PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Lattulosio Cooper 66.7 g/100 ml syrup

Equivalent Medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any of the 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 you notice worsening of symptoms after 7 days.

Contents of this leaflet

What Lattulosio Cooper is and what it is used for
What you need to know before using Lattulosio Cooper
How to use Lattulosio Cooper
Possible side effects
How to store Lattulosio Cooper
Package contents and other information

1. What Lactulose Cooper is and what it is used for

Lactulose Cooper is a laxative that stimulates intestinal motility.
Lactulose Cooper is indicated in adults and children for the short-term treatment of occasional constipation.
Consult your doctor if you do not feel better or if you feel worse after 7 days of treatment.

2. What you need to know before using Lactulose Cooper

Do not use Lactulose Cooper if you or your child

are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
have abdominal pain, even of unknown origin,
have episodes of nausea or vomiting,
have an obstruction or narrowing of the intestine (intestinal stenosis),
have unexplained rectal bleeding,
suffer from severe dehydration (excessive loss of water from the body),
have or are at risk of perforation of the digestive tract (stomach and intestine).

Warnings and precautions
Talk to your doctor or pharmacist before using Lactulose Cooper.
Health education notes
First of all, it should be noted that, in most cases, a balanced diet rich in water and fibre (bran, vegetables and fruit) can provide long-term relief from constipation.
Many people believe they suffer from constipation if they cannot defecate every day.
This is a mistaken belief, as this condition is completely normal for many individuals.
Instead, consider that constipation occurs when bowel movements are reduced compared to your usual habits and are associated with the passage of hard stools.
If episodes of constipation recur frequently, consult your doctor.
The treatment of chronic or recurring constipation always requires medical supervision for diagnosis, prescription of medicines, and monitoring during therapy.
Consult your doctor:

if the need for a laxative arises from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) lasting more than two weeks, or if use of the laxative fails to produce an effect.
if you are elderly or in poor general health.

Laxative abuse
Frequent or prolonged use, or use in excessive doses, of laxatives may cause persistent diarrhoea, resulting in loss of water, mineral salts (especially potassium), and other essential nutrients.
In severe cases, dehydration (excessive loss of water from the body) or hypokalaemia (low potassium levels in the blood) may occur, which can lead to cardiac or neuromuscular disorders, especially if you are also taking medicines such as cardiac glycosides (medicines used to treat heart problems), diuretics (medicines used to lower blood pressure), or corticosteroids (anti-inflammatory medicines).
Abuse of laxatives may lead to dependence (possible need to progressively increase the dose), chronic constipation, and intestinal atony (loss of normal intestinal function).
Other medicines and Lactulose Cooper
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid taking laxatives together with other medicines: if you are taking another medicine, wait at least 2 hours before taking the laxative.
Inform your doctor if you are taking:

Neomycin and other antibiotics (medicines used to treat bacterial infections);
Digitalis (a medicine used to treat heart conditions).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of this medicine during pregnancy and breastfeeding should only be considered if clearly needed and under direct medical supervision; see also Lactulose Cooper CH contains propylene glycol.
Lactulose Cooper contains:

sodium. This medicine contains less than 1 mmol (23 mg) of sodium per 15 mL dose, i.e. it is essentially “sodium-free”;
sodium benzoate. This medicine contains 1.18 mg of sodium benzoate per 1 mL. It may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age;
traces of galactose, lactose and fructose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine;
traces of sulphites. Rarely, these may cause severe hypersensitivity reactions and bronchospasm;
propylene glycol (in the citrus flavour). This medicine contains 2.45 mg of propylene glycol per 1 mL. If the child is less than 4 weeks old, speak to your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol;
ethanol (in the citrus flavour). This medicine contains 2.39 mg of ethanol (alcohol) per 1 mL of syrup, equivalent to 35.9 mg of ethanol in a 15 mL dose. The amount in 1 mL of this medicine is equivalent to 0.06 mL of beer or 0.024 mL of wine. The small amount of alcohol in this medicine will not produce significant effects.

Driving and using machines
This medicine does not impair the ability to drive or operate machinery.

3. How to use Lactulose Cooper

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Dosage

The correct dose is the minimum amount needed to produce easy passage of soft stools.
It is recommended to start with the lowest recommended doses. Do not exceed the maximum daily dose recommended.

Adults
The recommended dose is 15–30 ml (equivalent to 10–20 g of lactulose), taken in one or two doses per day.
When necessary, the dose may be increased.
The maximum daily dose is 45 ml (equivalent to 30 g of lactulose).

Adolescents and children > 10 years
The recommended dose is 15 ml (equivalent to 10 g of lactulose), taken in one or two doses per day.
The maximum daily dose is 15 ml.

Children 5 - < 10 years
The recommended dose is 10 ml (equivalent to 6.67 g of lactulose), taken in one or two doses per day.
The maximum daily dose is 10 ml.

Children >1 – < 5 years
The recommended dose is 5 ml (equivalent to 3.33 g of lactulose), taken in one or two doses per day.
The maximum daily dose is 5 ml.

Children 1 month - 1 year
The recommended dose is 2.5 ml (equivalent to 1.66 g of lactulose), taken as a single evening dose.
The maximum daily dose is 2.5 ml.

Duration of treatment
Laxatives should be used as infrequently as possible and for no longer than seven days. Use for longer periods requires medical prescription following adequate clinical assessment.

Method of administration
Shake the bottle well before use.
If taking a single daily dose, it is preferable to take it in the evening.
If the dose is divided into two daily administrations, take it preferably in the morning and evening.
You may take the solution diluted or undiluted, together with a large glass of water.
A single dose of lactulose should be swallowed all at once and should not be held in the mouth for a prolonged period.

If you take more Lactulose Cooper than you should
If you or someone else has taken an excessive dose of Lactulose Cooper, or if you suspect that a child may have accidentally taken this medicine, contact your doctor immediately or go to the nearest hospital Emergency Department.
In case of accidental ingestion/overdose, abdominal pain and diarrhoea may occur; in such cases, discontinue treatment and drink fluids to replace fluid and electrolyte losses (salts present in the blood).

If you forget to use Lactulose Cooper
Do not take a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, consult your doctor or pharmacist.
Very common (may affect more than 1 in 10 people):
Abdominal pain; flatulence (excessive intestinal gas production).
Common (may affect up to 1 in 10 people):
Abdominal distension; urgency to defecate; diarrhoea; nausea; reduced appetite; headache.
Uncommon (may affect up to 1 in 100 people):
Vomiting
Not known (frequency cannot be estimated from the available data):
Loss of electrolytes (blood salts), allergic reactions, skin rash, itching, urticaria.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lattulosio Cooper

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of medicines 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 Lattulosio Cooper contains

The active substance is lactulose. 100 ml of syrup contain 66.7 g of lactulose.
The other components are: sodium benzoate, citrus flavour, and purified water.

Description of the appearance of Lattulosio Cooper and contents of the pack
Syrup in a 200 mL glass bottle with a graduated polypropylene dosing cup ranging from 2.5 ml to 30 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Cooper Consumer Health B.V.
Verrijn Stuartweg 60 – 1112 AX Diemen
(The Netherlands)

Manufacturer
ABC Farmaceutici S.p.A., Canton Moretti 29 - 10015 S. Bernardo d'Ivrea (TO)