Dothiepin Hydrochloride Tablets 25mg

Dothiepin Hydrochloride Tablets 25mg
Dothiepin Hydrochloride Tablets 75mg

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 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 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:

What Dothiepin Hydrochloride Coated Tablets are and what they are used for

What you need to know before you take Dothiepin Hydrochloride

How to take Dothiepin Hydrochloride
Possible side effects
How to store Dothiepin Hydrochloride

Contents of the pack and other information

What Dothiepin Hydrochloride Coated Tablets are and what they are used for

The name of your medicine is Dothiepin Hydrochloride 75mg Coated Tablets (called Dothiepin Hydrochloride in this leaflet). The active ingredient in Dothiepin Hydrochloride is

Dothiepin Hydrochloride. Dothiepin Hydrochloride belongs to a group of medicines called tricyclic antidepressants.

Dothiepin Hydrochloride is used to treat depression and can also help reduce feelings of anxiety. Please ask your doctor or pharmacist if you need more information.

What you need to know before you take Dothiepin Hydrochloride

Do not take Dothiepin Hydrochloride Tablets if

You are allergic to dosulepin, ponceau 4R (E124), sunset yellow (E110) or any of the other ingredients in this medicine (see Section 6).

You have the eye condition known as glaucoma

You are pregnant or planning to become pregnant, or are breastfeeding.

You have an irregular heartbeat, recent heart attack or any other heart problem.
You have severe liver problems.

You suffer from periods of exaggerated behaviour (mania).

You are a child or adolescent under the age of 18 years.

You are taking any of the following medicines:

A mono-amine oxidase inhibitor (MAOI), used to treat depression.

You should not take Dothiepin

Hydrochloride with MAOI?s or within

14 days of stopping them.

Any hay fever/allergy treatment which contains terfenadine or astemizole.

Sotalol (for heart or blood pressure problems) or halofantrine (for malaria).

Warnings and precautions

Talk to your doctor or pharmacist before taking Dothiepin Hydrochloride if

You have difficulty in passing urine, or have prostate problems

You have epilepsy

You have a thyroid problem

The elderly are at risk of experiencing side effects while taking this medicine, especially agitation, confusion and lightheadedness.

Tell your surgeon or dentist that you are taking Prothiden if surgery is planned. It may affect the anesthetic used.

A small number of people may be sensitive to the ponceau 4R (E124) and sunset yellow (E110) contained in Dothiepin Hydrochloride tablets. They may cause an allergic reaction. Allergy is more common in those people who are allergic to aspirin.

A risk of suicide, self-

harm and hostility can

not be excluded with

dosulepin. 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 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 behavior 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 or have an anxiety disorder, and to 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 behavior.

Other medicines with Dothiepin Hydrochloride

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

If you are taking any of the following medicines:

Any of the class of medicines known as

SSRI?s (selective serotonin re-uptake inhibitors), used to treat depression.

Any thyroid medication such as Levothyroxine (thyroxine)

Any barbiturate (e.g. phenobarbitone for epilepsy, amylobarbitone for insomnia) or methylphenidate (used to treat behavioral problems)

Any medicine containing an opioid

(such as codeine, morphine dihydrocodeine, co-proxamol and co-dydramol)

Sympathomimetic agents – these include ephedrine, pseudoephedrine, adrenaline and noradrenaline. (These may be found in medicines used to treat heart problems and asthma as well as some

decongestants and cough/ cold remedies.) This list contains medicines that are prescribed by a doctor and also some that you can buy from your pharmacist.

You are receiving any treatment for hypertension (high blood pressure) e.g. guanethidine.

In particular if you are using:

Any monoamine oxidase inhibitor, nor within fourteen days of ceasing such treatment.

Any of the class of medicines known as SSRIs (selective serotonin reuptake inhibitors) used to treat depression as it may increase tricyclic antidepressant levels in plasma.

Sympathomimetic agents – these include ephedrine, pseudoephedrine, adrenaline and noradrenaline. (These may be found in medicines used to treat heart problems and asthma as well as some decongestants and cough/cold remedies). This list contains medicines that are prescribed by a doctor and also some that you can buy from a pharmacist.

Any barbiturates (e.g. phenobarbitone for epilepsy, amylobarbitone for insomnia) or methylphenidate to treat behavioral problems as they may affect the antidepressant action.

Any medicines that are used to regulate the heartbeat (e.g. sotalol, terfenadine, astemizole, halofantrine).

Dothiepin Hydrochloride with food, drink and alcohol

Drinking alcohol with Dothiepin Hydrochloride can make the feeling of drowsiness worse.

Pregnancy, Breast feeding and Fertility

You should not take Dothiepin Hydrochloride if you are pregnant or breastfeeding. If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Patients should be advised that the withdrawal of this medicine should be gradual. If you stop taking this medicine suddenly you may experience some withdrawal symptoms including insomnia, irritability and excessive perspiration. Similar symptoms may occur in newborn babies whose mothers have received this medicine during the last 3 months of pregnancy.

Driving and Using Medicines

Dothiepin Hydrochloride can make you feel drowsy. Do not drive, operate machinery or do anything that requires you to be alert until you know how the tablets affect you. Feeling drowsy in the day can improve with time, but if drowsiness becomes a problem, you should tell your doctor.

Dothiepin Hydrochloride contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.

Dothiepin Hydrochloride contains ponceau 4R (E124) and sunset yellow (E110) which may cause allergic reactions.

How to take Dothiepin Hydrochloride

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dothiepin Hydrochloride tablets should be swallowed whole with a drink of water.

If you chew the tablet, you may experience a bitter taste and a temporary numbness of your tongue.

It may take two to four weeks of treatment before you begin to see an improvement in your mood. You may, however, notice an earlier improvement in your anxiety symptoms. You must keep taking these tablets until your doctor tells you to stop. Don?t stop just because you feel better. If you stop taking the tablets too soon, your condition may get worse.

The exact number of tablets that you will need to take will be decided by your doctor. Your doctor will also tell you when you should take them. Some patients may be told to take a mixture of Dothiepin Hydrochloride tablets and Dothiepin Hydrochloride capsules. If you need more information, you should ask your doctor or pharmacist.

The following are given as guidelines.

Adults: As a starting dose, 1 tablet a day. These may be increased to a total of 2 or 3 tablets a day. The tablets may be taken in divided doses throughout the day, or as a single dose each

evening, usually a couple of hours before you go to bed.

Normally, not more than 3 tablets (equivalent to 225 mg dosulepin) should be taken each day.

Elderly: Initially, 50mg to 75mg a day (this medicine is also available in 25mg hard capsules)

Children: Not recommended.

If you take more Dothiepin Hydrochloride Tablets than you should:

If you have taken more than the stated dose (an overdose), go to the nearest hospital casualty department immediately. Show them the tablets and any other medicines that may have been taken.

If you forget to take Dothiepin Hydrochloride Tablets

If you forget to take a dose, take the next dose at the usual time. Never double-up on a dose to make up for the one you have missed.

If you stop taking Dothiepin Hydrochloride

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Contact your doctor (or go to a hospital straight away) if you get any of the following serious side effects:

Rare (between 1 and 10 of every 10,000 patientstreated):

Bone marrow depression or reduction in some blood cells (you may experience unusual bruising or abnormal bleeding, sore throat and fever, mouth ulcers),

Liver problems with yellowing of the skin and eyes (jaundice),
Convulsions (fits),

Irregular heartbeat (more likely with high dosage).

Other possible side effects during treatment

Common (between 1 and 10 of every 100patients) treated:

dry mouth,
blurred vision,
dizziness,

constipation,

sedation,
difficulty in passing urine.

These problems tend to improve with time. Uncommom (between 1 and 10 of every 1000patients)

severe allergic reaction to Dothiepin Hydrochloride (you may experience a skin rash, itching, swollen face or tongue, shortness of breath, collapse). If you develop an unexpected skin rash or difficulty breathing stop taking the tablets and contact your doctor,

severe low blood pressure,
increased sweating,

tiredness or sleepiness,

confusion and hallucination (strange vision or sounds),

tremors,
changes in sex drive,

changes in the heart beat.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

An increased risk of bone fractures has

been observed in patients taking these

types of medicines. 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.

How to store Dothiepin Hydrochloride

Do not take this product after the ?use by? (expiry) date shown on the carton or bottle. The expiry date refers to the last day of that month.

Blister pack: ?Store in the original package to protect from light and moisture?.

HDPE bottle: ?Keep the container tightly closed to protect from moisture, and store in the original package to protect from light?.

Do not store them above 25?C. They should be kept in a safe place (preferably a locked cupboard) where they are out of the reach and sight of children. Your medicine could harm them.

If your doctor decides to stop the treatment, return any leftover to your pharmacist.

Only keep the tablets if your doctor tells you to. 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

Contents of the pack and other information

What Dothiepin Hydrochloride Coated Tablets contain

The active ingredient in Dothiepin Hydrochloride is Dothiepin Hydrochloride. Each tablet contains 75mg of Dothiepin Hydrochloride with calcium phosphate, maize starch, talc, povidone and magnesium stearate. The coating of the tablets also contains small amounts of sucrose, liquid glucose, sandarac, white beeswax, sodium benzoate, titanium dioxide, ponceau 4R, sunset yellow, and povidone.

What Dothiepin Hydrochloride Coated Tablets Look Like and Contents of the Pack Dothiepin Hydrochloride coated tablets are red,

biconvex, sugar-coated tablets and are available in calendar packs of 28 and bottles of 100 tablets. Not all pack sizes may be marketed.

7. Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)