DEXCHLORPHENIRAMINE MALEATE ACCORD 5mg/ml INJECTABLE SOLUTION

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.

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/