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RINIWEL 120 mg FILM-COATED TABLETS

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About the medicine

How to use RINIWEL 120 mg FILM-COATED TABLETS

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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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.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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:

France:

Fexofenadine Arrow 120 mg film-coated tablet

Germany:

Fexofenadin PUREN 120 mg film-coated tablets

Netherlands:

Fexofenadine HCl Aurobindo 120 mg, film-coated tablets

Poland:

Fexofenadine Aurovitas

Portugal:

Fexofenadina Nazonite

Spain:

Riniwel 120 mg film-coated tablets EFG

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).

Online doctors for RINIWEL 120 mg FILM-COATED TABLETS

Discuss questions about RINIWEL 120 mg FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (839)
Doctor

Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

  • Respiratory infections: cold, flu, bronchitis, pneumonia, and lingering coughs.
  • ENT conditions: sinusitis, tonsillitis, otitis (ear infections), sore throat, allergic rhinitis.
  • Eye conditions: allergic or infectious conjunctivitis, red eyes, irritation.
  • Digestive issues: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), constipation, bloating, nausea.
  • Urinary and reproductive health: urinary tract infections (UTIs), cystitis, prevention of recurrent infections.
  • Chronic diseases: hypertension, elevated cholesterol, weight management.
  • Neurological complaints: headaches, migraines, sleep disturbances, fatigue, general weakness.
  • Children’s health: fever, infections, digestive issues, follow-ups, vaccination guidance.

She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
  • Personalised preventive care and wellness consultations.
  • Interpretation of test results and medical reports.
  • Follow-up care and medication review.
  • Support in managing multiple coexisting conditions.
  • Remote prescription management and medical documentation.

Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

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5.0 (32)
Doctor

Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

Areas of expertise:

  • Endocrinology: diabetes type 1 and type 2, prediabetes, thyroid disorders, metabolic syndrome, hormonal imbalance.
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  • Gastroenterology: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), liver and biliary conditions.
  • Pediatric care: infections, respiratory symptoms, digestive issues, growth and development monitoring.
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  • Pain management: chronic and acute pain, back pain, joint pain, post-traumatic pain syndromes.
  • Cardiovascular health: hypertension, cholesterol control, risk assessment for heart disease.
  • Preventive medicine: regular check-ups, health screenings, long-term management of chronic conditions.

Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

Whether you need help managing diabetes, tackling weight-related health issues, interpreting lab results, or receiving general family medicine support, Dr. Horobets provides professional online care tailored to your specific health goals.

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5.0 (2)
Doctor

Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

Patients commonly seek her help for:

  • High blood pressure, headaches, dizziness, swelling, palpitations.
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  • Respiratory symptoms: colds, flu, sore throat, cough, fever.
  • Digestive issues: heartburn, bloating, constipation, IBS symptoms.
  • Chronic conditions: diabetes, thyroid disorders.
  • Interpretation of lab tests and medical reports, therapy adjustment.
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Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.

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5.0 (2)
Doctor

Alexander Nazarchuk

Allergology 7 years exp.

Dr. Alexander Nazarchuk is a physician specialising in allergology and internal medicine. He provides online consultations for adults, following the principles of evidence-based medicine — no outdated treatments or unnecessary tests, with clear explanations and a personalised approach. He helps patients with a wide range of allergic and therapeutic conditions, from common day-to-day complaints to complex cases involving allergies, gastrointestinal issues, cardiovascular concerns, respiratory symptoms, and more.

You can consult Dr. Nazarchuk for:

  • Test interpretation and guidance on diagnostic plans.
  • Allergic rhinitis, hay fever, bronchial asthma (including severe cases).
  • Food and drug allergies, skin rashes, angioedema.
  • Atopic dermatitis, urticaria, contact allergies.
  • Allergen-specific immunotherapy (AIT) – initiation and ongoing management.
  • Abdominal pain, bloating, changes in bowel habits, nausea, heartburn.
  • High blood pressure and adjustment of baseline antihypertensive therapy.
  • Hyperlipidaemia and elevated cholesterol.
  • Cough, nasal congestion, fever, sore throat.
  • Anaemia, including iron deficiency and related conditions.
  • Other issues related to allergology and internal medicine.

During consultations, Dr. Nazarchuk takes a thorough, structured approach — analysing symptoms, identifying potential causes, and helping patients make informed decisions. Whether treatment, further investigation, or monitoring is needed, he explains each step clearly so you understand your health and how best to manage it.

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Frequently Asked Questions

Is a prescription required for RINIWEL 120 mg FILM-COATED TABLETS?
RINIWEL 120 mg FILM-COATED TABLETS does not require a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in RINIWEL 120 mg FILM-COATED TABLETS?
The active ingredient in RINIWEL 120 mg FILM-COATED TABLETS is fexofenadine. This information helps identify medicines with the same composition but different brand names.
Who manufactures RINIWEL 120 mg FILM-COATED TABLETS?
RINIWEL 120 mg FILM-COATED TABLETS is manufactured by Aurovitas Spain, S.A.U.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of RINIWEL 120 mg FILM-COATED TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether RINIWEL 120 mg FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to RINIWEL 120 mg FILM-COATED TABLETS?
Other medicines with the same active substance (fexofenadine) include FEXOFENADINE CIPLA 120 mg FILM-COATED TABLETS, FEXOFENADINE CIPLA 180 mg FILM-COATED TABLETS, FEXOFENADINE OPELLA 180 mg FILM-COATED TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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