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ALKA-SELTZER XS

Active substance(s): ASPIRIN / CAFFEINE / CITRIC ACID ANHYDROUS / PARACETAMOL / SODIUM HYDROGEN CARBONATE / ASPIRIN / CAFFEINE / PARACETAMOL / ASPIRIN / CAFFEINE / PARACETAMOL

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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 use Alka-Seltzer XS
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.
If you have any unusual effects after using this
product, tell your doctor or pharmacist.

IN THIS LEAFLET:
1. What is Alka-Seltzer XS and what is it used for?
2. Before you take Alka-Seltzer XS
3. How to take Alka-Seltzer XS
4. Possible side effects
5. How to store Alka-Seltzer XS
6. Further information

1. WHAT IS ALKA-SELTZER® XS AND WHAT IS IT USED FOR?
Alka-Seltzer XS are effervescent tablets which
dissolve in water to give a sparkling solution. The
active substances are: aspirin (acetylsalicylic acid),
paracetamol and caffeine.
Aspirin belongs to a group of medicines known as
non-steroidal anti-inflammatory drugs (NSAIDS).
Aspirin and paracetamol are both used for the
treatment of pain and reduction of fever. Aspirin also
has anti-inflammatory properties, whilst caffeine acts
as mild stimulant.

Alka-Seltzer XS can be used for the:
• Treatment of mild to moderate pain including
headache, migraine, backache (including
lumbago), nerve pain (neuralgia and sciatica),
period pain, toothache and sore throat.
• Symptomatic relief of colds and influenza.
• Relief of rheumatic pain (arthritis), muscle
tenderness and stiffness (including fibrositis),
muscular aches and pains.
• Effective reduction of high temperature.

2. BEFORE YOU TAKE ALKA-SELTZER® XS
DO NOT take Alka-Seltzer XS if you:
• Are allergic (hypersensitive) to aspirin,
paracetamol, caffeine or any of the ingredients
(listed in Section 6, - Further Information)
• Are allergic to any other pain relieving or
anti-inflammatory medicines (eg NSAIDS or
salicylates). For more information see section 4
‘Possible Side Effects’.
• Have a disorder which causes excessive bleeding
such as haemophilia.
• Have, or have had, a stomach or duodenal ulcer.
• Are on a high dose of methotrexate (15mg per
week or more). If you are not sure, check with
your doctor. Also see ‘Using other medicines’.
• Are pregnant or breast-feeding, unless advised
by a doctor.
Speak to your doctor before taking Alka-Seltzer
XS if you:
• Suffer from tightness in the chest or asthma.
• Have low uric acid excretion, which is commonly
associated with gout.
• Have a history of gastrointestinal disorders
(regular stomach upsets).
• Have kidney or liver problems .
• Are about to have surgery. Before the operation
tell the doctor or surgeon that you are taking
aspirin.
If you are not sure whether any of the above apply to
you, speak to a doctor or pharmacist before taking
Alka-Seltzer XS.
Important information about some of the
ingredients:
Each Alka-Seltzer XS tablet contains 472mg of
sodium. This should be taken into consideration by
people on a controlled sodium diet.
Use in children:
Aspirin can cause Reye’s syndrome when it is given
to children. Reye’s syndrome is a very rare disease,
which can be fatal. For this reason aspirin should
not be given to children under 16 years, unless your
doctor tells you to.

15220 PIL_Alka_XS_v2.4.indd 1

Using 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.
Aspirin can affect the way in which some medicines
work. These medicines include:
• Medication to prevent blood clotting (eg
warfarin, heparin, ticlopidine).
• Medication to treat heart problems or to lower
blood pressure (eg ACE inhibitors or digoxin).
• Medication to treat gout.
• Diuretics (to treat water retention).
• Medication to treat epilepsy (eg sodium
valproate, phenytoin).
• Medication to lower blood sugar if you are
diabetic.
• Methotrexate (to treat psoriasis, rheumatoid
arthritis, Crohn’s disease and some types of
cancer).
• Any pain-relieving or anti-inflammatory
medicines.
• Medication containing corticosteroids.
Paracetamol can affect the way in which some
medicines work. These medicines include:
• Metoclopramide (to treat nausea and vomiting).
• Domperidone (to treat nausea, vomiting,
indigestion).
• Colestyramine (to treat high cholesterol).
Do not take other products containing paracetamol
whilst taking this product.
Taking with food and drink:
Avoid taking alcohol while taking Alka-Seltzer XS.
Pregnancy and breast-feeding:
Do not take Alka-Seltzer XS if you are pregnant,
breast-feeding or trying for a baby unless directed by
your doctor. Aspirin can prolong labour and affect
blood clotting in the mother or baby.
Always ask your doctor or pharmacist for advice
before taking any medicine.

28/11/2013 13:06

3. HOW TO TAKE ALKA-SELTZER® XS
Follow the directions below closely. You should ask
your doctor or pharmacist if you are unsure how to
use this medicine.
Alka-Seltzer XS tablets must always be dissolved in
water before use.
Adults and children over 16:
Two tablets dissolved in half a glass (100ml) of water
may be taken every 4 hours as required. You should
not take more than 8 tablets in 24 hours.
Not recommended in children under 16.

Make sure you follow the dosage instructions and do
not take more than the stated dose.
Do not take Alka-Seltzer XS for more than 3 days in
a row. If you do not get better, talk to your doctor.
If you take more Alka-Seltzer XS than you
should:
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.

4. POSSIBLE SIDE EFFECTS
Like all medicines Alka-Seltzer XS can cause side
effects although not everybody gets them.
If you experience any of the following side effects,
stop taking Alka-Seltzer XS and go to your nearest
Accident and Emergency Department or doctor
immediately:
• An allergic reaction. Signs of allergic reaction
may include: difficulty in breathing or
swallowing, swelling of the face, lips, throat or
tongue, skin rashes, large or itchy wheals on the
skin, attacks of sneezing, runny nose and itching
eyes or water retention.
• Stomach bleeding, which may result in black or
tarry stools.
• Nausea or vomiting.
• Dizziness or ringing in the ears.
• Diarrhoea.
• Increased bleeding/blood thinning (if you cut
or injure yourself).




An asthma attack if you are asthmatic and
sensitive to aspirin.
Changes in normal liver activity in blood tests
(very rare).

If you have unusual stomach pains or react badly
to this medicine in any other way, stop taking
Alka-Seltzer XS and tell your doctor or pharmacist
immediately.
Reporting of side effects
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.

5. HOW TO STORE ALKA-SELTZER® XS
Keep out of the sight and reach of children.
Do not store above 25 °C. Store in a dry place. This
product should be stored in its original carton.
This product is packaged in pouches containing
2 tablets. If the pouch is opened and a tablet is not
used immediately, dispose of the tablet. If the pouch
is damaged or if a tablet is powdery or discoloured,
do not use the tablet.

Do not use Alka-Seltzer XS after the expiry date
which is stated on the carton and on the foil pouch.
The expiry date refers to the last day of that month.
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 Alka-Seltzer XS contains:
The active substances are aspirin (acetylsalicylic
acid) (267mg per tablet), paracetamol (133mg per
tablet) and caffeine (40mg per tablet).
The other ingredients are sodium hydrogen
carbonate and citric acid.
See section 2 ‘Important information about some
of the ingredients’ for sodium advice.
What Alka-Seltzer XS looks like and contents of
the pack:
Alka-Seltzer XS comes in cartons containing 2, 10,
12, 20 or 30 white effervescent tablets packaged in
foil pouches. Not all pack sizes may be marketed.

15220 PIL_Alka_XS_v2.4.indd 2

Marketing Authorisation Holder:
Bayer plc
Consumer Care Division
Bayer House, Strawberry Hill
Newbury, Berkshire RG14 1JA
United Kingdom
Manufacturer:
Bayer Bitterfeld GmbH
OT Greppin
Salegaster Chaussee 1
06803 Bitterfeld-Wolfen
Germany
This leaflet was last revised in November 2013.
Alka-Seltzer® is a registered trademark.

28/11/2013 13:06

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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