PANTOPRAZOL HEALTHKERN 20 mg GASTRO-RESISTANT TABLETS

2. What you need to know before taking Pantoprazol Healthkern

Do not take Pantoprazol Healthkern:

• If you are allergic (hypersensitive) to pantoprazol or any of the other ingredients of this medicine (listed in section 6 "Composition of Pantoprazol Healthkern").
• If you are taking any medicine that contains atazanavir (for the treatment of HIV infection).
• If you are under 18 years old.
• If you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor first:

?If you have received treatment for heartburn or dyspepsia continuously for 4 or more weeks.

?If you are over 55 years old and take a treatment for dyspepsia without a prescription every day.

?If you are over 55 years old and have new or recently changed symptoms.

?If you have previously had a stomach ulcer or stomach surgery.

?If you have liver problems or jaundice (yellowing of the skin or eyes).

?If you regularly visit your doctor for serious complaints or illnesses.

?If you are going to have an endoscopy or a test called a urea breath test.

?If you have ever had a skin reaction after treatment with a medicine similar to pantoprazol to reduce stomach acidity.

?If you suffer 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 interrupt treatment with pantoprazol. Remember to mention any other symptoms you may notice, such as joint pain.

If you take pantoprazol for longer periods, additional risks may occur, such as: decrease in blood magnesium levels (possible symptoms: fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate). Additionally, low magnesium levels can cause a decrease in blood potassium and calcium levels. You should consult your doctor if you have been taking this medicine for more than 4 weeks. Your doctor will decide whether to perform periodic blood tests to monitor magnesium levels.

Tell your doctor immediately before or after taking this medicine, if you noticeany of the following symptoms, which could be signs of a more serious illness:

• Involuntary weight loss (not related to any diet or exercise).
• Vomiting, especially if it is repeated.
• Blood in the vomit, which may appear as dark coffee grounds in the vomit.
• You notice blood in your stools, which may appear black or like tar.
• Difficulty swallowing or pain when swallowing.
• You are pale or feel weak (anemia).
• Chest pain.
• Stomach pain.
• Severe and/or persistent diarrhea, as pantoprazol has been associated with a slight increase in the occurrence of infectious diarrhea.

Your doctor may decide that it is necessary to perform some tests.

If you are going to have a blood test, inform your doctor that you are taking this medicine.

You may notice relief from acid reflux symptoms and heartburn after one day of treatment with pantoprazol, but this does not mean that the medicine will provide immediate relief. You should not take it as a preventive measure.

If you have had symptoms of dyspepsia or heartburn repeatedly for some time, remember to visit your doctor periodically.

Before taking this medicine, tell your doctor if:

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

Using pantoprazol with other medicines

Pantoprazol may prevent other medicines from working properly.

Tell your doctor if you are using any medicine that contains any of the following active ingredients:

• Ketoconazole (used to treat fungal infections).
• Warfarin or phenprocoumon (used to make blood more fluid and prevent clot formation). You may have additional blood tests.
• Atazanavir (used to treat HIV infection). You should not use pantoprazol if you are taking atazanavir.

Do not take pantoprazol with other medicines that limit the amount of acid produced in the stomach, such as another proton pump inhibitor (omeprazol, lansoprazol, or rabeprazol) or an H2 antagonist (e.g., Ranitidine, famotidine).

However, if necessary, you can take pantoprazol with antacids (e.g., magaldrate, alginate acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate, or combinations).

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription. This also includes herbal or homeopathic treatments.

Using pantoprazol with food and drinks

The tablets should be swallowed whole, with some liquid, before a meal.

Pregnancy and breastfeeding

Do not take pantoprazol if you are pregnant or breastfeeding, think you may 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 use machines if you experience side effects such as dizziness or blurred vision.

Pantoprazol Healthkern contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take Pantoprazol Healthkern

Follow the instructions for administration of this medicine described in this leaflet or as indicated by your doctor or pharmacist. If you are in doubt, ask your doctor or pharmacist.

Take one tablet per day. Do not exceed the recommended dose of 20 mg of pantoprazol per day.

You should take this medicine for at least two or three consecutive days. Stop taking pantoprazol when you are completely free of symptoms. You may notice relief from acid reflux symptoms and heartburn after one day of treatment with pantoprazol, but this does not mean that the medicine will provide immediate relief.

If you do not notice relief from symptoms after taking this medicine for 2 consecutive weeks, consult your doctor.

Do not take pantoprazol tablets for more than 4 weeks without consulting your doctor.

Take the tablet before one of the main meals, at the same time every day. You should swallow the tablet whole with a little water. Do not chew or break the tablet.

Use in children and adolescents

Pantoprazol should not be used in children or adolescents under 18 years old.

If you take more pantoprazol than you should

Inform your doctor or pharmacist immediately. If possible, take your medicine and this leaflet with you.

No symptoms of overdose are known.

If you forget to take pantoprazol

Do not take a double dose to make up for forgotten doses. Take the normal dose the next day, at the usual time.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediatelyor contact the emergency department of the nearest hospital, if you notice any of the following side effects. Stop taking this medicine immediately, but take this leaflet and/or the tablets with you.

• Severe allergic reactions (rare): hypersensitivity reactions, also called anaphylactic reactions, anaphylactic shock, and angioedema. Typical symptoms are: swelling of the face, lips, mouth, tongue, and/or throat, which can cause difficulty swallowing or breathing, hives (urticaria), intense dizziness with very rapid heartbeat and profuse sweating.
• Severe skin reactions (frequency unknown): skin rash with swelling, blistering, or peeling of the skin, skin loss, and bleeding around the eyes, nose, mouth, or genitals, and rapid deterioration of your general health, or skin rash after sun exposure.
• Other serious side effects (frequency unknown): yellowing of the skin and eyes (due to severe liver damage), or kidney problems such as pain when urinating and pain in the lower back with fever.

Side effects may occur with a certain frequency, and are described as follows:

• Very common: may affect more than 1 in 10 people.
• Common: may affect up to 1 in 10 people.
• Uncommon: may affect up to 1 in 100 people.
• Rare: may affect up to 1 in 1,000 people.
• Very rare: may affect up to 1 in 10,000 people.
• Frequency not known (cannot be estimated from available data).

Adverse reactions are listed in decreasing order of severity within each frequency interval.

• Common side effects (may affect up to 1 in 10 people)

Benign polyps in the stomach.

• Uncommon side effects(may affect up to 1 in 100 people)

Headache; dizziness; diarrhea; dizziness, vomiting; swelling and flatulence (gas); constipation; dry mouth; stomach pain and discomfort; skin rash or skin eruption; itching; feeling of weakness, fatigue, or general malaise; sleep disorders; increased liver enzymes in blood tests.

• Rare side effects(may affect up to 1 in 1,000 people)

Distortion or complete loss of taste; vision disorders such as blurred vision; joint pain; muscle pain; weight changes; elevated body temperature; swelling of the limbs; allergic reactions; depression; increased bilirubin and fat levels in the blood (detected in blood tests), increased breast size in men; high fever and sharp drop in circulating granulocytes (observed in blood tests).

• Very rare side effects(may affect up to 1 in 10,000 people)

Disorientation, decrease in platelet count in the blood that can lead to more frequent bleeding or bruising than normal; decrease in white blood cell count that can lead to more frequent infections; coexistence of an abnormal reduction in the number of red blood cells, white blood cells, and platelets (observed in blood tests).

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

Hallucinations, confusion (especially in patients with a history of these symptoms); decrease in sodium levels in the blood; decrease in magnesium levels in the blood.

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

If you are taking proton pump inhibitors like pantoprazol, 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 can increase the risk of osteoporosis).

Skin rash, possibly with joint pain.

Inflammation of the large intestine that causes persistent watery diarrhea.

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

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Pantoprazol Healthkern

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

Pantoprazol Healthkern in aluminum/aluminum blisters should be stored below 30°C.

Store in the original package.

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 unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Pantoprazol Healthkern

The active ingredient is pantoprazol. Each gastro-resistant tablet contains 20 mg of pantoprazol (as sodium sesquihydrate).

The other ingredients (excipients) are: Disodium phosphate, Mannitol, Microcrystalline cellulose, Sodium croscarmellose, Magnesium stearate, Hypromellose, Triethyl citrate, Sodium starch glycolate (Type A) (from potato), Methacrylic acid - ethyl acrylate copolymer (1:1), dispersion 30%, and Yellow iron oxide (E-172).

Appearance of the product and pack contents

Pantoprazol Healthkern 20 mg is presented in the form of gastro-resistant tablets, yellow, oval, concave, smooth. Each pack contains 7 or 14 gastro-resistant tablets.

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer:

Teva Pharma, S.L.U.

Polígono Malpica C/ C, 4

50016 Zaragoza

Spain

Or

Recipharm Parets, S.L.

C/ Ramón y Cajal 2

08150 Parets del Vallés (Barcelona)

Spain

Date of last revision:

October 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es