NOTICE
ANSM - Updated on : 22/04/2025
Product name
VITAMIN K1 CHEPLAPHARM 10 mg/1 ml, oral and injectable solution
Phytomenadione
Sidebar
Please read this leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine exactly as your doctor or pharmacist has instructed you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is VITAMIN K1 CHEPLAPHARM 10 mg/1 ml, oral and injectable solution and what is it used for?
2. What do I need to know before taking VITAMIN K1 CHEPLAPHARM 10 mg/1 ml, solution for oral use and injection?
3. How do I use VITAMIN K1 CHEPLAPHARM 10 mg/1 ml, solution for injection?
4. What are the possible side effects?
5. How to store VITAMIN K1 CHEPLAPHARM 10 mg/1 ml, solution for oral use and injection?
6. Package contents and other information.
1. WHAT IS VITAMIN K1 CHEPLAPHARM 10 mg/1 ml, oral and injectable solution AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code: ANTI-HEMORRAGICS / VITAMIN K and OTHER HEMOSTATICS (B02BA01: blood, hematopoietic organs)
This drug is recommended for the treatment and prevention of vitamin K deficiency hemorrhage in adults and children.
2. WHAT DO I HAVE TO KNOW BEFORE USING VITAMIN K1 CHEPLAPHARM 10 mg/1 ml, solution for oral and injectable use?
Never use VITAMIN K1 CHEPLAPHARM 10 mg/1 ml, oral and injectable solution:
- if you are allergic to the active substance (phytomenadione) or to any of the other ingredients listed in section 6;
- if you are allergic to larachide or soy, due to the presence of soy lecithin.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST.
Warnings and precautions
Talk to your doctor or pharmacist before using VITAMIN K1 CHEPLAPHARM 10 mg/1 ml.
Do not use this medicine if the contents of the ampoule have become cloudy or show two phases of separation.
You should inform your doctor if you (or a family member) suffer from glucose-6-phosphate dehydrogenase deficiency, as there is a risk of hemolysis (destruction of red blood cells) with vitamin K1.
NEVER LEAVE IN THE REACH OF CHILDREN.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST.
Other medicinal products and VITAMIN K1 CHEPLAPHARM 10 mg/1 ml, oral and injectable solution
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Pregnancy and breast-feeding
This medicine should only be used on the advice of your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and use of machinery
Vitamin K1 has no or negligible effect on the ability to drive vehicles and operate machinery.
VITAMIN K1 CHEPLAPHARM 10 mg/1 ml, solution for oral use and injection contains sodium and soya lecithin.
This medicine contains less than 1 mmol (23 mg) sodium per ampoule (2.64 mg sodium per 1 ml ampoule), i.e. it is essentially "sodium-free".
If you are allergic to larachide or soy, do not use this medicine (see section 2 "Never use VITAMIN K1 CHEPLAPHARM 10 mg/1 ml, solution for injection and drinking").
3. HOW TO USE VITAMIN K1 CHEPLAPHARM 10 mg/1 ml, oral and injectable solution
Dosage
Dosage and rate of administration of vitamin K1 vary according to age, indications, route of administration and results of laboratory tests.
Method of administration
Oral :
Oral administration of VITAMIN K1 CHEPLAPHARM 10 mg/1 ml, oral and injectable solution can be performed using a syringe as follows:
Open ampoules:
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Caution :
Open the ampoule with a compress (or equivalent).
"Tap the top of the ampoule to draw out the liquid. Then grasp the ampoule, with the white dot facing upwards and facing you. Cover the top of the bulb with the compress and place your thumb on the white spot. The bulb can be easily opened by applying pressure towards the back, as shown in the diagram".
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Draw up the required volume from the ampoule using a syringe fitted with its needle; then remove the needle from the syringe and inject the contents directly into the mouth; rinse mouth afterwards.
For low doses, your doctor may recommend using ampoules of Vitamin K1 CHEPLAPHARM 2 mg/0.2 ml NOURRISSONS oral and injectable solution.
Injection:
Any intravenous administration should be carried out by your doctor and/or nurse.
Frequency of administration
As prescribed by your doctor.
Duration of treatment
As prescribed by your doctor.
If you have taken more VITAMIN K1 CHEPLAPHARM 10 mg/1 ml, oral and injectable solution than you should have
In case of overdose, contact your doctor immediately.
If you forget to take VITAMIN K1 CHEPLAPHARM 10 mg/1 ml, solution for oral use and injection
Not applicable.
If you stop taking VITAMIN K1 CHEPLAPHARM 10 mg/1 ml, solution for oral use and injection
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
As with all medicines, this product may cause undesirable effects, but these do not always occur in everyone.
- Intramuscular: risk of hematoma (bruising) or bleeding disorders; exceptionally, thickening of the skin at the injection site.
- Intravenous: possible allergic reaction.
- All routes: due to the presence of soy lecithin, risk of hypersensitivity reactions (anaphylactic shock, urticaria).
IF YOU NOTICE ANY SIDE EFFECTS NOT LISTED IN THIS LEAFLET, OR IF ANY SIDE EFFECTS BECOME SERIOUS, PLEASE TELL YOUR DOCTOR OR PHARMACIST.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/...
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO CONSERVE VITAMIN K1 CHEPLAPHARM 10 mg/1 ml, oral and injectable solution?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date shown on thecarton. The expiry date refers to the last day of the month.
Store at a temperature not exceeding 25°C, protected from light.
After opening: use immediately.
Do not dispose of in the sewage system or with household waste. Ask your pharmacist to dispose of any medicines you no longer use. This will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What VITAMIN K1 CHEPLAPHARM 10 mg/1 ml, oral and injectable solution contains
- The active substance is :
Phytomenadione........................................................................................................ 10.00 mg
For one 1 ml ampoule
- The other components are :
Glycocholic acid, soy lecithin, 25% hydrochloric acid, sodium hydroxide, water for injection.
What VITAMIN K1 CHEPLAPHARM 10 mg/1 ml, oral and injectable solution is and what it contains
This medicine is available as an oral and injectable solution in 1 ml ampoules. Boxes of 3, 5, 6, 10, 25 and 30 ampoules.
Not all presentations may be marketed.
Marketing authorization holder
CHEPLAPHARM ARZNEIMITTEL GMBH
ZIEGELHOF 24
17489 GREIFSWALD
GERMANY
Marketing authorization holder
Cheplapharm France
68 Rue Marjolin
92300 Levallois-Perret
Manufacturer
CHEPLAPHARM ARZNEIMITTEL GMBH
ZIEGELHOF 23-24
17489 GREIFSWALD
GERMANY
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder]
< {MM/YYYY}>< {month/YYYY}.>
Other
Detailed information on this drug is available on the ANSM (France) website.