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DOSULEPIN 75MG TABLETS

Active substance(s): DOSULEPIN HYDROCHLORIDE / DOSULEPIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

 constipation and difficulty in passing water
These side effects tend to improve with time.

Dosulepin 75 mg Tablets

Rare (may affect up to 1 in 1,000 people):
 severe mood changes such as extreme excitability
 fits

Dosulepin hydrochloride

Not known (frequency cannot be estimated from the available data):
 drowsiness or disturbed sleep
 increased sweating
 feeling or being sick (nausea or vomiting) or an unusual taste in the mouth
 weight gain or weight loss
 increased appetite
 skin rashes
 confusion or nervousness
 tremor (shaking)
 changes in levels of sugar and sodium in the blood (seen in blood tests)
 changes in sexual function
 swelling of the breasts in men
 milk production in the breasts not related to pregnancy or breast feeding
 low blood pressure, which may cause dizziness or fainting
 impairment of movement
 abnormal body movements
 speech difficulties
An increased risk of bone fractures has been observed in patients taking this type of medicines.
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.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE DOSULEPIN
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last
day of that month.
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. CONTENTS OF THE PACK AND OTHER INFORMATION
What Dosulepin tablets contain
The active substance is dosulepin hydrochloride.
The other ingredients are lactose monohydrate 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 and plain on the other side.
Dosulepin tablets are available in blister packs of 14 or 28 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Genethics Europe Limited, 41 – 43 Klimentos, Klimentos Tower, Nicosia 1061, Cyprus
Manufacturer
DDSA Pharmaceuticals Limited, 310 Old Brompton Road, London SW5 9JQ, UK
This leaflet was last revised in 01/2017.

GE0045/O/PIL/GE2

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.
WHAT IS IN THIS LEAFLET
1. What Dosulepin is and what it is used for
2. What you need to know before you take Dosulepin
3. How to take Dosulepin
4. Possible side effects
5. How to store Dosulepin
6. Contents of the pack and other 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
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 of this medicine
(listed in section 6 of this leaflet)
 you have an irregular heart beat or any other heart problems
 you have liver problems
 you have been diagnosed as having mania (feeling over-excited with unusual behaviour)
Dosulepin tablets should not be given to children.
Warnings and precautions
Talk to your doctor or pharmacist before taking 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.
 you have a history of mania or psychoses
 you have an inherited disease called porphyria
 you have a disease called phaeochromocytoma
 you have fits (epilepsy)
 you have thyroid problems
 you are a man that has prostate problems (difficulty in passing water or enlarged prostate)
 you have an eye condition known as glaucoma
 you are undergoing electro-shock treatment
 you have severe kidney problems
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 of 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.

Dosulepin 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.

Other medicines and Dosulepin
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, as
they may affect how your Dosulepin tablets work. In particular, tell your doctor or pharmacist if you are taking
any of the following:
 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) (e.g. betanidine, debrisoquine,
guanethidine, clonidine)
 Any medicines to treat heart beat problems (e.g. amiodarone, sotalol)
 Any hay fever/allergy medicines which contains terfenadine or astemizole
 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)
 Oestrogen-containing contraceptives
 Rifampicin (an antibacterial)
 Baclofen (for muscle pain)

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.

Dosulepin and alcohol
If you drink alcohol with Dosulepin tablets, it can make the feeling of drowsiness worse.
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.
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.
Dosulepin tablets contain lactose, Ponceau Red and Sunset Yellow
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 Ponceau
Red and Sunset Yellow, which may cause allergic reactions.
3. HOW TO TAKE DOSULEPIN
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

The recommended dose is:
Adults: The usual starting dose is 1 tablets 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.

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.
Symptoms of an overdose include dry mouth, excitement, restlessness, difficulty in controlling movement,
feeling sleepy, loss of consciousness, muscle twitching, widely dilated pupils, low body temperature, confusion,
speech difficulty, hallucinations (seeing things that are not there), difficulty urinating, constipation, nausea,
vomiting, faster and irregular heartbeat, convulsion and sweating.
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 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. Withdrawal symptoms may include insomnia, irritability, headache, nausea,
giddiness, panic-anxiety, restlessness and increased sweating. If your doctor wants you to stop taking these
tablets, your doctor will ask you to stop gradually.
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.
If you get any of the following symptoms, STOP taking this medicine and contact your doctor immediately:
 have an allergic reaction, which may cause skin rash, itching, red and raised lumps (hives), swelling of
your face or tongue leading to difficulty in breathing or swallowing
 a fever (high temperature, sweating, shivering)
 hepatitis (damage to the liver causing dark urine, jaundice (yellowing of the skin or whites of the eyes),
nausea and fever)
 discomfort around the right lower rib cage
 skin sensitivity to light
 reduction in the number of red blood cells and blood platelets, which increases the risk of anaemia,
bleeding or bruising
 reduction in the number of white blood cells, which makes infections more likely
The following side effects have also been reported in patients taking Dosulepin:
Common (may affect up to 1 in 10 people):
 dry mouth
 blurred vision
 changes in the heart beat

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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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