180 mg film-coated tablets
fexofenadine hydrochloride
What Telfast is and what it is used for
Telfast contains fexofenadine hydrochloride which is an antihistamine that does not cause fatigue.
Telfast 180 mg is used by adults and adolescents from the age of 12 to relieve symptoms that occur in long-term allergic skin reactions ( chronic idiopathic urticaria ) such as itching, swelling, and rashes.
What you need to know before using Telfast
Do not use Telfast
- if you are allergic to fexofenadine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Telfast if:
- you have liver or kidney problems
- you have or have had heart disease as this medicine may cause a fast or irregular heart rhythm
- you are older
If any of this applies to you or if you feel unsure, always consult your doctor before using Telfast.
Other medicines and Telfast
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of Telfast can be impaired by reduced absorption if certain antiacid agents containing aluminum and magnesium hydroxide are taken at the same time. Telfast and these medicines should therefore be taken 2 hours apart.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Telfast should not be taken during pregnancy unless necessary.
Telfast is not recommended for breastfeeding women.
Driving ability and use of machinery
Telfast is unlikely to affect your ability to drive or use machines. However, you should check that these tablets do not make you tired or dizzy before driving or operating machinery. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Telfast contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How to use Telfast
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
For adults and children over 12 years
The recommended dose is one tablet (180 mg) daily.
Take the tablet with water before a meal.
This medicine starts to relieve your symptoms within 1 hour and the effect lasts for 24 hours.
If you have taken too much Telfast
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
Symptoms of overdose are dizziness, drowsiness, fatigue, and dry mouth.
If you forget to take Telfast
Do not take a double dose to make up for a missed tablet.
Take the next dose at the usual time as prescribed by the doctor.
If you stop using Telfast
Tell the doctor if you want to stop using Telfast before the end of the treatment.
If the treatment is stopped too soon, the symptoms may return.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell the doctor immediately and stop treatment with Telfast if:
- you experience swelling of the face, lips, tongue, or throat and difficulty breathing, as this may be a sign of a serious allergic reaction.
The following side effects have been reported in clinical studies, with an incidence similar to that observed in patients who did not receive the drug ( placebo ).
Common side effects ( may affect up to 1 in 10 users):
- headache
- drowsiness
- nausea (retching)
- dizziness.
Uncommon side effects ( may affect up to 1 in 100 users):
- fatigue
- somnolence.
Additional side effects ( have been reported (occurring in an unknown number of users)):
- difficulty sleeping (insomnia)
- sleep disorders
- nightmares
- nervousness
- fast or irregular heartbeat
- diarrhea
- skin rash and itching
- hives
- severe allergic reactions that may cause swelling of the face, lips, tongue, or throat, flushing, chest tightness, and difficulty breathing.
How Telfast should be stored
Keep this medicine out of sight and reach of children.
Use before the expiry date stated on the packaging after “Exp. dat”. or “Exp”. The expiration date is the last day of the specified month.
This medicine has no special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is fexofenadine hydrochloride. Each tablet contains 180 mg of fexofenadine hydrochloride.
Other ingredients are:
Tablet core: microcrystalline cellulose, pregelatinized corn starch, croscarmellose sodium, magnesium stearate.
Film coating: hypromellose, povidone, titanium dioxide (E171), anhydrous colloidal silicon dioxide, macrogol 400, and iron oxide (E172).
Appearance and package sizes of the medicine
Telfast 180 mg film-coated tablets are peach-colored, capsule-shaped tablets marked “ 018 ” on one side and an “e” printed on the other side.
Telfast is packed in blisters, one tablet in each blister.
Telfast is available in packs of 10, 15, 20, 30, 50, 100 and 200 (10×20) tablets.
Not all pack sizes may be marketed.
Opella Healthcare France SAS
82 Avenue Raspail, 94250
Gentilly, France
Manufacturer :
Opella Healthcare International SAS, 56, route de Choisy,
60200, Compiègne, France
Local Representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark
This medicine is approved in the European Economic Area under the names:
Telfast (Belgium, Denmark, Finland, Malta, Germany, Ireland, Italy, Luxembourg, Portugal, Sweden, United Kingdom). Fexofenadine Sanofi (Spain).