OMEPRAZOL COMBIX 20 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

PATIENT INFORMATION LEAFLET

Omeprazole Combix 20 mggastro-resistant hard capsulesEFG

Contents of the pack:

1. What Omeprazole Combix is and what it is used for
2. Before you take Omeprazole Combix
3. How to take Omeprazole Combix
4. Possible side effects
5. Storing Omeprazole Combix
6. Further information

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

Omeprazole belongs to a group of medicines called “proton pump inhibitors”. These medicines work by reducing the amount of acid produced by the stomach.

Omeprazole Combix 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 that 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 caused by an infection 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 that connects the throat to the stomach), causing pain, inflammation and heartburn.

In children, symptoms of the disease may include food coming back up into the mouth (regurgitation), vomiting and insufficient weight gain.

Children over 4 years of age and adolescents

Ulcers caused by an infection with 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. Before you take Omeprazole Combix

Do not take Omeprazole Combix

• if you are allergic (hypersensitive) to omeprazole or any of the other ingredients of Omeprazole Combix.
• if you are allergic to medicines that contain proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• if you are taking a medicine that contains nelfinavir (used to treat HIV infection).

If you are not sure, talk to your doctor or pharmacist before taking Omeprazole Combix.

Take special care with Omeprazole Combix

Tell your doctor before you start taking Omeprazole Combix:

• if you have ever had a skin reaction after treatment with a medicine similar to Omeprazole Combix to reduce stomach acid.

If you get a rash on your skin, especially in areas of your skin exposed to the sun, tell your doctor as soon as possible, as you may need to stop taking Omeprazole Combix. Also remember to mention any other symptoms that you may notice, such as joint pain.

• if you are due to have a specific blood test (Chromogranin A).

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

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Black stools (blood-stained faeces).
• If you have severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
• If you have severe liver problems.

If you take Omeprazole Combix 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 whenever you visit them.

When taking omeprazole, kidney inflammation can occur. The signs and symptoms can 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 these signs.

Using other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. Omeprazole Combix may affect the way some medicines work and some medicines may affect the way Omeprazole Combix works.

Do not take Omeprazole Combix 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 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 you start or stop taking Omeprazole Combix.
• 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 Combix.
• 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).

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

Taking Omeprazole Combix with food and drink

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

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Before taking Omeprazole Combix, tell your doctor if you are pregnant or trying to become pregnant. Your doctor will decide whether you can take Omeprazole Combix.

Your doctor will decide whether you can take Omeprazole Combix if you are breast-feeding.

Driving and using machines

Omeprazole Combix 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 operate machinery.

Important information about some of the ingredients of Omeprazole Combix

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

3. How to take Omeprazole Combix

Always take Omeprazole Combix exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Remember to take your medicine.

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

The usual doses are as follows.

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 prescribe a dose of 40 mg for another 8 weeks if the oesophagus has not yet healed.
• The usual dose once the oesophagus has healed is 10 mg once a day.
• If you do not have oesophageal damage, the usual dose is 10 mg once a day.

Treatment of duodenal ulcers:

• The usual dose is 20 mg once a day 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, the dose may be increased to 40 mg once a day for 4 weeks.

Treatment of gastric ulcers:

• The usual dose is 20 mg once a day 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, 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 duodenal and stomach ulcers caused by NSAIDs:

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

Prevention of duodenal and stomach ulcersduring NSAID therapy:

• The usual dose is 20 mg once a day.

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of their return:

• The usual dose is 20 mg of omeprazole twice a day for one week.
• Your doctor will also tell you to take two antibiotics from the following: 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 depending on your needs and will also decide how long you need to take the medicine.

Children:

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

• Children over 1 year of age who weigh more than 10 kg can take Omeprazole Combix. The dose for children is based on body weight and your doctor will decide the correct dose.

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of their return:

• Children over 4 years of age can take omeprazole. The dose for children is based on 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 still 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). Then 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 Combix than you should

If you have taken more Omeprazole Combix than your doctor prescribed, contact your doctor or pharmacist immediately. You can also contact the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Omeprazole Combix

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.

4. Possible Adverse Effects

Like all medicines, Omeprazol Combix can have adverse effects, although not all people suffer from them.

If you notice any of the following rare but serious adverse effects, stop taking Omeprazol Combix 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).
• 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".
• Yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver problems.

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

Other adverse effects are:

Frequent Adverse Effects

• 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

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

If you are taking proton pump inhibitors like Omeprazol Combix, especially for 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).

Rare Adverse Effects

• Blood problems, such as a decrease in white blood cells or platelets. This can cause weakness or bruising and increase the likelihood of infections.
• Allergic reactions, sometimes very intense, which include 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 alterations.
• Visual problems, such as blurred vision.
• Sudden feeling of difficult breathing (bronchospasm).
• Dry mouth.
• Inflammation of the inside of the mouth.
• Infection called "candidiasis" 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 with exposure to sunlight.
• Joint pain (arthralgias) or muscle pain (myalgias).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very Rare Adverse Effects

• Blood count alterations, such as agranulocytosis (lack of white blood cells).
• Aggressiveness.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems that 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.
• Increased breast size in males.
• Low magnesium levels in the blood.

In very rare cases, Omeprazol Combix can affect the white blood cells in the blood and cause immunodeficiency. If you have an infection with symptoms such as fever with a very 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. If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Unknown Frequency

Skin rash, possibly with joint pain.

If you are taking Omeprazol Combix for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you experience any of these symptoms, go to the 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 magnesium levels.

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 does not appear 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 medication.

5. Storage of Omeprazol Combix

• Keep out of the reach and sight of children.

• Do not use Omeprazol Combix after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Blister:

Store at a temperature below 30°C.

Store in the original packaging to protect it from moisture.

HDPE capsule containers:

Store at a temperature below 30°C.

Store in the original packaging to protect it from moisture.

Use within the first 3 months after opening the packaging.

Keep the packaging perfectly closed after use.

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and unused medicines in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This way, you will help protect the environment.

6. Additional Information

Composition of Omeprazol Combix

• The active ingredient is omeprazole. Each capsule contains 20 mg of omeprazole.
• The other components are: sugar spheres (cornstarch and sucrose), sodium lauryl sulfate, disodium hydrogen phosphate, mannitol (E-421), hypromellose, macrogol 6000, talc, polysorbate 80, titanium dioxide, and methacrylic acid copolymer and ethyl acrylate.

The gelatin capsule is composed of: gelatin, water, quinoline yellow (E-104), and titanium dioxide (E-171).

Appearance of the Product and Packaging Content

Omeprazol Combix is presented in the form of hard capsules containing gastric-resistant omeprazole microspheres.

The available packaging is:

Aluminum/aluminum blister pack. In packages of 14, 28, 56 capsules and in a clinical package of 500 capsules.

Opaque white polyethylene bottle with an opaque white polypropylene cap with a desiccant. Packages of 28 capsules.

Only some packaging sizes may be marketed.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

LICONSA, S.A.

Avda. Miralcampo, nº 7

Polígono Ind. Miralcampo

19200 Azuqueca de Henares (Guadalajara)

SPAIN

This prospectus was approved in March 2023

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