ZISPIN SOLTAB 30MG ORODISPERSIBLE TABLET

Active substance: MIRTAZAPINE

View full screen / Print PDF » Download PDF ⇩

Transcript
Package leaflet: Information for the patient

Zispin SolTab®
30 mg
orodispersible tablets

Mirtazapine
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 Zispin SolTab is and what it is used
for
2. What you need to know before you take
Zispin SolTab
3. How to take Zispin SolTab
4. Possible side effects
5. How to store Zispin SolTab
6. Contents of the pack and other
information

1. What Zispin SolTab is and what it is
used for
Zispin SolTab is one of a group of medicines
called antidepressants.
Zispin SolTab is used to treat depressive illness
in adults.
Zispin SolTab will take 1 to 2 weeks before
it starts working. After 2 to 4 weeks you may
start feeling better. You must talk to your
doctor if you do not feel better or if you feel
worse after 2 to 4 weeks. More information is
in section 3 heading “When can you expect
to start feeling better”.

2. What you need to know before you
take Zispin SolTab:
Do not take Zispin SolTab:
• if you are allergic to mirtazapine or any
of the other ingredients of this medicine
(listed in section 6). If so, you must talk to
your doctor as soon as you can before
taking Zispin SolTab.
• if you are taking or have recently taken
(within the last two weeks) medicines
called monoamine oxidase inhibitors
(MAO-Is).

Warnings and precautions
Talk to your doctor or pharmacist before
taking Zispin SolTab.

Children and adolescents
Zispin SolTab should normally not be used
for children and adolescents under 18 years
because efficacy was not demonstrated. Also,
you should know that patients under 18 have
an increased risk of side-effects such as
suicide attempt, suicidal thoughts and hostility
(predominantly aggression, oppositional
behaviour and anger) when they take this
class of medicines. Despite this, your doctor
may prescribe Zispin SolTab for patients under
18 because he/she decides that this is in their
best interests. If your doctor has prescribed
Zispin SolTab for a patient under 18 and you
want to discuss this, please go back to your
doctor. You should inform your doctor if any
of the symptoms listed above develop or
worsen when patients under 18 are taking
Zispin SolTab. Also, the long-term safety
effects concerning growth, maturation and
cognitive and behavioural development of
Zispin SolTab in this age group have not yet
been demonstrated. In addition, significant
weight gain has been observed in this age
category more often when treated with
Zispin SolTab compared with adults.

For Position Only

Mirtazapine

orodispersible tablets

XXXXXXX/XXXXXX-X

If you are depressed 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 straightaway.











Other medicines and Zispin SolTab

Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.
Do not take Zispin SolTab in combination with:
• monoamine oxidase inhibitors (MAO
inhibitors). Also, do not take Zispin SolTab
during the two weeks after you have
stopped taking MAO inhibitors. If you stop
taking Zispin SolTab, do not take MAO
inhibitors during the next two weeks either.
Examples of MAO inhibitors are
moclobemide, tranylcypromine (both are
antidepressants) and selegiline (used for
Parkinson’s disease).
Take care when taking Zispin SolTab in
combination with:
• antidepressants such as SSRIs,
venlafaxine and L-tryptophan or
triptans (used to treat migraine), tramadol
(a pain-killer), linezolid (an antibiotic),
lithium (used to treat some psychiatric
conditions), methylene blue (used to
treat high levels of methemoglobin in the



blood) and St. John’s Wort – Hypericum
perforatum preparations (a herbal
remedy for depression). In very rare cases
Zispin SolTab alone or the combination
of Zispin SolTab with these medicines, can
lead to a so-called serotonin syndrome.
Some of the symptoms of this syndrome
are: inexplicable fever, sweating, increased
heart rate, diarrhoea, (uncontrollable)
muscle contractions, shivering, overactive
reflexes, restlessness, mood changes
and unconsciousness. If you get a
combination of these symptoms, talk to
your doctor immediately.
the antidepressant nefazodone. It can
increase the amount of Zispin SolTab in
your blood. Inform your doctor if you are
using this medicine. It might be needed to
lower the dose of Zispin SolTab, or when
use of nefazodone is stopped, to increase
the dose of Zispin SolTab again.
medicines for anxiety or insomnia such
as benzodiazepines;
medicines for schizophrenia such as
olanzapine;
medicines for allergies such as cetirizine;
medicines for severe pain such as
morphine.
In combination with these medicines
Zispin SolTab can increase the drowsiness
caused by these medicines.
medicines for infections; medicines for
bacterial infections (such as erythromycin,
medicines for fungal infections (such as
ketoconazole) and medicines for HIV/
AIDS (such as HIV-protease inhibitors)
and drugs for stomach ulcers (such as
cimetidine).
In combination with Zispin SolTab these
medicines can increase the amount of
Zispin SolTab in your blood. Inform your
doctor if you are using these medicines.
It might be needed to lower the dose of
Zispin SolTab, or when these medicines
are stopped, to increase the dose of
Zispin SolTab again.
medicines for epilepsy such as
carbamazepine and phenytoin;
medicines for tuberculosis such as
rifampicin.
In combination with Zispin SolTab these
medicines can reduce the amount of
Zispin SolTab in your blood. Inform your
doctor if you are using these medicines.
It might be needed to increase the dose
of Zispin SolTab, or when these medicines
are stopped to lower the dose of
Zispin SolTab again.
medicines to prevent blood clotting such
as warfarin.
Zispin SolTab can increase the effects of
warfarin on the blood. Inform your doctor
if you are using this medicine. In case of
combination it is advised that a doctor
monitors your blood carefully.
medicines that may affect the heart’s
rhythm such as certain antibiotics and
some anti-psychotics.
For Position Only

Zispin SolTab®
30 mg

Thoughts of suicide and worsening of
your depression

You may find it helpful to tell a relative or
close friend that you are depressed, and
ask them to read this leaflet. You might ask
them to tell you if they think your depression
is getting worse, or if they are worried about
changes in your behaviour.
Also take special care with Zispin SolTab
• if you have, or have ever had one of the
following conditions.
➜ Tell your doctor about these conditions
before taking Zispin SolTab, if not done
previously
- seizures (epilepsy). If you develop
seizures or your seizures become
more frequent, stop taking
Zispin SolTab and contact your doctor
immediately;
- liver disease, including jaundice.
If jaundice occurs, stop taking
Zispin SolTab and contact your doctor
immediately;
- kidney disease;
- heart disease, or low blood pressure;
- schizophrenia. If psychotic symptoms,
such as paranoid thoughts become
more frequent or severe, contact your
doctor straightaway;
- manic depression (alternating periods
of feeling elated/overactivity and
depressed mood). If you start feeling
elated or over-excited, stop taking
Zispin SolTab and contact your doctor
immediately;
- diabetes (you may need to adjust your
dose of insulin or other antidiabetic
medicines);
- eye disease, such as increased
pressure in the eye (glaucoma);
- difficulty in passing water (urinating),
which might be caused by an
enlarged prostate;
- certain kinds of heart conditions
that may change your heart rhythm, a
recent heart attack, heart failure, or take
certain medicines that may affect the
heart’s rhythm.
• if you develop signs of infection such as
inexplicable high fever, sore throat and
mouth ulcers.
➜ Stop taking Zispin SolTab and consult
your doctor immediately for a blood
test.
In rare cases these symptoms can
be signs of disturbances in blood cell
production in the bone marrow. While
rare, these symptoms most commonly
appear after 4‑6 weeks of treatment.
• if you are an elderly person. You could
be more sensitive to the side-effects of
antidepressants.

Zispin SolTab with food and alcohol

You may get drowsy if you drink alcohol while
you are taking Zispin SolTab.
You are advised not to drink any alcohol.
You can take Zispin SolTab with or without
food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before taking this medicine.
Limited experience with Zispin SolTab
administration to pregnant women does not
indicate an increased risk. However, caution
should be exercised when used during
pregnancy.

now turn over ➤

For Position Only

For Position Only

If you use Zispin SolTab until, or shortly before
birth, your baby should be supervised for
possible adverse effects.
When taken during pregnancy, similar
drugs (SSRIs) may increase the risk of a
serious condition in babies, called persistent
pulmonary hypertension of the newborn
(PPHN), making the baby breathe faster and
appear bluish. These symptoms usually
begin during the first 24 hours after the baby
is born. If this happens to your baby you
should contact your midwife and/or doctor
immediately.

2. Tear off one tablet pocket

Driving and using machines

3. Peel off the lid

Zispin SolTab can affect your concentration
or alertness. Make sure these abilities are
not affected before you drive or operate
machinery. If your doctor has prescribed Zispin
SolTab for a patient under 18 years make sure
the concentration and alertness is not affected
before participation in traffic (e.g. on bicycle).

Zispin SolTab orodispersible tablets
contain sugar spheres, containing
sucrose.

Each blister contains six tablet pockets, which
are separated by perforations. Tear off one
tablet pocket along the dotted lines (Figure 1).

If you forget to take Zispin SolTab

Fig. 1.
Carefully peel off the lidding foil, starting in the
corner indicated by the arrow (Figures 2 and 3).

Fig. 2.

Zispin SolTab orodispersible tablets contain
sugar spheres, containing sucrose. If you
have been told by your doctor that you have
intolerance for some sugars, contact your
doctor before taking this medicinal product.

3. How to take Zispin SolTab
Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.

Fig. 3.

4. Take out the orodispersible tablet
Take out the orodispersible tablet with dry
hands and place it on the tongue.
(Figure 4).

The recommended starting dose is 15 or
30 mg every day. Your doctor may advise
you to increase your dose after a few days
to the amount that is best for you (between
15 and 45 mg per day). The dose is usually
the same for all ages. However, if you are an
elderly person or if you have renal or liver
disease, your doctor may adapt the dose.

4. Possible side effects
If you experience any of the following
serious side effects, stop taking
mirtazapine and tell your doctor
immediately.
Fig. 4.

➜ Take Zispin SolTab at the same time each
day.
It is best to take Zispin SolTab as a single dose
before you go to bed. However your doctor
may suggest to split your dose of Zispin SolTab
– once in the morning and once at night-time
before you go to bed. The higher dose should
be taken before you go to bed.

It will rapidly disintegrate and can be swallowed
without water.

In order to prevent crushing the orodispersible
tablet, do not push against the tablet pocket
(Figure A).

When can you expect to start feeling
better

Usually Zispin SolTab will start working after
1 to 2 weeks and after 2 to 4 weeks you may
start to feel better.
It is important that, during the first few weeks of
the treatment, you talk with your doctor about
the effects of Zispin SolTab:
➜ 2 to 4 weeks after you have started taking
Zispin SolTab, talk to your doctor about
how this medicine has affected you.
If you still don’t feel better, your doctor may
prescribe a higher dose. In that case, talk to
your doctor again after another 2 to 4 weeks.
Usually you will need to take Zispin SolTab
until your symptoms of depression have
disappeared for 4 to 6 months.

➜ If you or someone else has taken
too much Zispin SolTab, call a doctor
straightaway.

Uncommon (may affect up to 1 in 100 people):
• feeling elated or emotionally ‘high’ (mania)
Rare (may affect up to 1 in 1,000 people):
• yellow colouring of eyes or skin; this
may suggest disturbance in liver function
(jaundice)
Not known (frequency cannot be estimated
from the available data):
• signs of infection such as sudden
unexplainable high fever, sore throat
and mouth ulcers (agranulocytosis).
In rare cases mirtazapine can cause
disturbances in the production of
blood cells (bone marrow depression).
Some people become less resistant to
infection because mirtazapine can cause
a temporary shortage of white blood
cells (granulocytopenia). In rare cases
mirtazapine can also cause a shortage of
red and white blood cells, as well as blood
platelets (aplastic anemia), a shortage of
blood platelets (thrombocytopenia) or an
increase in the number of white blood
cells (eosinophilia).
• epileptic attack (convulsions)
• a combination of symptoms such as
inexplicable fever, sweating, increased

heart rate, diarrhoea, (uncontrollable)
muscle contractions, shivering, overactive
reflexes, restlessness, mood changes,
unconsciousness and increased salivation.
In very rare cases these can be signs of
serotonin syndrome.
• thoughts of harming or killing yourself
• severe skin reactions (Stevens-Johnson
Syndrome, toxic epidermal necrolysis)

Other possible side effects with
mirtazapine are:
Very common (may affect more than 1 in
10 people):
• increase in appetite and weight gain
• drowsiness or sleepiness
• headache
• dry mouth
Common (may affect up to 1 in 10 people):
• lethargy
• dizziness
• shakiness or tremor
• nausea
• diarrhoea
• vomiting
• constipation
• rash or skin eruptions (exanthema)
• pain in your joints (arthralgia) or muscles
(myalgia)
• back pain
• feeling dizzy or faint when you stand up
suddenly (orthostatic hypotension)
• swelling (typically in ankles or feet) caused
by fluid retention (oedema)
• tiredness
• vivid dreams
• confusion
• feeling anxious
• sleeping problems
Uncommon (may affect up to 1 in 100 people):
• abnormal sensation in the skin
e.g. burning, stinging, tickling or tingling
(paraesthesia)
• restless legs
• fainting (syncope)
• sensations of numbness in the mouth
(oral hypoaesthesia)
• low blood pressure
• nightmares
• feeling agitated
• hallucinations
• urge to move
Rare (may affect up to 1 in 1,000 people):
• muscle twitching or contractions (myoclonus)
• aggression
• abdominal pain and nausea; this may
suggest inflammation of the pancreas
(pancreatitis)
Not known (frequency cannot be estimated
from the available data):
• abnormal sensations in the mouth
(oral paraesthesia)
• swelling in the mouth (mouth oedema)
• swelling throughout the body (generalized
oedema)
• localized swelling
• hyponatraemia
• inappropriate anti-diuretic hormone
secretion
• severe skin reactions (dermatitis bullous,
erythema multiforme)
• sleep walking (somnambulism)
• speech disorder

Additional side effects in children and
adolescents

In children under 18 years the following
adverse events were observed commonly in
clinical trials: significant weight gain, hives and
increased blood triglycerides.

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 Website: 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 Zispin SolTab
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 and the blister.
The expiry date refers to the last day of that
month.
Store in the original package in order to
protect from light and moisture.
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 to protect the environment.

6. Contents of the pack and other
information
What Zispin SolTab contains

• The active substance is mirtazapine.
Zispin SolTab 30 mg orodispersible
tablets contain 30 mg mirtazapine per
orodispersible tablet.
• The other ingredients are sugar spheres,
hypromellose, povidone K30, magnesium
stearate, basic butylated methacrylate
copolymer, aspartame (E951), anhydrous
citric acid, crospovidone (type A), mannitol
(E421), microcrystalline cellulose,
natural and artificial orange flavour
(No. SN027512) and sodium hydrogen
carbonate.

What Zispin SolTab looks like and
contents of the pack

Zispin SolTab are orodispersible tablets.
Zispin SolTab 30 mg orodispersible tablets are
round, white, standard bevelled-edge tablets
coded with ‘TZ2’ on one side.
The orodispersible tablets are packed in a
child-resistant perforated unit dose blister.
For Zispin SolTab 30 mg orodispersible tablets
the following pack sizes are available: 6, 18,
30, 48, 90, 96 and 180 orodispersible tablets
(not all pack sizes may be marketed).

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Merck Sharp & Dohme Limited,
Hertford Road, Hoddesdon,
Hertfordshire, EN1
1 9BU,
United Kingdom

Manufacturer

N.V. Organon,
Kloosterstraat 6, P.O.Box 20,
5340 BH Oss,
The Netherlands
This medicinal product is authorised in the
Member States of the EEA under tradename
Zispin SolTab and under the following
associated invented names:
Belgium
Remergon SolTab
Denmark
Remeron Smelt
Germany
Remergil SolTab
Hungary
Remeron
Iceland
Remeron Smelt
Ireland
Zispin SolTab
Italy
Remeron
Luxembourg
Remergon SolTab
Norway
Remeron-S
Spain
Rexer Flas
Sweden
Remeron-S
United Kingdom Zispin SolTab
This leaflet was last revised June 2014

XXXXXXX/XXXXXX-X

If you take more Zispin SolTab than
you should
Fig. A.

➜ Only stop taking Zispin SolTab in
consultation with your doctor.
If you stop too early, your depression might
come back. Once you are feeling better, talk
to your doctor. Your doctor will decide when
treatment can be stopped.
Do not suddenly stop taking Zispin SolTab,
even when your depression has lifted. If you
suddenly stop taking Zispin SolTab you may
feel sick, dizzy, agitated or anxious, and have
headaches. These symptoms can be avoided
by stopping gradually. Your doctor will tell you
how to decrease the dose gradually.

Like all medicines, this medicine can cause
side effects, although not everybody gets them.

When to take Zispin SolTab

1. Do not crush the orodispersible
tablet

If you are supposed to take your dose twice
a day
• if you have forgotten to take your
morning dose, simply take it together with
your evening dose.
• if you have forgotten to take your
evening dose, do not take it with the next
morning dose; just skip it and continue
with your normal morning and evening
doses.
• if you have forgotten to take both doses,
do not attempt to make up for the missed
doses. Skip both doses and continue the
next day with your normal morning and
evening doses.

If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

How much to take

Take the orodispersible tablet as follows
Take your tablets orally.

If you are supposed to take your dose once
a day
• Do not take a double dose to make up for
a forgotten dose. Take your next dose at
the normal time.

If you stop taking Zispin SolTab

Zispin Soltab orodispersible tablets
contain aspartame, a source of
phenylalanine.
Zispin SolTab orodispersible tablets contain
aspartame, a source of phenylalanine. May
be harmful for people with phenylketonuria.

The most likely signs of an overdose of
Zispin SolTab (without other medicines or
alcohol) are drowsiness, disorientation and
increased heart rate. The symptoms of a
possible overdose may include changes to
your heart rhythm (fast, irregular heartbeat)
and/or fainting which could be symptoms of
a life-threatening condition known as Torsade
de Pointes.

Expand view ⇕

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.

Hide
(web4)