Skip to Content

TRIENTINE DIHYDROCHLORIDE CAPSULES 300MG

Active substance(s): TRIENTINE DIHYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
trientine
dihydrochloride
capsules
#cjj mg

1000009814

TRIENTINE DIHYDROCHLORIDE
CAPSULES 300mg

Aesica Queenborough Ltd.
North Road, Queenborough,
Kent ME11 5EL UK

Content: 100 capsules
Active Ingredient: Trientine Dihydrochloride 300mg
equivalent to 200mg of Trientine base.
Dosage: Up to 8 capsules per day, to be taken orally
an directed by your physician, divided up into 2-4 smaller
doses throughout the day. Take 30 mins to 1 hour before
food. lf taking iron supplements or antacid indigestion
remedies, these should be taken after food.
Stoage: Store in original container in the fridge
between 2 and 8°C.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
Use within 3 month of firs opening
PL 41626/0001
Marketing Authorisation Holder:


Univar BV



Schouwburgplein 30-34,



3012 CL Rotterdam.

POM


The Netherlands

1

NOTE: Artwork studio checks pre-press suitability of this artwork
only. Ensure the artwork has been thoroughly checked for textual
accuracy and has been approved as such!

Product name: Trientine GB
Creation date: 03/Mar/2016
DCMF No: 90567
Operator: TC
Commodity: 1000009814
Ref no: AO0316-001
Core spec size: 100x60 Lab/Leaf
Revision: Update received via Univar to update lable Leaflet
Amended by: TC
Page no: 1 of 16

Approved by:

Modification date: 21/Mar/2016

Date:

Braille text:
trientine
dihydrochloride
capsules
300 mg

trientine
dihydrochloride
capsules
#cjj mg
Font size body text: 7pt
Pharma code: 518
Colours:
Black
Pantone 312 C
Tech Info

Proof no: 02

For QA Use Only
Issued by:

Date

TRIENTINE DIHYDROCHLORIDE
CAPSULES 300mg
1x100 capsules
Read all of this leaflet carefully before
you start taking this medicine.
• Keep this leaflet. You might need to
read it again.
• If you have any further questions, ask
your doctor or pharmacist.
• This medicine has been prescribed
for you. Do not pass it on to others.
It may harm them, even if their
symptoms are the same as yours.
2

• If any of the side effects get serious, or
if you notice any side effect not listed
in this leaflet please tell your doctor or
pharmacist.
In this leaflet
1. What Trientine Dihydrochloride is and
what it is used for
2. Before you take Trientine
Dihydrochloride
3. How to take Trientine Dihydrochloride
4. Possible side effects
5. How to store Trientine Dihydrochloride
6. Further information

3

1. WHAT TRIENTINE
DIHYDROCHLORIDE IS
AND WHAT IT IS USED FOR
Trientine Dihydrochloride is used for the
treatment of Wilson’s disease which is
caused by having too much copper in your
body. It is used in patients who cannot
tolerate D-Penicillamine treatment.
Trientine Dihydrochloride is a chelating
agent. It controls the amount of copper in
the body by binding to it. The copper can
then be passed from the body.

2. BEFORE YOU TAKE
Trientine Dihydrochloride
Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Iron preparations and acid indigestion
remedies may be taken but at a different
time of day than Trientine Dihydrochloride.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice
before taking any medication. If you
become pregnant or are planning to

4

5

become pregnant, you must tell your
doctor. You and your doctor can fully
discuss the potential benefits of treatment
whilst considering any possible risks that
there may be with continuing treatment.
Pregnant women should be monitored
throughout pregnancy for any effects on
the baby or changes in copper levels in
the blood.

6

3. HOW TO TAKE TRIENTINE
DIHYDROCHLORIDE
Always take Trientine Dihydrochloride
exactly as your doctor has told you.
You should check with your doctor or
pharmacist if you are not sure.
Adults (including the elderly)

Babies born to mothers being treated
with Trientine Dihydrochloride should be
monitored for blood levels of copper and
ceruloplasmin.

The usual dose is between 4 and 8
capsules per day, to be taken orally.

Driving and using machines
Trientine Dihydrochloride is not known
to affect your ability to drive or operate
machinery.

In children, the dosage depends on age
and body weight and will be adjusted by
your doctor. At the start of treatment the

Children

7

dosage varies between 2 and 5 capsules,
to be taken orally.
Adults and children
The total daily dose should be divided into
2 to 4 smaller doses. Capsules should be
swallowed with a drink of water 30 minutes
to 1 hour before food.
If you take more Trientine
Dihydrochloride than you should
If you take an overdose contact your
doctor.
If you miss one of your doses
If you forget to take one or more doses,
take another dose as soon as possible
8

then continue as your doctor has
prescribed. Do not take a double dose to
make up for a forgotten dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Trientine
Dihydrochloride can cause side effects,
although not everybody gets them.
Occasionally, treatment with Trientine
Dihydrochloride can cause inflammation
of the small intestine or colon. If you
experience any of the following side effects
contact your doctor immediately.
• severe stomach pains
• persistent diarrhoea

9

Other side effects may include:
• nausea (especially when starting
treatment)
• skin rashes
• anaemia (you may feel unusually tired)
If you suffer from Wilson’s disease you
should tell your doctor if you experience:
• nervous system deterioration (for
example shaking, lack of co-ordination,
slurred speech, muscle stiffness,
worsening of muscle spasms)
Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
10

any possible side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow Card Scheme
at https://yellowcard.mhra.gov.uk/. By
reporting side effects you can help provide
more information on the safety of this
medicine.
5. HOW TO STORE Trientine
Dihydrochloride
Keep out of the sight and reach of children.
Store in the original container (also keep
the silica gel sachet in the bottle) in order
to protect from moisture. Store in a
refrigerator (20C -80C). Do not freeze.

11

Do not use after the expiry date which is
stated on the bottle label. The expiry date
refers to the last day of the month. Use
within 3 months after first opening. Do not
use if capsules become sticky or wet.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines
no longer required. These measures will
help to protect the environment.
6. FURTHER INFORMATION
What Trientine Dihydrochloride contains
Each gelatin capsule contains 300mg
of the active ingredient Trientine
Dihydrochloride (equivalent to 200mg of
12

Trientine base) and a very small amount
of two inactive ingredients (magnesium
stearate and colloidal anhydrous
silica which are commonly used in the
production of medicines. Also contains
gelatine and titanium dioxide (E171), and
grey ink (which contains Shellac, titanium
dioxide (E171), iron oxide black (E172), iron
oxide yellow (E172) and propylene glycol).
What Trientine Dihydrochloride looks
like and contents of the pack
100 hard gelatin capsules in an amber
glass bottle with a seal and plastic screw
cap, also containing a sachet of dried silica
gel as desiccant.

13

MA Holder:

Correspondence & Enquiries to:

Univar BV

Univar Ltd

TRIENTINE DIHYDROCHLORIDE
CAPSULES 300mg

Schouwburgplein 30-34, Bramley Road
3012 CL Rotterdam.

Milton Keynes

The Netherlands

MK1 1PT UK

Manufacturer:
Ansica Oueenborough Ltd.,
Queenborough, Kent, ME11 5EL,
United Kingdom

14

This leaflet was last approved in 03/2016

1000006996

Marketing Authorisation No: PL 41626/0001

Content: 100 capsules
Active Ingredient: Trientine Dihydrochloride 300 mg
equivalent to 200mg of Trientine base.
Dosage: Up to 8 capsules per day, to be taken orally
an directed by your physician, divided up into 2-4 smaller
doses throughout the day. Take 30 mins to 1 hour before
food. lf taking iron supplements or antacid indigestion
remedies, these should be taken after food.
Stoage: Store in original container in the fridge
between 2 and 8°C.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
Use within 3 month of firs opening
PL 41626/0001
Marketing Authorisation Holder:
Univar BV

POM

Schouwburgplein 30-34,
3012 CL Rotterdam.
The Netherlands

15

1000009814

16

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide