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Document: leaflet MAH GENERIC_PL 30306-0391 change

• leaflet MAH GENERIC_PL 24598-0028
• leaflet MAH GENERIC_PL 30306-0391

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Read all of this leaflet carefully before you are given this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor, nurse or pharmacist

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

11 What Paracetamol 10mg/ml Solution for Infusion is and what it is used for 21 Before you use 31 How to use 41 Possible side effects 51 How to store 61 Further information

J What Paracetamol 10mg/ml Solution for Infusion is

and what it is used for

Paracetamol 10mg/ml Solution for Infusion is used as an analgesic

(relieves pain) and an antipyretic (lowers fever).

It is used for:

•    short-term treatment of moderate pain, especially following surgery

•    short-term treatment of fever.

^ Before you use

Do not use Paracetamol 10mg/ml Solution for Infusion

if you:

•    are allergic (hypersensitive) to paracetamol or any of the other ingredients of Paracetamol 10mg/ml Solution for Infusion. An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.

•    are allergic (hypersensitive) to propacetamol (another analgesic similar to paracetamol).

•    suffer from severe liver disease.

Take special care with Paracetamol 10mg/ml Solution for Infusion

•    Use a suitable oral pain killer as soon as possible.

•    If you suffer from a liver disease, severe kidney disease or from alcohol abuse.

•    If you are taking other medicines containing paracetamol.

•    In cases of nutrition problems (malnutrition) or dehydration.

I nform your doctor before treatment if any of the above mentioned conditions apply to you.

Taking other medicines

Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or herbal medicines and natural products.

Take particular care if you are taking the following medicines while under treatment with Paracetamol 10mg/ml Solution for Infusion:

•    other paracetamol-containing products, in order not to exceed the recommended daily dose.

•    probenecid.

•    oral anticoagulants. More check-ups to look at the effect of the anticoagulant might be needed.

Pregnancy and breastfeeding

Inform your doctor or nurse if you are pregnant, may be pregnant or are breast feeding. Paracetamol 10mg/ml Solution for Infusion may be used during pregnancy, however, the doctor must evaluate if the treatment is advisable.

Ask your doctor, nurse or pharmacist for advice before taking any medicine.

Important information about some of the ingredients of Paracetamol 10mg/ml Solution for Infusion

This medicinal product contains 4.32 mmol sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

^ How to use

For intravenous use (injection into a vein).

The 50ml vial is restricted to term newborn infants, infants, toddlers and children weighing less than 33kg.

The 100ml vial is restricted to adults, adolescents and children weighing more than 33kg.

Dosage

Do not give anything else containing paracetamol while using this medicine.

The dose you will be given will be decided by the doctor and will depend on your weight, liver and kidney function.

* Pre-term newborn infants: No safety and efficacy data are available for pre-term newborn infants.

**Maximum daily dose: The maximum daily dose as presented in the table above is for patients that are not receiving other paracetamol containing products and should be adjusted accordingly taking such products into account.

***Patients weighing less will require smaller volumes.

The minimum interval between each administration must be at least 4 hours.

The minimum interval between each administration in patients with severe renal insufficiency must be at least 6 hours.

No more than 4 doses to be given in 24 hours.

In patients weighing 50kg or less or with risk factors* you will be given a maximum dose of 3g per day.

If you are given more Paracetamol 10mg/ml Solution for Infusion than you should

Talk to a doctor at once if you are given too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage. Contact your doctor, nurse or pharmacist immediately if you experience the following symptoms of an overdose within the first 24 hours: feeling or being sick, weight loss, pale skin (pallor) or abdominal pain.

If you forget to use Paracetamol 10mg/ml Solution for Infusion

If you forget to use Paracetamol 10mg/ml Solution for Infusion, pain or fever is likely to return. Do not take a double dose to make up for forgotten individual doses.

If you have any further questions on the use of Paracetamol 10mg/ml Solution for Infusion, ask your doctor, nurse or pharmacist.

Possible side effects

Like all medicines, Paracetamol 10mg/ml Solution for Infusion can cause side effects, although not everybody gets them.

Contact your doctor or nurse and stop treatment immediately if you experience an allergic reaction with symptoms such as swelling of the face, lips, tongue and throat, difficulty breathing or swallowing or a skin rash.

Continued top of next column

________

* Pre-term newborn infants: No safety and efficacy data are available for pre-term newborn infants.

"Maximum daily dose: The maximum daily dose as presented in the table overleaf is for patients that are not receiving other paracetamol containing products and should be adjusted accordingly taking such products into account.

***Patients weighing less will require smaller volumes.

The minimum interval between each administration must be at least 4 hours.

The minimum interval between each administration in patients with severe renal insufficiency must be at least 6 hours.

No more than 4 doses to be given in 24 hours.

Do not exceed the stated dose.

Kidney disease:

It is recommended when giving paracetamol to patients with severe renal impairment (creatinine clearance < 30mL/min), to increase the minimum interval between each administration to 6 hours.

Tell your doctor or nurse if you experience the following side effects: Rare (occurs in less than 1 in 1,000 patients):

•    a general feeling of being unwell (malaise)

•    a drop in blood pressure

•    changes in liver enzymes found during blood checks. Should this occur, inform your doctor as regular blood checks may be required later.

Very Rare (occurs in less than 1 in 10,000 patients):

•    very rare cases of serious skin reactions have been reported.

Not Known (cannot be estimated from available data):

•    other changes in laboratory test results which may result in regular blood checks: abnormally low levels of some types of blood cells (platelets, white cells) can occur, possibly leading to bleeding from the nose or gums.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www. mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

How to store

Keep out of the sight and reach of children.

Do not use Paracetamol 10mg/ml Solution for Infusion after the expiry date which is stated on the blister and carton after EXP The expiry date refers to the last day of that month.

Store below 30°C. Protect from light. Store in the original package. Do not refrigerate or freeze.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

61 Further information

What Paracetamol 10mg/ml Solution for Infusion contains

•    The active substance is paracetamol.

•    One ml contains 10mg paracetamol.

•    Each 50ml vial contains 500mg paracetamol.

•    Each 100ml vial contains 1000mg paracetamol in 100ml.

•    The other ingredients are: cysteine hydrochloride monohydrate, disodium phosphate dihydrate, hydrochloric acid (1M) (for pH-adjustment), sodium hydroxide (1M) (for pH-adjustment), mannitol, water for injections.

What Paracetamol 10mg/ml Solution for Infusion looks like and contents of the pack Vials 50ml and 100ml.

Paracetamol 10mg/ml Solution for Infusion is a clear solution.

The vials are packed in carton boxes. Each box contains:

50ml: 10 vials 100ml: 10 vials

Marketing Authorisation Holder

Actavis Group PTC ehf. , Reykjavfkurvegi 76-78,

220 HafnarfjorSur, Iceland Manufacturer

Neogen Developments N.V., Square Marie Curie , 50 Anderlecht ,

1070 Belgium

This leaflet was last revised in October 2014

If you would like a leaflet with larger ^% text, please contact 01271 385257.

Actavis, Barnstaple, EX32 8NS, UK

Method of administration

RISK OF MEDICATION ERRORS Take care to avoid dosing errors due to confusion between milligram (mg) and millilitre (mL), which could result in accidental overdose and death.

The paracetamol solution is administered as a 15-minute intravenous infusion (injection into a vein).

As for all solutions for infusion presented in glass vials, it should be remembered that close monitoring is needed notably at the end of the infusion, regardless of administration route. This monitoring at the end of the infusion applies particularly for central route infusions, in order to avoid air embolism.

Do not use Paracetamol 10mg/ml Solution for Infusion if you notice any particulate matter and discolouration.

For single use only. The product should be used immediately after opening. Any unused solution should be discarded.

For the 50ml and 100ml vials, a 0.8mm needle (21 gauge needle) has to be used and the stopper vertically perforated at the spot specifically indicated.

For the 50ml vial, it can also be diluted in 0.9% sodium chloride or 5% glucose up to one tenth (one volume paracetamol into nine volumes diluent).

Actavis, Barnstaple, EX32 8NS, UK