Prospect: information for the user

PANTOPRAZOL SERRACLINICS 40 mg powder for injectable solution EFG

Read this prospect carefully before starting to use the medicine.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this prospect, inform your doctor or pharmacist.

1. What is Pantoprazol Serraclinics 40 mg powder for injectable solution and how it is used

2. Before starting to use Pantoprazol Serraclinics 40 mg powder for injectable solution

3. How to use Pantoprazol Serraclinics 40 mg powder for injectable solution

4. Possible adverse effects

5. Storage of Pantoprazol Serraclinics 40 mg powder for injectable solution

6. Additional information

Pantoprazol Serraclinics 40 mg powder for injectable solution is a “proton pump inhibitor” that reduces the amount of acid produced in your stomach. It is used for the treatment of diseases related to stomach and intestinal acid.

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

Pantoprazol Serraclinics 40 mg powder for injectable solution is used for the treatment of:

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

Do not use Pantoprazol Serraclinics 40 mg powder for injectable solution

• if you are allergic (hypersensitive) to pantoprazole or to any of the other components of Pantoprazol Serraclinics 40 mg powder for injectable solution (see section 6).
• if you are allergic to medications that contain other proton pump inhibitors.

Be especially careful with Pantoprazol Serraclinics 40 mg powder for injectable solution

• 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 levels increase, treatment should be suspended.
• if you are taking medications that contain atazanavir (for HIV treatment) while taking pantoprazole, consult your doctor.

Long-term use (more than one year) of proton pump inhibitors such as Pantoprazol Serraclinics 40 mg powder for injectable solution may increase the risk of hip, wrist, and spinal fractures. Inform your doctor if you appear to have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

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 and/or persistent diarrhea, as the use of pantoprazole 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 pantoprazole alleviates cancer symptoms and could delay its diagnosis. If, despite treatment, your symptoms persist, further investigations will be performed.

Use of other medications

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

Pantoprazol Serraclinics 40 mg powder for injectable solution injections may interfere with the effectiveness of other medications, so you should inform your doctor if you are taking:

• Medications 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 injectable solution may make these medications not work correctly.
• Warfarin and phenprocoumon, which affect blood coagulation. You may need additional monitoring.
• Atazanavir (used in HIV treatment).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

There is insufficient data on the use of pantoprazole in pregnant women. The active ingredient passes into 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 that the benefit for you is greater than the potential risk to the fetus or baby.

Driving and operating machines

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

Important information about some of the components of Pantoprazol Serraclinics 40mg powder for injectable solution

This medication contains less than 23 mg (1 mmol) of sodium per vial, making it essentially "sodium-free".

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 and duodenal ulcers:

1 vial (40 mg of pantoprazol) per day.

For long-term treatment of Zollinger-Ellison syndrome and other conditions that cause an increase in stomach acid production:

2 vials (80 mg of pantoprazol) per day.

Your doctor may adjust your dose depending on the amount of stomach acid 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 temporarily prescribe a dose of more than 4 vials (160 mg) per day. 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). These injections are not recommended for use in children.

If you use more Pantoprazol Serraclinics 40 mg powder for injectable solution than you should

These doses have been 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 other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, Pantoprazol Serraclinics 40 mg powder for injectable solution may cause side effects, although not everyone will experience them.

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

Very common(in at least 1 in 10 patients)

Common(in at least 1 in 100 to 1 in 10 patients)

Uncommon(in at least 1 in 1,000 to 1 in 100 patients)

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

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

Frequency not known(cannot be estimated from available data)

If you notice any of the following side effects, inform your doctor immediately or contact the nearest hospital emergency service:

Severe allergic reactions(rare frequency):

Swelling of the tongue and/or throat, difficulty swallowing, urticaria, difficulty breathing, allergic facial swelling (Quincke's edema/angioedema), intense dizziness with rapid heart rate and excessive sweating.

Severe skin disorders(frequency not known):

Blisters on the skin 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 disorders(frequency not known):

Yellowing of the skin or white of the eyes (severe liver cell damage, jaundice) or fever, skin redness, and kidney enlargement sometimes with painful urination and lower back pain (severe kidney inflammation).

Other side effects are:

Common(in at least 1 in 100 to 1 in 10 patients):

Vein wall inflammation and blood clotting at the injection site (thrombophlebitis).

Uncommon(in at least 1 in 1,000 to 1 in 100 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(in at least 1 in 10,000 to 1 in 1,000 patients):

Visual disturbances such as blurred vision, urticaria; joint pain, muscle pain, weight changes; elevated body temperature; peripheral edema; allergic reactions; depression; gynecomastia in men.

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

Disorientation.

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

Hallucinations, confusion (especially in patients with a previous history of these symptoms); decreased sodium levels in blood. If you are taking Pantoprazol Serraclinics for more than three months, it is possible that magnesium levels in blood 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, see your doctor immediately. Low magnesium levels can also cause decreased potassium and calcium levels in blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

Side effects identified through blood tests:

Uncommon(in at least 1 in 1,000 to 1 in 100 patients):

Increased liver enzyme values.

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

Increased bilirubin values; increased blood lipid levels.

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

Reduced platelet count in blood, which may cause increased bleeding or more frequent bruising; reduced white blood cell count, which could lead to more frequent infections.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Keep out of reach and sight of children.

Do not use Pantoprazol Serraclinics 40 mg powder for injectable solution after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

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

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

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

Do not use Pantoprazol Serraclinics 40 mg powder for injectable solution if you observe that the visual appearance of the solution has changed (e.g.: if you observe turbidity or precipitates).

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

Pantoprazole Serraclinics 40 mg powder for injectable solution composition

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

Product appearance and packaging contents

Pantoprazole Serraclinics 40 mg powder for injectable solution is a uniform and porous powder of white or almost white appearance.

Each box contains 1 vial or 20 vials.

Not all presentations may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Laboratorios Serra Pamies, S.A.

Carretera de Castellvell, nº 24

43206 Reus (Tarragona)

Manufacturer responsible:

Laboratorios Alcalá Farma, S.L

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

VALDEPHARM

Parc Industriel d’incaville – BP 60627106 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

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

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THIS INFORMATION IS INTENDED ONLY FOR DOCTORS OR HEALTHCARE PROFESSIONALS:

The injectable solution to be used is prepared by injecting 10 ml of a 0.9% sodium chloride injectable 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 injectable solution or a 5% glucose injectable solution (55 mg/ml). Plastic or glass containers should be used to prepare the dilution.

Pantoprazole Serraclinics 40 mg powder for injectable solution should not be prepared or mixed with other solvents different from 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, conservation within the time and conditions of use are the responsibility of the user.

The prepared solution should be administered intravenously over 2-15 minutes.

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