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Indicated in adults and children over 6 years old for the relief of symptoms of occasional constipation, as produced by bed rest or travel and to facilitate the evacuation in cases of hemorrhoids and anal fissures.
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1. WHAT IS EVACUOL AND WHAT IT IS USED
Evacuol belongs to the group of medicines called laxatives. Its laxative action occurs by direct stimulation of the large intestine. This stimulation causes the emptying of the faecal mass after a latency period, which depends on the sensitivity of each individual and dose.
Evacuol is indicated in adults and children over 6 years old for the relief of symptoms of occasional constipation, as produced by bed rest or travel and to facilitate the evacuation in cases of hemorrhoids and anal fissures.
2. BEFORE YOU TAKE EVACUOL
Do not take Evacuol if:
- If you are allergic (hypersensitive) to picosulfate sodium or any of the other ingredients of Evacuol.
- If you have any inflammatory bowel disease, acute abdominal pain, appendicitis symptoms (nausea, vomiting, abdominal pain) or intestinal obstruction. In the case of other major abdominal discomfort type, consult your doctor beforehand.
- Evacuol should not be given to children under 6 years old.
Take special care with Evacuol
Do not take more doses than recommended in paragraph 3. "How to take Evacuol". Prolonged or high dose of Evacuol treatment can lead to excessive loss of potassium, with decreased blood potassium, which can be aggravated if Evacuol administered with other medicines that have a similar effect on potassium.
If the desired effect is not obtained following the scheme indicated by the physician or indicated in this leaflet, stop treatment and consult your doctor.
If no bowel movement after 72 hours did not occur, you should consult the doctor
Avoid continuous use for more than 6 days, be a risk of habituation
(Used) to laxative which will cause the desired effect is not achieved.
Consult your doctor, even if any of the above circumstances would have ever happened.
Use in elderly
In the case of elderly patients, loss of fluids due to repeated or excessive use can lead to weakness, lowering stress and psychomotor coordination problems.
Using other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Due to the increased traffic caused by gastrointestinal laxatives, it may be affected the absorption of other medicines administered together.
Use with Evacuol medicine effect on electrolytes (potassium) as amphotericin B (medicine to treat fungal infections), corticosteroids, tetracosáctido and diuretics (medicines that encourage urination) could aggravate a possible decrease blood potassium (hypokalemia) caused by Evacuol (see "Take special care with Evacuol").
The simultaneous administration of antibiotics can lead to loss laxative effect of sodium picosulfate (active ingredient Evacuol), because they can alter the gastrointestinal flora.
Also tell your doctor if you are taking any of the following medications:
- Vincamina (medicine for treating circulatory insufficiency of the brain)
- Bepridilo, Quinidine, sotalol, amiodarone (medicines used for heart rhythm disturbances)
- Digitalis glucosides (medicines used for heart failure)
Pregnancy and lactation
Consult your doctor or pharmacist before taking any medicine.
In animal studies they have not observed picosulfate effects of sodium (active ingredient of this medicine) on the fetus. However, due to the lack of data in humans, it is advisable, if possible, not to use it during pregnancy.
Picosulfate sodium (active ingredient of the medicine) and its metabolites pass into breast milk so it can be used by lactating women.
Driving and using machines
It has not been described any effect which affect driving and using machines.
Important information about some of the ingredients of Evacuol
It can produce (possibly delayed) allergic reactions because it contains methyl parahydroxybenzoate.
This medicine contains sorbitol. If your doctor has told you have an intolerance to certain sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE EVACUOL
Follow these instructions unless your doctor gave you different advice.
- Adults: Initial, 5-10 drops per day, taken all at once. If evacuating the next morning does not occur, the second day at night may be other 5 drops, so on up to 6 days (25 drops).
- Children over 6 years old: Initial, 2-5 drops per day, taken all at once. If evacuating the next morning does not occur, the second day at night can be taken other 2 drops, so on up to 6 days (10-13 drops).
- Children under 6 years old has not been evaluated safety and effectiveness in these children.
Method of administration
This medicine is for oral administration.
The medication can be taken alone or dissolved in a little water, milk or fruit juice, etc.
If it considers that the action of Evacuol is too strong or too weak, talk to your doctor or pharmacist.
If you take more than you should Evacuol
If you have taken more Evacuol than you should, immediately consult your doctor or pharmacist, go to the nearest or consult your local poison control center hospital, phone: (+34) 915 620 420 (indicating the medicine and the amount taken).
In case of overdose or prolonged use, as with other stimulant laxatives may appear gastrointestinal disorders with diarrhea and excessive loss of water and electrolytes, especially potassium, which can lead to muscle weakness and impaired heart function. If necessary compensatory measures should be taken, as the administration of large amounts of fluids and electrolytes.
Also, in cases of prolonged use it is possible to develop a cathartic effect (excessive loss of fecal mass), or worsens constipation.
If you forget to take Evacuol
Do not take a double dose to make up for missed doses. Take the missed dose when you remember and then continue with the usual dosing schedule. However, if few hours left for the next dose, skip the missed dose and wait to take the next dose at the regular time dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Evacuol can cause side effects, although not everybody gets them.
skin rashes, abdominal pain and diarrhea (frequency) These side effects may occur after high doses or prolonged treatment may occur, they are mild and transient and disappear deposition occur.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
5. HOW TO STORE EVACUOL
Keep out of reach and sight of children. It does not require any special storage conditions.
Do not use Evacuol after the expiration date on the carton after EXP. The expiry date is the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Place containers and medicines no longer required in Point SIGRE pharmacy. If in doubt, ask your pharmacist how to dispose of medicines no longer required. This way you will help to protect the environment.
6. FURTHER INFORMATION Evacuol
- The active substance is sodium picosulfate. Each milliliter (about 15 drops) contains 7.5 mg of sodium picosulfate.
- The other ingredients are sorbitol solution 70%, methyl parahydroxybenzoate (E218), purified water.
Looks like and contents of the pack
Evacuol is in the form of liquid limpid, transparent, colorless and odorless for oral administration. Each bottle contains 30 milliliters and has a dropper for dosing preparation.
Holder of the marketing authorization
Almirall, S.A. General Mitre, 151
08022 - Barcelona (Spain).
Responsible for manufacturing
Pharmaceutical Industries Almirall, S.A.
Ctra. Nacional II, Km. 593
08740 Sant Andreu de la Barca - Barcelona (Spain).
Almirall Hermal GMBH Scholtzstrasse 3 Reinbek Germany
Source: Spanish Agency for Medicines and Health Products