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ROLETRA 10 MG TABLETS
Active substance(s): LORATADINE / LORATADINE / LORATADINE
One A Day Allergy Relief 10mg Tablets
Read all of this leaflet carefully before you start taking this medicine, referred to as
One A Day Allergy Tablets because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist,
or nurse has told you.
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, pharmacist, or nurse. This includes
any possible side effects not listed in this leaflet.
You must talk to a doctor if you do not feel better, if you feel worse or if your
symptoms change. See section 4
What is in this leaflet:
1. What One A Day Allergy Tablets are and what they are used for
2. What you need to know before you take One A Day Allergy Tablets
3. How to take One A Day Allergy Tablets
4. Possible side affects
5. How to store One A Day Allergy tablets
6. Contents of the pack and other Information
1) WHAT ONE A DAY ALLERGY TABLETS ARE AND WHAT ARE THEY USED FOR
What One A Day Allergy Tablets are:
One A Day Allergy Tablets contain the active substance loratadine which belongs to a class
of medicines called “antihistamines”.
How One A Day Allergy Tablets work:
One A Day Allergy Tablets help to reduce your allergy symptoms by stopping the effects of a
substance called “histamine”, which is produced in the body when you are allergic to something.
When One A Day Allergy Tablets should be taken:
One A Day Allergy Tablets relieve symptoms associated with allergic rhinitis (for example,
hayfever) such as sneezing, runny or itchy nose and burning or itchy eyes in adults and
children over the age of 2 years who weigh more than 30kg.
One A Day Allergy Tablets may also be used to relieve symptoms of urticaria (itching and
redness) which is often known as hives or nettle rash.
The effect of One A Day Allergy Tablets will last a whole day and should help you to continue
your normal daily activities and sleep.
You must talk to a doctor if you do not feel better or if you feel worse.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE ONE A DAY ALLERGY TABLETS
Do not take One A Day Allergy Tablets if :
you are allergic (hypersensitive) to loratadine or any of the other ingredients of
this medicine (listed in section 6).
you are pregnant or breast-feeding
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking One A Day Allergy Tablets if:
you have liver disease
you are scheduled to have any skin tests for allergies. Do not take One A Day
Allergy Tablets for two days before having these tests. This is because it may affect
the test results.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse
before taking One A Day Allergy Tablets.
Do not give One A Day Allergy Tablets to children younger than 2 years old or to children
2 to 12 years old who weigh less than 30kg. There are other formulations more suitable for
children 2 to 12 years old who weigh less than 30kg.
Other medicines and One A Day Allergy Tablets
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take
any other medicines. This includes medicines taken without a prescription.
One A Day Allergy Tablets with alcohol
One A Day Allergy Tablets have not been shown to add to the effects of an alcoholic drink.
Pregnancy and breast-feeding
Do not take One A Day Allergy Tablets if you are pregnant.
Do not take One A Day Allergy Tablets if you are breast-feeding. Loratadine is excreted in
Driving and using machines
At the recommended dose, One A Day Allergy Tablets are not expected to cause you to be
drowsy or less alert. However, very rarely some people experience drowsiness, which may
affect their ability to drive or use machines.
One A Day Allergy Tablets contain lactose
This medicinal product 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.
3) HOW TO TAKE ONE A DAY ALLERGY TABLETS
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist
or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
Giving this medicine to children
Loratadine syrup may be preferable for children. It is important to know how much your
child weighs to make sure that you give the correct amount of medicine. For example, a 9
year old child weighs about 30kg (4st 7lb). If in doubt weigh your child and then follow the
instructions in the table.
Do not give to children under 2 years or who weigh 30 kg (4st 7lb) or less.
How much to take:
How much to take
How often to take
Adults and children
over 12 years
1 x tablet
Children of 2 to 12 years
who weigh more than
30kg (4st 7lb)
1 x tablet
If you have severe liver problems your doctor or pharmacist may advise you to take the
recommended amount every other day. If this applies to you, follow their instructions.
The tablet should be swallowed whole with a drink of water.
If you have taken more One A Day Allergy Tablets than you should
If you take more One A Day Allergy Tablets than you should, talk to your doctor or pharmacist
straight away. No serious problems are expected however, you may get a headache, have a
rapid heartbeat or feel sleepy.
If you forget to take One A Day Allergy Tablets
If you forget to take your dose, take it as soon as you remember, then continue to take it as
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist
4) POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Stop taking One A Day Allergy Tablets and talk to a doctor straight away, if you notice the
severe allergic reaction
This is a very rare side effect (may affect up to 1 in 10,000 people).
Other side effects
The side effects reported in adults and children over 12 years of age are:
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
The commonly (may affect up to 1 in 10 people) reported side effects in children aged 2 to
12 years are:
The following very rare side effects (may affect up to 1 in 10,000 people) have also been seen
during the marketing of loratadine:
rapid heartbeat, palpitations (awareness of heartbeat/racing)
nausea (feeling sick)
irritation of the stomach lining (gastritis)
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 ONE A DAY ALLERGY TABLETS
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 blister after Exp. The
expiry date refers to the last day of the month.
Store in the original package.
Do not throw away any medicines via waste water or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What One A Day Allergy Tablets contain:
The active substance is loratadine. Each tablet contains 10mg of loratadine.
The other ingredients are lactose monohydrate, maize starch and magnesium stearate.
What One A Day Allergy Tablets look like and contents of the pack
One A Day Allergy Tablets are white to off-white, round tablets debossed with ‘R’ on one side
and ‘10’ on the other.
One A Day Allergy Tablets are available in pack sizes of 7, 14 or 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Ranbaxy (UK) Limited,
5th floor, Hyde Park, Hayes 3
11 Millington Road
Hayes, UB3 4AZ. UK
Sun Pharmaceutical Industries Europe B.V.
2132 JH Hoofddorp
Alkaloida Chemical Company Zrt.
Kabay János u. 29
This leaflet was last revised November 2016.
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.