0.25 mg / ml injection solution 
digoxin

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 you will find information about: 
1. What Digoxin BioPhausia is and what it is used for 
2. What you need to know before you get Digoxin BioPhausia 
3. How to use Digoxin BioPhausia 
4. Possible side effects 
5. How to store Digoxin BioPhausia 
6. Contents of the packaging and other information 

1. What Digoxin BioPhausia is and what it is used for

Digoxin BioPhausia contains the active substance digoxin and is used in heart diseases such as heart failure, heart fibrillation, and irregular heartbeat.

Digoxin BioPhausia counteracts heart failure and increased heart rate by increasing the heart’s contractile force, reducing the number of heartbeats per minute, and regulating the heart’s rhythm. The bleeding is improved and the heart rate is lowered.

Digoxin contained in Digoxin BioPhausia 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.

2. What you need to know before you get Digoxin BioPhausia

Your doctor will not give you Digoxin BioPhausia:

  • if you are allergic to digoxin or any of the other ingredients of this medicine (listed in section 6).
  • if you suffer from certain types of heart rhythm disorders.
  • if you have a very slow heartbeat.

Warnings and cautions

Talk to your doctor or nurse before receiving Digoxin BioPhausia. When you are given this medicine, your doctor will take into account:

  • if you have severe heart disease (for example, enlarged or inflamed heart muscle)
  • if you have impaired kidney function
  • if you have hypothyroidism ( hypothyroidism )
  • if you have low potassium levels in your blood ( hypokalaemia )
  • if you have high calcium levels in your blood ( hypercalcemia )
  • if you have magnesium deficiency (hypomagnesemia)
  • if you have decreased oxygen content in the body tissues ( hypoxia )

In patients with atrial fibrillation treated with digoxin for a long time, there may be a certain increased risk of mortality.

Other medicines and Digoxin BioPhausia

Tell your doctor if you are taking, have recently taken, or might take any other medicines, including (traditional) herbal and herbal medicines.

Many medicines can affect or be affected by treatment with Digoxin BioPhausia. Therefore, always consult your doctor who will check what other medicines you are taking before you receive Digoxin BioPhausia.

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 for advice before taking this medicine.

Pregnancy

No known risks when used during pregnancy.

The medicine contains ethanol and propylene glycol, see “Digoxin BioPhausia contains ethanol and propylene glycol” below.

Breast-feeding

Digoxin passes into breast milk but is unlikely to affect breastfed infants.

The medicine contains ethanol and propylene glycol, see “Digoxin BioPhausia contains ethanol and propylene glycol” below.

Driving and using machines

Digoxin can cause side effects such as fatigue, confusion, and visual disturbances. This may affect your ability to drive or 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.

Digoxin BioPhausia contains ethanol and propylene glycol

Ethanol:

This medicine contains 20% by volume of ethanol (alcohol), ie up to 100 mg in a dose of 1 ml corresponding to 2.5 ml of beer, or 1 ml of wine. The number of ethanol varies depending on the size of the dose.

Harmful to people suffering from alcoholism.

This information should be taken into consideration by pregnant or lactating women, children, and high-risk groups such as patients with liver disease or epilepsy.

Propylene glycol:

This medicine contains 400 mg of propylene glycol per 1 ml equivalent to about 35 mg/kg/day for adults. The amount of propylene glycol varies depending on the dose.

If your child is younger than 5 years, the doctor needs to know if your child is using other medicines, especially if they contain propylene glycol or ethanol.

If you are pregnant or breast-feeding, do not use this medicine unless your doctor tells you to. The doctor may want to do extra checks during treatment.

If you, or your child, have impaired liver or kidney function, and are receiving this medicine, your doctor may want to do extra checks during treatment.

3. How to use Digoxin BioPhausia

Digoxin BioPhausia will be given to you by a doctor or nurse. It will be given as an injection directly into the bloodstream ( intravenously ).

Dose one is individually tailored and depends on various factors, e.g. renal function, age, and weight. Your doctor will decide which dose is right for you.

If you take more Digoxin BioPhausia then you should

It is unlikely that your doctor or nurse will give you too much medicine. Your doctor and nurse will monitor your treatment.

Tell your healthcare professional if you experience any of the following symptoms may occur if the unlikely received a high dose of Digoxin BioPhausia:

nausea, vomiting, headache, fatigue, confusion, decreased consciousness, hallucinations, seizures, visual disturbances, involuntary rapid body movements.

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.

Side effects occur mainly if you have been given too much medicine or if you have disturbances in the body’s salt balance.

Common  (may affect up to 1 in 10 people): loss of appetite, fatigue, headache, irregular heartbeat, disorders of the cardiovascular system, vomiting, nausea, diarrhea.

Uncommon (may affect up to 1 in 100 people): confusion, blurred vision (blurred vision, yellow and green vision).

Has been reported (occurs in an unknown number of users): Breast augmentation in men.

5. How to store Digoxin BioPhausia

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 carton after EXP.

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

Store in the outer carton. Sensitive to light.

6. Contents of the packaging and other information

Content declaration

  • The active substance is digoxin. 1 ml contains 0.25 mg digoxin .
  • The other ingredients are ethanol, propylene glycol, anhydrous citric acid, disodium phosphate dihydrate, and water for injections.

What the medicine looks like and the contents of the pack

Injection solution ( for injection ).

Transparent, colorless solution.

Pack sizes: Ampoule is 10 x 1 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Evolan Pharma AB, Box 120, 182 12 Danderyd

Manufacturer

Unimedic AB, Mats

Muhammad Nadeem

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