Panado Paediatric 120 mg/5 ml Syrup

The active ingredient paracetamol acts as an analgesic (pain reliever) and as an antipyretic (reduces fever). PANADO PAEDIATRIC SYRUP - STRAWBERRY is therefore used for the symptomatic treatment of mild to moderate pain and fever.

Do not give PANADO PAEDIATRIC SYRUP - STRAWBERRY if:

• the child is hypersensitive (allergic) to paracetamol or to any of the other ingredients of PANADO PAEDIATRIC SYRUP - STRAWBERRY (listed in section 6).
• the child has serious problems with liver function.

Warnings and precautions

Take special care with PANADO PAEDIATRIC SYRUP – STRAWBERRY PANADO PAEDIATRIC SYRUP - STRAWBERRY contains paracetamol which may be fatal in overdose. In the event of an overdose or suspected overdose, even if your child may not be showing or experiencing any symptoms, the nearest doctor, hospital or Poison Centre must be contacted immediately. Prompt specialised treatment is essential as soon as possible.

• Be sure to give the correct dosage of PANADO PAEDIATRIC SYRUP - STRAWBERRY. Severe liver damage may occur if the child is given doses higher than those recommended.
• If no pain relief is achieved, if fever persists or get worse with the recommended doses, if new symptoms occur, or if redness and swelling is present, please consult your doctor as these could be signs of a more serious condition.
• Do not use continuously for more than 10 days without consulting a doctor.
• Excessive and prolonged use of PANADO PAEDIATRIC SYRUP - STRAWBERRY may be dangerous.
• If your child suffers from hepatitis (disease of the liver) or is recovering from any form of liver disease, do not give excessive quantities of PANADO PAEDIATRIC SYRUP - STRAWBERRY.
• If the child suffers from liver or kidney disease, a doctor must monitor his/her condition while he/she is taking PANADO PAEDIATRIC SYRUP - STRAWBERRY.
• Use with caution if your child has kidney disease, chronic malnutrition or dehydration or if your child has not eaten in a few days.
• If the child is also taking a medicine that contains flucloxacillin, they may have a higher risk of developing a blood and fluid abnormality (high anion gap metabolic acidosis). Close monitoring, including measurement of 5-oxoproline in the child’s urine, is recommended.
• Serious skin reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS) acute generalised exanthematous pustulosis (AGEP), drug-reaction with eosinophilia and systemic symptoms (DRESS)/Drug-induced hypersensitivity syndrome (DIHS) and fixed drug eruptions (FDE) have been reported in patients receiving paracetamol. If your child experiences any signs of serious skin reactions such as swelling, itching, red severe rash, stop using PANADO PAEDIATRIC SYRUP - STRAWBERRY immediately and contact your doctor (see section 4).
• If the child is going to have any laboratory tests (such as a blood test, urine analysis, skin allergy test, etc.), you should tell your doctor that the child is taking PANADO PAEDIATRIC SYRUP - STRAWBERRY as it could affect the results of these tests.

Do not share medicines prescribed for you or your child with any other person. Always give PANADO PAEDIATRIC SYRUP - STRAWBERRY 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 recommended doses are as follows:

• Infants: 3 months to 1 year: 2,5 to 5 mL (60 to 120 mg)
• Children: 1 to 5 years: 5 to 10 mL (120 to 240 mg)
• 6 to 12 years: 10 to 20 mL (240 to 480 mg)

While symptoms persist, to be repeated every 4 hours if needed to a maximum of 4 doses per 24 hours for not longer than 5 days. Dose to be given orally. Shake the bottle before use. Consult a doctor if your child’s symptoms persist.

PANADO PAEDIATRIC SYRUP - STRAWBERRY – 5 mL Sachet

Always administer using a medicine measure or a syringe. For single use only. Discard remaining contents of sachet after administration of the correct dose.

If you give more PANADO PAEDIATRIC SYRUP - STRAWBERRY than you should

PANADO PAEDIATRIC SYRUP - STRAWBERRY contains paracetamol which may be fatal in overdose. In the event of an overdose or suspected overdose, even if your child may not be showing or experiencing any symptoms, the nearest doctor, hospital or Poison Centre must be contacted immediately. Prompt specialized treatment is essential as soon as possible. The initial symptoms of paracetamol overdose (within the first 24 hours) may include pallor (pale appearance), nausea, vomiting, anorexia (loss of appetite) and abdominal pain. Even though these initial symptoms may appear mild, paracetamol overdosage is a serious condition, as liver damage may only become apparent 12 to 48 hours after the paracetamol overdose. Abnormalities of glucose metabolism and metabolic acidosis may occur. Cardiac dysrhythmias have been reported.

If you forget to give PANADO PAEDIATRIC SYRUP - STRAWBERRY

If you forget to give a dose, give it as soon as you remember, unless it is almost time for the next dose. Remember to leave at least four hours between doses. Do not give a double dose to make up for forgotten individual doses.

PANADO PAEDIATRIC SYRUP - STRAWBERRY can have side effects. Not all side effects reported for PANADO PAEDIATRIC SYRUP – STRAWBERRY are included in this leaflet. Should your child’s general health worsen or if your child experiences any untoward effects while being given PANADO PAEDIATRIC SYRUP - STRAWBERRY please consult your health care provider for advice.

If any of the following happens, stop giving PANADO PAEDIATRIC SYRUP – STRAWBERRY and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, eyelids, face, tongue or lips,
• hives or welts (urticaria),
• difficulty in breathing and shortness of breath (dyspnoea),
• decrease in blood pressure (hypotension),
• severe dizziness,
• mouth ulcers, cold sores and ulcers or soreness of your tongue,
• skin lumps or hives (raised, red or white, itchy patches of skin),
• blisters on your skin or inside your mouth, nose, vagina or bottom,
• the appearance of a rash or sunburn when you have been outside (even on a cloudy day),
• serious skin reactions such as swelling, itching, red severe rash especially those covering your whole body (appearing as allergic wheals), stop giving PANADO PAEDIATRIC SYRUP - STRAWBERRY immediately and contact your doctor (see section 2).

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

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• nausea, vomiting, upper stomach pain, itching, loss of appetite,
• dark urine, clay-coloured stools,
• jaundice (yellowing of the skin or eyes).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Less frequent side effects:
• increase in number of nose bleeds or unusual bleeding,
• if your child bruises more easily,
• if your child has more infections,
• if your child has sudden decrease in the amount of urine or cloudy urine,
• if your child has unusual tiredness or weakness,
• if your child has a pale complexion.

Frequency unknown:

• if your child has hearing loss or deafness,
• if your child has an increase in blood pressure.

Long term use: PANADO PAEDIATRIC SYRUP - STRAWBERRY is NOT intended for long term use. People who use medicines containing paracetamol (i.e., PANADO PAEDIATRIC SYRUP - STRAWBERRY) every day for a long time (several months or more) could get certain side effects, including liver and kidney damage. People taking paracetamol in the usual way for shorter periods have not had these problems, but liver function tests may be affected. 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 side effects, talk to your doctor, pharmacist, or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who- umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of PANADO PAEDIATRIC SYRUP - STRAWBERRY.

Store all medicines out of reach of children. Store in a well closed container protected from light. Store at or below 25 °C. Do not refrigerate or freeze. Exposure to air should be kept to a minimum. Do not store in a bathroom. Do not give 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).