Package Insert: Information for the Patient

Citrel40 mg Gastric-Resistant Tablets EFG

Pantoprazol

Read this package insert carefully before starting to take the medication,because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experienceadverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1.What Citrel is and for what it is used

2.What you need to know before starting to take Citrel

3.How to take Citrel

4.Possible adverse effects

5. Storage of Citrel

6. Contents of the package and additional information

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

Citrel is used for:

Adults and adolescents 12 years of age and older:

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

Adults:

• Infection caused by a bacteria calledHelicobacter 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 ulcers reappearing.
• Stomach and duodenal ulcers, and
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

Do not take Citrel

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Citrel:

• If you have severe liver problems. Inform 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 liver enzyme levels increase, treatment should be interrupted.
• If you have decreased vitamin B12 reserves or risk factors for it and receive pantoprazole treatment for a long period. Like all medications that reduce acid production, pantoprazole may reduce vitamin B12 absorption.
• Consult your doctor if you are taking any medication that contains atazanavir (for HIV 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 fractures of the hip, wrist, or spine.

Inform your doctor if you have osteoporosis (reduced bone density) or if you have been told you are at risk of developing osteoporosis (for example, if you are taking corticosteroids).

• If you take pantoprazole for more than three months, you may experience a decrease in magnesium levels in the blood. Symptoms of low magnesium levels may 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 may also decrease potassium and calcium levels in the blood. Your doctor will decide to perform periodic blood tests to monitor magnesium levels.
• If you have ever had a skin reaction after treatment with a similar medication to Citrel for reducing stomach acid.
• If you experience a skin rash, especially in exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt 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 (Cromogranin A).

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

-Unintentional weight loss

-Recurring vomiting

-Difficulty swallowing

-Blood in the vomit; it mayappear as a dark brown powder in your vomit

-Blood in your stools, which may appear black or melena

-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 additional testing to rule out a malignant disease, as pantoprazole may alleviate cancer symptoms and delay diagnosis. If your symptoms persist despite treatment, further investigations will be performed.

If you take pantoprazole for a prolonged period (more than a year), your doctor may regularly monitor you. You should inform your doctor of any new or unexpected symptoms and/or events each time you attend your consultation.

Children and adolescents

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

Taking Citrel with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

Citrelmay affect the efficacy of other medications. Inform your doctor if you are taking:

• Medications such asketoconazole, itraconazole, and posaconazole (used for fungal infections) or erlotinib (used for certain types of cancer), as Citrel may make these and other medications less effective.
• Warfarinandfenprocumon, which affect blood clotting. You may need additional monitoring.
• Medications used for HIV treatment, such as atazanavir.
• Metotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer), if you are taking

metotrexate, your doctor may temporarily interrupt treatment with Citrel, as pantoprazole may increase metotrexate levels 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 insufficient data on the use of pantoprazole in pregnant women.Pantoprazole is excreted in human breast milk.If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

You should only use this medication if your doctor considers the benefits for you to be greater than the potential risk to the fetus or baby.

Driving and operating machinery

Citrel has no influence or this is insignificant on the ability to drive or operate machinery.

You should not drive or operate machinery if you experience adverse effects such as dizziness or blurred vision.

Citrelcontains sodium.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free.”

Follow exactly the administration instructions of this medication indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

When and how should you take Citrel?

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

Unless your doctor has indicated otherwise, theusual doseis:

Adults and adolescents 12 years and older:

Treatment of esophagitis by reflux

The usual dose is one tablet per day. Your doctor may indicate an increase to 2 tablets per day. The treatment time for esophagitis by reflux usually lasts between 4 and 8 weeks. Your doctor will tell you for how long you should take this medication.

Adults:

Treatment of an infection with a bacteria calledHelicobacter pyloriin patients with stomach and/or duodenal ulcer in combination with two antibiotics (eradication treatment)

One tablet twice a day plus the two antibiotic tablets, either amoxicillin, clarithromycin and metronidazole (or tinidazole),eachone must be taken twice a daywith your pantoprazole tablet. Take thefirstpantoprazole tablet 1 hour before breakfast and thesecond1 hour before dinner. Follow your doctor's instructions and make sure to read the antibiotic prospectuses.

The treatment duration is usually 1 to 2 weeks.

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 tell you for how long you should take this medication. 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.

Long-term treatment of Zollinger-Ellison Syndrome and other conditions in which there is an increase in stomach acid production

The recommended initial dose is two tablets per day.

Take the two tablets 1 hour before a meal. Your doctor may then adjust your dose, depending on the amount of stomach acid you produce. If you are prescribed more than two tablets per day, you should take the tablets divided into two times a 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 or severe liver problems,you should not take pantoprazole for the elimination ofHelicobacter pylori.

• If you havesevereliver problems, you should not take more thanone 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.

If you take more Citrel than you should

Inform your doctor or pharmacist or call the Toxicological Information Service phone 91 562 04 20, indicating the medication and the amount ingested. There are no known symptoms of overdose.

If you forgot to take Citrel

Do not take a double dose to compensate for the missed doses. Take your next dose as usual.

If you interrupt treatment with Citrel

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

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

Like all medicines, Citrel may have side effects, although not everyone will experience them.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist or contact the emergency service at 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, allergic swelling of the face (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats and excessive sweating.

• Severe skin disorders (frequency unknown; cannot be estimated from available data):)you may notice one or more of the following:blisters on the skin and a rapid deterioration in general condition, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals or skin sensitivity/eruption, particularly in areas of exposed skin to light/sun. You may also have joint pain or symptoms similar to the flu, fever, swollen lymph nodes (e.g. in the armpit) and blood tests may show changes in certain white blood cells or liver enzymes. (Stevens-Johnson syndrome, Lyell syndrome, Multiform erythema, Subacute cutaneous lupus erythematosus, Pharmacological reaction with eosinophilia and systemic symptoms (DRESS), Photosensitivity).

• Other serious conditions (frequency unknown):yellowing of the skin and the white of the eyes (severe liver cell damage, jaundice), or fever, hives, increased size of the kidneys sometimes with painful urination and lower back pain (severe kidney inflammation), possibly leading to kidney failure.

Other side effects are:

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

benign polyps in the stomach.

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

headache; dizziness; diarrhea; sensation of dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; hives on the skin, exanthema, rash; tingling; feeling of weakness, fatigue or general discomfort; sleep disturbances; hip fracture, wrist and spinal column fracture.

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

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

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

disorientation.

• Frequency unknown(cannot be estimated from available data)

hallucination, confusion (especially in patients with a history of these symptoms),sensation of tingling, pinpricks, numbness, burning or numbness, skin rash, possibly with joint pain, inflammatory bowel disease causing persistent watery diarrhea

Side effects identified through blood tests:

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

increase in liver enzymes.

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

increase in bilirubin; increase in blood lipid levels;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 could lead to bleeding or more frequent bruising; reduction in white blood cell count, which could lead to more frequent infections; abnormal reduction in the balance between red and white blood cells and platelets.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

This medication does not require special storage conditions.

Store in the original packaging.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Citrel

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

Theother components(excipients) are:

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

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

Appearance of the product and contents of the packaging

Gastro-resistant tablet of dark pink color and round shape.

Packaging:

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

Holder of the marketing authorization and Responsible for manufacturing

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Last review date of this leaflet: February 2024

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/