Citrel 20 mg comprimidos gastrorresistentes efg

Package Insert: Information for the Patient

Citrel 20 mg Gastrorresistant Tablets EFG

Pantoprazol

Read the entire package insert carefully before starting to take the medication, as it containsimportant information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse 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.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 and older:

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

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

Adults:

• Prevention of gastroduodenal ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in patients at risk who require continued treatment with this type of medication.

Do not take Citrel

• If you are allergic (hypersensitive) to pantoprazole or to any of the othercomponents ofCitrel (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 takeCitrel:

• 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 need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously and take pantoprazole, as there is a higher risk of developing complications in the stomach and intestine. Any increased risk will be assessed based on individual risk factors such as age (65 years or older), history of stomach or duodenal ulcers or gastrointestinal bleeding.
• If you have decreased vitamin B12 reserves or risk factors for it and receive treatment with pantoprazole for a long period of time. Like all acid-reducing medications, pantoprazole may reduce vitamin B12 absorption.
• Consult your doctor if you are taking any medication containing atazanavir (for HIV treatment) at the same time as pantoprazole.
• Long-term use of 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 (e.g., if you are taking corticosteroids).

• If you take pantoprazole for more than three months, you may experience a decrease in magnesium levels in your 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 can also cause a decrease in potassium and calcium levels in the blood. Your doctor will decide to perform regular 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 sun-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 immediately if you notice any of the following symptoms:

-Unintentional weight loss

-Recurring vomiting

-Difficulty swallowing

-Blood in your 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
• Abdominal 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 tests to rule out a malignant disease, as pantoprazole may alleviate cancer symptoms and potentially 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 monitor you regularly. You should inform your doctor of any new or unexpected symptoms and/or events each time you attend your appointment.

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

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.

Citrel may affect the efficacy of other medications, 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 medications not work correctly.
• Warfarin and fenprocumon, which affect blood clotting. 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 interrupt treatment with Anagastra

because pantoprazole may increase methotrexate 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 or breastfeeding, or think you may be pregnant or plan to become 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

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

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

Citrel contains sodium.

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

Follow exactly the administration instructions of this medication as 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 hour before a meal.

Unless your doctor has indicated otherwise, theusual doseis:

Adults and adolescents 12 years and older:

For treating symptoms associated with gastroesophageal reflux disease(heartburn, acid regurgitation, difficulty swallowing)

The usual dose is 1 tablet per day.

This dose usually provides relief within 2-4 weeks, and if not, within a maximum of 4 weeks. Your doctor will tell you how long you should continue taking the medication. Subsequently, any recurring symptoms can be controlled as needed by taking1 tablet per day.

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

The usual dose is 1 tablet per day. If the disease recurs, your doctor may double the dose, in which case you can take Pantoprazol 40 mg,onceper day. After recovery, you can reduce the dose again to1 tabletof 20 mg per day.

Adults:

For preventing duodenal and stomach ulcers in patients requiring long-term treatment with NSAIDs

The usual dose is 1 tablet per day.

Special patient groups:

- If you have severe liver problems,do not take more than1 tablet of 20 mg per day.

-Children under 12 years:This medication is not recommended for 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. No symptoms of overdose are known.

If you forget 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 tabletswithout consulting your doctor or pharmacist first.

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

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

If you experience any of the following side effects, stop taking these tablets and inform your doctor immediately, 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, swelling of the face due to an allergic reaction (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats, and excessive sweating.

• Severe skin changes (frequency unknown; cannot be estimated from available data): you may notice one or more of the followingblistering on the skin and a rapid deterioration of general conditions, erosion (including light bleeding) of eyes, nose, mouth/lips, or genitalsor 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, Multiforme erythema, Acute 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 kidney size with occasional pain while urinating, and lower back pain (severe kidney inflammation),possibly causing 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; swelling 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 fracture, and spinal column fracture.

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

alterationor complete loss of taste;vision changes 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, pinching, 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;brusque drop in granular white blood cells in circulation, associated with high fever.

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

reduction in the number of platelets that could cause bleeding or more frequent bruising; reduction in the number of white blood cells that could lead to more frequent infections;abnormal reduction in the balance between the number of red and white blood cells, as well as platelets.

• Frequency unknown(cannot be estimated from available data) reduction in the level of sodium, magnesium, calcium, or potassium 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 that does not appear in this leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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.

Store in the original packaging.

Medicines should not be disposed of through drains or trash. Dispose of packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Citrel

The active ingredient is pantoprazole.Each gastro-resistant tablet contains 20 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 content of the packaging

Gastro-resistant tablet of yellow-orange 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 on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/