RINIWEL 120 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Riniwel 120 mg Film-Coated Tablets EFG

fexofenadine hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for this medication exactly as stated in this package leaflet or as directed by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days.

Contents of the Package Leaflet

1. What is Riniwel and what is it used for
2. What you need to know before taking Riniwel
3. How to take Riniwel
4. Possible side effects
5. Storage of Riniwel
6. Package Contents and Additional Information

1. What is Riniwel and what is it used for

Riniwel contains fexofenadine hydrochloride, which is a non-drowsy antihistamine.

Fexofenadine is used in adults and adolescents 12 years of age and older to relieve symptoms associated with allergic rhinitis (such as hay fever), such as sneezing, itching, runny or stuffy nose, and itchy, red, or watery eyes.

You should consult a doctor if your symptoms worsen or do not improve after 7 days.

2. What you need to know before taking Riniwel

Do not take Riniwel:

• If you are allergic to fexofenadine or any of the other ingredients of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before taking Riniwel if:

• You have liver or kidney problems.
• You have or have had a heart condition, as this type of medication may cause an irregular or faster heartbeat.
• You are an elderly patient.

If you are in any of these situations or are unsure, consult your doctor before taking Riniwel.

Children and Adolescents

Fexofenadine is not recommended for children under 12 years of age.

In children 6 to 11 years old: the appropriate formulation for administration and dosing in this population is fexofenadine hydrochloride 30 mg.

Other Medications and Riniwel

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication.

If you are taking apalutamide (a medication for prostate cancer), as the effect of fexofenadine may be reduced.

It is especially important to talk to your doctor before taking fexofenadine if you are also taking any of the following medications:

• An antibiotic used to treat certain bacterial infections (erythromycin)
• An antifungal used to treat fungal infections (ketoconazole).

These medications increase the amount of fexofenadine absorbed.

Indigestion products containing aluminum and magnesium may alter the action of fexofenadine by reducing the amount of medication absorbed.

A gap of about 2 hours is recommended between taking fexofenadine and the indigestion product.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Do not take fexofenadine if you are pregnant unless advised by your doctor.

Fexofenadine is not recommended during breastfeeding.

Driving and Using Machines

Fexofenadine is unlikely to affect your ability to drive or use machines. However, make sure these tablets do not make you feel drowsy or dizzy before driving or operating machinery.

Riniwel contains Lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Riniwel contains Sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Riniwel

Follow the administration instructions for this medication exactly as stated in this package leaflet or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Adults and Children 12 years and older

The recommended dose is one tablet (120 mg) per day.

Take the tablet with water before a meal.

This medication starts to relieve your symptoms in 1 hour and lasts 24 hours.

If you take more Riniwel than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

The symptoms of an overdose in adults are dizziness, drowsiness, fatigue, and dry mouth.

If you forget to take Riniwel

Do not take a double dose to make up for forgotten doses.

Take the next dose at the scheduled time.

If you stop taking Riniwel

If you stop taking fexofenadine, your symptoms may return.

If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Consult your doctor immediately and stop taking Riniwel if you experience:

• Facial swelling, lips, tongue, or throat, and difficulty breathing, as these may be signs of a severe allergic reaction.

The following unwanted effects have been reported in clinical trials with an incidence similar to that observed in patients who did not receive the medication (placebo).

Common Side Effects(may affect up to 1 in 10 people):

• Headache
• Drowsiness
• Feeling of discomfort (Nausea)
• Dizziness

Uncommon Side Effects(may affect up to 1 in 100 people):

• Fatigue
• Numbness

Additional Side Effects(Frequency not known: cannot be estimated from available data) that may occur are:

• Difficulty sleeping (insomnia)
• Sleep disorders
• Nightmares
• Nervousness
• Blurred vision
• Fast or irregular heartbeat
• Diarrhea
• Hives and itching
• Rash
• Severe allergic reactions that can cause swelling of the face, lips, tongue, or throat, flushing, chest tightness, and difficulty breathing.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Riniwel

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE Point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Riniwel

• The active ingredient is fexofenadine hydrochloride. Each film-coated tablet contains 120 mg of fexofenadine hydrochloride, equivalent to 112 mg of fexofenadine.
• The other ingredients are:

Core of the tablet: croscarmellose sodium, lactose, lactose monohydrate, corn starch, colloidal anhydrous silica, pregelatinized starch, stearic acid.

Coating film: red iron oxide (E172), yellow iron oxide (E172), hypromellose 2910 6 mPas (E464), macrogol 400 (E1521), titanium dioxide (E171).

Appearance of the Product and Package Contents

Film-coated tablet.

Riniwel 120 mg are film-coated tablets, biconvex, capsule-shaped, peach-colored, with a beveled edge, engraved with "FE" on one side and "120" on the other side.

Riniwel 120 mg film-coated tablets EFG are available in blisters containing 7, 10, 15, 20, 30, 50, 60, and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

or

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19

2700-487 Amadora

Portugal

or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medication is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this package leaflet: April 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es).