PARACETAMOL 1000 MG EFFERVESCENT TABLETS

Active substance: PARACETAMOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Paracetamol 1000 mg Effervescent Tablets
Paracetamol 1000 mg

Read all of this leaflet carefully before you start taking
this medicine.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, please ask your doctor 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 become 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 1000 mg Effervescent Tablets are
and what they are used for
2. Before you take Paracetamol 1000 mg Effervescent
Tablets
3. How to take Paracetamol 1000 mg Effervescent Tablets
4. Possible Side Effects
5. How to store Paracetamol 1000 mg Effervescent
Tablets
6. Further Information
1. WHAT PARACETAMOL 1000 mg EFFERVESCENT
TABLETS ARE AND WHAT THEY ARE USED FOR

If you are already taking other pain medication containing
paracetamol do not use Paracetamol 1000 mg Effervescent
Tablets without first speaking to your doctor or a pharmacist.
Never take more Paracetamol 1000 mg Effervescent Tablets than
recommended. A higher dose does not increase pain relief;
instead it can cause severe liver damage. The symptoms of liver
damage occur first after a few days. It is important therefore that
you contact your doctor as soon as possible if you have taken
more Paracetamol 1000 mg Effervescent Tablets than
recommended in this leaflet.
Do not use Paracetamol 1000 mg Effervescent Tablets in children
and adolescents below 16 years of age.

3. HOW TO TAKE PARACETAMOL 1000 mg
EFFERVESCENT TABLETS
You should take Paracetamol 1000 mg Effervescent Tablets
exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Paracetamol 1000 mg Effervescent Tablets are for oral
administration. Place the tablet in a full glass of water. Allow it to
completely dissolve. Then drink the solution straight away.

If you have doubts on the correct dose of Paracetamol 1000 mg
Paracetamol 1000 mg Effervescent Tablets contain Paracetamol, Effervescent Tablets to use please consult your doctor.
which relieves pain (analgesic) and reduces the body temperature
This medicinal product is for use, only in adults and adolescents
in fever (antipyretic).
The tablets are recommended for use in treatment of mild to aged 16 years and above.
moderate pain and/or fever.
Adults and adolescents :
Take one tablet (1000 mg) every six hours, up to a maximum of 4
tablets (4000 mg) in 24 hours.
2. BEFORE YOU TAKE PARACETAMOL 1000 mg

EFFERVESCENT TABLETS

Maximum daily dose:
The maximum daily dose of Paracetamol must not exceed 4
Do not take Paracetamol 1000 mg Effervescent Tablets:
tablets (4000 mg).
Maximum single dose is 1000 mg (1 effervescent tablet)
 If you are allergic (hypersensitive) to Paracetamol or any of the
The minimum time interval between two doses should be 6 hours.
ingredients of Paracetamol 1000 mg Effervescent Tablets.
Talk to a doctor at once if you take too much of this medicine
Take special care with Paracetamol 1000 mg Effervescent
even if you feel well. This is because too much paracetamol
Tablets
can cause delayed, serious liver damage.
Tell your doctor:
 If you are suffering from kidney problems.
 If you are suffering from liver problems, including liver problems
due to excessive alcohol consumption.
 If you have Gilbert's syndrome (mild jaundice).
 If you have hemolytic anemia (abnormal breakdown of red blood
cells).
 If you are an asthmatic and sensitive to aspirin.
 If you are suffering from dehydration or chronic malnutrition.
 If you are on paracetamol containing drugs.
 If you have fever after paracetamol therapy.
 If you suffer from glucose-6-phosphate dehydrogenase
deficiency (enzyme deficiency).

If the pain persists for more than 5 days or the fever lasts for more
than 3 days, or gets worse or other symptoms appear, you should
stop the treatment and consult a doctor.
Kidney problems:
In moderate kidney problems: The usual dose is 500 mg repeated
every 6 hours.
In severe kidney problems: The usual dose is 500 mg repeated
every 8 hours.

Liver problems:
In case of problems with your liver please consult your doctor.
Your doctor may decide to reduce the dose.
In chronic alcoholics, a dose of 2000 mg per day should not be
Do not use paracetamol unless prescribed by your doctor if you exceeded.
have an addiction to alcohol or liver damage. If this concerns you Do not divide the 1000 mg tablet into two equal halves for the
lower doses. Paracetamol tablets of lower strengths are available
do not use with alcohol.

in the market.




Allergic reaction of the skin (erythema multiforme)
Severe life-threatening skin disease causing rash, skin
peeling, sores (Stevens-Johnson syndrome)
Accumulation of fluid in the voice box (larynx)
Severe allergic reaction (anaphylactic shock)
Decrease in red blood cells (anemia)
Severe kidney impairment (renal alteration)
Kidney disorder (nephrite interstitial)
Blood in urine (haematuria)
Inability to urinate (anuresis)
Stomach ulcers and bleeding (gastrointestinal effects)
Uneasiness.

Do not exceed the stated dose. Do not give to adolescents of
16 years of age and younger.


Cap contains desiccant. Do not eat.


If you take more Paracetamol 1000 mg Effervescent Tablets 
than you should:

Symptoms of paracetamol overdose in the first 24 hours may

include paleness, nausea (feeling sick), vomiting, lack of desire to

eat and stomach pain. If you or someone you know accidentally

takes more than the stated dose (overdose) you should contact a
doctor immediately even if you feel well, because there is risk of
If any of the side effects gets serious or if you notice any side
serious, delayed liver damage.
effects of listed in this leaflet, please tell your doctor or pharmacist.

If you forget to take Paracetamol 1000 mg Effervescent Tablets:
5. HOW TO STORE PARACETAMOL 1000 MG
If you forget to take a dose, take it as soon as you remember,
EFFERVESCENT TABLETS
unless it is almost time for your next dose. The minimum time
interval between two doses should be 6 hours. Never take a

Keep out of the reach and sight of children and adolescents.
double dose to make up for the one you have missed.

Do not use Paracetamol 1000 mg Effervescent Tablets after
expiry date which is stated on the label after EXP. The expiry
If you have any further questions on the use of this product, ask
date refers to last day of that month.
your doctor or pharmacist.

Store below 25°C. Store in the original package in order to
protect from moisture and light.
4. POSSIBLE SIDE EFFECTS

Do not use the product if you notice visible signs of
deterioration, like brown or black spots, bulging of tablets or
Like all medicines Paracetamol 1000 mg Effervescent Tablets can
discoloration.
cause side effects, although not everybody gets them.

Medicines should not be disposed of via wastewater or
You should stop taking Paracetamol 1000 mg Effervescent Tablets
household waste. Ask your pharmacist how to dispose of
and see your doctor immediately if you experience symptoms like
medicines no longer required. These measures will help to
swelling in the face, tongue or throat. difficulty swallowing, red and
protect the environment.
itchy swellings on the skin and difficulty in breathing.
Rare (affects less than 1 in 1.000 patients):

Bleeding problems or clotting disorders (Platelet disorders),
decreased formation of cells, severe decrease in white blood
cells which may lead to severe infections (agranulocytosis),
frequent infections due to poorly functioning white blood cells
or decrease in white blood cells (leucopenia), reduction in
blood platelets, which increases the risk of bleeding or
bruising (thrombocytopenia) abnormal breakdown of red
blood cells, which may cause weakness or pale skin
(haemolytic
anaemia),
decrease
in
blood
count
(pancylopenia), reduced neutrophil count in blood
(neutropenia).

Allergies (excluding swelling on the face, mouth, hands).

Depression, confusion, sensing unreal things

Tremor, headache

Abnormal vision.

Abnormal accumulation of fluid under the skin (oedema).

Stomach pain, diarrhoea, nausea (feeling sick), vomiting,
bleeding (haemorMage)

Abnormal liver function, liver failure, death of liver cells
(hepatic necrosis), jaundice

Dizziness, feeling of general discomfort or uneasiness
(malaise), fever, drowsiness, drug interaction.

Overdose and poisoning.
Very rare (affects less than 1 in 10.000 patients):

Damage caused to the liver (hepatotoxicity)

Immediate severe allergic reaction (hypersensitivity reaction
requiring discontinuation of treatment)

Low levels of glucose in the blood (hypoglycemia)

Cloudy urine and kidney disorders.

Life-threatening skin disease causing rash, skin peeling and
sores (epidermal necrolysis)

6.

FURTHER INFORMATION

What Paracetamol 1000 mg effervescent tablets contain
The active ingredient is Paracetamol. Each tablet contains 1000
mg.
The other ingredients are Anhydrous Citric acid (E330), Sodium
Bicarbonate (E500), Sucralose (E955), Sucrose monopalmitate (E
473), Sodium Benzoate (E211), Grapefruit flavour and and
Kollidon 30 (E1201).
What Paracetamol 1000 mg Effervescent Tablets look like and
contents of the pack
Paracetamol 1000 mg Effervescent Tablets are white to almost
white round, flat tablets.
The tablets are supplied in boxes containing 1 or 2 or 4 or 5 or 10
or 12 or 20 nylon/aluminium/PVC/lacquer blisters (2 tablets per
blister) and a patient leaflet.
Marketing Authorisation Holder
The Marketing Authorisation Holder in the UK is:
Alpex Pharma (UK) Limited,
Yew Tree Lodge,
Southill, Biggleswade, Beds.
SG18 9LP UK
Manufacturer
Alpex Pharma SA,
Via Cantonale,
CH 6805 Mezzovico
Switzerland
This leaflet was last approved in 04/2014.

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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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