Omeprazole Combix 20 mg gastro-resistant hard capsules EFG

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Omeprazol Combix 20 mg gastro-resistant hard capsules EFG

Package leaflet contents:

1. What Omeprazol Combix is and what it is used for
2. Before taking Omeprazol Combix
3. How to take Omeprazol Combix
4. Possible side effects
5. Storage of Omeprazol Combix
6. Further information

1. What Omeprazol 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.

Omeprazol Combix is used to treat the following conditions:

In adults:

• "Gastroesophageal reflux disease" (GERD). In this disorder, stomach acid passes 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 may 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 passes into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.

In children, symptoms of the disease may include regurgitation of stomach contents into the mouth, 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, the doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. Before taking Omeprazol Combix

Do not take Omeprazol Combix

• if you are allergic (hypersensitive) to omeprazole or to any of the other ingredients of Omeprazol Combix.
• 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, speak with your doctor or pharmacist before taking Omeprazol Combix.

Take special care with Omeprazol Combix

Talk to your doctor before starting to take Omeprazol Combix:

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

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 stop treatment with Omeprazol Combix. Remember to mention any other symptoms you may notice, such as joint pain.

• if you are scheduled to have a specific blood test (chromogranin A).

Omeprazol Combix may mask symptoms of other diseases. Therefore, if you experience any of the following conditions before starting to take Omeprazol Combix or during treatment, consult your doctor immediately:

• You lose weight significantly without apparent 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.

If you take Omeprazol Combix 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.

When taking omeprazole, kidney inflammation may occur. 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.

Use of other medicines

Inform your doctor or pharmacist if you are currently using, or have recently used, any other medicines, including those obtained without a prescription. Omeprazol Combix may affect the way some medicines work, and some medicines may affect Omeprazol Combix.

Do not take Omeprazol Combix 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, 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 treatment with Omeprazol Combix.
• 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 treatment with Omeprazol Combix.
• 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)).

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin along with Omeprazol Combix 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 Combix with food and drinks

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

Your doctor will decide whether you can take Omeprazol Combix if you are breastfeeding.

Driving and using machines

It is unlikely that Omeprazol Combix will affect your ability to drive or operate tools or machinery.

However, adverse effects such as dizziness and visual disturbances may occur (see section 4). If these occur, you should not drive or operate machinery.

Important information about some of the ingredients of Omeprazol Combix

Omeprazol Combix contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Omeprazol Combix

Follow exactly the administration instructions for Omeprazol Combix given by your doctor. Consult your doctor or pharmacist if you have any doubts.

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 your age.

The usual doses are indicated below.

Adults:

Treatment of GERD symptoms, 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 4–8 weeks. Your doctor may prescribe a dose of 40 mg for another 8 weeks if the esophagus has not yet healed.
• Once the esophagus has healed, the usual dose is 10 mg once daily.
• If you do not have esophageal damage, the usual dose is 10 mg once daily.

Treatment of upper intestinal ulcers (duodenal ulcer):

• The usual 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 fully heal, the dose may be increased to 40 mg once daily for 4 weeks.

Treatment of stomach ulcers (gastric ulcer):

• The usual 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 fully heal, the dose may be increased to 40 mg once daily for 8 weeks.

Prevention of recurrence of gastric 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 gastric and duodenal ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

• The usual dose is 20 mg once daily for 4–8 weeks.

Prevention of gastric and duodenal ulcers during NSAID treatment:

• The usual dose is 20 mg once daily.

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

• The usual 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 pancreatic tumor (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.

Children:

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

• Children over one year of age weighing more than 10 kg may take Omeprazol Combix. 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 breaking down in the 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 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 water to half, swirl it well, and drink the water. The solid particles contain the medicine; do not chew or crush them.

If you take more Omeprazol Combix than you should

If you have taken more Omeprazol Combix than prescribed by your doctor, consult your doctor or pharmacist immediately. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Omeprazol 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 forgotten doses.

4. Possible adverse effects

Like all medicines, Omeprazol Combix may have adverse effects, although not everyone experiences them.

If you notice any of the following rare but serious adverse effects, stop taking Omeprazol Combix and consult your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, throat, or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction).
• Red skin rash with blistering or peeling. Severe blisters and bleeding in the lips, eyes, mouth, nose, and genitals may also occur. These could be signs of "Stevens-Johnson syndrome" or "toxic epidermal necrolysis".
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems.

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

Other adverse effects are:

Frequent adverse effects

• Headache.
• Stomach or intestinal problems: diarrhoea, 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.
• Sensation of spinning (vertigo).
• Abnormal blood test results used to check liver function.
• Skin rash, hives and itching.
• General feeling of malaise and lack of energy.

If you are taking proton pump inhibitors such as Omeprazol Combix, especially for a period longer than one year, the risk of fracture of the hip, wrist and spine may slightly increase. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Rare adverse effects

• Blood problems, such as a decrease in white blood cells or platelets. This may cause weakness or bruising and increase the likelihood of developing 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 tiredness.
• 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

• Blood count abnormalities, such as agranulocytosis (lack of white blood cells).
• Aggressiveness.
• Seeing, feeling or hearing things that are not there (hallucinations).
• Serious liver problems leading to liver failure and brain inflammation.
• Sudden onset of severe rash, blistering or peeling of the skin. 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.
• Low magnesium levels in the blood.

In very rare cases, Omeprazol Combix may affect the 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 local 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 provide information about the 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 effects not listed in this leaflet, inform your doctor or pharmacist.

Frequency not known

Skin rash, possibly with joint pain.

If you are taking Omeprazol Combix for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness or increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Omeprazol Combix

• Keep out of the reach and sight of children.

• Do not use Omeprazol Combix after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Blister:

Store below 30°C.

Keep in the original packaging to protect from moisture.

HDPE capsule bottles:

Store below 30°C.

Keep in the original packaging to protect from moisture.

Use within 3 months of first opening the container.

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 you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This helps protect the environment.

6. Additional Information

Composition of Omeprazol Combix

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

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

Appearance of the product and contents of the pack

Omeprazol Combix is available as hard capsules containing spherical, gastro-resistant omeprazole microgranules.

Available pack sizes are:

Aluminum/aluminum blisters: packs of 14, 28, 56 capsules, and a clinical pack of 500 capsules.

White opaque high-density polyethylene bottle with a white opaque polypropylene cap and desiccant. Packs of 28 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/Badajoz 2, Building 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 leaflet was approved in March 2023

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