Duphalac 10 g oral solution in sachet

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Duphalac 10 g oral solution in sachet

lactulose

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Duphalac is and what it is used for
2. What you need to know before taking Duphalac
3. How to take Duphalac
4. Possible adverse effects
5. How to store Duphalac
6. Contents of the pack and other information

1. What is Duphalac and what is it used for

Duphalac contains a laxative called lactulose, which works by softening the stools to improve intestinal transit and defecation, by drawing water into 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, in cases of hemorrhoids, anal surgery, or surgery in the lower part of the intestine. In addition, it is used for the treatment and prevention of portosystemic hepatic encephalopathy (portosystemic encephalopathy), a liver disease that causes difficulty in thinking, tremor, reduced consciousness, and even coma.

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

2. What you need to know before starting to take duphalac

Do not take duphalac:

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

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

Warnings and precautions

Talk to 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 informed you that you have an intolerance to certain sugars, consult with him/her before taking this medicine.

This medicine may contain sulfites from the manufacturing process. Sulfites may rarely cause severe hypersensitivity reactions and bronchospasm.

You should consult your doctor if:

• You experience symptoms of abdominal pain of undetermined cause before starting treatment.
• The effect of the medicine is insufficient after several days of treatment.
• You are lactose intolerant.
• 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 quantity of sugar, so you may need to adjust the dose of your antidiabetic treatment.

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

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 infants and children, as it may cause disturbances in normal reflexes due to passive stools.

Under special circumstances, your doctor may prescribe it for infants or children. In such cases, your doctor will closely monitor the treatment.

Use of Duphalac with other medicines

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

The following medicines are not recommended to be used with Duphalac:

• Mesalazine (an intestinal anti-inflammatory): as it may reduce the effect of mesalazine.
• Antacids (reduce stomach pH): as they may alter the action of Duphalac.
• Diuretics (promote urine elimination): as they may increase potassium loss.
• Corticosteroids (used, for example, in inflammatory conditions, immune disorders, etc.): as they may increase potassium loss.
• Amphotericin B (an antibiotic): as it may increase potassium loss.
• Cardiac glycosides (medicines for heart disorders): Duphalac may enhance the effect of cardiac glycosides if a decrease in potassium levels occurs.

Use of Duphalac with food, drinks, and alcohol

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

Pregnancy, lactation, and fertility

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

Duphalac may be taken during pregnancy and during the breastfeeding period.

No effects of Duphalac on fertility are expected.

Driving and operating machinery

This medicinal product does not impair the ability to drive or operate machinery.

3. How to take Duphalac

Oral use.

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The dose should be adjusted according to the clinical response. The duration of treatment should be adapted according to symptoms.

Lactulose may be administered as a single daily dose or divided into two doses. If taken as a single daily dose, it should always be taken at the same time, for example, during breakfast.

The corresponding dose of the oral solution can be taken either diluted with liquids or undiluted, swallowing it quickly without holding 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 sufficient fluids (approximately 2 liters daily, equivalent to 6 to 8 glasses).

Adults

Dosage for constipation or when stool softening is necessary

The initial dose should be administered once daily, for example, with breakfast, or divided into two daily doses.

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 encephalopathy

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

The maintenance dose should be adjusted to achieve two or three soft stools per day.

Use in children and adolescents

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

Duphalac must not be used in children and adolescents under 14 years of age without first consulting a doctor and under medical supervision.

Dosage for constipation or when stool softening is required

The initial dose should be administered once daily, 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 of age, duphalac 667 mg/ml oral solution should be used.

Dosing in portosystemic encephalopathy:

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

Special populations

Elderly patients

Dosage adjustment is not required in this patient group, as systemic exposure to lactulose is negligible.

Renal impairment and hepatic impairment

Dosage adjustment is not required in this patient group, as systemic exposure to lactulose is negligible.

If you take more duphalac than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91.562.04.20, indicating the medication and the amount ingested.

If you have any further 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 then continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.

If you stop taking duphalac

Do not interrupt or discontinue treatment without consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects have been reported:

• Especially during the first days of treatment: flatulence (wind). These usually disappear after a few days.
• When a higher than recommended dose is taken: abdominal pain and diarrhoea. In these cases, the dose should be reduced.

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

The following adverse effects have been observed in clinical trials of patients treated with lactulose:

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

• 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 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP or CAD. The expiry date refers to the last day of the month indicated.

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

Store in the original container, tightly closed.

Do not freeze. Freezing may alter the characteristics of the solution, causing it to become almost solid, although it returns to its normal consistency when left at room temperature.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Duphalac

• The active substance is lactulose.

Each Duphalac sachet contains 10 g of lactulose.

Each Duphalac stick contains 10 g of lactulose.

Nature of the product and pack contents

Duphalac is a clear, viscous, colourless or yellowish-brown liquid.

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

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

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

The Netherlands

Manufacturer:

Abbott Biologicals B.V.

Veerweg 12, Olst, The Netherlands

For further 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

Date of the most recent revision of this leaflet: April 2024

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