Omeprazole Pensavital 20 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Omeprazol pensavital 20mg gastro-resistant hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 14 days.

Leaflet contents:

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

2. What you need to know before taking Omeprazol pensavital

3. How to take Omeprazol pensavital

4. Possible side effects

   1. Storage of Omeprazol pensavital

5. Contents of the pack and other information

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

Omeprazol pensavital 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 pensavital is indicated in adults for the short-term treatment of reflux symptoms (e.g., heartburn, acid regurgitation).

Reflux is the backflow of acid from the stomach into the esophagus, which may become inflamed and cause pain. This can lead to symptoms such as a painful burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).

You may need to take the capsules for 2–3 consecutive days to achieve symptom improvement.

You should consult your doctor if your symptoms worsen or do not improve after 14 days.

2. What you need to know before taking Omeprazol pensavital

Do not take Omeprazol pensavital

• 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).

Warnings and precautions

Talk to your doctor or pharmacist before taking Omeprazol pensavital.

Do not take Omeprazol pensavital for longer than 14 days without consulting your doctor. If you do not experience relief, or if you feel your symptoms worsen, consult your doctor.

Omeprazol pensavital may mask symptoms of other conditions. Therefore, consult your doctor immediately if you experience any of the following symptoms before starting or while taking Omeprazol pensavital:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Begin vomiting food or vomiting blood.
• Black stools (bloody stools).
• Severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
• History of gastric ulcer or gastrointestinal surgery.
• Receiving ongoing treatment for indigestion or heartburn for 4 weeks or more.
• Experiencing indigestion or heartburn continuously for 4 weeks or more.
• Have jaundice or severe liver disease.
• Are over 55 years old and your symptoms have recently changed or are new.
• Have ever had a skin reaction after treatment with a medicine similar to Omeprazol pensavital used to reduce stomach acid.
• Are scheduled to have a specific blood test (Chromogranin A).
• Kidney inflammation may occur while 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 must inform your treating doctor of such signs.

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Omeprazol pensavital. Remember to mention any other symptoms you may notice, such as joint pain.

Patients should not take omeprazole as preventive medication.

Children and adolescents

Children and adolescents under 18 years of age must not take this medicine.

Taking Omeprazol pensavital with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription. This is because Omeprazol pensavital may affect the action of some medicines, and some medicines may affect Omeprazol pensavital.

Do not take Omeprazol pensavital 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, to 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 pensavital
• 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 pensavital
• 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 discontinue treatment with Omeprazol pensavital

Taking Omeprazol pensavital with food and drink

See section 3.

Pregnancy and breastfeeding

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.

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

Driving and using machines

Omeprazol pensavital 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.

Omeprazol pensavital contains sucrose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; essentially “sodium-free”.

3. How to take Omeprazol pensavital

Follow exactly the instructions for using Omeprazol pensavital as given by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

The recommended dose is one 20 mg capsule once daily for 14 days. Contact your doctor if symptoms do not resolve after this period.

You may need to take the capsules for 2-3 consecutive days before experiencing improvement in symptoms.

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 breaking down due to stomach acid. It is important not to damage the granules. These granules contain omeprazol as the active substance and have an enteric coating that protects them and prevents breakdown as they pass through the stomach. The granules release the active substance in the intestine, where it is absorbed by the body to produce an effect.

What to do if you have difficulty swallowing the capsules

• If you 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 puree.

• Always shake the mixture well just before drinking it (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 it well, and drink it. Do not use milk or carbonated water. The solid particles contain the medicine; do not chew or crush them.

Use in children and adolescents

Children and adolescents under 18 years of age must not take this medicine.

If you take more Omeprazol pensavital than you should

If you have taken more Omeprazol pensavital 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 Omeprazol pensavital

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 one.

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 but serious adverse effects, stop taking Omeprazol pensavital and consult your doctor immediately:

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

Other adverse effects include:

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

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

Uncommon adverse effects (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Sensation of spinning (vertigo).
• Abnormal blood test results used to monitor liver function.
• Skin rash, hives and itching.
• General feeling of malaise and lack of energy.

Rare adverse effects (may affect up to 1 in 1,000 people)

• Blood disorders, such as reduced white blood cells or platelets. This may cause weakness, bruising and increased risk of 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 called "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 (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).
• Severe liver problems leading to liver failure and brain inflammation.
• Sudden appearance of severe rash, blistering or peeling of the skin. 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.

Frequency not known (cannot be estimated from available data)

• Inflammation in the intestine (causing diarrhoea).
• Hypomagnesemia.
• Skin rash, possibly with joint pain.

In very rare cases, Omeprazol pensavital may affect the white blood cells and cause immunodeficiency. If you develop an infection with symptoms such as fever accompanied by a markedly deteriorated general condition, or fever with signs of local infection such as neck, throat or mouth pain, or difficulty urinating, you should contact 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.

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 adverse effect, talk to your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You can also report them directly through 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 pensavital

• Keep out of the sight and reach of children.

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

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

• Al/Al blister: Do not store above 25°C. Keep in the original packaging to protect from moisture.

• Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Omeprazol pensavital

• The active substance is omeprazole. Omeprazol pensavital 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). See section 2. Omeprazol pensavital contains sucrose.

Appearance of the product and contents of the pack

Omeprazol pensavital 20 mg capsules consist of a white body marked with "20" and a white cap marked with "OM", containing spherical granules.

Pack sizes:

HDPE bottles containing 14 capsules.

Blister packs containing 14 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 revision of this leaflet: February 2023

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

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You may also access this information at the following URL: https://towapharmaceutical.es/prospecto2/pensavital-omeprazol-20mg-capsulas-efg/ and at the following internet address: https://cima.aemps.es/cima/dochtml/p/64477/P_64477.html