Omeprazole Cinfamed 20 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

omeprazol cinfamed 20 mg gastro-resistant hard capsules EFG

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 you should not give it to others, even if they have the same symptoms as you, because 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.

Leaflet contents

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

1. What omeprazol cinfamed is and what it is used for

omeprazol cinfamed contains the active substance omeprazol. 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 cinfamed is used to treat the following conditions:

In adults:

• "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.
• 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 a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs).
• Omeprazol 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 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 regurgitation of stomach contents into the mouth, vomiting, and poor 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 starting to take omeprazol cinfamed

Do not take omeprazol cinfamed

• 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 omeprazol if you fall into any of the above categories. If you are unsure, speak with your doctor or pharmacist before taking omeprazol.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take omeprazol cinfamed.

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

Omeprazole may mask symptoms of other conditions. Therefore, if you experience any of the following problems before starting omeprazole or during treatment, contact your doctor immediately:

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or vomiting blood.
• Black bowel movements (blood in stool).
• Severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• Severe liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to omeprazole used to reduce stomach acid.
• If you are scheduled to have a specific blood test (chromogranin A).

If you take omeprazole for a long period (more than 1 year), your doctor will likely schedule periodic check-ups. You should report any new or unusual symptoms or circumstances during each visit.

Taking a proton pump inhibitor such as omeprazole, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you 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 it may be necessary to discontinue treatment with omeprazole. Remember to mention any other symptoms you may notice, such as joint pain.

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 should report these signs to your treating doctor.

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 less than 10 kg.

Other medicines and omeprazol cinfamed

Inform 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 omeprazole may affect the way some medicines work, and some medicines may affect omeprazole.

Do not take omeprazol 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 omeprazole treatment.
• 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 omeprazole treatment.
• 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 omeprazole treatment.

If your doctor has prescribed omeprazole along with the antibiotics amoxicillin and clarithromycin 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 cinfamed with food and drinks

You may take your capsules with food or on an empty stomach (see section 3).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Omeprazole passes into breast milk, but it is unlikely to affect the infant when therapeutic doses are used.

Your doctor will decide whether you can take omeprazol during breastfeeding.

Driving and using machines

Omeprazole is unlikely to affect your ability to drive or operate 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 operate machinery.

omeprazol cinfamed contains sucrose

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

omeprazol cinfamed 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 omeprazole cinfamed

Follow exactly the instructions for using 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 to take and for how long. This will depend on your condition and your age.

The recommended dose is:

Use in adults

Treatment of GERD symptoms, 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 another 8 weeks if the esophagus has not yet healed.
• The recommended dose once the esophagus has healed is 10 mg once daily.
• If you do not have esophageal damage, the recommended 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 another 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 another 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 gastric 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 gastric 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 gastric and duodenal ulcers during NSAID treatment:

• The recommended dose is 20 mg once daily.

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

• The recommended dose is 20 mg of omeprazole 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 tumor in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is 60 mg per day.
• Your doctor will adjust the dose according to your needs and will also decide for how long you should take the medicine.

Use in children and adolescents

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

• Children over one year of age weighing more than 10 kg may take omeprazole. 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 omeprazole. 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 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.

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 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 omeprazole cinfamed than you should

If you have taken more omeprazole than prescribed by your doctor, consult your doctor or pharmacist immediately.

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, stating the medicine and the amount ingested.

If you forget to take omeprazole cinfamed

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 forgotten doses.

If you stop treatment with omeprazole cinfamed

Do not stop treatment with omeprazole 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 may cause adverse effects, although not everyone experiences 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 omeprazole and consult your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction) (rare).
• Skin redness with blistering or peeling. Severe 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 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:

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

• Headache.
• Stomach or intestinal effects: diarrhoea, stomach pain, 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 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 risk of infections.
• Low sodium levels in the blood. This may cause weakness, vomiting, and muscle cramps.
• Restlessness, confusion, or depression.
• Taste disturbances.
• Vision problems, such as blurred vision.
• Sudden shortness of breath (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 taking omeprazole 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 perform periodic blood tests to monitor your magnesium levels.
• Rash, possibly with joint pain.

In very rare cases, omeprazole may affect white blood cells and cause immunodeficiency. If you develop an infection with symptoms such as fever with a severely deteriorated 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 inform your doctor about any medication 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 side effects not listed in this leaflet. You can also report them directly via 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 omeprazole cinfamed

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 refers to the last day of the month indicated.

Blister pack: Do not store above 25°C. Keep in the original packaging to protect from moisture.

Bottle: Keep the bottle tightly closed to protect from moisture.

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

6. Contents of the pack and other information

Composition of omeprazole cinfamed

• The active substance is omeprazole. Each hard capsule contains 20 mg of omeprazole.
• The other excipients are:

Capsule contents: sugar spheres (containing maize starch and sucrose), hypromellose, disodium phosphate dihydrate, talc, titanium dioxide (E-171), methacrylic acid and ethyl acrylate copolymer (1:1) dispersion at 30% (sodium lauryl sulfate, polysorbate 80, methacrylic acid and ethyl acrylate copolymer), and triethyl citrate.

Capsule shell and cap: titanium dioxide (E-171), purified water, gelatin.

Printing ink: black 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 pack

Hard gelatin capsules with a white body printed with "20" and an opaque white cap printed with "OM", containing enteric-coated pellets.

Pack sizes:

PVC-PVDC/ALU blisters, available in packs of 14, 28, 56 and 500 (clinical pack) capsules.

HDPE bottles with screw cap and safety seal ring, available in packs of 14, 28, 56 and 500 (clinical pack) capsules.

Only some 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

TOWA PHARMACEUTICAL EUROPE S.L.

C/ Sant Martí, 75-97 – 08107 –Martorelles (Barcelona)

Spain

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Laboratorios Cinfa, S.A.

Avda. Roncesvalles, s/n

31699 Olloqui (Navarra) - Spain

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

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/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/62764/P_62764.html

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