Duphalac 3,3 g/5 ml Syrup

DUPHALAC contains a laxative called lactulose. It makes your stool softer and easier to pass, by drawing water into your bowel. It is not absorbed into your body. DUPHALAC is used to treat constipation (infrequent bowel movements, hard and dry stools). DUPHALAC is used to treat hepatic encephalopathy (a liver disease causing confusion, tremor, decreased level of consciousness). Hepatic encephalopathy can lead to a hepatic coma.

Do not take DUPHALAC:

• if you are hypersensitive (allergic) to lactulose (see section 6);
• if you have a rare problem called 'galactosaemia';
• if you have a blockage caused by anything else but normal constipation, gastrointestinal perforation or risk of perforation.

Do not take DUPHALAC if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking DUPHALAC.

Warnings and precautions

Take special care with DUPHALAC:

• if you suffer from unexplained tummy ache;
• if you are unable to digest milk sugar (lactose intolerant);
• if you have diabetes;
• if you have gastro-cardiac syndrome (Roemheld syndrome).

You should not take DUPHALAC if you suffer from:

• galactose or fructose intolerance;
• total lactase deficiency;
• glucose-galactose malabsorption.

If you have diabetes and are treated for hepatic encephalopathy, your dose of DUPHALAC will be higher. This high dose contains a large amount of sugar. Therefore, your doctor may recommend that you need to adjust the dose of your antidiabetic medicine. Chronic use of unadjusted dosages or misuse can lead to diarrhoea and disturbance of the electrolytes in your body. During the treatment with laxatives you should drink sufficient amounts of fluids. If you take DUPHALAC for several days and there is no improvement in your condition or if your symptoms worsen, please contact your doctor.

Children

In special circumstances your doctor may prescribe DUPHALAC for a child, infant or baby. In these cases, your doctor will supervise the treatment carefully. DUPHALAC should only be given to infants and smaller children if indicated as it can influence the normal reflexes for passing stools.

Other medicines and DUPHALAC

Always tell your health care provider if you are taking any other medicine. This includes all complementary or traditional medicines. Tell your doctor or pharmacist if you are currently using:

• any medicines that may affect the potassium levels in your body (including thiazides (used to treat high blood pressure), corticosteroids (used to treat inflammation) or amphotericin B (used to treat fungal infections));
• cardiac glycosides (used to treat heart failure or irregular heartbeats).

DUPHALAC with food and drink

See Section 3.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking DUPHALAC. No effects on fertility are to be expected.

Driving and using machines

DUPHALAC has no or negligible effect on your ability to drive a vehicle and use machines. DUPHALAC contains sugar and sulphite. DUPHALAC contains sugars, such as milk sugar (lactose), galactose and fructose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking DUPHALAC. DUPHALAC contains sulphite.

Do not share medicines with any other person. Always take DUPHALAC exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

The usual starting dose is:

• Adults: 30 mL (6 x 5 mL spoonfuls).
• Children (6 – 14 years): 15 mL (3 x 5 mL spoonfuls).
• Children (1 – 5 years): 10 mL (2 x 5 mL spoonfuls).
• Infants: 5 mL (1 x 5 mL spoonful).

The usual maintenance dose is:

• Adults: 15 – 30 mL (3 – 6 x 5 mL spoonfuls).
• Children (6 – 14 years): 10 – 15 mL (2 – 3 x 5 mL spoonfuls).
• Children (1 – 5 years): 5 – 10 mL (1 – 2 x 5 mL spoonfuls).
• Infants: 2.5 – 5 mL (½ – 1 x 5 mL spoonful).

You should take only one dose daily, preferably after breakfast. If you have the impression that the effect of DUPHALAC is too strong or too weak, tell your doctor or pharmacist.

If you take more DUPHALAC than you should

In the event of an overdosage, consult your doctor or pharmacist. If neither is available contact the nearest hospital or poison centre.

Take this leaflet and the rest of the remaining DUPHALAC with you so the doctor will know what you have taken. You may have diarrhoea, loss of electrolytes and pain in your stomach area.

If you forget to take DUPHALAC

Do not take a double dose to make up for forgotten individual doses.

DUPHALAC can have side effects. Not all side effects reported for DUPHALAC are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DUPHALAC, please consult your healthcare provider for advice.

If any of the following happens, stop taking DUPHALAC and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing;
• rash or itching;
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to DUPHALAC. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Side effects occurring frequently:

• diarrhoea;
• flatulence (excess wind);
• nausea (feeling sick);
• vomiting (being sick);
• pain in your stomach area.

Side effects occurring less frequently:

• electrolyte imbalance due to diarrhoea.

The following side effects may occur, but the frequency is not known:

• hives;
• redness of your skin.

Flatulence may occur during the first few days of treatment. As a rule it disappears after a few days. When dosages higher than instructed are used, abdominal pain and diarrhoea may occur. In such a case your dosage should be decreased. If you use high doses (normally only associated with hepatic encephalopathy) for an extended period of time, you may experience an electrolyte imbalance due to diarrhoea. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: http://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of DUPHALAC.

• Store at or below 25 °C.

• Store all medicines out of reach of children.

• Do not use after the expiry date printed on the carton.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).