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This is an X-PIL, which is a text only patient information leaflet, designed for people with sight problems.


Takeda Products Ireland Ltd

First Floor, 3013 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 642 0021
Fax: +353 1 642 0020
WWW: http://www.takeda.ie
Medical Information Direct Line: 1800 937970
Medical Information e-mail: medinfo@takeda.co.uk
Medical Information Facsimile: +44 (0)1628 526 617


Patient Information Leaflet last updated on medicines.ie: 12/04/2013
XPIL Protium 40mg

PACKAGE LEAFLET: INFORMATION FOR THE USER

Protium® 40 mg gastro-resistant tablets

Pantoprazole

Read all of this leaflet carefully before you start taking 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. 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.

In this leaflet:

1. What Protium is and what it is used for
2. Before you take Protium
3. How to take Protium
4. Possible side effects
5. How to store Protium
6. Further information

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1. WHAT PROTIUM IS AND WHAT IT IS USED FOR

Protium is a selective “proton pump inhibitor”, a medicine which reduces the amount of acid produced in your stomach. It is used for treating acid-related diseases of the stomach and intestine.

Protium is used for treating:

Adults and adolescents 12 years of age and above:

  • Reflux oesophagitis. An inflammation of your oesophagus (the tube which connects your throat to your stomach) accompanied by the regurgitation of stomach acid.

Adults:

  • An infection with a bacterium called Helicobacter pylori in patients with duodenal ulcers and stomach ulcers in combination with two antibiotics (Eradication therapy). The aim is to get rid of the bacteria and so reduce the likelihood of these ulcers returning.
  • Stomach and duodenal ulcers.
  • Zollinger-Ellison-Syndrome and other conditions producing too much acid in the stomach.
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2. BEFORE YOU TAKE PROTIUM

Do not take Protium

  • If you are allergic (hypersensitive) to pantoprazole or to any of the other ingredients of Protium (see section 6).
  • If you are allergic to medicines containing other proton pump inhibitors.

Take special care with Protium

  • 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, especially when you are taking Protium as a long-term treatment. In the case of a rise of liver enzymes the treatment should be stopped.
  • If you have reduced body stores or risk factors for reduced vitamin B12 and receive long-term treatment with pantoprazole. As with all acid reducing agents, pantoprazole may lead to a reduced absorption of vitamin B12.
  • 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.

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

  • an unintentional loss of weight
  • repeated vomiting
  • difficulty in swallowing
  • vomiting blood
  • you look pale and feel weak (anaemia)
  • you notice blood in your stools
  • severe and/or persistent diarrhoea, as Protium has been associated with a small increase in infectious diarrhoea.

Your doctor may decide that you need some tests to rule out malignant disease because pantoprazole also alleviates the symptoms of cancer and could cause delay in diagnosing it. If your symptoms continue in spite of your treatment, further investigations will be considered.

If you take Protium on a long-term basis (longer than 1 year) your doctor will probably keep you under regular surveillance. You should report any new and exceptional symptoms and circumstances whenever you see your doctor.

Taking other medicines

Protium may influence the effectiveness of other medicines, so tell your doctor if you are taking

  • Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer) because Protium may stop these and other medicines from working properly.
  • Warfarin and phenprocoumon, which affect the thickening, or thinning of the blood. You may need further checks.
  • Atazanavir (used to treat HIV-infection).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

There are no adequate data from the use of pantoprazole in pregnant women. Excretion into human milk has been reported. If you are pregnant, or think you may be pregnant, or if you are breast-feeding, you should use this medicine only if your doctor considers the benefit for you greater than the potential risk for your unborn child or baby.

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

Driving and using machines

If you experience side effects like dizziness or disturbed vision, you should not drive or operate machines.

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3. HOW TO TAKE PROTIUM

Always take Protium exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

When and how should you take Protium?

Take the tablets 1 hour before a meal without chewing or breaking them and swallow them whole with some water.

Unless told otherwise by your doctor, the usual dose is:

Adults and adolescents 12 years of age and above:

To treat reflux oesophagitis

The usual dose is one tablet a day. Your doctor may tell you to increase to 2 tablets daily. The treatment period for reflux oesophagitis is usually between 4 and 8 weeks. Your doctor will tell you how long to take your medicine.

Adults:

For the treatment of an infection with a bacterium called Helicobacter pylori in patients with duodenal ulcers and stomach ulcers in combination with two antibiotics (Eradication therapy).

One tablet, two times a day plus two antibiotic tablets of either amoxicillin, clarithromycin and metronidazole (or tinidazole), each to be taken two times a day with your pantoprazole tablet.

Take the first pantoprazole tablet 1 hour before breakfast and the second pantoprazole tablet 1 hour before your evening meal. Follow your doctor’s instructions and make sure you read the package leaflets for these antibiotics. The usual treatment period is one to two weeks.

For the treatment of stomach and duodenal ulcers.

The usual dose is one tablet a day. After consultation with your doctor, the dose may be doubled.

Your doctor will tell you how long to take your medicine. The treatment period for stomach ulcers is usually between 4 and 8 weeks. The treatment period for duodenal ulcers is usually between 2 and 4 weeks.

For the long-term treatment of Zollinger-Ellison-Syndrome and of other conditions in which too much stomach acid is produced.

The recommended starting dose is usually two tablets a day.

Take the two tablets 1 hour before a meal. Your doctor may later adjust the dose, depending on the amount of stomach acid you produce. If prescribed more than two tablets a day, the tablets should be taken twice daily.

If your doctor prescribes a daily dose of more than four tablets a day, you will be told exactly when to stop taking the medicine.

Special patient groups:

  • If you have kidney problems, moderate or severe liver problems, you should not take Protium for eradication of Helicobacter pylori.
  • If you suffer from severe liver problems, you should not take more than one tablet 20 mg pantoprazole a day (for this purpose tablets containing 20 mg pantoprazole are available).
  • Children below 12 years. These tablets are not recommended for use in children below 12 years.

If you take more Protium than you should

Consult your doctor or pharmacist. There are no known symptoms of overdose.

If you forget to take Protium

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

If you stop taking Protium

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

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

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4. POSSIBLE SIDE EFFECTS

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

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

very common (affects more than 1 user in 10)

common (affects 1 to 10 users in 100)

uncommon (affects 1 to 10 users in 1,000)

rare (affects 1 to 10 users in 10,000)

very rare (affects less than 1 user in 10,000)

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

If you get any of the following side effects, stop taking these tablets and tell your doctor immediately, or contact the casualty department at your nearest hospital:

  • Serious allergic reactions (frequency rare): swelling of the tongue and/or throat, difficulty in swallowing, hives (nettle rash), difficulties in breathing, allergic facial swelling (Quincke’s oedema / angioedema), severe dizziness with very fast heartbeat and heavy sweating.
  • Serious skin conditions (frequency not known): blistering of the skin and rapid deterioration of your general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson-Syndrome, Lyell-Syndrome, Erythema multiforme), and sensitivity to light.
  • Other serious conditions (frequency not known): yellowing of the skin or whites of the eyes (severe damage to liver cells, jaundice) or fever, rash, and enlarged kidneys sometimes with painful urination, and lower back pain (serious inflammation of the kidneys).

Other side effects are:

  • Uncommon (affects 1 to 10 users in 1,000)
    headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; itching; feeling weak, exhausted or generally unwell; sleep disorders. Taking a proton pump inhibitor like pantoprazole, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
  • Rare (affects 1 to 10 users in 10,000)
    distortion or complete lack of the sense of taste; disturbances in vision such as blurred vision; hives; pain in the joints; muscle pains; weight changes; raised body temperature; high fever; swelling of the extremities (peripheral oedema); allergic reactions; depression; breast enlargement in males.
  • Very Rare (affects less than 1 user in 10,000)
    disorientation.
  • Not known (frequency cannot be estimated from the available data)
    Hallucination, confusion (especially in patients with a history of these symptoms); decreased sodium level in blood. If you are on Protium 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 contractions, disorientation, convulsions, dizziness, 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.

Side effects identified through blood tests:

  • Uncommon (affects 1 to 10 users in 1,000)
    an increase in liver enzymes.
  • Rare (affects 1 to 10 users in 10,000)
    an increase in bilirubin; increased fat levels in blood; sharp drop in circulating granular white blood cells, associated with high fever.
  • Very Rare (affects less than 1 user in 10,000)
    a reduction in the number of blood platelets, which may cause you to bleed or bruise more than normal; a reduction in the number of white blood cells, which may lead to more frequent infections; coexisting abnormal reduction in the number of red and white blood cells, as well as platelets.

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.

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5. HOW TO STORE PROTIUM

Keep out of the reach and sight of children.

Do not use Protium after the expiry date, which is stated on the carton and the container after EXP. The expiry date refers to the last day of that month. For HDPE bottles: Do not use tablets beyond 120 days after first opening of the bottle.

This medicine does not require any special storage conditions.

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.

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6. FURTHER INFORMATION

What Protium contains

  • The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium sesquihydrate).
  • The other ingredients are:
    Core: sodium carbonate (anhydrous), mannitol, crospovidone, povidone K90, calcium stearate.
    Coating: hypromellose, povidone K25, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, methacrylic acid-ethyl acrylate copolymer (1:1), polysorbate 80, sodium laurilsulfate, triethyl citrate.
    Printing ink: shellac, red, black and yellow iron oxide (E172) and ammonia solution, concentrated.

What Protium looks like and contents of the pack

Yellow, oval, biconvex gastro-resistant tablet imprinted with “P 40” on one side.

Packs: bottles (high density polyethylene container with low density polyethylene screw cap closure) and blister (ALU/ALU blister) without cardboard reinforcement or with cardboard reinforcement (blister wallet).

Protium is available in the following pack sizes:

Packs with 7, 10, 14, 15, 24, 28, 30, 48, 49, 56, 60, 84, 90, 98, 98 (2x49), 100, 112, 168 gastro-resistant tablets.

Hospital packs with 50, 90, 100, 140, 140 (10x14), 150 (10x15), 700 (5x140) gastro-resistant tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Takeda GmbH
Byk-Gulden-Straße 2
D-78467 Konstanz
Germany

Manufacturer

Takeda GmbH
Production Site Oranienburg
Lehnitzstraße 70-98
D-16515 Oranienburg
Germany

Marketing Company

Takeda Products Ireland Ltd.
Unit 2051 Castle Drive
Citywest Business Campus
Dublin 24
Ireland

This medicine is authorised in the Member States of the EEA under the following names:

Name of Member State Name of the medicine

Austria Pantoloc 40 mg-Filmtabletten, Zurcal 40 mg-Filmtabletten

Belgium Pantozol, Zurcale

Bulgaria Controloc

Cyprus Controloc

Czech Republic Controloc 40 mg

Denmark Pantoloc

Estonia Controloc 40 mg

Finland Somac 40 mg

France Eupantol 40 mg, Inipomp 40 mg,

Germany Pantozol 40 mg, Pantoprazol NYC 40 mg, Rifun 40 mg, Zurcal S 40 mg

Greece Controloc, Zurcazol

Hungary Controloc 40 mg

Ireland Protium

Italy Pantorc, Pantopan, Pantecta, Peptazol

Latvia Controloc 40 mg

Lithuania Controloc 40 mg

Luxembourg Pantozol-40, Panto-Byk-40

Netherlands Pantozol, Pantoprazol Nycomed 40 mg

Norway Somac

Poland Controloc 40

Portugal Pantoc 40 mg, Zurcal 40 mg, Apton 40 mg, Pantoprazole ALTANA 40 mg

Romania Controloc 40 mg

Slovakia Controloc 40 mg

Slovenia Controloc 40 mg

Spain Pantecta 40 mg comprimidos gastrorresistentes, Anagastra 40 mg comprimidos gastrorresistentes, Ulcotenal 40 mg comprimidos gastrorresistentes

Sweden Pantoloc

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This leaflet was last approved in 02/2013

Detailed information on this medicinal product is available on the website of the Heads of Medicines Agencies (HMA) http://www.hma.eu

IRL F.1/0213/6xxxxxx



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Active Ingredients

 
   Pantoprazole sodium sesquihydrate