PEPTICUM 40 mg HARD GASTRORESISTENT CAPSULES

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 other 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:

Serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported in association with Pepticum treatment. Stop taking Pepticum and contact your doctor immediately if you experience any of these symptoms, as mentioned in section 4.

Pepticum may hide the symptoms of other diseases. Therefore, if you experience any of the following before or while taking Pepticum, consult your doctor immediately:

• Losing a lot of weight without reason and having trouble swallowing.
• Having stomach pain or indigestion.
• Starting to vomit food or vomit blood.
• Having black stools (faeces stained with blood).
• If you have severe or persistent diarrhoea, as omeprazole has been associated with a slightly increased risk of infectious diarrhoea.
• Having 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 of time (more than 1 year) your doctor will probably keep you under regular surveillance. You should report any new and unusual symptoms to your doctor, especially if you have been taking Pepticum for a long time.

Taking a proton pump inhibitor like Pepticum, especially over a period of more than one year, may slightly increase the risk of fracture of the hip, wrist or spine. 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, tell your doctor as soon as possible, as you may need to stop your treatment with Pepticum. Also remember to mention any other symptoms that you may notice, such as joint pain.

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 pain. You should inform your doctor of these signs.

This medicine may affect the way your body absorbs vitamin B12. If you have to take Pepticum for a long time, talk to your doctor, as you may need to have your vitamin B12 levels checked. If you notice any of the following, you should contact your doctor immediately:

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

Children

Some children with long-term illnesses may require long-term treatment, although this 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 for 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 Pepticum treatment

If your doctor has also prescribed the antibiotics amoxicillin and clarithromycin for your treatment of ulcers caused by Helicobacter pylori infection, it is very important that you inform 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 at doses used to treat acid-related diseases. Your doctor will decide whether you can take Pepticum if you are breast-feeding.

Driving and using machines

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

Pepticum capsules contain lactose, sucrose and sodium

Pepticum capsules contain lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Pepticum capsules contain less than 23 mg of sodium (1 mmol) per capsule, i.e. 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, check with 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 described below:

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 a dose of 40 mg for a further 8 weeks if your oesophagus has not yet fully healed.
• The recommended dose once the oesophagus has healed is 10 mg once a day.
• If your oesophagus has not been damaged, the usual 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 another 2 weeks if the ulcer has not yet fully healed.
• If the ulcer does not fully heal, the dose can 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 another 4 weeks if the ulcer has not yet fully healed.
• If the ulcer does not fully heal, the dose can 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 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 by Helicobacter pylori infectionand 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 too much 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 depending on 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 by Helicobacter pylori infectionand 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 which prevent the medicine from being broken down by the acid in the stomach. It is important not to damage the granules.
• Other presentations are available on the market with the same active substance for administration of 10 and 20 mg doses.

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, 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, refill the glass with water, rinse and drink it. 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 told you to, contact your doctor or pharmacist immediately. You can also contact the national poison centre, phone 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 first talking to your doctor or pharmacist.

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 (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious adverse effects, 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. (rare)

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 tests 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.
• An infection called "candidiasis" that can affect the intestine and is caused by a fungus.
• 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).
• 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 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 are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines.

Website: www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on 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 stated 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 disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Pepticum

• The active ingredient is omeprazole. Each capsule contains 40 mg of omeprazole.

The other ingredients are hydroxypropyl methylcellulose (E-464), Eudragit L30 D (methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30 percent), triethyl citrate, talc, lactose, sodium lauryl sulfate, disodium phosphate, hydroxypropyl cellulose, 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 and Package Contents

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

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).

Manufacturer

Laboratorios Medicamentos Internacionales, S.A.

C/ Solana, 26.

28850 Torrejón de Ardoz (Madrid).

Date of the Last Revision of this Leaflet: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.