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NOVARTIS CONSUMER HEALTH PAIN RELIEF TABLETS

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PACKAGE LEAFLET

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Novartis Consumer Health Pain Relief Tablets
Aspirin / Paracetamol / Caffeine
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 it 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.

You must contact a doctor if your symptoms worsen or do not improve after 3 days for migraine and 4
days for headache.

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 Novartis Consumer Health Pain Relief Tablets is and what it is used for
2.
Before you take Novartis Consumer Health Pain Relief Tablets
3.
How to take Novartis Consumer Health Pain Relief Tablets
4.
Possible side effects
5.
How to store Novartis Consumer Health Pain Relief Tablets
6.
Further information

1.

What Novartis Consumer Health Pain Relief Tablets is and what it is used for

Each tablet of Novartis Consumer Health Pain Relief Tablets contains three active substances: Aspirin,
paracetamol and caffeine.
 Aspirin and paracetamol reduce pain and fever, and Aspirin also reduces inflammation.
 Caffeine is a mild stimulant and increases the effect of Aspirin and paracetamol.
This medicine is used for the acute treatment of headache and migraine attacks (symptoms such as headache,
nausea, and sensitivity to light and sound) with or without aura.

2.

Before you take Novartis Consumer Health Pain Relief Tablets

Do not take Novartis Consumer Health Pain Relief Tablets if you:
 are allergic (hypersensitive) to Aspirin, paracetamol, caffeine or any of the other ingredients of this
medicine (see Section 6. Further Information).
Symptoms of an allergic reaction may include: asthma, wheezing or shortness of breath; skin rash or
hives; swelling of the face or tongue; runny nose. If you are not sure, ask your doctor or pharmacist.
 ever had an allergic reaction to other medicines used to treat pain, inflammation or fever, such as
diclofenac or ibuprofen.
 have a stomach or intestinal ulcer, or if you have a history of peptic ulceration.
 have noticed blood in your stools or black stools (symptoms of gastrointestinal bleeding or
perforation).
 are a haemophiliac or suffering from other blood disorders.
 have severe heart, liver and kidney problems
 take more than 15 mg methotrexate per week (see Taking other medicines)
 are in the last 3 months of pregnancy.
Take special care with Novartis Consumer Health Pain Relief Tablets:
The following are reasons why this medicine may not be suitable for you. Talk to your doctor before you
take this medicine if you:
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have a migraine that is so severe as to require bed rest, or a headache different from your usual
migraines, or if you have vomiting with your migraine headache.
start having headaches after or caused by head injury, exertion, coughing or bending.
have daily headaches, or if you experience your first headache after the age of 50.
suffer from a hereditary condition called glucose 6-phosphate dehydrogenase deficiency that affects
the red blood cells and could cause anaemia, jaundice or enlargement of the spleen when exposed to
certain foods, medicinal products such as certain anti-inflammatory drugs (eg., Aspirin), or to other
diseases.
have ever had gastrointestinal problems such as stomach ulcer, bleeding or black stools. If you have
had stomach discomfort or heartburn after taking pain relievers or anti-inflammatory medicines in the
past.
suffer from bleeding disorders or abnormal vaginal bleeding other than your menstrual period (eg.,
unusually heavy and prolonged menstrual period).
have recently undergone a surgical operation (including minor ones such dental surgery) or will
undergo one within the next 7 days.
have bronchial asthma, hay fever, nasal polyps, a chronic respiratory disease or develop allergic
symptoms (eg., skin reaction, itching, urticaria).
have gout, diabetes, hyperthyroidism, arrhythmia, uncontrolled hypertension, impaired kidney or
liver function.
have alcohol problems (see Taking Novartis Consumer Health Pain Relief Tablets with food and
drinks).
are already taking other medicinal products containing Aspirin or paracetamol, or other medicines,
since certain may interfere with Novartis Consumer Health Pain Relief Tablets and cause side effects
(see Taking other medicines).
are at risk of being dehydrated (e.g. by vomiting, diarrhoea, or before or after major surgery).
are less than 18 years of age. There is a possible association between Aspirin and Reye’s syndrome
when given to children and adolescents. Reye’s syndrome is a rare disease, which affects the brain and
liver, and can be fatal. For this reason, this medicine should not be given to children or adolescents under
18 years unless specifically indicated by your doctor.

Other precautions
Habitual use of analgesics may cause headache, which must not be treated with higher doses of the same
analgesic substance. If you think that this may be the case, please contact your doctor for advice.
This medicine may reduce the symptoms of an infection (e.g. headache, high temperature) and may therefore
make it more difficult to detect. If you feel unwell and need to see a doctor, remember to tell him or her that
you are taking Novartis Consumer Health Pain Relief Tablets.
This medicine may affect the results of laboratory tests. If you have been asked to have blood, urine or other
laboratory testing, remember to tell that you are taking Novartis Consumer Health Pain Relief Tablets.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
In particular, tell your doctor if you are taking any of the following:
 any other medicinal product that contains paracetamol, Aspirin or any other pain reliever/fever
reducer.
 medicines used to prevent blood-clotting ("blood thinners") such as oral anticoagulants (eg., warfarin),
heparin, thrombolytics (eg., streptokinase), or other antiplatelets (ticlopidine, clopidogrel, cilostazol).
 corticosteroids (used to provide relief of inflammation).
 barbiturates and benzodiazepines (to treat anxiety and insomnia).
 lithium, selective serotonin reuptake inhibitors or fluvoxamine (to treat depression).
 sulphonylureas and insulin (to treat diabetes).
 methotrexate (to treat some kinds of cancer, arthritis or psoriasis).

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some medicines used to treat infection (eg., rifampicin, isoniazide, chloramphenicol, ciprofloxacin or
pipemidic acid).
levothyroxine (to treat hypothyroidism).
metoclopramide (to treat nausea and vomiting).
epilepsy medication.
high blood pressure and heart failure medication.
diuretics (to increase urine production and reduce excess fluid).
medicines to treat gout.
oral contraceptives.
zidovudine (to treat HIV).
medicines to treat slow gastric emptying such as propantheline.
clozapine (to treat schizophrenia).
sympathomimetics (to raise low blood pressure or to treat nasal congestion).
antiallergics (to prevent or relieve allergies).
theophylline (to treat asthma).
terbinafine (to treat fungal infections).
cimetidine (to treat heartburn and peptic ulcers).
disulfiram (to treat alcohol dependence).
nicotine (used for smoking cessation)
cholestyramin (to treat high cholesterol levels)

Taking Novartis Consumer Health Pain Relief Tablets with food and drinks
 Alcohol:
If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take this
medicine or other pain relievers/fever reducers. Paracetamol and Aspirin may cause liver damage and
stomach bleeding.
 Caffeine:
The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit your
intake of caffeine-containing medications, foods, or beverages while taking this product because too
much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heart beat.
Pregnancy and breast-feeding
If you are pregnant or think that you may be pregnant, tell your doctor and do not take Novartis
Consumer Health Pain Relief Tablets. It is especially important not to take this medicine during the last 3
months of pregnancy, as it could harm your unborn child or cause problems at delivery.
Do not take Novartis Consumer Health Pain Relief Tablets if you are breast-feeding as it might be harmful
for your infant.
Ask your doctor or pharmacist for advice before taking any medicine.
Novartis Consumer Health Pain Relief Tablets belongs to a group of medicines (NSAIDs) which may impair
the fertility in women. This effect is reversible on stopping the medicine.

Driving and using machines
Taking Novartis Consumer Health Pain Relief Tablets is not known to affect your ability to drive and use
machines.
If you notice side effects such as dizziness or drowsiness, you should not drive or use machines. Tell your
doctor as soon as possible.

3.

How to take Novartis Consumer Health Pain Relief Tablets

Always take this medicine exactly as stated in this package leaflet. You should check with your doctor or
pharmacist if you are not sure.
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Adults (18 years of age and older):


For headache treatment:
Take 1 tablet with a full glass of water when headache pain appears. If needed, you can take another 1
tablet 4 to 6 hours later.
In case of more intense pain, take 2 tablets with a full glass of water when headache pain appears. If
needed, you can take another 2 tablets 4 to 6 hours later.
Do not use Novartis Consumer Health Pain Relief Tablets for more than 4 days for headache without
consulting your doctor.



For migraine treatment:
Take 2 tablets with a full glass of water when migraine symptoms or migraine aura appear. If needed
you can take an additional 2 tablets, with 4 to 6 hours between doses.
If you get no migraine relief within 2 hours from the first 2-tablet dose of Novartis Consumer Health
Pain Relief Tablets, you should seek the advice of a doctor.
Do not use Novartis Consumer Health Pain Relief Tablets for more than 3 days for migraine without
consulting your doctor.

For both headache and migraine treatment, do not exceed 6 tablets over a period of 24 hours. This
corresponds to a dose of 1500 mg Aspirin, 1500 mg paracetamol and 390 mg caffeine.
Prolonged use except under medical supervision may be harmful.
Children and adolescents:
Novartis Consumer Health Pain Relief Tablets should not be given to children and adolescents under the age
of 18 (see Take special care with Novartis Consumer Health Pain Relief Tablets).
Elderly (over 65 years of age):
There are no special dosage recommendations.
Patients with kidney or liver problems
You should tell your doctor if you have kidney or liver problems. Your doctor may need to adjust the dose
interval or treatment duration. Do not take Novartis Consumer Health Pain Relief Tablets if you suffer from
severe liver or kidney problems.
If you take more Novartis Consumer Health Pain Relief Tablets than you should
These tablets contain Aspirin, paracetamol and caffeine. Do not take more than the recommended dose and
do not take any other products which may contain either of these ingredients or any other non steroidal antiinflammatory drugs while using Novartis Consumer Health Pain Relief Tablets.
Contact your doctor, pharmacist or go to the nearest hospital as soon as you think you might have taken an
overdose. Immediate medical attention is critical, because of the potential risk of irreversible liver damage
due to paracetamol. Do not wait for symptoms to appear as the overdose might not, at first, produce any
noticeable symptoms.
If symptoms of overdose appear they could be:


For Aspirin: dizziness, ringing in the ears, deafness, sweating, hyperventilation, fever, nausea, vomiting,
headache, confusion or restlessness, circulatory collapse or respiratory failure.



For paracetamol: the first symptoms that may appear are nausea, vomiting, lack of appetite, pallor,
sleepiness, sweating, and later abdominal pain.

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For caffeine: anxiety, nervousness, restlessness, insomnia, excitement, muscle twitching, confusion,
convulsions, hyperglycemia, tachycardia or cardiac arrhythmia.

Even if these symptoms do not appear or if they vanish, it is essential to seek medical help
immediately.
If you forget to take Novartis Consumer Health Pain Relief Tablets
Take the dose as soon as you remember but do not take a double dose to make up for a forgotten dose. Do
not take more than 6 tablets over a period of 24 hours.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.

Possible side effects

Like all medicines, Novartis Consumer Health Pain Relief Tablets can cause side effects, although not
everybody gets them.
Stop taking Novartis Consumer Health Pain Relief Tablets and tell your doctor immediately if you
have any of these serious side effects:
 allergic reaction with swelling of the face, lips, mouth, tongue or throat.
This may cause difficulty in swallowing, wheezing, difficulty in breathing and feelings of tightness in the
chest (signs of asthma). You may also have a rash or itching and experience fainting.
 skin reddening, blistering of lips, eyes or mouth, skin peeling.
 bleeding in the stomach or intestine, ulcer in stomach or intestine, which may be accompanied by severe
stomach pain, bloody or black stools, or vomiting blood. As with all pain relievers and fever reducers,
this can happen at any time during the treatment, without prior history, and may be fatal. This side effect
is particularly serious in elderly people.
 yellowing of the skin or eyes (signs of liver failure).
 light-headedness or dizziness (signs of low blood pressure).
 irregular heart beat.
Below side effects were reported in the 16 clinical trials conducted with Novartis Consumer Health Pain
Relief Tablets over 4800 treated subjects. Tell your doctor if you notice any of these other side effects:
Common (affects 1 to 10 users in 100):
 nervousness, dizziness
 nausea, abdominal discomfort
Uncommon (affects 1 to 10 users in 1,000):
 insomnia, trembling, numbness, headache
 ringing in the ears
 dry mouth, diarrhoea, vomiting
 fatigue, feeling jittery
 heart rate increased
Rare (affects 1 to 10 users in 10,000):
 sore throat, difficulty in swallowing, numbness or tingling around the mouth, too much saliva
 decreased appetite, altered taste
 anxiety, euphoric mood, tension
 disturbance in attention, memory loss, altered coordination
 feeling of pain in the cheeks and forehead
 eye pain, vision disorder
 hot flushes, peripheral blood vessels problems (eg., in arms or legs)
 nose bleeds, slow and shallow breathing, runny nose
 eructation, flatulence
 excessive sweating, itching, itchy rash, increased skin sensitivity
 stiffness in muscles, bones or joints; neck pain, back pain, muscles spasms
 weakness, chest discomfort
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Below side effects have also been reported since marketing Novartis Consumer Health Pain Relief Tablets.
In general, frequency in post-marketing surveillance cannot be determined precisely, thus it is indicated as
“not known”:
 restlessness, generally feeling unwell or not normal
 somnolence, migraine
 skin reddening, rash
 palpitations, breathlessness, sudden difficulty breathing and feeling of tightness in chest with wheezing
or coughing (asthma)
 abdominal pain, stomach discomfort after meals
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 as soon as possible.

5.
How to store Novartis Consumer Health Pain Relief Tablets
 Keep out of the reach and sight of children.
 Do not use Novartis Consumer Health Pain Relief Tablets after the expiry date which is stated on the
blister and carton after EXP. The expiry date refers to the last day of that month.
 Do not store above 25°C.
 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 Novartis Consumer Health Pain Relief Tablets contains
 The active substances are: Aspirin, paracetamol, caffeine.
Each film-coated tablet contains 250 mg Aspirin, 250 mg paracetamol and 65 mg caffeine.


The other ingredients are:
Tablet core: hydroxypropyl cellulose low substitution, cellulose microcrystalline (E460), stearic acid.
Film-coating: hypromellose (E464), titanium dioxide (E171), propylene glycol, benzoic acid (E210),
carnauba wax (E903).

What Novartis Consumer Health Pain Relief Tablets looks like and content of the pack
Novartis Consumer Health Pain Relief Tablets is a white, oblong-shaped, film-coated tablet with the letter
“E” debossed on one side.
The tablets are provided in blisters which are packed in boxes containing 10, 16, 20, or 32 film-coated
tablets. Not all pack sizes may be marketed.
Marketing authorisation holder:

Novartis Consumer Health UK Limited
Park View, Riverside Way, Watchmoor Park, Camberley, Surrey GU15 3YL
Manufacturer:
Novartis Consumer Health GmbH, Zielstattstrae 40, 81379 Munich (Germany).
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria: Excedrin 250 mg/250 mg/65 mg - Filmtabletten
Belgium: Excedryn, filmomhulde tabletten
Bulgaria: Excedrin 250mg / 250mg / 65mg Филмирана таблетка
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Czech Republic: Excedrinil
France: Excedrinil 250 mg/250 mg/65 mg comprimé pelliculé
Germany: Optalidon Kopfschmerz & Migräne 250mg/250mg/65mg Filmtabletten
Greece: Excedrin
Ireland: Excedrin film-coated tablets
Italy: Cibalgina Emicrania e Cefalea
Luxemburg: Excedryn, comprimés pelliculés
The Netherlands: Excedrin, filmomhulde tabletten
Poland: Excedrin MigraStop
Portugal: Excedrin
Romania: Excedrinil 250 mg / 250 mg / 65 mg comprimate filmate
Slovenia: Excedrinil 250 mg/250 mg/65 mg filmsko obložene tablete
Slovakia: Excedrin
Spain: Excedrin comprimidos recubiertos con película
United Kingdom: Novartis Consumer Health Pain Relief Tablets
This leaflet was last approved on: 01/10/2013

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Expand Transcript

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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