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DOSULEPIN 25MG CAPSULES

Active substance(s): DOSULEPIN HYDROCHLORIDE

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TEVA UK Ref:












HOW TO TAKE DOSULEPIN

Version:

2

The usual dose is:
Adults:
The usual starting dose is 1 tablet or 3 capsules a
day. Your doctor may ask you to increase this.
Your doctor will tell you if you should take the
tablets/capsules as separate doses throughout the
day, or a single dose each evening, usually a
couple of hours before you go to bed. Normally,
not more than 3 tablets or 9 capsules should be
taken each day.

It may take two to four weeks of treatment before
you begin to see an improvement in your mood
although you might feel there is an improvement
in your anxiety symptoms before then. It is
important that you keep taking this medicine until
your doctor tells you to stop.

The tablets/capsules should be swallowed whole
with a drink of water. Do not chew the
tablets/capsules as you may get a bitter taste in
your mouth and a temporary numbness of your
tongue.

Your doctor will tell you how many
tablets/capsules to take and when you should
take them. This will also be on the carton label.
Ask your pharmacist or doctor for help if you are
not sure how to take your tablets/capsules or if
you want more information. The following
information is given as a guide only:

3

Dosulepin tablets also contain a colour called
sunset yellow which may cause allergic reactions.

Important information about some of the
ingredients of Dosulepin tablets and capsules
Dosulepin tablets contain a sugar called sucrose
and Dosulepin capsules contain a sugar called
lactose. If you have been told by your doctor that
you have an intolerance to some sugars, contact
your doctor before taking this medicine.

If you drink alcohol with these tablets/capsules,
this can make the feeling of drowsiness worse.

Driving and using machines
These tablets/capsules can make you feel drowsy.
Do not drive, operate machinery or do anything
that requires you to be alert until you know how
the tablets/capsules will affect you. Feeling
drowsy in the day can improve with time, but if
drowsiness becomes a problem, you should tell
your doctor.

Pregnancy and breast-feeding
If you are or think you might be pregnant or you
plan to become pregnant, or if you are
breast-feeding you must tell your doctor before
you take this medicine. Your doctor will decide if
you can take this medicine.

Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained without
a prescription.

A medicine used to treat depression called a
mono-amine oxidase inhibitor (MAOI). You
should not take Dosulepin tablets/capsules at
the same time as MAOIs or within 14 days of
stopping them.
Other medicines used to treat depression called
SSRIs (selective serotonin re-uptake inhibitors)
Any medicines given to you for treating high
blood pressure (hypertension)
Any hay fever/allergy medicines which contains
terfenadine or astemizole
Sotalol (a medicine for heart or blood pressure
problems) or halofantrine (a medicine for
malaria)
Any medicines called barbiturates (e.g.
phenobarbital for fits, amylobarbitone for
sleeplessness) or methylphenidate (used to
treat behavioural problems)
Any medicine that contains an opioid (these
include codeine, morphine, co-proxamol and
co-dydramol)
Medicines called sympathomimetic agents these include ephedrine, pseudoephedrine,
adrenaline and noradrenaline (these may be
found in medicines used to treat heart
problems and asthma as well as some
decongestants and cough/cold remedies).

231-30-67594-ZC LEA DOSULEPIN 25mg CAP AND 75mg TAB TUK

PAGE 1: FRONT FACE (INSIDE OF REEL)

DOSULEPIN CAPSULES 25 mg AND
DOSULEPIN TABLETS 75 mg
PACKAGE LEAFLET: INFORMATION
FOR THE USER

IN THIS LEAFLET:

Read all of this leaflet carefully before you start
taking this medicine.
• 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. Do
not pass it on to others. It may harm them,
even if their symptoms 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.

WHAT DOSULEPIN IS AND WHAT IT IS
USED FOR

1. What Dosulepin is and what it is used for
2. Before you take Dosulepin
3. How to take Dosulepin
4. Possible side effects
5. How to store Dosulepin
6. Further information

1

BEFORE YOU TAKE DOSULEPIN

Dosulepin belongs to a group of medicines called
antidepressants. Dosulepin is used to treat
depression and can also help reduce feelings of
anxiety. This medicine will only be used when
other medicines have been found to be
unsuitable. Please ask your doctor or pharmacist
if you need more information.

2
DO NOT take Dosulepin tablets/capsules and
speak to your doctor if:
• you know that you are allergic (hypersensitive)
to dosulepin or any of the other ingredients
(listed in section 6 of this leaflet) in Dosulepin
tablets and capsules
• you have an irregular heart beat or any other
heart problems
• you have liver problems
• you have an eye condition known as glaucoma
• you are a man that has prostate problems
(difficulty in passing water)
• you have been diagnosed as having mania
(feeling over-excited with unusual behaviour)
• you have fits (epilepsy).
Dosulepin should not be given to children.
Take special care with Dosulepin if:
• you are going to have general or dental
surgery, tell your surgeon you are taking
Dosulepin. It may affect the anaesthetic used.
Thoughts of suicide and worsening of your
depression or anxiety disorder
If you are depressed and/or have anxiety
disorders you can sometimes have thoughts of
harming or killing yourself. These may be
increased when first starting antidepressants,
since these medicines all take time to work,
usually about two weeks but sometimes longer.
You may be more likely to think like this:
• If you have previously had thoughts about
killing or harming yourself.
• If you are a young adult. Information from
clinical trials has shown an increased risk of
suicidal behaviour in adults (less than 25 years
old) with psychiatric conditions who were
treated with an antidepressant.
If you have thoughts of harming or killing yourself
at any time, contact your doctor or go to a
hospital straight away.
You may find it helpful to tell a relative or close
friend that you are depressed or have an anxiety
disorder, and ask them to read this leaflet. You
might ask them to tell you if they think your
depression or anxiety is getting worse, or if they
are worried about changes in your behaviour.
Taking other medicines
You should tell your doctor if you are taking or
have taken any of the following medicines as they
may affect how your Dosulepin tablets/capsules
work:

29 May 2015

Page 1 of 3
Approved
Version 2.5
REG0061845

Pharma code
1600

Top of page cut-off to middle of registration mark: 44 mm.

TEVA UK Ref:

231-30-67594-ZC LEA DOSULEPIN 25mg CAP AND 75mg TAB TUK

PAGE 2: REAR FACE (OUTSIDE OF REEL)

FURTHER INFORMATION

Version:

2

• The other ingredients in the capsules are
lactose monohydrate, maize starch, povidone,
sodium starch glycolate and magnesium
stearate (E572). The capsule shell contains
gelatin, red iron oxide (E172), yellow iron oxide
(E172), black iron oxide (E172), erythrosine
(E127) and titanium dioxide (E171). The printing
ink contains shellac, black iron oxide (E172) and
propylene glycol (E1520).

• The other ingredients in the tablets are calcium
phosphate, maize starch, povidone, sodium
carboxymethylcellulose, magnesium stearate
(E572), hydrolysed gelatin, sucrose and talc
(E553). The coating of the tablets also contains
small amounts of sucrose, shellac, carnauba
wax, beeswax, sodium benzoate, titanium
dioxide (E171), ponceau red (E124), sunset
yellow (E110) and indigotine (E132). The
printing ink contains shellac, black iron oxide
(E172) and propylene glycol (E1520).

• The active substance in both tablets and
capsules is dosulepin hydrochloride.

What Dosulepin contains

6

If your doctor decides to stop the treatment, you
must return any left over tablets to your
pharmacist. Only keep the tablets/capsules if your
doctor tells you to.

Do not take this product after the 'use by' date
Elderly:
The usual starting dose is 1 tablet or between 1 and shown on the carton.
3 capsules a day.
If you stop taking Dosulepin
Do not stop taking these tablets/capsules just
because you feel better. If you stop taking this
medicine too soon, your condition may get
worse. If your doctor wants you to stop taking
these tablets/capsules, your doctor will ask you to
stop gradually.
If you forget to take Dosulepin
Do not worry. Simply leave out that dose
completely and then take your next dose at the
right time. Do not take a double dose to make up
for a forgotten tablet/capsule. If you are unsure,
check again with your doctor or pharmacist.
If you take more tablets/capsules than you should
You should only ever take the number of
tablets/capsules that your doctor has told you to
take. Do not change the dose yourself. If you think
your tablets/capsules are not working well
enough, speak to your doctor to see if the dose
can be increased.

POSSIBLE SIDE EFFECTS

These tablets/capsules may seriously harm you
and may be life threatening if you take too many.
You should seek immediate help if a child takes
any tablets/capsules or if you or anybody else
accidentally takes too many tablets/capsules.
Remember to take the pack with you, even if it is
empty.

4

TEVA UK Limited
Eastbourne
East Sussex
BN22 9AG
United Kingdom
This leaflet was last revised: May 2015
PL 00289/0108
PL 00289/0158

67594-ZC
160 x 323

Marketing Authorisation Holder and Company
responsible for manufacture is

Not all pack sizes may be marketed.

Dosulepin Capsules are available in pack sizes of
10, 14, 20 and 28.
Dosulepin Tablets are available in pack sizes of 14
and 28.

Dosulepin tablets are red coded with ‘APS’ or
plain on one side and ‘75/1129’ on the reverse.
Dosulepin capsules are brown/pink printed ‘3D2
25’.

Like all medicines, Dosulepin tablets/capsules can What Dosulepin looks like and contents of the
pack
cause side effects, although not everybody gets
them.
If you get any of the following symptoms after
taking these tablets/capsules, you should contact
your doctor immediately:
• a fever (high temperature, sweating, shivering)
• discomfort around the right lower rib cage
• hepatitis (damage to the liver causing dark
urine, jaundice (yellowing of the skin or whites
of the eyes), nausea and fever).
The most common side effects (that affect less
than 1 person in 10) are:
• dry mouth
• blurred vision
• changes in the heart beat
• constipation and difficulty in passing water.
These side effect tend to improve with time.
Other side effects you may also experience are:
• drowsiness
• increased sweating
• skin rashes
• tremor (shaking)
• changes in sexual function
• low blood pressure, which may cause dizziness
or fainting.
Rare side effects (that affect less than 1 person in
1000) are:
• changes in the blood and changes in hormone
levels (these will be found if you have blood
tests)
• severe mood changes such as extreme
excitability
• fits.
An increased risk of bone fractures has been
observed in patients taking this type of medicine.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

HOW TO STORE DOSULEPIN

By reporting side effects you can help provide
more information on the safety of this medicine.

5

Keep these tablets/capsules in the original
container, and in a safe place (preferably a locked
cupboard) where children cannot see or reach
them. Your medicine could seriously harm them.

29 May 2015

Page 2 of 3
Approved
Version 2.5
REG0061845

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2
mockup-pil-uk-pl-00289-0108-0158-dosulepin-75mg-tablet-25mg-capsule

APPROVALS
Signed by
Arun Ramachandran

REG0061845

Meaning of Signature
Regulatory Affairs Approval

Version 2.5

Approved

Server Date
08-Jun-2015 10:59:25 AM

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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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