Paracetamol 10 mg/50 ml

PARACETAMOL FRESENIUS belongs to a group of medicines called antipyretics or antipyretic and anti-inflammatory analgesics.

PARACETAMOL FRESENIUS is used in adults and children of at least 1 year old (and weighing at least 10 kg) for:

• the short-term treatment of mild to moderate pain such as dental procedures, minor surgery, and for
• the short-term treatment of fever when medicine cannot be swallowed.

PARACETAMOL FRESENIUS should not be administered to you:

• if you are hypersensitive (allergic) to paracetamol, pro-paracetamol hydrochloride, or any of the other ingredients in PARACETAMOL FRESENIUS (listed in section 6).
• if you have severe liver disease including alcoholic liver disease.
• children weighing less than 10 kg (approximately 1 year old).

Warnings and precautions

During treatment with PARACETAMOL FRESENIUS, tell your doctor straight away:

If you have severe illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), or you suffer from malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (a blood and fluid abnormality) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: serious breathing difficulties with deep rapid breathing, drowsiness, feeling sick (nausea) and being sick (vomiting).

Take special care with PARACETAMOL FRESENIUS:

• if you are able to take medicine orally instead of an infusion
• if you are using any other medicines containing paracetamol
• if you have liver problems or any history of liver damage
• if you suffer from a inherited liver function disorder called Meulengracht Gilbert's syndrome
• if you have kidney problems or any history of kidney damage
• if you have glucose-6-phosphate dehydrogenase deficiency, an enzyme deficiency that may lead to red blood cell breakdown
• if you are using alcohol. Chronic use or excessive alcohol intake, i.e., three or more alcoholic drinks every day
• if you have an eating disorder such as anorexia or bulimia, or suspect that you may be undernourished or dehydrated

talk to your doctor or pharmacist if you are taking or will be taking flucloxacillin. There is a risk of blood and fluid abnormality (high anion gap metabolic acidosis) which occurs when there is an increase in plasma acidity, when paracetamol is used concomitantly with flucloxacillin, particularly in certain groups of patients at risk, e.g., patients with severe renal impairment, sepsis or malnutrition, especially if the maximum daily doses of paracetamol are used. High anion gap metabolic acidosis is a serious disease that must have urgent treatment. Inform your doctor before treatment if any of the above mentioned conditions apply to you. You should switch to taking pain killing tablets or syrup instead of PARACETAMOL FRESENIUS as soon as is possible.

Other medicines and PARACETAMOL FRESENIUS

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Tell your doctor if you are taking any of the following:

• Amoxicillin, clavulanic acid (antibiotics used to treat infection).
• Anticoagulants (medicines used for blood thinning such as warfarin).
• Barbiturates (used for certain mental conditions), including primidone.
• Carbamazepine (used to treat epilepsy and certain nerve conditions).
• Flucloxacillin (an antibiotic used to treat infection), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).
• Isoniazid (used to treat tuberculosis).
• Metoclopramide (used for nausea and stomach problems).
• Phenytoin (medicine used for epilepsy), as it may cause damage to the liver.
• Probenecid (medicine for treatment of gout), as it may interfere with the clearing of paracetamol by the liver.
• Rifampicin (used to treat infections such as tuberculosis).
• Salicylamide (medicine for treatment of pain and fever), as it may interfere with the clearing of paracetamol by the liver.
• Zidovudine (an antiretroviral medicine used in HIV).

You will not be expected to give yourself PARACETAMOL FRESENIUS. It will be given to you by a person who is qualified to do so.

PARACETAMOL FRESENIUS will be given to you by injection into a vein (intravenous infusion).

Adults: The dose of PARACETAMOL FRESENIUS will be different for different patients. Your doctor will decide on a suitable dose and the duration of the treatment based on your weight, your specific condition and needs.

Children: Your child’s doctor will work out what dose your child should receive, based on his/her weight. PARACETAMOL FRESENIUS is only given to children if they weigh more than 10 kg (approximately 1 year old). Tell your child’s doctor if you have given any other paracetamol containing pain medicine to your child. The doctor needs this information to work out how much PARACETAMOL FRESENIUS your child can receive.

If you receive more PARACETAMOL FRESENIUS than you should Since a healthcare provider will administer PARACETAMOL FRESENIUS, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage. If you receive higher doses than recommended, it can cause severe liver damage. The symptoms of liver damage are usually seen first after 2 days with the most severe symptoms experienced after 4 – 6 days. You may experience nausea, vomiting, anorexia (refusing to eat), pallor (pale skin) and abdominal pain and your doctor will treat these symptoms symptomatically. Mild symptoms during the first two days of acute poisoning do not reflect the potential seriousness of the overdosage. You may also have liver damage which will be indicated by high blood levels of liver enzymes. Liver damage may lead to brain disease, coma and death.

Prompt treatment is essential. In the event of an overdosage or suspected overdose and notwithstanding the fact that you or your child may not have symptoms, consult a doctor, hospital or poison centre immediately. A delay in starting treatment may mean that the antidote is given too late to be effective. Evidence of liver damage is often delayed until after the time for effective treatment has lapsed. If you forget to receive PARACETAMOL FRESENIUS Since a healthcare provider will administer PARACETAMOL FRESENIUS, it is unlikely that the dose will be missed.

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

If any of the following happens, stop receiving PARACETAMOL FRESENIUS and tell your doctor immediately:

• Hypersensitivity and allergic reactions: any sudden wheeziness, difficulty in breathing, angioedema (swelling of the affected area with a burning sensation), swelling of the eyelids, face or lips and rash or itching (especially affecting your whole body), flushing (redness of the skin). These are all very serious side effects. If you have them, you may have had a serious reaction to PARACETAMOL FRESENIUS. You may need urgent medical attention or further hospitalisation.

Tell your doctor if you notice any of the following:

Less frequent side effects:

• Blood disorders characterised by unusual tiredness or weakness.
• Low blood pressure.
• Liver problems (you may notice signs like dark urine, pale-coloured stools, yellow skin and eyes, abdominal pain).
• Skin rash, itching, redness of skin and other skin conditions.
• Kidney problems (you may notice signs like cloudy urine, need to urinate frequently, burning urine and back pain).
• General feeling of unease, weakness or discomfort.
• Inflammation of the pancreas, stomach pain.
• Blood and fluid abnormality (high anion gap metabolic acidosis) which occurs when there is an increase in plasma acidity, when paracetamol is used concomitantly with flucloxacillin, generally in the presence of risk factors (see section 2).

Side effects with an unknown frequency:

• A quick heartbeat.
• Nausea and vomiting.
• Pain and burning at the site of the injection.
• A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2).

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. 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 PARACETAMOL FRESENIUS. Patients are asked to report any suspected adverse drug reactions to their healthcare provider or Holder of the Certificate of Registration at the following email address: [email protected] and to the relevant medicine’s regulatory authority in the country where the product is marketed.

Store all medicines out of reach of children.

Glass bottles: Store at or below 30 °C.

Free flex ® bags: Store at or below 25 °C.

Do not refrigerate or freeze. Once opened, the contents should be used immediately. For single use only. Discard any unused portion. Do not use after the expiry date stated on the label. Do not use if you notice any particulate matter and discolouration. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).