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TROLACTIN 200MG PROLONGED-RELEASE HARD CAPSULES

Active substance(s): DIPYRIDAMOLE / DIPYRIDAMOLE / DIPYRIDAMOLE

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Package leaflet: Information for the user

Trolactin 200mg
Prolonged-release
Hard Capsules
dipyridamole
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
pharmacist.
•  This medicine has been
prescribed for you only. Do
not pass 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 or pharmacist.
This includes any possible side
effects not listed in this leaflet.
See section 4.
•  The full name of this medicine
is Trolactin 200mg Prolongedrelease Hard Capsules but
within the leaflet it will be
referred to as Trolactin.

What is in this leaflet
1 W
 hat Trolactin is and what
it is used for
2 W
 hat you need to know
before you take Trolactin
3 H
 ow to take Trolactin
4 P
 ossible side effects
5 H
 ow to store Trolactin
6 C
 ontents of the pack and
other information
1 W
 hat Trolactin is and what

it is used for

Trolactin contains the active
substance dipyridamole. This
belongs to a group of medicines
called ‘anti‑thrombotic agents’,
which are used to stop blood
clots forming.
Trolactin is used:
• To reduce the risk of having
another stroke in people who
have had a stroke caused by a
blood clot in the brain.

2 W
 hat you need to know

before you take Trolactin
Do not take Trolactin:
• if you are allergic to

dipyridamole or any of the other
ingredients of this medicine
(listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist
before taking Trolactin:
• If you have angina or other
heart diseases or have had a
recent heart attack
• If you have myasthenia gravis
(muscle weakness)
• If you have any bleeding
problems.

If you are having heart tests

Trolactin contains dipyridamole.
Dipyridamole is also sometimes
given as an injection during tests
to see if the heart is working
properly (also called ‘myocardial
imaging’). This means that the
test and your medicine may
contain the same substance.
If you are going to have an
injection of dipyridamole, tell
the doctor that you are taking
Trolactin.

Children and adolescents

Trolactin should not be given
to children since the safety and
efficacy has not been established.

Other medicines and
Trolactin

Tell your doctor or pharmacist
if you are taking, have recently
taken or might take any other
medicines. This includes herbal
medicines. This is because
Trolactin can affect the way some
other medicines work. Also some
other medicines can affect the
way Trolactin works.
In particular, tell your doctor or
pharmacist if you are taking any
of the following medicines:
• Medicines for high blood
pressure
• Medicines for muscle weakness
(myasthenia gravis), called a
‘cholinesterase inhibitor’

• Adenosine, used for heart
problems or tests on the heart
• Warfarin, acetylsalicylic acid or
other medicines to stop blood
clots forming
• Theophylline (a medicine for
respiratory problems).

Pregnancy and breastfeeding

If you are pregnant or breast‑
feeding, think you may be
pregnant or are planning to have
a baby, ask your doctor for advice
before taking this medicine.
Trolactin should generally not be
used in pregnancy.
Trolactin should only be used
during breast‑feeding if your
doctor considers it essential,
since dipyridamole is excreted in
breastmilk.

Driving and using machines
You may feel dizzy while taking
Trolactin. If this happens do
not drive or use any tools or
machines.

3 H
 ow to take Trolactin
Always take this medicine
exactly as your doctor has told
you. Check with your doctor or
pharmacist if you are not sure.
The recommended dose is one
capsule twice a day, usually one
in the morning and one in the
evening.
The capsules may be taken with
or without food.
Swallow the capsule whole. Do
not crush or chew it.

If you take more Trolactin
than you should

If you take more of this medicine
than you should, talk to a doctor
or go to a hospital straight away.
Take the medicine pack with you,
even if there are no capsules left.
Symptoms such as feeling warm,
flushes, sweating, faster pulse,
restlessness, feeling of weakness,
dizziness, drop in blood pressure
and chest pain can be expected.

If you forget to take Trolactin
If you forget a dose, take it
as soon as you remember it.
However, if it is time for the next
dose, skip the missed dose.
Do not take a double dose to
make up for a forgotten dose.

If you stop taking Trolactin

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

4 Possible side effects
Like all medicines, this medicine
can cause side effects, although
not everybody gets them.

Allergic reactions

If you have an allergic reaction,
stop taking your medicine and
see a doctor straight away.
The signs may include feeling
breathless, runny nose, severe
rash with itching, swelling and
swelling around the eyes.
Other side effects that have
been reported for Trolactin are
described below.
Very common (may affect more
than 1 in 10 people)
• Headache
• Feeling dizzy
• Feeling sick (nausea)
• Diarrhoea.
Common (may affect up to 1 in
10 people)
• Muscle pain
• Being sick (vomiting)
• Worsening of the symptoms of
heart disease such as chest pain
and shortness of breath.
Not known (frequency cannot
be estimated from the available
data)
• Hot flushes
• Lowering of blood pressure or
increased heart rate

Continued top of next column
AAAJ2369

Continued over page

Dipyridamole (Trolactin) 200mg 60 Capsules PIL - UK
item no: AAAJ2369

dimensions: 145 x 600

print proof no: 4

pharmacode:

origination date: 26.08.16

min pt size: 11

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 23.09.16

Technical Approval

revised by: S.Anson

date sent: 26.08.16

supplier: Actavis Bulgaria Dupnitsa

technically app. date: 30.08.16

Non Printing Colours
1.
2.
3.

* Please note that only Actavis Global Artwork Studios are permitted to make
changes to the above artwork. No changes are permitted by any 3rd party
other than added notes and mark ups for required changes.

• A blood problem called
‘thrombo‑cytopenia’ which can
cause bruising and prolonged
bleeding from wounds,
including during or after
surgery.
In people who have gallstones,
the dipyridamole in this medicine
can be absorbed into the
gallstones.

Reporting of side effects

If you get any side effects, talk to
your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet.
You can also report side effects
directly via the Yellow Card
Scheme Website:
www.mhra.gov.uk/yellowcard
By reporting side effects you can
help provide more information
on the safety of this medicine.

5 H
 ow to store Trolactin
Keep this medicine out of the
sight and reach of children.
Store in the original package in
order to protect from moisture.
Keep the bottle tightly closed.
Do not use this medicine after
the expiry date which is stated
on the label and carton after EXP.
The expiry date refers to the last
day of that month.
Shelf life after first opening:
100 days
Do not throw away any
medicines via wastewater or
household waste. Ask your
pharmacist how to throw away
medicines you no longer use.
These measures will help protect
the environment.

6 C
 ontents of the pack and

other information

What Trolactin contains

• The active substance is
dipyridamole. Each prolongedrelease capsule contains
dipyridamole 200mg. Trolactin
is a prolonged- release capsule
which releases the active
substance slowly in your body
over a number of hours.
• The other ingredients are:
Capsule content: Tartaric acid,
hypromellose, hydroxypropyl
cellulose, methacrylic acid –
methyl methacrylate copolymer
(1:2), triethyl citrate.
Capsule shell: Gelatin, titanium
dioxide (E171) and red iron
oxide (E172).

What Trolactin looks like and
contents of the pack
Trolactin 200mg Prolongedrelease Hard Capsules are
reddish-brown (orange) hard
capsules, 23.5mm.

Trolactin is available in packs of
60 capsules.
Marketing Authorisation
Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria
This leaflet was last revised in
September 2016.

If you would like a
leaflet with larger
text, please contact
01271 385257.

Actavis, Barnstaple, EX32 8NS, UK

AAAJ2369

Dipyridamole (Trolactin) 200mg 60 Capsules PIL - UK
item no: AAAJ2369

dimensions: 145 x 600

print proof no: 4

pharmacode:

origination date: 26.08.16

min pt size: 11

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 23.09.16

Technical Approval

revised by: S.Anson

date sent: 26.08.16

supplier: Actavis Bulgaria Dupnitsa

technically app. date: 30.08.16

Non Printing Colours
1.
2.
3.

* Please note that only Actavis Global Artwork Studios are permitted to make
changes to the above artwork. No changes are permitted by any 3rd party
other than added notes and mark ups for required changes.

Expand Transcript

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.

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