Leaflet: information for the user

Pepticum 40 mg hard gastro-resistant capsules

Omeprazole

Read this 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, consult your doctor or pharmacist.

- This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4

1. What Pepticum is and what it is used for

2. What you need to know before you start taking Pepticum

3. How to take Pepticum

4. Possible side effects

5. Storage of Pepticum

6. Contents of the pack and additional information

Pepticum contains the active ingredient omeprazole. It belongs to a group of medications called "proton pump inhibitors". These medications act by reducing the amount of acid produced by the stomach.

Pepticum is used to treat the following diseases:

For adults:

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

• Ulcers in the upper part of the small intestine (duodenal ulcer) or in the stomach (gastric ulcer).

• Ulcers infected by a bacteria called "Helicobacter pylori". If you have this disease, it is possible that your doctor will prescribe antibiotics to treat the infection and allow the ulcer to heal.

• Ulcers caused by certain medications called NSAIDs (nonsteroidal anti-inflammatory drugs). Pepticum may also be used to prevent the formation of ulcers if you are taking NSAIDs.

• Excess acid in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome).

For 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 that connects the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms of the disease may include the return of stomach contents to the mouth (regurgitation), vomiting, and inadequate weight gain.

Children over 4 years of age and adolescents

• Ulcers infected by a bacteria called "Helicobacter pylori". If your child has this disease, it is possible that your doctor will prescribe antibiotics to treat the infection and allow the ulcer to heal.

Do not take Pepticum

• 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 for HIV infection).

Do not take Pepticum if you fall into any of the above categories. If you are unsure, talk to your doctor or pharmacist before taking Pepticum.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pepticum:

Severe skin reactions have been reported in association with Pepticum treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized pustular psoriasis (AGPP). Stop taking Pepticum and consult your doctor immediately if you experience any of these symptoms related to severe skin reactions described in section 4.

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

• you lose weight significantly without apparent reason and have trouble swallowing.
• you have stomach pain or indigestion.
• you start vomiting food or blood.
• your stools are black (blood-stained stools).
• if you have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• you have severe liver problems.
• if you have ever had a skin reaction after treatment with a similar medicine to Pepticum for reducing stomach acidity.
• you are scheduled to have a specific blood test (chromogranin A).

If you take Pepticum for a long period (more than 1 year), your doctor will probably perform regular check-ups. You should inform your doctor of any new or unusual symptoms and circumstances whenever you visit your doctor.

Taking a proton pump inhibitor like Pepticum, especially for more than a 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 experience a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt Pepticum treatment. Remember to mention any other symptoms you may notice, such as joint pain.

Omeprazole may cause kidney inflammation. 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. Inform your doctor of these signs.

This medicine may affect the way 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 may indicate low vitamin B12 levels:

• extreme fatigue or lack of energy.
• tingling.
• mouth pain or red tongue, mouth ulcers.
• muscle weakness.
• vision changes.
• memory problems, confusion, depression.

Children

Some children with chronic diseases may require long-term treatment, although it is not recommended. Do not administer this medicine to children under 1 year of age or <10>

Use of Pepticum with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including those acquired by prescription. This is because Pepticum may affect the mechanism of action of some medicines and some medicines may affect Pepticum.

Do not take Pepticum if you are taking a medicine that contains nelfinavir (used to treat HIV infection).

Inform your doctor or pharmacist if you are taking any of the following medicines:

• ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections).
• digoxin (used to treat heart problems).
• diazepam (used to treat anxiety, relax muscles, or epilepsy).
• phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop Pepticum treatment.
• medicines used to prevent blood clotting, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when you start or stop Pepticum treatment.
• 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).
• 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 Pepticum treatment.

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

Taking Pepticum with food and drinks

See section 3.

Pregnancy, breastfeeding, and fertility

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

Pepticum passes into breast milk but is unlikely to affect the baby when used in therapeutic doses. Your doctor will decide if you can take Pepticum while breastfeeding.

Driving and operating machinery

Pepticum 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 they do, you should not drive or use machines.

Pepticum capsules contain lactose, sucrose, and sodium

Pepticum capsules contain lactose and sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Pepticum capsules contain less than 23 mg of sodium (1 mmol) per capsule; that is, it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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 described below:

Use in adults:

Treatment of symptoms of gastroesophageal reflux disease (GERD), such asheartburn and acid regurgitation:

• If your doctor checks that you have mild damage to the esophagus, 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 esophagus has not yet healed.
• The recommended dose once the esophagus has healed is 10 mg once a day.
• If you do not have damage to the esophagus, the usual dose is 10 mg once a day.

Treatment ofulcers in the upper part of the small intestine (duodenal ulcer):

• 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 ofstomach ulcers (gastric ulcer):

• 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 the recurrence ofstomach and duodenal 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 stomach and duodenal ulcers caused bynonsteroidal anti-inflammatory drugs (NSAIDs):

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

Prevention of stomach and duodenal ulcersduring the administration ofNSAIDs:

• The recommended dose is 20 mg once a day.

Treatment ofulcers causedby the infectionbyHelicobacter pyloriand prevention of their recurrence:

• The recommended dose is 20 mg of Pepticum twice a day for a week.
• Your doctor will also prescribe two antibiotics, amoxicillin, clarithromycin, and metronidazole.

Treatment of excess acid in the stomach caused by atumor in the pancreas (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 how long you should take the medication.

Use in children and adolescents:

Treatment of symptoms of gastroesophageal reflux disease (GERD), such asheartburn and acid regurgitation:

• Children over one year of age who weigh more than10 kgcan take Pepticum. The dose for children is based on body weight, and your doctor will decide the correct dose.

Treatment ofulcers causedby the infectionbyHelicobacter pyloriand prevention of their recurrence:

• Children over 4 years old can take Pepticum. 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 medication

• 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 medication from breaking down in the stomach acid. It is essential not to damage the granules.
• There are other commercial presentations available on the market with the same active ingredient for administering doses of 10 and 20 mg.

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 water without gas, a sour fruit juice (e.g., apple, orange, or pineapple), or a compote of apple.

- Always shake the mixture just before drinking it (the mixture will not be transparent). Then, drink the mixture immediately or within 30 minutes.

- To ensure that all the medication has been taken, fill the glass of water to half, rinse it well, and drink the water. The solid parts contain the medication; do not chew or crush them.

What to do if you take more Pepticum than you should

If you have taken more Pepticum than prescribed by your doctor, consult your doctor or pharmacist immediately. You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

What to do if you forget to take Pepticum

If you forget to take a dose, take it as soon as you remember. However, if there is little time left for the next dose, skip the missed dose. Do not take a double dose to compensate for the missed doses.

What to do if you interrupt the treatment with Pepticum

Do not stop taking this medication without first talking to your doctor or pharmacist.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

If you experience 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 Pepticum and consult your doctor immediately:

• Sudden hissing sounds when breathing (sudden sibilance), swelling of the lips, tongue, and throat or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction). (rare)
• Redness of the skin with blistering or peeling. Blisters may also appear intensely and bleeding in the lips, eyes, mouth, nose, and genitals. This may be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis". (very rare)
• Generalized rash, elevated body temperature, and inflammation of lymph nodes (DRESS syndrome or pharmacological hypersensitivity syndrome). (rare)
• A red, scaly, and generalized 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 fatigue, which may be symptoms of liver problems. (rare)

Other side effects are:

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

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, and gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach

Infrequent side effects (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling, drowsiness.
• Sensation of spinning (vertigo).
• Abnormal blood test results that check liver function.
• Rash on the skin, hives, and itching.
• General feeling of discomfort and lack of energy.

Rare side 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 infections.
• Low sodium levels in the blood. May cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Changes in taste.
• Visual problems, such as blurred vision.
• Sudden sensation of difficult breathing (bronchospasm).
• Dry mouth.
• Inflammation of the inside of the mouth.
• Infection called "candidiasis" that can affect the intestines and is caused by a fungus.
• Hair loss (alopecia).
• Rash on the skin with exposure to sunlight.
• Joint pain (arthralgias) or muscle pain (myalgias).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very rare side effects (may affect up to 1 in 10,000 people)

• Abnormal blood count, such as agranulocytosis (lack of white blood cells).
• Aggression.
• To see, feel, or hear things that do not exist (hallucinations).
• Severe liver problems that cause liver failure and brain inflammation.
• Erythema multiforme.
• Muscle weakness.
• Enlargement of the breasts in men.

Unknown frequency (cannot be estimated from available data)

• Inflammation in the intestines (causing diarrhea)
• If you are taking Pepticum for more than three months, it is possible that your magnesium levels in the blood will decrease. Low magnesium levels can manifest 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 can also lead to a decrease in potassium or calcium levels in the blood. Your doctor may decide to perform regular tests to monitor your magnesium levels.
• Rash, possibly with joint pain

In very rare cases, Pepticum may affect white blood cells in the blood and cause immunodeficiency. If you experience an infection with symptoms such as fever with a very deteriorated general state or fever with symptoms of local infection, such as neck pain, throat pain, 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 to provide information about the medication you are taking at that time.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through the Spanish Medication for Human Use Pharmacovigilance System

Website:www.notificaRAM.es

By reporting side effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

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

Do not store at a temperature above 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pepticum

The other components are hydroxypropylmethylcellulose (E-464),Eudragit L30 D (Acidic methacrylic copolymer - Ethyl acrylate copolymer (1: 1) Dispersion 30 percent), trietilcitrato, talco,lactose, lauril sulfato sódico, fosfato sódico dibásico, hydroxypropylcellulose, sacarosa, cornstarch. The gelatin capsule is composed of: gelatin and titanium dioxide (E-171). See section 2Pepticum capsules contain lactose, sacarose and sodium.

Appearance of the product and contents of the packaging

Pepticum 40 mg capsules are presented in the form of hard gelatin capsules with white body and head, containing omeprazole granules with enteric coating. They are presented in packaging containing 14, 28 or 56 capsules of 40 mg in aluminum/aluminum blisters.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 Torrejón de Ardoz (Madrid)

Responsible manufacturer

Laboratorios Medicamentos Internacionales, S.A.

C/ Solana, 26

28850 Torrejón de Ardoz (Madrid)

Last review date of this leaflet:August 2024.

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es