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DEXCHLORPHENIRAMINE MALEATE ACCORD 5mg/ml INJECTABLE SOLUTION

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About the medicine

How to use DEXCHLORPHENIRAMINE MALEATE ACCORD 5mg/ml INJECTABLE SOLUTION

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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

Dexclorfeniramine Maleate Accord 5mgInjectable Solution EFG

Read all of this leaflet carefully before you start using 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 symptoms 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.

Contents of the Package Leaflet

  1. What is Dexclorfeniramine Maleate Accord Injectable Solution and what is it used for
  2. What you need to know before you use Dexclorfeniramine Maleate Accord Injectable Solution
  3. How to use Dexclorfeniramine Maleate Accord Injectable Solution
  4. Possible side effects
  5. Storage of Dexclorfeniramine Maleate Accord Injectable Solution
  6. Contents of the pack and further information

1. What is Dexclorfeniramine Maleate Accord Injectable Solution and what is it used for

Dexclorfeniramine belongs to a group of medicines known as antihistamines that compete with histamine for cell effector receptors. Dexclorfeniramine Maleate Accord 5mg/ml Injectable Solution is presented as an injectable solution.

Dexclorfeniramine Maleate Accord 5mg Injectable Solution is indicated for the symptomatic treatment of acute urticaria when oral administration is not practicable.

You should consult a doctor if it worsens or does not improve.

Doctor consultation

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2. What you need to know before you use Dexclorfeniramine Maleate Accord Injectable Solution

Do not useDexclorfeniramine Maleate Accord Injectable Solution:

  • if you are allergic (hypersensitive) to the active substance or any of the other ingredients of this medicine (listed in section 6) or to other antihistamines with a similar chemical structure.
  • Dexclorfeniramine Maleate Accord should not be administered to children under 30 months of age.
  • if you are being treated with a type of antidepressant known as monoamine oxidase inhibitors (MAOIs) or have been in the last two weeks.
  • if you have a risk of closed-angle glaucoma.
  • if you have a risk of urinary retention due to problems in the urethra or prostate.
  • if you are in the third trimester of pregnancy.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Dexclorfeniramine Maleate Accord.

The use of this medicine should not delay the administration of adrenaline.

Dexclorfeniramine maleate should be used with caution:

  • In elderly patients who present: increased sensitivity to orthostatic hypotension, dizziness, and sedation, chronic constipation, or eventual prostate hypertrophy.
  • In case of severe renal and/or hepatic impairment.

Children

  • in pediatric population as it may cause excitement.

Interaction ofDexclorfeniramine Maleate AccordInjectable Solution with other medicines

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

In particular, tell your doctor if you are taking:

  • sedative antidepressants, barbiturates, benzodiazepines, clonidine, and similar, hypnotics (central nervous system depressants).
  • morphine derivatives (analgesics and antitussives).
  • methadone, neuroleptics, anxiolytics.
  • imipramine antidepressants, antiparkinsonian, anticholinergic, antispasmodic atropine, and other atropine-like substances, disopyramide, phenothiazine neuroleptics (atropine and other atropine-like substances).

Do not use dexclorfeniramine maleate with central nervous system depressants, as it may cause an increase in central depression and impairment of alertness.

Use ofDexclorfeniramine Maleate Accordwith food, drinks, and alcohol

You should avoid taking alcoholic beverages or medicines that contain alcohol. It increases the sedation of H1 antihistamines. Alertness decreases, and driving vehicles or using machines can be dangerous.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

Dexclorfeniramine maleate should not be administered during the third trimester of pregnancy or in newborns or premature babies.

During the first two trimesters of pregnancy, Dexclorfeniramine Maleate Accord should only be used if your doctor considers it necessary.

Breast-feeding

Dexclorfeniramine Maleate Accord Injectable Solution is excreted in breast milk. There is not enough information on the effects of dexclorfeniramine in newborns.

Dexclorfeniramine Maleate Accord 5mg/ml Injectable Solution should not be used during breast-feeding.

Fertility

There are no adequate data on the effect of dexclorfeniramine on patient fertility.

Driving and using machines

Dexclorfeniramine Maleate Accord 5mg Injectable Solution may cause drowsiness, altering mental and/or physical ability. If you notice these effects, avoid driving vehicles or using machines.

3. How to use Dexclorfeniramine Maleate Accord Injectable Solution

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 5 mg (1 ampoule) administered intravenously or intramuscularly.

The maximum daily dose is 20 mg (4 ampoules). In case of reaction during a transfusion, do not administer dexclorfeniramine maleate in the transfusion, but apart.

The dose should be personalized according to the patient's requirements and response.

Use in children

The safety and efficacy of dexclorfeniramine maleate in children under 30 months of age have not been established. There are no available data.

If you use moreDexclorfeniramine Maleate Accordthan 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 medicine and the amount ingested.

If you forget to useDexclorfeniramine Maleate Accord

Do not take a double dose to make up for forgotten doses. Use the usual dose when it is time (according to section 3. "How to use Dexclorfeniramine Maleate Accord Injectable Solution").

If you stop usingDexclorfeniramine Maleate AccordInjectable Solution

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

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, Dexclorfeniramine Maleate Accord can cause side effects, although not everybody gets them.

Nervous system disorders:

- Sedation or drowsiness (more pronounced at the start of treatment).

- Orthostatic hypotension.

- Balance disorders, dizziness, decreased memory or concentration (more frequent in the elderly).

- Lack of motor coordination.

- Mental confusion, hallucinations.

- Agitation, nervousness, insomnia.

Skin and subcutaneous tissue disorders:

- Skin rash, eczema, pruritus, purpura, urticaria, which can be very extensive.

- Edema.

Immune system disorders:

- Anaphylactic shock.

Blood and lymphatic system disorders:

- Leukopenia, neutropenia.

- Thrombocytopenia.

- Hemolytic anemia.

General disorders and administration site conditions:

- Dryness of the mucosa, constipation, disorders of ocular accommodation, mydriasis, heart palpitations, risk of urinary retention.

Reporting of side effects

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

5. Storage of Dexclorfeniramine Maleate Accord Injectable Solution

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

This medicine does not require any special storage conditions.

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

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

6. Contents of the pack and further information

Composition ofDexclorfeniramine Maleate Accord

  • The active substance is dexclorfeniramine maleate, 5 mg per ml.
  • The other ingredient is water for injectable preparations.

Appearance of the product and contents of the pack

Dexclorfeniramine Maleate Accord 5mg Injectable Solution is presented as an injectable solution. Each carton contains 5 ampoules of 1 ml.

Marketing Authorization Holder:

Accord Healthcare S.L.U.

World Trade Center. Moll de Barcelona, s/n,

Edifici Est, 6ª planta.

08039, Barcelona

Spain

Manufacturer:

Laboratorio Italiano Biochimico Farmaceutico

Lisapharma S.p.A.

Via Licinio, 11 – Erba (CO), Italy

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

Spain: Dexclorfeniramine Maleate Accord 5 mg Injectable Solution EFG

Portugal: Dexclorfeniramine Maleate Accord 5 mg/ml Solution for Injection MG

Date of last revision of thisleaflet: January 2012

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

Online doctors for DEXCHLORPHENIRAMINE MALEATE ACCORD 5mg/ml INJECTABLE SOLUTION

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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.

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Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

  • seasonal and perennial allergies
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  • general family medicine concerns

Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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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.

Cardiology – Diagnosis and treatment of:

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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.
  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
  • Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
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  • 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:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
  • Cancer prevention – screening strategies and risk assessment.
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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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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:

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Frequently Asked Questions

Is a prescription required for DEXCHLORPHENIRAMINE MALEATE ACCORD 5mg/ml INJECTABLE SOLUTION?
DEXCHLORPHENIRAMINE MALEATE ACCORD 5mg/ml INJECTABLE SOLUTION 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 DEXCHLORPHENIRAMINE MALEATE ACCORD 5mg/ml INJECTABLE SOLUTION?
The active ingredient in DEXCHLORPHENIRAMINE MALEATE ACCORD 5mg/ml INJECTABLE SOLUTION is dexchlorpheniramine. This information helps identify medicines with the same composition but different brand names.
How much does DEXCHLORPHENIRAMINE MALEATE ACCORD 5mg/ml INJECTABLE SOLUTION cost in pharmacies?
The average pharmacy price for DEXCHLORPHENIRAMINE MALEATE ACCORD 5mg/ml INJECTABLE SOLUTION is around 4.78 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures DEXCHLORPHENIRAMINE MALEATE ACCORD 5mg/ml INJECTABLE SOLUTION?
DEXCHLORPHENIRAMINE MALEATE ACCORD 5mg/ml INJECTABLE SOLUTION is manufactured by Accord Healthcare S.L.U.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of DEXCHLORPHENIRAMINE MALEATE ACCORD 5mg/ml INJECTABLE SOLUTION 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 DEXCHLORPHENIRAMINE MALEATE ACCORD 5mg/ml INJECTABLE SOLUTION 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 DEXCHLORPHENIRAMINE MALEATE ACCORD 5mg/ml INJECTABLE SOLUTION?
Other medicines with the same active substance (dexchlorpheniramine) include POLARAMINE 0.4 mg/ml SYRUP, POLARAMINE 2 mg TABLETS, POLARAMINE 5 mg/ml INJECTABLE SOLUTION. 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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