MIRTAZAPINE 30MG FILM-COATED TABLETS

Active substance: MIRTAZAPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

MIRTAZAPINE 30 mg TABLETS
(mirtazapine)

Read all of this leaflet carefully before you start taking
this medicine.
•  eep this leaflet. You may need to read it again.
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•  f you have any further questions, ask your doctor
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or pharmacist.
•  his medicine has been prescribed for you. Do not pass it on
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to others. It may harm them, even if their symptoms are the
same as yours.
•  f any of the side effects gets serious, or if you notice any
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side effects not listed in this leaflet, please tell your doctor
or pharmacist.
In this leaflet:
1.  hat Mirtazapine is and what it is used for.
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2.  efore you take Mirtazapine.
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3.  ow to take Mirtazapine.
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4.  ossible side effects.
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5.  ow to store Mirtazapine.
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6. Further information.
1. WHAT MIRTAZAPINE IS AND WHAT IT IS USED FOR
Mirtazapine is one of a group of medicines called
antidepressants. Mirtazapine is used to treat
depressive illnesses.
2. BEFORE YOU TAKE MIRTAZAPINE
Do not take Mirtazapine:
• f you are allergic (hypersensitive) to mirtazapine or any of
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the other ingredients of this medicine (see section 6 'Further
information'). If so, you must talk to your doctor as soon as you
can before taking Mirtazapine.
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• f you are taking or have recently taken (within the last two
weeks) medicines called monoamine oxidase inhibitors
(MAO‑Is).
Take special care with Mirtazapine
Use in children and adolescents under 18 years of age
Mirtazapine should normally not be used for children and
adolescents under 18 years because efficacy has not been
demonstrated. Also, you should know that patients under 18
have an increased risk of side effects such as suicide attempt,
suicidal thoughts and hostility (predominately aggression,
oppositional behaviour and anger) when they take this class of
medicines. Despite this, your doctor may prescribe Mirtazapine
for patients under 18 because he/she decides that this is in
their best interests. If the 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
18 are taking Mirtazapine. Also, the long‑term safety effects
concerning growth, maturation and cognitive and behavioural
development of Mirtazapine in this age group have not yet
been demonstrated.
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:
• f you have previously had thoughts about killing or
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harming yourself.
• f you are a young adult. Information from clinical trials has
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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, 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 Mirtazapine:
if you have, or have ever had one of the following conditions.
Tell your doctor about these conditions before taking
Mirtazapine, if not done previously:
• seizures (epilepsy). If you develop seizures or your seizures
become more frequent, stop taking Mirtazapine and contact
your doctor immediately.
• liver disease, including jaundice. If jaundice occurs, stop
taking Mirtazapine 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 Mirtazapine 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)
•  ifficulty in passing water (urinating), which might be caused
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by an enlarged prostate
• f you develop signs of infection such as inexplicable high
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fever, sore throat and mouth ulcers. Stop taking Mirtazapine
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.
• f you are an elderly person. You could be more sensitive to the
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side effects of antidepressants.
Taking other medicines
Tell your doctor or pharmacist if you are taking (or plan to take)
any of the medicines in the following list.
Please also tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including medicines
obtained without a prescription.
Do not take Mirtazapine in combination with:
monoamine oxidase inhibitors (MAO inhibitors). Also,
do not take Mirtazapine during the two weeks after you
have stopped taking an MAO inhibitors. If you stop taking
Mirtazapine, 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 Mirtazapine in combination with:
•  ntidepressants such as SSRIs, venlafaxine and L‑tryptophan
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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 Mirtazapine alone or the combination of Mirtazapine
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.
•  he antidepressant nefazodone. It can increase the amount
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of Mirtazapine in your blood. Inform your doctor if you are
using this medicine. It might be needed to lower the dose
of Mirtazapine, or when use of nefazodone is stopped, to
increase the dose of Mirtazapine again.
•  edicines for anxiety or insomnia such as benzodiazepines;
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medicines for schizophrenia such as olanzapine;
medicines for allergies such as cetirizine;
medicines for severe pain such as morphine.
In combination with these medicines Mirtazapine can increase
the drowsiness caused by these medicines.
•  edicines for infections, medicines for bacterial infections
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(such as erythromycin), medicines for fungal infections
(such as ketoconazole) and medicines for HIV/AIDS (such as
HIV‑protease inhibitors
•  edicines for stomach ulcers such as cimetidine.
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In combination with Mirtazapine these medicines can increase
the amount of mirtazapine in your blood. Inform your doctor
if you are using these medicines. It might be needed to lower
the dose of Mirtazapine, or when these medicines are stopped,
to increase the dose of Mirtazapine again.
•  edicines for epilepsy such as carbamazepine and phenytoin
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•  edicines for tuberculosis such as rifampicin.
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In combination with Mirtazapine these medicines can reduce
the amount of mirtazapine in your blood. Inform your doctor if
you are using these medicines. It might be needed to increase
the dose of Mirtazapine, or when these medicines are stopped
to lower your dose of Mirtazapine again.
•  edicines to prevent blood clotting such as warfarin.
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Mirtazapine 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.
Taking Mirtazapine with food and drink
You may get drowsy if you drink alcohol while you are
taking Mirtazapine.
You are advised not to drink any alcohol.
You can take Mirtazapine with or without food.
Pregnancy and breast‑feeding
Ask your doctor or pharmacist for advice before taking
any medicine.
Pregnancy
Limited experience with Mirtazapine administration to pregnant
women does not indicate an increased risk. However, caution
should be exercised when used during pregnancy.
If you are taking mirtazapine and you become pregnant or
you plan to get pregnant, ask your doctor whether you may
continue taking mirtazapine. If you use Mirtazapine until,
or shortly before birth, your baby should be monitored for
possible adverse effects.
Make sure your midwife and/or doctor knows you are on
Mirtazapine. 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.
Breast‑feeding
Mirtazapine passes into breast milk in small amounts. There is
a potential risk of an effect on the baby. Therefore, you should
discuss the matter with your doctor, and he/she will decide
whether you should stop breast‑feeding or stop the therapy
with Mirtazapine.
Driving and using machines
Mirtazapine can affect your concentration or alertness.
Make sure these abilities are not affected before you drive or
operate machinery.
Important information about some of the ingredients
of Mirtazapine
This medicine contains lactose. If you have been told by your
doctor that you have an intolerance for some sugars, contact
your doctor before taking this medicinal product.
3. HOW TO TAKE MIRTAZAPINE
Always take Mirtazapine exactly as your doctor or pharmacist
tells you to. You should check with your doctor or pharmacist if
you are not sure.
How much to take
Adults:
The usual 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 Mirtazapine
Take Mirtazapine at the same time each day. It is best to
take Mirtazapine as a single dose before you go to bed.
However your doctor may suggest you to split your dose of
Mirtazapine– 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 your tablets orally. Swallow your prescribed dose of
Mirtazapine without chewing, with some water or juice.
When can you expect to start feeling better
Usually Mirtazapine 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 Mirtazapine:
2 to 4 weeks after you have started taking Mirtazapine, 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 Mirtazapine until your symptoms
of depression have disappeared for 4 to 6 months.
Children and adolescents under the age of 18 years:
Mirtazapine should not be used in children and adolescents
under the age of 18 years (see also in section 2, 'Use in children
and adolescents under 18 years of age').
If you take more Mirtazapine than you should
If you or someone else have taken too much Mirtazapine, call a
doctor straight away.
The most likely signs of an overdose of Mirtazapine (without
other medicines or alcohol) are drowsiness, disorientation and
increased heart rate.

If you forget to take Mirtazapine
If you are supposed to take your dose once a day:
• f you have forgotten to take your dose of Mirtazapine, do not
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take the missed dose. Just skip it.
Take your next dose at the normal time.

• ever, sore throat, and fatigue, which may be followed by
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ulcers and other lesions, usually around the mouth and lips
(Stevens‑Johnson syndrome)
•  kin rash or lesions
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•  leepwalking.
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If you are supposed to take your dose twice a day:
• f you have forgotten to take your morning dose, simply take it
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together with your evening dose
• f you have forgotten to take your evening dose, do not take it
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with the next morning dose; just skip it and continue with your
normal morning and evening doses
• f you have forgotten to take both doses, do not attempt to
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make up for the missed doses. Skip both doses and continue
the next day with your normal morning and evening doses.

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

If you stop taking Mirtazapine
Only stop taking Mirtazapine 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 Mirtazapine, even when your
depression has lifted. If you suddenly stop taking Mirtazapine
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.

Do not use Mirtazapine after the expiry date which is stated on
the carton after 'EXP'. The expiry date refers to the last day of
that month.

If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Mirtazapine can cause side effects, although
not everybody gets these side effects.
In some cases the side effect is not caused by the medicine but
is a symptom of your illness.
If any of the following happen, stop taking Mirtazapine and
tell your doctor immediately or go to your nearest hospital
emergency department:
•  ou feel tired, suffer from a sore throat or mouth, unexplained
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fever, or bruise easily
•  ou notice yellowing of your skin or eyes.
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These are rare but serious effects. Your doctor may need to
change your medicine.
Contact your doctor or go to your nearest hospital emergency
department straight away if you have thoughts of harming or
killing yourself (see section 2 'Take special care').
The possible side effects of Mirtazapine are listed below and can
be divided as:
Very common: affects more than 1 user in 10.
Common: affects 1 to 10 users in 100.
Uncommon: affects 1 to 10 users in 1,000.
Rare: affects 1 to 10 users in 10,000.
Very rare: affects less than 1 user in 10,000.
Not known: cannot be estimated from the available data.

If any side effect gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE MIRTAZAPINE
Keep out of the reach and sight of children.

Store in the original container.
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 Mirtazapine contains
The active substance is mirtazapine. The 30 mg tablets contain
30 mg Mirtazapine.
The other ingredients are anhydrous lactose, maize starch,
colloidal anhydrous silica, hydroxypropyl cellulose low
substituted and magnesium stearate. The coating includes
titanium dioxide (E171), macrogol 4000, lactose monohydrate,
red iron oxide (E172), yellow iron oxide (E172), black iron oxide
(E172), and hypromellose (464).
What Mirtazapine looks like and contents of the pack
Your medicine comes as a round film‑coated tablet. The 30 mg
strength are buff‑coloured, marked 'MR/30'on one side and 'G'
on the other. The scoreline is only to facilitate breaking for ease
of swallowing and not to divide into equal doses.
Mirtazapine is available in blisters packs of 10, 14, 20, 28, 30, 50,
100, 250 and 500 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Manufacturer
Generics [UK] Ltd., Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange
Road, Dublin 13, Ireland.
Mylan Hungary Kft, H‑2900 Komarom, Mylan utca 1, Hungary.

Very common:
• ncrease in appetite and weight gain
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•  rowsiness or sleepiness
•  eadache
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•  ry mouth.
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Common:
• ethargy
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•  izziness
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•  hakiness or tremor
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•  ausea
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•  iarrhoea
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•  omiting
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• ash or skin eruptions (exanthema)
•  ain in your joints (arthralgia) or muscles (myalgia)
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•  ack pain
• eeling dizzy or faint when you stand up suddenly
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(orthostatic hypotension)
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•  welling (typically in ankles or feet) caused by fluid retention
(oedema)
• iredness
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•  ivid dreams
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•  onfusion
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• eeling anxious
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•  leeping problems.
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Uncommon:
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• eeling elated or emotionally 'high' (mania)
Stop taking Mirtazapine and tell your doctor straight away.
•  bnormal sensation in the skin e.g. burning, stinging, tickling
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or tingling (paraesthesia)
• estless legs
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• ainting (syncope)
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•  ensations of numbness in the mouth (oral hypoaesthesia)
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• ow blood pressure
•  ightmares
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• eeling agitated
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•  allucinations
•  rge to move.
u
Rare:
•  ellow colouring of eyes or skin; this may suggest disturbance
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in liver function (jaundice)
Stop taking Mirtazapine and tell your doctor straight away.
•  uscle twitching or contractions (myoclonus)
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•  ggressive behaviour.
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• nflammation of the pancreas. This causes moderate to severe
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pain in the stomach.
Not known:
•  igns of infection such as sudden unexplainable high fever,
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sore throat and mouth ulcers (agranulocytosis)
Stop taking Mirtazapine and contact your doctor straight away
for a blood test.
• n rare cases Mirtazapine can cause disturbances in the
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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).
•  pileptic attack (convulsions)
e
Stop taking Mirtazapine and tell your doctor straight away.
a
•  combination of symptoms such as inexplicable fever,
sweating, increased heart rate, diarrhoea, (uncontrollable)
muscle contractions, shivering, overactive reflexes,
restlessness, mood changes and unconsciousness. In very rare
cases these can be signs of serotonin syndrome.
Stop taking Mirtazapine and tell your doctor straight away.
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• houghts of harming or killing yourself
Contact your doctor or go to a hospital straight away.
a
•  bnormal sensations in the mouth (oral paraesthesia)
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•  welling in the mouth (mouth oedema)
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•  yponatraemia
• nappropriate anti‑diuretic hormone secretion
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•  ifficulty speaking
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• ncreased salivation
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This leaflet was last revised in
July 2013

10004992
50050505

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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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