Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Fexofenadine hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Telfast contains fexofenadine hydrochloride, which is a non-drowsy antihistamine. Telfast 120 mg is used in adults and adolescents of 12 years and older to relieve the symptoms that occur with hay fever (seasonal allergic rhinitis) such as sneezing, itchy, runny or blocked nose and itchy, red and watery eyes.
e Telfast Do not take 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 taking Telfast if: • you have problems with your liver or kidneys • you have or ever had heart disease, since this kind of medicine may lead to a fast or irregular heart beat • you are elderly If any of these apply to you, or if you are not sure, tell your doctor before taking Telfast. Other medicines and Telfast Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you are taking apalutamide (a medicine to treat prostate cancer), as the effect of fexofenadine may be decreased. Indigestion remedies containing aluminium and magnesium may affect the action of Telfast, by lowering the amount of medicinal product absorbed. 1
It is recommended that you leave about 2 hours between the time that you take Telfast and your indigestion remedy. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take Telfast if you are pregnant, unless necessary. Telfast is not recommended during breast-feeding. Driving and using machines Telfast is unlikely to affect your ability to drive or operate machinery. However, you should check that these tablets do not make you feel sleepy or dizzy before driving or operating machinery. Telfast contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodiumfree'.
Telfast Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. For adults and children aged 12 years and over The recommended dose is one tablet (120 mg) daily. Take your tablet with water before a meal. This medicine starts to relieve your symptoms within 1 hour and lasts for 24 hours. If you take more Telfast than you should If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately. Symptoms of an overdose in adults are dizziness, drowsiness, fatigue and dry mouth. If you forget to take Telfast Do not take a double dose to make up for a forgotten tablet. Take the next dose at the usual time as prescribed by your doctor. If you stop taking Telfast Tell your doctor if you want to stop taking Telfast before you have finished your course of treatment. If you stop taking Telfast earlier than planned, your symptoms may return. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor immediately and stop taking Telfast if you experience: • swelling of the face, lips, tongue or throat and difficulty breathing, as these may be signs of a serious allergic reaction. The following undesirable effects have been reported in clinical trials, with an incidence similar to those observed in patient who did not receive the drug (placebo). Common side effects (may affect up to 1 in 10 people): • headache • drowsiness 2
• •
feeling sick (nausea) dizziness.
Uncommon side effects (may affect up to 1 in 100 people): • tiredness/sleepiness. Additional side effects (frequency not known: cannot be estimated from the available data) which may occur are: • difficulty sleeping (insomnia) • sleeping disorders • bad dreams • nervousness • fast or irregular heart beat • diarrhoea • skin rash and itching • hives • serious allergic reactions which can cause swelling of the face, lips, tongue or throat, flushing, chest tightness, and difficulty breathing. • blurred vision Reporting of side effects If you get any side effects, talk to your doctor, 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 at: www.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
Telfast Keep this medicine out of the sight and reach of children. Do not use this medicine 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. This medicine does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Telfast 120 mg contains • The active substance is fexofenadine hydrochloride. Each film-coated tablet contains 120 mg of fexofenadine hydrochloride. • The other ingredients are: o Tablet core: microcrystalline cellulose, pregelatinised maize starch, croscarmellose sodium, magnesium stearate. o Film coating: hypromellose, povidone, titanium dioxide (E171), colloidal anhydrous silica, macrogol, red iron oxide (E172) and yellow iron oxide (E172).
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What Telfast 120 mg looks like and contents of the pack Telfast 120 mg film-coated tablets of 6.1 x 15.8 mm are peach coloured, capsule shaped tablets marked with "012" on one side and a scripted "e" on the other. Telfast is presented in blister packs. Each tablet is blistered. Telfast is available in packs of 2 (sample only), 7, 10, 15, 20, 30, 50, 100 and 200 (as 10×20) tablets per package. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Opella, 410 Thames Valley Park Drive Reading, Berkshire, RG6 1PT, UK Tel: 0800 035 2525 email: [email protected] Manufacturer Sanofi Winthrop industrie, 30-36 Avenue Gustave Eiffel, 37100 Tours, France This medicinal product is authorised in the Member States of the EEA under the following names: Austria: Allegra 120 mg Filmtabletten Belgium: Allegra tab 120 mg filmomhulde tablette Croatia: Allegra 120 mg filmom obložene tablete Czech Republic: Allegra 120 mg Denmark: Telfast, filmovertrukne tabletter 120 mg Estonia: Allegra Finland: Telfast 120 mg tabletti, kalvopäällysteinen Germany: Telfast 120 mg-Filmtabletten Greece: Allegra Ireland: Telfast 120 mg film-coated tablets Italy: Telfast 120 mg compresse rivestite con film Latvia: Allegra 120 mg apvalkotās tabletes Lithuania: Allegra 120 mg plėvele dengtos tabletės Luxembourg: Allegra tab 120 mg comprimés pelliculés Malta: Telfast 120 mg film-coated Tablets Portugal: Telfast 120, comprimidos revestidos por película Romania: Telfast 120 mg comprimate filmate Slovenia: Telfast 120 mg filmsko obložene tablete Slovakia: Allegra 120 mg Spain: Telfast 120 mg comprimidos recubiertos con película Sweden: Allegra United Kingdom: Telfast 120 mg film-coated tablets This leaflet was last revised in 07/2025
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Telfast 120mg Film-coated Tablets comes as tablet containing 120mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Telfast 120mg Film-coated Tablets is fexofenadine hydrochloride.
Medicines with the same active substance, strength and form include: Allevia 120mg tablets, Histallay 120mg Film-Coated Tablets, Pirilieve Hayfever Relief 120mg Film-Coated Tablets. In total there are 8 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Telfast 120mg Film-coated Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Telfast 120 mg is indicated in adults and children 12 years and older for the relief of symptoms associated with seasonal allergic rhinitis.
Posology
Adults
The recommended dose of fexofenadine hydrochloride for adults is 120 mg once daily taken before a meal.
Fexofenadine is a pharmacologically active metabolite of terfenadine.
Paediatric Population
• Children aged 12 years and over
The recommended dose of fexofenadine hydrochloride for children aged 12 years and over is 120 mg once daily taken before a meal.
• Children under 12 years of age
The efficacy and safety of fexofenadine hydrochloride 120 mg has not been studied in children under 12.
In children from 6 to 11 years of age: fexofenadine hydrochloride 30 mg tablet is the appropriate formulation for administration and dosing in this population.
Special populations
Studies in special risk groups (older people, renally or hepatically impaired patients) indicate that it is not necessary to adjust the dose of fexofenadine hydrochloride in these patients.
Hypersensitivity to the active substance or to any of the excipients (listed in section 6.1).
There is limited data in the elderly and renally or hepatically impaired patients. Fexofenadine hydrochloride should be administered with care in these special groups (see section 4.2).
Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines as a medicine class, have been associated with the adverse reactions, tachycardia and palpitations (see section 4.8).
Telfast contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
Fexofenadine does not undergo hepatic biotransformation and therefore will not interact with other medicinal products through hepatic mechanisms.
Fexofenadine is a P-glycoprotein (P-gp) and organic-anion-transporting polypeptide (OATP) substrate. Concomitant use of fexofenadine with P-gp inhibitors or inducers can affect the exposure to fexofenadine.Coadministration of fexofenadine hydrochloride with P-gp inhibitors, erythromycin or ketoconazole has been found to result in a 2-3 times increase in the level of fexofenadine in plasma. The changes were not accompanied by any effects on the QT interval and were not associated with any increase in adverse reactions compared to the medicinal products given singly.
A clinical drug-drug interaction study showed that co-administration of apalutamide (a weak inducer of P-gp) and a single oral dose of 30 mg fexofenadine resulted in a 30 % decrease in AUC of fexofenadine.
No interaction between fexofenadine and omeprazole was observed. However, the administration of an antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to fexofenadine hydrochloride caused a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave 2 hours between administration of fexofenadine hydrochloride and aluminium and magnesium hydroxide containing antacids.
Pregnancy
There are no adequate data from the use of fexofenadine hydrochloride in pregnant women.
Limited animal studies do not indicate direct or indirect harmful effects with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). Fexofenadine hydrochloride should not be used during pregnancy unless clearly necessary.
Breast-feeding
There are no data on the content of human milk after administering fexofenadine hydrochloride. However, when terfenadine was administered to nursing mothers fexofenadine was found to cross into human breast milk. Therefore fexofenadine hydrochloride is not recommended for mothers breast-feeding their babies.
Fertility
No human data on the effect of fexofenadine hydrochloride on fertility are available. In mice, there was no effect on fertility with fexofenadine hydrochloride treatment (see section 5.3).
On the basis of the pharmacodynamic profile and reported adverse reactions it is unlikely that fexofenadine hydrochloride tablets will produce an effect on the ability to drive or use machines. In objective tests, Telfast has been shown to have no significant effects on central nervous system function. This means that patients may drive or perform tasks that require concentration. However, in order to identify sensitive people who have an unusual reaction to medicinal products, it is advisable to check the individual response before driving or performing complicated tasks.
The following frequency rating has been used, when applicable:
Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1,000 and <1/100; Rare ≥1/10,000 and <1/1,000; Very rare <1/10,000 and not known (frequency cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
In adults, the following undesirable effects have been reported in clinical trials, with an incidence similar to that observed with placebo:
Nervous system disorders
Common: headache, drowsiness, dizziness
Eye disorders
Not known: Vision blurred
Gastrointestinal disorders
Common: nausea
General disorders and administration site conditions
Uncommon: fatigue
In adults, the following undesirable effects have been reported in post-marketing surveillance. The frequency with which they occur is not known (can not be estimated from available data):
Immune system disorders
hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis
Psychiatric disorders
insomnia, nervousness, sleep disorders or nightmares/excessive dreaming (paroniria)
Cardiac disorders
tachycardia, palpitations
Gastrointestinal disorders
diarrhoea
Skin and subcutaneous tissue disorders
rash, urticaria, pruritus
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Dizziness, drowsiness, fatigue and dry mouth have been reported with overdose of fexofenadine hydrochloride. Single doses up to 800 mg and doses up to 690 mg twice daily for 1 month or 240 mg once daily for 1 year have been administered to healthy subjects without the development of clinically significant adverse reactions as compared with placebo. The maximum tolerated dose of fexofenadine hydrochloride has not been established.
Standard measures should be considered to remove any unabsorbed medicinal product. Symptomatic and supportive treatment is recommended. Haemodialysis does not effectively remove fexofenadine hydrochloride from blood.
Ask anything about Telfast 120mg Film-coated Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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