Sertraline 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sertraline hydrochloride

Available from:

Milpharm Ltd

ATC code:

N06AB06

INN (International Name):

Sertraline hydrochloride

Dosage:

100mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030300; GTIN: 8901175007462

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SERTRALINE 50 MG FILM-COATED TABLETS
SERTRALINE 100 MG FILM-COATED TABLETS
(sertraline)
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.
WHAT IS IN THIS LEAFLET
1. What Sertraline is and what it is used for
2. What you need to know before you take Sertraline
3. How to take Sertraline
4. Possible side effects
5. How to store Sertraline
6. Contents of the pack and other information
1. WHAT SERTRALINE IS AND WHAT IT IS USED FOR
Sertraline contains the active substance sertraline. Sertraline is one
of a group of medicines
called Selective Serotonin Re-uptake Inhibitors (SSRIs); these
medicines are used to treat
depression and or anxiety disorders.
SERTRALINE CAN BE USED TO TREAT:
•
Depression and prevention of recurrence of depression (in adults).
•
Social anxiety disorder (in adults).
•
Post traumatic stress disorder (PTSD) (in adults).
•
Panic disorder (in adults).
•
Obsessive compulsive disorder (OCD) (in adults and children and
adolescents aged
6-17 years old).
Depression is a clinical illness with symptoms like feeling sad,
unable to sleep properly or to
enjoy life as you used to.
OCD and Panic disorders are illnesses linked to anxiety with symptoms
like being constantly
troubled by persistent ideas (obsessions) that make you carry out
repetitive rituals
(compulsions).
PTSD is a condition that can occur after a very emotionally traumatic
experience, and has
some symptoms that are similar to depression and anxiety. Social
anxiety disorder (social
phobia) is an illness linked t

Summary of Product characteristics

OBJECT 1
SERTRALINE 100MG TABLETS
Summary of Product Characteristics Updated 12-Jul-2022 | Aurobindo
Pharma - Milpharm Ltd.
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Sertraline 100 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 100 mg sertraline (as sertraline
hydrochloride).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White capsule shaped, film coated tablets debossed with 'A' on one
side and '82' on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Sertraline is indicated for the treatment of:
Major depressive episodes. Prevention of recurrence of major
depressive episodes.
Panic disorder, with or without agoraphobia.
Obsessive compulsive disorder (OCD) in adults and paediatric patients
aged 6-17 years.
Social anxiety disorder.
Post traumatic stress disorder (PTSD)
4.2 Posology and method of administration
POSOLOGY
_Initial treatment _
_Depressi