OMEPRAZOL ALTER 40 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Omeprazole Alter 40 mg Hard Gastro-Resistant Capsules

Omeprazole

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. See section 4.

Contents of the pack and other information

1. What is Omeprazole Alter and what is it used for
2. What you need to know before you take Omeprazole Alter
3. How to take Omeprazole Alter
4. Possible side effects
5. Storing Omeprazole Alter
6. Contents of the pack and other information

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

Omeprazole Alter 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 Alter is used to treat the following conditions:

In adults:

• “Gastro-oesophageal reflux disease” (GORD). In this condition, acid from the stomach passes 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 in the stomach (gastric ulcer).
• Ulcers caused by 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 Alter may also be used to prevent ulcers if you are taking NSAIDs.
• Excess acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).

Children over 1 year of age and ≥ 10 kg:

• “Gastro-oesophageal reflux disease” (GORD). In this condition, acid from the stomach passes into the gullet (the tube that connects the throat to the stomach), causing pain, inflammation and heartburn.

In children, the symptoms of the disease can include return of stomach contents 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 Alter

Do not take Omeprazole Alter:

• 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 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).

Talk to your doctor or pharmacist before taking omeprazole

Warnings and precautions

Omeprazole may hide the symptoms of other diseases. Therefore, if you experience any of the following before starting to take omeprazole or during treatment, consult your doctor immediately:

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or vomiting blood.
• Black stools (faeces stained with blood).
• If you have severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
• Severe liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to omeprazole to reduce stomach acid.
• If you are due to have a specific blood test (Chromogranin A).

If you take omeprazole 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 him.

Taking a proton pump inhibitor like omeprazole, especially over a period of more than one year, may slightly increase the risk of fractures of the hip, wrist or spine. Inform your doctor if you have osteoporosis or 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, tell your doctor as soon as possible, as you may need to stop taking omeprazole. Also, mention any other symptoms you notice, such as joint pain.

Taking Omeprazol Alter with other medicines

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

Do not take omeprazole 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, posaconazole, 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.
• 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)
• 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 (chemotherapy medicine used at high doses to treat cancer) - if you are taking high doses of methotrexate, your doctor may need to temporarily stop omeprazole treatment.

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

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 these signs.

Taking Omeprazol Alter with food and drinks

You can take your capsules with food or on an empty stomach. Do not chew or crush them. You should swallow the capsules whole with a glass of water.

Pregnancy and breast-feeding

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.

Omeprazole is excreted in breast milk but it is unlikely to affect the baby when used at therapeutic doses. Your doctor will decide whether you can take omeprazole if you are breast-feeding.

Driving and using machines

Omeprazole Alter is unlikely to affect your ability to drive or use tools or machines. However, side effects such as dizziness and visual disturbances (see section 4) may occur. If affected, you should not drive or operate machinery.

Omeprazol Alter 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 Alter

Always take this medicine exactly as your doctor 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. This will depend on your condition and age.

The recommended dose is:

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

• If your doctor finds that you have mild oesophageal damage, the recommended 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 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 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 a day for 4 weeks.

Treatment of gastric ulcers:

• The recommended 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 completely, the dose may be increased to 40 mg once a day for 8 weeks.

Preventionof duodenal and gastric ulcers:

• The recommended 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 of the stomach and duodenum caused by NSAIDs:

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

Prevention of ulcers of the stomach and duodenumduring NSAID therapy:

• The recommended dose is 20 mg once a day.

Treatment of ulcers caused byHelicobacter pyloriinfectionand prevention of recurrence:

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

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

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

Use in 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 Alter. The dose for children is based on body weight and your doctor will decide the correct dose.

Treatment of ulcers caused byHelicobacter pyloriinfectionand prevention of recurrence:

• Children over 4 years of age can take Omeprazole Alter. 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 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 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 Omeprazol Alter than you should

If you have taken more Omeprazol Alter than your doctor prescribed, talk to your doctor or pharmacist immediately. You can also contact the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Omeprazol Alter

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, this medicine can cause adverse effects, although not all people suffer from them.

If you notice any of the following rare but serious adverse effects, stop taking omeprazol 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.

Other adverse effects are:

Frequent 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 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.
• Feeling that everything is spinning (vertigo).
• Abnormal liver function tests.
• Skin rash, hives, and itching.
• General feeling of discomfort and lack of energy.

Rare Adverse Effects (may affect up to 1 in 1,000 people)

• Blood problems, such as a decrease in white blood cells or platelets. This can cause weakness or bruising and increase the risk of infection.
• Allergic reactions, sometimes very intense, 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.
• 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 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)

• Abnormal blood counts, 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.
• Enlargement of the breasts in men.

Frequency Not Known (cannot be estimated from available data)

• Inflammation of the intestine (which causes diarrhea).

• If you are being treated with omeprazol for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can manifest as fatigue, muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you have any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to a reduction 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.

In very rare cases, Omeprazol Alter 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 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 medicine.

5. Storage of Omeprazol Alter

• Keep this medicine out of sight and reach of children.

• Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

• Al/Al blister:

Store below 30°C.

Keep in the original packaging to protect it from moisture.

• PVC-PVDC/Al blister:

Store below 25°C.

Keep in the original packaging to protect it from moisture.

• HPDE bottle:

No special storage conditions are required.

Validity period after opening the bottle: 100 days.

Keep the bottle perfectly closed to protect it from moisture.

• Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Omeprazol Alter

• The active ingredient is omeprazol. Omeprazol Alter hard gastro-resistant capsules contain 40 mg of omeprazol.
• The other ingredients are sugar spheres (sucrose and cornstarch), hypromellose (E-464), talc (E-553b), titanium dioxide (E-171), disodium hydrogen phosphate dihydrate (E-339 ii), sodium lauryl sulfate, polysorbate 80, copolymer of methacrylic acid and ethyl acrylate, triethyl citrate (E-1505). Capsule:gelatin, titanium dioxide (E-171). See section 2 Omeprazol Alter contains sucrose.

Appearance of the Product and Package Contents

Omeprazol Alter 40 mg hard gastro-resistant capsules are white opaque gelatin capsules marked with OM40, which contain spherical granules.

White HDPE bottle with cap and safety ring equipped with a desiccant: 14 and 28 capsules.

Alu/Alu blister: 14 and 28 capsules.

PVC-PVDC/Al blister: 14 and 28 capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer

Towa Pharmaceutical Europe S.L.C/ Sant Martí, 75-97

08107 Martorelles, Barcelona

Spain

Date of the Last Revision of this Prospectus: March 2023

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