EMULIQUEN LAXATIVE 478.26 mg/ml + 0.3 mg/ml ORAL EMULSION

Introduction

Leaflet: Information for the user

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

Liquid paraffin/Sodium picosulfate

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

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

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

Contents of the leaflet

1. What is Emuliquen Laxante and what is it used for
2. What you need to know before taking Emuliquen Laxante
3. How to take Emuliquen Laxante
4. Possible side effects
5. Storage of Emuliquen Laxante
6. Package contents and additional information

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

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

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

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

2. What you need to know before taking Emuliquen Laxante

Do not take Emuliquen Laxante

• If you are allergic to the active ingredients or to any of the other components of this medicine (listed in section 6)
• If you suffer from appendicitis or its symptoms (nausea, vomiting, stomach or lower abdominal pain, abdominal cramps)
• If you suffer from gastrointestinal perforation
• If you suffer from abdominal pain of unknown origin
• If you suffer from paralytic ileus, obstruction, or intestinal hemorrhage
• If you have strong intestinal spasms
• If you suffer from inflammatory bowel diseases
• If you have diarrhea
• If you have difficulty or pain when swallowing (dysphagia)
• If you suffer from undiagnosed rectal bleeding
• If you have undergone a colonostomy or ileostomy (surgical intervention to remove a segment of the colon or small intestine)
• If you suffer from severe dehydration
• Children under 12 years of age
• If you experience sudden changes in bowel habits 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 medicine for prolonged periods, as tolerance to the laxative effect and dependence on it to achieve evacuation may occur
• Elderly, bedridden, mentally ill, or disabled patients who do not have difficulty swallowing should not use this medicine without consulting a doctor, as they are more prone to aspirating the oil drops of the medicine and developing a type of pneumonia (lipoid pneumonia). Do not take this medicine while lying down
• In elderly patients, fatigue, weakness, decreased blood pressure, and lack of coordination may occur or worsen
• Prolonged use of laxatives can 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
• Blood glucose levels may increase after prolonged administration of laxatives
• Cases of dizziness and/or fainting have been reported in patients who have used sodium picosulfate, which may be due to efforts during defecation or a reflex response to abdominal pain related to constipation and not necessarily 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 medicine should not be administered to children under 12 years of age.

Use of Emuliquen Laxante with other medicines

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

This medicine should not be administered within 2 hours before or after taking another medicine, 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 take this medicine 2 hours apart from the administration of:

• medicines that help control blood coagulation (oral anticoagulants derived from coumarin or indandione)
• medicines for treating heart failure (digitalis glycosides)
• female sex hormones (estrogens)
• oral contraceptives
• stool softener laxatives (emollients)
• medicines that cause potassium loss, such as diuretics (which promote urine elimination) and corticosteroids
• antibiotics

Taking Emuliquen Laxante with food and drinks

This medicine should not be administered within 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 breastfeeding

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

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

Driving and using machines

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

3. How to take Emuliquen Laxante

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. If in 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 sodium picosulfate) administered before bedtime and, if necessary, repeated 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 sodium picosulfate).

Use in children and adolescents

• Adolescents over 12 years of age: 5 ml or one small spoonful per day (2.391 mg of liquid paraffin and 1.5 mg of sodium picosulfate) or 10 ml or two small spoonfuls per day (4.782 mg of liquid paraffin and 3.0 mg of sodium picosulfate) before bedtime.

• Children under 12 years of age:

This medicine should not be administered to children under 12 years of age.

This medicine is administered orally.

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

The dose to be administered should 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 medicine while lying down.

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

Gradually decrease the dose as the desired effect is achieved.

If symptoms worsen, if no bowel movement occurs after 12 hours following the maximum daily administration, or if symptoms persist after 6 days of treatment, you should consult a doctor.

If you take more Emuliquen Laxante than you should

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

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

Like other laxatives, continuous use of high doses can cause chronic diarrhea, abdominal pain, decreased potassium levels in the blood with muscle weakness, secondary hyperaldosteronism (increased levels of aldosterone in the blood), kidney stones, and other kidney disorders, metabolic alkalosis (increased bicarbonate in the blood).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Emuliquen Laxante

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone may experience them.

The possible side effects of Emuliquen Laxante may be:

• Common side effects that may affect up to 1 in 10 people:

• Increased water, potassium, and other electrolyte losses, which can cause cardiac and muscular disorders.

• Very rare side effects that may affect up to 1 in 10,000 people:

• Allergic reactions (skin rash, or swelling of the skin, mouth, or face, or difficulty swallowing or breathing)
• Dehydration
• Deficiency of 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
• Colic, abdominal spasms, nausea, and vomiting
• Lipogranuloma (fatty tissue nodule).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Emuliquen Laxante

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

No special storage conditions are required.

Do not use this medicine after the expiration date stated on the bottle after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Emuliquen Laxante

• The active ingredients 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), arabic gum, vanillin, benzoic acid (E-210), and purified water.

Appearance of the product and package contents

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

Marketing authorization holder and manufacturer

LAINCO, S.A.

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

Date of the last revision of this leaflet:February 2018

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/