Label: information for the user

Emuliquen Laxative 7.173,9 mg/4.5 mg oral emulsion in sachet

Paraffin liquid/Picosulfate of sodium

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

Follow exactly the administration instructions of the medicine 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.

• Ifyou 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 improveafter 6 days.

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

2. What you need to know before starting totake Emuliquen Laxative

3. How to take Emuliquen Laxative

4. Possible adverse effects

5. Storage of Emuliquen Laxative

6. Contents of the package 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.

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 takeEmuliquen Laxative

• 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 or it hurts to swallow (dysphagia)
• If you have undiagnosed rectal bleeding

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

-If you have severe dehydration

-Children under 12 years old or adolescents

-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 Laxative.

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

-Elderly patients, bedridden patients, mentally ill patients, and invalids who do not have difficulty swallowing should not use this medication without consulting a doctor, as they are more prone to aspirate the oil droplets of the medication and develop a type of pneumonia (lipoid pneumonia). Do not take this medication in a lying position

In elderly patients, fatigue, weakness, decreased blood pressure, and lack of coordination of movements may occur or worsen

-Prolonged use of laxatives may cause 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 or adolescents.

Use of Emuliquen Laxative 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 delay the administration of this medication by 2 hours 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 Laxative 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 machinery

No effects on the ability to drive or operate machinery 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: 1 sachet 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 2 sachets per day (14.347.8 mg of liquid paraffin and 9 mg of picosulfate sodium).

Use in children and adolescents

It should not be used in children under 12 years or adolescents.

This medication is administered orally.

It is normal to observe a slight separation of the aqueous phase of the emulsion, due to the specific nature of the same. Before opening, press the sachet with your fingers, in different directions, to increase the fluidity of the emulsion and 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.).

Discard the sachet once opened.

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 to protect you from dehydration.

Gradually reduce the dose as the desired effect is obtained.

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

If you take more Emuliquen Laxativethan you should

If you take more Emuliquen Laxative than recommended, it may cause the 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 colonic 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 ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service at telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeEmuliquen Laxative

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

Likeall medications,this medicationcan cause adverse effects, although not everyone 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 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 usethis medicationafter the expiration date that appears onthe packagingafter CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Emuliquen Laxative

• The active principles are liquid paraffin and sodium picosulfate.

Each 15 ml sachet contains 7.173.9 mg of liquid paraffin and 4.5 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 contents of the packaging

Emuliquen Laxative is an oral emulsion presented in 15 ml sachets. Each package contains 10 sachets. The clinical package contains 200 sachets.

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 medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/