5 mg / ml injection solution 
ephedrine hydrochloride

Read all of this leaflet carefully before you are given this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor, pharmacist, or nurse.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Ephedrine Unimedic is and what it is used for 
2. What you need to know before you use Ephedrine Unimedic 
3. How to use Ephedrine Unimedic 
4. Possible side effects 
5. How to store Efedrin Unimedic 6. Contents of the pack 
and other information 

What Ephedrine Unimedic is and what it is used for

Ephedrine Unimedic is used to treat low blood pressure that can occur during various types of anesthesia. The drug may only be used by or under the supervision of an anesthetist.

Ephedrine contained in Ephedrine Unimedic may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before using Ephedrine Unimedic

Do not use Ephedrine Unimedic

  • if you are allergic to ephedrine or any of the other ingredients of this medicine (listed in section 6)

Warnings and cautions

Talk to your doctor before taking Ephedrine Unimedic if you:

  • have high blood pressure
  • have heart disease
  • have diabetes
  • has an overactive thyroid gland
  • have or suspect you have glaucoma (increased pressure in the eye)
  • has enlarged prostate
  • has severe renal impairment

Other medicines and Ephedrine Unimedic

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

It is especially important to tell your doctor if you are taking any of the following medicines:

  • drugs with a similar effect to ephedrine (eg phenylephrine )
  • certain medicines for nasal congestion (eg phenylpropanolamine, pseudoephedrine)
  • a drug for the treatment of ADHD (methylphenidate)
  • certain drugs that reduce pain during surgery (volatile halogenated anesthetics )
  • drugs for the treatment of depression such as:
    • tricyclic antidepressants (eg clomipramine, amitriptyline, nortriptyline) or  
    • serotonergic noradrenergic drugs (eg venlafaxine, reboxetine, duloxetine) or
    • a monoamine oxidase inhibitor ( MAOI ) (eg moclobemide). Talk to your doctor if you are taking or have taken a medicine called monoamine oxidase inhibitor( MAOI ) for the last 14 days to treat depression.
  • medicines used to lower blood pressure (eg clonidine, guanethidine, and medicines called alpha- and beta-blockers )
  • certain medicines used to treat heart failure and/or irregular heartbeats (cardiac glycosides eg digitalis, quinidine )
  • an antibiotic used to treat serious infections (linezolid)
  • certain medicines for Parkinson’s disease (eg rasagiline, safinamide, levodopa, bromocriptine, selegiline, entacapone, tolcapone)
  • a drug for respiratory diseases such as asthma (theophylline)
  • medicines that reduce inflammation and other consequences of allergic reactions ( corticosteroids such as dexamethasone)
  • a drug used during childbirth ( oxytocin )

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Ephedrine Unimedic may cause increased heart rate in the fetus. It should not be given during pregnancy unless your doctor decides it is necessary. It can be used in cesarean sections to prevent low blood pressure.

Breast-feeding

Talk to your doctor if you are breast-feeding. You should avoid breast-feeding for two days after receiving this medicine.

Driving and using machines

Not relevant.

Ephedrine Unimedic contains excipients

This medicine contains 32 mg of sodium (the main ingredient in table salt/table salt) in each 10 ml ampoule. This corresponds to 1.6% of the maximum recommended daily sodium intake for adults.

3. How to use Ephedrine Unimedic

This medicine will be given by healthcare professionals with relevant education and experience. Your doctor will decide what dose you should take.

If you use more Ephedrine Unimedic then you should  

Getting too much Ephedrine Unimedic can lead to symptoms such as nausea, vomiting, fever, paranoid psychosis (delusional disorder, altered perception of reality), irregular heartbeat, high blood pressure, decreased respiratory rate, seizures, and coma. If these symptoms occur, consult a healthcare professional.

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

4. Possible side effects

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

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

  • confusion, anxiety, depression
  • nervousness, irritability, restlessness, weakness, difficulty sleeping (insomnia), headache, sweating
  • high blood pressure, increased heart rate (palpitations, tachycardia )
  • difficulty breathing ( dyspnoea )
  • nausea, vomiting

Rare (may affect up to 1 in 1,000 people):

  • irregular heartbeat ( cardiac arrhythmias )
  • inability to urinate ( acute urinary retention )

Has been reported (occurs in an unknown number of users):

  • hypersensitivity
  • psychotic states (such as imagination and hallucinations), fear
  • tremor (tremors in eg hands), increased saliva production
  • episodes of narrow-angle glaucoma (an eye disease in which the optic nerve is damaged)
  • angina, slow heartbeat (reflex bradycardia), cardiac arrest, low blood pressure
  • cerebral hemorrhage (cerebral hemorrhage)
  • fluid accumulation in the lungs ( pulmonary edema )
  • decreased appetite
  • low potassium levels in the blood ( hypokalaemia ), altered blood glucose levels

5. How to store Ephedrine Unimedic

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 label and carton after EXP. The expiration date is the last day of the specified month.

Any unused product or waste material should be disposed of by local requirements.

6. Contents of the packaging and other information

Content declaration

  • The active substance is ephedrine hydrochloride. 
    1 ml solution for injection contains 5 mg of ephedrine hydrochloride. One ampoule of 10 ml contains 50 mg of ephedrine hydrochloride.

  • The other ingredients are sodium citrate, citric acid, sodium chloride, hydrochloric acid, sodium hydroxide, water for injections.

What the medicine looks like and the contents of the pack

Ephedrine Unimedic is a clear solution.

10 x 10 ml clear glass ampoules are packed in a carton.

Manufacturer

Unimedic AB

Box 91

864 21 Matfors

Muhammad Nadeem

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