Telfexo 180 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 a Specific Person. Do Not Pass it on to Others. The Medication May Harm Another Person, 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 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 to Relieve the 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 to Relieve the Symptoms of Chronic Skin Allergic Reactions (Chronic Idiopathic Urticaria), Such as: Itching, Swelling, and Rash.

2. Important Information Before Taking Telfexo

When Not to Take Telfexo

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

Warnings and Precautions

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

• The Patient Has Kidney or Liver Function Disorders;
• The Patient Has or Has Had Heart Disease in the Past, as this Medication May Cause Rapid or Irregular Heartbeat;
• The Patient is Elderly.

If Any of the Above Situations Apply to the Patient or if the Patient Has Any Doubts, Inform the Doctor Before Taking the Medication.

Telfexo 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 Containing Aluminum and Magnesium May Affect the Action of Telfexo by Reducing the Amount of Medication Absorbed. Therefore, it is Recommended to Maintain an Interval of Approximately 2 Hours Between Taking Telfexo and Antacids.
If the Patient Takes 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 Cause an Increase in Side Effects.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks She May be Pregnant or is Planning to Have a Child, Consult the Doctor or Pharmacist Before Taking this Medication.
Telfexo Should Not be Used During Pregnancy, Unless it is Absolutely Necessary.
Telfexo is Not Recommended for Use in Breastfeeding Women.

Driving and Operating Machinery

It is Unlikely that Telfexo Will Affect the Ability to Drive or Operate Machinery. However, Before Driving or Operating Machinery, Make Sure that the Medication Does Not Cause Drowsiness or Dizziness.

Telfexo 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 Telfexo

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

Taking a Higher Dose of Telfexo Than Recommended

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 the Doctor.

Stopping Telfexo Treatment

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

4. Possible Side Effects

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

Seek Immediate Medical Attention and Stop Taking Telfexo 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 Disorders,
• Nightmares,
• Nervousness,
• Rapid or Irregular Heartbeat,
• Diarrhea,
• Skin Rash and Itching,
• Hives,
• 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 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. By Reporting Side Effects, You Can Help Provide More Information on the Safety of this Medication.

5. How to Store Telfexo

Keep the Medication Out of Sight and Reach of Children.
Do Not Use this Medication After the Expiration Date Stated on the Carton and Blister. The Expiration Date Refers to the Last Day of the Month.
The Entry on the Packaging After the Abbreviation EXP Means the Expiration Date, and After the Abbreviation Lot/LOT Means the Batch Number.
There are No Special Storage Instructions.
Medications Should Not be Disposed of 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 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 Carboxymethylcellulose, 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 Carboxymethylcellulose, 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 Package

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 the Last Update of the Package Leaflet: