CITREL 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

Citrel 20 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. Storing Citrel
6. Contents of the pack and other 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:

• Treatment of symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, pain when swallowing) caused by acid reflux from the stomach.

• Long-term treatment and prevention of relapses of reflux esophagitis (inflammation of the esophagus accompanied by acid regurgitation from the stomach).

Adults:

• Prevention of gastroduodenal ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen) in patients at risk who require continued treatment with these types of drugs.

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 ingredients 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

Consult your doctor or pharmacist before starting to take Citrel:

• If you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor will perform more frequent monitoring of liver enzymes, especially when you are on long-term treatment with pantoprazole. In case of an increase in liver enzymes, treatment should be discontinued.
• If you need to take medicines called NSAIDs continuously and take pantoprazole, as there is a greater risk of developing complications in the stomach and intestine. Any increased risk will be assessed according to your personal risk factors such as age (65 years or older), history of stomach or duodenal ulcers or bleeding from the stomach or intestine.
• If you have decreased body stores 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.
• Consult your doctor if you are taking any medicine that contains atazanavir (for the treatment of HIV infection) at the same time as pantoprazole.
• Taking a proton pump inhibitor like pantoprazole, especially for more than a year, may increase the risk of fractures of the hip, wrist, or spine.

Inform 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 experience any of these symptoms, inform your doctor immediately. Low magnesium levels can lead to 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 suffer from a skin rash, especially in areas exposed to the sun, consult your doctor as soon as possible, as it may be necessary to discontinue 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 brown powder 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 if you need any additional tests to rule out a malignant disease because 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 may perform regular follow-up. You should inform your doctor of any symptoms and/or new or unexpected events each time you visit your doctor.

Children and adolescents

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

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. Inform 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 make these and other medicines not work properly.
• Warfarin and phenprocoumon, which affect blood coagulation. You may need additional tests.
• 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 interrupt treatment with Anagastra because pantoprazole may increase methotrexate levels in your blood.

due to the fact that pantoprazole may increase the levels of methotrexate in the blood.

• Fluvoxamine (used to treat depression and other psychiatric disorders). If you are taking fluvoxamine, your doctor may reduce your dose.
• Rifampicin (used to treat infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

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 exactly as 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 usual dose is:

Adults and adolescents from 12 years:

To treat symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, pain when swallowing)

The usual dose is one tablet per day.

This dose usually provides relief within 2-4 weeks, and if not, within the following 4 weeks. Your doctor will indicate how long you should continue taking the medicine. Subsequently, any recurring symptoms can be controlled by taking one tablet per day as needed.

For long-term treatment and prevention of relapses of reflux esophagitis

The usual dose is one tablet per day. If the disease recurs, your doctor may double the dose, in which case you can take Pantoprazole 40 mg once a day. After healing, you can reduce the dose back to one 20 mg tablet per day.

Adults:

For the prevention of duodenal and stomach ulcers in patients who require continued treatment with NSAIDs

The usual dose is one tablet per day.

Special patient groups:

• If you have severe liver problems, you should not take more than one 20 mg tablet per day.
• Children under 12 years: The use of these tablets is not recommended in children under 12 years.

If you take more Citrel than you should

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

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 experience any of the following side effects, stop taking these tablets and inform your doctor immediately, 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, rash (urticaria), difficulty breathing, swelling of the face of allergic origin (angioedema), severe dizziness with rapid heartbeat and excessive sweating.

• Severe skin reactions (frequency not known; 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/reaction, particularly in areas of skin exposed to light/sun. You may also experience 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 serious conditions (frequency not known): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increased kidney size with occasional pain when urinating, and lower back pain (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; fractures of the hip, wrist, and spine.

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

alteration or complete loss of taste; vision disturbances such as blurred vision; urticaria; 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)

hallucination, confusion (especially in patients with a history of these symptoms), tingling, pinching, numbness, burning sensation, or numbness, 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 blood fat levels; sudden drop in white blood cells, 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 side effects 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. Storing 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 EXP. The expiration date is the last day of the month indicated.

Store in the original packaging.

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

6. Contents of the pack and other information

Citrel composition

The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).

The other ingredients (excipients) are:

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

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

Appearance of the product and packaging contents

Gastro-resistant tablet, yellow-orange in color, and round in shape.

Packaging:

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

Marketing authorization holder and manufacturer

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid.

Spain

Date of last revision of this leaflet: February 2024

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