Pantoprazol Sandoz (Acipan) 20 mg and 40 mg gastro-resistant tablets – pantoprazole for reflux and ulcers

Pantoprazol Sandoz is the former name of a medicine that is now available in Serbia as Acipan® (name change decision of 26.03.2020; marketing authorisation holder Predstavništvo Sandoz Pharmaceuticals d.d. Belgrade). It contains pantoprazole – a proton pump inhibitor that reduces the production of stomach acid.

It is authorised as gastro-resistant tablets of 20 mg and 40 mg, in packs of 14 tablets. It is used for heartburn and reflux disease, reflux inflammation of the oesophagus, stomach and duodenal ulcers, eradication of Helicobacter pylori and conditions with excessive acid production. The indications differ by strength and should always be considered separately.

What is Pantoprazol Sandoz (Acipan) used for and how should it be taken correctly?

Key information about the medicine

What is Pantoprazol Sandoz (Acipan) used for?

How is it taken and dosed?

Swallow the tablets whole with enough water, 1 hour before a meal. Do not chew or break them. The usual doses from the leaflet are listed – your doctor decides on your dose and duration.

Special patient groups

• Children under 12 years: not recommended (no experience).
• Severe liver impairment: do not take more than 20 mg pantoprazole a day; the doctor checks liver enzymes more often and stops treatment if they rise.
• Kidney impairment and moderate/severe liver impairment: the 40 mg tablets should not be used for Helicobacter pylori eradication.

Contraindications – when the medicine must not be used

• allergy (hypersensitivity) to pantoprazole or any of the excipients;
• allergy to any medicine from the group of proton pump inhibitors.

Precautions and warnings

• severe liver disease or past liver problems – liver enzymes need to be checked more often;
• continuous NSAID use (20 mg) – the risk of complications is assessed by age (65 and over), previous ulcer or gastrointestinal bleeding;
• reduced vitamin B12 stores or risk factors for them – long-term use may reduce the absorption of vitamin B12;
• multiple daily doses for a year or longer – increased risk of hip, wrist and spine fractures (especially with osteoporosis or corticosteroids);
• low magnesium – may occur after at least 3 months, usually after a year of treatment (fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, fast heartbeat);
• severe or persistent diarrhoea – pantoprazole is associated with a small increase in infectious diarrhoea;
• concomitant atazanavir (HIV) – consult your doctor;
• with use for more than a year, the doctor will monitor you regularly – report any new or unusual symptoms.

Interactions with other medicines, food and drink

• ketoconazole, itraconazole and posaconazole (antifungals) and erlotinib (a medicine for certain cancers) – pantoprazole may prevent them from working properly;
• warfarin and phenprocoumon (anticoagulants) – additional tests may be needed;
• atazanavir and other medicines for HIV infection;
• methotrexate – the doctor may temporarily stop pantoprazole because it can increase methotrexate blood levels;
• food: the medicine is taken 1 hour before a meal.

Pregnancy and breast-feeding

• There are no reliable data on the use of pantoprazole in pregnancy, and it has been reported to pass into breast milk. During pregnancy and breast-feeding it may only be used if the doctor considers that the benefit outweighs the possible risk to the unborn child or baby.

Driving and using machines

• If you experience dizziness or visual disturbances, do not drive or use machines.

Possible side effects

• Stop taking the medicine and contact a doctor or hospital immediately: serious allergic reactions (rare) – swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, facial swelling, marked dizziness with fast heartbeat and heavy sweating; serious skin reactions (blisters, erosions of the eyes, nose, mouth or genitals, sensitivity to light); yellowing of the skin or whites of the eyes; fever, rash and pain on urination or in the lower back (kidney inflammation).
• Uncommon: headache, dizziness, diarrhoea, nausea, vomiting, bloating and wind, constipation, dry mouth, abdominal pain and discomfort, rash, itching, weakness and malaise, sleep disorders, fractures of the hip, wrist or spine; increased liver enzymes.
• Rare: taste disturbance, blurred vision, joint and muscle pain, weight changes, raised temperature, swelling of the arms and legs, allergic reactions, depression, breast enlargement in men; increased bilirubin and blood fats, sudden drop in granulocytes.
• Very rare and not known: disorientation, hallucinations, confusion, numbness and tingling, low sodium, magnesium, calcium and potassium in the blood, muscle spasms; reduced numbers of platelets, white blood cells or all blood cells.

Overdose, missed dose and stopping treatment

• Overdose: no symptoms are known, but consult a doctor or pharmacist immediately.
• Missed dose: do not take a double dose – take the next dose at the usual time.
• Stopping treatment: do not stop treatment without your doctor's advice.

Related information

For additional care and support with heartburn and stomach complaints, see also the category Heartburn (excess acid) – products from this category do not replace the medicine prescribed for you.

Composition, pack and manufacturer

• Active substance: pantoprazole 20 mg or 40 mg per gastro-resistant tablet (as pantoprazole sodium sesquihydrate).
• Excipients (according to the leaflet for the 20 mg tablets): core – anhydrous sodium carbonate; microcrystalline cellulose; crospovidone (type A); hydroxypropylcellulose (type EXF); colloidal anhydrous silica; calcium stearate. Coating – hypromellose, titanium dioxide (E171), macrogol 400, quinoline yellow aluminium lake (E104), yellow iron oxide (E172), Ponceau 4R aluminium lake (E124); methacrylic acid – ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triethyl citrate; printing ink.
• Pack: OPA/Al/PVC/Al unit-dose perforated blister with 14 tablets, in a carton.
• Marketing authorisation holder: Predstavništvo Sandoz Pharmaceuticals d.d. Beograd, Kneginje Zorke 2, Belgrade; manufacturer according to the leaflet: Lek farmacevtska družba d.d., Verovškova 57, Ljubljana, Slovenia.
• Authorisations: 515-01-02196-15-001 (20 mg) and 515-01-02197-15-001 (40 mg) of 25.12.2015, under the name Pantoprazol Sandoz; name changed to Acipan® on 26.03.2020. Acipan 20 mg and 40 mg is included in the ALIMS List of interchangeable medicines of 26.05.2026.

Storage

• The medicine does not require any special storage conditions.
• Shelf life: 3 years. Do not use after the expiry date stated on the pack.
• Keep out of the sight and reach of children. Return unused medicines to a pharmacy that collects them.

Frequently asked questions

Are Pantoprazol Sandoz and Acipan the same medicine?

Yes. By ALIMS decision of 26.03.2020 Pantoprazol Sandoz was renamed Acipan®; the active substance, strengths (20 mg and 40 mg) and form (gastro-resistant tablets) are the same.

When should pantoprazole be taken – before or after food?

Before food. The tablet is swallowed whole with water, 1 hour before a meal. For Helicobacter pylori eradication the 40 mg tablets are taken 1 hour before breakfast and 1 hour before dinner.

What is the difference between the 20 mg and 40 mg tablets?

The 20 mg tablets are used for symptoms of reflux disease, long-term maintenance and stomach protection during continuous NSAID use, while the 40 mg tablets are used to treat reflux oesophagitis and ulcers, for Helicobacter pylori eradication and Zollinger-Ellison syndrome.

Is long-term use of pantoprazole safe?

Long-term use is possible if the doctor decides, but after several months vitamin B12 and magnesium may decrease and the risk of fractures may increase slightly. This is why the doctor regularly monitors patients who take it for more than a year.

Sources

• ALIMS – Package leaflet Pantoprazol Sandoz 20 mg (PIL, Serbian; now Acipan)
• ALIMS – Summary of product characteristics Pantoprazol Sandoz 20 mg (SmPC, Serbian)
• ALIMS – Package leaflet Pantoprazol Sandoz 40 mg (PIL, Serbian; now Acipan)
• ALIMS – Summary of product characteristics Pantoprazol Sandoz 40 mg (SmPC, Serbian)

Sources checked on: 25.10.2026. Name change and validity: ALIMS list of name change decisions 21.01–30.04.2020; List of interchangeable medicines 26.05.2026.