OMEPRAZOL CINFAMED 20 mg HARD GASTRORESISTENT CAPSULES

Introduction

Package Leaflet: Information for the User

omeprazole cinfamed 20 mg hard gastro-resistant capsules EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

omeprazole cinfamed 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.

omeprazole cinfamed is used to treat the following conditions:

In adults:

• “Gastro-oesophageal reflux disease” (GORD). In this condition, acid from the stomach escapes into the gullet (the tube which connects the throat to the stomach), causing pain, inflammation and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcers) or in the stomach (gastric ulcers).
• Ulcers which are 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 non-steroidal anti-inflammatory drugs (NSAIDs). omeprazole cinfamed may also be used to prevent ulcers if you are taking NSAIDs.
• Too much acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and ≥ 10 kg

• “Gastro-oesophageal reflux disease” (GORD). In this condition, acid from the stomach escapes into the gullet (the tube which connects the throat to the stomach), causing pain, inflammation and heartburn. In children, the symptoms of the disease can include the return of stomach contents into the mouth (regurgitation), vomiting and insufficient weight gain.

Children over 4 years of age and adolescents

Ulcers caused by 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 you take omeprazole cinfamed

Do not take omeprazole cinfamed

• If you are allergic to omeprazole or 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 to treat HIV infection).
• Do not take omeprazole cinfamed if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking omeprazole cinfamed.

Warnings and precautions

Tell your doctor or pharmacist before taking omeprazole cinfamed:

Serious skin reactions have been reported with omeprazole, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). Stop taking omeprazole and tell your doctor immediately if you experience any of these symptoms.

omeprazole may hide the symptoms of other diseases. Therefore, if you experience any of the following before or while taking omeprazole, tell your doctor immediately:

• Losing a lot of weight without reason and having trouble swallowing.
• Having stomach pain or indigestion.
• Starting to vomit food or vomit blood.
• Having black stools (faeces stained with blood).
• If you have severe or persistent diarrhoea, as omeprazole has been associated with a slightly increased risk of infectious diarrhoea.
• Having severe liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to omeprazole to reduce stomach acid.
• If you are due to have a specific blood test (Chromogranin A).

If you take omeprazole for a long period of time (more than 1 year), your doctor will probably keep you under regular surveillance. You should report any new or unusual symptoms to your doctor whenever you visit them.

Taking a proton pump inhibitor like omeprazole, especially over a period of more than one year, may slightly increase the risk of fracture of the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you get a rash on your skin, especially in areas exposed to the sun, tell your doctor as soon as possible, as you may need to stop taking omeprazole. Remember to also mention any other symptoms that you may notice, such as joint pain.

When taking omeprazole, kidney inflammation can occur. The signs and symptoms may include decreased urine output or blood in the urine and/or hypersensitivity reactions such as fever, rash and joint stiffness. You should inform your doctor of these signs.

Children

Some children with chronic diseases 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 omeprazole cinfamed

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription. This is because omeprazole can affect the way some medicines work and some medicines can affect the way omeprazole works.

Do not take omeprazole cinfamed if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Tell 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 for 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 you start or stop taking omeprazole.
• Medicines used to prevent blood clots, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when you start or stop taking omeprazole.
• Rifampicin (used to treat tuberculosis).
• Atazanavir (used to treat HIV infection).
• Tacrolimus (in cases of 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 high doses of methotrexate, your doctor may need to temporarily stop your treatment with omeprazole.

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

Taking omeprazole cinfamed with food and drink

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. omeprazole passes into breast milk but it is unlikely to affect the baby at doses used to treat acid-related diseases.

Your doctor will decide whether you can take omeprazole cinfamed during breast-feeding.

Driving and using machines

omeprazole is unlikely to affect your ability to drive or use any tools or machines. However, side effects such as dizziness and blurred vision (see section 4) may occur. If affected, you should not drive or operate machinery.

omeprazole cinfamed contains sucrose

This medicine contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

omeprazole cinfamed contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per capsule, i.e. it is essentially “sodium-free”.

3. How to take omeprazole cinfamed

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how many capsules to take and for how long.

The recommended dose is:

Adults

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

• If your doctor confirms that you have mild oesophageal damage, the recommended dose is 20 mg once daily for 4-8 weeks. Your doctor may then prescribe a dose of 40 mg for another 8 weeks if the oesophagus has not yet healed.
• The recommended dose once the oesophagus has healed is 10 mg once daily.
• If you do not have oesophageal damage, the recommended dose is 10 mg once daily.

Treatment of duodenal ulcers:

• The recommended dose is 20 mg once daily for 2 weeks. Your doctor may then prescribe the same dose for another 2 weeks if the ulcer has not yet healed.
• If the ulcer does not heal, the dose may be increased to 40 mg once daily for 4 weeks.

Treatment of gastric ulcers:

• The recommended dose is 20 mg once daily for 4 weeks. Your doctor may then prescribe the same dose for another 4 weeks if the ulcer has not yet healed.
• If the ulcer does not heal, the dose may be increased to 40 mg once daily for 8 weeks.

Preventionof duodenal and gastric 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 duodenal and gastric ulcers caused by NSAIDs:

• The recommended dose is 20 mg once daily for 4-8 weeks.

Prevention of duodenal and gastric ulcersduring NSAID therapy:

• The recommended dose is 20 mg once daily

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of their recurrence:

• The recommended dose is 20 mg of omeprazole twice daily for one week.
• Your doctor will also prescribe two antibiotics, amoxicillin and clarithromycin.

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

• The recommended dose is 60 mg daily.
• Your doctor will adjust the dose according to your needs and decide how long you need to take the medicine.

Children and adolescents

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

• Children over 1 year of age who weigh more than 10 kg can take omeprazole. The dose for children is based on their body weight and your doctor will decide the correct dose.

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of their recurrence:

• Children over 4 years of age can take omeprazole. The dose for children is based on their body weight and your doctor will decide the correct dose.
• Your doctor will also prescribe two antibiotics, amoxicillin and clarithromycin, for your child.

How to take this medicine

• It is recommended to take the capsules in the morning.
• You can 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 which prevent the medicine from being broken down by the acid in the stomach. It is important not to damage the granules.

What to do if you or your child have trouble swallowing the capsules

• If you or your child have trouble 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, a glass of acidic fruit juice (e.g. apple, orange or pineapple) or apple sauce.
• Always stir the mixture just before drinking it (the mixture will not be clear). Drink the mixture immediately or within 30 minutes.
• To make sure that you have taken all the medicine, fill the glass with water, rinse it well and drink the water. The solid parts 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 your doctor prescribed, contact your doctor or pharmacist immediately.

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

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 a forgotten dose.

If you stop taking omeprazole cinfamed

Do not stop taking omeprazole cinfamed without first talking to your doctor or pharmacist.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from 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 adverse effects, stop taking omeprazole and consult your doctor immediately:

• Sudden whistling when breathing (sudden wheezing), swelling of the lips, tongue, and throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction) (rare).
• Redness of the skin with blistering or peeling. Intense blisters and bleeding on the lips, eyes, mouth, nose, and genitals may also appear. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis" (very rare).
• Widespread rash, high body temperature, and inflammation of the lymph nodes (DRESS or drug hypersensitivity syndrome) (rare).
• A red, scaly, and widespread rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis) (rare).
• Yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver problems (rare).

Other adverse effects are:

Common Adverse Effects (may affect up to 1 in 10 people)

• Headache.
• Effects on the stomach or intestine: diarrhea, 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 that everything is spinning (vertigo).
• Abnormal liver function tests.
• 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 decreased white blood cells or platelets. This can cause weakness or bruising and increase the risk of infection.
• Low sodium levels in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Taste disturbances.
• Visual problems, such as blurred vision.
• Sudden difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation of the mouth.
• Candidiasis, an infection that can affect the intestine and is caused by a fungus.
• Hair loss (alopecia).
• Skin rash when exposed to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very Rare Adverse Effects (may affect up to 1 in 10,000 people)

• Abnormal blood counts, such as agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems that can cause liver failure and brain inflammation.
• Erythema multiforme.
• Muscle weakness.
• Increased breast size in men.

Frequency Not Known (cannot be estimated from available data)

• Inflammation of the intestine (causing diarrhea).
• If you are taking omeprazole for more than three months, your magnesium levels in the blood may decrease. Low magnesium levels can manifest as fatigue, muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform periodic tests to monitor your magnesium levels.
• Rash, possibly with joint pain.

In very rare cases, omeprazole can affect the white blood cells and cause immunodeficiency. If you have an infection with symptoms such as fever with a severely deteriorated general condition or fever with symptoms of local infection, such as neck, throat, or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to perform a blood test and rule out a lack of white blood cells (agranulocytosis). It is essential to provide information about the medication you are taking at that time.

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that do not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

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

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Omeprazole Cinfamed

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

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

Capsule Body and Cap:titanium dioxide (E-171), purified water, gelatin.

Printing Ink:black printing ink (containing Shellac, ethanol, isopropanol, propylene glycol, n-butyl alcohol, ammonium hydroxide, potassium hydroxide, purified water, black iron oxide (E-172)).

Appearance of the Product and Package Contents

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

Package sizes:

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

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

Not all package 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 Last Revision of this Leaflet:March 2023

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

QR code to: https://cima.aemps.es/cima/dochtml/p/62764/P_62764.html