Dimenhydrinate for injection 50mg/mL Taj Pharma

Package leaflet: Information for the user

Dimenhydrinate 50mg/mL solution for injection (IM)

Dimenhydrinate

Read all of this leaflet carefully before you you are given this medicine because it contains important information for you.
  • Keep this leaflet. You may need to read it
  • If you have any further questions, ask your doctor, pharmacist or
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section

 

What is in this leaflet
  1. What Dimenhydrinate is and what it is used for
  2. What you need to know before you are given Dimenhydrinate
  3. How Dimenhydrinate is given
  4. Possible side effects
  5. How to store Dimenhydrinate
  6. Contents of the pack and other information

 

1.              What Dimenhydrinate is and what it is used for

Dimenhydrinate solution for injection (IM) belongs to a group of medicines called H1- Antihistamines. It.is is used to prevent and treat nausea and vomiting of various origins, especially motion sickness.

Note:

Dimenhydrinate solution for injection (IM) should not be used alone to treat chemotherapy-induced nausea and vomiting.

  1. What you need to know before you are given Dimenhydrinate You must not be given Dimenhydrinate :
    • if you are allergic (hypersentitive) to dimenhydrinate or any of the other ingredients of this medicine (listed in section 6);
    • if you have problems in haemoglobin production (porphyria);
    • if you have an acute asthma attack;
    • if you have green cataract (narrow-angle glaucoma);
    • if you have an adrenal gland tumour (phaeochromocytoma);
    • if you have an enlarged prostate gland (prostatic hyperplasia) with residual urine (urine retention in the bladder after passing water);
    • if you suffer from seizure disorders (epilepsy, eclampsia);
Children

Due to the benzyl alcohol content, this medicine should not be used in pre-term or full-term neonates unless strictly necessary because of the risk of severe toxicity including abnormal respiration

(“gasping syndrome”).

Warnings and precautions 

Talk to your doctor, pharmacist or nurse before you are given Dimenhydrinate. Take special care with Dimenhydrinate :

  • if you have an impaired liver function,
  • if you have heart rhythm disorders (e.g. racing heart),
  • if you have a potassium or magnesium deficiency,
  • if you have slowed heartbeat (bradycardia),
  • if you have certain heart conditions (congenital QT syndrome or other forms of clinically significant heart damage, particularly poor blood circulation through the coronary arteries, conduction disturbances, arrhythmias),
  • if you use medicines that also prolong the so-called QT interval in the ECG or lead to hypokalaemia (see “Other medicines and Dimenhydrinate”),
  • if you suffer from chronic breathing problems and asthma,
  • if you suffer from narrowing of the stomach outlet (pyloric stenosis).
Other medicines and Dimenhydrinate

Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.

  • Combined use of Dimenhydrinate with other medicines that suppress the central nervous system (medicines that affect the psyche, sleeping aids, sedatives/tranquilisers, painkillers and anaesthetics) can mutually enhance the
  • The “anticholinergic” effect of Dimenhydrinate may be enhanced as a result of co- administering other agents with anticholinergic effects (e.g. atropine, biperiden or certain medicines for depression [tricyclic antidepressants]).
  • If Dimenhydrinate is given at the same time as so-called monoamine oxidase inhibitors (medicines also used to treat depression), life-threatening intestinal paralysis, urine retention or increased pressure inside the eye may possibly develop. A drop in blood pressure,marked dysfunction of the central nervous system and breathing may also occur. Dimenhydrinate must therefore not be used at the same time as monoamine oxidase inhibitors.
  • Use of Dimenhydrinate together with medicines for high blood pressure can lead to increased
  • Your doctor should be told that you are taking Dimenhydrinate before carrying out allergy tests, as false-negative test results are
  • Dimenhydrinate can mask hearing damage that may possibly occur during treatment with certain antibiotics (aminoglycosides)
Do not use Dimenhydrinate and the following medicines at the same time:
  • medicines which prolong the QT interval, for example medicines used to treat heart rhythm problems (for example class IA or III anti-arrhythmic medicines such as quinidine, amiodarone),
  • medicines used to treat bacterial infections (macrolide antibiotics for example erythromycin),
  • medicines used to treat gastro-oesophageal reflux disease and bowel constipation (for example cisapride),
  • medicines used to treat malaria,
  • medicines used to treat allergies,
  • medicines used to treat stomach ulcers or intestine ulcers (antihistamines),
  • medicines used to treat special psychotic disorders (neuroleptics),
  • medicines, which lead to low blood levels of potassium (for example certain diuretics).

 

Dimenhydrinate with alcohol

During treatment with Dimenhydrinate do not drink alcohol, as the effect of Dimenhydrinate can be altered and enhanced in an unpredictable manner by alcohol.

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 you receive this medicine.

Dimenhydrinate should not be used during the third trimester because it may have the potential to stimulate preterm uterus contractions. During the first six months of pregnancy Dimenhydrinate should only be used if the benefits clearly outweigh the risks. Your doctor will decide whether you should receive this medicine.

Dimenhydrinate, the active ingredient of Dimenhydrinate is excreted in breast milk. No long term negative effects have been noticed in breast-fed babies to date. However, if your baby shows signs of discomfort or agitation change to bottle feeds or stop treatment with Dimenhydrinate [MAH] and contact your doctor for advice.

Driving and using machines

Dimenhydrinate can make you feel drowsy, affect your memory and reduce your ability to concentrate. Therefore, you must not drive, operate machinery, or work in dangerous situations after you have been given this medicine.

Especially when you have not had enough sleep, when you are starting with this medicine, or when you change medicines, you should not go home alone and should not drink alcohol when you receive this medicine.

Dimenhydrinate contains 52.5mg benzyl alcohol and 520mg propylene glycol per ml.

Benzyl alcohol may cause hypersensitivity (allergic) reactions and toxic reactions in infants and children up to 3 years old.

Propylene glycol can cause symptoms such as after drinking alcohol.

3.              How Dimenhydrinate is given

This medicine should be given to you by a doctor or a healthcare professional. In general, the dosage is:

For adults and adolescents over 14 years:

100-300mg dimenhydrinate (equivalent to 2-6 ml) per day. A maximum daily dose of 400mg should not be exceeded.

For children aged 6 to 14 years:

25-50mg dimenhydrinate 1-3 times daily.

A maximum daily dose of 150mg should not be exceeded.

Children weighing 6 kg or more:

1.25mg dimenhydrinate per kilogram of body weight, 1-3 times daily.

Overdosing dimenhydrinate can be life threatening, particularly in children below the age of three years and must therefore be absolutely avoided.

Method of administration:

For preventive treatment of motion sickness, you will receive the first dose approximately 30 minutes to 1 hour before you start your journey.

For the treatment of nausea and vomiting, you will receive the doses at regular intervals throughout the day.

 

Dimenhydrinate should be injected deep into the buttock muscle (intragluteally).

Duration of use:

Dimenhydrinate is usually limited to short term treatment. If the symptoms persist for 2 weeks, consult your doctor. Your doctor will then decide on an appropriate treatment for you.

If you are given more Dimenhydrinate than you should

 

Since Dimenhydrinate will usually be given to you by a doctor or nurse it is unlikely that you will be given too much or that you will miss a dose. If you think you might have received too much of this medicine, tell your doctor or contact your nearest hospital emergency department immediately.

An overdose of Dimenhydrinate can cause different stages of decreased consciousness, ranging from excessive sleepiness to loss of consciousness (coma).

You may also experience disturbance of your vision, faster heartbeat, fever, hot and reddening of your skin and dryness of mouth, constipation, restlessness, anxiety, excitation, increased muscle reflexes, and seeing or hearing things which are not there (hallucinations). Furthermore, convulsions (fits), irregular heartbeat and breathing difficulties which may lead to respiratory paralysis and cardiac arrest are possible.

Your doctor will decide how severe your symptoms are and how to treat them.

4.              Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Important side effects to look out for:

All medicines including Dimenhydrinate can cause allergic reactions. Contact your doctor immediately if you experience any of the following symptoms after receiving Dimenhydrinat:

  • sudden wheeziness,
  • difficulty in breathing,
  • swelling of the eyelids, face, lips or
Other possible side effects:

Very common (may affect more than 1 in 10 people):

  • feeling sleepy, which may possibly persist, decreased
  • drowsiness/dizziness and
  • muscle

These side effects may also still affect you on the following day after receiving treatment.

Common (may affect up to 1 in 10 people):

−     mood swings

  • restlessness,
  • agitation,
  • insomnia,
  • anxiety
  • shaking;
  • visual disturbances;
  • increase pressure inside the eye;
  • racing heart (tachycardia);
  • constipation,
  • diarrhoea,
  • nausea,
  • vomiting,
  • pain in your stomach region;
  • dry mouth,
  • the feeling that your nose is blocked;
  • problems with

Not known (frequency cannot be estimated from the available data):

  • After long term usage, drug dependency cannot be excluded. Therefore, Dimenhydrinate should only be used for a short time.
  • difficulty sleeping. This is temporary and may occur if the treatment is suddenly stopped after long term use. Therefore, the dose should be reduced gradually before treatment is
  • blood cell damages. This side effect only occurs in exceptional
  • yellowing of your skin or whites of your eyes. This side effect is caused by liver
  • swelling or reddening of the skin. These side effects may occur, due to an allergic reaction or in connection with sunlight. Therefore, you should not go directly into the sunlight when you are taking this

Benzyl alcohol may cause hypersensitivity (allergic) reactions and toxic reactions in infants and children up to 3 years old.

Side effects in children

Children may feel restless, excited or anxious, have difficulties sleeping and experience shaking of the body.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via <to be completed nationally>. By reporting side effects you can help provide more information on the safety of this medicine.

5.              How to store Dimenhydrinate

 

Store in the original package in order to protect from light. Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the ampoule and carton after “EXP”. 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.

  1. Contents of the pack and other information What Dimenhydrinate contains

The active substance is dimenhydrinate. One 1 mL ampoule contains 50mg of dimenhydrinate. One 2 mL ampoule contains 100mg of dimenhydrinate.

  • The other ingredients are benzyl alcohol (52.5mg/ml), propylene glycol (520.0mg/ml), hydrochloric acid (pH adjustment), water for

What Dimenhydrinate looks like and contents of the pack Clear and colourless solution in 1 mL or 2 mL colourless glass ampoules. Boxes of 5 or 50 ampoules of 1 mL.

Boxes of 5 or 50 ampoules of 2 mL. Not all pack sizes may be marketed.

 

  1. MANUFACTURED IN INDIA BY:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of  Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com