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.
Pregnancy
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.
Breast-feeding
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.
Fertility
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.
Adults
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:
Drowsiness
Unconsciousness
Muscle movements or stiffness
Fits
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
Drowsiness
Loss of coordination or altered muscle movements (including unusual movements of the mouth, tongue and eyeballs)
Tremor
Stiff or floppy muscles
Dizziness
Headache
Poor concentration or confusion
The rigidity of the whole body
Speech problems
Fits
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
Insomnia
Depression
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:
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)