Pepticum 40 mg gastro-resistant hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pepticum 40 mg gastro-resistant hard capsules

Omeprazole

Read the entire leaflet carefully before you start taking this medicine, as 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 and must not be given to other people, even if they have the same symptoms, as it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Pepticum is and what it is 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:

• “Gastroesophageal reflux disease” (GERD). In this disorder, stomach acid flows back 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 called NSAIDs (non-steroidal anti-inflammatory drugs). Pepticum 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).

In children:

Children over 1 year of age and ≥10 kg

• “Gastroesophageal reflux disease” (GERD). In this disorder, stomach acid flows back 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, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before taking Pepticum

Do not take Pepticum

• 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).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Pepticum:

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

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

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• New onset vomiting of food or vomiting blood.
• Black stools (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 Pepticum used to reduce stomach acidity.
• If 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 likely perform periodic check-ups. You should report any new or unusual symptoms or circumstances during these visits.

Taking a proton pump inhibitor such as Pepticum, particularly for more than one year, may slightly increase the risk of fracture 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 develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as treatment with Pepticum may need to be discontinued. Remember to mention any other symptoms you may notice, such as joint pain.

Kidney inflammation may occur when 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.

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 could indicate low levels of vitamin B12:

• Extreme tiredness or lack of energy
• Tingling
• Tongue pain or red, sore tongue, mouth ulcers
• Muscle weakness
• Vision changes
• Memory problems, confusion, depression

Children

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

Taking Pepticum with other medicines

Tell 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. 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).

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 in epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping treatment with Pepticum.
• 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 treatment with Pepticum.
• 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 (a 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 treatment with Losec.

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

Taking Pepticum with food and drink

See section 3.

Pregnancy, breastfeeding and fertility

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

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

Driving and using machines

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

Pepticum capsules contain lactose, sucrose and sodium

Pepticum capsules contain lactose and sucrose. If your doctor has informed 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; this is essentially “sodium-free”.

3. How to take Pepticum

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. 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 doses are described below:

Use in adults:

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

• If your doctor confirms you have mild damage to the esophagus, the recommended dose is 20 mg once daily for 4–8 weeks. Your doctor may prescribe a dose of 40 mg for an additional 8 weeks if the esophagus has not yet healed.
• The recommended dose after healing of the esophagus is 10 mg once daily.
• If you do not have esophageal damage, the usual dose is 10 mg once daily.

Treatment of ulcers in the upper intestine (duodenal ulcer):

• The recommended dose is 20 mg once daily for 2 weeks. Your doctor may prescribe the same dose for an additional 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 an additional 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 stomach 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 stomach 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 stomach and duodenal ulcers during NSAID treatment:

• The recommended dose is 20 mg once daily.

Treatment of ulcers caused by infection with Helicobacter pylori and prevention of their recurrence:

• The recommended dose is 20 mg of Pepticum 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 daily.
• Your doctor will adjust the dose according to your needs and will also decide how long you should take the medicine.

Use in children and adolescents:

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

• Children over one year of age weighing more than 10 kg may take Pepticum. The dose for children is based on body weight, and the doctor will determine the correct dose.

Treatment of ulcers caused by infection with Helicobacter pylori and prevention of their recurrence:

• Children over 4 years of age may take Pepticum. 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 the 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.
• Other commercial formulations containing the same active ingredient are available for administration of 10 mg and 20 mg doses.

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 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 puree.

• Always shake the mixture well before drinking (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes.

• To ensure you have taken all the medicine, fill the glass halfway with water, swirl well, and drink the water. The solid particles contain the medicine; do not chew or crush them.

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 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 Pepticum

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a missed dose.

If you stop taking Pepticum

Do not stop treatment with this medicine without first speaking to your doctor or pharmacist.

If you have any further questions about 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 everyone will experience 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 side effects, stop taking Pepticum and consult your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue or throat or of the body, skin rash, fainting or difficulty swallowing (severe allergic reaction). (rare)
• Redness of the skin 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”. (very rare)
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (rare)
• A widespread, red, scaly 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 signs of liver problems. (rare)

Other adverse effects include:

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

• Headache
• Stomach or intestinal problems: diarrhoea, 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 of spinning (vertigo)
• Abnormalities in blood tests used to monitor liver function
• 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 may cause weakness or bruising and increase the likelihood of infections.
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
• Restlessness, confusion, or depression
• Taste disturbances
• Vision problems, such as blurred vision
• Sudden feeling of difficulty breathing (bronchospasm)
• Dry mouth
• Inflammation inside the mouth
• Fungal infection called “candidiasis” that may affect the intestine
• 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)
• Serious liver problems leading to liver failure and brain inflammation
• Erythema multiforme
• Muscle weakness
• Enlargement of the breasts in males

Frequency not known (cannot be estimated from available data)

• Inflammation in the intestine (causing diarrhoea)
• If you are being treated with Pepticum 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 potassium or calcium levels in the blood. Your doctor may decide to carry out periodic blood tests to monitor your magnesium levels.
• Rash, possibly with joint pain

In very rare cases, Pepticum may affect white blood cells and cause immunodeficiency. If you develop an infection with symptoms such as fever accompanied by a very poor general condition, or fever with signs of local 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 provide information about the medicines you are taking at that time.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines:

Website: www.notificaRAM.es

By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Instead, return any unused medicines and their packaging to the SIGRE Point at your pharmacy. If you have any doubts, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pepticum

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

The other components are hypromellose (E-464), Eudragit L30 D (methacrylic acid – ethyl acrylate copolymer (1:1) dispersion 30 percent), triethyl citrate, talc, lactose, sodium lauryl sulfate, dibasic sodium phosphate, hydroxypropylcellulose, sucrose, and corn starch. The gelatin capsule consists of: gelatin and titanium dioxide (E-171). See section 2 Pepticum capsules contain lactose, sucrose and sodium.

Nature of the product and contents of the pack

Pepticum 40 mg capsules are presented as hard gelatin capsules with white body and cap, containing enteric-coated omeprazole granules. They are available in packs containing 14, 28 or 56 capsules of 40 mg, packaged in aluminum/aluminum blisters.

Only some pack 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 most recent revision of this leaflet: August 2024.

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