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CETIRIZINE DIHYDROCHLORIDE 10 MG FILM-COATED TABLETS

Active substance(s): CETIRIZINE DIHYDROCHLORIDE / CETIRIZINE DIHYDROCHLORIDE / CETIRIZINE DIHYDROCHLORIDE

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Packaging Leaflet: Information for the patient

Allergy and Hayfever relief
10mg Film Coated Tablets
Cetirizine Dihydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
• This medicine is available without prescription. However, you still need to take it carefully to get the best results.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after a few days.

1. What this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine tablets.
4. Possible side effects.
5. How to store this medicine
6. Contents of the pack and other information.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if:
• You have problems with your kidneys;
• You have predisposition factors of urinary retention (e,g. spinal cord
lesion, prostatic hyperplasia) as cetirizine increases the risk of
urinary retention;
• You suffer from epilepsy or are at risk of convulsions;
• You want to use for children less than 6 years of age.

1. What this medicine is and what it is used for

This medicine with food, drink and alcohol
Avoid alcoholic drink while you are taking this medicine.

What is in this leaflet:

The full name of this medicine is Careway Allergy and Hayfever relief
tablets 10mg Flim-coated tablets but within the leaflet it will be
referred to as this medicine. Cetirizine dihydrochloride, the active
ingredient of the tablets is an antihistamine. It blocks the effects of a
substance called histamine which occurs naturally in the body.
Histamine is involved in allergic reactions.
This medicine is used to treat people who have hayfever (seasonal
allergic rhinitis), year round allergies such as dust or pet allergies
(perennial allergic rhinitis) and urticaria (swelling, redness and
itchiness of the skin).
Antihistamines like Cetirizine dihydrochloride tablets relieve the
unpleasent symptoms and discomfort associated with these
conditions, such as sneezing, irritated, runny and blocked up nose,
itchy, red and watering eyes and skin rashes.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
Allergy Testing
If you are due to have an allergy test, ask your doctor if you should
stop taking this medicine for several days before testing. This
medicine may affect your allergy test results.
Driving and using machines
Some people have reported that they feel drowsy or dizzy while they
are taking this medicine. If you are affected DO NOT drive or use
machines.

2. What you need to know before you take this
medicine

This medicine contain lactose
This medicine contains lactose. If you have been told by your doctor
that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.

Do not take this medicine if:

3. How to take this medicine

• You are allergic to cetirizine dihydrochloride or any of the other
ingredients of this medicine (listed in section 6);
• You are breastfeeding
• You have severe kidney failure (creatinine clearance less than 10
ml/min);
• You have problems of urinary retention;
• You have hereditary problems of glactose intolerance, the Lapp
lactase deficiency or glucose-galactose malabsorption.
If any of the above applies to you talk to your pharmacist.

Remember. Take the tablet with a glass of water. DO NOT take more
than one tablet each day. If you do not feel better within a few days,
consult your doctor.
Children aged 6 to 12:
Take half a tablet twice a day.
Adults and children aged 12 years and over:
Take one tablet daily. If the tablets make you feel drowsy or dizzy,
taking half a tablet twice a day may be better than taking one tablet
once a day. This medicine are not suitable for children uder 6.

If you take more of this medicine than you should.
If you accidentally take too many tablets go and see your doctor
straight away.
If you forget to take this medicine.
If you forget to take a tablet, you should take one as soon as you
remember, but wait at least 24 hours before taking your next tablet.
If you have any further questions on the use of this medicine, ask
your pharmacist.

• Swelling of the skin particularly around the face
• Fanting
• A recurring rash
• Bed wetting, pain and/or difficulty passing water
Not known side effects
• Increased appetite
• Vertigo
• Urinary retention

4. Possible side effects

Some cases of memory loss and/or impairment have also been
reported.

Like all medicines, this medicine can cause side effects, although not
everybody gets them

In very rare cases people have thought about committing suicide and
if you feel this way then stop taking the tablets and see your doctor.

The following side effect is very rare, but you must stop taking the
tablets and speak to your doctor straight away if you notice these
symptoms:
• A severe allergic reaction including rash, itchiness and fever, swollen
throat, face, eyelids or lips. This reaction may start soon after you
first take the medicine, or it might start later.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.

The following side effects have also been reported.

5. How to store this medicine

Common side effects (affects less than 1 in 10 people)
• Tiredness, feeling sleepy
• Headache
• Dry mouth
• Nausea
• Diarrhoea (children only)
• Pain in the abdomen
• Dizziness
• Sore throat
• Cold-like symptoms of the nose (children only)

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF
CHILDREN
DO NOT use this medicine after the expiry date which is stated on the
carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.

Uncommon side effects (affects less than 1 in 100 people)
• Itching and rash
• Diarrhoea
• Feeling weak or generally unwell
• Tingling in the hands and feet
• Feeling agitated
Rare side effects (affects less than 1 in 1000 people)
• Fast heart beat
• Oedema (generalised swelling due to water retention)
• Abnormal liver function test results (your doctor will know what
to do)
• Convulsions
• Increased weight
• Aggression, confusion, depression, hallucination (hearing or seeing
things), sleeplessness
• Urticaria (hives)
Vary rare side effects (affects 1 in 10,000 people)
• Blurred vision, difficulty focussing
• Rotation of the eyes
• Unusual bleeding or bruising
• Bad taste in the mouth
• Tremor, tics
• Involuntary movements and/or jerking of the limbs
• Muscle spasms in the neck and shoulders

DO NOT throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What this medicine contains
• The active substance is cetirizine dihydrochloride.
• The other ingredients are lactose monohydrate, microcrystalline
cellulose, colloidal anhydrous silica, magnesium stearate,
hydroxpropylmethylcellulose(E464), polydextrose, titanium dioxide
(E171), and macrogol/polethyleneglycol 4000.
What this medicine looks like and contents of the pack
The tablets are white to off-white capsule-shaped film-coated tablets,
each with one plain face and with a break line on the other face.
Your medicine is supplied in clear colourless PVC/PVdC_Aluminium
blisters packs of 7, 14 or 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Crescent Pharma Limited,
Units 3 & 4, Quidhampton Business Units,
Polhampton Lane, Overton,
Hants RG25 3ED
United Kingdom
This leaflet was last revised in 05/2016

V2-160705

Package Leaflet: Information for the patient

Allergy and Hayfever Relief
10mg Film Coated Tablets
Cetirizine Dihydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
• This medicine is available without prescription. However, you still need to take it carefully to get the best results.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after a few days.

1. What this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine.
4. Possible side effects.
5. How to store this medicine
6. Contents of the pack and other information.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if:
• You have problems with your kidneys;
• You have predisposition factors of urinary retention (e.g. spinal cord
lesion, prostatic hyperplasia) as cetirizine increases the risk of
urinary retention;
• You suffer from epilepsy or are at risk of convulsions;
• You want to use for children less than 6 years of age.

1. What this medicine is and what it is used for

This medicine with food, drink and alcohol
Avoid alcoholic drink while you are taking this medicine.

What is in this leaflet:

The full name of this medicine is Careway Allergy and Hayfever Relief
10mg Film Coated Tablets but within the leaflet it will be referred to
as this medicine. Cetirizine dihydrochloride, the active ingredient of
the tablets is an antihistamine. It blocks the effects of a substance
called histamine which occurs naturally in the body. Histamine is
involved in allergic reactions.
This medicine is used to treat people who have hayfever (seasonal
allergic rhinitis), year round allergies such as dust or pet allergies
(perennial allergic rhinitis) and urticaria (swelling, redness and
itchiness of the skin).
Antihistamines like Cetirizine dihydrochloride tablets relieve the
unpleasant symptoms and discomfort associated with these
conditions, such as sneezing, irritated, runny and blocked up nose,
itchy, red and watering eyes and skin rashes.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
Allergy Testing
If you are due to have an allergy test, ask your doctor if you should
stop taking this medicine for several days before testing. This
medicine may affect your allergy test results.
Driving and using machines
Some people have reported that they feel drowsy or dizzy while they
are taking this medicine. If you are affected DO NOT drive or use
machines.

2. What you need to know before you take this
medicine

This medicine contains lactose
This medicine contains lactose. If you have been told by your doctor
that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.

Do not take this medicine if:

3. How to take this medicine

• You are allergic to cetirizine dihydrochloride or any of the other
ingredients of this medicine (listed in section 6);
• You are breastfeeding
• You have severe kidney failure (creatinine clearance less than 10
ml/min);
• You have problems of urinary retention;
• You have hereditary problems of galactose intolerance, the Lapp
lactase deficiency or glucose-galactose malabsorption.
If any of the above applies to you talk to your pharmacist.

Remember. Take the tablet with a glass of water. DO NOT take more
than one tablet each day. If you do not feel better within a few days,
consult your doctor.
Children aged 6 to 12:
Take half a tablet twice a day.
Adults and children aged 12 years and over:
Take one tablet daily. If the tablets make you feel drowsy or dizzy,
taking half a tablet twice a day may be better than taking one tablet
once a day. This medicine is not suitable for children under 6.

If you take more of this medicine than you should
If you accidentally take too many tablets go and see your doctor
straight away.
If you forget to take this medicine
If you forget to take a tablet, you should take one as soon as you
remember, but wait at least 24 hours before taking your next tablet.
If you have any further questions on the use of this medicine, ask
your pharmacist.

• Swelling of the skin particularly around the face
• Fainting
• A recurring rash
• Bed wetting, pain and/or difficulty passing water
Not known side effects
• Increased appetite
• Vertigo
• Urinary retention

4. Possible side effects

Some cases of memory loss and/or impairment have also been
reported.

Like all medicines, this medicine can cause side effects, although not
everybody gets them.

In very rare cases people have thought about committing suicide.
If you feel this way, stop taking the tablets and see your doctor.

The following side effect is very rare, but you must stop taking the
tablets and speak to your doctor straight away if you notice these
symptoms:
• A severe allergic reaction including rash, itchiness and fever, swollen
throat, face, eyelids or lips. This reaction may start soon after you
first take the medicine, or it might start later.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.

The following side effects have also been reported.

5. How to store this medicine

Common side effects (affects less than 1 in 10 people)
• Tiredness, feeling sleepy
• Headache
• Dry mouth
• Nausea
• Diarrhoea (children only)
• Pain in the abdomen
• Dizziness
• Sore throat
• Cold-like symptoms of the nose (children only)

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF
CHILDREN
DO NOT use this medicine after the expiry date which is stated on the
carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.

Uncommon side effects (affects less than 1 in 100 people)
• Itching and rash
• Diarrhoea
• Feeling weak or generally unwell
• Tingling in the hands and feet
• Feeling agitated
Rare side effects (affects less than 1 in 1000 people)
• Fast heart beat
• Oedema (generalised swelling due to water retention)
• Abnormal liver function test results (your doctor will know what
to do)
• Convulsions
• Increased weight
• Aggression, confusion, depression, hallucination (hearing or seeing
things), sleeplessness
• Urticaria (hives)
Very rare side effects (affects less than 1 in 10,000 people)
• Blurred vision, difficulty focussing
• Rotation of the eyes
• Unusual bleeding or bruising
• Bad taste in the mouth
• Tremor, tics
• Involuntary movements and/or jerking of the limbs
• Muscle spasms in the neck and shoulders

DO NOT throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What this medicine contains
• The active substance is cetirizine dihydrochloride.
• The other ingredients are lactose monohydrate, microcrystalline
cellulose, colloidal anhydrous silica, magnesium stearate,
hydroxpropylmethylcellulose (E464), polydextrose, titanium dioxide
(E171), and macrogol/polyethylene glycol 4000.
What this medicine looks like and contents of the pack
The tablets are white to off-white capsule-shaped film-coated tablets,
each with one plain face and with a break line on the other face.
Your medicine is supplied in clear colourless PVC/PVdC-Aluminium
blisters packs of 7, 14 or 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Crescent Pharma Limited,
Units 3 & 4, Quidhampton Business Units,
Polhampton Lane, Overton,
Hants RG25 3ED
United Kingdom
This leaflet was last revised in 03/2017

V7-170322

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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