Emuliquen Simple 478.26 mg/ml oral emulsion
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Emuliquen Simple 478.26 mg/ml oral emulsion
Liquid paraffin
Read all of this leaflet carefully before you start taking this medicine, as 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.
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Keep this leaflet, as you may need to read it again.
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If you need advice or more information, consult your pharmacist.
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If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
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You should consult a doctor if you worsen or do not improve after 6 days.
Contents of this leaflet
- What Emuliquen Simple is and what it is used for
- What you need to know before taking Emuliquen Simple
- How to take Emuliquen Simple
- Possible side effects
- How to store Emuliquen Simple
- 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, adolescents, and children over 6 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 ingredients 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 disease
- If you have diarrhea
- If you have difficulty or pain when swallowing (dysphagia)
- If you have undiagnosed rectal bleeding
- If you have undergone a colostomy or ileostomy (surgical procedure to remove a segment of the colon or small intestine)
- Children under 6 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 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 prone 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 an electrolyte imbalance (reduction of certain salts in the blood) and hypokalemia (decreased blood potassium levels). Therefore, it is recommended that patients be well hydrated before starting treatment and have normal electrolyte (blood salts) levels
- Blood glucose concentration may increase following prolonged administration of laxatives
- You should 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 6 years of age.
Use with caution in children aged 6 to 12 years due to the risk of aspiration.
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 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 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 drink
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 Emuliquen's 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 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: 15 ml or one large spoonful 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 exceed 30 ml or two large spoonfuls per day (14,347.8 mg of liquid paraffin).
Use in children and adolescents
- Children from 6 to 12 years of age: 5 ml or one small spoonful per day (2,391.3 mg of liquid paraffin), taken before bedtime, and if necessary, repeat the dose in the morning 2 hours before or after breakfast.
Do not exceed 10 ml or two small spoonfuls per day (4,782.6 mg of liquid paraffin).
- Children under 6 years of age: This medicine must not be given to children under 6 years of age.
Emuliquen Simple is taken orally.
A slight separation of the aqueous phase from the emulsion may normally be observed, due to the specific nature of the product. Shake the container well before opening to 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.).
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.
The full laxative effect is achieved starting from the third day after initiating treatment.
Gradually reduce the dose once the desired effect is achieved.
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.
If you take more Emuliquen Simple than you should
If you take more Emuliquen Simple than recommended, elimination of liquid paraffin in the stools, diarrhea with electrolyte loss (reduction of certain salts in the blood), cramps, intestinal 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 may cause adverse effects, although not everyone will experience them.
The possible adverse effects of Emuliquen Simple may include:
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Very rare adverse effects (may affect up to 1 in 10,000 people):
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Allergic reactions (skin rash, or swelling of the skin, mouth, or face, or difficulty swallowing or breathing)
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Dehydration
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Deficiency of fat-soluble vitamins (vitamins A, D, E, and K)
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A type of pneumonia called lipoid pneumonia
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Anal leakage of liquid paraffin (anal pruritus, anal incontinence)
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Worsening of constipation
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Abdominal pain
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Watery stools
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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 via the Spanish Pharmacovigilance System for 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 Simple
Keep this medicine out of sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Emuliquen Simple
- The active substance 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), acacia gum, vanillin, benzoic acid (E-210), and purified water.
Appearance of the product and contents of the container
Emuliquen Simple is an oral emulsion supplied in 230 ml glass bottles containing emulsion.
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 medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/