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ALTRIDEXAMOL 1000 MG EFFERVESCENT TABLETS

Active substance(s): PARACETAMOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Altridexamol 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 Altridexamol 1000 mg Effervescent Tablets are
and what they are used for
2. Before you take Altridexamol 1000 mg Effervescent
Tablets
3. How to take Altridexamol 1000 mg Effervescent Tablets
4. Possible Side Effects
5. How to store Altridexamol 1000 mg Effervescent Tablets
6. Further Information
1. WHAT Altridexamol 1000 MG EFFERVESCENT TABLETS
ARE AND WHAT THEY ARE USED FOR
Altridexamol 1000 mg Effervescent Tablets contain Paracetamol,
which relieves pain (analgesic) and reduces the body temperature
in fever (antipyretic).The tablets are recommended for use in the
treatment of mild to moderate pain and/or fever.

2. BEFORE YOU TAKE Altridexamol 1000 MG
EFFERVESCENT TABLETS
Do not take Altridexamol 1000 mg Effervescent Tablets:
• If you are allergic (hypersensitive) to Paracetamol or any of the
ingredients of Altridexamol 1000 mg Effervescent Tablets.

Take special care with Altridexamol 1000 mg Effervescent
Tablets
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 are already taking other pain medication containing
paracetamol do not use Altridexamol 1000 mg Effervescent Tablets
without first speaking to your doctor or a pharmacist.
Never take more Altridexamol 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 Altridexamol
1000 mg Effervescent Tablets than recommended in this leaflet.
Do not use Altridexamol 1000 mg Effervescent Tablets in children
and adolescents below 16 years of age.

3. HOW TO TAKE Altridexamol 1000 MG EFFERVESCENT
TABLETS
You should take Altridexamol 1000 mg Effervescent Tablets exactly
as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Altridexamol 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 Altridexamol 1000 mg
Effervescent Tablets to use please consult your doctor.
This medicinal product is for use only in adults and adolescents
aged 16 years and above.
Adults and adolescents:
Take one tablet (1000 mg) every six hours, up to a maximum of
4 tablets (4000 mg) in 24 hours.
Maximum daily dose:
The maximum daily dose of Paracetamol must not exceed 4
tablets (4000 mg).
Maximum single dose is 1000 mg (1 effervescent tablet).
The minimum time interval between two doses should be 6 hours.

Talk to a doctor at once if you take too much of this
medicine even if you feel well. This is because too much
paracetamol can cause delayed, serious liver damage.
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:

• If you have haemolytic anaemia (abnormal breakdown of red

In moderate kidney problems: The usual dose is 500 mg repeated
every 6 hours.

• If you are an asthmatic and sensitive to aspirin.

In severe kidney problems: The usual dose is 500 mg repeated
every 8 hours.

blood cells).

• 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).

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
exceeded.

Do not divide the 1000 mg tablet into two equal halves for the
Do not use paracetamol unless prescribed by your doctor if you
have an addiction to alcohol or liver damage. If this concerns you do lower doses. Paracetamol tablets of lower strengths are available
not use with alcohol.
in the market.

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

• Severe allergic reaction (anaphylactic shock).

If you take more Altridexamol 1000 mg Effervescent Tablets
than you should:

• Kidney disorder (interstitial nephritis).

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 a risk of serious,
delayed liver damage.

• Inability to urinate (anuresis).

If you forget to take Altridexamol 1000 mg Effervescent
Tablets:

Reporting of side effects

If you forget to take a dose take it as soon as you remember, unless
it is almost time for your next dose. The minimum time interval
between two doses should be 6 hours. Never take a double dose to
make up for the one you have missed.

• Decrease in red blood cells (anaemia).
• Severe kidney impairment (renal alteration).
• Blood in urine (haematuria).
• Stomach ulcers and bleeding (gastrointestinal effects).
• Uneasiness.
If any of the side effects get serious or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
If you get any side effects talk to your doctor, pharmacist or nurse.
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.

If you have any further questions on the use of this product ask your 5. HOW TO STORE Altridexamol 1000 MG EFFERVESCENT
doctor or pharmacist.
TABLETS

4. POSSIBLE SIDE EFFECTS

• Keep out of the reach and sight of children and adolescents.

Like all medicines Altridexamol 1000 mg Effervescent Tablets can
cause side effects, although not everybody gets them. You should
stop taking Altridexamol 1000 mg Effervescent Tablets and see your
doctor immediately if you experience symptoms like swelling in the
face, tongue or throat, difficulty swallowing, red and itchy swellings
on the skin and difficulty in breathing.

• Do not use Altridexamol 1000 mg Effervescent Tablets after
expiry date which is stated on the label after EXP. The expiry date
refers to the last day of that month.

Rare (affects less than 1 in 1000 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 or hands).
• Depression, confusion or sensing unreal things.
• Tremor or headache.
• Abnormal vision.
• Abnormal accumulation of fluid under the skin (oedema).
• Stomach pain, diarrhoea, nausea (feeling sick), vomiting or
bleeding (haemorrhage).
• Abnormal liver function, liver failure, death of liver cells (hepatic
necrosis) or jaundice.
• Dizziness, feeling of general discomfort or uneasiness (malaise),
fever, drowsiness or drug interactions.
• Overdose and poisoning.
Very rare (affects less than 1 in 10000 patients):
• Damage caused to the liver (hepatotoxicity).
• Immediate severe allergic reaction (hypersensitivity reaction
requiring discontinuation of treatment).
• Low levels of glucose in the blood (hypoglycaemia).
• Cloudy urine and kidney disorders.
• Life-threatening skin disease causing rash, skin peeling and
sores (epidermal necrolysis).
• 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).

• Store below 25°C. Store in the original package in order to
protect from moisture and light.
• Do not use the product if you notice visible signs of deterioration
like brown or black spots, bulging of tablets or discoloration.
• 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.

6. FURTHER INFORMATION
What Altridexamol 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
(E473), sodium benzoate (E211), grapefruit flavour and Kollidon 30
(E1201).

What Altridexamol 1000 mg Effervescent Tablets look like
and contents of the pack
Altridexamol 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.
Warren Plantation – Church End
Haynes, Bedford
MK45 3RJ - UK
Contact address:
PO BOX 849,
Bedford, MK45 9EG






Manufacturer
Alpex Pharma SA
Via Cantonale
CH 6805 Mezzovico
Switzerland

Distributed by
Fontus Health Ltd.
60 Lichfield Street,
Walsall. West Midlands.
WS4 2BX

This leaflet was last revised in 12/2015.

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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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