Package Insert: Information for the User

PantoprazolPharma Combix 40 mg gastro-resistant tablets EFG

• Read this package insert carefully before starting to take this medicine, as it contains important information for you.
• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine 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:

• Esophagitis caused by reflux. It is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by regurgitation of acid from your stomach.

Adults:

• Infection caused by a bacteria called Helicobacter pylori in patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment). The goal is to get rid of the bacteria and thus reduce the likelihood of ulcers reappearing
• Stomach and duodenal ulcers, and
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

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 containing 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:

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

If you suffer from a skin rash, especially in sun-exposed 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.

• 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 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.
• If you are scheduled to have a specific blood test (Cromogranin A).
• Consult your doctor if you are taking a medication containing atazanavir (for HIV treatment) at the same time as pantoprazole.
• If you take pantoprazole for more than three months, you may experience a decrease in blood magnesium levels. 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 blood potassium and calcium levels. Your doctor will decide to perform periodic blood tests to monitor magnesium levels.

Inform your doctor immediatelyif you notice any of the following symptoms:

• Unintentional weight loss
• Repeated vomiting
• Difficulty swallowing
• Blood in vomit
• Pale appearance and feeling of weakness (anemia)
• Blood in 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 malignant disease, as pantoprazole may alleviate cancer symptoms and potentially delay diagnosis. If your symptoms persist despite treatment, additional explorations will be performed.

If you take pantoprazole for a prolonged 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 phenprocoumon, which affect blood coagulation. You may need additional monitoring.
• Atazanavir (used to treat HIV infection).

Informyour 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 is excreted in human breast milkIf 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.

If you are pregnant or breastfeeding, or think you may be pregnant, or have plans 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 indicated by your doctor. In case of doubt, consult your doctor 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 another schedule, the recommended dose is:

Adults and adolescents 12 years and older:

Treatment of esophagitis by reflux:

The usual dose is 1 tablet per day. Your doctor may indicate an increase to 2 tablets per day. The treatment time for esophagitis by reflux usually ranges from 4 to 8 weeks. Your doctor will indicate for how long you should take this medication.

Adults:

Treatment of an infection with a bacteria calledHelicobacter pyloriin patients with stomach and/or duodenal ulcer in combination with two antibiotics (eradication treatment)

1 tablet twice a day, plus the two antibiotic tablets, either amoxicillin, clarithromycin, and metronidazole (or tinidazole), each taken twice a day, with your pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second 1 hour before dinner. Follow your doctor's instructions and make sure to read the antibiotic prospectuses.

The treatment duration is usually 1 to 2 weeks.

Treatment of stomach and duodenal ulcers:

The usual dose is 1 tablet per day. The dose may be doubled by your doctor.

Your doctor will indicate for how long you should take this medication. The treatment duration for stomach ulcers is usually 4 to 8 weeks, and for duodenal ulcers, it is usually 2 to 4 weeks.

Long-term treatment of Zollinger-Ellison Syndrome and other conditions with increased stomach acid secretion:

The initial recommended dose is 2 tablets per day.

Take the 2 tablets 1 hour before a meal. Your doctor may then adjust your dose, depending on the amount of stomach acid you produce. If you are prescribed more than 2 tablets per day, you should take the tablets twice a day.

If you are prescribed more than 4 tablets per day, you will be told exactly when to stop treatment.

Special patient groups:

• If you have kidney problems, or moderate or severe liver problems, you should not take pantoprazole for the elimination ofHelicobacter pylori.

• If you have severe liver problems, you should not take more than1 tablet of 20 mg of pantoprazole per day(for this case, tablets of 20 mg of pantoprazole are available).

• Children(under 12 years):the use of these tablets is not recommended in 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 phone91 562 04 20, indicating the medication and the amount ingested. There are no known symptoms of overdose.

If you forgot to take Pantoprazol Pharma Combix

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

If you interrupt the treatment with Pantoprazol Pharma Combix

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

If you have any other doubts 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 100)

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

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

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

Unknown frequency (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 effect 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 heartbeat and excessive sweating.

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

Other side effects are:

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

benign polyps in the stomach.

• Uncommon(affects between 1 and 10 patients in 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 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

• Unknown frequency(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 painsensation of tingling, prickling, paresthesia (tingling), burning or numbness, inflammation of the large intestine causing persistent watery diarrhea.

Side effects identified through blood tests:

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

increased liver enzymes

• Rare(affects between 1 and 10 patients in 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 40 mg in a bottle does not require special storage conditions.

Pantoprazol Pharma Combix 40 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 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 pantoprazol.Each gastro-resistant tablet contains 40 mg of pantoprazol (in the form of sodium sesquihydrate).

Theother components(excipients) are:

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

Coating:Hydroxypropyl methylcellulose (hydroxypropyl methylcellulose) (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 14 and 28 tablets and blister (Aluminum/Aluminum) with 14, 28, and 56 tablets.

Only some sizes of packaging may be commercially marketed.

Marketing Authorization Holder and Responsible for Manufacturing

Marketing Authorization Holder

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

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/