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DESLORATADINE ACTAVIS 5 mg FILM-COATED TABLETS

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About the medicine

How to use DESLORATADINE ACTAVIS 5 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 User

Desloratadina Actavis 5 mg film-coated tablets EFG

desloratadine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

  1. What is Desloratadina Actavis and what is it used for
  2. What you need to know before you take Desloratadina Actavis
  3. How to take Desloratadina Actavis
  4. Possible side effects
  5. Storage of Desloratadina Actavis
  6. Contents of the pack and other information

1. What is Desloratadina Actavis and what is it used for

What is Desloratadina Actavis

Desloratadina Actavis contains desloratadine, which is an antihistamine.

How Desloratadina Actavis works

Desloratadina Actavis is a non-drowsy antiallergic medicine that helps control allergic reactions and their symptoms.

When to use Desloratadina Actavis

Desloratadina Actavis relieves the symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, such as hay fever or house dust mite allergy) in adults and adolescents aged 12 years and older. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.

Desloratadina Actavis is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and skin rashes.

Relief from these symptoms lasts a full day and helps you to carry out your daily activities and have normal sleep periods.

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 you take Desloratadina Actavis

Do not take Desloratadina Actavis

  • if you are allergic to desloratadine or any of the other ingredients of this medicine (listed in section 6) or to loratadine.

Warnings and precautions

Consult your doctor, pharmacist or nurse before taking Desloratadina Actavis

  • if you have kidney problems.
  • if you have a history of seizures.

Use in children and adolescents

Do not give this medicine to children under 12 years of age.

Other medicines and Desloratadina Actavis

There are no known interactions between Desloratadina Actavis and other medicines.

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

Desloratadina Actavis with food, drinks and alcohol

Desloratadina Actavis can be taken with or without food.

Be careful when taking Desloratadina Actavis with alcohol.

Pregnancy, breastfeeding and fertility

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 medicine.

It is not recommended to take Desloratadina Actavis if you are pregnant or breastfeeding.

Fertility

There is no available data on male and female fertility.

Driving and using machines

At the recommended dose, this medicine is not expected to affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended not to engage in activities that require a state of alertness, such as driving a car or using machines, until you have determined your own response to the medicine.

3. How to take Desloratadina Actavis

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

Adults and adolescents aged 12 years and older

The recommended dose is one tablet once daily with water, with or without food.

This medicine is for oral use.

Swallow the tablet whole.

Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you have and for how long you should take Desloratadina Actavis.

If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days a week or for less than 4 weeks), your doctor will recommend a treatment schedule based on the evaluation of your medical history.

If your allergic rhinitis is persistent (presence of symptoms for 4 or more days a week and for more than 4 weeks), your doctor may recommend long-term treatment.

For urticaria, the duration of treatment may vary from one patient to another and therefore you should follow your doctor's instructions.

If you take more Desloratadina Actavis than you should

Take Desloratadina Actavis only as your doctor has told you. An accidental overdose is not expected to cause any serious problems. However, if you take more Desloratadina Actavis than you should, tell your doctor, pharmacist or nurse immediately.

If you forget to take Desloratadina Actavis

If you forget to take your dose at the scheduled time, take it as soon as possible, and then continue with your normal dosing schedule. Do not take a double dose to make up for forgotten doses.

If you stop taking Desloratadina Actavis

If you have any further questions on the use of this medicine, 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 medicines, this medicine can cause side effects, although not everybody gets them.

During the marketing of desloratadine, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, urticaria and swelling) have been reported. If you experience any of these serious side effects, stop taking this medicine and seek medical attention immediately.

In clinical trials in adults, side effects were approximately the same as with a placebo. However, fatigue, dry mouth and headache were reported more frequently than with a placebo. In adolescents, headache was the most commonly reported adverse reaction.

In clinical trials with desloratadine, the following side effects were reported:

Frequent: may affect up to 1 in 10 people

  • fatigue
  • dry mouth
  • headache

Adults

During the marketing of desloratadine, the following side effects have been reported:

Very rare: may affect up to 1 in 10,000 people

  • severe allergic reactions
  • skin rash
  • strong or irregular heartbeat
  • fast heartbeat
  • stomach pain
  • nausea
  • vomiting
  • upset stomach
  • diarrhea
  • dizziness
  • drowsiness
  • difficulty sleeping
  • muscle pain
  • hallucinations
  • seizures
  • agitation with increased body movement
  • liver inflammation
  • abnormal liver function tests

Frequency not known: frequency cannot be estimated from the available data

  • unusual weakness
  • yellowing of the skin and/or eyes
  • increased sensitivity of the skin to the sun, even on cloudy days, and to ultraviolet light, such as that from a sunlamp.
  • changes in heart rhythm
  • abnormal behavior
  • aggression
  • weight gain
  • increased appetite
  • depressed mood
  • dry eyes

Children

Frequency not known: frequency cannot be estimated from the available data

  • slow heartbeat
  • changes in heart rhythm
  • abnormal behavior
  • aggression

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Desloratadina Actavis

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, label and blister after EXP. The expiry date is the last day of the month stated.

Blister packs:

This medicine does not require any special storage conditions.

Bottles:

This medicine does not require any special storage temperature.

Keep the bottle tightly closed to protect from light.

If you notice any change in the appearance of the tablets, inform your pharmacist.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Desloratadina Actavis

  • The active substance is desloratadine. Each film-coated tablet contains 5 mg of desloratadine.
  • The other ingredients are:

Core of the tablet: Microcrystalline cellulose, pregelatinized starch, mannitol, talc, magnesium stearate. Coating of the tablet: Hypromellose 6cP, titanium dioxide (E171), macrogol 6000, carmine indigo (E132).

Appearance and packaging

Blue, round, 6 mm diameter, biconvex, film-coated tablets with "LT" engraved on one side.

Desloratadina Actavis 5 mg film-coated tablets EFG are available in:

Blister packs: 7, 10, 14, 21, 30, 50, 90 or 100 tablets.

Plastic bottles containing a desiccant and closed with a plastic cap: 30 or 100 tablets.

Do not swallow the desiccant.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78

220 Hafnarfjörður

Iceland

Manufacturers

Actavis Ltd.

BLB 015-016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

or

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

2600 Dupnitsa

Bulgaria

You can request more information about this medicine from the local representative of the marketing authorisation holder:

België/Belgique/Belgien

Teva Pharma Belgium N.V./S.A./AG

Tél/Tel: +32 38207373

Lietuva

UAB Teva Baltics

Tel: +370 52660203

Text in Bulgarian language with company name Тева Фарма ЕАД and phone number +359 24899585

Luxembourg/Luxemburg

Teva Pharma Belgium N.V./S.A./AG

Belgique/Belgien

Tél/Tel: +32 38207373

Ceská republika

Teva Pharmaceuticals CR, s.r.o.

Tel: +420 251007111

Magyarország

Teva Gyógyszergyár Zrt.

Tel: +36 12886400

Danmark

Teva Denmark A/S

Tlf: +45 44985511

Malta

Teva Pharmaceuticals Ireland

Ireland

Tel: +44 2075407117

Deutschland

ratiopharm GmbH

Tel: +49 73140202

Nederland

Teva Nederland B.V.

Tel: +31 8000228400

Eesti

UAB Teva Baltics Eesti filiaal

Tel: +372 6610801

Norge

Teva Norway AS

Tlf: +47 66775590

Ελλáδα

Specifar A.B.E.E.

Τηλ: +30 2118805000

Österreich

ratiopharm Arzneimittel Vertriebs-GmbH

Tel: +43 1970070

España

Teva Pharma, S.L.U.

Tel: +34 913873280

Polska

Teva Pharmaceuticals Polska Sp. z o.o.

Tel: +48 223459300

France

Teva Santé

Tél: +33 155917800

Portugal

Teva Pharma - Produtos Farmacêuticos, Lda.

Tel: +351 214767550

Hrvatska

Pliva Hrvatska d.o.o.

Tel: +385 13720000

România

Teva Pharmaceuticals S.R.L.

Tel: +40 212306524

Ireland

Teva Pharmaceuticals Ireland

Tel: +44 2075407117

Slovenija

Pliva Ljubljana d.o.o.

Tel: +386 15890390

Ísland

Teva Pharma Iceland ehf.

Sími: +354 5503300

Slovenská republika

TEVA Pharmaceuticals Slovakia s.r.o.

Tel: +421 257267911

Italia

Teva Italia S.r.l.

Tel: +39 028917981

Suomi/Finland

Teva Finland Oy

Puh/Tel: +358 201805900

Κúπρος

Specifar A.B.E.E.

Ελλ?δα

Τηλ: +30 2118805000

Sverige

Teva Sweden AB

Tel: +46 42121100

Latvija

UAB Teva Baltics filiale Latvija

Tel: +371 67323666

United Kingdom (Northern Ireland)

Teva Pharmaceuticals Ireland

Ireland

Tel: +44 2075407117

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency web site http://www.ema.europa.eu.

Online doctors for DESLORATADINE ACTAVIS 5 mg FILM-COATED TABLETS

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Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

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Endocrinology – Diabetes, thyroid, metabolism:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
  • Individual treatment plans including oral medications and insulin therapy.
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  • Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
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Gastroenterology – Digestive health:
  • Abdominal pain, nausea, heartburn, gastroesophageal reflux (GERD).
  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
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Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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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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  • Pain management: chronic and acute pain, back pain, joint pain, post-traumatic pain syndromes.
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  • 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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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.
  • Diagnosis and management of hypertension, arrhythmias, and tachycardia.
  • Metabolic syndrome, excess weight, high cholesterol.
  • Chronic fatigue, insomnia, poor concentration, anxiety.
  • 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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  • Cardiovascular disease prevention and metabolic risk reduction.
  • Long-term follow-up and dynamic health monitoring.

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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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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Marta Reguero Capilla

Allergology 8 years exp.

Dr Marta Reguero Capilla is an allergist and immunologist who works with both adults and children. She specialises in the diagnosis, treatment, and ongoing management of allergic and immune-related conditions through online consultations.

In her practice, Dr Reguero Capilla helps patients understand the causes of their symptoms, review test results, and choose appropriate treatment or monitoring strategies. Her consultations are suitable both for first-time assessments and for follow-up care over time.

Patients commonly consult Dr Marta Reguero Capilla for:

  • allergic rhinitis, seasonal allergies, and perennial allergy symptoms;
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  • immune system concerns, frequent infections, and reduced immune response;
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Dr Reguero Capilla works in a structured and attentive manner, explaining medical decisions clearly and helping patients make informed choices about their own health or their child’s care.

When clinically appropriate, she may provide recommendations for further tests or referrals that patients can use within Spanish medical networks, including Sanitas and DKV, in accordance with the terms and conditions of those services.

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Frequently Asked Questions

Is a prescription required for DESLORATADINE ACTAVIS 5 mg FILM-COATED TABLETS?
DESLORATADINE ACTAVIS 5 mg FILM-COATED TABLETS requires 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 DESLORATADINE ACTAVIS 5 mg FILM-COATED TABLETS?
The active ingredient in DESLORATADINE ACTAVIS 5 mg FILM-COATED TABLETS is desloratadine. This information helps identify medicines with the same composition but different brand names.
Who manufactures DESLORATADINE ACTAVIS 5 mg FILM-COATED TABLETS?
DESLORATADINE ACTAVIS 5 mg FILM-COATED TABLETS is manufactured by Actavis Group Ptc Ehf.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of DESLORATADINE ACTAVIS 5 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 DESLORATADINE ACTAVIS 5 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 DESLORATADINE ACTAVIS 5 mg FILM-COATED TABLETS?
Other medicines with the same active substance (desloratadine) include AERIUS 0.5 mg/ml ORAL SOLUTION, AERIUS 5 mg ORALLY DISINTEGRATING TABLETS, AERIUS 5 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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