Leaflet: information for the user

Emuliquen Simple 478.26 mg/ml oral emulsion

Liquid paraffin

Read this leaflet carefully before you start taking this medicine, as it contains important information for you

Follow exactly the administration instructions for the medicine contained in this leaflet or those 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.

• Ifyou experience any 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 you worsen or do not improveafter 6 days.

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

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

3. How to take Emuliquen Simple

4. Possible side effects

5. Storage of Emuliquen Simple

6. Contents of the pack and additional information

Emuliquen Simple contains the active ingredient liquid paraffin. It belongs to a group of medicines called stool softeners. It acts as a laxative by lubricating, softening, and plasticizing the stools, thus facilitating intestinal evacuation.

Emuliquen Simple is a medicine indicated for the symptomatic relief of occasional constipation in adults, adolescents, and children over 6 years old.

You should consult a doctor if no bowel movement is produced after 72 hours following the maximum daily dose or if it worsens or does not improve after 6 days.

Do not takeEmuliquen Simple

• If you are allergic to the active ingredient or 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 unknown abdominal pain
• If you have gastrointestinal perforation
• If you have intestinal obstruction or hemorrhage
• If you have severe intestinal spasms
• If you have inflammatory bowel diseases
• If you have diarrhea
• If you have difficulty swallowing (dysphagia)
• If you have undiagnosed rectal bleeding
• If you have undergone a colostomy and ileostomy (surgical procedure to remove a segment of the colon or small intestine)
• Children under 6 years old.

Warnings and precautions

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

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

-Older patients, bedridden, mentally ill, and disabled patients, 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

-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 (salts in the blood) before starting treatment

-Blood glucose levels may increase after prolonged administration of laxatives

-Use this medication with caution if you have sudden changes in bowel habits that persist for more than 2 weeks

Children and adolescents

This medication should not be administered to children under 6 years old.

It should be used with caution in children aged 6 to 12 years due to the risk of aspiration.

Use of Emuliquen Simple 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 take this medication 2 hours apart 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 laxatives (emollients).

Taking Emuliquen Simple with food and drinks

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 breastfeeding

If you are pregnant or breastfeeding, or think you may be 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:15 ml or one large spoonful per day (7.173.9 mg of liquid paraffin) administered before bedtime and, if necessary, repeat the dose 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).

Use in children and adolescents

• Children aged 6 to 12 years:5 ml or one small spoonful per day (2.391.3 mg of liquid paraffin) administered before bedtime and, if necessary, repeat the dose in the morning 2 hours before or after breakfast.

Do not take more than 10 ml or two small spoonfuls per day (4.782.6 mg of liquid paraffin) per day.

• Children under 6 years:Children under 6 years should not take this medication.

Emuliquen Simple is taken 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, shake the container well to 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.).

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.

The complete laxative effect is achieved from the third day after starting treatment.

Gradually reduce the dose as the desired effect is obtained.

If symptoms worsen, if no stool is produced after 72 hours after the maximum daily dose, or if symptoms persist after 6 days of treatment, consult a doctor.

If you take more Emuliquen Simple than you should

If you take more Emuliquen Simple 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 pain, and muscle weakness.

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 Simple

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

Likeall medications,this medicationcan produce adverse effects, although not all people will experience them.

The possible adverse effects ofEmuliquen Simplemay be:

• Very 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 of constipation
• Abdominal pain
• Watery stools
• 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 about 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 bottleafter 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 containers and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Emuliquen Simple

• The active principle is liquid paraffin.

Each ml of oral emulsion contains 478.26 mg of liquid paraffin.

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

Appearance of the product and contents of the packaging

Emuliquen Simple is an oral emulsion presented inglass bottles of 230 ml emulsion.

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 ofthe Spanish Agencyof Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/