Prospect: information for the user

PantoprazolTecniGen 40 mg gastro-resistant tablets EFG

Pantoprazol

Read this prospect carefully before starting to take the medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in the prospect. See section 4.

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

2.What you need to know before starting to take Pantoprazol TecniGen

3.How to take Pantoprazol TecniGen

4.Possible adverse effects

5Storage of Pantoprazol TecniGen

6.Contents of the package and additional information

Pantoprazol TecniGen is a selective proton pump inhibitor, a medication 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 TecniGen 40 mg is used for:

Adults and adolescents 12 years and older:

-Gastroesophageal reflux esophagitis. This is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by acid regurgitation from your stomach.

Adults:

-Infection caused by a bacteria called Helicobacter pylori in patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment). The goal is to eliminate the bacteria and thus reduce the likelihood of ulcers reappearing

-Stomach and duodenal ulcers, and

-Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

Do not take Pantoprazol TecniGen 40 mg

• If you are allergic (hypersensitive) to pantoprazole or to any of the other components of this medication (see section 6)
• If you are allergic to medications that contain other proton pump inhibitors (e.g., omeprazole, lansoprazole, rabeprazole, esomeprazole)

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pantoprazol 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. Additionally, low magnesium levels may cause a decrease in potassium and calcium levels in your blood. Your doctor will 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 your liver enzymes more frequently, especially when you are on long-term treatment with pantoprazole. If liver enzyme levels increase, treatment should be interrupted.
• If you have decreased vitamin B12 reserves or risk factors for it and receive long-term treatment with pantoprazole. Like all medications that reduce acid production, pantoprazole may reduce vitamin B12 absorption.
• Consult your doctor if you are taking any medication that contains atazanavir (for HIV treatment) at the same time as pantoprazole.
• If you have ever had a skin reaction after treatment with a similar medication to Omeprazol TecniGen for reducing stomach acid.

If you experience a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Omeprazol TecniGen. Remember to mention any other symptoms you may notice, such as joint pain.

Before taking this medication, inform your doctor if:

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

Inform your doctor immediately if you notice any of the following symptoms:

-Unintentional weight loss

-Recurring vomiting

-Difficulty swallowing

-Blood in your 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 if you need additional testing to rule out a malignant disease, as pantoprazole may alleviate cancer symptoms and potentially delay diagnosis. If your symptoms persist despite treatment, additional explorations will be performed.

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

Other medications and Pantoprazol TecniGen

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

Pantoprazol TecniGen may affect the efficacy of other medications, so inform your doctor if you are taking:

• Medications such as ketoconazole, itraconazole, and posaconazole (used for fungal infections) or erlotinib (used for certain types of cancer), as Pantoprazol TecniGen may make these and other medications less effective.

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

• Atazanavir (used for HIV treatment).

Pregnancy, breastfeeding, and fertility

There is insufficient data on the use of pantoprazole in pregnant women.Pantoprazole is excreted in human breast milk.If you are pregnant, or think you may be pregnant, or if you are breastfeeding, you should only use this medication if your doctor considers the benefits for you to be greater than the potential risk to the fetus or baby.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

You should not drive or operate machinery if you experience adverse effects such as dizziness or blurred vision.

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

When and how should you take Pantoprazol TecniGen?

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

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

Adults and adolescents 12 years and older:

Treatment of esophagitis by reflux:

The usual dose is 1 tablet per day. Your doctor may indicate an increase to 2 tablets per day. The treatment time for esophagitis by reflux is usually between 4 and 8 weeks. Your doctor will tell you for how long you should take this medication.

Adults:

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

1 tablet twice a day, plus the two antibiotic tablets, either amoxicillin, clarithromycin, and metronidazole (or tinidazole), each taken twice a day, with your pantoprazole tablet. Take thefirstpantoprazole tablet 1 hour before breakfast and thesecond1 hour before dinner. Follow your doctor's instructions and make sure to read the antibiotic prospectuses.

The treatment duration is usually 1 to 2 weeks.

Treatment of stomach and duodenal ulcers:

The usual dose is 1 tablet per day. The dose may be doubled by your doctor.

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

Long-term treatment of Zollinger-Ellison Syndrome and other conditions in which there is an increase in stomach acid production:

The initial recommended dose is 2 tablets per day.

Take the 2 tablets 1 hour before a meal. Your doctor may then adjust your dose, depending on the amount of stomach acid you produce. If you are prescribed more than 2 tablets per day, you should take the tablets twice a day.

If you are prescribed more than 4 tablets per day, you will be told exactly when to stop treatment.

Special patient groups:

• If you have kidney problems, or moderate or severe liver problems,do nottake pantoprazole for the elimination ofHelicobacter pylori.

• If you have severe liver problems, do not take more than1 tablet of 20 mg of pantoprazole per day(for this case, tablets of 20 mg of pantoprazole are available).

Use in children and adolescents:

• Children(under 12 years):do notrecommend the use of these tablets in children under 12 years.

If you take more Pantoprazol TecniGen 40 mg than you should:

Inform your doctor or pharmacist or call the Toxicological Information Service at phone 91 562 04 20, indicating the medication and the amount ingested. There are no known symptoms of overdose.

If you forgot to take Pantoprazol TecniGen 40 mg:

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

If you interrupt treatment with Pantoprazol TecniGen 40 mg:

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

Very common (affects more than one patient in every 10)

Common (affects between 1 and 10 patients in every 100)

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

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

Very rare (affects fewer than one patient in every 10,000)

Frequency not known (cannot be estimated from 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 frequency): swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, allergic swelling of the face (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats and excessive sweating.

• Severe skin alterations (frequency not known):skin blisters and rapid deterioration of general condition, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme) and light sensitivity.

• Other severe conditions (frequency not known):yellow discoloration of the skin and the white of the eyes (severe liver cell damage, jaundice), or fever, hives, increased kidney size with occasional pain while urinating and lower back pain (severe kidney inflammation)

Other side effects are:

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

benign polyps in the stomach

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

headache; dizziness; diarrhea; sensation of dizziness, vomiting; swelling and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; hives on the skin, exanthema, rash; tingling; feeling of weakness, fatigue or general discomfort; sleep disturbances.

If you are taking proton pump inhibitors such as Pantoprazol TecniGen, especially for a period of more than one year, you may slightly increase the risk of hip fracture, wrist fracture, and spinal column fracture. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (they may increase the risk of osteoporosis).

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

alteration or complete absence of taste;vision disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling in the extremities (peripheral edema); allergic reactions; depression; gynecomastia in men.

• Very rare(affects fewer than one patient in every 10,000)

disorientation

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

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

cutaneous eruption,possibly with joint pain.

sensation of tingling, prickling, paresthesia (tingling), burning or numbness.

inflammatory bowel disease that causes persistent watery diarrhea.

Side effects identified through blood tests:

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

increased liver enzymes

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

increased bilirubin; increased levels of fats in the blood; sudden drop in granular white blood cells in circulation, associated with high fever.

• Very rare(affects fewer than one patient in every 10,000)

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

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

If you are taking Pantoprazol TecniGen for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also cause decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

Reporting side effects

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

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

Do not use Pantoprazol TecniGen after the expiration date that appears 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 through drains or trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Pantoprazol TecniGen

The active ingredient is pantoprazole.Each gastro-resistant tablet contains 40 mg of pantoprazole (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),Pre-gelatinized cornstarch (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:Copolymer of methacrylic acid and ethyl acrylate, Polysorbate 80, Sodium lauryl sulfate, Triethyl citrate,Purified water (removed during the process).

Appearance of the product and contents of the packaging

Yellow, convex, and oblong gastro-resistant tablets.

PVC+ PCTFE+ PVC/Aluminum blister packaging with 14, 28, or 56 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd floor. Edificio América. Arroyo de la Vega Industrial Estate,

28108 Alcobendas (Madrid) SPAIN

Responsible manufacturer:

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande nº 2, Abrunheira. 2710 – 089 Sintra (Portugal).

This leaflet was approved in June 2019

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/