Mirtazapine 15mg Orodispersible Tablets

Document: leaflet MAH GENERIC_PL 20395-0060 change

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WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIRTAZAPINE ORODISPERSIBLE TABLETS

bo not take Mirtazapine

• If you are allergic (hypersensitive) to mirtazapine or any of the other

I ingredients of Mirtazapine Orodispersible tablets (see section 6).

• If you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAO-ls).

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(Mirtazapine I5mg, 30mg and 45mg I Orodispersible Tablets

PACKAGE LEAFLET: INFORMATION FORTHE USER

bead all of this leaflet carefully before you start taking this medicine because it contains important information foryou.

|> Keep this leaflet. You may need to read it again.

• If you have any further questions, askyour doctor or pharmacist or nurse

|> This medicine has been prescribed foryou only. Do not give it to others, it may harm them even if their signs of illness are the same as yours i> If you get any side effects, talk to your doctor or pharmacist or nurse. This ¹ includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

4. What Mirtazapine Orodispersible tablets are and what they are used for

U. What you need to know before you take Mirtazapine Orodispersible tablets 3. Howto take Mirtazapine Orodispersible tablets |4. Possible side effects

5. Howto store Mirtazapine Orodispersible tablets |6. Contents of the pack and other information

WHAT MIRTAZAPINE ORODISPERSIBLE TABLETS ARE AND WHAT THEYARE USEDFOR

Mirtazapine belongs to a group of medicines called antidepressants and is usedtotreatdepression.

lit may take 2 to 4 weeks before you start to feel or sleep better. It is important to take Mirtazapine every day and not to stop taking it unless your doctor tells you |to. If you do, your symptoms may come back.

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Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Mirtazapine if you have have had:

Epilepsy (seizures orfits)

Kidney or liver disease (including jaundice)

Heartdisease Low blood pressure

Difficulty in passing water (urinating), which may be caused by an enlarged prostate

|> Eye disease, such as glaucoma

• Diabetes

]• Psychiatric disorders such as schizophrenia or manic depression

• Bone marrow depression (reductions of blood cells) i> Akathisia (restlessness)

Serotonin syndrome

p Hyponatraemia (low sodium concentration in the blood)

In rare cases there may be changes in the white blood cells. If you get fever, bore mouth or throat and recurrent minor infections such as coughs and colds tell yourdoctoras you may need to stop taking your medicine.

llse in children and adolescents under 18 years of age (Mirtazapine should normally not be used for children and adolescents under 18 years except for patients with depression. Patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility \mainly aggression, oppositional behaviour and anger) when they take this lass of medicines. In addition, significant weight gain has been observed in his age category more often when treated with mirtazapine compared with adults. Despite this, your doctor may prescribe Mirtazapine for patients under |18 because he/she decides that this is in their best interests. If your doctor has prescribed Mirtazapine 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 18are taking (Mirtazapine. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development in this age group have not yet been| demonstrated.

Other medicines and Mirtazapine Orodispersible Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might] take any other medicines. In particular: ¹

• Otherantidepressants:

You should not take Mirtazapine Orodispersible tablets if you are taking other, antidepressants known as Monoamine Oxidase Inhibitors (MAOIs), or in thel two weeks after they have been stopped. The use of other antidepressants or medicines containing the product serotonin can lead to the development ot| serotonin syndrome and should be used with caution.

Drugs foranxiety or insomnia:

• Mirtazapine can increase the drowsiness caused by benzodiazepines antipsychotics, antihistamines and opioids.

Take care when taking any of the following medicines:

Drugs used in the treatment of HIV Antibiotics such as erythromycin or rifampicin Antifungal agents such as ketoconazole Nefazodone, an antidepressant Drugs for epilepsy e.g.phenytoinorcarbamazepine Cimetidine a drug used to treat for indigestion or stomach ulcers Drugs to prevent blood clotting e.g. warfarin

Mirtazapine with food drinkand alcohol

You may get drowsy if you drink alcohol while you are taking Mirtazapine. It i therefore advisable to avoid drinking any alcohol.

You can take Mirtazapine Orodispersible tablets with or withoutfood.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking this medicine, as mirtazapine should not be taken if you are pregnant, trying to become pregnant^ or are breast-feeding.

Make sure your midwife and/or doctor know you are on Mirtazapine. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Mirtazapine may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the new born (PPHN),. making the baby breathe faster and appear bluish. These symptoms usuallyl 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

Mirtazapine can make you drowsy, affect your concentration or make you less' alert. When you first start taking Mirtazapine, make sure your abilities are not affected before you drive or operate machinery. ¹

Mirtazapine Orodispersible Tablets contain aspartame

These tablets contain aspartame which is a source of phenylalanine.

May be harmful for people with phenylketonuria.

3. HOW TO TAKE MIRTAZAPINE ORODISPERSIBLE TABLETS

Important: only take Mirtazapine as your doctor or pharmacist tells you to. Don't] stop taking it unless your doctor tells you to.

Dosage

Adults and elderly patients: .

The usual starting dose is 15mg, taken preferably in the evening. Your docton may advise you to increase your dose after a few days to the amount that may be best for you.

Patients with kidney or liver problems may be given a lower dose of Mirtazapine.

Duration of treatment

After 2 to 4 weeks, talk to your doctor about the effect the treatment has had. I' you still don't feel well, your doctor may prescribe a higher dose. After another 2 to 4 weeks talk to your doctor again.

If you have the impression that the effect of Mirtazapine is too strong or too weak, talk to yourdoctoror pharmacist.

Method and route of administration

Your doctor will probably advise you to take Mirtazapine as a single dose before you go to bed, as it may help you to sleep. However, your doctor may suggest] you split your dose for example one tablet in the morning, and another in the evening before you goto bed.

Take the tablets as follows; .

Keep your hands dry. Put the tablet on your tongue. The tablet will disintegrate! and can be swallowed without water.

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Ifyou take more Mirtazapine than you should

|Overdose are drowsiness and disorientation.

.If you experience immediately:

Jf you forget to take Mirtazapine

Do not take a double dose to make up for forgotten individual doses. Just skip that dose and take your next one at the normal time.

Effects when treatment with Mirtazapine is stopped

po not suddenly stop taking Mirtazapine even if your depression has lifted. If you stop suddenly, you may feel sick, anxious or agitated and have headaches, ilt is possible that some ofyoursymptoms may come back.

Once you are feeling better, talk to your doctor who will tell you how to reduce .the dose gradually. This will usually be about 4 to 6 months after you start reeling better.

|4. POSSIBLE SIDE EFFECTS |_ike all medicines, this medicine can cause side effects, although not everybody gets them. Please remember that it can sometimes be hard to tell [the difference between some of the milder side effects and the symptoms of yourdepression.

ierious Side Effects

any of the following events you should tell your doctor ftare (occurs in 1 to 10 in 10,000 users)

• Inflammation of pancreas (Pancreatitis)

|> An allergic reaction; signs are swelling of the lips, face and tongue, difficulty breathing, feeling faint

i> Signs of infection such as fever, sore throat, mouth ulcer or stomach upset. ¹ In very rare cases, people become less resistant to infection in the first few I weeks of taking Mirtazapine, as it can cause a temporary shortage of white

I blood cells. If you have these symptoms, your doctor will arrange a blood test to check

L Increased liver enzyme levels (seen in blood tests).

Frequency not known

• Fits (seizures or convulsions)

ther side effects

iThe following events are less serious but you may wish to discuss them with your doctor or pharmacist if they become troublesome or last a long time:

.Very common (occurs in more than 1 in 10 users) l Increase in appetite and weight gain

• Drowsiness or sleepiness |> Headache

• Dry mouth

Common (occurs in 1 to 10 in 100 users)

l> Increase in appetite and weight gain

• Drowsiness during the firstfew weeks of treatment

C Swollen ankles caused by fluid retention (oedema)

Sleeping problems

C Abnormal dreams Confusion • Anxiety |> Lethargy • Dizziness |> Diarrhoea • Vomiting i> Nausea • Shakiness or tremor

m Feeling dizzy or faint especially when you stand up quickly (orthostatic hypotension)

CRash orskin eruptions (exanthema)

Pain in your joints (arthralgia) or muscles (myalgia)

• Back pain

In children under 18 years the following adverse events were observed (commonly in clinical trials:

• Significant weight gain b Hives and

l Increased blood triglycerides.

• Feeling agitated H

• Restlessness

• Numbness or'pins and needles'(paraesthesia) |

• Restless legs

• Low blood pressure

Rare (occurs in 1 to 10 in 10,000 users)

• Arashorskin eruptions

• Aggression

• Muscle twitching or contractions (myoclonus)

Frequency not known

• Abnormal sensations in the mouth (oral paraesthesia)

• Swelling in the mouth (mouth oedema)

• Speech disorder (dysarthria)

• Increased salivation

• Sleepwalking

• Low level of sodium in the blood (hyponatraemia)

• Inappropriate anti-diuretic hormone secretion

• Bone marrow depression

• Serotonin syndrome

• Severe skin reactions (Stephens-Johnson Syndrome, dermatitis bullous, erythema multiforme, toxic epidermal necrolysis)

An increased risk of bone fractures has been observed in patients taking this) type of medicines.

Reportingofsideeffects '

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 reportl 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 MIRTAZAPINE ORODISPERSIBLE TABLETS i

Keep out of the sight and reach of children .

Do not store above 25°C. Store in the original package in order to protect from light. .

Keep the container tightly closed.* (onlyprinted on bottle packs only) I

Do not use after the expiry date stated on the carton orfoil.

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. CONTENTS OF THE PACK AND OTHER INFORMATION i

What Mirtazapine Orodispersible tablets contain .

• The active substance is mirtazapine. Each tablet contains either 15mgJ 30mg and 45mg of the active ingredient mirtazapine.

• The other ingredients are mannitol DC, microcrystalline cellulose,!

crospovidone, hydroxylpropyl cellulose low substituted, magnesium

carbonate heavy, silica colloidal anhydrous, methionine, magnesium|

stearate, guargum, aspartame (E951), orange flavour.

Each Mirtazapine Orodispersible tablets is a white, round, biconvex, uncoated¹tablet with the following markings: i

15mg orodispersible tablets -M1 ¹

30mg orodispersible tablets - M2 .

45mg orodispersible tablets - M4 I

The tablets are supplied in blister and bottle packs of 5,6,7,10,14,15,20,21, 28,30,50,56,60,84,90,98 and 100 Tablets.**