Pantoprazole

• For heartburn
• For acid reflux and stomach ulcers
• Swallow tablet whole
• Not suitable for children under 12 years of age

Pantoprazole is a type of medicine called a proton pump inhibitor. It acts in the stomach to decrease the production of stomach acid to relieve stomach problems such as acid reflux.

Pantoprazole is used to treat adults and adolescents aged 12 years and above for:

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

In adults, Pantoprazole is used for:

• Stomach and duodenal ulcers, including infection with a bacterium called Helicobacter pylori.
• Zollinger-Ellison syndrome and other conditions that cause increased production of stomach acid.

Always use this medication as directed by your doctor. Take the tablets one hour before a meal without chewing or breaking them. Swallow them whole with some water.

Dosage

Dosage varies per person and is determined by a doctor for each specific patient depending on the symptoms. The general guidelines for use are listed below.

To treat symptoms associated with reflux oesophagitis:

• Adults and adolescents 12 years of age and above: one tablet a day. Your doctor may tell you to increase to two tablets daily.The treatment period for reflux oesophagitis is usually between four and eight weeks. Your doctor will tell you how long you need to take your medicine.

To treat Helicobacter pylori infection in patients with duodenal ulcers and stomach ulcers in combination with two antibiotics (eradication therapy):

• Adults: one tablet, twice a day, plus two antibiotic tablets (see the package leaflet), each to be taken twice a day with your Pantoprazole tablet. Take the first Pantoprazole tablet one hour before breakfast and the second Pantoprazole tablet one hour before your evening meal. Follow your doctor’s instructions and make sure you read the package leaflets for the antibiotics. The usual treatment period is one to two weeks.

To treat stomach and duodenal ulcers:

• Adults: 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 four and eight weeks. The treatment period for duodenal ulcers is usually between two and four weeks.

Please refer to the package leaflet for more information on dosage for other conditions and in special patient groups. This medicine is not suitable for use in children and adolescents under 12 years of age.

Alcohol/driving

This medicine does not interact with alcohol and will normally not affect your ability to drive or operate machinery.

If you use too much/forget to use/stop using Pantoprazole

If you take more Pantoprazole tablets than you were told to, consult your doctor or pharmacist.

If you forget to take a dose of Pantoprazole, do not take a double dose to make up for the forgotten one. Skip the missed dose and continue with your regular dosing schedule.

Do not stop using Pantoprazole without consulting a doctor first.

Pantoprazole is not suitable for everyone. Do not take Pantoprazole if you are allergic to pantoprazole or to any of the other ingredients in this medicine (see section 'What Pantoprazole contains'). Do not take Pantoprazole if you are allergic to medicines containing other proton pump inhibitors, such as omeprazole or esomeprazole.

When should this medicine be used with caution?

Talk to you doctor before taking Pantoprazole if:

• You have severe liver problems. Your doctor will check your liver enzymes more frequently.
• 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.
• You are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV infection) at the same time as pantoprazole.

Pantoprazole also alleviates the symptoms of cancer and could cause delay in diagnosing it. Tell your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another, more serious, disease:

• Unintentional loss of weight.
• Vomiting (particularly if repeated), vomiting blood.
• Difficulty in swallowing or pain when swallowing.
• You look pale and feel weak (anaemia).
• You notice blood in your stools, which may be black or tarry in appearance.
• Severe and/or persistent diarrhoea.

For more information on warnings, please see the package leaflet. Consult a doctor if you are not sure if Pantoprazole is suitable for you.

Pregnancy and breastfeeding

Do not use Pantoprazole if you are pregnant or breastfeeding without consulting a doctor first.

Other medicines and Pantoprazole

Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines.

This is because Pantoprazole may influence the effectiveness of other medicines, including:

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer) because Pantoprazole 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.
• Medicines used to treat HIV infection, such as atazanavir.

Talk to your doctor or pharmacist if you are taking any of these medicines.

Medicines can cause side effects, although some people may not experience any.

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's syndrome, Erythema multiforme), or increased sensitivity to UV 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 that are known to be associated with Pantoprazole include:

Uncommon (may affect up to 1 in 100 people):

• Headache.
• Dizziness.
• Diarrhoea.
• Nausea, vomiting.
• Bloating, flatulence, constipation.
• Dry mouth.
• Abdominal pain and discomfort.
• Itchy skin rash, itching.
• Feeling weak, exhausted or generally unwell.
• Sleep problems.

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

• Disturbances in vision such as blurred vision.
• Hives (nettle rash).
• Pain in the joints, muscle pains.
• Weight changes.
• Raised body temperature.
• Swelling of the arms and/or legs (peripheral oedema).
• Allergic reactions.
• Feeling of dejection and despair (depression).
• Breast enlargement in males.

For a list of all possible side effects, see the package leaflet. Consult a doctor if you experience side effects, also if the side effects are not listed in the package leaflet.

The active substance in Pantoprazole Nycomed is pantoprazole. Each gastro-resistant tablet contains 40 mg 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), ammonia solution, concentrated.

The manufacturer of Pantoprazole Nycomed is:

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

Read the package leaflet before use. The official package leaflet of Pantoprazole Nycomed is available for download here.