Evacuol Oral Drops Solution 30 Ml

VER PROSPECTO

1. What Evacuol is and what it is used for

Evacuol belongs to the group of medicines called laxatives. Its laxative action is produced by direct stimulation of the large intestine. This stimulus produces the emptying of the fecal mass after a latency period, which depends on the sensitivity of each individual and the dose.

Evacuol is indicated, in adults and children over 6 years of age, for the relief of the symptoms of occasional constipation, such as that produced by staying in bed or traveling, and to facilitate evacuation in cases of hemorrhoids and anal fissures.

2. Before taking Evacuol

Do not take Evacuol

• If you are allergic (hypersensitive) to sodium picosulfate or any of the other ingredients of Evacuol.
• If you have any inflammatory bowel disease, acute abdominal pain, symptoms of appendicitis (nausea, vomiting, abdominal pain) or intestinal obstruction. In the case of having other important abdominal discomfort, consult a doctor first.
• Evacuol should not be given to children under 6 years of age.

Take special care with Evacuol

Do not take more doses than those recommended in section 3. “How to take Evacuol”. Long-term treatment or high doses of Evacuol can cause excessive potassium loss, with a decrease in potassium in the blood, which may be aggravated if Evacuol is administered together with other medicines that have a similar effect on potassium.

If the desired effect is not obtained following the scheme indicated by the doctor or the one indicated in this leaflet, stop the treatment and consult your doctor.

If no bowel movement occurs after 72 hours, you should see a doctor.

Avoid continuous use for more than 6 days, because there is a risk of habituation (getting used to) the laxative, which will prevent the expected effect from being achieved.

Consult your doctor, even if any of the above circumstances have ever happened to you.

Use in the elderly

In the case of elderly patients, fluid loss due to repeated or excessive use can lead to weakness, low blood pressure and psychomotor coordination problems.

Use of other medications

Please 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 gastrointestinal transit caused by laxatives, the absorption of other co-administered drugs may be affected.

The use together with Evacuol of drugs with an effect on electrolytes (potassium) such as amphotericin B (drug for the treatment of fungal infections), corticosteroids, tetracosactide and diuretics (drugs that promote urine elimination), could aggravate a possible decrease in potassium in the blood (hypokalaemia) caused by Evacuol (see section “Take special care with Evacuol”).

The simultaneous intake of antibiotics can lead to the loss of the laxative effect of sodium picosulfate (active ingredient of Evacuol), since they can alter the gastrointestinal flora.

Also tell your doctor if you are taking any of the following medicines:

• Vincamine (medicine for the treatment of circulatory insufficiency of the brain)
• Bepridil, quinidine, sotalol, amiodarone (medicines used for heart rhythm disturbances)
• Digitalis glycosides (medicines used for heart failure)

Pregnancy and lactation

Consult your doctor or pharmacist before taking any medicine.

Pregnancy

In animal studies, no effects of sodium picosulfate (active ingredient of this medicine) have been observed on the fetus. However, due to the lack of data in the human species, it is advised, if possible, not to use it during pregnancy.

Lactation

Sodium picosulfate (active ingredient of the drug) and its metabolites do not pass into breast milk, so it can be used by women who are breastfeeding.

Driving and using machines

No effects have been described that affect driving and the use of machines.

Evacuol contains methyl parahydroxybenzoate

May cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate.

Evacuol contains sorbitol

This medicine contains 151.7 mg of sorbitol in 5 drops (unit dose for adults) and 60.7 mg of sorbitol in 2 drops (unit dose for children over 6 years of age).

Sorbitol is a source of fructose. If you (or your child) have been told by your doctor that you (or your child) have an intolerance to some sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease, in which the patient cannot break down fructose, consult you (or your child) with your doctor before taking this medicine.

3. How to take Evacuol

Follow these instructions unless your doctor has given you different instructions.

Posology

The presentation of Evacuol in the form of drops allows the dosage to be adapted to each individual case.

Since the laxative effect manifests itself 8 to 12 hours after taking the medication, it is preferable that it be taken at night. In this way, the laxative effect can occur the next morning.

Use in adults

The initial dose in adult patients is 5 to 10 drops a day in a single dose. In the event that the evacuation does not occur the next morning, the second day at night another 5 drops can be taken, and so on for a maximum of 6 days, as summarized in the following table:

Use in children over 6 years of age

The initial dose in children over 6 years of age is 2 to 5 drops a day in a single dose. In case the evacuation does not take place the next morning, the second day at night another 2 drops can be taken, and so on for a maximum of 6 days, as summarized in the following table:

Administration form

This medication is for oral administration.

The medication can be taken alone or dissolved in a little water, milk or fruit juice, etc.

If you think that the action of Evacuol is too strong or weak, tell your doctor or pharmacist.

If you take more Evacuol than you should

If you have taken more Evacuol than you should, immediately consult your doctor or pharmacist, go to the nearest hospital or consult the Toxicological Information Service, telephone: 915 620 420 (indicating the medicine and the amount ingested).

In case of overdose or prolonged use, as with other stimulant laxatives, gastrointestinal disturbances may occur with diarrhea and excessive loss of water and electrolytes, especially potassium, which may lead to muscle weakness and impaired heart function. If necessary, compensatory measures should be taken, such as the administration of copious amounts of fluids and electrolytes.

Likewise, in cases of prolonged use, there is the possibility of developing a purgative effect (excessive loss of fecal mass), or of worsening constipation.

If you forget to take Evacuol

Do not take a double dose to make up for a forgotten dose. Take the missed dose when you remember, and then go back to your regular schedule. However, if the next dose is a few hours away, skip the missed dose and wait to take the next dose at the time it is due.

4. Possible adverse effects

Like all medicines, Evacuol can cause side effects, although not everyone gets them.

Skin rashes, abdominal pain and diarrhea (frequency unknown) may occur

These adverse effects may appear after high doses or in prolonged treatment, are mild and transitory and disappear when deposition occurs.

Communication of adverse effects

If you get any side effects, talk to your doctor, pharmacist or nurse including possible side effects not listed in this leaflet. You can also notify them directly through the Spanish Pharmacovigilance System for Medicines for Human Use: https://www.notificaram.es. By reporting side effects you can help provide more information on the safety of this medicine.

5. Storage of Evacuol

Keep out of the reach and sight of children.

It does not require any special storage conditions.

Do not use Evacuol after the expiry date which is stated on the pack after EXP. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or in the trash. Deposit the containers and medicines that you do not need at the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines that you do not need. This way you will help to protect the environment.

6. Additional information

Composition of Evacuol

• The active substance is sodium picosulfate. Each milliliter (approximately 15 drops) contains 7.5 mg of sodium picosulfate.
• The other ingredients are 70% sorbitol solution, methyl parahydroxybenzoate (E-218), purified water.

Appearance of the product and contents of the container

Evacuol is presented as a clear, transparent, colorless and odorless liquid for oral administration. Each bottle contains 30 milliliters and has a dropper for dosing the preparation.

Marketing authorization holder and manufacturer

Marketing Authorization Holder

Almirall, SA

General Mitre, 151

08022 - Barcelona (Spain).

Responsible for manufacturing

ALMIRALL HERMAL GmbH

Scholtzstraße 3

D-21465 Reinbek (Germany)

either

Responsible for manufacturing

Almirall Pharmaceutical Industries, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain).

This leaflet has been approved in December 2003

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