Omeprazole Alter 40 mg gastro-resistant hard capsules

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the user

Omeprazol Alter 40 mg gastro-resistant hard capsules

Omeprazole

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; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet contents

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

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

Omeprazol Alter contains the active substance omeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These medicines work by reducing the amount of acid produced by the stomach.

Omeprazol Alter 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 medicines known as NSAIDs (non-steroidal anti-inflammatory drugs).
• Omeprazol Alter 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).

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 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, their doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before taking Omeprazol Alter

Do not take Omeprazol Alter:

• 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).

Consult your doctor or pharmacist before starting to take omeprazole.

Warnings and precautions

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

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or vomiting blood.
• Black stools (indicating blood in the stool).
• 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 used to reduce stomach acid.
• If you are scheduled to have a specific blood test (chromogranin A).

If you take omeprazole for a long period (more than 1 year), your doctor will likely schedule periodic check-ups. You should report any new or unusual symptoms or circumstances during these visits.

Taking a proton pump inhibitor such as omeprazole, especially for 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 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.

Taking Omeprazol Alter with other medicines

Inform 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, 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 (chemotherapy medicine used in high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor will need to temporarily stop omeprazole treatment

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

Kidney inflammation may occur while taking omeprazole. Signs and symptoms may include reduced 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.

Taking Omeprazol Alter with food and drinks

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

Pregnancy and breastfeeding

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

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

Driving and using machines

Omeprazol Alter is unlikely to 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 use machinery.

Omeprazol Alter contains sucrose

If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Omeprazol Alter

Follow exactly the instructions for use of this medicine given by your doctor. 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 dose is:

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

• If your doctor determines that you have mild esophageal damage, the recommended 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.
• The recommended dose once the esophagus has healed is 10 mg once daily.
• If you do not have esophageal damage, the recommended dose is 10 mg once daily.

Treatment of upper intestinal ulcers (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 gastric and duodenal ulcers:

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

Prevention of gastric and duodenal ulcers during NSAID therapy:

• 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 Omeprazol Alter twice daily for one week.
• Your doctor will also instruct you to take two of the following antibiotics: amoxicillin, clarithromycin, and metronidazole.

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

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

Use in 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 Alter. 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 Omeprazol Alter. The dose for children is based on body weight, and the doctor will determine the correct dose.
• The 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 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 breaking down due to 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 that all the medicine is taken, fill the glass halfway with water, rinse it well, and drink the water. The solid particles 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 prescribed by your doctor, contact 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 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 missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you notice any of the following rare but serious adverse 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).
• Skin redness 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".
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems.

Other adverse effects include:

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

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

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).
• Abnormal blood test results indicating liver function problems.
• Skin rash, hives, and itching.
• General malaise and lack of energy.

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

• Blood problems, such as decreased white blood cells or platelets. This may cause weakness or bruising and increase the 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 muscle cramps.
• Restlessness, confusion, or depression.
• Taste disturbances.
• Vision problems, such as blurred vision.
• Sudden shortness of breath (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 adverse 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.
• Breast enlargement in males.

Frequency not known (cannot be estimated from available data)

• Inflammation of the intestine (causing diarrhea).

• 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 levels of potassium or calcium 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, Omeprazol Alter may affect white blood cells and cause immunodeficiency. If you develop an infection with symptoms such as fever with a very 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 that you inform your doctor about any medication you are taking at that time.

Reporting of adverse effects

If you experience any adverse effect, talk to 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Omeprazole Alter

• 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 EXP. The expiry date refers to the last day of the month indicated.

• Al/Al blister:

Store below 30°C.

Keep in the original packaging to protect from moisture.

• PVC-PVDC/Al blister:

Store below 25°C.

Keep in the original packaging to protect from moisture.

• HPDE bottle:

No special storage conditions required.

Validity period after first opening of the bottle: 100 days.

Keep the bottle tightly closed to protect from moisture.

• Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Omeprazol Alter

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

Nature and contents of the container

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

HDPE white bottle with cap and security ring, equipped with a desiccant agent: 14 and 28 capsules.

Alu/Alu blister: 14 and 28 capsules.

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

Only certain pack 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 most recent review of this leaflet: March 2023

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