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ALLEGRON 25MG TABLETS

Active substance(s): NORTRIPTYLINE / NORTRIPTYLINE HYDROCHLORIDE

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Allegron® 25mg Tablets
Paxtibi® 25mg Tablets
Nortriptyline Hydrochloride 25mg Tablets
(nortriptyline hydrochloride)
Your medicine is known by the above names, but will be referred to as
Allegron tablets throughout this:
Patient Information Leaflet






Read all of this leaflet carefully before you start taking this
medicine.
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. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
If any of the side effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1) What Allegron tablets are and what they are used for
2) Before you take Allegron tablets
3) How to take Allegron tablets
4) Possible side effects
5) How to store Allegron tablets
6) Further information

1) What Allegron tablets is and what is it used for?
Allegron tablets contain the active ingredient nortriptyline hydrochloride,
which is a tricyclic antidepressant. Allegron tablets relieve the symptoms of
depression.
Allegron tablets may also be used for the treatment of bedwetting in children
6 years and older.

2) Before you take Allegron tablets
Do not take Allegron tablets if:
 you are allergic (hypersensitive) to nortriptyline or any of the other
ingredients of Allegron tablets (see list of ingredients in Section 6). An
allergic reaction may include rash, itching, difficulty breathing or swelling
of the face, lips, throat or tongue;
 you have had a recent heart attack or heartbeat disorder;
 you have severe liver disease;
 you suffer from mania (abnormally raised mood);
 you are breast-feeding;
 the child is under 6 years of age;
 you are taking, or have taken in the last two weeks, monoamine oxidase
inhibitors (another type of antidepressant);
 you are taking adrenaline-like drugs including ephedrine, isoprenaline,
noradrenaline, phenylephrine and phenylpropanolamine. These drugs are
often contained in cough and cold remedies.
Take special care with Allegron tablets if:
 you feel suicidal or aggressive - tell your doctor;
 you are agitated, overactive, or suffer from schizophrenia;
 you have heart disease;
 you have a thyroid condition;
 you have a history of epilepsy;
 you have high pressure in the eyes (glaucoma);
 you have an enlarged prostate;
 your child taking Allegron tablets has a change in behaviour;
 you are going to have electroconvulsive therapy (electric shock);
 you are diabetic;
 you are going to receive an anaesthetic, e.g. for an operation – tell your
doctor;
 you have had an allergic reaction to another tricyclic antidepressant
in the past;
 you are pregnant, think you might be pregnant or planning to become
pregnant or breast-feeding you should not take Allegron tablets unless
your doctor tells you to.
Thoughts of suicide and worsening of your depression or anxiety
disorder
If you are depressed and/or have anxiety disorders 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 hospital straight away.
You may find it helpful to tell a relative or close friend that you are
depressed or have an anxiety disorder, and ask them to read this leaflet. You
might ask them to tell you if they think your depression or anxiety is getting
worse, or if they are worried about changes in your behaviour.
If any of the above apply to you, tell your doctor or pharmacist.

Taking other medicines
You should tell your doctor if you are taking or have taken any medicines,
including medicines obtained without a prescription.
The following medicines may interact with your Allegron tablets:
 guanethidine, debrisoquine, bethanidine, clonidine (used to treat high
blood pressure);
 barbiturates (used for anxiety or to make you feel sleepy);
 alcohol (you should not drink alcohol);
 fluoxetine (another antidepressant);
 cimetidine (for heartburn and ulcers);
 phenothiazines (for mental illness);
 carbamazepine (for epilepsy);
 propafenone, flecainide, encainide, quinidine (for heartbeat
disorders).
It may still be all right for you to be given Allegron tablets. Your doctor will be
able to decide what is suitable for you.
Driving and using machines
Allegron tablets may affect alertness. Use caution when driving or operating
heavy machinery until you’re aware of how this drug affects you. If you feel
Allegron tablets affect your ability to drive or use machines, tell your doctor
immediately.
Important information about some of the ingredients of Allegron tablets
Allegron tablets contain lactose. If you are lactose intolerant, contact your
doctor before taking this medicine. Allegron tablets contain sunset yellow lake
(E110), which may cause allergic reactions.

3) How to take Allegron tablets
Always take Allegron tablets exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Dosage
Adults:
The usual adult dose is 25mg three or four times daily or the dose may be
given once a day, usually at night.
The dose should begin at a low level, 10mg, 3-4 times daily, for example and
be increased gradually as required. The maximum dose is 150mg per day.
The elderly:
The usual dose is 30 to 50mg/day in divided doses.
Treatment may start with 10mg three times a day.
Adolescent patients:
The usual dose is 30 to 50mg/day in divided doses.
Treatment may start with 10mg three times a day.
Lower dosages are recommended for outpatients than for patients in hospital
who will be under close supervision.
Following remission maintenance treatment may be needed longer term. This
should be at the lowest dose that stops the symptoms of depression coming
back.
Children (for bed-wetting only)
Age (years)
Weight
Kg
lb
6-7
20-25
44-55
8-11
25-35
55-77
Over 11
35-54
77-119

Dose (mg)
10
10-20
25-35

The dose should be given thirty minutes before bedtime.
The maximum length of treatment should be three months. Another course of
treatment should not be started until a full physical examination has been
made.
If you take more Allegron tablets than you should
Go to the nearest casualty department or contact your doctor immediately.
Take the tablet carton with you.
If you forget to take Allegron tablets
If you miss a dose, take one as soon as you can. If you have missed several
doses, tell your doctor. Do not take a double dose to make up for a forgotten
dose.
If you stop taking Allegron tablets
Do not stop taking the tablets or reduce the dose without telling your doctor
first.
If you suddenly stop taking the tablets you may feel sick (nausea), have a
headache or feel generally unwell.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4) Possible side effects

5) How to store Allegron tablets

Like all medicines, Allegron tablets can cause side effects, although not
everybody gets them. If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet, please tell your doctor or
pharmacist.
All medicines can cause allergic reactions, although serious allergic reactions
are very rare.
Tell your doctor straight away if you get any sudden wheeziness,
difficulty in breathing, swelling of the eyelids, face or lips, rash or
itching, especially affecting your whole body.
The following side effects have been reported:

low or high blood pressure

fast or irregular heartbeat

palpitations

heart attack (myocardial infarction)

stroke

oedema (swelling of the ankles)














confusion (especially in the elderly) with seeing or hearing things
(hallucinations)
not knowing where you are (disorientation)
false beliefs (delusions)
anxiety, restlessness, agitation
not sleeping (insomnia)
nightmares
panic
long-lasting abnormal mood
worsening of mental illness









numbness, tingling, pins and needles in the hands or feet
coordination problems
tremors
abnormal movements
fits (seizures)
altered brainwave (ECG) patterns
ringing in the ears (tinnitus)







dry mouth
rarely, inflamed glands under the tongue or inflammation of the
gums (gingivitis)
blurred vision, difficulty in focusing, dilated pupils
constipation, blockage of the digestive tract
unable to urinate or delayed urination








rash
itching
light sensitivity
swelling (oedema)
fever
reaction to other similar drugs



blood disorders which may cause you to bruise easily, become
anaemic or be unable to fight off infections











feeling sick (nausea) and vomiting
not eating (anorexia)
indigestion
diarrhoea
constipation
peculiar taste
inflamed mouth
abdominal cramps
black tongue



development of breasts in men, breast enlargement and milk
production in women
increased or decreased sex drive
failure to have an erection (impotence)
swollen testicles
altered blood sugar levels





















yellow eyes and skin (jaundice)
altered liver function
inflamed liver (hepatitis) and liver damage
weight gain or loss
sweating
flushing
urinating often and at night
sleepiness
dizziness
weakness
tiredness
headache
swollen glands
hair loss (alopecia).
An increased risk of bone fractures has been observed in patients
taking this type of medicine.

Reporting of side effects
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 report 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.




Keep all medicines out of the sight and reach of children.
Do not take your medicine after the expiry date printed on the carton, and
blister label.
If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.
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 Allegron tablets contain:
The active substance is nortriptyline hydrochloride.
Each film-coated tablet contains the active ingredient nortriptyline
hydrochloride equivalent to 25mg nortriptyline base.
The other ingredients are: lactose, calcium phosphate, maize starch,
magnesium stearate, sunset yellow lake (E110), hypromellose, ethylcellulose
and glycerol.
What Allegron tablets looks like and contents of the pack
The tablets are round, orange, film-coated with a scoreline on one side and
plain on the other.
Allegron tablets are available as blister packs of 25 and 100 tablets.
PL 10383/1821

Allegron 25mg Tablets
Paxtibi 25mg Tablets
Nortriptyline Hydrochloride 25 mg Tablets.

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Laboratorios Biomed S.L., C/Licorers, 169170 Nave 14, Poligono Ca’n Robiols, E07141 Marratxi (Islas Baleares),
Spain. Procured from within the EU and repackaged by Product Licence
Holder: Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex, UB5 5QS.
Leaflet date: 22.05.2014
Allegron® is a registered trademark of King Pharmaceuticals Ltd., Ireland.

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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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