Cosmofer Injection

Possible side effects

Like all medicines CosmoFer can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Allergic reactions (affecting less than 1 in 100 people)

If you have an allergic reaction to CosmoFer tell your doctor or nurse straight away so that they can stop it if necessary. The signs of this may include:

• shortness of breath
• nettle rash or hives, flushing, rashes, itching
• nausea and shivering.

More serious allergic reactions, may happen in the first few minutes of having CosmoFer (affecting less than 1 in 10,000 people). The signs may include:

• sudden onset of difficulty breathing (respiratory difficulty)
• serious problems with your heart and circulation (cardiovascular collapse)
• fatalities have been reported.

Also, there have been reports of delayed allergic reactions, that may happen a few hours or up to four days after being given CosmoFer. The signs may include:

• pain in your joints or muscles
• sometimes a high temperature (fever).

Please contact your doctor if you have any of these signs.

Other side effects include:

Uncommon (affecting less than 1 in 100 people):

• pain in and around the stomach (abdominal pain), being sick (vomiting)
• blurred vision
• feeling hot
• cramps
• numbness.

Rare (affecting less than 1 in 1,000 people): 

• loss of consciousness
• altered mental status
• seizure (fits)
• dizziness, restlessness, fatigue
• low blood pressure
• angioedema, a type of severe allergic reaction, signs may include swelling
• uneven (irregular) heart beat, high pulse rate, chest pain
• diarrhoea, sweating and tremor.

Very rare (affecting less than 1 in 10,000 people):

• lower red blood cells than usual (this would show up in some blood tests)
• headache
• unusual feeling on the surface of your body
• raised blood pressure
• temporary deafness
• palpitations
• in pregnancy, the baby’s heart rate may slow.

Some other side effects have been reported. People with ‘rheumatoid’ arthritis may have worsening of joint pain.

Possible side effects after an injection into your vein

• If you have CosmoFer into a vein, there may be reactions, such as soreness and swelling (inflammation) around the vein. There have also been reports of inflammation of the vein.

Possible side effects after an injection into your muscle

• If you have CosmoFer into a muscle, there may be reactions, such as staining of the skin, bleeding, formation of boils, tissue damage (necrosis or atrophy) and pain.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

How to store CosmoFer

• This medicinal product does not require any special storage conditions. Do not freeze. Inspect ampoules visually for sediment and damage before use. Use only those containing sediment-free, homogeneous solution.
• Hospital staff will make sure that the product is stored and disposed of correctly. CosmoFer should not be used after the expiry date which is stated on the ampoule. Exp. is the abbreviation used for expiry date. The expiry date refers to the last day of that month. Keep out of the reach and sight of children.

Administration:

CosmoFer solution for infusion and injection can be administered by an intravenous drip infusion or by a slow intravenous injection of which the intravenous drip infusion is the preferred route of administration, as this may help to reduce the risk of hypotensive episodes. However, CosmoFer may also be administered as undiluted solution intramuscularly.

Adults and elderly

• The total cumulative dose of CosmoFer is determined by haemoglobin level and body weight.
• The dose and dosage schedule for CosmoFer must be individually estimated for each patient based on a calculation of the total iron deficit.

Children (under 14 years)
CosmoFer should not be used for children. There is no documentation for efficacy and safety.
Dosage:

• The normal recommended dosage schedule is 100-200 mg iron corresponding to 2-4 ml, two or three times a week depending on the haemoglobin level. However, if clinical circumstances require rapid delivery of iron to the body iron stores CosmoFer may be administered as a total dose infusion up to a total replacement dose corresponding to 20 mg iron/kg body weight.
• The CosmoFer injection should not be administered concomitantly with oral iron preparations as the absorption of oral iron will be reduced.

If you have any more questions please ask your Pharmacist.

Remember to keep all medicines out of reach of children
Please Note: We have made every effort to ensure that the content of this information sheet is correct at time of publish, but remember that information about drugs may change. This sheet does not list all the uses and side-effects associated with this drug. For full details please see the drug information leaflet which comes with your medicine. Your doctor will assess your medical circumstances and draw your attention to any information or side-effects which may be relevant in your particular case.

References:

https://en.wikipedia.org/wiki/Pharmacosmos

http://www.cosmofer.com/product/dose-calculation/dose-calculator.aspx

https://www.hpra.ie/img/uploaded/swedocuments/2138687.PA0982_001_001.f539b554-769a-4bbd-8ba9-843e4bffcfac.000001Product%20Leaflet%20Approved.140312.pdf

http://www.drugs.com/uk/cosmofer-50mg-ml-solution-for-injection-and-for-infusion-leaflet.html

http://www.medicines.org.uk/emc/medicine/14139/SPC/