Pantoprazole Tecnigen 40 mg gastro-resistant tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Pantoprazole TecniGen 40 mg gastro-resistant tablets EFG

Pantoprazole

Read the entire leaflet carefully before you start taking this medicine, as 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, pharmacist, or nurse.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. See section 4.

Leaflet Contents:

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

1. What is Pantoprazol TecniGen and what is it used for?

Pantoprazol TecniGen 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 acid-related diseases of the stomach and intestine.

Pantoprazol TecniGen 40 mg 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 gastric and/or duodenal ulcer, in combination with two antibiotics (eradication therapy). The aim is to eliminate the bacteria and thereby reduce the likelihood of ulcer recurrence.
• Gastric 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 TecniGen

Do not take Pantoprazole TecniGen 40 mg

• If you are allergic (hypersensitive) 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 TecniGen

• 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. 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.
• If you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor will monitor liver enzymes more frequently, especially if you are on long-term pantoprazole treatment. If liver enzymes increase, treatment should be discontinued.
• 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 levels, pantoprazole may reduce the absorption of vitamin B12.
• Consult your doctor if you are taking a medicine containing atazanavir (used to treat HIV infection) at the same time as pantoprazole.
• If you have ever had a skin reaction after treatment with a medicine similar to Omeprazole TecniGen used to reduce stomach acidity.

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 discontinue treatment with Omeprazole TecniGen. Remember to mention any other symptoms you may notice, such as joint pain.

Before taking this medicine, inform your doctor if:

• You are scheduled to have a specific blood test (chromogranin A)

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 weak (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 you need additional tests to rule out malignancy, as pantoprazole can relieve symptoms of cancer and may 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 may monitor you regularly. You should inform your doctor of any new or unexpected symptoms or events during each visit.

Other medicines and Pantoprazole TecniGen

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

Pantoprazole TecniGen may affect the effectiveness 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 for certain types of cancer), as Pantoprazole TecniGen may cause these and other medicines to not work properly.

• Warfarin and phenprocoumon, which affect blood clotting. You may need additional monitoring.

• Atazanavir (used to treat HIV infection).

• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily discontinue treatment with Pantoprazole TecniGen 40 mg, as pantoprazole may increase methotrexate levels in the blood.

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.

Consult your doctor or pharmacist before using any 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 TecniGen

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

When and how should you take Pantoprazol TecniGen?

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 usual 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 tell you how long you should 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, plus two antibiotic tablets—either amoxicillin, clarithromycin, and metronidazole (or tinidazole)—each to be taken twice daily together 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 be 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 advise you on 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 normally 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. Subsequently, your doctor may adjust your dose depending on the amount of gastric acid secreted. 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 Helicobacter pylori eradication.

• 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).

Use in children and adolescents:

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

If you take more Pantoprazole TecniGen 40 mg 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 TecniGen 40 mg

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

If you stop treatment with Pantoprazol TecniGen 40 mg

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, this medicine can cause adverse effects, although not everyone will experience 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 100 people)
uncommon (affects between 1 and 10 in 1,000 people)
rare (affects between 1 and 10 in 10,000 people)
very rare (affects less than 1 in 10,000 people)
frequency not known (cannot be estimated from available data).

If you experience any of the following adverse effects, stop taking these tablets immediately and inform your doctor right away, or contact the emergency department of your nearest hospital:

• Severe allergic reactions (rare frequency): swelling of the tongue and/or throat, difficulty swallowing, rash (urticaria), difficulty breathing, facial swelling due to allergy (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 in general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme), and sensitivity to light.

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

Other adverse effects include:

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

benign gastric polyps

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

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

If you are taking proton pump inhibitors such as Pantoprazole TecniGen, especially for more than one year, you may have a slightly increased risk of hip, wrist and spine fractures. 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 10,000 people)

disturbance or complete loss of taste; vision disorders such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increase in body temperature; high fever; swelling in the limbs (peripheral oedema); allergic reactions; depression; breast enlargement in men.

• Very rare (affects less 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 levels of sodium in the blood;

skin rash, possibly with joint pain.

Sensation of tingling, prickling, paraesthesia (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 1,000 people)

increase in liver enzymes

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

increase in bilirubin; increase in blood fat levels; sudden drop in circulating granular white blood cells, associated with high fever.

• 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; abnormal reduction in the balance between red blood cells, white blood cells and platelets.

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

If you are taking Pantoprazole TecniGen for more than three months, magnesium levels in your blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, seek medical attention immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

Reporting of adverse effects

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

5. Storage of Pantoprazol TecniGen

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

Do not use Pantoprazol TecniGen after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store below 30°C.

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

6. Contents of the pack and other information

Composition of Pantoprazole TecniGen

The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium sesquihydrate).

The other components (excipients) are:
Core: Mannitol (Pearitol 160C) (E-421), Microcrystalline cellulose (Avicel PH101), Microcrystalline cellulose (Avicel PH102), Pregelatinized maize starch (Starch 1500), Sodium starch glycolate from potato (Explotab), Anhydrous sodium carbonate, Calcium stearate, Purified water (removed during processing).
Isolating coating: Hypromellose, Propylene glycol, Titanium dioxide (E-171), Yellow iron oxide (E-172).
Enteric coating: Methacrylic acid–ethyl acrylate copolymer, Polysorbate 80, Sodium lauryl sulfate, Triethyl citrate, Purified water (removed during processing).

Appearance of the product and contents of the container

Yellowish, convex, oblong gastro-resistant tablets.

PVC+PCTFE+PVC/Aluminum blister packs containing 14, 28 or 56 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Tecnimede España Industria Farmacéutica, S.A.
Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,
28108 Alcobendas (Madrid), SPAIN

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas SA
Rua da Tapada Grande nº 2, Abrunheira, 2710–089 Sintra (Portugal).

This patient information leaflet was approved in 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/