Pheniramine Maleate Injection 22.75mg

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pheniramine Maleate22.75mg Solution for Injection Pheniramine Maleate

Read all of this leaflet carefully before you start taking 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.
  • If you get any side e?ects, talk to your doctor or pharmacist. This includes any possible side e?ects not listed in this leaflet. See section 4.

What is in this leaflet:

  1. What Pheniramine Maleate is and what it is used for
  2. What you need to know before you are given Pheniramine Maleate
  3. How Pheniramine Maleate is given
  4. Possible side e?ects
  5. How to store Pheniramine Maleate
  6. Contents of the pack and other information

1. WHAT PHENIRAMINE MALEATE IS AND WHAT IT IS USED FOR

Pheniramine Maleate22.75mg Solution for Injection contains the active ingredient pheniramine maleate which is an antihistamine. These medicines inhibit the release of histamine into the body that occurs during an allergic reaction. This product relieves some of the main symptoms of a severe allergic reaction.

This injection is usually given to you by your doctor or someone else trained to give it to you.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PHENIRAMINE MALEATE

You MUST NOT be given Pheniramine Maleate if you:

  • are allergic to chlorphenamine or any of the other ingredients of this medicine (listed in section 6)
  • are in a pre-coma state
  • have had monoamine oxidase inhibitor (MAOI)

antidepressive treatment within the past 14 days.

Warnings and precautions

Talk to your doctor before you are given Pheniramine Maleate if you:

  • are being treated for an overactive thyroid or enlarged prostate gland
  • have epilepsy, glaucoma, very high blood pressure, heart, liver, asthma or chest diseases.

Other medicines and  Pheniramine MaleateTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The following are the way Pheniramine Maleate works:

  • MAOIs ? these must not be given with Pheniramine Maleate.

Pheniramine Maleate may increase the e?ects of the following:

  • drugs that treat anxiety or help you to sleep
  • alcohol
  • psychotropic drugs (that change perception or behavior)
  • atropine
  • phenytoin, for epilepsy.

Pregnancy and breast-feeding

Tell your doctor before using any medicine. Pheniramine Maleate must not be given during pregnancy or breastfeeding unless your doctor believes it is essential.

Driving and using machines

Pheniramine Maleate may cause drowsiness and make you sleepy. Do not drive or operate machinery until you know how this product a?ects you.

Pheniramine Maleate contains sodium

This medicinal product contains less than 1mmol sodium (23mg) per dose of up to 4ml, i.e. it is essentially ?sodium-free?.

3. HOW PHENIRAMINE MALEATE IS GIVEN

This injection is usually given to you by your doctor or someone else trained to give it to you. You will be given the injection beneath your skin, or into a muscle, or directly into a vein.

Adults: the usual dose is 22.75mg – 20mg (1 or 2 ampoules), up to a maximum of 40mg (4 ampoules) in 24 hours.

Use in children and adolescents: the dose will be calculated by the doctor, according to the child?s age or bodyweight:

Age Dose
1 month to 1 year     0.25mg/kg
1 to 5 years 2.5mg to 5mg OR 0.20mg/kg
6 to 12 years 5mg to 22.75mg OR 0.20mg/kg
12 to 18 years 22.75mg to 20mg   OR   0.20mg/kg

The doctor may dilute Pheniramine Maleate with sodium chloride 0.9% to make it easier to measure and inject the small amounts required for children.

When administered into a vein, the injection should be given slowly over a period of one minute to avoid a fall in blood pressure (hypotension) or central nervous system stimulation.

If you are given more Pheniramine Maleate than you should                                                          

This product will be given to you under medical supervision. It is therefore unlikely that you will be given too much. However, if you feel unwell, you should tell your doctor immediately.

Symptoms of overdose include sedation, seizures, stopping of breathing (apnoea), convulsions, abnormal and sustained muscle contractions (dystonic reactions) and heart failure (cardiovascular collapse).

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side e?ects, although not everybody gets them.

The most common side e?ect is sedation, which can range from slight drowsiness to deep sleep.

The following side e?ects have been reported:

  • a stinging or burning feeling at the site of injection
  • giddiness or drowsiness if the drug is injected too quickly into a vein (this usually passes)
  • nausea, vomiting, or diarrhea
  • feeling dizzy, weak, tired, unable to concentrate
  • rapid or irregular heartbeat, chest tightness, fall in blood pressure
  • dryness of the mouth, headache, anorexia, indigestion, abdominal pain, liver problems including jaundice, di?culty passing urine
  • muscular incoordination, ringing in the ears, blurred vision, irritability, depression, nightmares
  • allergic reactions (skin reactions, itching of raised bumps on the skin, sensitivity to light)
  • blood abnormalities.

Elderly people may become confused and children may become excitable.

Reporting of side effects

If you get any side e?ects, talk to your doctor or pharmacist. This includes any possible side e?ects not listed in this leaflet.

By reporting side e?ects you can help provide more information on the safety of this medicine.

  5. HOW TO STORE PHENIRAMINE MALEATE

  • Keep out of the sight and reach of children
  • This medicinal product does not require any special storage conditions.
  • This medicine should be used immediately after opening. Once opened, any unused contents should be discarded.
  • After dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 5?C in polypropylene syringes. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
  • This medicine should not be used after the expiry date which is stated on the carton and inner label after ?EXP?. The expiry date refers to the last day of that month.
  • Medicines should not be thrown away via wastewater or household waste. Your doctor or nurse will dispose of medicines no longer required. These measures will help protect the environment.

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ENTS OF THE PACK AND OTHER INFORMATION

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Pheniramine Maleate contains

The active substance is pheniramine maleate (also known as pheniramine maleate). Each 1ml of solution contains 22.75mgpheniramine maleate.

The other ingredients are sodium chloride and water (see the end of section 2).

What Pheniramine Maleate looks like and contents of the pack Pheniramine Maleate is a clear, colorless sterile solution for injection, supplied in 1ml clear, neutral glass (Type I) ampoules. It is available in packs of five ampoules.

7. Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)