Package Insert: Information for the Patient

Duphalac 667 mg/ml Oral Solution

Lactulose

Read this package insert carefully before starting to use this medication, as it contains important information for you.

-Keep this package insert, as you may need to refer to it again.

-If you have any questions, consult your doctor, pharmacist, or nurse.

-This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Duphalac contains a laxative called lactulosa, which acts by softening the stool for better transit and defecation, and by promoting water inside the intestine. It is not absorbed by the body.

Duphalac is used in the treatment of constipation (infrequent bowel movements, hard and dry stools) to produce semi-solid stools. It is used, for example, when there are hemorrhoids, in anal surgery or in surgery in the lower part of the intestine. Additionally, it is used for the treatment and prevention of portosystemic encephalopathy (portosystemic encephalopathy), which is a liver disease that causes difficulty in thinking, tremor, decreased consciousness, and even coma.

You should consult a doctor if it worsens or does not improve after several days of treatment.

Do not take duphalac:

• If you are allergic to lactulose or any of the other components of this medication (listed in section 6).
• If you have galactosemia (a severe genetic disorder that prevents the digestion of galactose).
• If you have a gastrointestinal obstruction, perforation, or risk of perforation (other than habitual constipation).

Consult your doctor or pharmacist if you have any doubts.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take duphalac.

This medication contains lactose, galactose, and fructose from the manufacturing process. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication may contain sulfites from the manufacturing process. Rarely, it may cause severe hypersensitivity reactions and bronchospasm.

It is recommended that you consult your doctor in the case of:

• Presenting symptoms of undetermined abdominal pain before initiating treatment.
• If after several days of treatment, the effect of the medication is insufficient.
• If you are lactose intolerant.
• If you are diabetic.

If you are diabetic and being treated for hepatic encephalopathy, your duphalac dose will be higher. This amount of duphalac contains a large amount of sugar, so you will need to adjust your antidiabetic treatment dose.

• Chronic use of unadjusted duphalac doses (exceeding 2-3 semi-solid bowel movements per day) or misuse may lead to diarrhea and electrolyte balance disturbances.

Do not use duphalac without medical supervision for more than two weeks.

?You should be aware that the defecation reflex may deteriorate during treatment.

Children

Duphalacshould not be given frequently to babies and children, as it may cause disturbances in normal reflexes for passive stools.

In special cases, your doctor may prescribe it for babies or children. In those cases, your doctor will closely monitor the treatment.

Use of duphalac with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

It is not advisable to use the following medications with duphalac:

• Mesalazine (intestinal anti-inflammatory): as it may reduce the effect of mesalazine.
• Antacids (which decrease the pH of the stomach): as it may alter the action of duphalac.
• Diuretics (which promote urine elimination): as it may increase potassium loss.
• Corticosteroids (used, for example, in inflammatory processes, immune disorders, etc.): as it may increase potassium loss.
• Ampicillin B (antibiotic): as it may increase potassium loss.
• Cardiac glycosides (medications for heart disorders): duphalac may increase the effect of cardiac glycosides if there is a decrease in potassium levels.

Use of duphalac with food, drinks, and alcohol

Duphalac can be taken with or without food. There are no restrictions on what can be eaten or drunk with duphalac.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Duphalaccan be taken during pregnancy and during breastfeeding.

No effects of duphalac on fertility are expected.

Driving and operating machinery

This medication does not alter the ability to drive and operate machinery.

Oral administration.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

To facilitate the dosing of this medication, the following equivalences should be taken into account. One tablespoon contains 15 ml of oral solution. One dessert spoon contains 5 ml of oral solution.

The dose should be evaluated based on the clinical response. The duration of treatment should be adapted according to the symptoms.

Lactulose can be administered in a single daily dose or divided into two doses. In the case of a single daily dose, it should be taken at the same time every day, for example, during breakfast.

The corresponding dose of the oral solution can be taken either diluted with liquids or undiluted by swallowing it quickly without keeping it in the mouth.

During treatment with laxatives, such as duphalac, you should drink a sufficient amount of liquids (approximately 1.5 - 2 liters per day, equivalent to 6-8 glasses).

Adults

Dosage in constipation or when a softening of the stools is necessary

The initial dose should be administered once a day, for example, during breakfast, or divided into two doses per day.

The maintenance dose should be adjusted after a few days, based on the response to treatment, which requires several days (2-3).

Dosage in portosystemic encephalopathy

The recommended initial dose is 20 - 30 g, which corresponds to 30 - 45 ml, equivalent to 2 - 3 tablespoons, administered 3-4 times a day.

The maintenance dose will be adjusted to achieve 2-3 semi-solid stools per day.

Use in children and adolescents

The use of laxatives in children and babies should be exceptional and under medical supervision, as it may alter normal defecation reflexes.

Duphalac should not be used in children and adolescents under 14 years old without consulting your doctor and without their supervision.

Dosage in constipation or when a softening of the stools is necessary

The initial dose should be administered once a day, for example during breakfast, or divided into two doses per day.

The maintenance dose should be adjusted after a few days, based on the response to treatment, which requires several days (2-3).

Dosage in portosystemic encephalopathy:

The safety and efficacy in pediatric population (from newborns to 18 years) with portosystemic encephalopathy have not been established. There are no available data.

Special populations

Renal insufficiency and liver insufficiency

No dose adjustment is necessary in this group of patients.

Geriatric patients

No dose adjustment is necessary in this group of patients, as the systemic exposure to lactulose is insignificant.

If you take more duphalac than you should

If you have taken more duphalac than you should, you may experience diarrhea, abdominal pain, and loss of electrolytes. In this case, discontinue treatment with duphalac and consult your doctor for proper treatment of your symptoms.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount ingested.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

If you forget to take duphalac

If you forget to take a dose, take it as soon as you remember and continue with the normal treatment.Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with duphalac

Do not interrupt treatment or discontinue it without consulting your doctor.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The following adverse effects have been reported:

-Especially during the first few days of treatment: flatulence (gas), These usually disappear after a few days.

-When a higher dose than recommended is taken: abdominal pain and diarrhea. In these cases, the dose should be reduced.

If lactulose is administered at high doses (usually only associated with hepatic encephalopathy) or for a prolonged period of time, the patient may experience an electrolyte imbalance (minerals present in the blood and other bodily fluids) due to diarrhea.

In clinical trials of patients treated with lactulose, the following adverse effects were found:

Gastrointestinal disorders: very frequent (may affect more than 1 in 10 patients): diarrhea; frequent (may affect up to 1 in 10 patients): flatulence, abdominal pain, nausea, and vomiting. Additional diagnostic tests: infrequent (may affect up to 1 in 100 patients): electrolyte imbalance due to diarrhea.

-Immune system disorders: unknown frequency (frequency cannot be estimated from available data): allergic reactions

-Skin and subcutaneous tissue disorders: unknown frequency (frequency cannot be estimated from available data): rash, pruritus, urticaria.

Reporting 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 prospectus. You can also report them directly through the Spanish System for 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 this medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

Do not store above 25°C. Even under recommended storage conditions, a darkening of the color may occur, which is characteristic of sugar solutions and does not affect the therapeutic action.

Store in the original packaging, perfectly closed.

Do not freeze. If frozen, the solution's characteristics may be modified, becoming almost solid, although it returns to its normal consistency when left at room temperature.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Duphalac Composition

- The active ingredient is lactulose. 1 ml of duphalac oral solution contains 667 mg of lactulose.

Product appearance and packaging contents

Duphalac oral solution is a transparent, viscous, colorless or pale yellow liquid.

It is available in plastic bottles with a polypropylene screw cap, sealed, white, of 200 ml and 800 ml.

Only some packaging sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Responsible Manufacturer:

AbbottBiologicals B.V.

Veerweg 12, Olst, Holland

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 – Barcelona

Spain

Last review date of this leaflet: April 2024

Further detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.es/