Paracetamol

UNI-PHARMA

10 mg/ml Solution for Infusion ► Paracetamol

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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

•    If you have any further questions, ask your doctor.

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

•    If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Paracetamol Uni-Pharma isand what it is used for

2.    What you need to know before you use Paracetamol Uni-Pharma

3.    How to use Paracetamol Uni-Pharma

4.    Possible side effects

5.    Howtostoie Paracetamol Uni-Pharma

6.    Contents of the pack and other information

1.    What Paracetamol Uni-Pharma is and what it is used for

This medicine is an analgesic (it relieves pain) and an antipyretic (it lowers fever).

It is indicated for the short-term treatment of moderate pain, especially following surgery, and for the short-term treatment of fever.

2.    What you need to know before you use Paracetamol Uni-Pharma Do not use Paracetamol Uni-Pharma

•    if you are allergic (hypersensitive) to paracetamol or to any of the other ingredients of this medicine (listed in section 6)

•    if you are allergic (hypersensitive) to propacetamol (another analgesic for infusion and a precursor of paracetamol)

•    if you suffer from a severe liver disease.

Warnings and precautions

Talkto your doctor before using Paracetamol Uni-Pharma

•    use a suitable analgesic oral treatment as soon as this administration route is possible.

•    if you suffer from a liver or kidney disease, or from alcohol abuse,

•    if you are taking other medicines containing paracetamol,

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

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

Other medicines and Paracetamol Uni-Pharma

Tell your doctor if you are taking have recently taken or might take any other medicines.

•    This medicine contains paracetamol and this must be taken into account if other medicines containing paracetamol or propacetamol are taken, in order not to exceed the recommended daily dose. Inform your doctor if you are taking other medicinescontaining paracetamol or propacetamol.

•    A dose reduction should be considered if you are also talking Probenecid.

•    Please inform your doctor or pharmacist if you are taking oral anticoagulants. Closer check-ups of the effect of the anticoagulant might be necessary. Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Paracetamol Uni-Pharma can be used during pregnancy. You should use the lowest possible dose that reduces your pain and/or yourfever and useitforthe shortest time possible. Contact your doctor if the pain and/or fever are not reduced or if you need to take the medicine more often.

Paracetamol Uni-Pharma may be used during breast-feeding.

Paracetamol Uni-Pharma contains sodium This medicinal product contains less than 10.9 mmol sodium (250 mg) per 100 ml of Paracetamol Uni-Pharma. To be taken into consideration by patients on a controlled sodium diet.

3. Howto use Paracetamol Uni-Pharma

•    The recommended dose is

The dose will be individually adjusted by your dodor, based on your weight and general condition.

Method of administration

This medicine will be given to you by a doctor through a drip into a vein (intravenous use). This usually takes about 15 minutes. You will be closely monitored during and especially towards the end of the infusion.

If you have the impression that the effect of Paracetamol Uni-Pharma is too strong ortoo weak, talkto your doctor.

If you are given more Paracetamol than you should

Overdose is unlikely as you will be given this medicine by a healthcare

professional.

The following information is intended for healthcare professionals only:

Posoloav

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

The volume to be administered must not exceed the determined dose.

Prolonged or frequent use is discouraged. It is recommended that a suitable analgesic oral treatment will be used as soon as this route of administration is possible.

Dosing based on patient weight (please see the dosing table here below)

^Maximum daily dose: The maximum daily dose as presented in the table above is for patients that are not receiving other paracetamol containing productsand 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.

Severe renal insufhdena:

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

In adults with hepatocellular insufficiency chronic alcoholism, chronic malnutrition How reserves ofhepabcalutathione). dehvdrabon:

The maximum daily dose must not exceed 3 g.

Method of administration

The paracetamol solution is administered as a 15-minute intravenous infusion. In children, the volume of solution to be infused is 1.5 ml per kg per administration

For single use. The overwrap should be removed shortly before use. The product should be used immediately after opening. Any unused solution should be discarded.

Shelf-life after first opening

Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C without overwrapping.

From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Before administration, the product should be visually inspected for any particulate matter and discoloration. Do not use this medicine if you notice any particulate matter and discoloration. There could be a potential presence of moisture between the bag and the outer packaging as a result of the sterilisation process. This does not impact the quality of the solution.

You r doctor will assure not to g ive you doses higher than recommended.

In overdose cases, symptoms generally appear within the first 24 hours and comprise: feeling sick, being sick, anorexia (loss of appetite), pasty skin and abdominal pa in. These symptoms could reflect liver injury.

If you think you may have been given an overdose, tell a doctor immediately. Immediate medical advice should be sought in the event of an overdose, even if you feel well, toavoid risk of seriousand irreversible liver damage. If reguired an antidote may be given to you.

If you have any further guestions on the use of this product, ask your doctor.

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

I n rare cases (may affect up to 1 in 1,000 people):

•    malaise (a feeling of being unwell),

•    drop in blood pressure

•    changes in laboratory test results such as abnormally high levels of liver enzymes found during blood checks. Should this occur, inform your doctor as regular blood checks may be reguired later.

Very rare cases (may affect up to 1 in 10,000 people),

•    of serious skin reactions have been reported

•    of allergic reaction may occur.

Stop the treatment immediately and inform your doctor.

Other changes in laboratory test results have been observed which have resulted in regular blood checks: abnormally low levels of some types of blood cells (platelets, white cells), possibly leading to bleeding from the nose or gums. Should this occur, inform your doctor.

Cases of redness of the skin, flushing, itching and abnormally rapid beating of the heart have been reported.

Cases of pain and burning sensation at injection site have been reported. Additional side effects in children and adolescents

Please read the above sectionfor side effects. There a re no additional side effects that are specific to children and adolescents.

Reporting of side effects

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

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

5.    How to store Paracetamol Uni-Pharma

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label after EXP.

The expiry date refers to the last day of that month.

This medicinal product does not require any special temperature storage conditions. Do not refrigerate or freeze. Keep the bag in the outer carton to protect the product from light.

Do not throw away any medicines via wastewater. Ask your pharmacist howto throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Paracetamol Uni-Pharma contains

•The active substance is paracetamol. One ml contains 10 mg paracetamol.

• The other ingredients are: hydroxypropylbetadex, disodium edetate, sodium chloride, sodium dihydrogen phosphate dihydrate (E339), disodium hydrogen phosphate dihydrate (E339) and water for injections.

What Paracetamol Uni-Pharma looks like and contents of the pack Paracetamol Uni-Pharma is a dearto slightly yellowish solution Paracetamol Uni-Pharma is supplied in 100ml polypropylene bags eguipped with an infusion site, consisting of a tube sealed with a rubber stopper and an aluminium cap. The bags are overwrapped with an aluminium foil, a metalized film or with a polyethylene - based multilayer film and are available in packs of 1 x 100 ml, 10 x 100 ml, 20 x 100 ml or 50 x 100 ml bags. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

Uni-Pharma KleonTsetis Pharmaceutical Laboratories S.A.

14th km National Road 1, GR-145 64 Kifissia - Greece Manufacturer

SALF SpA Laboratorio Farmacoloqico

Via Marconi 2,24069 Cenate Sotto (Bergamo), Italy

Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

14th km National Road 1, GR-145 64 Kifissia - Greece

This medianal product is authorised in the Member States of the EEA

under the following names:

Italy: Exopon 10 mg/ml Solution for Infusion

Netherlands: Apotel 10 mg/ml Solution for Infusion

Spain: Apotel 10 mg/ml Solution for Infusion

France: Apotel 10 mg/ml Solution for Infusion

Germany: Exopon 10 mg/ml Solution for Infusion

Portugal: Paracetamol Uni-Pharma 10 mg/ml Solution for Infusion

Denmark: Apotel 10 mg/ml Solution for Infusion

Sweden: Exopon 10 mg/ml Solution for Infusion

United Kingdom: Paracetamol Uni-Pharma 10 mg/ml Solution for Infusion

This leaflet was last revised in 11/2015

UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.    11.2015 U1S1186

14th km National Road 1,145 64 Kifissia, Greece

Tel.: +30-210-80 72 512, Fax:+30- 210-80 78 907, e-mail: unipharma@uni-pharma.gr, www.uni-pharma.gr