AFAPRAZOL® Pantoprazole (as sodium) 40mg

AFAPRAZOL®

Pantoprazole

Powder for injection 40mg

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. t

it is used f

AFAPRAZOL® is used to treat:

• inflammation of the gullet (oesophagus) caused by acid from the stomach escaping into the gullet(usually with heartburn)
• ulcers in the stomach (gastric ulcer)
• ulcers in the upper part of the intestines (duodenal ulcer)
• severely increased acid secretion in the stomach (Zollinger-Ellison syndrome).

 

Before use this drug, ask your doctor:

• if you are allergic (hypersensitive) to pantoprazole
• if you suffer from kidney or liver disease because this is important for your doctor in order to give you the right dose.
• if you have recently:
• suffered any unintentional weight loss
• been vomiting frequently
• experienced pain or difficulty when swallowing
• vomited blood or dark particles that look like coffee-grounds
• passed black tarry stools.
• if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It is especially important to mention to your doctor if you are also taking:
• ketoconazole (used to treat fungal infections of the skin or nails) or other medicines whose uptake in the blood depends on the degree of acidity in the stomach
• anticoagulants (blood thinning tablets like warfarin or phenprocoumon): your doctor may check your blood clotting to adapt the dose

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Experience in pregnant women is very limited. If you are pregnant you should not be given this medicine unless your doctor considers it absolutely necessary.

There is no information on the excretion of pantoprazole, the active substance in this medicine, into human breast milk. If you are breast-feeding and treatment with this medicine is necessary, your doctor should decide whether to continue or discontinue breast-feeding.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given Pantoprazole

• if you have severe liver problems. Please tell your doctor if you ever had problems with your liver in the past. He will check your liver enzymes more frequently. In the case of a rise of liver enzymes the treatment should be stopped.
• if you are taking a medicine containing atazanavir (for the treatment of HIV-infection) at the same time as pantoprazole, ask your doctor for specific advice.
• if you are on Pantoprazole for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle V021 3 contractions, disorientation, convulsions, dizziness or increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
• if you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole that reduces stomach acid.
• if you are due to have a specific blood test (Chromogranin A).

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

Driving and using machines

No effect on the ability to drive and use machines is to be expected.

Medical Tests

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking pantoprazole.

Method of administration

• Slow I.V injection

Inject 10 mL of physiological sodium chloride solution into the vial containing the dry substance. The resulting potency of the solution is 4 mg/mL of pantoprazole, and can be administered by slow injection over 2 to 5 minutes.

• 40 mg I.V infusion

Prepare the 40 mg intravenous injection as described above. The ready-to-use solution should then be further diluted with 90 mL 0.9% Sodium Chloride Injection, or 90 mL of 5% Dextrose Injection. The resulting potency of the diluted solution is 0.4 mg/mL of pantoprazole, and can be

administered by infusion over 15 minutes.

• 80 mg I.V infusion:

Two vials of PANTOPRAZOLE FOR INJECTION are required. Each vial

should be reconstituted with 10 mL of physiological sodium chloride solution. The contents of the two vials should be further diluted together with 80 mL 0.9% Sodium Chloride Injection USP, or 80 mL 5% Dextrose

Injection USP. The resulting potency of the diluted solution is 0.8 mg/mL of pantoprazole, and can be administered by infusion over 15 minutes.

The recommended dose

Treatment of the inflammation of the gullet and ulcers in the stomach or intestine:

The usual dose is one injection/infusion of 40 mg each day, given over a 2 to 15 minute period of time, for up to a week.

Treatment of Zollinger-Ellison syndrome:

The usual starting dose is a daily treatment of 80 mg. Thereafter, the dosage can be adjusted as necessary, based on measurements of gastric acid secretion. With doses above 80 mg daily, the dose should be divided and given twice daily. A temporary increase of the dosage above 160 mg pantoprazole is possible but should not be applied longer than necessary.

Patients with liver problems:

If you have severe liver disease your doctor may reduce your dose to 20 mg. Your doctor may take blood tests to watch how well your liver is working.

Patients with kidney problems and elderly patients:

The daily dose should not exceed 40 mg.

Children:

This medicine is not recommended for children.

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

 

If you are given more Afaprazol for injection than you should

Seek emergency medical attention or call the Poison Help line.

 

If you forget to use Afaprazol for injection

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

If you stop using Afaprazol for injection

Do not stop taking Pantoprazole for injection unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor or nurse.

Adverse reactions

Like all medicines, Pantoprazole 40 mg powder for solution for injection can cause side effects, although not everybody gets them.

Serious side effects

Tell your doctor or nurse straight away if you have any of the following symptoms of a severe allergic reaction:

• sudden difficulty in breathing, speaking and swallowing
• swelling of the lips, face and neck
• extreme dizziness or collapse
• severe or itchy skin rash, especially if this shows blistering and there is soreness of the eyes, mouth or genital organs

Contact your doctor as soon as possible if you experience any of the following side effects:

• yellowing of the skin or whites of the eyes caused by liver problems
• increased or reduced urine output, or traces of blood in your urine, sometimes with swollen limbs and/or flank pain caused by kidney problems
• skin rash caused by sensitivity to sunlight
• unusual bruising or bleeding caused by reduction of blood platelets

These are all serious side effects. You may need urgent medical attention. Serious side effects are very rare (affecting less than 1 in 10,000 people).

Other possible side effects:

Common (may affect up to 1 in 10 people)

• stomach pain
• diarrhoea, constipation, wind
• headache

Uncommon (may affect up to 1 in 100 people)

• nausea, vomiting
• dizziness
• blurred vision
• itchiness, skin rash

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

• dry mouth
• joint pain

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

• redness and/or swelling at the injection site
• swollen ankles
• fever
• muscle pain
• feeling sad or depressed
• reduction in the number of white blood cells, which makes infections more likely
• increased levels of blood lipids (triglycerides)
• blood tests which show changes of the way the liver is working.
• If you use this medicine for long term treatment tell your doctor if you experience any of the following signs of a lack of vitamin B12:
• tiredness, sore mouth, tingling and numbness of hands and feet, pale skin.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

 

Special precautions for storage

• Keep out of the reach and sight of children.
• Do not use Pantoprazole 40 mg powder for solution for injection after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
• Do not store above 25°C. Keep container in outer carton.
• After preparation of the solution by your doctor or nurse, it must be stored below 25°C and used within 12 hours. From a microbiological point of view , the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
• Pantoprazole 40 mg powder for solution for injection should not be used if you notice cloudiness or precipitation. These are visible signs of deterioration.
• The contents of the vial is meant for single use; any product that has remained in the vial has to be discarded.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

 

 

AFAPRAZOL®

Each vial contains:

Pantoprazole (as sodium) 40mg

Manufacture by Afa chemie pharmaceutical co. Tehran-Iran.