Mfd. By

P.O. Box : 4265 Sana’a /Yemen.

INSTRUCTIONS TO THE PATIENT

- Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you.

- Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.

- The doctor and the pharmacist are experts in medicine, its benefits and risks.

- Do not by yourself interrupt the period of treatment prescribed for you.

- Do not repeat the same prescription without consulting your doctor.

Keep medicament out of reach of children

Council of Arab Health Ministers

012-06-082 3/16 Union of Arab Pharmacists

Precautions

- When treatment is discontinued, the dose should be gradually reduced so as to minimise

the seriousness of the symptoms occurs when the drug is abruptly discontinued.

- If Sertraline is administered to patients with hepatic impairment, lower or less frequent

doses should be considered.

- Sertraline should be used with caution in patients with renal insufficiency.

- The treatment should be discontinued in any patient who develops seizures.

Effect on the capacity to drive vehicles or use machines

Sertraline has no effect on psycomotor performance but , as drugs used to treat depression,

OCD or panic, caution should be taken during drive vehicles or using machines.

Use in pregnancy and lactation

The drug should be used during pregnancy and lactation only if the benefits outweigh the

risks.

DRUG INTERACTION:

- Sertraline should not be used in combination with a MAO inhibitors or within 14 days of

discontinuing treatment with a MAOI, similarly, at least 14 days should elapse after

discontinuing Sertraline before starting a MAO inhibitor.

- Co-administration of Sertraline with warfarin resulted in a small but statistically significant

increase in prothrombin time.

- Co-administration of Sertraline with lithium may lead to a higher incidence of

serotonin-associated side effects. Therefore, It is recommended that plasma lithium

levels be monitored following initiation of Sertraline therapy, so that appropriate

adjustments to the lithium dose may be made if necessary.

- Serotonergic drugs, such as tryptophan or fenfluramine, should not be used concomitantly

with Sertraline.

- The concomitant use of alcohol and Sertraline should be avoided in depressed patients.

- Co-administration of Sertraline with cimetidine caused a substantial decrease in

Sertraline clearance.

ADVERSE EFFECTS:

The most common adverse effects occurred are : dry mouth, increased sweating,

palpitation, headache , dizziness , tremor , nausea , diarrhea , dyspepsia, anorexia, fatigue,

insomnia, sexual dysfunctions, somnolence, and a gitation.

STORAGE INSTRUCTIONS:

Store below 25°C, in a dry place. Protect from light.

PRESENTATIONS:

Sertex Tablets : Pack of 30 tablets and hospital packs of different sizes.

COMPOSITION :

Each f/c tablet contains :

Sertraline hydrochloride equivalent to Sertraline 50 mg.

DESCRIPTION:

Sertex (Sertraline) is a potent and selective serotonin reuptake inhibitor (SSRI). After

oral administration, peak blood levels occur at about 6-8 hours.

Approximately 98% of the circulating drug is bound to plasma proteins.The plasma

half-life of Sertraline is approximately 26 hours. Sertraline is extensively

metabolized and the resultant metabolites excreted in the feces and urine in equal

amounts, only a small amount of unchanged Sertraline is excreted in urine.

INDICATIONS:

Sertex is indicated in the treatment of the following cases :

- Major depressive disorders in adult patients.

- Obsessive compulsive disorders (OCD) both in adult and pediatric patients (6-12 years).

- Panic disorder with or without agoraphobia.

DOSAGE & ADMINISTRATION :

Sertex should be given as a single daily dose. It can be administered with or without food.

Adults :

- Major depressive disorder and obsessive compulsive disorder, therapeutic

dose is 50 mg / day.

- Panic disorder, treatment should be initiated with a dose of 25 mg / day, increasing

to 50 mg / day after one week.

"The daily dose for all indications may be increased in case of lack of response in 50 mg

increments (at intervals of at least one week) to a maximum of 200 mg /day".

Children :

The safety and efficacy of Sertex has been established in pediatric OCD

patients (aged 6-17 years)

- From 13 to 17 years : Therapy should commence at 50 mg / day.

- From 6 to 12 years : Therapy should commence at 25 mg / day, increasing to

50 mg / day after one week.

"Subsequent doses may be increased in case of lack of response in 50 mg / day

increments up to 200 mg / day as needed. However, the generally lower body

weights of children compared to adults should be taken into consideration in

advancing the dose from 50 mg, in order to avoid excessive dosing".

RESTRICTIONS ON USE:

Contraindications

- In patients with hypersensitivity to Sertraline or to other agents which are closely

related from a chemical point of view.

- In patients with unstable epilepsy.

- In patients receiving electroconvulsive therapy.

- In patients with a recent history of myocardial infarction or unstable heart diseases.

SERTEX