Sozol  40 mg Gastro-resistant tablets





Sozol  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.

Sozol 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.


– 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



Do not take Sozol 

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

Take special care with  Sozol

  • 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 Sozol 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 pantoprazole long-term treatment. 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 advise.

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 Sozol 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 Sozol 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 Sozol other medicines

Sozol may influence the effectiveness of other medicines, so tell you 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 Sozol 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 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.



Always take Sozol 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 Sozol?

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.


For the treatment of an infection with a bacterium called Helicobacter pylori in patients withduodenal 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 Sozol 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 sozol than you should

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

If you forget to take sozol

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 sozol

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.



Like all medicines, Sozol 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.

–         Rare (affects 1 to 10 users in 10,000)

 disturbances in vision such as blurred vision; hives; pain in the joints; muscle pains; weight changes; raised body temperature; swelling of the extremities (peripheral oedema); allergic reactions; depression; breast enlargement in males.

–        Very Rare (affects less than 1 user in 10,000)


–         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.


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 fats in the blood.

–         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.

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.



Keep out of the reach and sight of children.

Do not use Sozol after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

Do not store above 25 ºC.

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.



What sozol contains

The active substance is pantoprazole. Each tablet contains 40 mg of pantoprazole in active substance (equivalent to 45.11 mg of pantoprazole sodium sesquihydrate).

The other ingredients are:


Mannitol, microcrystalline cellulose, pregelatinized starch (maize), sodium glycolate starch (Type A), anhydrous sodium carbonate, calcium stearate.

Isolating coating:

Hypromellose, propylenglycol, titanium dioxide (E171), yellow iron oxide (E172).

Enteric coating:

Methacrylic acid ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulphate, triethyl citrate.

What Sozol looks like and contents of the pack

Sozol are gastro-resistant tablets. Tablets are dosed at 40 mg. They are pale yellow to yellowish, oblong and convex.

Sozol is available in packages with 60 tablets.

Not all pack sizes may be marketed.

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