Package Leaflet: Information for the User

Dexclorfeniramina Maleate Accord 5mgInjectable Solution EFG

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet.

1. What isDexclorfeniramina Maleate AccordInjectable Solutionand what it is used for

2. What you need to know before usingDexclorfeniramina Maleate AccordInjectable Solution

3. How to useDexclorfeniramina Maleate AccordInjectable Solution

4. Possible side effects

5. Storage ofDexclorfeniramina Maleate AccordInjectable Solution

6. Contents of the pack and additional information

Dexclorfeniramina belongs to a group of medications known as antihistamines that compete with histamine for receptors on effector cells.Dexclorfeniramina MaleatoAccord5mg/ml injectable solution is presented as an injectable solution.

Dexclorfeniramina MaleatoAccord5mginjectable 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.

No useDexclorfeniramina Maleato Accord solución inyectable:

- if you are allergic (hypersensitive) to the active ingredient or to any of the other components of this medication (listed in section 6) or to other antihistamines with a similar chemical structure.

- Dexclorfeniramina Maleato 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 treated with them in the past two weeks.

- if you have a risk of angle-closure 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 Dexclorfeniramina Maleato Accord.

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

Dexclorfeniramina maleate should be used with caution:

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

Children

- in pediatric populations as it may cause excitement.

Interaction of Dexclorfeniramina Maleato Accord solution for injection with other medications

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

Particularly inform your doctor if you are taking:

- sedating antidepressants, barbiturates, benzodiazepines, clonidine, and similar, hypnotics (central nervous system depressants).

- morphine derivatives (analgesics and antitussives).

- methadone, neuroleptics, anxiolytics.

- imipramine antidepressants, antiparkinsonian drugs, anticholinergics, atropine antispasmodics, disopyramide, phenothiazine neuroleptics (atropine and other atropine-like substances).

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

Use of Dexclorfeniramina Maleato Accord with food, drinks, and alcohol

You should avoid taking alcoholic beverages or medications that contain alcohol. It increases the sedation of H1 antihistamines. Alertness decreases, making it hazardous to drive vehicles and use machines.

Pregnancy,lactation,and fertility

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

Pregnancy

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

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

Lactation

Dexclorfeniramina Maleato Accord solution for injection is excreted in breast milk. There is not enough information on the effects of dexclorfeniramina in newborns.

Dexclorfeniramina Maleato Accord 5mg/ml solution for injection should not be used during lactation.

Fertility

There are no adequate data on the effect of dexclorfeniramina on the fertility of patients.

Driving and operating machines

Dexclorfeniramina Maleato Accord 5mg solution for injection may cause drowsiness, altering mental and/or physical ability. If you notice these effects, avoid driving vehicles or operating machines.

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

The recommended dose is 5 mg (1 ampule) administered via intravenous or intramuscular route.

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

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

Use in children

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

If you take more Dexclorfeniramina Maleate Accord than you should

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

If you forgot to use Dexclorfeniramina Maleate Accord

Do not take a double dose to compensate for the missed doses. Use the usual dose when it is time (according to section 3. “How to use Dexclorfeniramina Maleate Accord injectable solution”).

If you interrupt treatment with Dexclorfeniramina Maleate Accord injectable solution

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

Like all medications, Dexclorfeniramina Maleate Accord can produce adverse effects, although not everyone will experience them.

Nervous System Disorders:

-Drowsiness or drowsiness (more pronounced at the beginning of treatment).

-Orthostatic hypotension.

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

-Motor coordination disorders.

-Confusion, hallucinations.

-Agitation, nervousness, insomnia

Skin and Subcutaneous Tissue Disorders:

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

-Edema.

Immune System Disorders:

-Anaphylactic shock.

Blood and Lymphatic System Disorders:

-Leucopenia, neutropenia.

-Thrombocytopenia.

-Hemolytic anemia.

General Disorders and Administration Site Conditions:

-Dry mucosa, constipation, eye accommodation disorders, mydriasis, heart palpitations, risk of urinary retention.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication..

Keepthis medicationout of sightand out of reachof children.

This medication does not require special storage conditions.

Do not usethis medicationafter the expiration date that appears onthe box.The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash..Deposit containers and medications you no longer need at the SIGRE collection point at the pharmacy.In case of doubtask your pharmacist how to dispose ofcontainers and medications you no longerneed.By doing so, you will help protect the environment.

Composition ofDexclorfeniramina Maleate Accord

• The active ingredient is dexclorfeniramina maleate, 5 mg per ml.
• The other component is water for injection preparations.

Appearance of the product and contents of the packaging

Dexclorfeniramina Maleate Accord 5mg injectable solution is presented as an injectable solution.Cada caja contains 5 ampoules of 1 ml.

Holder of the marketing authorization:

Accord Healthcare S.L.U.

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

Edifici Est, 6th floor.

08039, Barcelona

Spain

Responsible for manufacturing:

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 with the following names:

Spain: Dexclorfeniramina Maleate Accord5 mg injectable solution EFG

Portugal:Dexclorofeniramina Maleate Accord 5 mg/ml injectable solution MG

Date of the last review of thisleaflet: January 2012

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/