PATIENT INFORMATION LEAFLET

Evacol 7.5 mg/ml Oral Drops in Solution

Picosulfate Sodium

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

• This medicine can be obtained without a prescription. However, for 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.
• Do not use for more than 6 consecutive days. If symptoms worsen or persist after 6 days, consult your doctor.
• If no bowel movement occurs after 72 hours, consult your doctor.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

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

Evacuol is indicated,in adults and in children over 6 years,for relief of symptoms of occasional constipation, such as that caused by bed rest or travel, and to facilitate evacuation in cases of hemorrhoids and anal fissures.

Do not take Evacuol

• If you are allergic (hypersensitive) to sodium picosulfate or to any of the other components of Evacuol.
• If you have any inflammatory intestinal disease, acute abdominal pain, appendicitis symptoms (nausea, vomiting, abdominal pain) or intestinal obstruction. In the case of having other significant abdominal discomforts, consult your doctor beforehand.
• Evacuol should not be administered to children under 6 years old.

Be especially careful with Evacuol

Do not take more than the recommended doses indicated in section 3. “How to take Evacuol”. Prolonged treatment or high doses of Evacuol may cause excessive potassium loss, with a decrease in blood potassium levels, which may be worsened if Evacuol is taken with other medications that have a similar effect on potassium.

If you do not obtain the desired effect by following the scheme indicated by your doctor or the one indicated in this prospectus, interrupt the treatment and consult your doctor.

If no defecation occurs after 72 hours, you should consult your 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 previously mentioned circumstances have occurred at any time.

Use in the elderly

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

Use of other medications

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

Due to the increased gastrointestinal transit caused by laxatives, the absorption of other medications taken concurrently may be affected.

The use of Evacuol with medications that affect electrolytes (potassium) such as amphotericin B (medication for fungal infections), corticosteroids, tetracosactide, and diuretics (medications that promote urine elimination), may worsen a possible decrease in blood potassium levels (hypokalemia) caused by Evacuol (see section “Be especially careful with Evacuol”).

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

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

• Vincamina (medication for cerebral circulatory insufficiency)
• Bepridilo, quinidina, sotalol, amiodarona (medications used for heart rhythm disorders)
• Digitalis glycosides (medications used for heart failure)

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Pregnancy

In animal studies, no effects of sodium picosulfate (active principle of this medication) on the fetus were observed. However, due to the lack of data in humans, it is recommended, if possible, not to use it during pregnancy.

Breastfeeding

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

Driving and operating machinery

No effects have been described that affect driving and operating machinery.

Evacuol contains parahydroxybenzoate of methyl

It may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoate of methyl.

Evacuol contains sorbitol

This medication 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 old).

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

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

Dosage

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

Since the laxative effect manifests itself between 8 and 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. If there is no evacuation 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 old

The initial dose in children over 6 years old is 2 to 5 drops per day in a single dose. If there is no evacuation 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:

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 estimate that 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 contact the Toxicological Information Service, phone: 915 620 420 (indicating the medication and the amount ingested).

In the event of an overdose or prolonged use, as with other stimulant laxatives, gastrointestinal disturbances with diarrhea and excessive loss of water and electrolytes, especially potassium, may occur, leading to muscle weakness and heart function disorders. If necessary, compensatory measures should be taken, such as the administration of abundant amounts of liquids and electrolytes.

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

If you forgot to take Evacuol

Do not take a double dose to compensate for the missed doses. Take the missed dose as soon as you remember and then continue with your regular schedule. However, if there are only a few hours left before the next dose, do not take the missed dose and wait for the next dose at the scheduled time.

Like all medications, Evacuol may produce adverse effects, although not all people may experience them.

They may cause skin eruptions, abdominal pain, and diarrhea (unknown frequency)

These adverse effects may appear after high doses or prolonged treatments, are mild and transient, and disappear upon excretion.

Reporting Adverse Effects

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

Keep out of reach and sight of children.

No special storage conditions are required.

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

Medicines should not be disposed of through drains or in the trash.Deposit empty containers and unused medicines at the SIGRE collection point at the pharmacy. If in doubtask your pharmacist how to dispose of empty containers and unused medicines. By doing so, you will help protect the environment..

Evacuol Composition

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

Product Appearance and Packaging Content

Evacuol is presented in the form of a clear, transparent, colorless, and odorless liquid for oral administration. Each bottle contains 30 milliliters and is equipped with a dropper for dosing the preparation.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Teofarma S.r.l.

Via F.lli Cervi, 8

27010 Valle Salimbene (PV) – Italy

Responsible Manufacturer

ALMIRALL HERMAL GmbH

Scholtzstraße 3

D-21465 Reinbek (Germany)

or

Responsible 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

The information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/