OMEPRAZOL SANDOZ FARMACEUTICA 40 mg HARD GASTRORESISTENT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Omeprazole Sandoz Pharmaceutical 40 mg Hard Gastro-Resistant Capsules

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.

Contents of the pack and other information:

1. What Omeprazole Sandoz Pharmaceutical is and what it is used for
2. What you need to know before you take Omeprazole Sandoz Pharmaceutical
3. How to take Omeprazole Sandoz Pharmaceutical
4. Possible side effects
5. Storage of Omeprazole Sandoz Pharmaceutical
6. Pack contents and further information

1. What Omeprazole Sandoz Pharmaceutical is and what it is used for and what it is used for

Omeprazole Sandoz Pharmaceutical 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 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 stomach (gastric ulcer).
• Ulcers which are infected with 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 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, the symptoms of the disease can include the return of food to the mouth (regurgitation), vomiting and insufficient 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 Sandoz Pharmaceutical

Do not take Omeprazole Sandoz Pharmaceutical

• 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).

If you are not sure, talk to your doctor or pharmacist before taking this medicine

Warnings and precautions

Talk to your doctor or pharmacist before taking omeprazole

Severe skin reactions, including 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.

This medicine may hide the symptoms of other diseases. Therefore, if you experience any of the following before or while taking omeprazole, contact your doctor immediately:

• you have ever had a skin reaction after treatment with a medicine similar to omeprazole to reduce stomach acid,
• you lose a lot of weight without reason and have problems swallowing,
• you have stomach pain or indigestion,
• you start vomiting food or vomit blood,
• your stools are black (blood-stained stools),
• you have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea,
• you have severe liver problems,
• a specific blood test (Chromogranin A) is scheduled.

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

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

Remember to also mention any other symptoms that you may notice, such as joint pain.

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

This medicine may affect how your body absorbs vitamin B12. If you have to take omeprazole 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,
• tingling
• mouth pain or redness, ulcers in the mouth,
• muscle weakness,
• vision problems,
• 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 <10 kg in weight.

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.

Remember to also mention any other symptoms that you may notice, such as joint pain.

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

Other medicines and Omeprazole Sandoz Pharmaceutical

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Omeprazole may affect the way some medicines work and some medicines may affect the way omeprazole works.

Do not take this medicine 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 or voriconazole (used to treat fungal infections),
• digoxin (used for heart problems),
• diazepam (used to treat 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 omeprazole,
• 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,
• 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),
• 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 a high dose of methotrexate, your doctor may need to temporarily stop your treatment with omeprazole.

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

Taking Omeprazole Sandoz Pharmaceutical 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.

Before taking omeprazole, tell your doctor if you are pregnant or trying to become pregnant. Your doctor will decide whether you can take omeprazole during this time.

Your doctor will decide whether you can take this medicine if you are breast-feeding.

Driving and using machines

Omeprazole is unlikely to affect your ability to drive or use 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.

Omeprazole Sandoz Pharmaceutical contains sucrose and sodium

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, i.e. it is essentially “sodium-free”.

3. How to take Omeprazole Sandoz Pharmaceutical

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.

The recommended doses are described below.

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 usual 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 the oesophagus is not yet healed.
• The recommended dose once the oesophagus has healed is 10 mg once a day.
• If you do not have oesophageal damage, 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 healed.
• If the ulcer does not 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 healed.
• If the ulcer does not heal, the dose may be increased to 40 mg once a day for 8 weeks.

Preventionof duodenal and stomach ulcers:

• The usual 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 byHelicobacter pyloriinfectionand prevention of their return:

• The recommended dose is 20 mg omeprazole twice a day for one week.
• Your doctor will also tell you to take two antibiotics among amoxicillin, clarithromycin and metronidazole.

Treatment of excess acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome):

• The usual dose is 60 mg a day.
• Your doctor will adjust the dose according to your needs and will also decide how long you need to take the medicine.

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

Treatment of ulcers caused byHelicobacter pyloriinfectionand prevention of their return:

• Children over 4 years of age can take omeprazole. 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 which 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 problems swallowing the capsules

If you or your child have problems 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 without gas, 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, refill the glass with water, rinse it well and drink it.

If you take more Omeprazole Sandoz Pharmaceutical than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Omeprazole Sandoz Pharmaceutical

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 Sandoz Pharmaceutical

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

If you have any further questions on the use of this medicine, 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.

Adverse effects can occur with certain frequencies, which are defined as follows:

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 omeprazole 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 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:

Common 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 stomach polyps.

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.
• Hip, wrist, and spine fractures.*

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

• Blood problems, such as decreased white blood cells or platelets. This can cause weakness or bruising and increase the risk of infection.
• Allergic reactions, sometimes severe, including swelling of the lips, tongue, and throat, fever, and wheezing.
• 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.
• Candidiasis, an infection that can affect the intestine and is caused by a fungus.
• Liver problems, such as jaundice, which can cause yellowing of the skin, dark urine, and fatigue.
• 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)

• Blood count changes, 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.
• Sudden appearance of an intense rash, blistering, or peeling of the skin. This can be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Enlargement of the breasts in men.

Adverse effects of unknown frequency (cannot be estimated from available data)

• Inflammation of the intestine (which can cause diarrhea).
• If you are taking omeprazole for more than three months, your magnesium levels in the blood may decrease. Low magnesium levels can cause 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 decrease in potassium or calcium levels in the blood. Your doctor may decide to perform periodic tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.

If you are taking omeprazole for more than three months, your magnesium levels in the blood 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 lead to a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

*If you are taking proton pump inhibitors like omeprazole, especially for more than a year, you may have a slightly increased risk of hip, wrist, and spine fractures. Inform your doctor if you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).

In very rare cases, omeprazole 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: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Omeprazole Sandoz Pharmaceutical

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/EXP". The expiration date is the last day of the month indicated.

Blisters:

Store in the original packaging to protect it from moisture.

Store below 25°C.

HDPE capsule container with screw cap and silica gel desiccant:

Do not store at a temperature above 30°C.

Keep the bottle tightly closed to protect it from moisture.

Keep the container tightly closed after use.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Omeprazole Sandoz Pharmaceutical

• The active ingredient is omeprazole. Each 40 mg omeprazole capsule.
• The other components (excipients) are: sugar spheres (consisting of cornstarch and sucrose), magnesium hydroxide, sodium lauryl sulfate, disodium hydrogen phosphate, mannitol (E421), hypromellose type 2910, sodium carboxymethyl starch (type A, potato), macrogol 6000, talc, polysorbate 80, titanium dioxide (E-171), and methacrylic acid - ethyl acrylate copolymer (1:1), 30% dispersion. The hard gelatin capsule is composed of: gelatin, black iron oxide (E-172), and titanium dioxide (E171).

Appearance of the Product and Package Contents

Omeprazole Sandoz Pharmaceutical 40 mg is presented in the form of hard gastro-resistant gelatin capsules, size "3", with a white cap and gray body, containing white to cream-colored spherical granules. It is presented in blisters containing 14, 28, or 56 gastro-resistant capsules or in HDPE containers with a screw cap and silica gel desiccant containing 28 or 56 gastro-resistant capsules.

Only certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Pharmaceutical, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Liconsa, S.A.

Avda. Miralcampo, nº 7,

Polígono Industrial Miralcampo,

Azuqueca de Henares, (Guadalajara),

Spain

Date of the Last Revision of this Leaflet:July 2024

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