Medine.co.uk

Wilko One A Day Hayfever And Allergy Relief 10 Mgtablets

Document: leaflet MAH BRAND_PL 14894-0207 change

Package Leaflet: Information for the user

Roletra 10mg tablets

(Loratadine)


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, pharmacist, or nurse has told you.

•    Keep this leaflet. You may need to read it again.

•    Askyour 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 Roletra tablets are and whatthey are used for

2.    Whatyou need to know before you take Roletra tablets

3.    How to take Roletra tablets

4.    Possible side effects

5.    Howto store Roletra tablets

6.    Contents of the packand other information

1)    What Roletra Tablets are and what they are used for_

The full name of your medicine is Roletra 10 mg Tablets.

What Roletra Tablets are

Roletra tablets contain the active substance loratadine which belongs to a class of medicines called “antihistamines’’.

How Roletra Tablets work

Roletra 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 RoletraTablets should be taken

Roletra tablet relieves symptoms associated with allergic rhinitis (for example, hay fever) such as sneezing, runny or itchy nose, and burning or itchy eyes in adults and children overthe age of 2 years who weigh more than 30kg.

Roletra 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 Roletra tablets will last a whole day and should help you to continue your normal daily activities and sleep.

You musttalkto a doctor if you do notfeel better or if you feel worse.

2)    What you need to know before you take Roletra Tablets_

Do not take Roletra 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 breastfeeding

Warnings and precautions

Talkto your doctor, pharmacist or nurse before taking Roletra tablets if:

•    you have liver disease

•    you are scheduled to have any skin tests for allergies. Do not take Roletra 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 Roletra tablets.

Children

Do not give Roletra tablets to children youngerthan 2 years old orto children 2 to 12 years old who weigh less than 30kg. There are otherformulations more suitable for children 2 to 12 years old who weigh less than 30kg.

Other medicines and RoletraTablets

Tell your doctor or pharmacist or nurse if you are taking, have recently taken ormighttake any other medicines. This includes medicines taken without a prescription.

Roletra Tables with alcohol

Roletra tablets have not been shown to add to the effects of an alcoholic drink.

Pregnancy and breast-feeding

Do not take Roletra tablets if you are pregnant.

Do not take Roletra tablets if you are breast-feeding. Loratadine is excreted in breast milk. Driving and using machines

At the recommended dose, Roletra 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.

Roletra 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 Roletra Tablets_

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist ornurse has told you. Check with yourdoctor, 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:

Age

How much to take

How often to take

Adults and children over 12 vears

1 x tablet

Once dailv

Children of 2 to 12 vears who weiah more than 30ka Mst 7lb1

1 x tablet

Once dailv


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 adrinkof water.

If you have taken more Roletra Tablets than you should

If you take more Roletra tablets than you should, talkto 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 Roletra Tablets

•    If you forget to take your dose, take it as soon as you remember, then continue to take it as usual.

•    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 ornurse.

4) Possible side effects_


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

Serious side effects

Stop taking RoletraTablets and talktoadoctor straight away, if you notice the following:

•    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)

•    drowsiness

Uncommon (may affect up to 1 in 100 people)

•    headache

•    increased appetite

•    difficulty sleeping

The commonly (may affect up to 1 in 10 people) reported side effects in children aged 2 to 12 years are:

•    headache

•    nervousness

•    tiredness

The following very rare side effects (may affect up to 1 in 10,000 people) have also been seen during the marketing of loratadine:

•    dizziness

•    fit (convulsion)

•    rapid heartbeat, palpitations (awareness of heat beaf/racing)

•    nausea (feeling sick)

•    dry mouth

•    irritation of the stomach lining (gastritis)

•    liver problems

•    hair loss

•    rash

•    tiredness

Reporting of side effects

If you get any side effects, talkto 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.

5) How to store Roletra 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 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 Roletra tablets contain

-    The active substance is loratadine. Each table contains 10mg loratadine.

-    The other ingredients are lactose monohydrate, maize starch, magnesium stearate.

What Roletra tablets looks like and contents of the pack

Roletra tablets are white to off-white, round tablets debossed with 'R' on one side and '1 O' on the other.

Roletra 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,

Building 4, Chiswick Park,

566 Chiswick High Road,

London,

W45YE, U.K.

Manufacturer:

Ranbaxy Ireland Limited,

Spafield, Cork Road, Cashel,

Co-Tipperary,

Republic of Ireland.

This leaflet was last revised in January 2015.


in

T

05


RANBAXY