Flupentixol Hydrochloride Tablets BP 0.5mg

Flupentixol Hydrochloride Tablets BP 0.5mg
Flupentixol Hydrochloride Tablets BP 1mg
Flupentixol Hydrochloride Tablets BP 3mg

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 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 Flupentixol hydrochloride is and what it is used for

2.What you need to know before you take Flupentixol hydrochloride

3.How to take Flupentixol hydrochloride

4.Possible side effects

5.How to store Flupentixol hydrochloride

6.Contents of the pack and other information

1.What Flupentixol hydrochloride is and what it is used for

Flupentixol hydrochloride contains the active substance flupentixol. Flupentixol hydrochloride belongs to a group of medicines known as antidepressants. These medicines act on nerve pathways in specific areas of the brain and help to correct certain chemical imbalances that are causing the symptoms of your illness.

Flupentixol hydrochloride is used to treat depression in patients who may, or may not, also be showing signs of anxiety.

2.What you need to know before you take Flupentixol hydrochloride

 Do not take Flupentixol hydrochloride

If you are allergic (hypersensitive) to flupentixol, other thioxanthene drugs or antipsychotic drugs or to any of the other ingredients of this medicine (listed in section 6).

If you are feeling less alert than usual, or are drowsy or sleepy, or have serious problems with your blood circulation

If you suffer from severe depression, which needs you to stay in the hospital or if you need electroconvulsive therapy (ECT)

If you suffer from periods of excitement, overactivity or mania.

Warnings and precautions

Talk to your doctor or pharmacist before taking Flupentixol hydrochloride if you:

have a heart condition (including an irregular heartbeat) or severe breathing problems (such as asthma or bronchitis)

have liver, kidney or thyroid problems

suffer from epilepsy, or have been told that you are at risk of having fits (for example because of a brain injury or because of alcohol withdrawal)

suffer from Parkinson?s disease, or myasthenia gravis (a condition causing severe muscular weakness)

have an enlarged prostate or suffer from a condition known as phaeochromocytoma (a rare type of cancer of a gland near the kidney)

suffer from glaucoma (raised pressure within the eye)

are diabetic

or someone else in your family has a history of blood clots, as medicines like these have been associated with the formation of blood clots.

Children and adolescents

Flupentixol hydrochloride is not recommended in these patients.

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 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 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.

Other medicines and Flupentixol hydrochloride

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The following medicines should NOT be taken at the same time as Flupentixol hydrochloride:

Antipsychotics or other medicines that change the heartbeat (quinidine, amiodarone, sotalol, dofetilide, erythromycin, moxifloxacin, cisapride, lithium)

Tell your doctor if you are taking any of the following medicines:

Tricyclic anti-depressants

Barbiturates or other medicines that make you feel drowsy

Anticoagulant drugs used to prevent blood clots (e.g. warfarin)

Anticholinergic drugs (contained in some cold, allergy or travel sickness remedies as well as other medicines)

Metoclopramide (used to treat nausea and other stomach conditions)

Piperazine (used to treat worm infections)

Levodopa or other medicines used to treat Parkinson?s disease

Sibutramine (used to reduce appetite)

Digoxin (to control heart rhythm)

Corticosteroids (e.g. prednisolone)

Medicines used to lower the blood pressure such as hydralazine, alpha-blockers (e.g. doxazosin) beta-blockers, methyldopa, clonidine or guanethidine

Medicines used to treat epilepsy

Medicines used to treat diabetes

Flupentixol hydrochloride can reduce the effect of adrenaline (epinephrine) and similar drugs.

Tell your doctor, dentist, surgeon or anaesthetist before any operation as Flupentixol hydrochloride can increase the effects of general anaesthetics, muscle relaxing drugs and drugs used to prevent clots.

Flupentixol hydrochloride with food, drink and alcohol

Flupentixol hydrochloride can be taken with or without food.

Flupentixol hydrochloride may increase the sedative effects of alcohol making you drowsier. It is recommended not to drink alcohol during treatment with Flupentixol hydrochloride.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.


If you are pregnant or think you might be pregnant, tell your doctor. Flupentixol hydrochloride should not be used during pregnancy unless it is necessary.

The following symptoms may occur in newborn babies, of mothers that have used Flupentixol hydrochloride Tablets in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/ or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.


If you are breastfeeding, ask your doctor for advice. You should not use Flupentixol hydrochloride when breastfeeding your baby because small amounts of the medicine can pass into the breast milk.


Flupentixol may decrease your sexual activity and fertility. These are not lasting effects. Please talk to your doctor about any problems.

Driving and using machines

There is a risk of feeling drowsy and dizzy when using Flupentixol hydrochloride especially at the start of your treatment. If this happens do not drive or use any tools or machines until you know you are not affected in this way.

Do not drive if you have blurred vision.

Flupentixol hydrochloride film-coated tablets contain lactose

If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3.How to take Flupentixol hydrochloride

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

The dose varies and depends on the severity of the illness.


The starting dose is usually 1 mg daily taken as a single dose in the morning. This may be increased to 2 mg per day after one week. The maximum daily dose is 3 mg per day.

If you have liver problems, the level of flupentixol in your blood may be checked.

Older patients (above 65 years)

The starting dose is usually 0.5 mg daily taken as a single dose in the morning. This may be increased to 1 mg per day after one week. The maximum daily dose is 1.5 mg per day.

Use in children

Flupentixol hydrochloride is not recommended for children.

How and when to take Flupentixol hydrochloride

Swallow the tablets with a drink of water. Do not chew them. You may feel an improvement within two to three days.

If you think that the effect of Flupentixol hydrochloride is too strong or too weak, talk to your doctor or pharmacist.

Continue to take the tablets for as long as your doctor recommends. The underlying illness may persist for a long time and if you stop your treatment too soon your symptoms may return.

Never change the dose of the medicine without talking to your doctor first.

If you take more Flupentixol hydrochloride than you should

If you think that you or anyone else may have taken too many Flupentixol hydrochloride film-coated tablets to contact your doctor or nearest hospital casualty department immediately. Do this even if there are no signs of discomfort or poisoning. Take the Flupentixol hydrochloride container with you if you go to a doctor or hospital.

Symptoms of overdose may include:



Muscle movements or stiffness


Low blood pressure, weak pulse, fast heart rate, pale skin, restlessness

High or low body temperature

Changes in the heartbeat including irregular heartbeat or slow heart rate

If you forget to take Flupentixol hydrochloride

If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Flupentixol hydrochloride

Do not stop taking Flupentixol hydrochloride even if you begin to feel better unless you have agreed on this with your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Older patients tend to be more prone to some of these effects than younger patients and this may mean your treatment is supervised more closely.

Serious side effects

Stop taking Flupentixol hydrochloride and seek medical advice immediately if you have any of the following allergic reactions:

Difficulty in breathing

Swelling of the face, lips, tongue or throat which causes difficulty in swallowing or breathing

Severe itching of the skin (with raised lumps)

Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately.

If you get any of the following symptoms you should contact your doctor immediately as your dose may need to be reduced or stopped:

High fever, unusual stiffness of the muscles and changes in consciousness, especially if occurring with sweating and fast heart rate. These symptoms may be signs of a rare but serious condition called neuroleptic malignant syndrome that has been reported with the use of Flupentixol hydrochloride and similar medicines

Unusual movements of the mouth and tongue as these may be early signs of a condition known as tardive dyskinesia

Unusual muscle movements (such as circular movements of the eyes), stiffness, tremor and restlessness (for example difficulty in sitting or standing still) as these may be signs of a so-called ?extrapyramidal? reaction

Any yellowing of the skin and the white in the eyes (jaundice); your liver may be affected

Other side effects:

Side effects are most pronounced at the beginning of the treatment and most of them usually wear off during continued treatment.

Throbbing or fast heartbeats

Reduction in blood platelets (which increases the risk of bleeding or bruising) and other blood cell changes


Loss of coordination or altered muscle movements (including unusual movements of the mouth, tongue and eyeballs)


Stiff or floppy muscles



Poor concentration or confusion

The rigidity of the whole body

Speech problems


Blurred or abnormal vision

Shortness of breath

Dry mouth or increase in saliva

Feeling sick or vomiting

Indigestion or stomach pain

Flatulence (wind), constipation or diarrhoea

Abnormal urination (such as a decrease in the frequency or amount)

Increased sweating or greasy skin

Itching, rashes or skin reactions (including sensitivity to sunlight)

Muscle pain

Raised blood levels of glucose or the hormone prolactin

Loss of control of blood sugar levels

Changes in appetite or weight

Low blood pressure

Hot flushes

General weakness or pain, tiredness or feeling unwell

Abnormal liver function tests

Unexpected excretion of breast milk



Nervousness or agitation

Reduction in your sex drive

Men may experience breast enlargement or problems with ejaculation or erections

Women may experience an absence of menstrual periods

As with other medicines that work in a way similar to flupentixol (the active ingredient of Flupentixol hydrochloride film-coated tablets), rare cases of the following side effects have been reported:

Slow heartbeat and abnormal ECG heart tracing.

Life-threatening irregular heartbeats.

In rare cases, irregular heartbeats (arrhythmias) may have resulted in sudden death.

In older people with dementia, a small increase in the number of deaths has been reported for patients taking antipsychotics compared with those not receiving antipsychotics.

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 (see details below).

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Flupentixol hydrochloride

Keep this medicine out of the sight and reach of children

Do not use this medicine after the expiry date that is printed on the label. The expiry date refers to the last day of that month

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Flupentixol hydrochloride contains

The active substance is flupentixol (as dihydrochloride). Each tablet contains 0.5 mg or 1 mg flupentixol.

The other ingredients are betadex, lactose monohydrate, maize starch, hydroxypropyl cellulose, microcrystalline cellulose, croscarmellose sodium, talc, hydrogenated vegetable oil and magnesium stearate.

Coating and colour: macrogol 6000, polyvinyl alcohol, macrogol 3350, talc, iron oxide yellow and titanium dioxide.

They are available in blister packs of tablets.

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