Pantoprazole Tecnigen 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pantoprazole TecniGen 20 mg gastro-resistant tablets EFG

Pantoprazole

Read the 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, 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 they are adverse effects 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 Pantoprazol TecniGen is and what it is 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 20 mg 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 Pantoprazole TecniGen

Do not take Pantoprazole TecniGen 20 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

Consult your doctor, pharmacist, or nurse before starting Pantoprazole TecniGen:

• If you take pantoprazole for more than three months, you may experience a decrease in magnesium levels in your blood. 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 potassium and calcium levels in the blood. Your doctor will decide whether periodic blood tests are needed to monitor magnesium levels.
• 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 long-term pantoprazole treatment. Like all medicines that reduce acid levels, pantoprazole may reduce the absorption of vitamin B12.
• Consult your doctor if you are taking any 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 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 or events at each visit.

Other medicines and Pantoprazole TecniGen

Pantoprazole TecniGen 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 TecniGen may cause these and other medicines to be less effective.

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

• Atazanavir (used to treat HIV infection).

• Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

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 infant.

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 Pantoprazole TecniGen

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

When and how should you take Pantoprazole TecniGen?

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

Unless your doctor has instructed otherwise, the usual dose is:

Adults and adolescents aged 12 years and older:

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

The usual dose is one tablet daily.

This dose generally provides relief within 2–4 weeks, and if not, at most within the following 4 weeks. Your doctor will advise you on how long you should continue taking the medicine. Afterwards, any recurring symptoms may 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 this case, you may take Pantoprazole 40 mg once daily. After healing, the dose may be reduced again to one tablet of 20 mg 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 daily.
• 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 20 mg than you should

Inform your doctor or pharmacist or call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount ingested. Symptoms of overdose are not known.

If you forget to take Pantoprazole TecniGen 20 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 20 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 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 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 immediately, or contact the nearest hospital's emergency service:

• Severe allergic reactions (frequency: rare): swelling of the tongue and/or throat, difficulty swallowing, rash (urticaria), difficulty breathing, facial swelling of allergic origin (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 with occasional pain when urinating and lower back pain (severe kidney inflammation).

Other adverse effects are:

• 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; 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 Pantoprazol TecniGen, especially for more than one year, you may have a slightly increased risk of fractures of the hip, wrist and spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (these may increase the risk of osteoporosis).

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

disturbance or complete loss of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling in the limbs (peripheral oedema); allergic reactions; depression; enlargement of the breasts 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 granular white blood cells in circulation, associated with high fever.

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

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

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

If you are taking Pantoprazol TecniGen for more than three months, magnesium levels in the 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 they are adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products. Website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazole TecniGen

Keep this medicine out of sight and reach of children.

Do not use Pantoprazole TecniGen after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. 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 20 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 corn 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 pack

Yellowish, convex, oblong gastro-resistant tablets.

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

Only certain 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 up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/