Who is it for: Teenagers (15+), Adults
Pregnancy: Only with medical advice
Breastfeeding: Only with medical advice
Form: Oral jelly

DESCRIPTION

Lansoyl Sugar-Free Raspberry Jelly is an oral laxative containing liquid paraffin, which works through a purely mechanical action. It lubricates the contents of the colon and softens stools, making them easier to pass.

This over-the-counter medicine is indicated for the treatment of occasional constipation in adults and adolescents aged 15 and over.

How to Use Lansoyl Sugar-Free

Dosage:
Take 1 to 3 tablespoons per day.

Timing:
Take on an empty stomach, or at least 2 hours before or after meals.

If taken in the evening, do not lie down within 2 hours after taking Lansoyl due to the risk of bronchial inhalation, which could lead to pneumonia.
Keep in mind that the laxative effect may occur during the night.

Use should be limited to a maximum of 10 days.

Warnings & Precautions

Do NOT use if:

• You are under 15 years old

• You are allergic to any of the ingredients: liquid paraffin, lactulose syrup, sorbitol, citric acid monohydrate, gelatin, cochineal red A (E124), sodium saccharin, drinking water

• You have unexplained abdominal pain or swallowing difficulties — consult a doctor instead

• You have fructose intolerance

• You are pregnant (not recommended due to reduced absorption of fat-soluble vitamins A, D, E, K)

Possible side effects:
Diarrhea, anal leakage, and irritation around the anus.

Important:
Managing constipation should never rely on laxatives alone. Improve lifestyle habits such as drinking enough water, increasing physical activity, and eating more fiber (whole grains, bran, leafy vegetables, fruits). Fiber supplements like Ultrabiotique Fibres may also help.

Packaging

215 g jar of oral jelly.

Please read the following full disclosure before purchasing or using this product.

SUMMARY OF PRODUCT CHARACTERISTICS

ANSM – Updated: 20/05/2025

1. NAME OF THE MEDICINAL PRODUCT

LANSOYL SANS SUCRE 78.23 g %, oral gel in a jar, sweetened with sodium saccharin

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Liquid paraffin ....................................................................................... 78.230 g
For 100 g of gel.

Excipients with known effect: sorbitol, cochineal red A (E124), sodium, ethanol contained in the flavoring (11.32 mg per tablespoon).

For the complete list of excipients, see section 6.1.

Caloric intake: 4 kcal per tablespoon

3. PHARMACEUTICAL FORM

Oral gel.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Symptomatic treatment of occasional constipation.

4.2 Posology and method of administration

For adults and children over 15 years only.

Posology

1 tablespoon = 15 ml
1 to 3 tablespoons per day.

Liquid paraffin may be taken in one or several administrations.

Do not exceed the recommended maximum doses.

If the treatment is ineffective, do not increase the dose — seek medical advice.

Maximum duration of treatment: 10 days.

Method of administration

Oral use.

Preferably taken away from meals.

If taken in the evening, advise the patient not to lie down within two hours and to consider the delay of action (6–8 hours).

4.3 Contraindications

• Hypersensitivity to the active substance or any excipient listed in section 6.1.

• Do not use in cases of intestinal obstruction or abdominal pain of unknown origin.

• Do not use in individuals with swallowing difficulties due to the risk of bronchial inhalation and lipoid pneumonia.

4.4 Special warnings and precautions for use

Special warnings

Do not use for prolonged periods; long-term use of liquid paraffin may reduce absorption of fat-soluble vitamins (A, D, E, K).

Drug treatment of constipation is only an adjunct to lifestyle and dietary measures, which include:

• increasing fiber and fluid intake,

• physical activity,

• bowel habit retraining.

In children, use of laxatives must be exceptional due to risk of disrupting the normal defecation reflex.

Precautions

Use with caution in children, debilitated patients, bedridden patients, or in cases of gastroesophageal reflux due to increased risk of bronchial inhalation and lipoid pneumonia (see section 4.8).

If symptoms persist, worsen, or new symptoms appear, the patient must stop treatment and consult a doctor.

This medicine contains 4.2 g of sorbitol per 100 g. Patients with hereditary fructose intolerance (HFI) must not take this medicine.

Contains azo dye cochineal red A (E124), which may cause allergic reactions.

Contains less than 1 mmol (23 mg) of sodium per tablespoon — essentially “sodium-free.”

Contains 11.32 mg of ethanol per 15 ml tablespoon. This small amount is not expected to cause noticeable effects.

4.5 Interaction with other medicinal products

Available data do not suggest any clinically significant interactions.

4.6 Fertility, pregnancy, and breastfeeding

No adequate clinical exposure studies in pregnancy or breastfeeding.

No sufficiently relevant data to assess potential teratogenic or fetotoxic effects of liquid paraffin.

Liquid paraffin has minimal gastrointestinal absorption but can interfere with absorption of fat-soluble vitamins (A, D, E, K), which may have neonatal consequences (e.g., potential bleeding).

It is unknown whether liquid paraffin or its metabolites are excreted in breast milk.

This medicine should not be used during pregnancy or breastfeeding unless the potential benefit to the mother outweighs the potential risk to the fetus or infant.
Use must be limited in duration.

4.7 Effects on ability to drive and use machines

No or negligible influence.

4.8 Undesirable effects

The table below describes adverse reactions reported with liquid paraffin. Frequency categories: very common (≥1/10), common (≥1/100,<1/10), uncommon (≥1/1000,<1/100), rare (≥1/10000,<1/1000), very rare (<1/10000), frequency not known.

Reporting of suspected adverse reactions:
Healthcare professionals should report any suspected adverse reactions via the national reporting system: ANSM & Regional Pharmacovigilance Centers – website: www.signalement-sante.gouv.fr.

4.9 Overdose

Symptoms:
Excessive laxative effect and related undesirable effects.

Treatment:
Stop treatment and provide local symptomatic management.

Keep out of the sight and reach of children. In case of overdose, seek immediate medical advice or contact a poison control center.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic class: Lubricant laxatives, ATC code: A06AA01.

Liquid paraffin acts mechanically by lubricating colonic contents and softening stools to facilitate evacuation.

5.2 Pharmacokinetic properties

Minimal absorption of liquid paraffin.

Oral onset of action: 6 to 8 hours.

5.3 Preclinical safety data

Preclinical data from literature on single and repeated doses, genotoxicity, carcinogenicity, reproductive and developmental toxicity revealed no particular risk for humans.

General toxicology:
Very low acute oral toxicity in rats. In a 2-year repeated-dose dietary study, no adverse effects were observed up to 1,200 mg/kg/day.

Genotoxicity:
No genotoxic potential detected in in vitro and in vivo studies.

Carcinogenicity:
No increased tumor incidence in rats receiving 1,200 mg/kg/day.

Teratogenicity:
No adverse effects observed in rat teratogenicity studies.

Fertility:
No adverse effects observed; NOAEL = 1,000 mg/kg/day.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactulose syrup, sorbitol, citric acid monohydrate, gelatin, cochineal red A (E124), flavoring composition (1), sodium saccharin, purified water.

(1) Flavoring composition: natural raspberry flavor (alcoholates of raspberry, blackcurrant buds, iris, vanilla tincture), artificial raspberry flavor (ethanol, amyl esters, ethyl esters, ethylprotocatéchic and pelargonic aldehydes), natural plum flavor (tincture and alcoholate of plum).

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Store at temperatures not exceeding 25°C.

6.5 Nature and contents of container

Glass jars of 180 g and 215 g.

Not all presentations may be marketed.

6.6 Special precautions for disposal

Dispose of unused medicinal products or waste in accordance with local regulations.

7. MARKETING AUTHORISATION HOLDER

KENVUE FRANCE
43 Rue Camille Desmoulins
92130 Issy-les-Moulineaux
France

8. MARKETING AUTHORISATION NUMBER(S)

• 34009 345 585 3 5: 180 g glass jar

• 34009 332 340 7 2: 215 g glass jar

9. DATE OF FIRST AUTHORISATION / RENEWAL

[To be completed later by the MAH]

10. DATE OF TEXT REVISION

[To be completed later by the MAH]

11. DOSIMETRY

Not applicable.

12. PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

PRESCRIPTION / DISPENSING CONDITIONS

Medicinal product not subject to medical prescription