Adco-Salterpyn ® Syrup

ADCO-SALTERPYN ® SYRUP contains three active ingredients namely, paracetamol, codeine phosphate and promethazine hydrochloride. It is used to treat mild to moderate pain, associated with fever.

Do not give ADCO-SALTERPYN ® to your child:

• if he / she is hypersensitive (allergic) to paracetamol, opiates or phenothiazines or any of the other ingredients of ADCO-SALTERPYN ® SYRUP (listed in section 6).
• if he / she is younger than 2 years old.

Warnings and precautions

Take special care with ADCO-SALTERPYN ® SYRUP:

• do not give your child more than the recommended dose (see section 3: “How to give ADCO-SALTERPYN ® SYRUP to your child” for the dosing instructions).
• giving too much ADCO-SALTERPYN ® SYRUP to your child may cause serious liver problems (due to the paracetamol component of ADCO-SALTERPYN ® SYRUP).
• giving too much of ADCO-SALTERPYN ® SYRUP to your child over a long period of time can lead to dependency and addiction (due to the codeine component of ADCO-SALTERPYN ® SYRUP).
• high doses of promethazine, a component of ADCO-SALTERPYN ® SYRUP, may cause fits (seizures).
• if your child does not get better, talk to your child’s doctor.
• do not give your child ADCO-SALTERPYN ® SYRUP continuously for more than 10 days without talking to your child’s doctor.
• ADCO-SALTERPYN ® SYRUP may cause your child to feel drowsy and have decreased concentration. This may be worsened if taken with other medicines that contain alcohol or that are known as “central nervous system depressants”.
• your child’s skin and eye pigmentation (colour) should be checked regularly for changes. Speak to your doctor or pharmacist if you are not sure.
• if your child has liver or kidney problems, you should not give ADCO-SALTERPYN ® SYRUP to him or her.

Children

Do not give ADCO-SALTERPYN ® SYRUP to children younger than 2 years, as it can cause serious and life-threatening breathing problems.

Do not share medicines prescribed for you, or your child, with any other person. Always give ADCO-SALTERPYN ® SYRUP exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. Check with your doctor, pharmacist or nurse if you are not sure.

DO NOT EXCEED THE RECOMMENDED DOSE.

The usual dose:

• for children 2 to 5 years: 5 ml three times a day.
• for children 6 to 12 years: 5 to 10 ml three times a day.

Do not give ADCO-SALTERPYN ® SYRUP continuously for more than 10 days without consulting a doctor.

If you give more ADCO-SALTERPYN ® SYRUP to your child than you should

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

ADCO-SALTERPYN ® SYRUP can have side effects. Not all side effects reported for ADCO-SALTERPYN ® SYRUP are included in this leaflet. Should your child’s general health worsen or if your child experiences any untoward effects while taking ADCO-SALTERPYN ® SYRUP, please consult your health care provider for advice.

If any of the following happens, stop giving ADCO-SALTERPYN ® SYRUP to your child, and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing;
• rash or itching;
• fainting;
• muscle rigidity or spasms, rapid and shallow breathing, rapid heart rate, very high body temperature, sweating excessively, and patchy, irregular skin colour (mottled skin).

These are all very serious side effects. If your child has them, he / she may have had a serious allergic reaction to ADCO-SALTERPYN ® SYRUP. Your child may need urgent medical attention or hospitalisation.

Stop giving ADCO-SALTERPYN ® SYRUP and call your doctor at once if your child experience any of the following:

• nausea, vomiting, stomach pain, itching and loss of appetite;
• dark urine and jaundice (yellowing of the skin or eyes);
• tiredness or extreme drowsiness / sleepiness;
• nervousness/excitement, hallucinations (seeing, hearing, feeling or smelling things that are not there), tremors, muscle twitching, fits (seizures) and high fever.

These are all serious side effects and may be due to liver problems or that your child has been given too much of this medicine. Your child may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• constipation.

Less frequent side effects:

• skin rash and / or redness, hives and skin sensitivity (increase in the reactivity to light known as photosensitivity);
• dizziness, low blood pressure (also known as hypotension which may cause dizziness) and blurred vision;
• nausea (feeling sick), vomiting (being sick), loss of appetite and dry mouth;
• changes in blood count (be picked up with a blood test) and a type of anaemia known as haemolytic anaemia (lack of red blood cells due to destruction of circulating cells);
• feeling irritable or restless;
• increase in heart rate;
• difficulty in passing urine.

Side effects with an unknown frequency:

• lack of concentration or confusion;
• generally feeling unhappy, restless, dissatisfied or depressed;
• feeling extremely happy or exhilarated;
• hallucinations (seeing, hearing, smelling or feeling things that are not there i.e., perception of a non-existent object or event);
• difficulty in sleeping (insomnia);
• lassitude (lack of energy, fatigue, lethargy), tiredness and weakness;
• muscular weakness (including of the hands) and in-coordination;
• headache;
• ringing in ears (tinnitus);
• changes to the eyes or vision;
• feeling tight chested;
• colic or upper stomach pain and diarrhoea;
• passing of more than usual / excessive amounts of urine;
• increase (fever) or decrease of body temperature;
• mucosal skin lesions (which appear, for example, on soft skin tissue or inside the body, like the lips, mouth, skin around genitals);
• pancreatitis (which may include signs and symptoms like stomach pain that also radiates to the back, nausea and vomiting, fever, chills, tender and swollen stomach, diarrhoea and indigestion).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If your child gets any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of ADCO-SALTERPYN ® SYRUP.

Store all medicines out of reach of children.

• Store at or below 25 °C.
• Protect from light.
• Do not use after the expiry date stated on the label.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).