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Loratadine 10 Mg Tablets

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Document: leaflet GENESIS PHARMACEUTICALS_PL 28444-0016 change

PACKAGE LEAFLET: INFORMATION FOR THE USER

Loratadine 10 mg Tablets

Loratadine

Read all of this leaflet carefully before you start taking this medicine.

•    Please keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Loratadine 10 mg Tablets are and what they are used for

2.    Before you take Loratadine 10 mg Tablets

3.    How to take Loratadine 10 mg Tablets

4.    Possible side effects

5.    How to store Loratadine 10 mg Tablets

6.    Further information

1.    WHAT LORATADINE 10 MG TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Loratadine 10 mg Tablets. The active ingredient is Loratadine.

Loratadine is one of a group of medicines called non-sedating anti-histamines. It helps relieve the symptoms of some allergies.

Loratadine 10 mg Tablets can relieve symptoms such as sneezing, runny or itchy nose; irritation inside the nose and eyes; itchy or burning eyes whether these are caused by hay fever or whether they occur all year around. It is also used to help relieve the symptoms associated with skin conditions such as rash, itching and hives.

2.    BEFORE YOU TAKE LORATADINE 10MG TABLETS Do not take this medicine if:

•    you have ever had an allergic reaction to any of the ingredients of Loratadine 10mg Tablets or any other medicines that you may have taken to treat allergies (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing).

Take special care with this medicine and tell your doctor or pharmacist if:

•    you suffer from severe liver problems

•    you are due to have any skin tests, as loratadine may interfere with the results

Tell your doctor before taking this medicine if you have been told that you have an intolerance to some sugars. This is because Loratadine 10mg Tablets contain lactose, a type of sugar.

Taking other medicines

There are no known side effects when loratadine has been taken at the same time with other medicines. However, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Tell your doctor if you become pregnant, planning to become pregnant or if you are breast-feeding.

Driving and using machines

Loratadine should not cause drowsiness. This medicine should not affect your ability to drive or operate machinery, provided that it is used only as recommended. However, very rarely this medicine may cause drowsiness in some people. If this happens to you, you should not drive or operate machinery.

3.    HOW TO TAKE LORATADINE 10 MG TABLETS

Always take your medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The tablet should be swallowed with water.

The usual doses of Loratadine 10 mg Tablets are as follows:

Adults and children over 12

10mg a day to be taken once daily.

If youlake more labels than you should

If you accidentally take too much of your medicine, tell your doctor at once or contact your nearest hospital pasualty department immediately. Take your medicine with you.

If you forget to take your medicine

|lf you forget to take a dose, just take the next dose at the usual time. DO NOT take a double dose.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Loratadine 10 mg Tablets can cause side effects, although not everybody gets them. You are unlikely to get any of the following, but if you do, tell your doctor immediately:

•    Allergic reaction causing difficulty i n breathing or dizziness

•    Drowsiness

•    Increased hunger

•    Headache

•    Difficulty in sleeping

If you notice any side effects mentioned above, please tell your doctor or pharmacist.

Other side effects may include:

•    Fast or irregular heartbeat

•    Symptoms of liver disease, e.g. yellowing of the skin or whites of the eyes (a condition known as jaundice) or inflammation (hepatitis) although these are rare

•    Symptoms of stomach disorders, e.g. nausea

•    Hair loss

•    Rash

•    Tiredness

If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist immediately.

5.    HOW TO STORE LORATADINE 10 MG TABLETS

Do not use after the expiry date that is stated on the carton or label.

Store the tablets in the original package.

KEEP OUT OF REACH AND SIGHT OF CHILDREN

Return any unused medicine to your pharmacist.

6.    FURTHER INFORMATION

What Loratadine 10 mg Tablets contain:

Each tablet contains 10 mg of the active substance, loratadine. The other ingredients are lactose monohydrate, maize starch and magnesium stearate.

What Loratadine 10mg Tablets look like and the contents of the pack

Loratadine 10 mg Tablets are small, white, round tablets marked with an “L” on one side. They are packed in foil blister packs and are available in cartons of 30 tablets.

Marketing Authorisation Holder

Activase Pharmaceuticals Limited, 11 Boumpoulinas Street, PO Box 27783, Nicosia 2433, Cyprus Manufacturer

jDDSA Pharmaceuticals Limited, 310 Old Brampton Road, London SW5 9JQ, UK Distributor

Genesis Pharmaceuticals Limited, 15 Runnelfield, Harrow on the Hill, Middlesex HA1 3NY, UK.

This leaflet does not contain all the available information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

The information in this leaflet applies only to Loratadine 10 mg Tablets.

Date of preparation of the leaflet: September 2015.