Citrel 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Citrel 20 mg gastro-resistant tablets EFG

Pantoprazole

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

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

Leaflet contents:

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

1. What Citrel is and what it is used for

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

Citrel is used for:

Adults and adolescents aged 12 years and older:

• Treatment of symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, pain when swallowing) caused by reflux of acid 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 ongoing treatment with these medicines.

2. What you need to know before taking Citrel

Do not take Citrel

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

Warnings and precautions

Consult your doctor or pharmacist before taking 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 if you are on long-term treatment with pantoprazole. If liver enzymes increase, treatment should be discontinued.
• If you need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously while taking pantoprazole, as there is an increased risk of developing stomach and intestinal complications. Any increase in risk will be assessed according to personal risk factors such as age (65 years or older), history of stomach or duodenal ulcer, or gastrointestinal bleeding.
• If you have reduced body stores of vitamin B12 or risk factors for this and are receiving long-term pantoprazole treatment. Like all medicines that reduce acid levels, pantoprazole may reduce the absorption of vitamin B12.
• Consult your doctor if you are taking a medicine containing atazanavir (for treatment of HIV infection) at the same time as pantoprazole.
• Taking a proton pump inhibitor such as pantoprazole, especially for more than one 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 osteopor游戏副本

3. How to take Citrel

Follow exactly the instructions for administration of this medicine as given by your doctor. If 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 instructed you otherwise, the usual dose is:

Adults and adolescents aged 12 years and older:

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

The usual dose is one tablet daily.

This dose generally provides relief within 2–4 weeks, or at most within the following 4 weeks. Your doctor will advise you on how long you should continue taking the medicine. Subsequently, any recurring symptoms may be managed as needed by taking one tablet daily.

For long-term treatment and prevention of relapse of reflux esophagitis:

The usual dose is one tablet daily. If the disease recurs, your doctor may double your dose; in such case, you may take Pantoprazole 40 mg once daily. After healing, the dose may be reduced again to one 20 mg tablet daily.

Adults:

For prevention of duodenal and gastric ulcers in patients requiring ongoing treatment with NSAIDs:

The usual dose is one tablet daily.

Special patient groups:

• If you have severe liver problems, you should not take more than one 20 mg tablet daily.
• 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

Inform your doctor or pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. Symptoms of overdose are not known.

If you forget to take Citrel

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

If you stop taking Citrel

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

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

4. Possible adverse effects

Like all medicines, Citrel can cause adverse effects, although not everyone experiences them.

If you experience any of the following adverse effects, stop taking these tablets immediately and contact your doctor straight away, or contact the emergency department of your nearest hospital:

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

• Severe skin disorders (frequency not known; frequency cannot be estimated from available data): you may notice one or more of the following blisters on the skin and a rapid worsening of general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, particularly in areas of skin exposed to light/sun. You may also experience joint pain or flu-like symptoms, 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's 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, enlarged kidneys with occasional pain when urinating and lower back pain (severe kidney inflammation), which could possibly lead to kidney failure.

Other adverse effects include:

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

benign gastric polyps.

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

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

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

disturbance or complete loss of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; swelling in the limbs (peripheral oedema); allergic reactions; depression; enlargement of the breasts 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), sensation of tingling, pricking, numbness, burning or anaesthesia, skin rash, possibly with joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse 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 blood fats; sudden 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, which could cause bleeding or more bruising than usual; reduction in the number of white blood cells, which could lead to more frequent infections; abnormal decrease in the balance between red blood cells, white blood cells, and platelets.

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse 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 expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store in the original packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Citrel

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

The other components (excipients) are:

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

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

Appearance of the product and contents of the pack

Yellow-orange, round gastro-resistant tablet.

Packs:

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer:

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036 Madrid

Spain

or

Laboratorios Alter, S.A.

C/ Zeus, 6

Polígono Industrial R2

28880 Meco (Madrid)

Spain

Date of the most recent review of this leaflet: February 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/