Pantoprazole Pharma Combix 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Pantoprazole 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 questions, ask 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, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

Pantoprazol Pharma Combix is a selective proton pump inhibitor, a medicine that reduces the amount of acid produced in the stomach. It is used to treat conditions related to stomach and intestinal acid.

Pantoprazol Pharma Combix is used for:

Adults and adolescents aged 12 years and older:

• Treatment of symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, painful 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 at-risk patients who require ongoing treatment with these types of medications.

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

Do not take Pantoprazol Pharma Combix

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Pantoprazol Pharma Combix.

Take special care with Pantoprazol Pharma Combix

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

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop 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 if you are on long-term pantoprazole treatment. 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 pantoprazole treatment for a long period of time. Like all medicines that reduce acid, pantoprazole could reduce the absorption of vitamin B12.
• If you are scheduled to have a specific blood test (chromogranin A).
• Talk to your doctor if you are taking any medicine containing atazanavir (used to treat HIV infection) 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, confusion, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. In addition, low magnesium levels may lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

Contact your doctor immediately if 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 your stools
• Severe or persistent diarrhea, as pantoprazole has been associated with a small increased risk of infectious diarrhea.

Your doctor will decide whether additional tests are needed to rule out malignancy, as pantoprazole may relieve symptoms of cancer and could delay diagnosis. If your symptoms persist despite treatment, further investigations will be carried out.

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

Taking Pantoprazol Pharma Combix with other medicines

Pantoprazol Pharma Combix may affect the effectiveness of other medicines. Therefore, inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, posaconazole (used to treat fungal infections), or erlotinib (used for certain types of cancer), as Pantoprazol Pharma Combix may reduce the effectiveness of these and other medicines.

• Warfarin and fenprocoumon, which affect blood clotting. You may require additional monitoring.

• Atazanavir (used to treat HIV infection).

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy, breastfeeding, and fertility

There are insufficient data on the use of pantoprazole in pregnant women. It has been reported that pantoprazole is excreted in human breast milk. If you are pregnant, think you may be pregnant, or are breastfeeding, you should only use this medicine if your doctor considers that the benefit to you outweighs the potential risk to the fetus or baby.

If you are pregnant or breastfeeding, think you may 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 operate machinery if you experience adverse effects such as dizziness or blurred vision.

3. How to take Pantoprazol Pharma Combix

Always follow exactly the instructions for administering this medicine as given by your doctor. If in 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 instructed you otherwise, the recommended dose is:

Adults and adolescents aged 12 years and older:

For treating symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, painful swallowing)

The usual dose is one tablet daily.

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

For long-term treatment and prevention of relapses 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 must 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 of age.

If you take more Pantoprazol Pharma Combix 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 Pantoprazol Pharma Combix

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

If you stop taking Pantoprazol Pharma Combix

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

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

4. Possible adverse effects

Like all medicines, Pantoprazol Pharma Combix may have adverse effects, although not everyone experiences them.

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

very common (affects more than 1 in 10 people)
common (affects between 1 and 10 in every 100 people)
uncommon (affects between 1 and 10 in every 1,000 people)
rare (affects between 1 and 10 in every 10,000 people)
very rare (affects fewer than 1 in 10,000 people)
frequency not known (cannot be estimated from available data).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not mentioned in this leaflet, inform your doctor or pharmacist or contact the nearest hospital emergency service.

• Severe allergic reactions (rare frequency): 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): blisters on the skin and rapid deterioration of general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme), and 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 sometimes with pain when urinating and lower back pain (severe kidney inflammation).

Other adverse effects are:

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

benign gastric polyps.

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

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

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

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

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

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

disorientation.

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

hallucinations, confusion (especially in patients with a history of these symptoms), decreased sodium levels in the blood, skin rash possibly accompanied by joint pain, tingling, pricking, paresthesia (tingling), burning or numbness, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse effects identified through blood tests:

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

increased liver enzymes.

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

increased bilirubin; increased levels of fat in the blood.

• Very rare (affects fewer 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 adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Pantoprazol Pharma Combix 20 mg in vial does not require any special storage conditions.

Pantoprazol Pharma Combix 20 mg in blister pack must be stored below 30°C.

Keep in the original packaging.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazole Pharma Combix

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

The other components (excipients) are:

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

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

Appearance of the product and contents of the pack

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

It is available in:

Bottle (high-density polyethylene container with polypropylene cap equipped with desiccant) containing 28 tablets, and blister (Aluminium/Aluminium) containing 28 and 56 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2. Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

TEVA PHARMA S.L.U.

Polígono Malpica, c/C nº 4

50016 Zaragoza

Spain

Date of the most recent revision of this leaflet: June 2019

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/