What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 00031/0254.

Konakion MM 10mg/ml

Package Leaflet: Information for the patient

Konakion® MM Ampoules 10mg/ml

solution for injection

Phytomenadione (vitamin K1)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or nurse.
  • If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

What is in this leaflet:

1. What Konakion MM is and what it is used for
2. What you need to know before you are given Konakion MM
3. How Konakion MM is given
4. Possible side effects
5. How to store Konakion MM
6. Contents of the pack and further information

1. What Konakion MM is and what it is used for

Konakion MM contains a medicine called phytomenadione. This is a man-made vitamin called vitamin K1. Konakion MM is used for the following:

  • To prevent and treat bleeding after the use of certain medicines to thin the blood (called anti-coagulants).
  • To treat children (aged 1 year and older) who have liver disease or low levels of vitamin K in their body because of illness. Konakion MM is normally used to treat these children after advice from a specialist haematologist (blood doctor).

Konakion MM works by helping your body make blood clotting factors. These blood clotting factors help stop bleeding.

2. What you need to know before you are given Konakion MM

You must not be given Konakion MM if you are allergic (hypersensitive) to phytomenadione or any of the other ingredients of Konakion MM (listed in Section 6: Further information).

If you are not sure if this applies to you, talk to your doctor or nurse before having Konakion.

Warnings and precautions

Check with your doctor or nurse before having Konakion MM if:

  • You have severe problems with your liver.
  • You have an artificial heart valve.

Other medicines and Konakion MM

Please tell your doctor or nurse if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Konakion MM can affect the way some medicines work. Also some other medicines may affect the way Konakion MM works. In particular, tell your doctor or nurse if you are taking medicines to stop your blood clotting (anticoagulants).

Pregnancy and breast-feeding

Talk to your doctor before having Konakion if you are pregnant, think you are pregnant, or breastfeeding. Your doctor will then decide if you should receive Konakion.

Driving and using machines

Konakion MM is not likely to affect you being able to drive or use any tools or machines. Talk to your doctor if you notice any problems that might affect driving, using tools or machines while having Konakion.

Important information about some of the ingredients of Konakion MM

Konakion MM is essentially ‘sodium (a type of salt) free’ as it contains less than 1 mmol sodium (2.64mg per 1ml).

3. How Konakion MM is given

Konakion MM will be given to you by a doctor or nurse. It will be given to you by injection into a vein or through a small tube into one of your veins (intravenous infusion).

Adults

  • For people who are bleeding after taking blood-thinning (anticoagulant) medicines, the usual dose is 5 to 10 mg.
  • For people who have severe bleeding the Konakion dose (5 to 10 mg) is usually given with a blood transfusion.
  • For people with mild bleeding or at risk of bleeding, the usual dose is 0.5 to 1 mg.
  • If you need to have emergency surgery you may be given 5 mg Konakion before surgery to reverse the effects of blood-thinning (anticoagulant) medicines.
  • The maximum dose is usually no more than 40 mg Konakion in 24 hours.

Your doctor will usually check your blood for the levels of clotting factors, 3 hours after having Konakion MM and, if you need them give you more doses of Konakion MM.

Elderly

Because elderly adults are sometimes more sensitive to Konakion MM your doctor may decide to start you on a lower dose. This dose may be increased or repeated if necessary.

Children (aged 1 to 18 years)

Konakion MM is normally used to treat children following advice from a specialist haematologist (blood doctor).

  • The dose is usually no more than 5 mg.
  • Some children may also need a blood transfusion.

The doctor will usually check the child’s blood for the levels of clotting factors, 2 to 6 hours after they have Konakion MM and, if necessary, give more doses of Konakion MM.

If you are given more Konakion MM than you should

Because Konakion MM is given by a doctor or nurse, it is unlikely that you or your child will be given too much or that you or your child will miss a dose. However, if you are worried talk to your doctor or nurse.

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

4. Possible side effects

Like all medicines Konakion MM may cause side effects, although not everyone will get them.

The following side effects may happen with this medicine:

Allergic reactions

The signs may include:

  • Swelling of the throat, face, lips and mouth. This may make it difficult to breathe or swallow.
  • Sudden swelling of the hands, feet and ankles.

If you have an allergic reaction, tell a doctor straight away.

A reaction where the injection was given

The signs may include swelling and redness along the vein where the medicine was given, which is very tender or painful when touched.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

5. How to store Konakion MM

  • Your doctor or pharmacist is responsible for storing Konakion MM. They are also responsible for disposing of any unused Konakion MM correctly.
  • Keep out of the sight and reach of children.
  • Do not use Konakion MM after the expiry date printed on the pack.
  • Konakion MM ampoules should be stored at a temperature below 25°C.

6. Contents of the pack and other information

What Konakion MM contains

The active substance in Konakion MM Ampoules 10 mg/ml is vitamin K1 (phytomenadione). Each 1 ml of liquid medicine contains 10 mg vitamin K1.

Other ingredients are glycocholic acid, sodium hydroxide, lecithin, hydrochloric acid and water for injections.

What Konakion MM looks like and contents of the pack

Konakion MM is a slightly opalescent, pale yellow liquid (‘solution for infusion’). This liquid will be further diluted to make it weaker before it is given to you.

Konakion MM is supplied in amber coloured glass ampoules in packs of 10.

Marketing Authorisation Holder and Manufacturer

Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

This leaflet was last revised in August 2016

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