Omeprazole Sandoz Care 20 mg gastro-resistant hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Omeprazol Sandoz Care 20 mg gastro-resistant hard capsules

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

Always follow exactly the instructions for use of this medicine as described in this leaflet or as provided by your doctor or pharmacist.

• Keep this leaflet as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 14 days.

Contents of the leaflet:

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

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

3. How to take Omeprazol Sandoz Care

4. Possible side effects

5. How to store Omeprazol Sandoz Care

6. Contents of the pack and other information

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

Omeprazol Sandoz Care gastro-resistant hard capsules 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 indicated in adults for the short-term treatment of reflux symptoms (for example, heartburn, acid regurgitation).

Reflux is the backflow of acid from the stomach into the oesophagus, which can become inflamed and cause pain. This may lead to symptoms such as a painful burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).

You may need to take the capsules for 2-3 consecutive days to achieve symptom improvement.

You should consult a doctor if your symptoms worsen or do not improve after 14 days.

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

Do not take Omeprazol Sandoz Care

• 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 other proton pump inhibitors (such as pantoprazole, lansoprazole, rabeprazole, esomeprazole),
• if you are taking any medicine containing nelfinavir (for HIV infection).

Do not take this medicine if any of the above apply to you. If you are unsure, speak with your doctor or pharmacist before taking Omeprazol Sandoz Care.

Warnings and precautions

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

Do not take omeprazole for longer than 14 days without consulting your doctor. If you do not experience relief, or if you feel your symptoms worsen, consult your doctor.

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 these symptoms related to serious skin reactions described in section 4.

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

• You are losing weight significantly without reason and have difficulty swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or vomiting blood.
• Your stools are black (bloody stools).
• You have severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
• You have a history of gastric ulcer or gastrointestinal surgery.
• You are undergoing continuous treatment for indigestion or heartburn for 4 weeks or longer.
• You have had persistent indigestion or heartburn for 4 weeks or longer. You have jaundice or a severe liver disease.
• You are over 55 years of age and your symptoms have recently changed or are new.
• You have ever had a skin reaction after treatment with a medicine similar to omeprazole for reducing stomach acid.
• You are scheduled to have a specific blood test (chromogranin A).

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 you need to take it 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.

Patients should not take omeprazole as preventive medication.

Other medicines and Omeprazol Sandoz Care

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. Omeprazole may affect how some medicines work, and some medicines may affect omeprazole.

Do not take omeprazole 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, posaconazole, itraconazole, or voriconazole (used to treat fungal infections).
• Digoxin (used to treat heart problems).
• Diazepam (used to treat anxiety, to 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 drug used in high doses to treat cancer).
• If you are taking a high dose of methotrexate, your doctor will need to temporarily stop your omeprazole treatment.

Omeprazol Sandoz Care with food and drinks

See section 3.

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.

Omeprazole passes into breast milk, but it is unlikely to affect the infant when therapeutic doses are used. Your doctor will decide whether you can take omeprazole while breastfeeding.

Driving and using machines

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

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 Care contains sucrose and sodium

If your doctor has told 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; essentially “sodium-free”.

3. How to take Omeprazol Sandoz Care

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is one 20 mg capsule once daily for 14 days. Contact your doctor if symptoms do not resolve after this period.

You may need to take the capsules for 2-3 consecutive days before experiencing symptom improvement.

How to take this medicine

• It is recommended to take the capsules in the morning.
• You may 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 designed to prevent the medicine from breaking down due to stomach acid. It is important not to damage the granules. These granules contain omeprazole as the active substance and are enteric-coated to protect them from breaking down in the stomach. The granules release the active substance in the intestine, where it is absorbed by the body to produce its effect.

What to do if you have difficulty swallowing the capsules

• If you have trouble 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 juice), or apple puree.
• Always shake the mixture well just 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, refill the glass with half a glass of water, swirl it well, and drink it. Do not use milk or carbonated water. The solid particles contain the medicine; do not chew or crush them.

If you take more Omeprazol Sandoz Care than you should

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

If you forget to take Omeprazol Sandoz Care

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 forgotten doses.

If you stop taking Omeprazol Sandoz Care

Do not stop treatment with omeprazole without first speaking 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 can cause adverse effects, although not everyone experiences 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 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),
• redness of the skin with blistering or peeling. Severe blisters and bleeding in the lips, eyes, mouth, nose and genitals may also occur. This could 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),
• 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 tiredness, which may be symptoms of liver problems (rare).

Other adverse effects include:

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

• headache,
• stomach or intestinal problems: diarrhoea, 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,
• sensation of spinning (vertigo),
• abnormalities in blood tests used to check liver function,
• 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/people):

• blood problems, such as decreased white blood cells or platelets. This may cause weakness, bruising or increased risk of infections,
• low sodium levels in the blood. This may cause weakness, vomiting and cramps,
• agitation, confusion or depression,
• taste disturbances,
• vision problems, such as blurred vision,
• sudden feeling of shortness of breath (bronchospasm),
• dry mouth,
• inflammation inside the mouth,
• a fungal infection called “candidiasis” that may affect the intestine,
• 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 adverse effects (may affect up to 1 in 10,000 patients/people):

• blood count abnormalities, such as agranulocytosis (lack of white blood cells),
• aggression,
• seeing, feeling or hearing things that are not real (hallucinations),
• serious liver problems leading to liver failure and brain inflammation,
• erythema multiforme,
• muscle weakness,
• breast enlargement in males.

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

• inflammation in the intestine (causing diarrhoea),
• if you are being treated with 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.

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 very poor 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 that you inform your doctor about any medication you are taking at that time.

Do not be alarmed by this list of possible adverse effects. You may not experience any of them. If you consider any of the adverse effects you experience to be severe or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect 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 adverse effects, you can help provide more information on the safety of this medicine.

5. Omeprazole Sandoz Care Storage

Keep this medicine out of the 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.

Aluminum/Aluminum blister:

Store in the original packaging to protect it from moisture.

Store below 30 °C.

HDPE plastic bottle with screw cap and silica gel desiccant:

Store below 25 °C.

Keep the container tightly closed to protect it from moisture.

After opening, use within the first 3 months.

Medicines must not be disposed of via wastewater drains or household waste.

Dispose of unused medicines and their containers at the SIGRE Point at your usual pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Omeprazol Sandoz Care

• The active substance is omeprazole. Each gastro-resistant capsule contains 20 mg of omeprazole.
• The other components (excipients) are: sugar spheres (containing sucrose and maize starch), sodium lauryl sulfate, disodium phosphate, mannitol (E-421), hypromellose type 2910, macrogol 6000, talc, polysorbate 80, titanium dioxide (E-171), and 30% dispersion of methacrylic acid-ethyl acrylate copolymer (1:1). The hard gelatin capsule consists of: gelatin, quinoline yellow (E-104), and titanium dioxide (E-171).

Appearance of the product and contents of the pack

Yellow opaque hard gastro-resistant capsule containing spherical microgranules of whitish to cream-white colour.

Alu/Alu blister: 7, 14 capsules.

HDPE container with silica gel desiccant in the polypropylene cap: 7, 14 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

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

Manufacturer:

Laboratorio Liconsa, S.A.
Av. Miralcampo nº7,
Miralcampo Industrial Estate
19200 Azuqueca de Henares (Guadalajara)
Spain

Date of the most recent review of this leaflet: July 2024

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