Omeprazole Pensa 20 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Omeprazol Pensa 20 mg gastro-resistant hard capsules EFG

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 and should not be given to other people, even if they have the same symptoms, as it may 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 Omeprazol Pensa is and what it is used for

2. What you need to know before taking Omeprazol Pensa

3. How to take Omeprazol Pensa

4. Possible adverse effects

   1. How to store Omeprazol Pensa

5. Contents of the pack and other information

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

Omeprazol Pensa 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.

Omeprazol Pensa 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). Omeprazol Pensa may also be used to prevent ulcers from forming 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 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 starting to take Omeprazol Pensa

Do not take Omeprazol Pensa

• if you are allergic (hypersensitive) to omeprazole or any of the other components of Omeprazol Pensa.
• 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).

If you are unsure, speak with your doctor or pharmacist before taking Omeprazol Pensa.

Warnings and precautions

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

• You lose weight significantly without reason and have difficulty swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or vomiting blood.
• Your bowel movements are black in color (blood-stained stools).
• You have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• You have severe liver problems.
• You have ever had a skin reaction after treatment with a medicine similar to Omeprazol Pensa used to reduce stomach acidity. If you develop a skin rash, especially on areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Omeprazol Pensa. Remember to mention any other symptoms you may notice, such as joint pain.
• You are scheduled to have a specific blood test (chromogranin A).
• Kidney inflammation may occur while taking omeprazole. 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. You must report these signs to your treating doctor.

If you take Omeprazol Pensa 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 each visit to your doctor.

Other medicines and Omeprazol Pensa

Inform your doctor or pharmacist if you are currently using, or have recently used, any other medicines, including those obtained without a prescription. Omeprazol Pensa may affect the action of certain medicines, and some medicines may affect Omeprazol Pensa.

Do not take Omeprazol Pensa 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 Omeprazol Pensa
• 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 Omeprazol Pensa
• 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 at high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor will need to temporarily discontinue treatment with Omeprazol Pensa.

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

Taking Omeprazol Pensa with food and drinks

You may take your capsules with food or on an empty stomach.

Pregnancy and breastfeeding

Before taking Omeprazol Pensa, inform your doctor if you are pregnant or trying to become pregnant. Your doctor will decide whether you can take Omeprazol Pensa during this time.

Your doctor will decide whether you can take Omeprazol Pensa if you are breastfeeding.

Driving and using machines

Omeprazol Pensa is unlikely to affect your ability to drive or use 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 Pensa contains sucrose

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

3. How to take Omeprazol Pensa

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult 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 your age.

The recommended doses are:

Adults:

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

• If your doctor confirms that you have mild damage to the esophagus, the usual 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 usual dose once the esophagus has healed 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 usual 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 fully heal, the dose may be increased to 40 mg once daily for 4 weeks.

Treatment of stomach ulcers (gastric ulcer):

• The usual 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 fully heal, the dose may be increased to 40 mg once daily for 8 weeks.

Prevention of recurrence of gastric and duodenal ulcers:

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

Prevention of gastric and duodenal ulcers during NSAID therapy:

• The usual dose is 20 mg once daily.

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

• The usual dose is 20 mg of Omeprazol Pensa twice daily for one week.

• Your doctor will also instruct you to take two antibiotics from the following: amoxicillin, clarithromycin, and metronidazole.

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

• The usual 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 medicine.

Children:

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

• Children over one year of age weighing more than 10 kg may take Omeprazol Pensa. 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 Pensa. The dose for children is based on body weight, and the doctor will determine the correct dose.
• Your 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 being broken down by 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 juice), or apple sauce.
  • 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 has been taken, fill the glass halfway with water, swirl it well, and drink the water. The solid particles contain the medicine; do not chew or crush them.

If you take more Omeprazol Pensa than you should

If you have taken more Omeprazol Pensa 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 ingested.

If you forget to take Omeprazol Pensa

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 everybody will experience them.

If you notice any of the following rare but serious adverse effects, stop taking Omeprazol Pensa and consult your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue or throat, or swelling of the face, skin rash, fainting, or difficulty swallowing (severe allergic reaction).
• Reddening of the skin with blistering or peeling. Severe blisters and bleeding in the lips, eyes, mouth, nose, and genitals may also occur. These could be signs of “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”.
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems.

Adverse effects may occur with certain frequencies defined as follows:

Other adverse effects are:

Frequent adverse effects

• Headache.
• Stomach or intestinal problems: diarrhoea, stomach pain, benign stomach polyps, constipation, and gas (flatulence).
• Nausea or vomiting.

Uncommon adverse effects

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Sensation of spinning (vertigo).
• Abnormalities in blood tests used to check liver function.
• Skin rash, hives, and itching.
• General malaise and lack of energy.

Rare adverse effects

• Blood disorders, such as reduced white blood cells or platelets. This may cause weakness or bruising and increase the likelihood of developing 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 cramps.
• Agitation, confusion, or depression.
• Taste disturbances.
• Visual problems, such as blurred vision.
• Sudden sensation of difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• Fungal infection known as “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

• Blood count abnormalities, such as agranulocytosis (lack of white blood cells).
• Aggressiveness.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems leading to liver failure and brain inflammation.
• Sudden onset of severe skin 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.
• Enlargement of the breasts in males.
• Low magnesium levels in the blood.

In very rare cases, Omeprazol Pensa 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 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 all medications you are taking at that time.

Adverse effects with unknown frequency

• Inflammation of the intestine (causing diarrhoea).
• If you are taking Omeprazol Pensa for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to decreased potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.

If you are taking proton pump inhibitors such as Omeprazol Pensa, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Do not be alarmed by this list of possible adverse effects. You may not experience any of them. If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Omeprazol Pensa

• Keep out of the sight and reach of children.

• Do not use Omeprazol Pensa after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

• Blister pack: Do not store above 25°C. Keep this blister pack in the original packaging.

• Bottle: No special storage conditions required. Keep the container tightly closed to protect it from moisture.

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

6. Contents of the container and other information

Composition of Omeprazol Pensa

• The active substance is omeprazole. Omeprazol Pensa capsules contain 20 mg of omeprazole.

• The other components are hypromellose, disodium phosphate dihydrate, talc, titanium dioxide (E 171), methacrylic acid copolymer, triethyl citrate, and sugar spheres (containing corn starch and sucrose). Capsule shell: titanium dioxide (E 171), water, gelatin, printing ink (containing shellac, ethyl alcohol, isopropyl alcohol, propylene glycol, n-butyl alcohol, ammonium hydroxide, potassium hydroxide, purified water, black iron oxide E-172).

Appearance of the product and contents of the container

Omeprazol Pensa capsules consist of a white body marked with "20" and a white cap marked with "OM".

Container sizes:

HDPE bottles containing 14, 28, and 56 capsules.

Blister packs containing 14, 28, and 56 capsules; clinical pack containing 504 capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Towa Pharmaceutical Europe, S.L.

C/ de Sant Martí 75-97

08107 Martorelles (Barcelona)

Spain

Date of the most recent review of this leaflet: February 2023

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