Patient leaflet - Ultarin 10 mg tablets
1. WHAT ULTARIN 10 MG TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Ultarin 10 mg Tablets. It will be referred to as Ultarin Tablets throughout this leaflet.
Ultarin 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 when you are allergic to something.
Ultarin Tablets relieve symptoms associated with allergic rhinitis (for example, hay fever), such as sneezing, runny or itchy nose, and burning or itchy eyes.
Ultarin Tablets may also be used to help relieve symptoms of urticaria (itching, redness) which is known as hives or nettle rash).
Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ULTARIN TABLETS
DO NOT TAKE Ultarin Tablets
- if you are allergic to loratadine or any of the other ingredients of Ultarin Tablets. An allergic reaction can include skin rash, itching, swelling or breathing difficulties.
- if you are pregnant or planning to become pregnant.
- if you are breast feeding currently.
Warnings and precautions
Talk to your doctor or pharmacist before taking Loratadine Tablets
- if you have severe liver problems.
- if you are due to have skin tests since Loratadine could affect the results.
Children
Do not give Ultarin Tablets to children younger than 6 years old or to children who weigh 30 kg or less. There are other formulations more suitable for children younger than 6 years old or with a body weight of 30 kg or less.
Children under 2 years of age:
The safety and efficacy of Ultarin Tablets have not been established. No data are available.
Other medicines and Ultarin Tablets
The side effects of Ultarin Tablets may increase when used together with medicines that alter the performance of some enzymes responsible for drug-metabolism in the liver. However, in clinical studies, no increase in side effects of loratadine was seen with products that altered the performance of these enzymes.
Please tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Laboratory tests
Antihistamines may prevent response to allergens in skin allergy testing, therefore this medicine should be stopped two days prior to such testing.
Ultarin Tablets with food and drink
This medicine may be taken with or without food.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.
As a precautionary measure, it is preferable to avoid the use of Ultarin Tablets during pregnancy. Do not take Ultarin Tablets if you are breast-feeding. Loratadine is excreted in breast milk.
Driving and using machines
In clinical trials that assessed driving ability, no impairment was observed in patients receiving Ultarin. At the recommended dose, Ultarin Tablets are not expected to cause you to be drowsy or less alert. However, very rarely some patients experience drowsiness, which may affect their ability to drive oruse machines. Please make sure you are not drowsy before performing these activities.
Ultarin tablets contain lactose
Ultarin Tablets contain lactose (milk sugar). If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal produc
Information on sodium content:
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.
3. HOW TO TAKE ULTARIN TABLETS
Always take Ultarin Tablets exactly as your doctor or pharmacist or nurse has told you. You should check withyour doctor or pharmacist if you are not sure.
Try to get into the habit of taking it at the same time every day. This will make it easier for you to remember.
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 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.
There are other formulations more suitable for children younger than 6 years or with a body weight of 30 kg or less. Not recommended for children under 2 years old.
How much to take:
| Age | How much to take | How often to take |
|---|---|---|
| Adults and children 6 years and older who weigh more than 30kg (4st 7lb) | 1 x tablet | Once daily |
| Children who weigh 30 kg (4st 7lb) or less | Not recommended. | |
| 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. | ||
If you take more Ultarin Tablets than you should
If you may have taken more Loratadine than you should, talk to your doctor or pharmacist immediately. Overdose may cause headache, sleepiness or a faster heart beat. Immediate medical attentionshould be sought in the event of an overdose; take your tablets along to show to your doctor, if possible.
If you forget to take Ultarin Tablets
If you have forgotten to take your tablet, take it as soon as you remember and continue 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 product, ask your doctor or pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must stop taking Ultarin immediately and consult your doctor if you develop any allergic reaction to this medicine.
This can consist of
- skin rash or eruptions (including inside the mouth)
- itching
- swelling of the face, tongue, lips, hands, feet
- breathing difficulties
The most commonly reported side effects in adults and children over 12 years of age are:
- drowsiness
- headache
- increased appetite
- difficulty sleeping.
The most commonly 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:
- severe allergic reaction (including swelling)
- dizziness
- convulsion
- fast or irregular heartbeat
- nausea (feeling sick)
- dry mouth
- upset stomach
- liver problems
- hair loss
- rash
- tiredness
The frequency of the following side effect is not known:
- weight gain
Reporting of side effects
If you get any side effects, talk to your doctor or 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, websitewww.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ULTARIN TABLETS
Keep your tablets out of the sight and reach of children.
- Do not take Ultarin Tablets after the expiry date which is stated on the carton after “Exp”. The expiry date refers to the last day of that month.
- Store in the original package.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Ultarin Tablets contain
- The active substance is Loratadine 10 mg.
- The other ingredients are lactose monohydrate, colloidal anhydrous silica, croscarmellose sodium, talc and magnesium stearate.
What Ultarin Tablets look like and contents of the pack
Ultarin Tablets are white coloured, circular, flat beveled uncoated tablets, with central breakline on one side and ‘L’ on other side.
Ultarin Tablets are available in blister strips in pack sizes of 7 and 14 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Torrent Pharma (UK) Ltd.
3rd Floor, Nexus Building
4 Gatwick Road,
Crawley,
West Sussex
RH10 9BG
United Kingdom
Manufacturer
APC Pharmaceuticals & Chemicals (Europe) Ltd.,
9th floor,C.P. House, 97-107 Uxbridge Road, Ealing, W5 5TL This leaflet was last revised in 07/2023.