Phenindione 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Phenindione

Available from:

Advanz Pharma

ATC code:

B01AA02

INN (International Name):

Phenindione

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02080200; GTIN: 5021691108450

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PHENINDIONE 10 MG TABLETS, PHENINDIONE 25 MG TABLETS
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, pharmacist or nurse.
- This medicine has been prescribed for you only.
Do not pas
s it on to others. It may harm them,
even if their signs of illness are the same as
yours.
- If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
The name of your medicine is Phenindione 10 mg
Tablets, Phenindione 25 mg Tablets. It will be referred to
as ‘Phenindione Tablets’ for ease hereafter.
WHAT IS IN THIS LEAFLET
1. What Phenindione Tablets are and what they are
used for
2. What you need to know before you take
Phenindione Tablets
3. How to take Phenindione Tablets
4. Possible side effects
5. How to store Phenindione Tablets
6. Contents of the pack and other information
1. WHAT PHENINDIONE TABLETS ARE
AND WHAT THEY ARE USED FOR
Phenindione Tablets (either 10 or 25 mg) belong to a
group of medicines called anticoagulants. These
medicines increase the time it takes for your blood to
clot.
Phenindione is used to prevent and treat blood clots
in the veins and arteries, for example clots in the legs,
lungs, brain or heart.
The tablets come in two strengths: 10 mg (creamy
white) and 25 mg (green).
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE PHENINDIONE TABLETS
DO NOT TAKE PHENINDIONE TABLETS
• if you are allergic to Phenindione or any of the
other ingredients of this medicine (listed in
section 6)
• if you have severe liver or kidney problems
• if you are pregnant or trying for a baby
• if you within the last 72 hours have had an
operation or you have given birth within the last
48 hours
• if you are currently breast-feeding
• if you suffer from any unusual bruising or bleeding
• if you suffer from u

Summary of Product characteristics

OBJECT 1
PHENINDIONE 10MG TABLETS
Summary of Product Characteristics Updated 28-Jul-2017 | ADVANZ Pharma
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Dindevan 10mg Tablets
Phenindione 10mg Tablets
2. Qualitative and quantitative composition
Each tablet contains 10mg phenindione.
Excipient with known effect:
Each tablet contains -30mg lactose
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
Creamy, white, flat, bevel-edged uncoated tablets, scored on one side,
engraved D10 on the scored side.
The score line is not intended for breaking the tablet.
4. Clinical particulars
4.1 Therapeutic indications
Dindevan (Phenindione BP) is a synthetic anticoagulant which acts by
interfering with the formation of
clotting factors II, VII, IX and X. It produces its effect in 36-48
hours after the initial dose; the effect
wanes over a period of 48-72 hours after Dindevan is stopped.
Anticoagulant therapy can be initiated with Heparin and Dindevan
togethe