Omeprazole Cinfalab 20 mg gastro-resistant hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Omeprazol cinfalab 20 mg gastro-resistant hard capsules

Omeprazole

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

Always follow exactly the instructions for use of this medicine as described in this leaflet or as given by your doctor or pharmacist.

• Keep this leaflet. You may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any 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 your condition worsens or if you do not improve after 14 days.

Contents of this leaflet

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

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

Omeprazol cinfalab 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 cinfalab is indicated in adults for short-term treatment of reflux symptoms (for example, 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 before experiencing symptom improvement.

Consult a doctor if your symptoms worsen or do not improve after 14 days.

2. What you need to know before taking Omeprazol cinfalab

Do not take Omeprazol cinfalab

• 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, rabeprazol, esomeprazole).
• if you are taking a medicine containing nelfinavir (used for HIV infection).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Omeprazol cinfalab.

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

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

• Unexplained significant weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• New onset of vomiting food or vomiting blood.
• Black stools (bloody stools).
• Severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• A 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 cinfalab used to reduce stomach acid.
• Are scheduled to have a specific blood test (Chromogranin A).

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 cinfalab. Remember to mention any other symptoms you may notice, such as joint pain.

Patients should not take omeprazole as preventive medication.

When taking omeprazole, kidney inflammation may occur. 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 should report these signs to your treating doctor.

Children and adolescents

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

Other medicines and Omeprazol cinfalab

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 cinfalab may affect the action of some medicines and some medicines may affect Omeprazol cinfalab.

Do not take Omeprazol cinfalab 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, posaconazole, itraconazole, 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 cinfalab.
• 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 omeprazole.
• 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 (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 Omeprazol cinfalab.

Taking Omeprazol cinfalab 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 cinfalab while breastfeeding.

Driving and using machines

Omeprazol cinfalab 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 cinfalab contains sucrose

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Omeprazol cinfalab contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; therefore, it is essentially "sodium-free".

3. How to take Omeprazol cinfalab

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

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 symptom improvement.

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 designed to prevent the medicine from breaking down under the action of stomach acid. It is important not to damage the granules. These granules contain omeprazole as the active substance and are enteric-coated to protect them and prevent 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 its 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), or apple sauce.

• 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, refill 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 cinfalab than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Omeprazol cinfalab

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 forgotten doses.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets them.

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

• Sudden wheezing, swelling of the lips, tongue or throat, 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. This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”.
• Yellowing of the skin, dark urine, and tiredness, which may be symptoms of liver problems.

Other adverse effects are:

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

• Headache.
• Stomach or intestinal effects: diarrhoea, stomach pain, constipation, and 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.
• 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 (may affect up to 1 in 1,000 people)

• Blood problems, such as reduced white blood cells or platelets. This may cause weakness or bruising and increase the likelihood 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.
• Restlessness, confusion, or depression.
• Taste disturbances.
• Visual problems, such as blurred vision.
• Sudden sensation of shortness of breath (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 tiredness.
• 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.
• Sudden onset of severe 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.

Frequency not known (cannot be estimated from available data)

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

In very rare cases, Omeprazol cinfalab may affect the white blood cells and cause immunodeficiency. If you develop an infection with symptoms such as fever with 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.

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 a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Omeprazol cinfalab

Keep this medicine out of sight and reach of children.

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

Al/Al blister: Store below 30°C. Keep in the original packaging to protect from moisture.

PVC-PVDC/Al blister: Store below 25°C. Keep in the original packaging to protect from moisture.

Bottle: This medicine does not require any special storage conditions. Keep the bottle tightly closed to protect from moisture.

Validity period after first opening of the bottle: 100 days.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Omeprazol Cinfalab

• The active substance is omeprazole. Each hard capsule contains 20 mg of omeprazole.
• The other components are: sugar spheres (sucrose and corn starch), hypromellose, talc, titanium dioxide (E-171), sodium hydrogen phosphate dihydrate, methacrylic acid and ethyl acrylate copolymer (1:1) dispersion, 30% (sodium lauryl sulfate, polysorbate 80 and methacrylic acid and ethyl acrylate copolymer), triethyl citrate.
  Hard gelatin capsule: Body and cap: gelatin and titanium dioxide (E-171).
  Printing ink: black ink (shellac, propylene glycol, potassium hydroxide and black iron oxide (E-172)).

Nature of the product and contents of the container

White, opaque hard gelatin capsules (size #3), marked with "OM" on the cap and "20" on the body, containing spherical pellets.

Presented in white HDPE bottles with closure and security ring equipped with a desiccant. Each container contains 7 or 14 capsules.

Presented in Alu/Alu blisters. Each container contains 7 or 14 capsules.

Presented in PVC-PVDC/Alu blisters. Each container contains 7 or 14 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain

or

TOWA PHARMACEUTICAL EUROPE S.L.
C/ de Sant Martí, 75-97, Martorelles, 08107 Barcelona, Spain

Date of the most recent revision of this leaflet: March 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/.