Package Insert: Information for the User

Pantoprazol Pharma Combix 20 mg gastro-resistant tablets EFG

• Read this package insert carefully before starting to take this medication, as it contains important 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 only, 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.

Pantoprazol Pharma Combix 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.

Pantoprazol Pharma Combix 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 recurrences 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 Pharma Combix

• If you are allergic to pantoprazole or any of the other components of this medication (listed in 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 or pharmacist before starting to take Pantoprazol Pharma Combix.

Be especially careful with Pantoprazol Pharma Combix

• Si you have ever had a skin reaction after treatment with a similar medication to Pantoprazol Pharma Combix to reduce stomach acid.

If you suffer from a skin rash, especially in exposed skin areas, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Pantoprazol Pharma Combix. Remember to mention any other symptoms you may notice, such as joint pain.

• Si you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor will monitor your liver enzyme levels more frequently, especially when you are on long-term treatment with pantoprazole. If liver enzyme levels increase, treatment should be interrupted.
• Si you need to take nonsteroidal anti-inflammatory drugs (NSAIDs) continuously and take pantoprazole, as there is a higher risk of developing complications in the stomach and intestines. Any increased risk will be evaluated based on individual risk factors such as age (65 years or older), history of stomach or duodenal ulcers, or gastrointestinal bleeding.
• Si you have reduced vitamin B12 reserves or risk factors for it and receive long-term treatment with pantoprazole. Like all acid-reducing medications, pantoprazole may reduce vitamin B12 absorption.
• Si you are scheduled to have a specific blood test (Cromogranin A).
• Consult your doctor if you are taking any medication containing atazanavir (for HIV treatment) at the same time as pantoprazole.
• Si 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. Additionally, low magnesium levels may cause a decrease in potassium and calcium levels in the blood. Your doctor will decide to perform periodic blood tests to monitor magnesium levels.

Inform your doctor immediately if you notice any of the following symptoms:

• Unintentional weight loss
• Recurring vomiting
• Difficulty swallowing
• Blood in your vomit
• Pale appearance and feeling of weakness (anemia)
• Blood in your stool
• 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 potentially delay diagnosis. If your symptoms persist despite treatment, additional explorations will be performed.

Si you take pantoprazole for an extended 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.

Taking Pantoprazol Pharma Combix with other medications

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

• Medications such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as Pantoprazol Pharma Combix may make these and other medications less effective.

• 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, have used recently, or may need to use any other medication.

Pregnancy, breastfeeding, and fertility

There is insufficient data on the use of pantoprazole in pregnant women.Pantoprazole has been excreted in human breast milk.If you are pregnant, or think you may be pregnant, or if you are breastfeeding, 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.

Si 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.

Driving and operating machinery

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

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 Pantoprazol Pharma Combix?

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

Unless your doctor has indicated otherwise, the recommended dose is:

Adults and adolescents 12 years and older:

For treating symptoms associated with gastroesophageal reflux disease (stomach burning, 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. Any recurring symptoms can be controlled as needed by taking 1 tablet per day.

For long-term treatment and prevention of esophagitis relapses 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, once a day. After recovery, you can reduce the dose again to 1 tablet of 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 than 1 tablet of 20 mg per day.
• Children under 12 years:This medication is not recommended for children under 12 years.

If you take more Pantoprazol Pharma Combix 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 Pharma Combix

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

If you interrupt treatment with Pantoprazol Pharma Combix

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

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

Like all medicines, Pantoprazol Pharma Combix may cause side effects, although not everyone will experience them.

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

Very common (affects more than 1 in 10 patients)

Common (affects between 1 and 10 patients in every 100)

Uncommon (affects between 1 and 10 patients in every 1,000)

Rare (affects between 1 and 10 patients in every 10,000)

Very rare (affects fewer than 1 in 10,000 patients)

Frequency cannot be estimated (cannot be estimated from available data).

If you consider that any of the side effects you are experiencing are severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist or contact the emergency department of the nearest hospital.

• Severe allergic reactions (rare): 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):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 unknown):yellowing of the skin and the white of the eyes (severe liver cell damage, jaundice), or fever, hives, increased kidney size sometimes with painful urination and lower back pain (severe kidney inflammation)

Other side effects are:

• Common(affects between 1 and 10 patients in every 100)

benign stomach polyps.

• Uncommon(affects between 1 and 10 patients in every 1,000)

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 malaise; sleep disturbances.

If you are taking proton pump inhibitors such as Pantoprazol Pharma Combix, especially for a period of more than one year, you may slightly increase the risk of hip, wrist, and spinal column fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

• Rare(affects between 1 and 10 patients in every 10,000)

vision disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; swelling in the extremities (peripheral edema); allergic reactions; depression; breast enlargement in men.

• Very rare(affects fewer than 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), decreased sodium levels in the blood, skin rash, possibly with joint pain,tingling, prickling, paresthesia (tingling), burning or numbness, inflammatory bowel disease that causes persistent watery diarrhea.

Side effects identified through blood tests:

• Uncommon(affects between 1 and 10 patients in every 1,000)

increased liver enzymes

• Rare(affects between 1 and 10 patients in every 10,000)

increased bilirubin; increased levels of fat in the blood

• Very rare(affects fewer than 1 in 10,000 patients)

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

Reporting 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 the leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://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 this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Pantoprazol Pharma Combix 20 mg in a bottle does not require special storage conditions.

Pantoprazol Pharma Combix 20 mg in blister packaging should be stored below30°C.

Store in the original packaging

Medications should not be disposed of through drains or trash. Dispose of the packaging and medications you no longer need 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.

Composition of Pantoprazol Pharma Combix

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:Dihydrate sodium phosphate anhydrous (E339ii), mannitol (E421), microcrystalline cellulose (E460i), croscarmellose sodium (E468), magnesium stearate (E470b).

Covering:Hydroxypropyl methylcellulose (hypromellose) (E464), triethyl citrate, potato starch sodium glycolate, copolymer of methacrylic acid – ethyl acrylate (1:1) (dispersion at 30%), yellow iron oxide (E172).

Appearance of the product and contents of the packaging

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

It is presented in:

Bottle (high-density polyethylene container with a polypropylene cap provided with a desiccant) with 28 tablets and blister (Aluminum/Aluminum) with 28 and 56 tablets.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Combix, S.L.U.

C/ Badajoz 2. Building 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

TEVA PHARMA S.L.U.

Malpica Industrial Estate, c/C nº 4

50016 Zaragoza

Spain

Last review date of this leaflet: June 2019

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/