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Paracetamol 250mg Orodispersible Tablets

Document: leaflet MAH GENERIC_PL 44704-0001 change

1.3.1.3 Package leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 of the other ingredients of Paracetamol.

Take special care with Paracetamol

-    if you have kidney or 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.

-    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.

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.

The maximum daily dose is 60 mg/kg body weight.

The usual dose is:

4-8 years (17-25 kg):

8-11 years (26-32 kg):

11-12 years (33-43 kg):

from 12 years up (44 kg and more):


1 tablet at a time, max 4 tablets per 24 hours

1    tablet at a time, max 6 tablets per 24 hours

2    tablets at a time, max 8 tablets per 24 hours 2 tablets at a time, max 12 tablets per 24 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

Immediately contact your doctor or pharmacist in the event of an overdose, even if you feel 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, this medicine can cause side effects, although not everybody gets them.

Rare (may affect up to 1 in 1,000 people)

•    Various blood disorders, including agranulocytosis, thrombopenia, thrombocytopenic purpura, leucopenia and haemolytic anemia

•    Allergies (excluding angioedema)

•    Abnormal liver function, liver failure, liver necrosis and jaundice

•    Itch (pruritus), rash, sweating, purpura and nettle-rash (urticaria)

•    Overdosing and poisoning

•    Depression, confusion and hallicunations

•    Tremor and headache

•    Blurred vision

•    Oedema

•    Bleeding, stomach pain, diarrhea, nausea, vomiting

•    Dizziness, fever and sleepiness

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

•    Pancytopenia (decrease in the amount of blood cells)

•    Hypersensitivity reactions requiring discontinuation of treatment, such as angioedema, breathing difficulties, sweating, nausea, hypotension, shock and anaphylaxis

•    Breathing problems caused by contraction of the muscles of the bronchi (bronchospasm) in persons sensitive to aspirin and other NSAIDs (group of painkillers with anti-inflammatory and antipyretic action)

•    Toxicity of the liver

•    Skin rash (exanthema)

•    Serious skin reactions

•    Hypoglycemia (low blood sugar)

•    Cloudy urine (sterile pyuria) and renal side effects

Not known: frequency cannot be estimated from the available data.

•    Acute generalised exanthematous pustulosis, toxic necrolysis, drug-induced dermatosis and Stevens-Johnson-Syndrome

After chronic use of 3 to 4 grams of paracetamol (= 12 to 16 tablets) daily, liver damage may occur. The intake of 6 grams of paracetamol (= 24 tablets) as a single dose may lead to liver damage.

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 Yellow Card Scheme (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

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

Adare Pharmaceuticals Srl

Via Martin Luther King 13

20060 Pessano con Bornago - Milano

Italy

Manufacturer(s)

Adare Pharmaceuticals Srl

Via Martin Luther King 13

20060 Pessano con Bornago - Milano

Italy

Dragenopharm Apoteker Pueschl Gmbh Gollstrasse 1

84529 Tittmoning Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

<{Name of the Member State}> <{Name of the medicinal product}>

This leaflet was last approved in {MM/YYYY}.

<[To be completed nationally]>

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