DOSULEPIN 75MG TABLETS

Active substance: DOTHIEPIN HYDROCHLORIDE

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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 effects tend to improve with time.
Other side effects you may also experience are:
 drowsiness or disturbed sleep
 increased sweating
 feeling sick (nausea) or an unusual taste in the mouth
 skin rashes
 confusion
 tremor (shaking)
 changes in sexual function
 low blood pressure, which may cause dizziness or fainting
 an increased risk of bone fractures has been observed in patients taking this type of mdicines.
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.
If any of these side effects becomes serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE DOSULEPIN
Keep these tablets 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.
Do not take this product after the 'use by' date shown on the carton.
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.
6. FURTHER INFORMATION
What Dosulepin tablets contain
- The active substance is dosulepin hydrochloride
- The other ingredient are lactose monohydrate, maize starch, povidone, sodium starch glycollate
and magnesium stearate.
- The coating of the tablets contains lactose monohydrate, polyethylene glycol, hypromellose and
small amounts of ponceau 4R (E124), sunset yellow (E110), yellow iron oxide (E172) and titanium
dioxide (E171).
What Dosuepin Tablets look like and contents of the pack
Dosulepin tablets are red with the marking 'MP76' on one side.
Dosulepin tablets are provided in blister packs of 14 or 28 tablets.
Marketing Authorisation Holder
Metwest Pharmaceuticals Ltd, 15 Runnelfield, Harrow on the Hill, Middlesex HA1 3NY
Manufacturer
DDSA Pharmaceuticals Limited, 310 Old Brompton Road, London SW5 9JQ, UK
This leaflet was last approved in {07/2010}.

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 serious, 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
1. WHAT DOSULEPIN IS AND WHAT IT IS USED FOR
Dosulepin belongs to a group of medicines called antidepressants. Dosulepin is used to treat
depression and can also help reduce feelings of anxiety. You will only be prescibed Dosulepin if
other medicines have been found to be unsuitable for you.
Please ask your doctor or pharmacist if you need more information.
2. BEFORE YOU TAKE DOSULEPIN TABLETS
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 or thyroid 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 are undergoing electro-shock treatment
- you have an inherited disease called porphyria
- you have a disease called phaeochromocytoma.
Dosulepin tablets should not be given to children.
Take special care with Dosulepin tablets if:
- you are going to have surgery or dental treatment. Tell your surgeon or dentist that you are taking
Dosulepin tablets as it may affect the anaesthetic used.

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 used to treat other mental health problems (antipsychotics).
 Any medicines given to you for treating high blood pressure (hypertension).
 Any medicines to treat heart beat problems (e.g. Sotalol).
 Any hay fever/allergy medicines.
 Any medicines to treat epilepsy or fits.
 Halofantrine (for malaria) or Ritonavir (a medicine for viral infection).
 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,
co-dydramol and tramadol.)
 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.)
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
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 these tablets.
Driving and using machines
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.
If you drink alcohol with these tablets, this can make the feeling of drowsiness worse.
Important information about some of the ingredients of Dosulepin tablets
These tablets 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. They also contain
colourants called penceau red and sunset yellow, which may cause allergic reactions.
3. HOW TO TAKE DOSULEPIN
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.
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 of your tongue.

Adults: The usual starting dose is 1 tablet a day. Your doctor may ask you to increase this to 2 or 3
tablets a day. Your doctor will tell you if you should take the tablets 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 should be taken each day.
Elderly: The usual starting dose is 1 tablet a 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 these tablets until your doctor tells you to stop.
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 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. If you are unsure, check again with your
doctor or pharmacist.
If you take more Dosulepin than you should
You should only ever take the number of tablets that your doctor has told you 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.
These tablets may seriously harm you and may be life threatening if you take 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 take the pack with you, even if it is empty.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Dosulepin tablets can cause side effects, although not everybody gets them
If you get any of the following symptoms after taking these tablets, you should contact your doctor
immediately:
 yellowing of the skin or whites of the eyes (jaundice)
 a fever (high temperature, sweating, shivering)
 hepatitis (damage to the liver causing dark urine, jaundice, nausea and fever)
 discomfort around the right lower rib cage.
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 trial studies has shown an increased risk of
suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated
with an anti-depressant.
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..
continued overleaf.

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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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