. Each capsule (gastro-resistant capsule) contains 20 mg of omeprazole.

• The other ingredients are disodium phosphate dihydrate, low-substituted hydroxypropylcellulose, hypromellose, anhydrous lactose, magnesium stearate, mannitol, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, microcrystalline cellulose, macrogol (polyethylene glycol 400), sodium lauryl sulfate, iron oxide E172, titanium dioxide E171, gelatin, printing ink (containing shellac, ammonia, potassium hydroxide, and iron oxide black E172), anhydrous colloidal silica, and liquid paraffin. See section 2 "Losec contains lactose".

Product appearance and packaging contents

• Losec 20 mg capsules are pink with "20" marked on the body and brown-red with "A/OM" marked on the cap.

Package sizes:

• 20 mg: Blisters of 14 capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Local representative:

Laboratorios Rubió, S.A.

Industria, 29

Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Manufacturer

Saneca Pharmaceuticals a.s., Nitrianska 100, 920 27 Hlohovec, Slovakia

CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 23-24, 17489 Greifswald, Germany

This medicine is authorized in the countries of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Date of last revision of this leaflet:August 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/