EVACUOL 7.5 mg/ml Oral Drops in Solution

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Evacuol 7.5 mg/ml Oral drops in solution

Sodium picosulfate

Read all of this leaflet carefully because it contains important information for you.

• This medicine can be obtained without a prescription. Nevertheless, to obtain the best results, it should be used properly.
• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• It should not be used for more than 6 consecutive days. If symptoms worsen or persist after 6 days, you should consult a doctor.
• If no defecation occurs after 72 hours, you should consult a doctor.
• If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the package leaflet:

1. What is Evacuol and what is it used for
2. Before taking Evacuol
3. How to take Evacuol
4. Possible side effects
5. Storage of Evacuol
6. Additional information

1. What is Evacuol and what is it used for

Evacuol belongs to the group of medicines called laxatives. Its laxative action is produced by direct stimulation of the large intestine. This stimulation 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 in children over 6 years, for the relief of symptoms of occasional constipation, such as that produced by bed rest or travel, 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 components of Evacuol.
• If you have any inflammatory intestinal disease, acute abdominal pain, symptoms of appendicitis (nausea, vomiting, abdominal pain) or intestinal obstruction. In the case of having other significant abdominal discomfort, consult your doctor beforehand.
• Evacuol should not be administered to children under 6 years.

Be careful with Evacuol

Do not take more doses than recommended in section 3. "How to take Evacuol". Prolonged treatment or with high doses of Evacuol can produce excessive loss of potassium, with a decrease in potassium in the blood, which can be worsened if Evacuol is administered together with other medicines that have a similar effect on potassium.

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

If no defecation occurs after 72 hours, you should consult a doctor.

Avoid continuous use for more than 6 days, as there is a risk of habituation (getting used to) the laxative, which will make it impossible to achieve the expected effect.

Consult your doctor, even if any of the aforementioned circumstances have occurred to you at some point.

Use in the elderly

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

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those purchased without a prescription.

Due to the increased gastrointestinal transit caused by laxatives, the absorption of other medicines administered jointly may be affected.

The use of Evacuol together with medicines that affect electrolytes (potassium), such as amphotericin B (a medicine for the treatment of fungal infections), corticosteroids, tetracosactide, and diuretics (medicines that favor the elimination of urine), could worsen a possible decrease in potassium in the blood (hypokalemia) caused by Evacuol (see section "Be careful with Evacuol").

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

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

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

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

Breastfeeding

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

Driving and using machines

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

Evacuol contains methyl parahydroxybenzoate

It can produce 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).

Sorbitol is a source of fructose. If your doctor has told you (or your child) that you suffer from an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease, in which the patient cannot break down fructose, consult 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 for each individual case.

Given that the laxative effect occurs 8 to 12 hours after taking the medication, it is preferable to take it 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 per day in a single dose. In case defecation does not occur the next morning, on the second night, 5 more drops can be taken, and so on, up to a maximum of 6 days, as summarized in the following table:

Use in children over 6 years

The initial dose in children over 6 years is 2 to 5 drops per day in a single dose. In case defecation does not occur the next morning, on the second night, 2 more drops can be taken, and so on, up to a maximum of 6 days, as summarized in the following table:

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

If you take more Evacuol than you should

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

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

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

If you forget to take Evacuol

Do not take a double dose to make up for forgotten doses. Take the forgotten dose when you remember and then follow the usual schedule. However, if there are only a few hours left until the next dose, do not take the forgotten dose and wait to take the next dose at the corresponding time.

4. Possible side effects

Like all medicines, Evacuol can produce side effects, although not all people suffer from them.

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

These side effects may appear after high doses or prolonged treatments, are mild and transient, and disappear after defecation.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Evacuol

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Evacuol after the expiration date that appears on the packaging after EXP. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines that are no longer needed in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Additional information

Composition of Evacuol

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

Appearance of the product and packaging content

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

Teofarma S.r.l.

Via F.lli Cervi, 8

27010 Valle Salimbene (PV) – Italy

Manufacturer

ALMIRALL HERMAL GmbH

Scholtzstraße 3

D-21465 Reinbek (Germany)

or

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

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

This leaflet was 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/