Evacuol 7.5 mg/ml oral solution drops

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Evacuol 7.5 mg/ml Oral drops solution

Sodium picosulfate

Read the entire leaflet carefully because it contains important information for you.

• This medicine is available without a prescription. However, to achieve the best results, it must be used correctly.
• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• It should not be used for more than 6 consecutive days. If symptoms worsen or persist after 6 days, you must consult your doctor.
• If no bowel movement occurs within 72 hours, you must consult your doctor.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Evacuol is and what it is used for
2. Before you take Evacuol
3. How to take Evacuol
4. Possible side effects
5. How to store Evacuol
6. Further information

1. What Evacuol is and what it is used for

Evacuol belongs to a group of medicines called laxatives. Its laxative effect is produced by direct stimulation of the large intestine. This stimulation causes evacuation of the fecal mass after a latency period, which depends on the individual's sensitivity and the dose administered.

Evacuol is indicated in adults and children over 6 years of age for the relief of symptoms of occasional constipation, such as that caused by bed rest or travel, and to facilitate bowel 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 bowel disease, acute abdominal pain, symptoms suggestive of appendicitis (nausea, vomiting, abdominal pain), or intestinal obstruction. If you have other significant abdominal discomfort, consult your doctor first.
• Evacuol must not be given to children under 6 years of age.

Take special care with Evacuol

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

If you do not achieve the desired effect following the regimen recommended by your doctor or described in this leaflet, stop treatment and consult your doctor.

If no bowel movement occurs within 72 hours, you must consult your doctor.

Avoid continuous use for longer than 6 days due to the risk of laxative dependence (habituation), which may result in loss of desired effect.

Consult your doctor, even if any of the above circumstances have occurred in the past.

Use in elderly patients

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

Use of other medicines

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

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

Concurrent use of medicines that affect electrolyte levels (potassium), such as amphotericin B (an antifungal medication), corticosteroids, tetracosactide, and diuretics (medicines that increase urine elimination), may worsen a potential decrease in blood potassium (hypokalaemia) caused by Evacuol (see section “Take special care with Evacuol”).

Concomitant use of antibiotics may reduce the laxative effect of sodium picosulfate (the active substance in Evacuol), as they may alter gastrointestinal flora.

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

• Vincamine (a medicine used to treat 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

Animal studies have not shown any effects of sodium picosulfate (the active ingredient in this medicine) on the fetus. However, due to the lack of data in humans, it is advisable, whenever possible, to avoid using this medicine during pregnancy.

Breastfeeding

Sodium picosulfate (the active ingredient) and its metabolites do not pass into breast milk; therefore, Evacuol may be used by women who are breastfeeding.

Driving and use of machines

No effects affecting driving or operating machinery have been reported.

Evacuol contains methyl parahydroxybenzoate

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

Evacuol contains sorbitol

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

Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot metabolize fructose, consult your (or your child’s) doctor before taking this medicine.

3. How to take Evacuol

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

Dosage

The Evacuol drop formulation allows the dosage to be adjusted according to each individual case.

Since the laxative effect occurs 8 to 12 hours after taking the medication, it is preferable to take it at night. This way, the laxative effect may occur the following morning.

Use in adults

The initial dose for adult patients is 5 to 10 drops once daily. If bowel movement does not occur the following morning, 5 additional drops may be taken the second night, and so on, up to 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 per day, taken once daily. If evacuation does not occur the following morning, an additional 2 drops may be taken the second night, and so on, up to a maximum of 6 days, as summarized in the following table:

Administration method

This medicine is for oral administration.

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

If you feel that the effect 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, contact your doctor or pharmacist immediately, go to the nearest hospital, or contact the Toxicology Information Service at telephone number: 915 620 420 (indicating the medicine and the amount ingested).

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

Additionally, with prolonged use, there is a 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 missed doses. Take the missed dose as soon as you remember, then continue with your regular schedule. However, if it is almost time for your next dose, do not take the missed dose and wait to take the next dose at the scheduled time.

4. Possible adverse effects

Like all medicines, Evacuol may cause adverse effects, although not everybody experiences them.

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

These adverse effects may appear after high doses or prolonged treatment, are mild and transient, and disappear once defecation occurs.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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.

No special storage conditions are required.

Do not use Evacuol after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or in household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help 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 components are 70% sorbitol solution, methyl parahydroxybenzoate (E-218), and purified water.

Appearance of the product and contents of the container

Evacuol is a clear, transparent, colourless and odourless liquid for oral administration. Each bottle contains 30 millilitres and is supplied with a dropper for dosing.

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 patient information leaflet was approved in December 2003.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/