PANTO-DENK 40 Tablet

To treat adults and adolescents aged 12 years and older for

- reflux oesophagitis. An inflammation of the oesophagus accompanied by the regurgitation of stomach acid.

To treat adults for

- an infection with a bacterium called Helico-bacter 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.

Method of administration

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

The recommended dose is:

Adults and adolescents aged 12 years and older

For the treatment of reflux oesophagitis

The usual dose is 1 tablet a day. Your doctor may tell you to increase to 2 tablets daily. The treatment period for reflux oesophagitis is usually 4-8 weeks.

Adults

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

1 tablet, two times a day (1 hour before breakfast and evening meal.)

+ amoxicillin or clarithromycin

+ metronidazole or tinidazole

The usual treatment period is 1-2 weeks.

For the treatment of stomach and duodenal ulcers

The usual dose is 1 tablet a day. After consultation with your doctor, the dose may be doubled.

The treatment period for stomach ulcers is usually 4-8 weeks, for duodenal ulcers is usually 2-4 weeks.

For the long-term treatment of Zollinger-Ellison-Syndrome and of other conditions producing too much acid in the stomach

The recommended staring dose is usually 2 tablets a day. (1 hour before a meal)

If prescribed more than 2 tablets a day, the tablets should be taken twice daily.

Please see the package insert about the details below:

Patients with kidney/liver problems

Use in children and adolescents

- if you are allergic to pantoprazole, soya, peanuts or any of the ingredients of this medicine.

- if you are allergic to medicines containing other proton pump inhibitors.

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), possibly leading to kidney failure.

Other side effects are:

Common

Benign polyps in the stomach.

Uncommon

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, fracture in the hip, wrist or spine.

Rare

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

Disorientation.

Very rarely, lecithin from soya beans may cause allergic reactions.

Not known

Hallucination, confusion (especially in patients with a history of these symptoms), decreased sodium level in blood, decreased magnesium level in blood, feeling of tingling, prickling, pins and needles, burning sensation or numbness, rash, possibly with pain in the joints.

Side effects identified through blood tests:

Uncommon

Increase in liver enzymes.

Rare

Increase in bilirubin, increased fat levels in blood, sharp drop in circulating granular white blood cells, associated with high fever.

Very rare

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.

See the package insert about details.

- medicines such as ketoconazole, itraconazole and Posaconazole or erlotinib.

- warfarin and phenprocoumon

- medicines used to treat HIV-infection, such as atazanavir

- methotrexate

- fluvoxamine

- rifampicin

- St John’s wort.

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 breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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.

See the package insert about details.

Talk to your doctor or pharmacist before taking this medicine:

- If you have severe liver problems.

- If you have reduced body stones 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 HIV protease inhibitors such as atazanavir at the same time as pantoprazole.

- Taking a proton pump inhibitor like pantoprazole, especially over a period of more than 1 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).

- If you are on pantoprazole for more than 3 months it is possible that the levels of magnesium in your blood may fall.

- If you have ever had a skin reaction after treatment with a medicine similar to Pant0-Denk 40 that reduces stomach acid. If you get a rash on your skin, especially in area exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Panto-Denk 40. Remember to also mention any other ill-effects like pain in your joints.

- If you are due to have a specific blood test (Chromogranin A).

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:

- an unintentional loss of weight

- vomiting, particularly if repeated

- vomiting blood, this may appear as dark coffee grounds in your vomit

- blood in your stools; which may be black or tarry in appearance

- difficultly in swallowing or pain when swallowing

- you look pale and feel weak (anaemia)

- chest pain

- stomach pain

- severe and/or persistent diarrhoea, because this medicine has been associated with a small increase in infectious diarrhoea.

Children and adolescents

This medicine is not recommended for use in children as it has not been proven to work in children below 12 years of age.

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

Pantoprazole is a substituted benzimidazole which inhibits gastric acid secretion by specifically reacting with the proton pumps of parietal cells.

Pantoprazole is converted to its active form in the acid compartment of parietal cells, where it inhibits H+/K+-ATPase, i.e. the final stage of acid production in the stomach. Inhibition is dose-dependent and acts on both basal and stimulated gastric acid secretion. In most patients, symptomatic relief is achieved within 2 weeks. As with other proton pump inhibitors and H2-receptor blockers, gastric acid is reduced by treatment with pantoprazole, leading to a rise in gastrin levels in proportion to acid reduction. The rise in gastrin levels is reversible. As pantoprazole binds to the enzyme distal to the receptor level, it can influence acid secretion irrespectively of stimulation by other substances (acetylcholine, histamine, gastrin). The effect is the same, regardless of whether the medicinal product is administered orally or intravenously.

Fasting levels of gastrin rise during pantoprazole treatment. In short-term use, they do not usually exceed the upper threshold value. In long-term treatment, gastrin levels double in most cases. However, an excessive rise occurs only in isolated cases. As a result, a mild to moderate increase in specific endocrine cells in the stomach is observed (simple to adenomatous hyperplasia) in a small number of long-term treatments. However, based on the studies conducted to date, the development of carcinoid precursors (atypical hyperplasia) or gastric carcinoids can be ruled out in humans.

Based no data from animal studies, effects on endocrine thyroid and liver enzyme parameters cannot be excluded in long-term treatment with pantoprazole beyond 1 year.