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TRAZODONE HYDROCHLORIDE 50MG CAPSULES

Active substance(s): TRAZODONE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Molipaxin 50mg and 100mg
Capsules
Trazodone 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 gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Molipaxin Capsules are and what they are
used for
2. Before you take Molipaxin Capsules
3. How to take Molipaxin Capsules
4. Possible side effects
5. How to store Molipaxin Capsules
6. Further information
1. What Molipaxin Capsules are and what they
are used for
The name of your medicine is Molipaxin 50mg or
100mg Capsules (called Molipaxin Capsules in this
leaflet). Molipaxin Capsules contain a medicine called
trazodone hydrochloride. This belongs to a group of
medicines called antidepressants.
Molipaxin Capsules can be used to treat anxiety and
depression.
2. Before you take Molipaxin Capsules
Do not take this medicine and tell your doctor if:






You are allergic (hypersensitive) to trazodone
hydrochloride or any of the other ingredients of
Molipaxin Capsules (listed in Section 6 Further
Information). Signs of an allergic reaction can
include: a rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue.
You have recently had a heart attack.
You are a heavy drinker or are taking sleeping
tablets.
You are under 18 years of age.

Do not take this medicine if any of the above applies to
you. If you are not sure, talk to your doctor or
pharmacist before taking Molipaxin Capsules.
Take special care with Molipaxin Capsules
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 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.
Molipaxin Capsules should not be used in children
and adolescents under 18 years of age.
If you are elderly, you may be more prone to side
effects, increased caution is necessary especially
when taking other medicines at the same time as
Molipaxin or if you have some other diseases.
Check with your doctor or pharmacist before
taking this medicine if you:
• Have or have ever had fits or seizures (epilepsy)
• Have severe liver, kidney or heart problems
• Are pregnant, trying to become pregnant or are
breast-feeding
• Have an overactive thyroid gland
(hyperthyroidism)
• Have problems passing water or need to pass
water (urine ) frequently
• Have narrow angle glaucoma (an eye disorder)
• Have schizophrenia or other type of mental
disorder
• Are elderly, as you may be more prone to side
effects
If you are not sure if any of the above applies to you,
talk to your doctor or pharmacist before taking
Molipaxin Capsules.

Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines.
This includes medicines you buy without a
prescription, including herbal medicines. This is
because Molipaxin Capsules can affect the way
some other medicines work. Also some medicines
can affect the way Molipaxin Capsules work.
Tell your doctor if you are taking any of the
following medicines:
• MAOI (MonoAmine Oxidase Inhibitors) medicines
such as tranylcypromine, phenelzine and
isocarboxazid (for depression) or selegiline (for
Parkinson’s disease), or have taken them in the
last 2 weeks
• Other antidepressants (such as amitriptyline or
fluoxetine)
• Sedatives (such as tranquilizers or sleeping pills)
• Medicines used to treat epilepsy such as
carbamazepine and phenytoin
• Medicines used to treat high blood pressure, for
example, clonidine
• Digoxin (used to treat heart problems)
• Medicines used to treat fungal infections such as
ketoconozole and itraconazole
• Some medicines used to treat HIV such as
ritonavir and indinavir
• Erythromycin, an antibiotic used to treat infections
• Levodopa (used to treat Parkinson’s disease)
• St. John’s Wort (a herbal remedy)
• Warfarin (used to stop your blood from clotting)
Anaesthetics
If you are going to have an anaesthetic (for an
operation), tell your doctor or dentist that you are
taking Molipaxin Capsules.
Taking Molipaxin Capsules with food and drink
You should avoid drinking alcohol while taking
Molipaxin Capsules
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you
are pregnant, might become pregnant, or think you
may be pregnant.
Taking Molipaxin Capsules in the late stages of
pregnancy may lead to your baby experiencing
withdrawal symptoms when they are born.
If you are breast-feeding or planning to breast-feed,
talk to your doctor or pharmacist before taking any
medicine.
Driving and using machines
Molipaxin Capsules may make you feel sleepy or
dizzy. If this happens do not drive or use any tools or
machines.
Important information about some of the
ingredients of Molipaxin Capsules
Molipaxin Capsules contain lactose. If you have
been told that you cannot digest or tolerate some
sugars, talk to your doctor before taking trazodone.
3. How to take Molipaxin Capsules
Always take Molipaxin Capsules exactly as your
doctor has told you. You should check with your
doctor of pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth
• Swallow the capsules whole with a drink of water
• Take with or after food. This can help lower the
chances of side effects
• If you have been told to take Molipaxin Capsules
only once each day then you should take it before
going to bed
• If you feel the effect of your medicine is too weak
or strong, do not change the dose yourself, but
ask your doctor
How much to take
Adults:
Depression
• Adults usually start by taking 150mg each day
• Your doctor may increase the dose to 300mg
each day depending on your condition
• For adults in hospital the dose may be as high as
600mg each day
Anxiety
• Adults usually start by taking 75mg each day
• Your doctor may increase the dose to 300mg
each day
Elderly
• Older people or those who are frail will usually be
given a starting dose of 100mg each day
Children
Children and adolescents under 18 years should not
take Molipaxin Capsules.
If you take more Molipaxin Capsules than you
should
If you take more Molipaxin Capsules than you should, tell a
doctor or go to a hospital casualty department
straight away. Take the medicine pack with you. This
is so the doctor knows what you have taken.
The following effects may happen: feeling sick or
being sick, feeling sleepy, dizzy or faint, fits
(seizures), confusion, breathing or heart problems.

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If you forget to take Molipaxin Capsules
If you forget to take a dose, take it as soon as you
remember it. However, if it is nearly 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 Molipaxin Capsules
Keep taking Molipaxin Capsules until your doctor
tells you to stop. Do not stop taking Molipaxin
Capsules just because you feel better. When your
doctor tells you to stop taking these capsules he/she
will help you to stop taking them gradually.
4. Possible side effects
Like all medicines, Molipaxin Capsules can cause
side effects, although not everybody gets them.
Stop taking Molipaxin Capsules and see a doctor
or go to a hospital straight away if:
• You get swelling of the hands, feet, ankles, face,
lips or throat which may cause difficulty
swallowing or breathing, itching of the skin and
nettle rash. This may mean you are having an
allergic reaction to Molipaxin Capsules
• Painful erection of the penis, unrelated to sexual
activity, that will not go away (priapism)
• Yellowing of the eyes or skin. This could be a
liver problem (such as jaundice)
• Getting infections more easily than usual. This could
be because of a blood disorder (agranulocytosis)
• Bruising more easily than usual. This could be
because of a blood disorder (thrombocytopenia)
• You have severe abdominal pain and bloating,
are being sick (vomiting) and have constipation.
These may be signs that your intestine is not
working properly (paralytic ilius)
Talk to your doctor straight away if you notice
the following side-effects:
• You have thoughts of harming or killing yourself
• Feeling tired, faint, dizzy, having pale skin. These
could be signs of anaemia
• Convulsions/fits
• Unusual skin sensations such as numbness,
tingling, pricking, burning or creeping on the skin
(parasthesia)
• Feeling confused, restless, sweating, shaking,
shivering, hallucinations (strange visions or
sounds), sudden jerks of the muscles or a fast
heartbeat, you may have something called
Serotonin syndrome.
• Feeling very unwell, possibly with shortness of
breath (dyspnoea), difficulty in walking or walking
with a shuffling gait, shaking, uncontrolled muscle
twitching and a high temperature (above 38°C).
This could be a rare condition known as
Neuroleptic Malignant Syndrome.
• Rapid, slow or irregular heartbeat.
Below is a list of other side effects that have
been reported:
• Feeling drowsy or sleepy, tiredness
• Feeling less alert than usual
• Feeling sick (nausea) or being sick (vomiting),
indigestion
• Constipation, diarrhoea
• Dry mouth, altered taste, increased amounts of
saliva, blocked nose
• Sweating more than usual
• Dizziness, headache, confusion, weakness,
tremor (shaking)
• Blurred vision
• Loss of appetite and weight loss
• Feeling dizzy or light-headed on standing or
sitting up quickly (postural hypotension), fainting
(syncope)
• Feeling restless and having difficulty sleeping
• Water retention which may cause swollen arms
or legs
• Skin rash, itching
• Chest pain
• Pain in limbs, back pain, pain in your muscles,
pain in your joints
• Jerking movements that you can not control,
mainly in the arms and legs, uncontrolled muscle
movements or twitches
• Frequent infections with high temperature, severe
chills, sore throat or mouth ulcers. These could
be signs of a blood problem called leucopenia.
• Feeling anxious or more nervous than usual,
feeling agitated
• Overactive behaviour or thoughts (mania),
believing things that are not true (delusions),
memory disturbance
• Nightmares
• Decreased sex drive
• Feeling dizzy, possibly with a “spinning” feeling
(vertigo)
• High blood pressure
• High temperature
• Flu type symptoms
• Difficulty with speaking
• Higher than normal number of white blood cells
(seen by a blood test)
• High levels of liver enzymes in your blood (shown
by a blood test)
• Severe liver disorders such as hepatitis
• Liver failure with potentially fatal outcome
• Feeling tired, weak and confused, having muscle
that ache, are stiff or do not work well. There may
also be headache, loss of appetite, nausea or
vomiting, convulsion. This may be due to low
sodium levels in your blood.

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 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 Molipaxin Capsules
Keep this medicine in a safe place where children
cannot see or reach it.
Do not use Molipaxin Capsules after the expiry date
which is stated on the blister and carton after EXP.
The expiry date refers to the last day of that month.
Store below 30°C in a dry place.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.
6. Further information
What Molipaxin Capsules contains
• Each Molipaxin 50mg Capsule contains 50mg of
the active substance, trazodone hydrochloride
• Each Molipaxin 100mg Capsule contains 100mg
of the active substance, trazodone hydrochloride
• Other ingredients include lactose, magnesium
stearate, gelatin, titanium dioxide (E171),
erythrosine (E127), indigo carmine (E132), yellow
iron oxide (E172) and ink (black iron oxide E172,
shellac, propylene glycol and ammonium
hydroxide (pH adjustment) or black iron oxide
E172, shellac, propylene glycol, strong ammonia
solution (pH adjustment) and potassium hydroxide
(pH adjustment)). The 100mg capsules also
contain red iron oxide (E172).
What Molipaxin Capsules looks like and contents
of the pack
Molipaxin 50mg capsules are violet and green,
printed with the Roussel logo on one half and R365B
on the other.
Molipaxin 100mg capsules are violet and fawn
coloured, printed with the Roussel logo on one half
and R365C on the other.
Molipaxin 50mg Capsules are supplied in blister
packs of 84 and 100 capsules.
Molipaxin 100mg Capsules are supplied in blister
packs of 56 and 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Zentiva, One Onslow Street, Guildford, Surrey,
GU1 4YS, UK
Manufacturer
Sanofi-Aventis Sp.z.0.0, Drug Production and
Distribution Plant, Ul. Lubelska 52, 35-233 Rzeszow,
Poland
or
Zentiva, k. s.
U Kabelovny 130, 102 37 Prague 10,
Dolni Mecholupy, Czech Republic.
This leaflet does not contain all the information about
your medicine. If you have any questions or are not
sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in 01/2015
© Zentiva, 2015

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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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