Emuliquen Simple 7.173,9 mg oral emulsion in sachets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Emuliquen Simple 7,173.9 mg oral emulsion in sachet

Liquid paraffin

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for administration of this medicine provided in this leaflet or those given 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 any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

• You should consult a doctor if you worsen or do not improve after 6 days.

Contents of the leaflet

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

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

Emuliquen Simple contains the active substance liquid paraffin. It belongs to a group of medicines called stool softeners. It works as a laxative by lubricating, softening, and making stools more pliable, thereby facilitating intestinal evacuation.

Emuliquen Simple 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 72 hours after taking 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 Simple

Do not take Emuliquen Simple

• If you are allergic to the active substance 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 abdominal pain of unknown origin

• If you have gastrointestinal perforation

• If you have intestinal obstruction or intestinal bleeding

• If you have severe intestinal spasms

• If you have inflammatory bowel diseases

• If you have diarrhea

• 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)

• Children under 12 years of age

Warnings and precautions

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

• Do not take this medicine for prolonged periods, as tolerance to its laxative effect may develop and dependence may occur to achieve bowel evacuation
• Elderly patients, bedridden patients, mentally ill patients, and disabled individuals who do not have difficulty swallowing should not use this medicine without consulting a doctor, as they are more likely to aspirate the oil droplets from the medicine and develop a type of pneumonia (lipoid pneumonia). Do not take this medicine while lying down
• Prolonged use of laxatives may cause electrolyte imbalance (reduction of certain blood salts) and hypokalemia (decreased potassium levels in the blood). Therefore, it is recommended that patients are well hydrated and have normal electrolyte levels (blood salts) before starting treatment
• Blood glucose concentration may increase following prolonged administration of laxatives
• Use this medicine with caution if you experience sudden changes in bowel habits that persist for more than 2 weeks

Children and adolescents

This medicine must not be given to children under 12 years of age.

Use of Emuliquen Simple with other medicines

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

This medicine should 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 at least 2 hours from:

• Medicines used to control blood clotting (oral anticoagulants derived from coumarin or indandione)
• Medicines used to treat heart failure (digitalis glycosides)
• Female sex hormones (estrogens)
• Oral contraceptives
• Stool softening laxatives (emollients)

Taking Emuliquen Simple 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 Emuliquen's 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 outweighs the potential risks.

Driving and using machines

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

3. How to take Emuliquen Simple

Follow exactly the administration instructions 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 and adolescents over 12 years of age: 1 sachet per day (7,173.9 mg of liquid paraffin), taken 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).

Use in children and adolescents

Emuliquen Simple must not be used in children under 12 years of age.

Emuliquen Simple is taken orally.

Before opening, press the sachet with your fingers in different directions to increase the fluidity of the emulsion and homogenize its contents.

The dose should always be diluted with brief agitation in a glass of water or another 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.

Complete laxative effect is achieved starting from the third day after beginning treatment.

Gradually reduce the dose as the desired effect is obtained.

If symptoms worsen, if no bowel movement occurs within 72 hours after taking the maximum daily dose, or if symptoms persist beyond 6 days of treatment, consult a doctor who will evaluate your clinical condition.

If you take more Emuliquen Simple than you should

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

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 Simple

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 will experience them.

Possible adverse effects of Emuliquen Simple may include:

• Very rare adverse effects affecting 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 (vitamin 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

• Lipogranuloma (fatty tissue nodule)

Reporting of 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 through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Emuliquen Simple

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 packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or in household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the package and other information

Composition of Emuliquen Simple

• The active substance is liquid paraffin.

Each sachet (15 ml) contains 7,173.9 mg of liquid paraffin.

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

Nature of the product and contents of the package

Emuliquen Simple is an oral emulsion supplied in 15 ml sachets. Each pack contains 10 sachets. The hospital pack contains 200 sachets.

Marketing Authorization Holder and Manufacturer

LAINCO, S.A.

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

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

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