Duphalac

PATIENT LEAFLET: INFORMATION FOR THE PATIENT

DUPHALAC 66.7 g/100 ml syrup

Lactulose
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 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 improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

1. What DUPHALAC is and what it is used for
2. What you need to know before using DUPHALAC
3. How to use DUPHALAC
4. Possible side effects
5. How to store DUPHALAC
6. Contents of the pack and other information

1. What DUPHALAC is and what it is used for

DUPHALAC contains the active substance lactulose, a laxative that stimulates intestinal motility.
DUPHALAC 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.

2. What you should know before using DUPHALAC

Do not use DUPHALAC if you or your child

• are allergic to lactulose or to any of the other ingredients of DUPHALAC (listed in section 6);
• have abdominal pain, even of unknown origin;
• are experiencing episodes of nausea and vomiting;
• have intestinal stenosis (obstruction or narrowing of the intestine);
• have unexplained rectal bleeding;
• suffer from severe dehydration (excessive loss of water from the body);
• have gastrointestinal perforation or are at risk of gastrointestinal perforation (stomach and intestine).

Warnings and precautions
Talk to your doctor or pharmacist before using DUPHALAC.
Health education notes
First of all, it should be noted that in most cases, a balanced diet rich in water and fiber (bran, vegetables, and fruit) can permanently resolve constipation problems.
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 a large number of individuals.
Instead, constipation should be considered 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 recurrent constipation always requires medical supervision for diagnosis, prescription of medications, 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 when the use of the laxative fails to produce an effect.
Laxative abuse
Frequent, prolonged, or excessive-dose use of laxatives may cause persistent diarrhea, resulting in loss of water, electrolytes (especially potassium), and other essential nutrients.
In severe cases, dehydration (excessive loss of water from the body) or hypokalemia (low blood potassium levels) may occur, potentially leading to cardiac or neuromuscular disorders, especially if you are also taking medications such as cardiac glycosides (medications used to treat heart problems), diuretics (medications used to lower blood pressure), or corticosteroids (anti-inflammatory drugs).
Laxative abuse may lead to dependence (possible need to progressively increase dosage), chronic constipation, and intestinal atony (loss of normal intestinal function).
Other medicines and DUPHALAC
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 need to take another medicine, wait at least 2 hours before using the laxative.
Inform your doctor if you are taking:

• antibiotics (medicines used to treat bacterial infections);
• digitalis (a medicine used to treat heart conditions);
• diuretics (medicines used to reduce blood pressure);
• corticosteroids (medicines used to treat allergies and inflammation).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
During pregnancy and breastfeeding, you may take this medicine.
DUPHALAC contains:

• traces of galactose, lactose, and fructose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine;
• traces of sulfites. Rarely, these may cause severe hypersensitivity reactions and bronchospasm.

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

3. How to take DUPHALAC

Use this medicine exactly as stated in this leaflet or according to the instructions provided by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dosage
The correct dose is the lowest dose sufficient to produce easy passage of soft stools.
It is recommended to initially use the lowest recommended doses. Do not exceed the maximum daily dose recommended.
The recommended doses to be taken in one or two administrations per day are listed in the table below:

Duration of treatment
Laxatives should be used as infrequently as possible and for no longer than seven days. Prescription for prolonged use should be made only after adequate clinical evaluation.

Method of administration
For oral use.
Shake the bottle before use.
Use the graduated dosing cup supplied with the package.
If taking a single daily dose, it is preferable to take it in the evening. If the dose is divided into two administrations per day, it is preferable to take it in the morning and in the evening.
The lactulose solution may be administered diluted or undiluted, together with an adequate amount of water (a generous glass).
A single dose of lactulose should be swallowed entirely at once and should not be held in the mouth for a prolonged period.

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

If you forget to use DUPHALAC
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following side effects, consult your doctor or pharmacist. The following side effects have been reported with unknown frequency (frequency cannot be estimated from the available data):

• flatulence (gas)*,
• abdominal pain (stomach ache)*,
• nausea,
• vomiting,
• diarrhoea (mainly following excessive doses),
• electrolyte imbalance (alteration in blood salt levels) due to diarrhoea,
• allergic reactions,
• skin rash,
• pruritus,
• urticaria. *These effects are more frequent in cases of severe constipation. Moreover, they are generally mild and resolve spontaneously after the first few days of treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You may also report side effects directly through the national reporting system at 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 DUPHALAC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”.
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 DUPHALAC contains
The active substance is lactulose.
100 ml of syrup contain 66.7 g of lactulose.
The other ingredient is purified water.
Description of the appearance of DUPHALAC and contents of the pack
Syrup in a 200 ml HDPE bottle with a tamper-evident closure made of polypropylene, equipped with a dropper.
A graduated polypropylene dosing cup is included in the pack.
Marketing Authorisation Holder
Cooper Consumer Health B.V.
Verrijn Stuartweg 60 – 1112 AX Diemen
(The Netherlands)
Manufacturer
Abbott Biologicals B.V. - Olst, The Netherlands