MedeliX
Start asking

Lactulose

Duphalac Fruit, Lactulose Genericon, Lactulose Hexal, Lactulose Mip · ATC code A06AD11

Also known as: Β-Lactulose, Laktuloz · Brand names: Duphalac Fruit, Lactulose Genericon, Lactulose Hexal, Lactulose Mip, Bifiteral, Lactuflor, Lactulade, Duphalac, Hepalac, Lacselac, Lactozen, Lactulac, Laevolac, Laktilit, Laxamot …

Key facts
Active substance
Lactulose
Drug class
Hyperosmotic laxative
ATC code
A06AD11
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Lactulose is, per the US prescribing information, a poorly absorbed sugar (disaccharide) that is broken down by colonic bacteria and is used to treat constipation.

What it is used for

  • Treatment of constipation.
  • In chronic constipation, lactulose solution increases the number of bowel movements per day and the number of days with bowel movements.

Dosing

  • Usual dose: 1 to 2 tablespoonfuls (15 to 30 mL, containing 10 g to 20 g of lactulose) daily.
  • May be increased to 60 mL daily if necessary.
  • 24 to 48 hours may be needed to produce a normal bowel movement, as it acts only once it reaches the colon.
  • The solution may be mixed with fruit juice, water or milk.

Contraindications

  • Patients who require a low galactose diet (the solution contains galactose).

Important warnings

  • During electrocautery at proctoscopy or colonoscopy there is a theoretical risk of an explosive reaction from accumulated hydrogen gas; thorough bowel cleansing with a non-fermentable solution is advised.
  • Use with caution in diabetics, as the solution contains galactose and lactose.
  • Elderly, debilitated patients treated for more than six months should have serum electrolytes (potassium, chloride, carbon dioxide) measured periodically.
  • Patients should contact a physician if an unusual diarrheal condition occurs.

Side effects

  • Precise frequency data are not available.
  • Initial flatulence and intestinal cramps, usually transient.
  • Excessive dosage can lead to diarrhea with loss of fluids, hypokalemia and hypernatremia.
  • Nausea and vomiting have been reported.

Interactions

  • Non-absorbable antacids may inhibit the desired drop in colonic pH and reduce the effect.

Pregnancy and breastfeeding

  • Animal studies showed no evidence of harm to the fetus; there are no adequate studies in pregnant women.
  • It is not known whether lactulose is excreted in human milk; use caution in nursing women.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • Duphalac FruitCooper Consumer Health B.V. · 1 register entry
  • Lactulose GenericonGenericon Pharma Gesellschaft M.B.H. · 1 register entry
  • Lactulose HexalHexal Pharma Gmbh · 1 register entry
  • Lactulose MipMip Pharma Austria Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • BifiteralCooper Consumer Health Deutschland Gmbh, Cooper Consumer Health B.V. · 2 register entries
  • LactuflorMip Pharma Gmbh · 1 register entry
  • LactuladeCnp Pharma Gmbh · 1 register entry
  • Lactulose1 A Pharma Gmbh, T&d Pharma Gmbh, Ratiopharm Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Hexal Ag, Stada Consumer Health Deutschland Gmbh, Chephasaar Chemisch-Pharmazeutische Fabrik Gmbh, Abz-Pharma Gmbh, Aliud Pharma Gmbh · 10 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • DuphalacABBOTT LABORATUARLARI İTHALAT İHRACAT VE TİC. LTD. ŞTİ. · 2 register entries
  • HepalacSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • LacselacTEBEM İLAÇ SAN. TUR. VE TİC. A.Ş. · 1 register entry
  • LactozenDR. SERTUS İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry
  • LactulacKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 3 register entries
  • LaevolacMENARİNİ SAĞLIK VE İLAÇ SAN. TİC. A.Ş. · 2 register entries
  • LaktilitBERKO İLAÇ VE KİMYA SAN. A.Ş. · 4 register entries
  • LaxamotBERAT BERAN İLAÇ SAN. VE TİC. LTD. ŞTİ. · 4 register entries
  • Medulac WMWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • OralacŞİFA KİMYA İLAÇ KOZMETİK SANAYİ VE TİC. A.Ş. · 4 register entries
  • OsmalakBİOFARMA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • RexlacMCG PHARMA İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry
Show all 14 brand names
  • TulozLİBA LABORATUARLARI A.Ş. · 1 register entry
  • ZubeyraWORLD MEDICINE OPHTHALMICS İLAÇLARI LTD. ŞTİ. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • ConstuloseActavis Pharma, Inc. · 1 register entry
  • EnuloseActavis Pharma, Inc. · 2 register entries
  • GenerlacChartwell RX, LLC · 1 register entry
  • KristaloseCumberland Pharmaceuticals Inc. · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Brand names in 26 more European countries
Belgium
Bifiteral, Duphalac, Lactulose Eg
Bulgaria
Дуфалак, Лактулакс, Лактулоза Mip, Лактус, Медулак-Вм
Croatia
Portalak
Cyprus
Duphalac
Czechia
Duphalac, Lactulosa Biomedica, Lactulose Al
Denmark
Lactulose Orifarm, Medilax
Estonia
Duphalac, Lactulose Mip
Finland
Duphalac, Lactulos Ratiopharm, Laktufarm, Levolac
France
Duphalac, Lactulose Arrow, Lactulose Biogaran, Lactulose Cooper, Lactulose Sandoz, Lactulose Viatris, Lactulose Zentiva
Greece
Duphafruit, Duphalac
Iceland
Medilax
Ireland
Brillphalac, Lactecon, Laxose
Italy
Duphalac, Epalfen Eps, Laevolac, Lattulac, Lattulosio Abc, Lattulosio Almus, Lattulosio Alter, Lattulosio Aurobindo, Lattulosio Cooper, Lattulosio Eg, Lattulosio Pensa, Lattulosio Sandoz, Lattulosio Teva, Lattulosio Zentiva, Normase
Latvia
Duphalac Fruit, Lactulose Mip
Lithuania
Duphalac, Lactulose Mip
Luxembourg
Bifiteral, Duphalac, Lactulose Eg, Lactulose Ratiopharm
Malta
Duphalac, Lactulose
Netherlands
Duphalac, Lactulose Aurobindo, Lactulose Cch, Lactulose Greenwood, Lactulose Leidapharm, Lactulose Marel, Lactulose Sam, Lactulose Sandoz, Lactulosestroop Albert Heijn, Laxeerdrank, Laxeersiroop
Norway
Duphalac
Poland
Duphalac, Lactulose Mip, Lactulosum Espefa, Lactulosum Forte Orifarm, Lactulosum Forte Polfarmex, Lactulosum Orifarm, Lactulosum Polfarmex, Normalac
Portugal
Duphalac, Lactulose Farmoz, Lactulose Generis, Lactulose Novalie, Lactulose Sandoz, Laevolac, Perphyl, Solax
Romania
Duphalac Fruit, Lactecon, Lactulose Eipico, Lactulose Mip
Slovakia
Duphalac, Lactecon, Lactulosa Biomedica
Slovenia
Prorektal
Spain
Duphalac, Lactulosa Lainco, Lactulosa Level
Sweden
Duphalac, Laktulos Cooper

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. U.S. Food and Drug Administration. Lactulose (APOZEAL PHARMACEUTICALS INC) – Prescribing Information, 2026-07-23. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=72ac130a-de85-464d-9e9b-05cac0c54db1
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/
  6. Wikidata (CC0): ATC A06AD.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.