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.
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:
Adults:
Warnings and precautions
Consult your doctor or pharmacist before starting to takeCitrel:
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).
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
-Pale appearance and feeling of weakness (anemia)
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:
because pantoprazole may increase methotrexate levels in the blood.
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:
Other side effects are:
benign polyps in the stomach.
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.
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.
disorientation
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:
increase in liver enzymes.
increase in bilirubin; increase in blood lipid levels;brusque drop in granular white blood cells in circulation, associated with high fever.
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.
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/
The average price of Citrel 20 mg comprimidos gastrorresistentes efg in July, 2025 is around 8.74 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.