TELFEXO 120 MG

Patient Information Leaflet

Telfexo 120 mg, film-coated tablets
Telfexo 180 mg, film-coated tablets
Fexofenadini hydrochloridum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Telfexo is and what it is used for
2. What you need to know before taking Telfexo
3. How to take Telfexo
4. Possible side effects
5. How to store Telfexo
6. Contents of the pack and other information

1. What Telfexo is and what it is used for

Telfexo contains fexofenadine hydrochloride, which is an antihistamine medicine.
Telfexo 120 mg is indicated for use in adults and children aged 12 years and older to relieve symptoms of hay fever (seasonal allergic rhinitis), such as:
sneezing, runny nose, itchy nose, as well as itchy, watery and red eyes.
Telfexo 180 mg is indicated for use in adults and children aged 12 years and older to relieve symptoms of chronic skin allergic reactions (chronic idiopathic urticaria), such as:
itching, swelling and rash.

2. Information before using Telfexo

When not to take Telfexo

• if the patient is allergic to fexofenadine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting Telfexo, consult a doctor or pharmacist if:

• the patient has kidney or liver function impairment;
• the patient has or has had heart disease in the past, as this medicine may cause rapid or irregular heartbeat;
• the patient is elderly.

If any of the above situations apply or if the patient has any doubts, the doctor should be informed before starting treatment with Telfexo.
Telfexo and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
If the patient is taking apalutamide (a medicine used to treat prostate cancer), the effect of fexofenadine may be reduced.
Taking antacids containing aluminium and magnesium may affect the action of Telfexo by reducing the amount of medicine absorbed. Therefore, it is recommended to maintain an interval of approximately 2 hours between taking Telfexo and antacids.
If the patient takes fexofenadine together with erythromycin or ketoconazole, or with a single dose of lopinavir in combination with ritonavir, the plasma concentration of fexofenadine may increase. This may lead to an increased risk of adverse effects.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Telfexo should not be used during pregnancy unless absolutely necessary.
Use of Telfexo is not recommended in breastfeeding women.
Driving and operating machinery
It is unlikely that Telfexo affects the ability to drive or operate machinery. However, before driving or operating machinery, ensure that the medicine does not cause drowsiness or dizziness.
Telfexo contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Telfexo

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Adults and children aged 12 years and above
Telfexo 120 mg, tablets: The usual dose is one tablet (120 mg) once daily.
Telfexo 180 mg, tablets: The usual dose is one tablet (180 mg) once daily.
The tablets should be taken before a meal, with water.
Taking more Telfexo than recommended
If you take more Telfexo than recommended, contact your doctor immediately or go to the
accident and emergency department of your nearest hospital. Symptoms of overdose in adults may include dizziness, drowsiness, fatigue, and dryness of the oral mucosa.
Missing a dose of Telfexo
Do not take a double dose to make up for a missed dose.
Take the next dose at the usual time, as directed by your doctor.
Stopping Telfexo treatment
If the patient plans to stop taking Telfexo before the end of treatment, inform the doctor.
If Telfexo is discontinued earlier than recommended, symptoms of the disease may return.
In case of any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should immediately contact a doctor and stop using Telfexo if the following occur:

• swelling of the face, lips, tongue or throat, and breathing difficulties, as these may be symptoms of a severe allergic reaction.

Common adverse reactions (occurring in less than 1 in 10 people):

• headache,
• drowsiness,
• nausea,
• dizziness.

Uncommon adverse reactions (occurring in less than 1 in 100 people):

• feeling of fatigue/drowsiness.

Other adverse reactions (frequency unknown: cannot be estimated based on available data) which may occur include:

• difficulty sleeping (insomnia),
• sleep disturbances,
• nightmares,
• nervousness,
• rapid or irregular heartbeat,
• diarrhoea,
• skin rash and itching,
• urticaria,
• severe allergic reactions which may include swelling of the face, lips, tongue or throat, sudden redness of the skin, feeling of pressure in the chest, and breathing difficulties,
• blurred vision.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Telfexo 120 mg

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the stated month.
The marking on the packaging: EXP indicates the expiry date, and Lot/LOT indicates the batch number.
No special storage conditions are required.
Medicines must not be disposed of in the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Telfexo contains

• The active substance is fexofenadine hydrochloride.

Each Telfexo 120 mg tablet contains 120 mg of fexofenadine hydrochloride.

• Other ingredients are:
  • Core: microcrystalline cellulose, sodium croscarmellose, maize starch, povidone PVP, magnesium stearate.
  • Coating: hypromellose 6cP (E 464), titanium dioxide (E 171), polyethylene glycol PEG 400, polyethylene glycol PEG 4000, yellow iron oxide (E 172) and red iron oxide (E 172).

Each Telfexo 180 mg tablet contains 180 mg of fexofenadine hydrochloride.

• Other ingredients are:
  • Core: microcrystalline cellulose, sodium croscarmellose, maize starch, povidone PVP, magnesium stearate.
  • Coating: hypromellose 6cP (E 464), titanium dioxide (E 171), polyethylene glycol PEG 400, polyethylene glycol PEG 4000, yellow iron oxide (E 172).

What Telfexo looks like and contents of the pack
Telfexo 120 mg coated tablets are peach-coloured, elongated, film-coated tablets, smooth on both sides.
Telfexo 180 mg coated tablets are yellow, elongated, film-coated tablets, smooth on one side and with a central dividing line on the other.
Telfexo is packed in packs containing 20 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański, Poland
tel. + 48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański, Poland
Chanelle Medical Unlimited Company
Loughrea, Co. Galway
Ireland