Package leaflet: Information for the user
Dexchlorpheniramine Maleate 5mg/ml solution for injection
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, or 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, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
What is in this leaflet: 1. What Dexchlorpheniramine Maleate 5mg/ml solution for injection is and what it is used for 2. What you need to know before you use Dexchlorpheniramine Maleate 5mg/ml solution for injection 3. How to use Dexchlorpheniramine Maleate 5mg/ml solution for injection 4. Possible side effects 5. How to store Dexchlorpheniramine Maleate 5mg/ml solution for injection 6. Contents of the pack and other information
1. What is DEXCHLORPHENIRAMINE MALEATE 5mg/ml SOLUTION FOR INJECTION is and what it is used for
Dexchlorpheniramine belongs to a group of medicinal products known as antihistamines which compete with histamine for the receptor sites in effector cells. Dexchlorpheniramine Maleate 5mg/ml solution for injection is presented in the form of an injectable solution.
Dexchlorpheniramine Maleate 5mg/ml solution for injection is indicated in the symptomatic treatment of acute urticaria when oral administration is not possible.
You must talk to a doctor if you do not feel better or if you feel worse.
2. What you need to know before you use DEXCHLORPHENIRAMINE MALEATE 5mg/ml SOLUTION FOR INJECTION
Do not use Dexchlorpheniramine Maleate 5mg/ml solution for injection:
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 of similar chemical structure. Dexchlorpheniramine Maleate 5mg/ml solution for injection should not be administered to children less than 30 months of age. if you are under treatment with a particular type of anti-depressant known as monoamine oxidase inhibitor (MAOI) or have been in the previous two weeks. if you have risk of closed-angle glaucoma.
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if you have risk of urinary retention related to urethroprostatic disorders. if you are in the 3rd trimester of pregnancy.
Warnings and precautions
Talk to your doctor or, pharmacist or nurse before using Dexchlorpheniramine Maleate 5mg/ml solution for injection.
The use of Dexchlorpheniramine should not delay the administration of adrenalin.
Dexchlorpheniramine Maleate should be used with precaution: -in elderly patients that presents: a greater sensitivity to orthostatic hypotension, vertigos and sedation, chronic constipation or eventual prostate hypertrophy.
-in case of severe hepatic and/or renal insufficiency.
Children -in paediatric population since may cause excitation.
Other medicines and Dexchlorpheniramine Maleate 5mg/ml solution for injection
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 any of the following:
-sedative antidepressants, barbiturates, benzodiazepines, clonidine and similar, hypnotics (depressors of the central nervous system).
-morphine derivatives (analgesics and anti-tussives).
-methadone, neuroleptics, anxiolytics.
-imipramine anti-depressants, anti-Parkinsons, anti-cholinergics, atropinic anti- spasmodics, disopyramide, phenothiazinic neuroleptics (atropine and other atropinic substances).
Do not use Dexchlorpheniramine Maleate with depressors of the central nervous system as this may result in the increase in central depression and deterioration in the state of alertness.
Dexchlorpheniramine Maleate with food, drink and alchohol It should be avoided drink alcoholic beverages or medicinal products that contain alcohol. It increases in sedation of antihistamine H1. The alteration in alertness could be dangerous when driving or operating machinery.
Pregnancy and, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planing to have a baby, ask your doctor or pharmacist for advise before taking this medicine.
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Pregnancy Dexchlorpheniramine Maleate should not be administered in the third trimester of pregnancy as new-borns and premature babies.
During the first two trimesters of pregnancy, Dexchlorpheniramine Maleate 5mg/ml solution for injection should only be taken if your doctor considers it necessary.
Breast-feeding Dexchlorpheniramine Maleate 5mg/ml solution for injection is excreted via maternal milk. There is insufficient information on the effects of dexchlorpheniramine in newborns. Dexchlorpheniramine Maleate 5mg/ml solution for injection should not be used during breast-feeding.
Fertility There are no adequate data about the effect of Dexchlorpheniramine to patient fertility.
Driving and using machines: Dexchlorpheniramine Maleate 5mg/ml solution for injection can cause somnolence, patients should be warned to not carry out mechanical operations that require maximum concentration such as driving or operating equipment, machinery.
3. How to use DEXCHLORPHENIRAMINE MALEATE 5mg/ml SOLUTION FOR INJECTION
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is 5mg (1 ampoule) administered intravenously or intramuscularly. The maximum daily dose is of 20 mg (4 ampoules). In the case of a reaction during a transfusion, do not administer Dexchlorpheniramine Maleate 5mg/ml solution for injection in the transfusion, but apart.
The dose should be personalised according to the requirements and the response of the patient.
Use in children The safety and efficacy of Dexchlorpheniramine Maleate 5mg/ml solution for injection in children aged less than 30 months has not yet been established. No data are available.
If you use more Dexchlorpheniramine Maleate 5mg/ml solution for injection than you should
If you have use more Dexchlorpheniramine Maleate 5mg/ml solution for injection than you should, immediately consult your doctor or your pharmacist.
If you forget to use Dexchlorpheniramine Maleate 5mg/ml solution for injection
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Do not take a double dose to make up for a forgotten dose. Use the regular dose when it is due (according to section 3 “How to use Dexchlorpheniramine Maleate 5mg/ml”).
If you stop using Dexchlorpheniramine Maleate 5mg/ml solution for injection If you have any further questions on the use of this medicine, ask your doctor, or pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Nervous system disorders: -Sedation and drowsiness (more pronounced at the start of treatment). -Orthostatic hypotension. -Equilibrium disorders, dizziness, reduction in memory or concentration (more frequent in the elderly). -Lack of motor coordination. -Mental confusion, hallucinations. -Agitation, nervousness, insomnia.
Skin and subcutaneous tissue disorders: -Rash, eczema, pruritus, purpura, urticaria possible giant. -Oedema.
Immune system disorders: -Anaphylactic shock.
Blood and lymphatic system disorders: -Leucopenia, neutropenia. -Thrombocytopenia. -Haemolytic anaemia.
General disorders and administration site condictions: -Dryness of the mucosa, constipation, accommodation disorders, mydriasis, cardiac palpitations, risk of urinary retention.
If you get any side effects, talk to your doctor or, pharmacist or nurse.This includes any side effects not listed in this leaflet.
5. How to store DEXCHLORPHENIRAMINE MALEATE 5mg/ml SOLUTION FOR INJECTION
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
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Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Dexchlorpheniramine Maleate 5mg/ml solution for injection contains
The active substance is Dexchlorpheniramine Maleate, 5 mg per 1 ml ampoule. The other ingredient is water for injections q.s.
What Dexchlorpheniramine Maleate 5mg/ml solution for injection looks like and contents of the pack
Dexchlorpheniramine Maleate injectable is presented in the form of an injectable solution. Each package contains 5 ampoules of 2 ml.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder Combino Pharm Portugal, Unipessoal, Lda. Quinta da Fonte, Rua dos Malhões, Edifício D. Pedro I, Escritório nº 26 2770-071 Oeiras Portugal
Manufacturer Combino Pharm SL Fructuós Gelabert, 6-8 08970- Sant Joan Despí (Barcelona) Spain
This medicinal product is authorised in the Member States of the EEA under the following names:
Portugal: Dexclorofeniramina Maleato Combino 5mg/ml solução injectável MG
Spain: Dexclorfeniramina Maleato Combino Pharm 5mg/ml solución inyectable EFG
This leaflet was last revised in
Detailed information on this medicine is available on the web site of Portugal/Infarmed or Spain/AEMPS
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