PARACETAMOL 250MG ORODISPERSIBLE TABLETS

Active substance: PARACETAMOL

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Cod. 00005/4

TM
Tipo di materiale

Descrizione

PROSPETTO
Formato mm

148 x 420

Destinazione

PARACETAMOL 250 mg
N°. colori

Colore 1

1

Paese

VENDITA
Colore 2

Off. di Produzione

UK

CODICE

Tacche LAETUS

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Colore 3

Colore 4

Corpo

NERO

PELLICOLA DI PROPRIETÀ

10

Aptalis

VIETATA LA MANOMISSIONE - RENDERE DOPO LA STAMPA

06-06-2012

Paracetamol 250 mg orodispersible tablets
paracetamol
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take Paracetamol
carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- This product should only be used for a short period of time without consulting a doctor.
- 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:
1. What Paracetamol is and what it is used for
2. Before you take Paracetamol
3. How to take Paracetamol
4. Possible side effects
5. How to store Paracetamol
6. Further information
1. WHAT PARACETAMOL IS AND WHAT IT IS USED FOR
Paracetamol is a pain relieving, fever reducing medicinal product (analgesic and antipyretic).
Paracetamol is used for symptomatic treatment of mild to moderate pain and/or fever.
Paracetamol 250 mg orodispersible tablets may be used in children from the age of four
and adolescents.
2. BEFORE YOU TAKE PARACETAMOL
Do not take Paracetamol
- if you are allergic (hypersensitive) to Paracetamol or any other Ingredients see section 6.
Take special care with Paracetamol
- if you have kidney or liver disease (including alcoholic liver disease);
- if you regularly take large amounts of alcohol;
- in case of dehydration or chronic malnutrition
Do not take paracetamol for longer periods or in higher doses without your doctor’s or
dentist’s advice, since:
- the use of high doses of pain-relieving agents (analgesics) for longer periods may cause
headache. This headache should never be treated by increasing the dose of paracetamol.
- regular use of pain relieving agents, especially combinations of various pain relieving
agents, may cause permanent kidney damage including the risk of kidney failure (analgesic
nephropathy).
- abrupt discontinuation after longer use of high doses of pain relieving agents may lead
to headache, tiredness, muscular pain, nervousness and vegetative symptoms.
These symptoms fade away in a few days. In the meantime do not start using pain relieving
agents again without consulting your doctor.
If your symptoms get worse, or if complaints do not begin to improve after three days, seek
medical advice.
Using other medicines
Please see your doctor before you take paracetamol in case you use one of the following
medicines:
- metoclopramide or domperidone (medicines used to treat nausea and vomiting);
- colestyramine (used to lower your cholesterol);
- anti-coagulants (medicines to thin the blood, e.g. warfarin), in case you need to take a
painkiller on a daily basis over a long period. Occasional doses have no significant effect.
- salicylamide (a pain killer)
- probenecide (a medicine used to treat gout)
- isoniazid (a medicine used to treat tuberculosis)
- lamotrigine (a medicine used to treat epilepsy)
Please tell your doctor pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
If you are going to have any laboratory tests (such as a blood test, urine analysis, skin allergy
test, etc.), you should tell your doctor that you are taking this medicine as it could affect the
results of these tests.
Taking Paracetamol with food and drink
Be careful with the use of paracetamol if you frequently take large amounts of alcohol.
Pregnancy
Studies with paracetamol do not indicate that there are adverse effects on the pregnancy
or on the health of the unborn child. You may take paracetamol in the recommended doses
during pregnancy.
During pregnancy, paracetamol should not be taken for long periods, at high doses or in
combination with other medicinal products.
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
Although paracetamol is excreted in the breast milk in small amounts it has no unwanted
effects on the child that is breast fed. Paracetamol may be used by breastfeeding women
as long as the recommended dosage is not exceeded. In case of long term use caution
should be exercised.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Using paracetamol does not influence your ability to drive or use machines.

Cod. 00005/4

TM
Tipo di materiale

Descrizione

PROSPETTO
Formato mm

148 x 420

Destinazione

PARACETAMOL 250 mg
N°. colori

VENDITA

Colore 1

1

Colore 2

Paese

Off. di Produzione

CODICE

UK

Tacche LAETUS

000000

Colore 3

Colore 4

Corpo

NERO

PELLICOLA DI PROPRIETÀ

10

Aptalis

VIETATA LA MANOMISSIONE - RENDERE DOPO LA STAMPA

06-06-2012

Important information about some of the ingredients of Paracetamol
Paracetamol contains aspartame, which is a source of phenylalanine. The phenylalanine in
the tablets may be harmful to people with phenylketonuria.
3. HOW TO TAKE PARACETAMOL
Always take paracetamol exactly as stated in the package information leaflet. You should
check with your doctor or pharmacist if you are not sure.
Dosage depends on body weight and age; a single dose ranges from 10 to 15 mg/kg body
weight.
Do not give more than 60 mg/kg body weight daily.
The usual dose is:
Childs Age (Years)
4-8 (17-25 kg)
8-11 (26-32 kg)
11-12 (33-43 kg)
12 and over (>43 kg)

How much per dose (maximum in 24 hours)
1 tablet, no more than 4 tablets
1 tablet, no more than 6 tablets
2 tablets, no more than 8 tablets
2 tablets, no more than 12 tablets

Dosing should never falls below 6 hours between each dose, for patients with kidney
problems the minimum interval between doses should be 8 hours
Do not exceed the stated dose.
Method of administration:
The tablet should be placed in the mouth where it melts on the tongue so it can be easily
swallowed. Alternatively, to facilitate the intake, the tablet can be swallowed with a glass
of water or, especially in younger children, dispersed in a spoonful or teaspoonful of water.
This medicinal product may be taken with or without food.
If you take more Paracetamol than you should
Immediate medical advice should be sought in the event of an overdose, even if the child
seems well, because of the risk of delayed, serious liver damage.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, paracetamol can cause side effects, although not everybody gets them.
Once you stop taking the medicine these effects should however go away.
• Occasionally some people may get allergic reactions, such as skin rash or fever.
• There have been very rare reports of blood disorders.
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.
5. HOW TO STORE PARACETAMOL
Keep out of the reach and sight of children.
Do not use Paracetamol after the expiry date which is stated on the carton after “EXP.”.
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
6. FURTHER INFORMATION
What Paracetamol contains
The active substance is paracetamol.
Each orodispersible tablet contains 250 mg of paracetamol.
The other ingredients are:
ethylcellulose, mannitol (E421), microcrystalline cellulose (E460), crospovidone type B,
aspartame (E951), magnesium stearate (E572), strawberry flavour (contains amongst other,
maltodextrine, arabic gum (E414)).
What Paracetamol looks like and contents of the pack
Paracetamol 250 mg orodispersible tablets are white to off-white round, flat face radius
edge orodispersible tablets.
Paracetamol 250 mg orodispersible tablets are packed in blisters. Each box contains 12 or
20 orodispersible tablets.
Marketing Authorisation Holder and Manufacturer
Aptalis Pharma Srl
Via Martin Luther King 13
20060 Pessano con Bornago – Milano
Italy
This leaflet was last revised in June 2012.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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