CITREL 40 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

Citrel40 mg Gastro-Resistant Tablets EFG

Pantoprazole

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 and other information:

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

1. What is Citrel and what is it used for

Citrel is a selective inhibitor of the "proton pump", a medicine that reduces the amount of acid produced in your stomach. It is used for the treatment of diseases related to stomach and intestine acid.

Citrel is used for:

Adults and adolescents from 12 years:

• Reflux esophagitis. It is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by acid reflux from the stomach.

Adults:

• Infection with a bacterium called Helicobacter pyloriin patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment). The goal is to get rid of the bacteria and thus reduce the likelihood of ulcer recurrence.
• Stomach and duodenal ulcers, and
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

2. What you need to know before you take Citrel

Do not take Citrel

• If you are allergic (hypersensitive) to pantoprazole or any of the other components of Citrel (see section 6).
• If you are allergic to medicines that contain other proton pump inhibitors (e.g., omeprazole, lansoprazole, rabeprazole, esomeprazole).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start taking Citrel:

• If you have severe liver problems. Tell your doctor if you have ever had liver problems. Your doctor will monitor your liver enzymes more frequently, especially when you are on long-term treatment with pantoprazole. If there is an increase in liver enzymes, treatment should be discontinued.
• If you have decreased body reserves of vitamin B12 or risk factors for it and receive long-term treatment with pantoprazole. Like all medicines that reduce acid, pantoprazole may reduce the absorption of vitamin B12.
• Talk to your doctor if you are taking any medicine that contains atazanavir (for HIV infection treatment) at the same time as pantoprazole.
• Taking a proton pump inhibitor like pantoprazole, especially for more than a year, may increase the risk of hip, wrist, or spine fractures.

Tell your doctor if you have osteoporosis (reduced bone density) or if you have been told that you are at risk of osteoporosis (e.g., if you are taking corticosteroids).

• If you take pantoprazole for more than three months, you may suffer from a decrease in magnesium levels in your blood. Symptoms of low magnesium levels can include fatigue, involuntary muscle contractions, disorientation, dizziness, or increased heart rate. If you have any of these symptoms, tell your doctor immediately. Low magnesium levels can cause a decrease in potassium and calcium levels in your blood. Your doctor will decide whether to perform periodic blood tests to monitor magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to Citrel to reduce stomach acid.
• If you get a skin rash, especially in areas of skin exposed to the sun, talk to your doctor as soon as possible, as it may be necessary to stop treatment with Citrel. Remember to mention any other symptoms you may notice, such as joint pain.
• If you are scheduled to have a specific blood test (Chromogranin A)

Tell your doctor immediatelyif you notice any of the following symptoms:

• unintentional weight loss
• repeated vomiting
• difficulty swallowing
• blood in your vomit; it may appear as a dark coffee grounds-like substance in your vomit
• blood in your stools, which may appear black or tarry
• difficulty swallowing, or pain when swallowing
• pale appearance and feeling of weakness (anemia)
  • chest pain
  • stomach pain

• severe or persistent diarrhea, as pantoprazole has been associated with a small increase in infectious diarrhea.

Your doctor will decide whether you need any additional tests to rule out a malignant disease, as pantoprazole may alleviate the symptoms of cancer and could delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

If you take pantoprazole for a prolonged period (more than a year), your doctor will probably monitor you regularly. You should tell your doctor about any symptoms and/or new or unexpected events each time you visit your doctor.

Children and adolescents

The use of Citrel is not recommended in children, as it has not been tested in children under 12 years of age.

Taking Citrel with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Citrel may affect the efficacy of other medicines. Tell your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as Citrel may cause these and other medicines to not work properly.
• Warfarin and phenprocoumon, which affect blood coagulation. You may need additional monitoring.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily stop treatment with Citrel, as pantoprazole may increase methotrexate levels in your blood.

Pregnancy and breastfeeding

There is not enough data on the use of pantoprazole in pregnant women. It has been reported that in humans, pantoprazole is excreted in breast milk. 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.

You should only use this medicine if your doctor considers that the benefit to you is greater than the potential risk to the fetus or baby.

Driving and using machines

Citrel has no influence or negligible influence on the ability to drive or use machines.

You should not drive or use machines if you experience side effects such as dizziness or blurred vision.

Citrel contains sodium.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Citrel

Follow the instructions for administration of this medicine indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again.

When and how should you take Citrel?

Take the tablets whole, without chewing or crushing, with a little water, 1 hour before a meal.

Unless your doctor has indicated otherwise, the normal dose is:

Adults and adolescents from 12 years:

For the treatment of reflux esophagitis

The usual dose is one tablet per day. Your doctor may indicate an increase to two tablets per day. The treatment time for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will indicate how long you should take this medicine.

Adults:

For the treatment of an infection with a bacterium calledHelicobacter pyloriin patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment)

One tablet twice a day plus the two antibiotic tablets, either amoxicillin, clarithromycin, and metronidazole (or tinidazole), each taken twice a day with your pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second 1 hour before dinner. Follow your doctor's instructions and make sure to read the package inserts of the antibiotics.

The normal treatment duration is usually one to two weeks.

For the treatment of stomach and duodenal ulcers

The usual dose is one tablet per day. The dose may be doubled by your doctor.

Your doctor will indicate how long you should take this medicine. The treatment duration for stomach ulcers is usually between 4 and 8 weeks. The treatment duration for duodenal ulcers is usually between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions in which there is an increase in stomach acid secretion

The recommended initial dose is two tablets per day.

Take the two tablets 1 hour before a meal. Later, your doctor may adjust the dose, depending on the amount of acid secretion you produce. If you are prescribed more than two tablets per day, you should take the tablets divided into two doses per day.

If you are prescribed more than four tablets per day, you will be told exactly when to stop treatment.

Special patient groups

• If you have kidney problems or moderate to severe liver problems, you should not take pantoprazole for Helicobacter pylorieradication.

• If you have severe liver problems, you should not take more than one 20 mg pantoprazole tablet per day (for this case, 20 mg pantoprazole tablets are available).

• Children (under 12 years): the use of these tablets is not recommended in children under 12 years of age.

If you take more Citrel than you should

Tell your doctor or pharmacist or call the Toxicology Information Service telephone 91 562 04 20, indicating the medicine and the amount taken. There are no known symptoms of overdose.

If you forget to take Citrel

Do not take a double dose to make up for forgotten doses. Take your next dose as usual.

If you stop taking Citrel

Do not stop taking these tablets without consulting your doctor or pharmacist first.

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

4. Possible side effects

Like all medicines, Citrel can cause side effects, although not everybody gets them.

If you think any of the side effects you are experiencing is serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist or contact the emergency department of the nearest hospital.

• Severe allergic reactions (rare;may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, swelling of the face of allergic origin (Quincke's edema/angioedema), severe dizziness with very rapid heartbeats and excessive sweating.

• Severe skin reactions (frequency not known;frequency cannot be estimated from available data):you may notice one or more of the following blisters on the skin and rapid deterioration of general conditions, erosion (including slight bleeding) of eyes, nose, mouth/lips, or genitals, or sensitivity/skin rash, particularly in areas of skin exposed to light/sun. You may also have joint pain or symptoms similar to those of the flu, fever, swollen glands (e.g., in the armpit), and blood tests may show changes in certain white blood cells or liver enzymes. (Stevens-Johnson syndrome, Lyell syndrome, Erythema Multiforme, Subacute Cutaneous Lupus Erythematosus, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Photosensitivity).

• Other severe conditions (frequency not known):yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increased kidney size, sometimes with pain when urinating, and pain in the lower back (severe kidney inflammation), which may lead to kidney failure.

Other side effects are:

• Common(may affect up to 1 in 10 patients)

benign stomach polyps.

• Uncommon(may affect up to 1 in 100 patients)

headache; dizziness; diarrhea; feeling of dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; tingling; feeling of weakness, fatigue, or general malaise; sleep disturbances; hip, wrist, and spine fractures.

• Rare(may affect up to 1 in 1,000 patients)

alteration or complete loss of taste; vision disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; swelling in the limbs (peripheral edema); allergic reactions; depression; breast enlargement in men.

• Very rare(may affect up to 1 in 10,000 patients)

disorientation.

• Frequency not known(cannot be estimated from available data)

hallucinations, confusion (especially in patients with a history of these symptoms), tingling, pinching, numbness, burning sensation, or tingling, skin rash, possibly with joint pain, inflammation of the large intestine that causes persistent watery diarrhea

Side effects identified through blood tests:

• Uncommon(may affect up to 1 in 100 patients)

increased liver enzymes.

• Rare(may affect up to 1 in 1,000 patients)

increased bilirubin; increased levels of fat in the blood; sudden drop in granulocytes in the circulation, associated with high fever.

• Very rare(may affect up to 1 in 10,000 patients)

reduction in platelet count, which may cause bleeding or more bruising than usual; reduction in white blood cell count, which may lead to more frequent infections; abnormal reduction in the balance between red and white blood cell count, as well as platelets.

• Frequency not known(cannot be estimated from available data) decrease in sodium, magnesium, calcium, or potassium levels in the blood (see section 2).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Citrel

Keep this medicine out of the sight and reach of children.

Do not use Citrel after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Store in the original packaging.

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

6. Packaging Content and Additional Information

Citrel Composition

The active ingredient is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (in the form of sodium sesquihydrate).

The other components (excipients) are:

Core: mannitol (E-421), sodium carbonate, pregelatinized corn starch, crospovidone, calcium stearate.

Coating: hypromellose, glycerol triacetate, titanium dioxide, methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion, talc, triethyl citrate, red iron oxide (E-172), yellow iron oxide (E-172).

Product Appearance and Packaging Content

Dark pink, round, gastro-resistant tablet.

Packaging:

Each package contains 28 or 56 gastro-resistant tablets in a Poliamida/Al/PVC-Al blister pack.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Date of the Last Revision of this Leaflet: February 2024

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