Loratadine 10mg Orodispersible Tablets
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Loratadine
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take Loratadine 10 mg Orodispersible Tablets carefully to get the best results from them.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve after 10 days.
• If any of the side effects gets serious, 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 Orodispersible Tablets are and what they are used for
2. Before you take Loratadine 10 mg Orodispersible Tablets
3. How to take Loratadine 10 mg Orodispersible Tablets
4. Possible side effects
5. How to store Loratadine 10 mg Orodispersible Tablets
6. Further information
. What Loratadine 10 mg
1 Orodispersible Tablets are and
what they are used for
Loratadine 10 mg Orodispersible Tablets belong to a class of medicines known as antihistamines. Antihistamines help to reduce allergic symptoms by preventing the effects of a substance called histamine, which is produced in the body.
The tablet relieves symptoms associated with allergic rhinitis (for example, hayfever) such as sneezing, runny or itchy nose and burning or itchy eyes.
The tablet may also be used to help relieve symptoms of urticaria (itching and redness), which is often known as hives or nettle rash.
Before you take Loratadine 10 mg Orodispersible Tablets
Do not take Loratadine 10 mg Orodispersible Tablets:
• if you are hypersensitive (allergic) to loratadine, or any of the other ingredients of Loratadine 10 mg Orodispersible Tablets (see section 6. Further Information).
• if you are pregnant or breastfeeding
• if you have phenylketonuria (a metabolism disorder)
Take special care with Loratadine 10 mg Orodispersible Tablets:
Before taking these tablets, tell your doctor or pharmacist
• if you have severe liver disease or
• if you have to undergo any skin tests (it may be necessary to stop taking this medicine at least 2 days before the test to make sure the result of the test is correct)
Taking other medicines
This medicine is not expected to affect any other medicines that you may be taking. However, some medicines may affect the way that the active ingredient in this medicine is broken down in the body.
If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicines you have bought for yourself, including herbal and homeopathic remedies.
Taking Loratadine 10 mg orodispersible tablets with food and drink
The tablets can be taken with or without a meal. The tablets will normally disintegrate in the mouth in contact with saliva, therefore water or other liquids are not normally needed.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Do not take Loratadine 10 mg Orodispersible Tablets if you are pregnant or breastfeeding.
Driving and using machines
At the recommended dose, Loratadine 10 mg Orodispersible 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.
Important information about some of the ingredients of Loratadine 10 mg Orodispersible Tablets
Loratadine 10 mg Orodispersible Tablets contain 0.5 mg aspartame/dose. Aspartame is a source of phenylalanine which may be harmful for people with phenylketonuria a metabolism disorder. Loratadine 10 mg Orodispersible Tablets contain lactose and sorbitol. If you have intolerance to some sugars, contact your doctor or pharmacist before taking this medicine.
How to take Loratadine 10 mg Orodispersible Tablets
Loratadine 10 mg Orodispersible (“melt in the mouth”) Tablets are intended to be put on the tongue (see below) and for oral use.
Always take Loratadine 10 mg Orodispersible Tablets exactly as recommended. You should check with your doctor or pharmacist if you are not sure.
Loratadine 10 mg Orodispersible Tablets break easily, so you should handle the tablets carefully and with dry hands only.
1. Tear one blister unit along the perforations.
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2. Peel open the backing in direction of the arrow and take the tablet out carefully. The tablet shouldn’t be pushed through the backing.
3. Put the tablet on your tongue as soon as it is removed from the packaging. It will melt in your mouth directly. Water is not required to swallow the tablet.
Loratadine 10 mg Orodispersible Tablets are dispersed in your mouth in contact with saliva and can be therefore taken without water. They have a sweet orange taste.
Giving this medicine to 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 30 kg (four and half stone).
and contact your pharmacist or doctor at once.
The most commonly reported side effects in children aged 2 through 12 years include headache, nervousness and tiredness.
The most commonly reported side effects in adults and adolescents include drowsiness, headache, increased appetite and difficulty sleeping.
Other side effects reported very rarely were dizziness, irregular or rapid heart beat, nausea (feeling sick), dry mouth, upset stomach, liver problems, hair loss, rash and tiredness.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 less than 30 kg (four and half stone).
|
Age |
How many to take |
How often to take |
|
Adults and children over 12 years |
One tablet |
Once a day |
|
Children of 2 to 12 years who weigh more than 30 kg (four and half stone) |
One tablet |
Once a day |
|
Children of 2 to 12 years who weigh less than 30 kg (four and half stone |
Do not give this medicine. For children over 2 years of age and who weigh less than 30 kg a syrup form of this medicine may be more suitable. | |
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.
Duration of treatment:
You must contact a doctor if your symptoms do not improve or even get worse after 10 days.
If you take more tablets than you should:
If you take more Loratadine 10 mg Orodispersible Tablets than recommended, contact your doctor or pharmacist. Taking more tablets than recommended may cause drowsiness, rapid heart beat and headache.
If you forget to take a tablet:
If you forget to take your dose on time, take it as soon as possible, then go back to your regular dosing schedule. Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, Loratadine 10 mg can cause side effects, although not everybody gets them.
Patients have very rarely experienced hypersensitive reactions, such as difficulty in breathing, swelling of the face, neck, tongue or throat after use of this product. If you experience any of these side effects stop taking the tablets
How to store Loratadine 10 mg Orodispersible Tablets
Keep out of the reach and sight of children.
Do not use Loratadine 10 mg Orodispersible Tablets after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Store the tablets in the original packaging in order to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist howto dispose of medicines no longer required. These measures will help to protect the environment.
6 Further information
What Loratadine 10 mg Orodispersible Tablets contains
• The active substance is loratadine.
• The other ingredients are sweet orange flavour, aspartame (E951), citric acid anhydrous (E330), silica colloidal anhydrous (E551), maize starch dried, lactose anhydrous, magnesium stearate (E470b), croscarmellose sodium (E468), mannitol (E421), sorbitol (E420), crospovidone, silica colloidal hydrated (E551) polysorbate 80 (E433), povidone (E1201), microcrystalline cellulose (E460).
What Loratadine 10 mg Orodispersible Tablets looks like and contents of the pack
Loratadine 10 mg Orodispersible Tablets are white, round and flat.
The packs may contain 7, 14, 21 or 30 tablets, packed in aluminium/aluminium unit dose perforated blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer:
Lek Pharmaceuticals d.d.,
Verovskova 57, 1526 Ljubljana,
Slovenia.
This leaflet was last revised in 06/2013.
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