Pantoprazole Pharma Combix 40 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Pantoprazole Pharma Combix 40 mg gastro-resistant tablets EFG

• Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.
• Keep this leaflet as 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions 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 your stomach. It is used for the treatment of diseases related to stomach and intestinal acid.

Pantoprazol Pharma Combix is used for:

Adults and adolescents aged 12 years and older:

• Reflux esophagitis. This is inflammation of your esophagus (the tube connecting your throat to your stomach), accompanied by regurgitation of acid from the stomach.

Adults:

• Infection with a bacterium called Helicobacter pylori in patients with stomach and/or duodenal ulcer, in combination with two antibiotics (eradication therapy). The aim is to eliminate the bacterium and thereby reduce the likelihood of ulcers recurring.
• Stomach and duodenal ulcers, and
• Zollinger-Ellison syndrome and other conditions in which excessive acid is produced in the stomach.

2. What you need to know before starting to take Pantoprazole Pharma Combix

Do not take Pantoprazole 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 Pantoprazole Pharma Combix.

Take special care with Pantoprazole Pharma Combix:

• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole 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 Pantoprazole 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 have low 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 levels, pantoprazole may 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 (for treatment of HIV infection) at the same time as pantoprazole.
• If you take pantoprazole for more than three months, you may experience a decrease in magnesium levels in the blood. 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.

Immediately inform your doctor if you notice any of the following symptoms:

• Unintentional weight loss
• Repeated vomiting
• Difficulty swallowing
• Blood in vomit
• Pale appearance and feeling weak (anemia)
• Blood in your stools
• Severe or persistent diarrhoea, as pantoprazole has been associated with a small increased risk of infectious diarrhoea.

Your doctor will decide whether you need additional tests to rule out malignant disease, as pantoprazole may relieve cancer symptoms 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 report any new or unexpected symptoms or events at each medical visit.

Taking Pantoprazole Pharma Combix with other medicines

Pantoprazole Pharma Combix may affect the effectiveness of other medicines. Therefore, 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 Pantoprazole Pharma Combix may cause these and other medicines to be less effective.
• Warfarin and phenprocoumon, which affect blood clotting. You may require additional monitoring.
• Atazanavir (used for the treatment of HIV infection).

Inform your doctor or pharmacist if you are using, have recently used, or might need to use 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 might 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 infant.

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 operate machinery if you experience adverse effects such as dizziness or blurred vision.

3. How to take Pantoprazol Pharma Combix

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor 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 the treatment of reflux esophagitis:

The usual dose is one tablet daily. Your doctor may instruct you to increase the dose to 2 tablets daily. The treatment duration for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will advise you on how long to take this medicine.

Adults:

For the treatment of infection with a bacterium called Helicobacter pylori in patients with gastric and/or duodenal ulcer, in combination with two antibiotics (eradication therapy):

One tablet twice daily, together with two antibiotic tablets—either amoxicillin, clarithromycin, and metronidazole (or tinidazole)—each to be taken twice daily along 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 package leaflets of the antibiotics.

The duration of treatment is normally one to two weeks.

For the treatment of gastric and duodenal ulcers:

The usual dose is one tablet per day. Your doctor may double the dose.

Your doctor will inform you how long you should take this medicine. The usual duration of treatment for gastric ulcers is between 4 and 8 weeks. The usual duration of treatment for duodenal ulcers is between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with increased gastric acid secretion:

The recommended initial dose is two tablets per day.

Take both tablets 1 hour before a meal. Afterwards, your doctor may adjust your dose depending on the amount of acid secretion. If you are prescribed more than two tablets per day, you should take the tablets divided into two daily doses.

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

Special patient groups:

• If you have kidney problems, or moderate to severe liver problems, you should not take pantoprazole for the eradication of Helicobacter pylori.

• If you have severe liver impairment, you should not take more than one 20 mg pantoprazole tablet per day (20 mg pantoprazole tablets are available for this purpose).

• Children (under 12 years): the use of these tablets is not recommended in children under 12 years of age.

If you take more Pantoprazole 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 medication and the amount ingested. There are no known symptoms of overdose.

If you forget to take Pantoprazol Pharma Combix

Do not take a double dose to make up for missed doses. 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, Pantoprazole 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 listed 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 oedema/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 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, increase in kidney size sometimes with pain on urination 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 Pantoprazole 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 if you are taking corticosteroids (which may increase the risk of osteoporosis).

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

visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; swelling in the extremities (peripheral oedema); allergic reactions; depression; enlargement of the breasts 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 may 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 40 mg in bottle does not require special storage conditions.

Pantoprazol Pharma Combix 40 mg in blister pack must be stored below 30°C.

Keep in the original packaging.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be returned to the SIGRE point at your pharmacy. If you have any doubts, please 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 40 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: Hydroxypropyl methylcellulose (hypromellose) (E464), triethyl citrate, sodium starch glycolate from potato, 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 14 and 28 tablets, and blister (aluminum/aluminum) containing 14, 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. Building 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

TEVA PHARMA, S.L.U.

Malpica Industrial Estate, Street C No. 4

50016 Zaragoza

Spain

Date of the most recent review of this package 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/