EMULIQUEN LAXATIVE 7.173,9 mg/4,5 mg ORAL EMULSION IN SACHETS

Introduction

Leaflet: information for the user

Emuliquen Laxante 7.173,9 mg/4,5 mg oral emulsion in sachet

Liquid paraffin/Sodium picosulfate

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

Follow the administration instructions of the medication 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 side effects 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 medications called 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 occurs after 12 hours after 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 takeEmuliquen 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 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
• Not for children under 12 years or adolescents
• 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 medication for prolonged periods, as tolerance to the laxative effect and dependence on it to achieve evacuation may occur
• Elderly patients, bedridden patients, mentally ill patients, and disabled patients who do not have difficulty swallowing should not use this medication without consulting a doctor, as they are more prone to aspirating the oil drops of the medication and developing a type of pneumonia (lipoid pneumonia). Do not take this medication 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 before starting treatment, patients are well-hydrated and their electrolyte levels (blood salts) are normal
• 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 could be due to 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 or adolescents.

Using Emuliquen Laxante with other medications

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

This medication should not be administered within 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 out the administration of this medication by 2 hours from the administration of:

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

Taking Emuliquen Laxante with food and drinks

This medication 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 medication.

This medication 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 medication contained in this leaflet or as 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 sodium picosulfate) 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 sodium picosulfate).

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 its specific character. 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 should always be diluted with a brief agitation in a glass of water or other cold or hot liquid (milk, juices, etc.).

The sachet should be discarded once opened.

Do not take this medication 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 after the maximum daily administration, or if symptoms persist after 6 days of treatment, you should consult a doctor

If you take more Emuliquen Laxantethan you should

If you take more Emuliquen Laxante than recommended, it may cause 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 colonic mucosal 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 medication and the amount ingested.

If you forget to takeEmuliquen Laxante

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone may experience them.

The possible side effects of Emuliquen Laxante may be:

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

• Increased loss of water, potassium, and other electrolytes, 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, 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Emuliquen Laxante

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications 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 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), 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 15 ml sachets. Each package contains 10 sachets. The clinical package contains 200 sachets.

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