Prospect: information for the user

Pantoprazol Qualigen 20 mg gastro-resistant tablets EFG

Read this prospect carefully before starting to take the medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to other people, 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 prospect. See section 4.

1.Pantoprazol Qualigen and its use

2.What you need to know beforestartingtotake Pantoprazol Qualigen

3.How to take Pantoprazol Qualigen

4.Possible adverse effects

5.Storage of Pantoprazol Qualigen

6.Contents of the package and additional information

Pantoprazol 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 and intestinal acid.

Pantoprazol 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 recurrence 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 Pantoprazol Qualigen

• If you are allergic (hypersensitive) to pantoprazole or to any of the othercomponents ofthis medicine(including in thesection 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 Pantoprazol Qualigen:

• Si usted padece problemasgravesde hígado. Comunique a su médico si alguna vez ha tenido problemas en el hígado. Su médico le realizará un seguimiento más frecuente de las enzimas hepáticas,especialmente cuando esté en tratamiento a largo plazo con pantoprazol. En caso de un aumento de las enzimas del hígado el tratamiento deberá interrumpirse.
• Si necesita tomar medicamentos de los llamados AINEs continuamente y toma pantoprazol, ya que existe mayor riesgo de desarrollar complicaciones en el estómago e intestino. Cualquier incremento del riesgo se valorará conforme a los factores personales de riesgo tales como la edad (65 años o mayores), antecedentes de úlcera de estómago o duodeno o hemorragia de estómago o intestino.
• Si usted tiene reservas corporales de vitamina B12 disminuidas o factores de riesgo para ello y recibe tratamiento con pantoprazol durante un largo periodo de tiempo. Como todos los medicamentos que reducen la cantidad de ácido, pantoprazol podría reducir la absorción de vitamina B12.
• Consulte a su médico si usted está tomando algún medicamento que contenga atazanavir (para el tratamiento por infección de VIH) al mismo tiempo que pantoprazol.
• Si está tomando inhibidores de la bomba de protones como pantoprazol , especialmente durante un periodo de más de un año puede aumentar ligeramente el riesgo de fractura de cadera, muñeca y columna vertebral. Informe a su médico si tiene osteoporosis o si está tomando corticosteroides (pueden incrementar el riesgo de osteoporosis).
• Si toma pantoprazol durante más de tres meses, es posible que sufra una disminución de losniveles de magnesio en sangre. Los síntomas de unos niveles bajos de magnesio pueden incluirfatiga, contracciones musculares involuntarias, desorientación, mareo o aumento del ritmocardíaco. Si tiene alguno de estos síntomas, comuníqueselo a su médico inmediatamente.Además, niveles bajos de magnesio pueden producir una disminución de los niveles de potasio ycalcio en sangre. Su médico decidirá realizar análisis de sangre periódicos para controlar los niveles de magnesio.
• Si alguna vez ha tenido una reacción en la piel después del tratamiento con un medicamento similar a pantoprazol para reducir la acidez de estómago.
• Está previsto que le realicen un análisis específico de sangre (Cromogranina A)

Si sufre una erupción cutánea, especialmente en zonas de la piel expuestas al sol, consulte a su médico lo antes posible, ya que puede ser necesario interrumpir el tratamiento con pantoprazol. Recuerde mencionar cualquier otro síntoma que pueda notar, como dolor en las articulaciones.

Comunique inmediatamente a su médicosi nota cualquiera de los siguientes síntomas:

-unintentional weight loss

-repeated vomiting

-difficulty swallowing

-blood in the vomit

-pale appearance and feeling of weakness (anemia)

• blood in your stools
• severe or persistent diarrhea, as pantoprazol 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, as pantoprazol may alleviate the symptoms of cancer and potentially delay its diagnosis. If your symptoms persist despite treatment, further investigations will be performed.

If you take pantoprazol for a prolonged period (more than one 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.

Other medicines and Pantoprazol Qualigen

Pantoprazol may affect the efficacy of other medicines, so inform your doctor if you are taking,

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as pantoprazol may make these and other medicines not work correctly.
• Warfarin and fenprocoumon, which affect blood clotting. You may need additional monitoring.
• Atazanavir (used to treat HIV infection).

Inform your doctor or pharmacist if you are using or have recently used other medicines, including thoseobtainedwithout a prescription.

Pregnancy and breastfeeding

There is insufficient data on the use of pantoprazol in pregnant women.Pantoprazol is excreted in human milk.If you are pregnant, or think you may be pregnant, or if you are breastfeeding, you should only use this medicine if your doctor considers that the benefit for you is greater than the potential risk to the fetus or baby.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

Pantoprazol is unlikely to affect your ability to drive or use tools or machines. However, side effects such as dizziness and visual disturbances (see section 4) may occur. If they do, you should not drive or use machines.

Pantoprazol Qualigen contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

When and how should you take Pantoprazol Qualigen?

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 one tablet a 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 takingone tablet a day.

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

The usual dose is one tablet a day. If the disease recurs, your doctor may double the dose, in which case you can take Pantoprazol 40 mg,oncea day. After healing, you can reduce the dose again toone tabletof 20 mg a day.

For the prevention of duodenal and stomach ulcers in patients requiring continued treatment with NSAIDs:

The usual dose is one tablet a day.

Special patient groups:

- If you have severe liver problems,do nottake more thanonetablet of 20 mg a day.

-Childrenunder 12 years:This medication is not recommended for children under 12 years.

If you take more Pantoprazol Qualigen 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 Pantoprazol Qualigen

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

If you interrupt treatment with Pantoprazol Qualigen

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 medications, Pantoprazol Qualigenmay cause side effects, although not everyone will experience them.

The frequency of possible side effects described below is classified as follows:

• Very common (may affect more than 1 in 10 people)
• Common (may affect up to 1 in 10 people)
• Uncommon (may affect up to 1 in 100 people)
• Rare (may affect up to 1 in 1,000 people)
• Very rare (may affect up to 1 in 10,000 people)
• Frequency not known (the frequency cannot be estimated from available data).

If you experience any of the following side effects, stop taking these tablets and inform your doctor immediately, or contact the nearest hospital emergency service:

• Severe allergic reactions(rare frequency): 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 alterations(frequency not known):skin blisters and rapid deterioration of general condition, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme) and light sensitivity.

• Other severe conditions (frequency not known):yellowing of the skin and 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)

Other side effects are:

• Common

Benign stomach polyps

• Uncommon

Headache; dizziness; diarrhea; sensation of dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; skin hives, exanthema, rash; tingling; feeling of weakness, fatigue or general discomfort; sleep disturbances.

• Rare

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

Disorientation

• Frequency not known

Illusion, confusion (especially in patients with a history of these symptoms), decreased sodium levels in the blood, sensation of tingling, prickling, paresthesia (tingling), burning, numbness or inflammation of the large intestine causing persistent watery diarrhea.

Side effects identified through blood tests:

• Uncommon

Increased liver enzymes

• Rare

Increased bilirubin levels; increased levels of fats in the blood

• Very rare

Reduced platelet count, which could cause bleeding or more frequent bruising; reduced white blood cell count, which could lead to more frequent infections.

Frequency not known:

Skin rash, possibly with joint pain.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish 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 medication.

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

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

Blister: Do not store at a temperature above30°C.

Bottle: No special storage conditions are required.

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

Pantoprazole CompositionQualigen

The active ingredient is pantoprazole.Each gastro-resistant tabletcontains 20 mg of pantoprazole(in the form of sodium sesquihydrate).

The other components (excipients) are:

Core:Anhydrous sodium phosphate, mannitol(E-421), microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Coating:Hypromellose, triethyl citrate, sodium glycolate starch (derived from potato), copolymer of methacrylic acid-ethyl acrylate (1:1), 30% dispersion, yellow iron oxide(E-172).

Product appearance and container content

Yellow, oval, concave, smooth gastro-resistant tablet.

Containers:

Bottles (high-density polyethylene container with a polyethylene low-density cap with a polyethylene cap provided with a desiccant) and blisters (Alu/Alu blisters).

Containers with 28 gastro-resistant tablets.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Responsible for Manufacturing

Teva Pharma, S.L.U.

Polígono Malpica, c/C, nº 4

50016 Zaragoza

Spain

Last review date of this leaflet:June 2021

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