Go-Pain P 120 mg/5 ml Syrup

GO-PAIN P contains paracetamol. Paracetamol acts as an analgesic (to relieve pain) and as an antipyretic (to reduces fever). GO-PAIN P can be used in children (3 months to 12 years of age) for the treatment of mild or moderate pain and feverishness.

Do not give GO-PAIN P

• If your child is hypersensitive (allergic) to paracetamol or any of the other ingredients of GO- PAIN P (listed in section 6).
• If your child has serious problems with his/her liver.

Warnings and precautions

GO - PAIN P contains paracetamol which may be fatal in overdose. In the event of over dosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Centre must be contacted immediately.

Take special care with GO-PAIN P

• If you give more GO-PAIN P than you should as it can cause damage to your child’s liver.
• You should tell your doctor if pain or fever persists or gets worse at the recommended dosage, or if new symptoms occur or if redness and swelling is present, as these could be signs of a more serious condition.
• Do not use GO-PAIN P continuously without consulting your doctor:
• for pain for more than 7 days in adults, or 5 days for children,
• for fever for more than 3 days.
• Store GO-PAIN P in a safe place out of reach of children.

If your child has a liver disease, you should not give more than the recommended dose of GO-PAIN P.

If your child is recovering from any form of liver disease you should not give more than is necessary of GO-PAIN P.

If your child has problems with his/her kidneys, your doctor might monitor his/her condition while he/she is taking this medicine.

If your child has skin rashes, often accompanied by flu-like symptoms after taking GO-PAIN P. The rash may progress to widespread blistering or peeling of the skin. This can be a serious skin reaction to GO-PAIN P. Stop GO-PAIN P and seek urgent advice from your doctor.

Other medicines and GO-PAIN P

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines.)

• The risk of side effects with paracetamol may be increased when taking other medicines that may be harmful to the liver or medicines that can influence the functioning of the liver.
• The absorption of paracetamol may be increased by metoclopramide (used to treat nausea or vomiting).
• Cholestyramine (used to lower cholesterol) reduces the absorption of paracetamol as in GO- PAIN P.
• The use of GO-PAIN P with salicylates (e.g., aspirin) for long periods may increase the risk of damage to the kidneys.
• Warfarin or other blood thinning medicines (anticoagulants) together with GO-PAIN P may increase the risk of bleeding. Your doctor might monitor your child’s blood clotting factors more regularly.
• Medicines used for epilepsy, such as carbamazepine, phenobarbital, phenytoin, or primidone. Your doctor might lower the dosage of GO-PAIN P.
• Probenecid (used to prevent gout) may affect the excretion of paracetamol as in GO-PAIN P and plasma (blood) concentrations of paracetamol can increase.
• Antibiotics used for the treatment of tuberculosis such as rifampicin and isoniazid may increase the blood concentration of paracetamol as in GO-PAIN P and your doctor might lower the GO-PAIN P dose.
• Zidovudine (used to treat viral infections) and co-trimoxazole (used to treat bacterial infections) together with GO-PAIN P can cause damage to the liver.
• The effect of Interferon alfa (used to treat cancers and viral infections) can be increased when used together with GO-PAIN P and your doctor might change the dose.

Do not share medicines prescribed for you with any other person. Always give GO-PAIN P 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 per mouth is:

• Infants 3 to 12 months: 2,5 mL every six to eight hours
• Children 1 to 6 years: 5 mL to 10 mL every six to eight hours
• Children 7 to 12 years: 10 mL to 20 mL every six to eight hours

Do not use more than 4 doses per 24 hours. If needed, repeat the dose to treat the symptoms of pain and fever every six to eight hours for not longer than 5 days.

If you take/give more GO-PAIN P than you should

In the event of overdosage, even if your child may not be showing or experiencing any symptoms, consult your doctor or pharmacist without delay. If neither is available, go to the nearest hospital or poison control centre. GO-PAIN P contains paracetamol which may be fatal in overdose. Prompt specialized treatment is essential as soon as possible.

If you missed a dose of GO-PAIN P

If you forget to give a dose, give it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

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

If any of the following happens, stop giving GO-PAIN P and tell your doctor immediately or go to the casualty department at your nearest hospital.

• Feeling tired, pale skin, shortness of breath, light-headedness, dizziness or a fast heartbeat, increase in nose bleeds or unusual bleeding (blood test shows changes in blood cell counts).
• An allergic reaction with skin rash, difficulty to breath, and low blood pressure.
• Severe blistering of the skin. These serious skin reactions include toxic epidermal necrolysis (Lyell's syndrome), Steven-Johnson syndrome (SJS), systemic lupus erythematosus to name a few (see also section 2, Warnings and precautions).
• Pancreas disease with pain in the upper part of the belly, nausea, vomiting.
• Liver disease with nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, and dark coloured urine. These are all very serious side effects. If you have them, you may have had a serious reaction to GO-PAIN P. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following

Less frequent side effects

• Loss of hearing
• High blood pressure
• Nausea and vomiting
• Skin rash, itching
• Kidney failure (changed in urination and swelling of ancles)

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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. 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 GO-PAIN P

Store all medicines out of reach of children.

• Store in a cool dry place at or below 25 °C
• Protect from light
• Store in the original container
• Keep the container tightly closed
• Do not use after the expiry date stated on the bottle