Telfexo 120 mg

Package Leaflet: Information for the Patient

Telfexo 120 mg, Film-Coated Tablets

Telfexo 180 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 You. 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 Those Not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

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

1. What is Telfexo and What is it Used For

Telfexo Contains Fexofenadine Hydrochloride, Which is an Antihistamine.
Telfexo 120 mg is Indicated for Use in Adults and Children Aged 12 Years and Older for the Relief of Symptoms of Hay Fever (Seasonal Allergic Rhinitis), Such as:
Sneezing, Runny Nose, and Itching of the Nose, Itching, Tearfulness, and Redness of the Eyes.
Telfexo 180 mg is Indicated for Use in Adults and Children Aged 12 Years and Older for the Relief of Symptoms of Chronic Idiopathic Urticaria (Chronic Skin Allergic Reactions), Such as: Itching, Swelling, and Rash.

2. Important Information Before Taking Telfexo

When Not to Take Telfexo

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

Warnings and Precautions

Before Taking Telfexo, Discuss with Your Doctor or Pharmacist if:

• You Have Kidney or Liver Problems;
• You Have or Have Had Heart Disease, as this Medication May Cause Rapid or Irregular Heartbeat;
• You are an Elderly Patient.

If Any of the Above Applies to You, or if You Have Any Doubts, Inform Your Doctor Before Taking the Medication.

Telfexo and Other Medications

Tell Your Doctor or Pharmacist About All Medications You are Currently Taking, or Have Recently Taken, or Plan to Take.
If You are Taking Apalutamide (a Medication Used to Treat Prostate Cancer), the Effect of Fexofenadine May be Reduced.
Taking Antacids Containing Aluminum and Magnesium May Affect the Action of Telfexo by Reducing the Amount of Medication Absorbed. Therefore, it is Recommended to Leave a 2-Hour Interval Between Taking Telfexo and Antacids.
If You Take Fexofenadine with Erythromycin or Ketoconazole, or with a Single Dose of Lopinavir in Combination with Ritonavir, the Concentration of Fexofenadine in the Blood May Increase. This May Increase the Risk of Side Effects.

Pregnancy and Breastfeeding

If You are Pregnant or Breastfeeding, Think You May be Pregnant, or are Planning to Have a Baby, Ask Your Doctor or Pharmacist for Advice Before Taking this Medication.
Telfexo Should Not be Used During Pregnancy, Unless Clearly Necessary.
Telfexo is Not Recommended for Use in Breastfeeding Women.

Driving and Using Machines

It is Unlikely that Telfexo Will Affect Your Ability to Drive or Use Machines. However, Before Driving or Using Machines, Make Sure that the Medication Does Not Cause Drowsiness or Dizziness.

Telfexo Contains Sodium

This Medication Contains Less Than 1 mmol (23 mg) of Sodium per Tablet, Which Means it is Essentially Sodium-Free.

3. How to Take Telfexo

Always Take this Medication Exactly as Your Doctor Has Told You. If You are Not Sure, Ask Your Doctor or Pharmacist.

Adults and Children Aged 12 Years and Older

Telfexo 120 mg, Film-Coated Tablets:The Usual Dose is One Tablet (120 mg) Once a Day.
Telfexo 180 mg, Film-Coated Tablets:The Usual Dose is One Tablet (180 mg) Once a Day.
Take the Tablets Before a Meal, with a Glass of Water.

Overdose of Telfexo

If You Take More Telfexo Than You Should, Contact a Doctor or Go to the Nearest Hospital Immediately. Symptoms of Overdose in Adults Include Dizziness, Drowsiness, Fatigue, and Dryness of the Mouth.

Missing a Dose of Telfexo

Do Not Take a Double Dose to Make Up for a Forgotten Dose.
Take the Next Dose at the Usual Time, as Advised by Your Doctor.

Stopping Telfexo Treatment

If You Plan to Stop Taking Telfexo Before Completing the Treatment, Inform Your Doctor. If You Stop Taking Telfexo Earlier Than Recommended, Your Symptoms May Return.
If You Have Any Further Questions on the Use of this Medication, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

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

Stop Taking Telfexo and Tell Your Doctor Immediately if You Experience:

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

Common Side Effects(Affecting Less Than 1 in 10 People):

• Headache,
• Drowsiness,
• Nausea,
• Dizziness.

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

• Feeling of 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,
• Rapid or Irregular Heartbeat,
• Diarrhea,
• 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 Tightness in the Chest, and Difficulty Breathing
• Blurred Vision.

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. You Can Also Report Side Effects 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. You Can Also Report Side Effects to the Marketing Authorization Holder. By Reporting Side Effects, You Can Help Provide More Information on the Safety of this Medication.

5. How to Store Telfexo

Keep this Medication Out of the Sight and Reach of Children.
Do Not Use this Medication After the Expiry Date Stated on the Carton and Blister. The Expiry Date Refers to the Last Day of the Month.
The Label on the Packaging After the Abbreviation EXP Indicates the Expiry Date, and After the Abbreviation Lot/LOT Indicates the Batch Number.
There are No Special Storage Instructions.
Medications Should Not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications No Longer Required. This Will Help Protect the Environment.

6. Package Contents and Other Information

What Telfexo Contains

• The Active Substance is Fexofenadine Hydrochloride.

Each Telfexo 120 mg Tablet Contains 120 mg of Fexofenadine Hydrochloride.

• The Other Ingredients are:
• Core: Microcrystalline Cellulose, Sodium Croscarmellose, Corn Starch, Povidone PVP, Magnesium Stearate.
• Coating: Hypromellose 6cP (E 464), Titanium Dioxide (E 171), Macrogol PEG 400, Macrogol PEG 4000, Yellow Iron Oxide (E 172) and Red Iron Oxide (E 172).

Each Telfexo 180 mg Tablet Contains 180 mg of Fexofenadine Hydrochloride.

• The Other Ingredients are:
• Core: Microcrystalline Cellulose, Sodium Croscarmellose, Corn Starch, Povidone PVP, Magnesium Stearate.
• Coating: Hypromellose 6cP (E 464), Titanium Dioxide (E 171), Macrogol PEG 400, Macrogol PEG 4000, Yellow Iron Oxide (E 172).

What Telfexo Looks Like and Contents of the Pack

Telfexo 120 mg Film-Coated Tablets are Peach-Colored, Prolonged-Shape Tablets, Smooth on Both Sides.
Telfexo 180 mg Film-Coated Tablets are Yellow, Prolonged-Shape Tablets, Smooth on One Side, with a Score Line in the Middle of the Other Side.
Telfexo is Packaged in Blisters of 20 Tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Polpharma S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, Poland, tel. +48 22 364 61 01

Manufacturer

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

Date of Last Revision of the Package Leaflet: