PANTOPRAZOL PHARMA COMBIX 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Pantoprazol Pharma Combix 20 mg Gastro-Resistant Tablets EFG

• Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

1. What is Pantoprazol Pharma Combix and what is it used for

Pantoprazol Pharma Combix is a selective inhibitor of the "proton pump", a medicine that reduces the amount of acid produced in your stomach. It is used for the treatment of diseases related to stomach and intestine acid.

Pantoprazol Pharma Combix is used for:

Adults and adolescents from 12 years:

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

2. What you need to know before you take Pantoprazol Pharma Combix

Do not take Pantoprazol Pharma Combix

• If you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 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 Pharma Combix.

Be especially careful with Pantoprazol Pharma Combix

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

If you get a skin rash, especially in areas of the skin exposed to the sun, 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 serious liver problems. Inform your doctor if you have ever had liver problems. Your doctor will perform more frequent monitoring of liver enzymes, especially when you are on long-term treatment with pantoprazole. In case of an increase in liver enzymes, treatment should be discontinued.
• If you need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously and take pantoprazole, as there is a greater risk of developing complications in the stomach and intestine. Any increased risk will be assessed according to your personal risk factors such as age (65 years or older), history of stomach or duodenal ulcer or stomach or intestinal bleeding.
• If you have decreased body stores of vitamin B12 or risk factors for it and receive long-term treatment with pantoprazole. Like all medicines that reduce the amount of acid, pantoprazole may reduce the absorption of vitamin B12.
• If you are scheduled to have a specific blood test (Chromogranin A).
• Consult your doctor if you are taking any medicine that contains atazanavir (for the treatment of HIV infection) at the same time as pantoprazole.
• If you take pantoprazole for more than three months, you may suffer from a decrease in magnesium levels in the blood. Symptoms of low magnesium levels can include fatigue, involuntary muscle contractions, disorientation, dizziness, or increased heart rate. If you have any of these symptoms, inform your doctor immediately. Additionally, low magnesium levels can cause a decrease in potassium and calcium levels in the blood. Your doctor will decide to perform periodic blood tests to monitor magnesium levels.

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

• 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 pantoprazole 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 pantoprazole may alleviate the symptoms of cancer and could delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

If you take pantoprazole for a prolonged period (more than one year), your doctor will probably monitor you regularly. You should inform your doctor of any symptoms and/or new or unexpected events each time you visit your doctor.

Taking Pantoprazol Pharma Combix with other medicines

Pantoprazol Pharma Combix 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 to treat certain types of cancer), as Pantoprazol Pharma Combix may cause them and other medicines to not work properly.

• Warfarin and fenprocoumon, which affect blood coagulation. You may need additional controls.

• Atazanavir (used to treat HIV infection).

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

Pregnancy, breastfeeding, and fertility

There is not enough data on the use of pantoprazole in pregnant women. It has been reported that in humans, pantoprazole is excreted in breast milk. If you are pregnant, or think you might be, or if you are breastfeeding, you should only use this medicine if your doctor considers that the benefit to you is greater than the potential risk to the fetus or baby.

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

You should not drive or use machines if you experience side effects such as dizziness or blurred vision.

3. How to take Pantoprazol Pharma Combix

Follow exactly the administration instructions of this medicine 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 tablets whole, 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 from 12 years:

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

The usual dose is one tablet per day.

This dose usually provides relief within 2-4 weeks, and if not, at most, within the following 4 weeks. Your doctor will indicate how long you should take the medicine. Later, any recurring symptoms can be controlled as needed, takingone tablet per day.

For long-term treatment and prevention of relapses of reflux esophagitis

The usual dose is one tablet per day. If the disease returns, your doctor may double the dose, in which case you can take Pantoprazol 40 mg, once a day. After healing, you can reduce the dose back to one 20 mg tablet per day.

Adults:

To prevent duodenal and stomach ulcers in patients who require continued treatment with NSAIDs

The usual dose is one tablet per day.

Special patient groups:

• If you have serious liver problems, you should not take more than one 20 mg tablet per day.
• 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. No symptoms of overdose are known.

If you forget to take Pantoprazol Pharma Combix

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

If you stop taking Pantoprazol Pharma Combix

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

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

4. Possible side effects

Like all medicines, Pantoprazol Pharma Combix can cause side effects, although not everybody gets them.

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

very common (affects more than 1 in 10 people)

common (affects between 1 and 10 people in 100)

uncommon (affects between 1 and 10 people in 1,000)

rare (affects between 1 and 10 people in 10,000)

very rare (affects less than 1 in 10,000 people)

frequency not known (cannot be estimated from the available data).

If you consider that any of the side effects you are suffering from is serious, 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, swelling of the face of allergic origin (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and profuse sweating.

• Severe skin disorders (frequency not known): blisters on the skin and rapid deterioration of general conditions, erosion (including slight bleeding) of eyes, nose, mouth/lips, or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme) and sensitivity to light.

• Other severe conditions (frequency not known): yellowing of the skin and the whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increase in kidney size sometimes with pain when urinating and pain in the lower back (severe kidney inflammation)

Other side effects are:

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

benign polyps in the stomach.

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

headache; dizziness; diarrhea; feeling of dizziness, vomiting; swelling and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; tingling; feeling of weakness, fatigue, or general malaise; sleep disturbances.

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

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

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

• Very rare(affects less than 1 in 10,000 people)

disorientation

• Frequency not known(cannot be estimated from the available data)

hallucination, confusion (especially in patients with a history of these symptoms), decrease in sodium levels in the blood, skin eruption, possibly with joint pain, tingling, pricking, paresthesia (tingling), burning, or numbness, inflammation of the large intestine that causes persistent watery diarrhea.

Side effects identified through blood tests:

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

increase in liver enzymes

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

increase in bilirubin; increase in blood fat levels

• Very rare(affects less than 1 in 10,000 people)

reduction in platelet count, which could lead to bleeding or more bruising than usual; reduction in white blood cell count, which could lead to more frequent infections.

Reporting of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazol Pharma Combix

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

Do not use this medicine after the expiration date that appears on the packaging after EXP. 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 packs should be stored below 30°C.

Store in the original package

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

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).

The other ingredients (excipients) are:

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

Coating: Hypromellose (E464), triethyl citrate, potato starch sodium glycolate, methacrylic acid - ethyl acrylate copolymer (1:1) (30% dispersion), yellow iron oxide (E172).

Appearance of the product and contents of the pack

Gastro-resistant tablet, yellow, oval, biconvex, smooth.

It comes in:

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2. Building 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

TEVA PHARMA S.L.U.

Malpica Industrial Estate, c/C nº 4

50016 Zaragoza

Spain

Date of the last revision of this leaflet: June 2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/