EMULIQUEN SIMPLE 478.26 mg/ml ORAL EMULSION

2. What you need to know before taking Emuliquen Simple

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 its symptoms (nausea, vomiting, stomach 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 hemorrhage
• 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 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 tolerance to the laxative effect and dependence on it to achieve bowel movements may occur
• Elderly, 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 aspirating the oil drops from the medication and developing a type of pneumonia (lipoid pneumonia). Do not take this medication while lying down
• 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
• This medication should be used with caution if you experience 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 between 6 and 12 years old due to the risk of aspiration.

Using Emuliquen Simple 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).

Taking Emuliquen Simple 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 Simple

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly. 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) 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).

Use in children and adolescents

• Children from6 to12 years: 5 ml or one small spoonful per day (2.391.3 mg of liquid paraffin) administered before bedtime and, if necessary, repeated 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 old should not take this medication.

Emuliquen Simple is taken orally.

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

The dose to be administered should always be diluted with a brief stir in a glass of water or other cold or hot liquid (milk, juices, etc.).

Do not take this medication while lying down.

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

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

Gradually decrease the dose as the desired effect is achieved.

If symptoms worsen, if no bowel movement occurs after 72 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 Simplethan you should

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

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 Simple

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 will experience them.

The possible side effects of Emuliquen Simple may be:

• 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 (vitamin A, D, E, and K)
• A type of pneumonia called lipoid pneumonia
• Anal loss of liquid paraffin (anal pruritus, anal incontinence)
• Worsening of constipation
• Abdominal pain
• Watery stools
• 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 Simple

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

No special storage conditions are required.

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

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

6. Package contents and additional information

Composition of Emuliquen Simple

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

Appearance of the product and package contents

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

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/