PANTOPRAZOL SERRACLINICS 40 mg POWDER FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

PANTOPRAZOL SERRACLINICS 40 mg Powder for Solution for Injection EFG

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, inform your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the Package Leaflet:

1. What Pantoprazol Serraclinics 40 mg Powder for Solution for Injection is and what it is used for
2. Before you start using Pantoprazol Serraclinics 40 mg Powder for Solution for Injection
3. How to use Pantoprazol Serraclinics 40 mg Powder for Solution for Injection
4. Possible side effects
5. Storage of Pantoprazol Serraclinics 40 mg Powder for Solution for Injection
6. Further information

1. What is PANTOPRAZOL SERRACLINICS 40 mg POWDER FOR SOLUTION FOR INJECTION and what is it used for

Pantoprazol Serraclinics 40 mg Powder for Solution for Injection is a "proton pump inhibitor" that reduces the amount of acid produced in your stomach. It is used to treat diseases related to stomach and intestine acid.

This medicine is injected into a vein and will only be administered to you if your doctor considers that an injection of pantoprazol is more convenient for you than pantoprazol tablets at this time. The tablets will replace the injections as soon as your doctor considers it appropriate.

Pantoprazol Serraclinics 40 mg Powder for Solution for Injection is used to treat:

• Reflux esophagitis (inflammation of your esophagus, which is the tube that connects your throat to your stomach) accompanied by acid reflux from the stomach.
• Duodenal ulcers.
• Stomach ulcers.
• Zollinger-Ellison syndrome and other diseases in which a lot of acid is produced in the stomach.

2. PANTOPRAZOL SERRACLINICS 40 mg POWDER FOR SOLUTION FOR INJECTION

Do not use Pantoprazol Serraclinics 40 mg Powder for Solution for Injection

• if you are allergic (hypersensitive) to pantoprazol or any of the other ingredients of Pantoprazol Serraclinics 40 mg Powder for Solution for Injection (see section 6).
• if you are allergic to medicines that contain other proton pump inhibitors.

Be cautious with Pantoprazol Serraclinics 40 mg Powder for Solution for Injection

• 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. If the levels increase, treatment should be discontinued.
• if you are taking medicines that contain atazanavir (for the treatment of HIV infection) while taking pantoprazol, consult your doctor.

Taking proton pump inhibitors like Pantoprazol Serraclinics 40 mg Powder for Solution for Injection for prolonged periods (more than one year) may increase the risk of hip, wrist, and spine fractures. Inform your doctor if you seem to have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Inform your doctor immediatelyif 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 and/or persistent diarrhea, as the use of pantoprazol has been associated with a small increase in infectious diarrhea.

Your doctor may decide to perform some tests to rule out the presence of a malignant disease, as pantoprazol relieves the symptoms of cancer and could delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

Taking other medicines

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

The injections of Pantoprazol Serraclinics 40 mg Powder for Solution for Injection may interfere with the effectiveness of other medicines, so you should inform your doctor if you are taking:

• Medicines used to treat fungal infections (such as ketoconazole, itraconazole, and posaconazole) or erlotinib (used in certain types of cancer) because Pantoprazol Serraclinics 40 mg Powder for Solution for Injection may prevent these medicines from working properly.
• Warfarin and phenprocoumon, which affect blood coagulation. You may need additional checks.
• Atazanavir (used in the treatment of HIV infection).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

There is not enough data on the use of pantoprazol in pregnant women. The active ingredient passes into 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.

Driving and using machines

Do not drive or operate machines if you notice side effects such as dizziness or vision disturbances.

Important information about some of the ingredients of Pantoprazol Serraclinics 40mg Powder for Solution for Injection

This medicine contains less than 23 mg (1 mmol) of sodium per vial, so it is considered essentially "sodium-free".

3. How to use PANTOPRAZOL SERRACLINICS 40 mg POWDER FOR SOLUTION FOR INJECTION

Your doctor or nurse will administer the daily dose as an injection into a vein over a period of 2-15 minutes.

The normal dose is:

For the treatment of reflux esophagitis, stomach ulcers, and duodenal ulcers:

1 vial (40 mg of pantoprazol) per day.

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

2 vials (80 mg of pantoprazol) per day.

Subsequently, your doctor may adjust the dose depending on the amount of acid secretion you produce. If you are prescribed more than 2 vials (80 mg) per day, the injections will be administered in equal doses. Your doctor may prescribe a dose of more than 4 vials (160 mg) per day for a short period. If you need to quickly control your stomach acid levels, an initial dose of 160 mg (4 vials) should be sufficient to significantly reduce the amount of stomach acid.

Special patient groups:

If you have severe liver problems, the daily injection should be only 20 mg (1/2 vial).

Children (under 18 years). The use of these injections is not recommended in children.

If you use more Pantoprazol Serraclinics 40 mg Powder for Solution for Injection than you should

These doses are carefully checked by a nurse or doctor, so it is extremely unlikely that an overdose will occur.

No symptoms of overdose are known.

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

4. Possible side effects

Like all medicines, Pantoprazol Serraclinics 40 mg Powder for Solution for Injection can cause side effects, although not everybody gets them.

The frequency of the possible side effects mentioned below is defined using the following convention:

Very common(at least 1 in 10 patients)

Common(at least 1 in 100 patients)

Uncommon(at least 1 in 1,000 patients)

Rare(at least 1 in 10,000 patients)

Very rare(less than 1 in 10,000 patients)

Not known(cannot be estimated from the available data)

If you notice any of the following side effects, 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, urticaria, difficulty breathing, swelling of the face of allergic origin (Quincke's edema/angioedema), intense dizziness with very rapid heartbeat and profuse sweating.

Severe skin disorders(not known):

With 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 disorders(not known):

Yellowing of the skin or the whites of the eyes (severe liver cell damage, jaundice) or fever, redness of the skin, and enlargement of the kidneys, sometimes with pain when urinating and pain in the lower back (severe kidney inflammation).

Other side effects are:

Common(at least 1 in 100 patients):

Inflammation of the vein wall and blood clotting at the injection site (thrombophlebitis).

Uncommon(at least 1 in 1,000 patients):

Headache; dizziness; diarrhea; nausea; vomiting, bloating, and flatulence; constipation; dry mouth; abdominal pain and discomfort; erythema; exanthema, rash; itching; feeling of weakness, fatigue, or general malaise; sleep disturbances.

Rare(at least 1 in 10,000 patients):

Changes in vision such as blurred vision, urticaria; joint pain, muscle pain, weight changes; elevated body temperature; swelling of the limbs (peripheral edema); allergic reactions; depression; breast enlargement in men.

Very rare(less than 1 in 10,000 patients):

Disorientation.

Not known(cannot be estimated from the available data):

Hallucinations, confusion (especially in patients with a history of these symptoms); decrease in sodium levels in the blood. If you are taking Pantoprazol Serraclinics for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, see your 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.

Side effects identified through blood tests:

Uncommon(at least 1 in 1,000 patients):

Increased liver enzyme values.

Rare(at least 1 in 10,000 patients):

Increased bilirubin values; increased blood fat levels.

Very rare(less than 1 in 10,000 patients):

Reduction in the number of platelets in the blood, which can cause more bleeding or bruising than usual; reduction in the number of white blood cells, which could lead to more frequent infections.

If you experience any of the side effects, inform your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storage of PANTOPRAZOL SERRACLINICS 40 mg POWDER FOR SOLUTION FOR INJECTION

Keep out of the reach and sight of children.

Do not use Pantoprazol Serraclinics 40 mg Powder for Solution for Injection after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Keep the vial in the outer packaging to protect it from light.

After reconstituting the solution or reconstituting and diluting it, it has been shown to be stable for up to 12 hours at 25°C.

From a microbiological point of view, the product should be used immediately. Otherwise, the storage within the time and conditions of use are the responsibility of the user.

Do not use Pantoprazol Serraclinics 40 mg Powder for Solution for Injection if you notice that the visual appearance of the solution has changed (e.g., if you notice turbidity or precipitates).

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. FURTHER INFORMATION

Composition of Pantoprazol Serraclinics 40 mg Powder for Solution for Injection

• The active ingredient is pantoprazol. Each vial contains 40 mg of pantoprazol (as sodium sesquihydrate).
• The other ingredients (excipients) are: mannitol (E-421), sodium citrate dihydrate, sodium hydroxide (pH adjustment).

Appearance of the product and packaging contents

Pantoprazol Serraclinics 40 mg Powder for Solution for Injection is a uniform and porous powder with a white or almost white color.

Each pack contains 1 vial or 20 vials.

Not all presentations may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorios Serra Pamies, S.A.

Carretera de Castellvell, nº 24

43206 Reus (Tarragona)

Manufacturer:

Laboratorios Alcalá Farma, S.L

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

VALDEPHARM

Parc Industriel d’incaville – BP 606 27106 Val de Reuil Cedex

France

LABORATORIOS SERRA PAMIES, S.A.

Carretera de Castellvell, 24, Reus (Tarragona) 43206 España

Sofarimex - Indústria Química e Farmacêutica, S.A.

Av. das Indústrias -Alto do Colaride

2735 - 213 Cacém PORTUGAL

This leaflet was approved in November 2012

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

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THIS INFORMATION IS INTENDED ONLY FOR DOCTORS OR HEALTHCARE PROFESSIONALS:

The intravenous solution to be used is prepared by injecting 10 ml of a 0.9% sodium chloride injection solution (9 mg/ml) into the vial containing the lyophilized powder. This solution can be administered directly or after mixing it with 100 ml of a 0.9% sodium chloride injection solution or 5% glucose solution (55mg/ml). Plastic or glass containers should be used to prepare the dilution.

Pantoprazol Serraclinics 40 mg Powder for Solution for Injection should not be prepared or mixed with solvents other than those specified.

After reconstitution or reconstitution and dilution, the solution has a physical and chemical stability of 12 hours at 25°C.

From a microbiological point of view, the product should be used immediately. If not, the storage within the time and conditions of use are the responsibility of the user.

The preparation should be administered intravenously over 2-15 minutes.

The contents of the vial are for single intravenous use. Any remaining product in the vial or any vial in which a change in appearance is detected (e.g., if turbidity or precipitates are observed) should be discarded.