Telfast 30

Package Leaflet: Information for the Patient

Telfast 30, 30 mg, Film-Coated Tablets

Fexofenadine Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Have Any Further Questions, Ask Your Doctor or Pharmacist.
• This Medication Has Been Prescribed for a Specific Person. Do Not Pass it on to Others. The Medication May Harm Them, Even if Their Symptoms are the Same.
• If the Patient Experiences Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell the Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

• 1. What is Telfast 30 and What is it Used For
• 2. Important Information Before Taking Telfast 30
• 3. How to Take Telfast 30
• 4. Possible Side Effects
• 5. How to Store Telfast 30
• 6. Package Contents and Other Information

1. What is Telfast 30 and What is it Used For

Telfast 30 Contains Fexofenadine Hydrochloride, Which is a Non-Sedating Antihistamine.
Telfast 30 is Used in Children Aged 6 to 11 Years to Treat Symptoms of Hay Fever (Seasonal Allergic Rhinitis), Such as: Sneezing, Runny or Itchy Nose, or Nasal Congestion, and Itchy, Red, or Watery Eyes.

2. Important Information Before Taking Telfast 30

When Not to Take Telfast 30:

• If the Child is Allergic to Fexofenadine or Any of the Other Ingredients of this Medication (Listed in Section 6).

Warnings and Precautions

Before Taking Telfast 30, Discuss with the Doctor or Pharmacist if:

• The Child Has Kidney or Liver Problems
• The Child Currently Has or Has Had Heart Disease in the Past, as this Medication May Cause Rapid or Irregular Heartbeat.

If Any of These Conditions Apply to the Child or if There are Any Doubts, Consult the Doctor Before Giving Telfast 30 to the Child.

Telfast 30 and Other Medications

Tell the Doctor or Pharmacist About All Medications the Patient is Currently Taking or Has Recently Taken, as Well as Any Medications the Patient Plans to Take.
If the Patient is Taking Apalutamide (a Medication Used to Treat Prostate Cancer), the Effect of Fexofenadine May be Reduced.
Taking Antacids that Contain Aluminum and Magnesium May Affect the Action of Telfast 30 by Reducing the Amount of Medication Absorbed.
A 2-Hour Interval is Recommended Between Taking the Above Antacids and Taking Telfast 30.

Pregnancy and Breastfeeding

This Medication is Indicated for Use in Children Aged 6-11 Years. However, for Safety Reasons, the Following Information Should be Considered.
Before Giving Any Medication to a Child, Consult the Doctor or Pharmacist.
Telfast 30 Should Not be Used During Pregnancy, Unless it is Absolutely Necessary.
Telfast 30 is Not Recommended During Breastfeeding.

Driving and Operating Machinery

It is Unlikely that Telfast 30 Will Affect the Ability to Drive or Operate Machinery. However, Check if the Medication Causes Drowsiness or Dizziness in the Child.
If Such Symptoms Occur, Do Not Allow the Child to Drive or Operate Machinery.

Telfast 30 Contains Sodium

The Medication Contains Less Than 1 mmol (23 mg) of Sodium per Tablet, Which Means the Medication is Considered "Sodium-Free".

3. How to Take Telfast 30

Always Take this Medication Exactly as Prescribed by the Doctor.
If in Doubt, Consult the Doctor or Pharmacist.

Children Aged 6 to 11 Years

The Recommended Dose is 1 Tablet (30 mg) Twice a Day.
Tablets Should be Taken Orally, with a Glass of Water.

Overdose of Telfast 30

If the Child Takes More Than the Recommended Dose, Seek Medical Attention Immediately. Symptoms of Overdose Include: Dizziness, Drowsiness, Fatigue, and Dry Mouth.

Missed Dose of Telfast 30

Do Not Give a Double Dose to Make Up for a Missed Dose.
Give the Next Dose at the Scheduled Time, as Directed by the Doctor.

Stopping Telfast 30

Inform the Doctor if You Plan to Stop Giving Telfast 30 to the Child Before the End of the Prescribed Treatment Period.
If Telfast 30 is Stopped Prematurely, the Symptoms of the Disease May Return.
If You Have Any Further Questions About the Use of this Medication, Consult the Doctor or Pharmacist.

4. Possible Side Effects

Like All Medications, Telfast 30 Can Cause Side Effects, Although Not Everybody Gets Them.

Seek Medical Attention Immediately and Stop Taking Telfast 30 if the Child Experiences:

• Swelling of the Face, Lips, Tongue, or Throat, and Difficulty Breathing. These May be Symptoms of a Severe Allergic Reaction.

In Clinical Studies with Children Aged 6 to 11 Years, the Most Common Side Effect Was Headache.
In Adults, the Following Side Effects Were Observed (in Clinical Studies, These Side Effects Occurred with a Similar Frequency to Those Observed in Patients Who Did Not Receive the Medication (Placebo)):
Common Side Effects(Occurring in Less Than 1 in 10 People):

• Headaches
• Drowsiness
• Nausea
• Dizziness

Uncommon Side Effects(Occurring in Less Than 1 in 100 People):

• Fatigue
• Drowsiness

Other Side Effects(Frequency Not Known: Cannot be Estimated from the Available Data), Which May Include:

• Difficulty Sleeping (Insomnia)
• Sleep Disturbances
• Nightmares
• Nervousness
• Blurred Vision
• Rapid or Irregular Heartbeat
• Diarrhea
• Rash and Itching
• Hives, Severe Allergic Reactions, Which May Cause Swelling of the Face, Lips, Tongue, and Throat, Sudden Redness of the Skin, Feeling of Tightness in the Chest, and Difficulty Breathing.

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell the Doctor or Pharmacist. Side Effects Can be Reported Directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Side Effects Can Also be Reported to the Marketing Authorization Holder or Their Representative in Poland.
Reporting Side Effects Will Help to Gather More Information on the Safety of this Medication.

• 5. How to Store Telfast 30

Keep the Medication Out of Sight and Reach of Children.
Do Not Use this Medication After the Expiration Date Shown on the Packaging, After "EXP". The Expiration Date is the Last Day of the Specified Month.
There are No Special Storage Instructions for this Medication.
Do Not Dispose of Medications via Wastewater or Household Waste. Ask the Pharmacist How to Dispose of Medications That are No Longer Needed. This Will Help Protect the Environment.

6. Package Contents and Other Information

What Telfast 30 Contains

• The Active Substance of Telfast 30 is Fexofenadine Hydrochloride. Each Film-Coated Tablet Contains 30 mg of Fexofenadine Hydrochloride.
• Other Ingredients of the Medication are: o Core Tablet:Sodium Carboxymethylcellulose, Povidone, Microcrystalline Cellulose, Magnesium Stearate. o Coating:Hypromellose E-15, Hypromellose E-5, Povidone, Titanium Dioxide (E171), Colloidal Anhydrous Silica, Macrogol 400, Pink Mixture [Iron Oxide Red (E172), Titanium Dioxide (E171)] and Yellow Mixture [Iron Oxide Yellow (E172), Titanium Dioxide (E171)].

What Telfast 30 Looks Like and Contents of the Package

Telfast 30 Tablets are Peach-Colored, Film-Coated, Round Tablets with "03" Engraved on One Side and "e" on the Other Side.
Telfast 30 Tablets are Packaged in Blisters and a Carton Box.
The Package Contains 30 or 60 Film-Coated Tablets.
Not All Pack Sizes May be Available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Tel.: +48 22 280 00 00
Manufacturer:
Sanofi-Aventis S.p.A.
Strada Statale 17 km 22
67019 Scoppito (L’Aquila)
Italy
Sanofi Winthrop Industrie
30-36 avenue Gustave Eiffel
37100 Tours
France

This Medication is Authorized for Use in the Member States of the European Economic Area Under the Following Names:

Belgium: Telfast 30 mg filmomhulde tabletten
Denmark: Telfast, filmovertrukne tabletter 30 mg
Finland: Telfast 30 mg tabletti, kalvopäällysteinen
Ireland: Telfast 30 mg film coated tablets
Iceland: Telfast 30 mg filmuhúðaðar töflur
Luxembourg: Telfast 30 mg filmomhulde tabletten
Norway: Telfast 30 mg filmdrasjerte tabletter
Poland: Telfast 30
Portugal: Telfast 30, comprimidos revestidos por película
United Kingdom: Telfast 30 mg film coated tablets
Italy: Telfast 30 mg compresse rivestite con film
Date of Last Revision of the Package Leaflet:April 2024