PANTOPRAZOL TECNIGEN 40 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

PantoprazoleTecniGen 40 mg gastro-resistant tablets EFG

Pantoprazole

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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Pantoprazole TecniGen and what is it used for
2. What you need to know before you take Pantoprazole TecniGen
3. How to take Pantoprazole TecniGen
4. Possible side effects

5 Storage of Pantoprazole TecniGen

1. Contents of the pack and other information

1. What is Pantoprazole TecniGen and what is it used for

Pantoprazole TecniGen is a selective inhibitor of the "proton pump", a medicine that reduces the amount of acid produced in your stomach. It is used to treat diseases related to stomach and intestine acid.

Pantoprazole TecniGen 40 mg is used for:

Adults and adolescents from 12 years:

• Reflux esophagitis. It is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by acid regurgitation 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 treatment). The goal is to get rid of the bacteria and thus reduce the likelihood of ulcer recurrence
• Stomach and duodenal ulcer, and
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

2. What you need to know before you take Pantoprazole TecniGen

Do not take Pantoprazole TecniGen 40 mg

• If you are allergic (hypersensitive) 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 Pantoprazole TecniGen

• 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 may 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 may cause a decrease in potassium and calcium levels in the blood. Your doctor will decide whether 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 you more frequently for 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 have decreased body stores of vitamin B12 or risk factors for it and receive treatment with pantoprazole for a long period. Like all medicines that reduce acid, pantoprazole may reduce the absorption of vitamin B12.
• 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 have ever had a skin reaction after treatment with a medicine similar to Pantoprazole TecniGen to reduce stomach acid.

If you suffer from 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 discontinue treatment with Pantoprazole TecniGen. Remember to mention any other symptoms you may notice, such as joint pain.

Before taking this medicine, inform your doctor if:

• a specific blood test (Chromogranin A) is scheduled for you

Inform 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 whether 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 may monitor you regularly. You should inform your doctor of any symptoms and/or new or unexpected events each time you visit your doctor.

Other medicines and Pantoprazole TecniGen

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Pantoprazole TecniGen 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 Pantoprazole TecniGen may cause these and other medicines to not work properly.

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

• 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 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, think you may be pregnant, or 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.

Consult your doctor or pharmacist before using any 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 Pantoprazole TecniGen

Follow the instructions for administration of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

When and how should you take Pantoprazole TecniGen?

Take the tablets whole, without chewing or crushing, with the help of a little water, 1 hour before a meal.

Unless your doctor has indicated otherwise, the normal dose is:

Adults and adolescents from 12 years:

For the treatment of reflux esophagitis:

The usual dose is one tablet per day. Your doctor may indicate an increase to 2 tablets per day. The treatment time for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will indicate how long you should take this medicine.

Adults:

For the treatment of an infection with a bacterium calledHelicobacter pyloriin patients with stomach and/or duodenal ulcer in combination with two antibiotics (eradication treatment):

One tablet twice a day plus the two antibiotic tablets, either amoxicillin, clarithromycin, and metronidazole (or tinidazole), each to be 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 leaflets of the antibiotics.

The duration of treatment is usually one to two weeks.

For the treatment of stomach and duodenal ulcers:

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

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

For long-term treatment of Zollinger-Ellison syndrome and other conditions in which there is an increase in stomach acid secretion:

The recommended initial dose is two tablets per day.

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

If you are prescribed more than four tablets per day, you will be told exactly when to finish the 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 problems, you should not take more than one 20 mg pantoprazole tablet per day (for this case, 20 mg pantoprazole tablets are available).

Use in children and adolescents

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

If you take more Pantoprazole TecniGen 40 mg than you should

Inform your doctor or pharmacist or call the Toxicology Information Service telephone 91 562 04 20, indicating the medicine and the amount ingested. There are no known symptoms of overdose.

If you forget to take Pantoprazole TecniGen 40 mg

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

If you stop taking Pantoprazole TecniGen 40 mg

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, this medicine 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 experience any of the following side effects, stop taking these tablets and inform your doctor immediately, 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 with occasional pain when urinating, and lower back pain (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 Pantoprazole TecniGen, especially for a period of 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 if you are taking corticosteroids (which may increase the risk of osteoporosis).

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

alteration or complete loss of taste; visual disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling in the limbs (peripheral edema); 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 the available data)

hallucinations, confusion (especially in patients with a history of these symptoms), decreased sodium levels in the blood;

skin rash, possibly with joint pain.

feeling of tingling, prickling, 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; sudden drop in granular white blood cells in the circulation, associated with high fever.

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

reduction in the number of platelets that could cause bleeding or more bruising than usual; reduction in the number of white blood cells that could lead to more frequent infections; abnormal reduction in the balance between the number of red and white blood cells, as well as platelets.

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

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

Reporting of side effects

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

5. Storage of Pantoprazole TecniGen

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

Do not use Pantoprazole TecniGen after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 30°C

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Pantoprazol TecniGen

The active ingredient is pantoprazol. Each gastro-resistant tablet contains 40 mg of pantoprazol (in the form of sodium sesquihydrate).

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

Appearance of the product and packaging content

Gastro-resistant tablets of yellowish color, convex and oblong in shape.

PVC+PCTFE+PVC/Aluminum blister packs with 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 leaflet was approved in June 2019

Detailed and updated 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/