PEPTICUM 20 mg HARD GASTRORESISTENT CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pepticum 20mg hard gastro-resistant capsules EFG

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.

• Keep this leaflet, as 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 Pepticum and what is it used for
2. What you need to know before you take Pepticum
3. How to take Pepticum
4. Possible side effects
   1. Storing Pepticum

1. Contents of the pack and further information

1. What is Pepticum and what is it used for

Pepticum 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.

Pepticum 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 which connects the throat to the stomach), causing pain, inflammation and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcers) or stomach (gastric ulcers).
• 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). Pepticum can 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 which connects the throat to the stomach), causing pain, inflammation and heartburn. In children, the symptoms of the disease can include the return of stomach contents into 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 Pepticum

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 containing proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Do not take Pepticum if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Pepticum.

Warnings and precautions

Talk to your doctor or pharmacist before taking Pepticum:

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported with Pepticum. Stop taking Pepticum and contact your doctor immediately if you experience any of these symptoms.

Pepticum may mask the symptoms of other diseases. Therefore, if you experience any of the following before or while taking Pepticum, consult 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.
• Severe liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to Pepticum to reduce stomach acid.
• If you are due to have a specific blood test (Chromogranin A).

If you take Pepticum for a long period (over 1 year), your doctor will probably keep you under regular surveillance. You should report any new or unusual symptoms to your doctor, especially if you have had them for some time.

Taking a proton pump inhibitor like Pepticum, especially over a period of more than one year, may slightly increase the risk of hip, wrist or spine fractures. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you get a rash on your skin, especially in areas exposed to the sun, you should contact your doctor as soon as possible, as you may need to stop your treatment with Pepticum. Also remember to mention any other symptoms you might notice, such as joint pain.

When taking omeprazole, kidney inflammation can occur. 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.

This medicine may affect the way your body absorbs vitamin B12. If you have to take it for a long time, contact your doctor if you notice any of the following symptoms, which could indicate low vitamin B12 levels:

• Extreme tiredness or lack of energy
• Numbness or tingling
• Pain in the tongue or red tongue, mouth ulcers
• Muscle weakness
• Altered vision
• Memory problems, confusion, depression.

Children

Some children with chronic diseases may require long-term treatment, although it is not recommended. Do not give this medicine to children under 1 year of age or weighing less than 10 kg.

Using Pepticum with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you can buy without a prescription. This is because Pepticum can affect the way some medicines work and some medicines can affect Pepticum.

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

Tell 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 for 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 Pepticum
• 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 Pepticum
• 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 (a chemotherapy medicine used in high doses to treat cancer). If you are taking high-dose methotrexate, your doctor may need to temporarily stop your treatment with Pepticum.

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

Taking Pepticum with food and drink

See section 3.

Pregnancy, breast-feeding and fertility

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.

Pepticum passes into breast milk but it is unlikely to affect the baby when used in recommended doses.

Your doctor will decide whether you can take Pepticum during breast-feeding.

Driving and using machines

Pepticum 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.

Pepticum contains lactose, sucrose and sodium

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

Pepticum contains less than 1 mmol sodium (23 mg) per capsule, i.e. it is essentially “sodium-free”.

3. How to take Pepticum

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

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 as follows:

Use in adults:

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 tell you to take 40 mg once a day for a further 8 weeks if the oesophagus has not yet fully 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 tell you to take the same dose for a further 2 weeks if the ulcer has not yet fully healed.
• If the ulcer does not fully heal, 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 tell you to take the same dose for a further 4 weeks if the ulcer has not yet fully healed.
• If the ulcer does not fully heal, the dose may be increased to 40 mg once a day for 8 weeks.

Preventionof duodenal and stomach 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 caused by NSAIDs(non-steroidal anti-inflammatory drugs):

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

Prevention of ulcers caused by NSAIDs:

• The recommended dose is 20 mg once a day

Treatment of ulcers caused byHelicobacter pyloriinfectionand prevention of their return:

• The recommended dose is 20 mg of Pepticum twice a day for one week.

• Your doctor will also tell you to take two antibiotics among amoxicillin, clarithromycin and metronidazole.

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 and adolescents:

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

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

Treatment of ulcers caused byHelicobacter pyloriinfectionand prevention of their return:

• Children over 4 years of age can take Pepticum. The dose for children is based on their 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.
• Other commercial presentations with the same active substance are available on the market to administer 10 and 40 mg doses (for 40 mg you can also take two 20 mg capsules).

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, fruit juice with acid (e.g. apple, orange or pineapple) or apple sauce.
  • Always stir the mixture just before drinking it (the mixture will not be clear). 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 Pepticum than you should

If you have taken more Pepticum than your doctor recommended, talk to your doctor or pharmacist.

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 Pepticum

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.

If you stop taking Pepticum

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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 adverse effects (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious, stop taking Pepticum 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). (rare)
• 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". (very rare)
• Widespread rash, high body temperature, and inflammation of the lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (rare)
• A red, scaly, and widespread rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis). (rare)
• Yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver problems.

Other adverse effects are:

Common 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 blood test results that check liver function.
• Skin rash, hives, and itching.
• Feeling of general 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.
• Low sodium levels in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Taste disorders.
• Visual problems, such as blurred vision.
• Sudden feeling of difficult breathing (bronchospasm).
• Dry mouth.
• Inflammation of the mouth.
• Infection called "candidiasis" that can affect the intestine and is caused by a fungus.
• Hair loss (alopecia).
• Skin rash with exposure 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 count, such as agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems that cause liver failure and brain inflammation.
• Erythema multiforme.
• Muscle weakness.
• Increased breast size in males.

Frequency Not Known (cannot be estimated from available data)

• Inflammation in the intestine (causing diarrhea).
• If you are being treated with Pepticum for more than three months, your magnesium levels in the blood may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you experience 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.
• Rash, possibly with joint pain.

In very rare cases, Pepticum 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 about the safety of this medicine.

5. Storage of Pepticum

Keep this medicine out of the 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.

Do not store above 25°C.

Medicines should not be thrown down the drain 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. Package Contents and Additional Information

Composition of Pepticum

• The active ingredient is omeprazole. Each capsule contains 20 mg of omeprazole.
• The other components are hydroxypropylmethylcellulose (E-464), Eudragit L30 D (methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30 percent), triethyl citrate, talc, lactose, sodium lauryl sulfate, disodium phosphate, hydroxypropylcellulose, sucrose, cornstarch. The gelatin capsule is composed of: gelatin and titanium dioxide (E-171). See section 2 Pepticum capsules contain lactose, sucrose, and sodium.

Appearance of the Product and Package Contents

Pepticum 20 mg capsules are presented in the form of gelatin capsules with a white body and blue head containing omeprazole pellets with enteric coating, packaged in aluminum/aluminum blisters in containers containing 14, 28, or 56 capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 Torrejón de Ardoz (Madrid)

Spain

Manufacturer

Laboratorios Medicamentos Internacionales, S.A.

C/ Solana, 26

28850 Torrejón de Ardoz (Madrid)

Spain

Date of the Last Revision of this Prospectus:

August 2024.

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