50 mg / ml injection solution 
ephedrine hydrochloride

Read all of this leaflet carefully before you start using 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, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Ephedrine Mylan is and what it is used for 
2. What you need to know before you get Ephedrine Mylan 
3. How to take Ephedrine Mylan 
4. Possible side effects 
5. How to store Ephedrine Mylan 
6. Package contents and other information 

What Ephedrine Mylan is and what it is used for

Ephedrine Mylan is used for asthma and as a medication before spinal anesthesia (a form of central nerve block or spinal anesthesia).

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

What you need to know before you take Ephedrine Mylan

Do not use Ephedrine Mylan:

  • if you are allergic to ephedrine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
  • as tocolysis (treatment that prevents pain and premature birth) if you have pre-existing heart disease.
  • if you are at risk of heart disease.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before receiving Ephedrine Mylan.

You must talk to your doctor before treatment with Ephedrine Mylan if you:

  • has an overactive thyroid gland ( hyperthyroidism )
  • have severe heart disease (eg ischemic heart disease, arrhythmias, or severe heart failure ). If you experience symptoms such as chest pain or difficulty breathing, you should contact a doctor immediately as there may be symptoms of worsening of your heart disease.
  • have diabetes
  • have glaucoma (increased pressure in the eye)
  • has enlarged prostate
  • have untreated hypokalaemia (abnormally low levels of potassium in the blood)
  • treated with heart failure drugs (cardiac glycosides, quinidine )
  • treated with antidepressants called tricyclic antidepressants
  • treated with non-selective beta-blockers (medicines for heart problems)

Other medicines and Ephedrine Mylan

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

This is especially important if you use any of the following:

  • MAO inhibitors (antidepressants)
  • antihypertensive drugs
  • dexamethasone (medicine for inflammation and allergies )

Pregnancy and breastfeeding

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 taking this medicine.

There are no known risks of use during pregnancy.

There is no information on whether ephedrine passes into breast milk.

Driving and using machines

Ephedrine Mylan has no or negligible effect on the ability to drive and use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to take Ephedrine Mylan

Ephedrine Mylan is given as an injection by a doctor or a specially trained nurse. The injection is given under the skin. Your doctor will decide which dose is right for you.

If you take more Ephedrine Mylan then you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

It is unlikely that you will receive too much of this medicine as it is only given by a doctor or nurse.

Overdose of Ephedrine Mylan may cause fatigue, slurred speech, tremors, headache, anxiety, irritability, increased heart rate, nausea, and vomiting. At high doses you also see drowsiness, dilation of pupils, irritated mood, hallucinations (seeing and hearing something that does not exist), seizures, increased body temperature, high blood pressure, drop in blood pressure, heart rhythm disturbances, abnormally low levels of potassium in the blood and difficulty Pee. In severe cases, there is a risk of abnormal muscle breakdown ( rhabdomyolysis ) and kidney failure.

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

4. Possible side effects

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

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

  • concern
  • insomnia
  • palpitation
  • difficult to urinate
  • inability to urinate

Uncommon side effects (may affect up to 1 in 100 people):

  • shaking
  • nausea, vomiting
  • muscle weakness
  • dizziness
  • headache
  • sweating
  • thirst

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

  • lack of oxygen in the heart.

5. How to store Ephedrine Mylan

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. or EXP. The expiration date is the last day of the specified month.

Store in the original package.

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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is ephedrine hydrochloride. 1 ml contains 50 mg of ephedrine hydrochloride.
  • The other ingredient is water for injections (to 1 ml).

Ephedrine Mylan solution for injection has a pH of about 6.

What the medicine looks like and the contents of the pack

10 x 1 ml, glass ampoule is

Marketing Authorization Holder

Mylan AB

Box 23033

104 35 Stockholm

Muhammad Nadeem

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