Mirtazapine 15mg Orodispersible Tablets
1176
08.08.16[18]
PATIENT INFORMATION LEAFLET
Zispin® SolTab® 15 mg Orodispersible Tablets
Mirtazapine 15 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.
This medicine is available using any one of the above names but will be referred to as Zispin SolTab throughout this leaflet.
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 longterm 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 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.
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.
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 increase 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.
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 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.
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. on bicycle).
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 with phenylketonuria.
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).
Fig A
Fig. 2 Fig. 3
4. Take out the orodispersible tablet
Take out the orodispersible tablet with dry hands and place it on the tongue. (Figure 4).
POM
PL 20636/1176
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).
Fig 1
3. Peel off the lid
Carefully peel off the lidding foil, starting in the corner indicated by the arrow (Figures 2 and 3).
Fig. 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 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 take more Zispin SolTab than you should
^If you or someone else has 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. 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.
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 time.
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 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 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.
If you have any further questions on the use of this product, 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 doctor immediately.
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 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 out of the sight and reach of children.
Do not use Zispin SolTab after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month.
Do not store above 30°C. Store in the original package.
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.
If your tablets become discoloured or show any other signs of deterioration, consult your doctor or pharmacist who will tell you what to do.
6. Contents of the pack and other information What Zispin SolTab contains
• The active substance is mirtazapine.
Zispin SolTab 15 mg orodispersible tablets contain 15 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 bicarbonate.
What Zispin SolTab looks like and contents of the pack
Zispin SolTab are white, round tablets marked with ‘TZ 1' on one side and plain on the other side. Zispin SolTabs come in packs of 30 tablets.
Product licence holder and Manufacturer
Manufactured by N.V.Organon, PO Box 20, 5340 BH Oss, The Netherlands and are procured from the EU by Product Licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.
Leaflet revision and issue date (Ref): 08.08.16[18] Zispin® and SolTab® are trademarks of N.V.Organon.