670 mg / ml oral solution lactulose

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.

  • Save this information, you may need to read it again.
  • Contact the pharmacy staff if you need more information or advice.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.
  • You need to talk to a doctor if you do not feel better or if you feel worse after a few days.

In this leaflet: 
1. What Duphalac is and what it is used for 
2. What you need to know before you take Duphalac 
3. How to take Duphalac 
4. Possible side effects 
5. How to store Duphalac 
6. Contents of the packaging and other information 

1. What Duphalac is and what it is used for

Duphalac is used to treat constipation and liver disease.

When the active substance lactulose is broken down in the small intestine, acids are formed which bind water and increase the volume of the intestine. In this way, bowel movements are normalized and constipation is relieved. The effect of the drug in liver disease is considered to be related to the greatly increased production of acids in the colon when the drug is administered in high doses.

What you need to know before you take Duphalac

Do not take Duphalac

  • if you are allergic to lactulose or any of the other ingredients of this medicine (listed in section 6)
  • if you are galactose intolerant
  • if you have obstructions in the gastrointestinal tract ( gastrointestinal obstruction )
  • if you have cracks or risk of cracking in the gastrointestinal tract.

If you are not sure, talk to your doctor or pharmacist before taking Duphalac.

Warnings and cautions

Talk to your doctor or pharmacist before taking Duphalac:

  • if you have a stomach ache for unknown reasons

Children

Treatment of children should be done only after a prescription by a doctor.

Other medicines and Duphalac

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

Duphalac with food

Duphalac can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Ask your doctor or pharmacist for advice before taking any medicine.

Duphalac can be used during pregnancy and lactation.

No effects on fertility are expected.

Driving and using machines

Duphalac has no known effects on the ability to drive and use machines.

Duphalac contains lactose, galactose, fructose, and sulfite

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Duphalac may contain up to 67 mg/ml lactose, up to 100 mg/ml galactose, and up to 9 mg/ml fructose as traces of manufacture. The higher dose in the treatment of liver disease may affect blood sugar and should be considered by patients with diabetes mellitus.

If you (or your child) do not tolerate certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance, a rare, inherited disease that prevents you from breaking down fructose, consult your doctor before using this medicine.

This medicine contains sulfite as traces of manufacture.

3. How to take Duphalac

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Constipation: The usual starting dose for adults and adolescents over 14 years is 30 ml for 2-4 days. Thereafter, the dose may be gradually reduced. 10-25 ml daily is a standard maintenance dose. The full daily dose should be taken in the morning. The drug can be taken undiluted or advantageously mixed in food, such as juice, cocoa, film milk, or porridge. Use the dosage measure provided. Dose one can be given once a day, e.g. for breakfast, or divided into two doses per day.

Take your dose at the same time each day. Swallow the medicine quickly. Do not keep it in your mouth.

During treatment with laxatives, you should drink a sufficient amount of fluid (about 2 liters/day, equivalent to 6-8 glasses).

If you are taking Duphalac for several days and there is no improvement in your condition or if your symptoms worsen, contact your doctor.

Use in children

Treatment of children should be done only after a prescription by a doctor.

Liver disease :

Dose one is determined by the doctor, who adjusts it individually for the patient. Treatment of chronic liver disease takes place only in hospitals.

Use for children

There are no data available for the treatment of children (0 to 18 years) with liver disease.

If you take more Duphalac then you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

Symptoms of overdose may include abdominal pain and diarrhea.

If you stop taking Duphalac

Do not stop taking Duphalac or change your treatment without talking to your doctor.

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

4. Possible side effects

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

Very common (affects more than 1 user in 10):

  • Diarrhea.

Common (affects more than 1 user in 100) :

  • Gases in the stomach (flatulence)
  • Nausea
  • Vomiting
  • Stomach pain.

Rare (affects less than 1 user in 1,000) :

  • Electrolyte disturbances (an imbalance of salts in blood, urine, or body fluids) due to diarrhea.

Gases in the stomach (flatulence) may occur during the first days of treatment, but it disappears after a few days. You may experience abdominal pain and diarrhea with high doses (if this occurs, the dose should be reduced). In situations where high- dose treatment is needed (eg with hepatic encephalopathy, HE) you may experience electrolyte disturbances (an imbalance of salts in the blood, urine, or body fluids) due to diarrhea

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 bottle after EXP: The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

No special storage instructions.

6. Contents of the packaging and other information

Content declaration

  • The active substance is lactulose. 1 ml of oral solution contains 667 mg of lactulose.
  • The other ingredients are purified water. Duphalac contains traces from the manufacture, see section 2.

What the medicine looks like and the contents of the pack

Duphalac is delivered in plastic bottles of 200, 500, and 1000 ml. The dosage measure is labeled with 2.5 ml, 5 ml, 10 ml, 15 ml, 20 ml, 25 ml, and 30 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

BGP Products AB

Box 23033

104 35 Stockholm

Muhammad Nadeem

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