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
Warnings and precautions
Talk to your doctor or pharmacist before taking Zispin SolTab.
Take special care with Zispin SolTab
Use in children and adolescents under 18 years of age
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.
Thoughts of suicide and worsening of your depression
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
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
- 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, 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
(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 straight away;
- 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
- eye disease, such as increased pressure in the eye (glaucoma);
- difficulty in passing water
(urinating), which might be caused by an enlarged prostate.
- 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
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) 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
the antidepressant nefazodone. It can increase the amount of Zispin SolTab in your blood.
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 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.
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.
If you use Zispin SolTab until, or shortly before birth, your baby should be supervised for possible adverse
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.
Driving and using machines
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.
Zispin SolTab orodispersible tablets contain sugar spheres containing sucrose.
Zispin SolTab orodispersible tablets contain sugar spheres, containing sucrose. If you have been told by your
doctor that you have an intolerance for some
sugars, contact your doctor before taking this medicinal product.
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
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.
How much to take
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.
When to take Zispin SolTab
- 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.
Take the orodispersible tablet as follows
Take your tablets orally.
1. Do not crush the orodispersible tablet
In order to prevent crushing the orodispersible tablet, do not push against the tablet pocket (Figure A).
2. Tear off one tablet pocket
Each blister contains six tablet pockets, which are separated by perforations. Tear off one tablet pocket
along the dotted lines (Figure 1).
3. Peel off the lid
Carefully peel off the lidding foil, starting in the corner indicated by the arrow (Figures 2 and 3).
4. Take out the orodispersible tablet
Take out the orodispersible tablet with dry hands and place it on the tongue. (Figure 4).
It will rapidly disintegrate and can be swallowed without water.
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
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 take more Zispin SolTab than you should
- If you or someone else have taken too much Zispin SolTab, call a doctor straight away.
The most likely signs of an overdose of Zispin SolTab (without other medicines or alcohol) are
drowsiness, disorientation and increased heart rate.
If you forget to take Zispin SolTab
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
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
- 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 stop taking Zispin SolTab
- 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
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. 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 experience any of the following serious side effects, stop taking mirtazapine and tell your
(may affect up to 1 in 100 people):
- feeling elated or emotionally ‘high’ (mania)
(may affect up to 1 in 1,000 people):
- yellow colouring of eyes or skin; this may suggest disturbance in liver function (jaundice)
(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
- 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:
(may affect more than 1 in 10 people):
- increase in appetite and weight gain
- drowsiness or sleepiness
- dry mouth
(may affect up to 1 in 10 people):
- shakiness or tremor
- 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)
- vivid dreams
- feeling anxious
- sleeping problems
(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
- feeling agitated
- urge to move
(may affect up to 1 in 1,000 people):
- muscle twitching or contractions (myoclonus)
(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
- 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
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet.
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 of medicines you no longer use. These measures will help to protect the
6. Contents of the pack and other information
What Zispin SolTab contains
- The active substance is mirtazapine.
Zispin SolTab 45 mg orodispersible tablets contain 45 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 45 mg orodispersible tablets are round, white, standard bevelled-edge tablets coded with ‘TZ/4’
on one side.
The orodispersible tablets are packed in a child-resistant perforated unit dose blister.
For Zispin SolTab 45 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
5340 BH Oss
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 SolTab Smelt
Germany Remergil SolTab
Iceland Remeron Smelt
Ireland Zispin SolTab
Luxembourg Remergon SolTab
Spain Rexer Flas
United Kingdom Zispin SolTab