Omeprazole Sandoz Farmaceutica 40 mg gastro-resistant hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Omeprazol Sandoz Farmacéutica 40 mg gastro-resistant hard capsules

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Leaflet contents:

1. What Omeprazol Sandoz Farmacéutica is and what it is used for
2. What you need to know before taking Omeprazol Sandoz Farmacéutica
3. How to take Omeprazol Sandoz Farmacéutica
4. Possible adverse effects
5. How to store Omeprazol Sandoz Farmacéutica
6. Contents of the pack and other information

1. What Omeprazol Sandoz Farmacéutica is and what it is used for

Omeprazol Sandoz Farmacéutica 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:

• "Gastroesophageal reflux disease" (GERD). In this disorder, stomach acid flows back into the esophagus (the tube connecting 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 infected with a bacterium 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 a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Omeprazole can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excess stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and ≥10 kg

• "Gastroesophageal reflux disease" (GERD). In this disorder, stomach acid flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms of the disease may include return of stomach contents to the mouth (regurgitation), vomiting, and inadequate weight gain.

Children over 4 years of age and adolescents

• Ulcers infected with a bacterium called "Helicobacter pylori". If your child has this condition, his/her doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before taking Omeprazol Sandoz Farmacéutica

Do not take Omeprazol Sandoz Farmacéutica

• if you are allergic to omeprazole or to 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 containing nelfinavir (used for HIV infection).

If you are unsure, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take omeprazole.

Serious skin adverse reactions have been reported with omeprazole treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop taking omeprazole and contact your doctor immediately if you experience any of the symptoms related to these serious skin reactions described in section 4.

This medicine may mask symptoms of other conditions. Therefore, if you experience any of the following symptoms before starting omeprazole or during treatment, contact your doctor immediately:

• you have previously had a skin reaction after treatment with a medicine similar to omeprazole used to reduce stomach acid,
• you lose weight significantly without reason and have difficulty swallowing,
• you have stomach pain or indigestion,
• you start vomiting food or vomiting blood,
• your bowel movements are black (blood-stained stools),
• you have severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea,
• you have severe liver problems,
• you are scheduled for a specific blood test (chromogranin A).

If you take this medicine for a long period (more than 1 year), your doctor will likely perform periodic check-ups. You should report any new or unusual symptoms or circumstances during each visit to your doctor.

Taking a proton pump inhibitor such as omeprazole, especially for more than one year, may slightly increase the risk of fracture of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with omeprazole.

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

Kidney inflammation may occur while taking omeprazole. Signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You should report these signs to your treating doctor.

This medicine may affect how your body absorbs vitamin B12, especially if taken for a long time. Contact your doctor if you notice any of the following symptoms, which could indicate low vitamin B12 levels:

• extreme tiredness or lack of energy,
• tingling,
• sore or red tongue, mouth ulcers,
• muscle weakness,
• altered vision,
• memory problems, confusion, depression.

Children

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

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with omeprazole.

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

If you take this medicine for a long period (more than 1 year), your doctor will likely perform periodic check-ups. You should report any new or unusual symptoms or circumstances during each visit to your doctor.

Other medicines and Omeprazol Sandoz Farmacéutica

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

Do not take this medicine 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, or voriconazole (used to treat fungal infections),
• digoxin (used to treat 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 starting or stopping omeprazole treatment,
• medicines used to prevent blood clots, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when starting or stopping omeprazole treatment,
• 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 (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 treatment with omeprazole.

If your doctor has prescribed amoxicillin and clarithromycin antibiotics along with omeprazole to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform them about any other medicines you are taking.

Taking Omeprazol Sandoz Farmacéutica with food and drinks

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Before taking omeprazole, inform 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 while breastfeeding.

Driving and using machines

Omeprazole is unlikely to affect your ability to drive or use tools and machinery.

Adverse effects such as dizziness and visual disturbances may occur (see section 4). If these occur, you should not drive or use machines.

Omeprazol Sandoz Farmacéutica contains sucrose and sodium

This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially “sodium-free”.

3. How to take Omeprazol Sandoz Farmacéutica

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will tell you how many capsules you should take and for how long. This will depend on your condition and your age.

The recommended doses are described below.

Use in adults

Treatment of symptoms of GERD (gastroesophageal reflux disease), such as heartburn and acid regurgitation:

• If your doctor confirms you have mild damage to the esophagus, the usual dose is 20 mg once daily for 4 to 8 weeks. Your doctor may prescribe 40 mg for another 8 weeks if the esophagus has not yet healed.
• The recommended dose after healing of the esophagus is 10 mg once daily.
• If you do not have esophageal damage, the recommended dose is 10 mg once daily.

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

• The recommended dose is 20 mg once daily for 2 weeks. Your doctor may prescribe the same dose for another 2 weeks if the ulcer has not yet healed.
• 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 ulcer):

• The recommended dose is 20 mg once daily for 4 weeks. Your doctor may prescribe the same dose for another 4 weeks if the ulcer has not yet healed.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once daily for 8 weeks.

Prevention of recurrence of stomach and duodenal ulcers:

• The usual dose is 10 mg or 20 mg once daily. Your doctor may increase the dose to 40 mg once daily.

Treatment of stomach and duodenal ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

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

Prevention of stomach and duodenal ulcers during treatment with NSAIDs:

• The recommended dose is 20 mg once daily.

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

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

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

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

Use in children and adolescents

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

• Children over one year of age who weigh more than 10 kg may take omeprazole. The dose for children is based on body weight, and the doctor will determine the correct dose.

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

• Children over 4 years of age may take omeprazole. The dose for children is based on body weight, and the doctor will determine the correct dose.
• Your doctor will also prescribe two antibiotics for your child: amoxicillin and clarithromycin.

How to take this medicine

• It is recommended to take the capsules in the morning.
• You may take the 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 stomach acid. It is important not to damage the granules.

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

If you or your child have difficulty swallowing the capsules:

• Open the capsule and swallow the contents directly with half a glass of water, or pour the contents into a glass of still water, acidic fruit juice (e.g., apple, orange, or pineapple), or apple puree.
• Always shake the mixture well before drinking (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes.
• To ensure you have taken all the medicine, fill the glass with water up to halfway, swirl well, and drink the water. The solid particles contain the medicine; do not chew or crush them.

If you take more Omeprazol Sandoz Farmacéutica than you should

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

If you forget to take Omeprazol Sandoz Farmacéutica

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Omeprazol Sandoz Farmacéutica

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

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

Adverse effects may occur with certain frequencies, defined as follows:

If you experience 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 omeprazole and consult your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, throat, or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction) (rare).
• Skin redness with blistering or peeling. Severe blisters and bleeding in the lips, eyes, mouth, nose, or genitals may also occur. This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis” (very rare).
• Widespread rash, high temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) (rare).
• A widespread, red, scaly rash with bumps under the skin 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 problems (rare).

Other side effects are:

Common side effects (may affect up to 1 in 10 people)

• Headache.
• Stomach or intestinal problems: diarrhea, stomach pain, constipation, and gas (flatulence).
• Nausea or vomiting.
• Benign stomach polyps.

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

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Feeling of spinning (vertigo).
• Abnormalities in blood tests used to assess liver function.
• Skin rash, hives, and itching.
• General feeling of malaise and lack of energy.
• Fracture of hip, wrist, or spine.*

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

• Blood problems, such as decreased white blood cells or platelets. This may cause weakness, bruising, or increased risk of infections.
• Allergic reactions, sometimes severe, including swelling of the lips, tongue, and throat, fever, and wheezing.
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
• Restlessness, confusion, or depression.
• Taste disturbances.
• Vision problems, such as blurred vision.
• Sudden sensation of difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• Fungal infection called “candidiasis” that may affect the intestine.
• Liver problems, such as jaundice, which may cause yellowing of the skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Skin rash upon exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Serious kidney problems (interstitial nephritis).
• Increased sweating.

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

• Blood count abnormalities, such as agranulocytosis (lack of white blood cells).
• Aggressiveness.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Severe liver problems leading to liver failure and brain inflammation.
• Sudden onset of severe rash, blistering, or skin peeling. This may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Enlargement of the breasts in males.

Side effects with unknown frequency (cannot be estimated from available data)

• Inflammation in the intestine (causing diarrhea).
• If you are taking omeprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.

If you are taking omeprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also result in decreased 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 such as omeprazole, especially for more than one year, there may be a slight increase in the risk of hip, wrist, and spine fractures. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

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

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Omeprazole Sandoz Farmacéutica

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after “CAD/EXP”. The expiry date refers to the last day of the month indicated.

Blister pack:

Store in the original packaging to protect it from moisture.

Do not store above 30°C.

HDPE bottle of capsules with screw cap and silica gel desiccant:

Do not store above 30°C.

Keep the bottle tightly closed to protect it from moisture.

Keep the container tightly closed after use.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Omeprazol Sandoz Farmacéutica

• The active substance is omeprazole. Each capsule contains 40 mg of omeprazole.
• The other components (excipients) are: sugar spheres (consisting of corn starch 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 (E171), and methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion. The hard gelatin capsule is composed of: gelatin, black iron oxide (E172), and titanium dioxide (E171).

Appearance of the product and contents of the pack

Omeprazol Sandoz Farmacéutica 40 mg is presented as hard, gastro-resistant gelatin capsules of size "3", with a white cap and a grey body, containing white to cream-colored spherical granules. It is available in blisters containing 14, 28 or 56 gastro-resistant capsules, or in HDPE containers with polypropylene screw cap and silica gel desiccant, containing 28 or 56 gastro-resistant capsules.

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.
Parque Norte Business Park
Roble Building
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer

Licona, S.A.
Avda. Miralcampo, nº 7
Miralcampo Industrial Estate
Azuqueca de Henares (Guadalajara)
Spain

Date of latest review of this package leaflet: July 2024

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