Nortriptyline 10mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
09-07-2021
Summary of Product characteristics
(SPC)
09-07-2021
Public Assessment Report
(PAR)
20-04-2020
Active ingredient:
Nortriptyline hydrochloride
Available from:
King Pharmaceuticals Ltd
ATC code:
N06AA10
INN (International Name):
Nortriptyline hydrochloride
Dosage:
10mg
Pharmaceutical form:
Oral tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 04030100; GTIN: 5033003002271
Patient Information leaflet
Package leaflet: Information for the user
NORTRIPTYLINE
10MG & 25MG TABLETS
Nortriptyline
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
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Keep this leaflet. You may need to read it again.
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If you have any further questions, ask your doctor
or pharmacist.
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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.
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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.
WHAT IS IN THIS LEAFLET
1. What Nortriptyline tablets are and
what they are used for
2. What you need to know before you take
Nortriptyline tablets
3. How to take Nortriptyline tablets
4. Possible side effects
5. How to store Nortriptyline tablets
6. Contents of the pack and other information
1 WHAT NORTRIPTYLINE TABLETS ARE AND
WHAT THEY ARE USED FOR
Nortriptyline tablets contain the active ingredient
nortriptyline hydrochloride, which is a tricyclic
antidepressant. Nortriptyline tablets relieve the
symptoms of depression.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
NORTRIPTYLINE TABLETS
DO NOT TAKE NORTRIPTYLINE TABLETS:
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If you are allergic to nortriptyline hydrochloride or
any of the other ingredients of this medicine (listed
in section 6). An allergic reaction may include rash,
itching, difficulty breathing or swelling of the face,
lips, throat or tongue;
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If you have had a recent heart attack or
heartbeat disorder;
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If you have severe liver disease;
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If you suffer from mania (abnormally raised mood);
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If you are breast-feeding;
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If the child is under 6 years of age;
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If you are taking, or have taken in the last two weeks,
monoamine oxidase inhibitors (another type of
antidepressant);
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If you are taking adrenaline-like drugs including
ephedrine, isoprenaline, noradrenaline, phenylephrine
and phenylpropanolamine. These drugs are often
contained in cough and cold remedies.
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Allegron Tablets 10 mg
Nortriptyline 10 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ALLEGRON TABLETS 10 MG/ NORTRIPTYLINE 10 MG TABLETS:
Tablets each containing Nortriptyline Hydrochloride EP equivalent to
10mg nortriptyline
base.
Tablets are white, unscored and have a diameter of 5.5mm.
They are marked ´KING’.
Excipient(s) with known effect
Lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Allegron Tablets 10 mg/ Nortriptyline 10 mg Tablets:
Tablet.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal
doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nortriptyline is indicated for the relief of symptoms of depression.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults:_ The usual adult dose is 25mg three or four times daily.
Dosage should begin
at a low level and be increased as required. Alternatively, the total
daily dose may be
given once a day. When doses above 100mg daily are administered,
plasma levels of
nortriptyline should be monitored and maintained in the optimum range
of 50 to
150ng/ml. Doses above 150mg per day are not recommended.
Lower than usual dosages are recommended for elderly patients and
adolescents.
Lower dosages are also recommended for outpatients than for
hospitalised patients
who will be under close supervision. The physician should initiate
dosage at a low
level and increase it gradually, noting carefully the clinical
response and any evidence
of intolerance. Following remission, maintenance medication may be
required for a
longer period of time at the lowest dose that will maintain remission.
If a patient develops minor side-effects, the dosage should be
reduced. The drug
should be discontinued promptly if adverse effects of a serious nature
or allergic
manifestations occur.
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_The elderly:_ 30 to 50mg/day in divided doses.
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_Adolescent patients:_ 30 to 50mg/day in divided doses.
_Plasma levels: _Optimal respon
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