OMEPRAZOL SUN 20 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

PATIENT INFORMATION LEAFLET

Omeprazole SUN 20 mg gastro-resistant hard capsules EFG

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:

1. What Omeprazole SUN is and what it is used for
2. What you need to know before you take Omeprazole SUN
3. How to take Omeprazole SUN
4. Possible side effects
5. Storage of Omeprazole SUN
6. Contents of the pack and other information

1. What Omeprazole SUN is and what it is used for

Omeprazole SUN 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.

Omeprazole SUN 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 connects the throat to the stomach), causing pain, inflammation and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcer) or in the stomach (gastric ulcer).
• Ulcers caused by a 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). Omeprazole SUN may also be used to prevent ulcers 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 connects the throat to the stomach), causing pain, inflammation and heartburn.

In children, symptoms of the disease may include vomiting or regurgitation of food, and poor weight gain.

Children over 4 years of age and adolescents

• Ulcers caused by a 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 Omeprazole SUN

Do not take Omeprazole SUN

• 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 proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).

• If you are taking a medicine that contains nelfinavir (used to treat HIV infection).

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

Warnings and precautions

Consult your doctor or pharmacist before taking Omeprazole SUN.

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

Kidney inflammation has been reported with omeprazole. Signs and symptoms may include decreased urine output or blood in the urine and/or hypersensitivity reactions such as fever, rash and joint pain. You should inform your doctor of these signs.

Omeprazole SUN may hide the symptoms of other diseases. Therefore, if you experience any of the following before you start taking Omeprazole SUN or during treatment, consult your doctor immediately:

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Black stools (faeces stained with blood).
• If you have severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
• Severe liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to Omeprazole SUN to reduce stomach acid.
• If you are due to have a specific blood test (Chromogranin A).

If you take Omeprazole SUN for a long period (more than 1 year), your doctor will probably keep you under regular surveillance. You should inform your doctor of any new or unusual symptoms.

If you are taking proton pump inhibitors like Omeprazole SUN, especially over a period of more than one year, you may have a slightly increased risk of hip, wrist and spine fractures. Inform 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 Omeprazole SUN. Also, remember to mention any other symptoms that you may notice, such as joint pain.

This medicine may affect how your body absorbs vitamin B12. If you have to take it for a long time, contact your doctor if you notice any of the following symptoms, which could indicate low levels of vitamin B12:

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

Children

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

Taking Omeprazole SUN with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Omeprazole SUN may affect how these medicines work and these medicines may affect how Omeprazole SUN works.

Do not take Omeprazole SUN if you are taking a medicine that contains 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, to 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 Omeprazole SUN
• Medicines used to prevent blood clots, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when you start or stop taking Omeprazole SUN
• 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 doses of methotrexate, your doctor may need to temporarily stop your treatment with Omeprazole SUN.

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

Omeprazole SUN with food and drink

You can take your capsules with food or on an empty stomach.

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 at doses used to treat acid-related diseases.

Driving and using machines

Omeprazole SUN is unlikely to affect your ability to drive or use tools or machines. However, side effects such as dizziness and blurred vision (see section 4) may occur. If affected, you should not drive or use machines.

Omeprazole SUN contains 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.

3. How to take Omeprazole SUN

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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

The recommended doses are given below.

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 4-8 weeks. Your doctor may tell you to take a dose of 40 mg for another 8 weeks if your oesophagus has not yet fully healed.
• The recommended dose once the oesophagus has healed is 10 mg once a day.
• If your oesophagus has not been damaged, the recommended 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 another 2 weeks if the ulcer has not yet fully healed.
• If the ulcer does not fully heal, 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 another 4 weeks if the ulcer has not yet fully healed.
• If the ulcer does not fully heal, 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. Your doctor may increase the dose to 40 mg once a day.

Treatment of ulcers caused by NSAIDs:

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

Prevention of ulcers caused by NSAIDs:

• The recommended dose is 20 mg once a day.

Treatment of ulcers caused by Helicobacter pyloriand prevention of their return:

• The recommended dose is 20 mg of Omeprazole SUN 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 per day.
• Your doctor will adjust the dose depending on your needs and decide how long you need to take the medicine.

Use in children:

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 Omeprazole SUN. The dose for children is based on their body weight and your doctor will decide the correct dose.

Treatment of ulcers caused by Helicobacter pyloriand prevention of their return:

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

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 that prevent 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 non-fizzy water, acidic fruit juice (e.g. apple, orange or pineapple) 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 you have taken all the medicine, fill the glass with water, rinse it well and drink the water. The solid parts contain the medicine; do not chew or crush them.

If you take more Omeprazole SUN than you should

If you have taken more Omeprazole SUN than your doctor told you to, contact your doctor or pharmacist immediately. You can also contact the national poison centre, telephone 91 562 04 20, and inform them of the medicine and the amount you have taken.

If you forget to take Omeprazole SUN

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 Omeprazole SUN

Do not stop taking Omeprazole SUN 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 but serious adverse effects, stop takingOmeprazol SUNand 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).
• 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".
• Widespread rash, high body temperature, and inflammation of the lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• 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).
• Yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver problems.

Other adverse effects are:

Common Adverse Effects (may affect up to 1 in 10 patients)

• 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 patients)

• 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.
• General feeling of discomfort and lack of energy.

Rare Adverse Effects (may affect up to 1 in 1,000 patients)

• Blood problems, such as decreased 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.
• Vision 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 patients)

• 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.
• Enlargement of the breasts in males.

Adverse Effects of Unknown Frequency (frequency cannot be estimated from available data)

• Inflammation of the intestine (causing diarrhea).
• If you are taking Omeprazol SUN for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels can also cause a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.

In very rare cases, Omeprazol SUN can affect the white blood cells 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.

Do not worry about this list of possible adverse effects. You may not experience any of them.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Omeprazol SUN

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

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

Blister: Do not store above 25°C. Keep this blister in the original packaging to protect it from moisture.

Bottle: Do not store above 25°C. Keep the bottle tightly closed to protect it from moisture. After the first opening, it must be used within 100 days.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in your usual pharmacy. In case of doubt, 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 Other Information

Composition of Omeprazol SUN

The active ingredient is omeprazole. Omeprazol SUN capsules contain 20 mg of omeprazole.

The other ingredients are mannitol, anhydrous lactose, microcrystalline cellulose, hydroxypropyl cellulose, disodium phosphate dihydrate, sodium lauryl sulfate, hypromellose, ethyl acrylate-methacrylic acid copolymer, macrogol, magnesium stearate, gelatin, red iron oxide (E172), black iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), printing ink (shellac, propylene glycol, black iron oxide, potassium hydroxide).

Appearance of the Product and Package Contents

Omeprazol SUN 20 mg capsules are pink and brown, marked with 20/O.

Package sizes: 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, or 100 capsules;

The bottle contains two desiccant sachets with silica gel. DO NOT INGEST the contents of the sachets

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp,

Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

or

TERAPIA S.A.

124 Fabricii Street,

400 632 Cluj Napoca

Romania

Local Representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona, Spain

Tel.:+34 93 342 78 90

This product is authorized in the Member States of the European Economic Area under the following names:

Germany:OMEPRAZOL BASICS 10 mg/20 mg/40 mg magensaftresistente Hartkapseln

Spain:Omeprazol SUN 20 mg hard gastro-resistant capsules EFG

France:OMEPRAZOLE CRISTERS LAB 10 mg/20 mg, gélule gastro-résistante

Italy:Omeprazolo SUN 10 mg/20 mg capsule rigide gastroresistenti

Date of the last revision of this prospectus: September 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/