Laxative drops Aicardi

Patient Information Leaflet: Instructions for the User

Aicardi Laxative Drops 7.5 mg/ml oral drops, solution

sodium picosulfate
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after a few days.

Contents of this leaflet:

1. What Aicardi Laxative Drops are and what they are used for
2. What you need to know before using Aicardi Laxative Drops
3. How to use Aicardi Laxative Drops
4. Possible side effects
5. How to store Aicardi Laxative Drops
6. Contents of the pack and other information

1. What Gocce Lassative Aicardi is and what it is used for

Gocce Lassative Aicardi is an oral solution containing the active substance sodium picosulfate.
This active substance belongs to the class of stimulant laxatives (contact laxatives).
Gocce Lassative Aicardi is used for the short-term treatment of occasional constipation.
Consult your doctor if you do not feel better or if you feel worse after a few days.

Health education notes:
Many people believe they suffer from constipation if they are unable to defecate every day.
This is a mistaken belief, as this situation is completely normal for a large number of individuals.
Constipation, instead, refers to a condition in which bowel movements are less frequent than an individual's usual pattern and are associated with the passage of hard stools.
In most cases, a balanced diet rich in water and fibre (bran, vegetables, and fruit) can provide a lasting solution to constipation.
If episodes of constipation occur repeatedly, you should consult your doctor.

2. What you should know before using Aicardi Laxative Drops

Do not use Aicardi Laxative Drops

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have problems in the final part of the intestine called the “rectum” (rectal bleeding of unknown origin);
• if you have abdominal pain or abdominal cramps (colic), nausea and vomiting;
• if you suffer from intestinal muscle paralysis (paralytic ileus);
• if you have intestinal disorders (intestinal obstruction or stenosis) or obstruction or narrowing of the bile ducts (through which bile flows, a substance involved in certain digestive processes);
• if you are dehydrated (you have lost too much water);
• if you suffer from acute inflammation of the stomach and intestine (e.g. appendicitis);
• if you have diarrhea or are severely weakened (you have cachexia), because the laxative effect could become excessive;
• if you suffer from gallstones (presence of small stones obstructing bile flow);
• if you have reduced liver function (hepatic insufficiency);
• in children under 3 years of age;
• in children over 3 years of age without first consulting a doctor (see also section “Children”); Aicardi Laxative Drops is generally contraindicated during pregnancy and breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor before using Aicardi Laxative Drops:

• if constipation is persistent. Treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, prescription of medication, and monitoring during therapy;
• if you have noticed a sudden change in your bowel habits (frequency and characteristics of bowel movements) lasting more than two weeks;
• if you are elderly;
• if your general health condition is poor. Consult your doctor if, after a short period of treatment with this medicine, you do not achieve noticeable results. The use of laxatives may sometimes cause symptoms such as dizziness and/or loss of consciousness up to fainting, due to a nervous reflex mechanism in response to abdominal pain or straining during defecation, related to the constipation condition (especially in cases of severe constipation) that the medicine is intended to resolve.

Do not use this medicine for prolonged treatments.
Abuse of laxatives (frequent or prolonged use, or excessive doses) may cause:

• dependence, leading to a possible need to progressively increase the dose;
• chronic constipation;
• loss of normal intestinal function (intestinal atony);
• persistent diarrhea, which may lead to loss of water, minerals (especially potassium), and other essential nutrients. In more severe cases, dehydration or low blood potassium levels (hypokalemia) may occur, which can cause heart or nerve dysfunction affecting muscle control. The risk is increased if you are simultaneously taking medicines for heart conditions (cardiac glycosides), medicines for high blood pressure (diuretics), or medicines used for allergies and inflammation (corticosteroids).

Children
This medicine must not be used in children under 3 years of age.
In children aged between 3 and 12 years, the medicine may be used only after consulting a doctor.

Other medicines and Aicardi Laxative Drops
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Laxatives may reduce the intestinal transit time, and therefore the absorption, of other medicines taken simultaneously by mouth. Therefore, avoid taking laxatives and other medicines at the same time: after taking a medicine, wait at least 2 hours before taking the laxative.
Medicines used for stomach acidity (antacids) may alter the action of this medicine: after taking antacid medicines, wait at least 1 hour before taking the laxative.
If this medicine is taken together with magnesium citrate (also used to treat constipation), the laxative effect occurs more quickly, approximately 3 hours after administration.
The use of sodium picosulfate-based laxatives, such as Aicardi Laxative Drops, may also:

• interfere with oral anticoagulants (increasing their effect) if taken continuously;
• alter your glucose tolerance if taken continuously;
• increase the risk of loss of water, minerals, and other essential nutrients (electrolyte imbalances; see also section “Warnings and precautions”), which may increase your response to medicines taken to regulate heart function such as cardioactive glycosides;
• be influenced by the intake of antibiotics, which may reduce its effectiveness.

Aicardi Laxative Drops with food and drinks
Milk may alter the way this medicine works: after drinking milk, wait at least 1 hour before taking the laxative.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist.
The effect of this medicine on pregnancy or breastfeeding has not been studied.
Therefore, during pregnancy and breastfeeding, use this medicine only if considered necessary, under direct medical supervision, after evaluating with your doctor the risk/benefit ratio in your specific case.
The use of Aicardi Laxative Drops during pregnancy and breastfeeding is generally contraindicated.

Driving and using machines
No effects on the ability to drive or use machines are known. However, bear in mind that using a laxative to treat constipation may cause abdominal pain, sometimes very severe, which may occasionally lead to dizziness and/or fainting, even following intense straining during defecation. If you experience severe abdominal spasms, avoid driving, using machinery, or performing potentially dangerous activities.

Aicardi Laxative Drops oral drops, solution contains:

• sodium methyl parahydroxybenzoate: may cause allergic reactions (including delayed reactions);
• sorbitol: if your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to use Aicardi Laxative Drops

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The correct dose is the lowest amount needed to produce an easy evacuation of soft stools.
Start with the lowest recommended dose. A diet rich in fluids helps the effect of the medicine.
The recommended dose in adults is 5 - 10 drops, diluted in water, to be taken preferably in the evening. Do not exceed the recommended dose.

Use in children
This medicine must not be used in children under 3 years of age.
This medicine may be used in children over 3 years of age only after consulting a doctor.
The recommended dose in children aged 3 to 12 years is 2 - 5 drops, diluted in water, to be taken preferably in the evening.
Do not exceed the recommended dose.

Method of administration
This medicine should be taken with a full glass of water.

To open: To close:
Press and turn simultaneously. Screw tightly.

Duration of treatment
This medicine, like all laxatives, should be used as infrequently as possible and for no longer than seven days. Use for longer periods requires appropriate medical evaluation and prescription.

If you take more Aicardi Laxative Drops than you should
In case of accidental overdose of Aicardi Laxative Drops, contact your doctor immediately or go to the nearest hospital. Bring this leaflet with you.
Excessive doses may cause abdominal pain and diarrhea (even chronic), which can lead to loss of water and mineral salts (potentially resulting in disorders such as hypokalemia, aldosteronism, and kidney stones). Prolonged abuse of laxatives may cause kidney damage and life-threatening conditions characterized by changes in blood pH and muscle weakness. See section “Warnings and precautions” for information on laxative abuse. If diarrhea occurs, drink plenty of fluids.
Taking significantly higher doses than prescribed may cause a marked reduction in blood supply to the colon (mucosal ischemia).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Frequency not known (frequency cannot be estimated from the available data):

• allergic-type immune responses (hypersensitivity), such as excessive swelling of the mucous membranes (angioedema) or skin reactions such as rashes or itching;
• dizziness;
• fainting;
• diarrhoea;
• cramps, pain or discomfort in the abdomen;
• nausea, vomiting;
• isolated abdominal pain or abdominal colic (especially in cases of severe constipation)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the website:
http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aicardi Laxative Drops

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Expiry”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Gocce Lassative Aicardi contains

• The active substance is sodium picosulfate. 1 ml of solution contains 7.5 mg of sodium picosulfate.
• The other ingredients are sodium methyl parahydroxybenzoate, non-crystallizable liquid sorbitol, purified water.

Description of the appearance of Gocce Lassative Aicardi and contents of the pack
Gocce Lassative Aicardi oral drops, solution comes as 1 dropper bottle made of polyethylene containing 15 ml.
Marketing Authorization Holder and Manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)