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

Patient Information Leaflet

Introduction

Patient Information Leaflet

Emuliquen Laxative 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 exactly the administration instructions provided in this leaflet or as directed by your doctor or pharmacist.

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

Leaflet Contents

1. What Emuliquen Laxative is and what it is used for
2. What you need to know before taking Emuliquen Laxative
3. How to take Emuliquen Laxative
4. Possible side effects
5. How to store Emuliquen Laxative
6. Contents of the pack and other information

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

Emuliquen Laxative contains the active substances liquid paraffin and sodium picosulfate. It belongs to a group of medicines known as stool softeners. It acts as a laxative by lubricating, softening, and plasticizing the stools, thereby facilitating and stimulating intestinal evacuation.

Emuliquen Laxative 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 within 12 hours after the maximum daily dose, or if symptoms worsen or do not improve after 6 days.

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

Do not take Emuliquen Laxative

• If you are allergic to the active substances or to any of the other components of this medicine (listed in section 6)
• If you have appendicitis or its symptoms (nausea, vomiting, stomach pain or lower abdominal pain, abdominal cramps)
• If you have gastrointestinal perforation
• If you have abdominal pain of unknown origin
• If you have paralytic ileus, intestinal obstruction or intestinal bleeding
• If you have severe intestinal spasms
• If you have inflammatory bowel diseases
• If you have diarrhoea
• If you have difficulty or pain when swallowing (dysphagia)
• If you have undiagnosed rectal bleeding
• If you have undergone a colonostomy or ileostomy (surgical procedure to remove a segment of the colon or small intestine)
• If you have severe dehydration
• Children under 12 years of age
• If sudden changes in bowel habits occur and persist for more than 2 weeks.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Emuliquen Laxative.

• Do not take this medicine for prolonged periods, as tolerance to the laxative effect and dependence for bowel evacuation may develop
• 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 likely to aspirate the oil drops from the medicine and develop 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 of movements may occur or worsen
• Prolonged use of laxatives may cause electrolyte imbalance (reduction of certain salts in the blood) and hypokalaemia (decreased potassium levels in the blood). Therefore, it is recommended that patients are well hydrated before starting treatment and that their electrolyte levels (blood salts) are normal
• Blood glucose levels may increase following prolonged administration of laxatives
• Cases of dizziness and/or syncope have been reported in patients using sodium picosulfate, which may be due to straining 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 must not be given to children under 12 years of age.

Use of Emuliquen Laxative with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might need to take any other medicines.

This medicine must not be taken within 2 hours before or after taking any other 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 separate the administration of this medicine by 2 hours from:

• Medicines that help control blood clotting (oral anticoagulants derived from coumarin or indandione)
• Medicines used to treat heart failure (digitalis glycosides)
• Female sex hormones (oestrogens)
• Oral contraceptives
• Stool softeners (emollient laxatives)
• Medicines that cause potassium loss such as diuretics (which promote urine elimination) and corticosteroids
• Antibiotics.

Taking Emuliquen Laxative with food and drinks

This medicine must not be taken 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine must not be used during pregnancy unless the expected benefit outweighs the possible risks.

Driving and using machines

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

3. How to take Emuliquen Laxative

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

• Adults: 15 ml or one large tablespoon per day (7,173.9 mg of liquid paraffin and 4.5 mg of sodium picosulfate), taken before bedtime, and, if necessary, repeat the dose in the morning 2 hours before or after breakfast.

Do not exceed 30 ml or two large tablespoons 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 tablespoon per day (2,391 mg of liquid paraffin and 1.5 mg of sodium picosulfate), or 10 ml or two small tablespoons per day (4,782 mg of liquid paraffin and 3.0 mg of sodium picosulfate), taken 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.

A slight separation of the aqueous phase of the emulsion may be observed, which is normal due to the specific nature of the formulation. Shake the container well before opening to homogenize the contents.

The dose 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 drink at least 6 to 8 glasses (approximately 240 ml each) of liquid daily to help produce soft stools and protect against dehydration.

Gradually reduce the dose once the desired effect is achieved.

If symptoms worsen, if no bowel movement occurs within 12 hours after taking the maximum daily dose, or if symptoms persist after 6 days of treatment, consult your doctor.

If you take more Emuliquen Laxative than you should

If you take more Emuliquen Laxative than recommended, liquid paraffin may be expelled in the stools, and diarrhea with electrolyte loss (reduction of certain salts in the blood), cramps, abdominal spasms, and muscle weakness may occur.

At doses higher than recommended, cases of colonic mucosal ischemia (reduced blood supply to the colon) have been reported.

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

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

If you forget to take Emuliquen Laxative

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Possible adverse effects of Emuliquen Laxante may include:

• 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 disturbances.

• Very rare adverse 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 leakage of liquid paraffin (anal itching, anal incontinence)

• Worsening of constipation

• Abdominal pain

• Watery stools

• Colic, abdominal cramps, nausea, and vomiting

• Lipogranuloma (fatty 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 leaflet. You may also report them directly via the Spanish System of Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Emuliquen Laxative

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

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Emuliquen Laxante

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

Appearance of the product and contents of the pack

Emuliquen Laxante is an oral emulsion supplied in 230 ml glass bottles containing the emulsion.

Marketing Authorization Holder and Manufacturer

LAINCO, S.A.

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

Date of the most recent review of this leaflet: February 2018

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/