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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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Discuss your symptoms and treatment with a doctor online.

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/

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Dr. Nuno Tavares Lopes is a licensed physician in Portugal with 17 years of experience in emergency medicine, family and general practice, and public health. He is the Director of Medical and Public Health Services at an international healthcare network and serves as an external consultant for the WHO and ECDC.

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Dr. Anastasiia Shalko is a general practitioner with a background in both paediatrics and general medicine. She graduated from Bogomolets National Medical University in Kyiv and completed her paediatric internship at the P.L. Shupyk National Medical Academy of Postgraduate Education. After working as a paediatrician in Kyiv, she relocated to Spain, where she has been practising general medicine since 2015, providing care for both adults and children.Her work focuses on urgent, short-term medical concerns – situations where patients need quick guidance, symptom assessment and clear next steps. She helps people understand whether their symptoms require in-person evaluation, home management or a change in treatment. Common reasons for booking an online consultation include:

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Chikeluo Okeke

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Dr Chikeluo Okeke is an internal medicine doctor with extensive international clinical experience. Originally from Nigeria, he has worked across multiple European healthcare systems and currently practises in Sweden. This professional path has given him a strong understanding of different medical approaches and the ability to work effectively with patients from diverse cultural and linguistic backgrounds.

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Dr. Tarek Agami is a general practitioner registered in both Portugal and Israel, with broad experience in family and preventive medicine. He offers online consultations for adults and children, providing personalised support for primary care needs, chronic disease management, and everyday health concerns.

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Dr. Agami provides medical support for patients using GLP-1 medications (such as Ozempic or Mounjaro) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Portugal and Israel.

Dr. Agami is committed to evidence-based, patient-centred care, ensuring that each person receives trusted medical support tailored to their health goals.

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Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

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Daniel Cichi

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Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance. His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation. Patients commonly consult Dr Daniel Cichi for: 

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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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