DUPHALAC 10 G ORAL SOLUTION IN SACHET

2. What you need to know before you take Duphalac

Do not take Duphalac:

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

If you have any doubts, consult your doctor or pharmacist.

Warnings and precautions

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

This medicine 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 medicine.

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

It is advisable to consult your doctor in the following cases:

• If you present symptoms of abdominal pain of unknown cause before starting treatment.
• If, after several days of treatment, the effect of the medicine is insufficient.
• If you are lactose intolerant.
• If you are diabetic.

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

• The chronic use of unadjusted doses of Duphalac (which exceed 2-3 semi-solid defecations per day) or misuse can lead to diarrhea and electrolyte imbalance.

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

Duphalac should not be given frequently to babies and children, as it can cause alterations in normal defecation reflexes.

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

Using Duphalac with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

It is not advisable to use the following medicines with Duphalac:

• Mesalazine (intestinal anti-inflammatory): as it may decrease the effect of mesalazine.
• Antacids (decrease stomach pH): as it may alter the action of Duphalac.
• Diuretics (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.
• Amphotericin B (antibiotic): as it may increase potassium loss.
• Cardiac glycosides (medicines for heart disorders): Duphalac may increase the effect of cardiac glycosides if there is a decrease in potassium levels.

Using Duphalac with food, drinks, and alcohol

Duphalac can be taken with or without food. There are no restrictions on what you can eat or drink with Duphalac.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Duphalaccan be taken during pregnancy and breastfeeding.

No effects of Duphalac on fertility are expected.

Driving and Using Machines

This medicine does not affect the ability to drive and use machines.

3. How to take Duphalac

Oral use.

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

The dose should be assessed based on the clinical response. The duration of treatment should be adapted according to 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 always at the same time, for example, during breakfast.

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

The corner of the sachet should be torn and the contents taken immediately.

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

Adults

Dosage in Constipation or when 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 Hepatic Portosystemic Encephalopathy

The recommended initial dose is 20 - 30 g, corresponding to 30 - 45 ml, equivalent to 2 - 3 sachets, administered three to four times a day.

The maintenance dose will be adjusted to achieve two or three semi-solid defecations per day.

Use in Children and Adolescents

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

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

Dosage in Constipation or when 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).

• If the maintenance dose is below 10 g (equivalent to 1 sachet of 15 ml), Duphalac 667 mg/ml oral solution should be used. For precise dosing in infants and children up to 7 years, Duphalac 667 mg/ml oral solution should be used.

Dosage in Hepatic Portosystemic Encephalopathy:

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

Special Populations

Elderly patients

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

Renal and Hepatic Impairment

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

If you take more Duphalac than you should

In case you have taken more Duphalac than you should, you may experience diarrhea, abdominal pain, and electrolyte loss. In that case, stop the treatment with Duphalac and consult a doctor for adequate treatment of your symptoms.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91.562.04.20, indicating the medicine 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 make up for forgotten doses.

If you stop taking Duphalac

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

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported:

• Especially during the first days of treatment: flatulence (gas), usually disappears after a few days.
• When taking a higher dose than recommended: abdominal pain and diarrhea. In these cases, the dose should be reduced.

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

In clinical trials of patients treated with lactulose, the following side effects have been found:

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

Immune system disorders: frequency not known (frequency cannot be estimated from the available data): allergic reactions

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

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 carton after EXP. The expiry date is the last day of the month shown.

Do not store above 25°C. Even in the 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 package, tightly closed.

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

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. Ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the Pack and Other Information

Composition of Duphalac

• The active substance is lactulose.

Each sachet of Duphalac contains 10 g of lactulose.

Each stick of Duphalac contains 10 g of lactulose.

Appearance of the Product and Contents of the Pack

Duphalac is a transparent, viscous, colorless or yellowish-brown liquid.

It is available in single-dose sachets of 15 ml, in a pack with a polyester/aluminum/polyethylene laminate. Each pack contains 10 or 50 sachets.

It is also available in sticks (longer sachet) of polyester/aluminum/polyethylene of 15 ml. Each pack contains 10 or 50 sticks.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Manufacturer:

Abbott Biologicals B.V.

Veerweg 12, Olst, Netherlands

You can request more information about this medicine by contacting the local representative of the Marketing Authorization Holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5ª planta

08011 – Barcelona

Spain

Date of the last revision of this leaflet: April 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.es/