Label: information for the user

Emuliquen Laxante 478.26 mg/ml + 0.3 mg/ml oral emulsion

Liquid paraffin/Picosulfate sodium

Read this label carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.
• You should consult a doctor if you worsen or do not improve after 6 days.

1. What Emuliquen Laxante is and for what it is used

2. What you need to know before starting to take Emuliquen Laxante

3. How to take Emuliquen Laxante

4. Possible adverse effects

5. Storage of Emuliquen Laxante

6. Contents of the container and additional information

Emuliquen Laxante contains the active ingredients liquid paraffin and sodium picosulfate. It belongs to the group of medications known as stool softeners. It acts as a laxative by lubricating, softening, and plasticizing the stool, facilitating and stimulating intestinal evacuation.

Emuliquen Laxante is a medication indicated for the symptomatic relief of occasional constipation in adults and adolescents over 12 years old.

You should consult a doctor if no bowel movement is produced after 12 hours following the maximum daily dose, or if it worsens or does not improve after 6 days.

Do not take Emuliquen Laxante

-If you are allergic to the active ingredients or to any of the other components of this medication (listed in section 6)

-If you have appendicitis or symptoms (nausea, vomiting, stomach pain or lower abdominal pain, abdominal cramps)

-If you have gastrointestinal perforation

-If you have unknown abdominal pain

-If you have paralytic ileus, obstruction, or intestinal hemorrhage

-If you have severe intestinal spasms

-If you have inflammatory intestinal diseases

-If you have diarrhea

-If you have difficulty swallowing (dysphagia)

-If you have undiagnosed rectal bleeding

-If you have had a colonostomy and ileostomy (surgical intervention to remove a segment of the colon or small intestine)

-If you have severe dehydration

-Children under 12 years old

-If sudden changes in bowel habits are observed that persist for more than 2 weeks.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Emuliquen Laxante.

-Do not take this medication for prolonged periods as it may cause tolerance to the laxative effect and dependence to achieve bowel evacuation

-Patients who are elderly, bedridden, mentally ill, or disabled, who do not have difficulty swallowing, should not use this medication without consulting a doctor, as they are more prone to aspirating the oil droplets of the medication and developing a type of pneumonia (lipoid pneumonia). Do not take this medication in a lying down position

-In elderly patients, it may cause or worsen states of fatigue, weakness, decreased blood pressure, and lack of coordination of movements

-Prolonged use of laxatives may cause an electrolyte imbalance (decrease in certain salts in the blood) and hypokalemia (decrease in potassium levels in the blood), so it is recommended that patients be well hydrated and have normal electrolyte levels before starting treatment

-The concentration of glucose in the blood may increase after prolonged administration of laxatives

-Cases of dizziness and/or syncope have been described in patients who have used sodium picosulfate, which may be due to the efforts during defecation or a reflex response to abdominal pain related to constipation and not necessarily due to the use of sodium picosulfate

If symptoms worsen or persist for more than 6 days, the clinical situation should be evaluated.

Children and adolescents

This medication should not be administered to children under 12 years old.

Use of Emuliquen Laxante with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

This medication should not be taken 2 hours before or after taking another medication, as it may interfere with the absorption of certain substances such as some vitamins (A, D, E, K, etc.), calcium, phosphorus, and potassium or potassium supplements,although this interference is minimal due to the special formulation of Emuliquen.

It is recommended to space the administration of this medication 2 hours apart from the administration of:

-Medications that help control blood clotting (oral anticoagulants derived from coumarin or indandione)

-Medications to treat heart failure (digitalis glycosides)

-Female sex hormones (estrogens)

-Oral contraceptives

-Softening agents for stool (emollients)

-Medications that cause potassium loss such as diuretics (promote urine elimination) and corticosteroids

-Antibiotics.

Administration of Emuliquen Laxante with food and beverages

This medication should not be taken 2 hours before or after meals, as it may interfere with the absorption of certain vitamins and minerals from food,although this effect is minimal due to the high stability of the Emuliquen formulation.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

This medication should not be used during pregnancy unless the expected benefit is greater than the possible risks.

Driving and operating machines

No effects on the ability to drive or operate machines have been described.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

• Adults:15 ml or one large spoonful per day (7.173.9 mg of liquid paraffin and 4.5 mg of picosulfate sodium) administered before bedtime and, if necessary, repeat the dose in the morning 2 hours before or after breakfast.

Do not take more than 30 ml or two large spoonfuls per day (14,347.8 mg of liquid paraffin and 9 mg of picosulfate sodium).

Use in children and adolescents

• Older adolescents over 12 years: 5 ml or one small spoonful per day (2,391 mg of liquid paraffin and 1.5 mg of picosulfate sodium)or 10 ml or two small spoonfuls per day (4,782 mg of liquid paraffin and 3.0 mg of picosulfate sodium)before bedtime.

• Children under 12 years:

This medication should not be administered to children under 12 years.

This medication is administered orally.

It is normal to observe a slight separation of the aqueous phase of the emulsion due to its specific nature. Before opening, shake the container well to homogenize the contents.

The dose to be administered must always be diluted with a brief agitation in a glass of water or other cold or hot liquid (milk, juices, etc.).

Do not take this medication in a lying position.

During treatment, it is necessary for you to ingest at least 6 to 8 glasses (with approximately 240 ml each) of liquid per day to help produce soft stools and protect you from dehydration.

Gradually decrease the dose as the desired effect is obtained.

If symptoms worsen, if no stool is produced after 12 hours of the maximum daily dose, or if symptoms persist after 6 days of treatment, consult your doctor.

If you take more Emuliquen Laxante than you should

If you take more Emuliquen Laxante than recommendedyou may experience elimination of liquid paraffin with the stool, diarrhea with loss of electrolytes (decrease in certain salts in the blood), cramps, abdominal pain, and muscle weakness.

At higher doses than recommended, cases of ischemia of the colon mucosa (decrease in blood flow to the colon) have been described.

Like other laxatives, the continued use of high doses produces chronic diarrhea, abdominal pain, decrease in potassium in the blood with muscle weakness, secondary hyperaldosteronism (increase in aldosterone hormone levels in the blood), kidney stones, and other kidney alterations, metabolic alkalosis (increase in bicarbonate in the blood).

In case of overdose or accidental ingestionconsult your doctor or pharmacist immediately or call the Toxicological Information Service at telephone91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeEmuliquen Laxante

Do not take a double dose to compensate for the missed doses.

Likeall medications,this medicationcan produce adverse effects, although not all people will experience them.

The possible adverse effects ofEmuliquen Laxativemay be:

• Frequent adverse effects that may affect up to 1 in 10 people:

• Increased loss of water, potassium, and other electrolytes, which may cause cardiac and muscular alterations.

• Rare adverse effects that may affect up to 1 in 10,000 people:

• Allergic reactions (skin rash, skin swelling, mouth or face swelling, or difficulty swallowing or breathing)
• Dehydration
• Vitamin deficiency in fat-soluble vitamins (vitamins A, D, E, and K)
• A type of pneumonia called lipoid pneumonia
• Anal loss of liquid paraffin (anal itching, anal incontinence)
• Worsening of constipation
• Abdominal pain
• Watery stools
• Colics, abdominal cramps, nausea, and vomiting
• Lipogranuloma (fat tissue nodule).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the bottle after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines.This will help protect the environment.

Composition of Emuliquen Laxative

-The active principles are liquid paraffin and sodium picosulfate.

Each ml of oral emulsion contains 478.26 mg of liquid paraffin and 0.3 mg of sodium picosulfate.

-The other components (excipients) are: lichen extract, glycerol (E-422), gum arabic, vanillin, benzoic acid (E-210) and purified water.

Appearance of the product and content of the packaging

Emuliquen Laxative is an oral emulsion presented in glass bottles of 230 ml of emulsion.

Holder of the marketing authorization and responsible for manufacturing

LAINCO, S.A.

Avda. Bizet, 8-12 –08191 Rubí (Barcelona)

Date of the last review of this leaflet:February 2018

The detailed and updated information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/