Clasteon 800mg tablets

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Sodium clodronate

Tillgänglig från:

Kent Pharma (UK) Ltd

ATC-kod:

M05BA02

INN (International namn):

Sodium clodronate

Dos:

800mg

Läkemedelsform:

Oral tablet

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 06060200; GTIN: 5060061160964

Bipacksedel

ABXP225BNG
CLASTEON 800MG FILM-COATED TABLETS
(SODIUM CLODRONATE)
Please read this leaflet carefully before taking Clasteon
tablets.
Keep the leaflet in case you need to refer to it again. If you
want to know more about Clasteon tablets or have any
questions, you should ask your doctor or pharmacist.
What is in this leaflet
1.What Clasteon tablets are used for
2.What you need to know before taking Clasteon tablets
3.How to take Clasteon tablets
4.Possible side effects
5.How to store this medicine
6.Contents of the pack and other information
1. W
HAT C
LASTEON T
ABLETS
ARE
USED
FOR
Clasteon tablets contain sodium clodronate, which is one of a
group of medicines known as bisphosphonates. These
medicines help prevent loss of calcium from bones.
Clasteon tablets are used to manage bone diseases,
particularly those associated with cancer. They also help to
maintain normal levels of calcium in your blood.
2. W
HAT
YOU
NEED
TO
KNOW
BEFORE
TAKING
CLASTEON
TABLETS
YOU MUST NOT TAKE CLASTEON TABLETS AND SHOULD TALK TO
YOUR DOCTOR IF:
●
you are allergic to sodium clodronate, similar medicines or
any of the ingredients (listed in section 6)
●
you have very poor kidney function
●
you are pregnant or breast feeding
●
you are already taking a similar medicine (containing
bisphosphonates).
TELL YOUR DOCTOR IF:
●
you have ever had/have pain, numbness or swelling of your
jaw or a heavy jaw feeling or loosening of a tooth
●
you are having dental treatment or will undergo dental
surgery, tell your dentist that you are being treated with a
bisphosphonate (Sodium clodronate). Certain types of
dental treatment are not recommended while taking
bisphosphonates
●
you have problems with your kidneys.
OTHER MEDICINES AND CLASTEON
Tell your doctor or pharmacist if you are taking or have
recently taken any other medicine including those obtained
without a prescription.
This is particularly important if you are taking any of the
following:
●
antibiotics
●
non-steroidal anti-inflammatory medicines such as
ibuprofen or diclofen

Produktens egenskaper

OBJECT 1
CLASTEON 800MG TABLETS
Summary of Product Characteristics Updated 05-Dec-2022 | Beacon
Pharmaceuticals / Kent Pharma UK Ltd
•
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
CLASTEON
®
800mg film-coated tablets
2. Qualitative and quantitative composition
Each tablet contains 1000mg of disodium clodronate tetrahydrate,
equivalent to 800mg of anhydrous sodium
clodronate. Each tablet contains 128.24 mg sodium. For a full list of
excipients, see 6.1.
3. Pharmaceutical form
Film coated tablets.
White, oval, convex tablet with breakline. The scoreline is only to
facilitate breaking for ease of swallowing
and not to divide into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Sodium clodronate is indicated for the management of osteolytic
lesions, hypercalcaemia and bone pain
associated with skeletal metastases in patients with carcinoma of the
breast or multiple myeloma. Sodium
clodronate tablets are also indicated for the maintenance of
clinically acce