CETIRIZINE HYDROCHLORIDE 1 MG | ML ORAL SOLUTION

Active substance: CETIRIZINE HYDROCHLORIDE

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CETIRIZINE HYDROCHLORIDE
1 mg/ml ORAL SOLUTION
PACKAGE LEAFLET: INFORMATION FOR THE USER

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 Cetirizine 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.
• 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.
IN THIS LEAFLET:

1. What Cetirizine is and what it is used
for
2. Before you take Cetirizine
3. How to take Cetirizine
4. Possible side effects
5. How to store Cetirizine
6. Further information

1

WHAT CETIRIZINE IS AND WHAT
IT IS USED FOR

• Cetirizine is an antihistamine.
Antihistamines help to relieve the
symptoms of some allergies.
• In children 2 to 6 years, Cetirizine is
used:
• to relieve the nasal symptoms of
hay fever (runny and itchy nose)
• In adults and children 6 years and
above, Cetirizine is used:
• to relieve the nasal symptoms of
hay fever and non-seasonal rhinitis
(runny and itchy nose)
• to relieve the symptoms of other
allergies e.g. pet or house dust mite
allergies
• for skin allergies such as rash,
itching and urticaria (hives).
• In adults and children 12 years and
above, Cetirizine is also used:
• to relieve the symptoms of allergic
eye conditions.

Not recommended in children aged less
than 2 years of age.
Taking other medicines
Talk to your doctor if you are taking any
of the following:
Due to the profile of cetirizine, no
interactions with other drugs are expected.
Please tell your doctor or pharmacist if
you are taking or have recently taken any
other medicines, including medicines
obtained without a prescription.
Important information about some of
the ingredients of Cetirizine
• If you have been told by your doctor
that you have an intolerance to some
sugars, contact your doctor before
taking this medicine
• Propyl parahydroxybenzoate E216 and
methyl parahydroxybenzoate E218
may cause allergic reactions (possibly
delayed).
Taking Cetirizine with food and drink
• DO NOT take large amounts of alcohol
whilst taking Cetirizine, as Cetirizine
may increase the effects of alcohol.
Pregnancy and breast-feeding
• If you are pregnant or planning to
become pregnant, ask your doctor for
advice before taking any medicine
• DO NOT take Cetirizine if you are
breast-feeding.
Driving and using machines
• When taken at the recommended dose,
Cetirizine is not expected to affect your
ability to drive or operate machinery.
However, there are exceptions and
you should take care when using this
medicine for the first time. If this
product makes you feel drowsy, DO
NOT drive or operate machinery. This
effect will be worse if you are also
taking sedatives or drinking alcohol.

3

HOW TO TAKE CETIRIZINE

If your doctor has prescribed this
medicine, always take Cetirizine exactly
as your doctor has told you. Otherwise,
follow the instructions below. If you are
not sure how to take this medicine talk
to your doctor or pharmacist.
Use the spoon provided to make sure
you have the correct dose.
The usual dosage instructions are given
below:
• Adults and children over 12 years
BEFORE YOU TAKE CETIRIZINE
2
of age
10 mg once daily as 10 ml oral solution
DO NOT take Cetirizine and talk to your
(two full measuring spoons) once daily.
doctor if you:
• Children aged 6 – 12 years (for
• are allergic (hypersensitive) to
hay fever, runny and itchy nose
cetirizine or similar products (e.g.
due to allergy and skin allergies)
hydroxyzine, cyclizine, meclozine) or
5 mg twice daily as 5 ml oral solution
to any of the other ingredients in this
(one full measuring spoon) twice daily.
medicine
• Children aged 2 – 6 years (for hay
• are undergoing dialysis for kidney
fever only)
problems
2.5 mg twice daily as 2.5 ml oral
• have a hereditary fructose intolerance.
solution (a half-measuring spoon)
Take special care with Cetirizine
twice daily.
Tell your doctor before you start to take
• Children under 2 years of age
this medicine if you:
Cetirizine is not recommended for use.
• have kidney problems, as the dose
• Patients with moderate to severe
may need to be adjusted
kidney problems
• are epileptic or at risk of convulsions.
In patients with kidney impairment,
Allergy tests: If you are going to have an
the dose may need to be reduced as
allergy skin test stop taking this medicine
recommended by a doctor. Please talk
3 days before the test.
to your doctor or pharmacist.

• weight gain
• fits or unusual movements of your
arms and/or legs
• aggression or depression
• confusion
• hallucinations
• difficulty in sleeping
• red and/or blotchy skin rash.
The effects of an overdose may cause
Very rare (affecting less than one person
confusion, diarrhoea, dizziness,
tiredness, headache, a general feeling of in 10,000):
• bleeding and bruising easily (could
being unwell, dilated pupils, itching,
indicate problems with your blood)
restlessness, drowsiness, sleepiness, a
• sight problems including difficulty
state of semi-unconsciousness, faster
focusing and blurred vision
heartbeat, shaking or problems urinating.
• unusual movements of the eyeball
Please take this leaflet, any remaining
• fainting
solution and the container with you to
• decreased sense of taste
the hospital or doctor so that they know
• bed wetting
which solution was taken.
• pain in passing water
If you forget to take Cetirizine
• inflammatory skin eruption
If you forget to take a dose, take one as • unusual movements or contractions in
soon as you remember, unless it is
the face
nearly time to take the next one. DO
• abnormal muscle rigidity or movements
NOT take a double dose to make up for • shaking.
a forgotten dose.
Side effects with frequency not known:
If you have any further questions on the • partial or total loss of memory.
use of this product, ask your doctor or
If any of the side effects get serious, or if
pharmacist.
you notice any side effects not listed in
this leaflet, please tell your doctor or
4 POSSIBLE SIDE EFFECTS
pharmacist.
Like all medicines, Cetirizine can cause
5 HOW TO STORE CETIRIZINE
side effects, although not everybody
gets them.
Keep out of the reach and sight of
Stop taking the solution and tell your
children. There are no special storage
doctor immediately or go to the
conditions. Do not transfer to another
casualty department at your nearest
container. Do not use Cetirizine after the
hospital if the following happens:
expiry date that is stated on the outer
• a severe allergic reaction (swelling of packaging. The expiry date refers to the
the face, lips, mouth or throat leading last day of that month.
to severe difficulty in breathing or
Medicines should not be disposed of via
swallowing; skin rash or hives).
wastewater or household waste. Ask your
This is a very serious but rare side
pharmacist how to dispose of medicines
effect. You may need urgent medical
no longer required. These measures will
attention or hospitalisation.
help to protect the environment.
The following side effect has been
reported with Cetirizine. Tell your doctor 6 FURTHER INFORMATION
if you notice the following:
What Cetirizine solution contains:
• abnormal liver function tests
(diagnosed by blood and/or urine tests). • The active ingredient is cetirizine
hydrochloride. Each 1 ml of solution
The following side effects have been
contains 1 mg of cetirizine
reported at the approximate frequencies
hydrochloride.
shown:
The other ingredients are glycerol,
Common (affecting fewer than one person propylene glycol, sorbitol solution (E420),
in 10 but more than one person in 100): methyl parahydroxybenzoate (E218),
propyl parahydroxybenzoate (E216),
• tiredness or sleepiness
sodium acetate, glacial acetic acid,
• dizziness or headache
saccharin sodium, banana flavour and
• nausea or diarrhoea
purified water.
• dry mouth or difficulty in swallowing
accompanied by earache and swollen What Cetirizine solution looks like and
glands, sore throat
contents of the pack:
• runny and itchy nose.
• Cetirizine solution is a clear, colourless
solution with a banana flavour
Uncommon (affecting less than one
person in 100 but more than one person • The product is available in pack sizes of
70 ml, 75 ml, 100 ml, 150 ml and 200 ml.
in 1,000):
Not all pack sizes may be marketed.
• agitation
• abdominal pain
Marketing Authorisation Holder and
• lethargy or feeling weak and/or unwell Manufacturer
• pins and needles
Marketing Authorisation holder and
• skin itchiness or rashes.
company responsible for manufacture:
TEVA UK Limited, Eastbourne, BN22 9AG.
Rare (affecting less than one person in
1,000 but more than one person in 10,000): This leaflet was last revised: February 2011
• rapid heartbeat
PL 00289/0416
• water retention

If you take more Cetirizine than you should
If you (or someone else) swallow a lot of
the solution all together, or if you think a
child has accidentally swallowed any of
the solution, contact your nearest
hospital casualty department or your
doctor immediately.

• liver problems

12345-A

CETIRIZINE HYDROCHLORIDE
1 mg/ml ORAL SOLUTION
PACKAGE LEAFLET: INFORMATION FOR THE USER

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 Cetirizine 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.
• 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.
IN THIS LEAFLET:

1. What Cetirizine is and what it is used
for
2. Before you take Cetirizine
3. How to take Cetirizine
4. Possible side effects
5. How to store Cetirizine
6. Further information

1

WHAT CETIRIZINE IS AND WHAT
IT IS USED FOR

• Cetirizine is an antihistamine.
Antihistamines help to relieve the
symptoms of some allergies.
• In children 2 to 6 years, Cetirizine is
used:
• to relieve the nasal symptoms of
hay fever (runny and itchy nose)
• In adults and children 6 years and
above, Cetirizine is used:
• to relieve the nasal symptoms of
hay fever and non-seasonal rhinitis
(runny and itchy nose)
• to relieve the symptoms of other
allergies e.g. pet or house dust mite
allergies
• for skin allergies such as rash,
itching and urticaria (hives).
• In adults and children 12 years and
above, Cetirizine is also used:
• to relieve the symptoms of allergic
eye conditions.

Not recommended in children aged less
than 2 years of age.
Taking other medicines
Talk to your doctor if you are taking any
of the following:
Due to the profile of cetirizine, no
interactions with other drugs are expected.
Please tell your doctor or pharmacist if
you are taking or have recently taken any
other medicines, including medicines
obtained without a prescription.
Important information about some of
the ingredients of Cetirizine
• If you have been told by your doctor
that you have an intolerance to some
sugars, contact your doctor before
taking this medicine
• Propyl parahydroxybenzoate E216 and
methyl parahydroxybenzoate E218
may cause allergic reactions (possibly
delayed).
Taking Cetirizine with food and drink
• DO NOT take large amounts of alcohol
whilst taking Cetirizine, as Cetirizine
may increase the effects of alcohol.
Pregnancy and breast-feeding
• If you are pregnant or planning to
become pregnant, ask your doctor for
advice before taking any medicine
• DO NOT take Cetirizine if you are
breast-feeding.
Driving and using machines
• When taken at the recommended dose,
Cetirizine is not expected to affect your
ability to drive or operate machinery.
However, there are exceptions and
you should take care when using this
medicine for the first time. If this
product makes you feel drowsy, DO
NOT drive or operate machinery. This
effect will be worse if you are also
taking sedatives or drinking alcohol.

3

HOW TO TAKE CETIRIZINE

If your doctor has prescribed this
medicine, always take Cetirizine exactly
as your doctor has told you. Otherwise,
follow the instructions below. If you are
not sure how to take this medicine talk
to your doctor or pharmacist.
Use the spoon provided to make sure
you have the correct dose.
The usual dosage instructions are given
below:
• Adults and children over 12 years
BEFORE YOU TAKE CETIRIZINE
2
of age
10 mg once daily as 10 ml oral solution
DO NOT take Cetirizine and talk to your
(two full measuring spoons) once daily.
doctor if you:
• Children aged 6 – 12 years (for
• are allergic (hypersensitive) to
hay fever, runny and itchy nose
cetirizine or similar products (e.g.
due to allergy and skin allergies)
hydroxyzine, cyclizine, meclozine) or
5 mg twice daily as 5 ml oral solution
to any of the other ingredients in this
(one full measuring spoon) twice daily.
medicine
• Children aged 2 – 6 years (for hay
• are undergoing dialysis for kidney
fever only)
problems
2.5 mg twice daily as 2.5 ml oral
• have a hereditary fructose intolerance.
solution (a half-measuring spoon)
Take special care with Cetirizine
twice daily.
Tell your doctor before you start to take
• Children under 2 years of age
this medicine if you:
Cetirizine is not recommended for use.
• have kidney problems, as the dose
• Patients with moderate to severe
may need to be adjusted
kidney problems
• are epileptic or at risk of convulsions.
In patients with kidney impairment,
Allergy tests: If you are going to have an
the dose may need to be reduced as
allergy skin test stop taking this medicine
recommended by a doctor. Please talk
3 days before the test.
to your doctor or pharmacist.

• weight gain
• fits or unusual movements of your
arms and/or legs
• aggression or depression
• confusion
• hallucinations
• difficulty in sleeping
• red and/or blotchy skin rash.
The effects of an overdose may cause
Very rare (affecting less than one person
confusion, diarrhoea, dizziness,
tiredness, headache, a general feeling of in 10,000):
• bleeding and bruising easily (could
being unwell, dilated pupils, itching,
indicate problems with your blood)
restlessness, drowsiness, sleepiness, a
• sight problems including difficulty
state of semi-unconsciousness, faster
focusing and blurred vision
heartbeat, shaking or problems urinating.
• unusual movements of the eyeball
Please take this leaflet, any remaining
• fainting
solution and the container with you to
• decreased sense of taste
the hospital or doctor so that they know
• bed wetting
which solution was taken.
• pain in passing water
If you forget to take Cetirizine
• inflammatory skin eruption
If you forget to take a dose, take one as • unusual movements or contractions in
soon as you remember, unless it is
the face
nearly time to take the next one. DO
• abnormal muscle rigidity or movements
NOT take a double dose to make up for • shaking.
a forgotten dose.
Side effects with frequency not known:
If you have any further questions on the • partial or total loss of memory.
use of this product, ask your doctor or
If any of the side effects get serious, or if
pharmacist.
you notice any side effects not listed in
this leaflet, please tell your doctor or
4 POSSIBLE SIDE EFFECTS
pharmacist.
Like all medicines, Cetirizine can cause
5 HOW TO STORE CETIRIZINE
side effects, although not everybody
gets them.
Keep out of the reach and sight of
Stop taking the solution and tell your
children. There are no special storage
doctor immediately or go to the
conditions. Do not transfer to another
casualty department at your nearest
container. Do not use Cetirizine after the
hospital if the following happens:
expiry date that is stated on the outer
• a severe allergic reaction (swelling of packaging. The expiry date refers to the
the face, lips, mouth or throat leading last day of that month.
to severe difficulty in breathing or
Medicines should not be disposed of via
swallowing; skin rash or hives).
wastewater or household waste. Ask your
This is a very serious but rare side
pharmacist how to dispose of medicines
effect. You may need urgent medical
no longer required. These measures will
attention or hospitalisation.
help to protect the environment.
The following side effect has been
reported with Cetirizine. Tell your doctor 6 FURTHER INFORMATION
if you notice the following:
What Cetirizine solution contains:
• abnormal liver function tests
(diagnosed by blood and/or urine tests). • The active ingredient is cetirizine
hydrochloride. Each 1 ml of solution
The following side effects have been
contains 1 mg of cetirizine
reported at the approximate frequencies
hydrochloride.
shown:
The other ingredients are glycerol,
Common (affecting fewer than one person propylene glycol, sorbitol solution (E420),
in 10 but more than one person in 100): methyl parahydroxybenzoate (E218),
propyl parahydroxybenzoate (E216),
• tiredness or sleepiness
sodium acetate, glacial acetic acid,
• dizziness or headache
saccharin sodium, banana flavour and
• nausea or diarrhoea
purified water.
• dry mouth or difficulty in swallowing
accompanied by earache and swollen What Cetirizine solution looks like and
glands, sore throat
contents of the pack:
• runny and itchy nose.
• Cetirizine solution is a clear, colourless
solution with a banana flavour
Uncommon (affecting less than one
person in 100 but more than one person • The product is available in pack sizes of
70 ml, 75 ml, 100 ml, 150 ml and 200 ml.
in 1,000):
Not all pack sizes may be marketed.
• agitation
• abdominal pain
Marketing Authorisation Holder and
• lethargy or feeling weak and/or unwell Manufacturer
• pins and needles
Marketing Authorisation holder:
• skin itchiness or rashes.
TEVA UK Limited, Eastbourne, BN22 9AG.
Company responsible for manufacture:
Rare (affecting less than one person in
1,000 but more than one person in 10,000): Teva Czech Industries s.r.o., Opava,
Czech Republic.
• rapid heartbeat
• water retention
This leaflet was last revised: February 2011
• liver problems
PL 00289/0416
01025-C

If you take more Cetirizine than you should
If you (or someone else) swallow a lot of
the solution all together, or if you think a
child has accidentally swallowed any of
the solution, contact your nearest
hospital casualty department or your
doctor immediately.

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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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