Consumer medicine information

Amcal Loratadine Tablets

contain the active ingredient Loratadine


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Amcal Loratadine Tablets.

It does not contain all of the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you taking Amcal Loratadine Tablets against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Amcal Loratadine Tablets are used for

Amcal Loratadine Tablets relieve symptoms associated with allergic rhinitis (including hayfever), such as sneezing, runny or itchy nose, and burning or itchy eyes.

Amcal Loratadine Tablets may also be used to relieve symptoms associated with a skin condition called chronic urticaria (also called hives); these symptoms include itching, redness and lumps on the skin.

Amcal Loratadine Tablets can be used in adults and children 12 years and over.

Amcal Loratadine Tablets belong to a class of medicines known as antihistamines.

Antihistamines help reduce allergic symptoms by preventing the effects of a substance called histamine.

Histamine is produced by the body in response to foreign substances which the body is allergic to.

Your doctor or pharmacist, however, may prescribe Amcal Loratadine Tablets for another purpose.

Ask your doctor or pharmacist if you have any questions about why Amcal Loratadine Tablets have been prescribed for you.

There is no evidence that Amcal Loratadine Tablets are addictive.

Before you take Amcal Loratadine Tablets

When you must not take them

Do not take Amcal Loratadine Tablets if:

  • you have an allergy to loratadine or any of the ingredients listed at the end of this leaflet.
  • you have allergy to desloratadine.

Some of the symptoms of an allergic reaction may include skin rash, difficulty in breathing or faintness.

Do not take Amcal Loratadine Tablets if you are pregnant or breastfeeding unless you and your doctor or pharmacist have discussed the risks and benefits involved.

Do not give Amcal Loratadine Tablets to children less than 12 years old.

Do not take Amcal Loratadine Tablets after the expiry date printed on the pack.

Do not take Amcal Loratadine Tablets if the packaging is torn or shows signs of tampering.

Before you start to take them

You must tell your doctor or pharmacist:

  • if you are allergic to any other medicines or any foods, dyes or preservatives
  • if you have liver disease or any other medical conditions.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.

How to take Amcal Loratadine Tablets

How much to take

Adults and children 12 years and over: One Amcal Loratadine tablet once daily.

It does not matter if you take Amcal Loratadine Tablets before or after food.

If you do not follow the directions for use, you may not get relief from your symptoms.

How to take Amcal Loratadine Tablets

Take it with a glass of water.

Amcal Loratadine Tablets can be stopped when you obtain relief from your symptoms, and restarted if symptoms recur.

If you take too many Amcal Loratadine Tablets (overdose)

Immediately telephone your doctor, pharmacist or Poisons Information Centre (13 11 26) for advice, or go to the Accident and Emergency Department at your nearest hospital, if you think that you or anyone else may have taken too many Amcal Loratadine Tablets. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep telephone numbers for these places handy.

While you are taking Amcal Loratadine Tablets

Things you must do

Tell all doctors, dentists and pharmacists who are treating you that you are taking Amcal Loratadine Tablets.

Tell your doctor or pharmacist if you become pregnant while you are taking Amcal Loratadine Tablets.

Things you must not do

Do not give Amcal Loratadine Tablets to anyone else, even if their symptoms seem similar to yours.

Do not use them to treat any other complaints unless your doctor or pharmacist says to.

Things to be careful of

Make sure you know how you react to Amcal Loratadine Tablets before you drive a car or operate machinery.

Amcal Loratadine Tablets are unlikely to make you drowsy. If you are drowsy, do not drive a car or work with machinery.

Stop taking Amcal Loratadine Tablets 48 hours before you have any skin tests. Antihistamines may interfere with the results of skin tests.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Amcal Loratadine Tablets. Amcal Loratadine Tablets help most people with allergies, but they may have unwanted effects in a few people.

Like other medicines, Amcal Loratadine Tablets can cause some side effects. If they occur, they are most likely to be minor and temporary.

However, some may be serious and need medical attention.

Ask your doctor or pharmacist any questions you may have.

The most commonly reported unwanted events were:

  • headache
  • sleepiness
  • fatigue
  • dry mouth

Rare instances of hair loss were also reported.

Other unwanted effects may occur in some people taking Amcal Loratadine Tablets.

After using Amcal Loratadine Tablets

Storage

Keep your tablets in the blister pack in a dry place until it is time to take them. If you take your tablets out, they will not keep well.

Keep your tablets in a cool dry place where the temperature stays below 25°C.

Do not leave them in the car on hot days or on window sills.

Keep them where children cannot reach them.

Disposal

If your doctor or pharmacist tells you to stop taking Amcal Loratadine Tablets or the medicine has passed the expiry date, ask your pharmacist what to do with any that are left over.

Product description

Amcal Loratadine Tablets can be bought without a doctor’s prescription.

What they look like

Amcal Loratadine Tablets are white to off white normal convex tablets, with a score on one side.

Each blister pack contains 10, 30 or 50 tablets.

Ingredients

Amcal Loratadine Tablets contain:

  • loratadine 10 mg
  • starch – pregelatinised maize
  • sodium starch glycollate
  • magnesium stearate
  • lactose

They do not contain sucrose or gluten.

Sponsor

Amcal Loratadine Tablets are available only from:

Amcal Allied Master Chemists of Australia Limited
(ACN 005 393 957)
1408 Centre Road
Clayton Victoria 3168
Australia

Australian registration number:

AUST R 127576

Date of preparation:

February 2006.

Last updated in May 2006.

Published by MIMS October 2006