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GBR 726-4039-APIL
Patient Information Leaflet

Dosulepin 75 mg Tablets Dosulepin hydrochloride
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 any of the side effects becomes severe, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Dosulepin is and what it is used for
2. Before you take Dosulepin tablets
3. How to take Dosulepin
4. Possible side effects
5. How to store Dosulepin
6. Further information
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.
Do not take Dosulepin tablets 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;
• 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).

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 aged less than 25 years
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 work:
• A medicine used to treat depression called a mono-amine oxidase
inhibitor (MAOI). You should not take Dosulepin tablets 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
• Any hayfever/allergy medicines which contains terfenadine or
• Sotalol (a medicine for heart or blood pressure problems) or
halofantrine (a medicine for malaria).
• Any medicines called barbiturates (e.g. phenobarbitone 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).

Take special care with Dosulepin tablets if:
Please tell your doctor or pharmacist if you are taking or have
• you are going to have general or dental surgery. Tell your surgeon recently taken any other medicines, including medicines obtained
or dentist you are taking Dosulepin tablets. It may affect the without a prescription.
anaesthetic used.
Pregnancy and breast-feeding
Thoughts of suicide and worsening of your depression or
If you are or think you might be pregnant or you plan to become
anxiety disorder
pregnant, or if you are breast-feeding you must tell your doctor before you
If you are depressed and/or have anxiety disorders you can sometimes take this medicine. Your doctor will decide if you can take these tablets.
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.

SIZE : 210 X 140 (mm) Front
Dt. 21/01/06

Driving and using machine
These tablets 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 will
affect you. Feeling drowsy in the day can improve with time, but if drowsiness
becomes a problem, you should tell your doctor.

taking these tablets, you should contact your
doctor immediately:
• yellowing of skin or whites of the eyes (jaundice);
• a fever (high temperature, sweating, shivering);
• discomfort around the right lower rib cage;
• hepatitis (damage to the liver causing dark urine,
jaundice, nausea and fever).

If you drink alcohol with these tablets this can make the feeling of drowsiness
Important information about some of the ingredients of
Dosulepin tablets
These tablets contain a colour called ponceau 4R which may cause allergic

The most common side effects
(that affect less than 1 person in 10) are:
• dry mouth;
• blurred vision;
• changes in heart beat;
• constipation and difficulty in passing water.
These side effects tend to improve with time.

Your doctor will tell you how many tablets 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 or if you want more information.
The following information is given as a guide only:

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.

The tablets should be swallowed whole with a drink of water. Do not chew the
tablets as you may get a bitter taste in your mouth and a temporary numbness Rare side effects (that affect less than 1 person in 1000) are:
of your tongue.
• changes in the blood and changes in hormone levels
(these will be found if you have blood tests);
Adults: The usual starting dose is 1 tablet a day. Your doctor may ask you to • severe mood changes such as extreme excitability;
increase this to 2 or 3 tablets a day. Your doctor will tell you if you should take • fits.
the tablets as separate doses throughout the day, or a single dose each evening, An increased risk of bone fractures has been observed in patients
usually a couple of hours before you go to bed. Normally, not more than taking these types of medicines.
3 tablets should be taken each day.
If any of these side effects becomes severe, or if you notice
any side effects not listed in this leaflet, please tell your
Elderly: The usual starting dose is 1 tablet a day.
doctor or pharmacist.
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 5.
Keep these tablets in the original container, and in a safe place
symptoms before then. It is important that you keep taking these tablets until (preferably a locked cupboard) where children cannot see or reach
your doctor tells you to stop.
them. Your medicine could seriously harm them.
Dosulepin tablets are not recommended for children.

Do not take this product after the 'use by' date shown on the carton.

If you stop taking Dosulepin
Do not stop taking these tablets just because you feel better. If you stop taking
the tablets too soon, your condition may get worse. If your doctor wants you to
stop taking these tablets, your doctor will ask you to stop gradually.

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

What Dosulepin contains
- The active substance is dosulepin hydrochloride.
If you forget to take Dosulepin
Do not worry. Simply leave out that dose completely and then take your next - The other ingredients are tricalcium phosphate, maize
starch, povidone and magnesium stearate.
dose at the right time. Do not take a double dose to make up for a forgotten
- The coating of the tablets also contains small amounts of talc,
tablet. If you are unsure, check again with your doctor or pharmacist.
polyethylene glycol, lecithin, ponceau 4R (E124),
quinoline yellow (E104), titanium dioxide (E171) and
If you take more tablets than you should
indigo carmine (E132).
You should only ever take the number of tablets that your doctor has told you
Dosulepin looks like and contents of the pack
to take. Do not change the dose yourself. If you think your tablets are not working
well enough, speak to your doctor to see if the dose can be increased.
Dosulepin tablets are red.
These tablets may seriously harm you and may be life threatening if you take Dosulepin is provided in calendar packs of 28 tablets.
too many tablets. You should seek immediate help if a child takes any tablets
or if you or anybody else accidentally takes too many tablets. Remember to Marketing Authorisation Holder and Manufacturer responsible
for release:
take the pack with you, even if it is empty.
Waymade PLC, trading as Sovereign Medical
Sovereign House
Miles Gray Road
Like all medicines, Dosulepin tablets can cause side
effects, although not everybody gets them.
If you get any of the following symptoms after
SS14 3FR
United Kingdom.
This leaflet was last approved in January 2011

SIZE : 210 X 140 (mm) Back
Dt. : 21/01/06

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Further information

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