Wednesday, September 28, 2016

Prochlorperazine Tablets 5mg (Actavis UK Ltd)






Prochlorperazine Tablets 5mg



  • Please read this leaflet carefully before you start to take your medicine.


  • It gives you important information about your medicine.


  • If you want to know more, or you are not sure about anything, ask your pharmacist or doctor.


  • Keep the leaflet until you have finished the medicine.



What's In Your Medicine


Prochlorperazine Tablets are white, circular, uncoated tablets which come in one strength. Each tablet contains 5mg of the active ingredient Prochlorperazine maleate.


The tablets also contain: lactose, magnesium stearate, maize starch, microcrystalline cellulose (E460).


Prochlorperazine Tablets are available in a pack size of 28 and 84.
Prochlorperazine Tablets is one of a group of medicines called phenothiazine tranquillisers. These can be used for the treatment of mental illness.




MA holder/Manufacturer:



Actavis

Barnstaple

EX32 8NS

UK




About Your Medicine


The name of your medicine is Prochlorperazine Tablets which is the generic name. Your doctor may have given you this medicine before from another company and it may have looked slightly different. Either brand will have the same effect.


Prochlorperazine Tablets may be used for:


  • the treatment of dizziness due to ear diseases such as Meniere's syndrome, labyrinthitis or due to other causes.

  • in the treatment of nausea and vomiting.

  • for the treatment of migraine, and mental illnesses such as schizophrenia and mania.

  • to help in the short term treatment of anxiety.



Before Taking Your Medicine


Do not take Prochlorperazine Tablets BP if you:


  • are sensitive to prochlorperazine or similar drugs (ie perphenazine, trifluoperazine) or to any other of the ingredients in the product.

  • have liver or kidney problems.

  • have or have had jaundice.

  • suffer with epilepsy.

  • suffer with muscle weakness (myasthenia gravis).

  • have an underactive thyroid gland.

  • suffer from high blood pressure due to a tumour near the kidney (a condition known as phaeochromocytoma).

  • suffer from Parkinson’s disease.

  • suffer with increased pressure in the eye (a condition known as glaucoma).

  • have an enlarged prostate gland.

Make sure you have told your doctor or pharmacist if you:


  • are elderly. Prochlorperazine Tablets should be used with caution during very hot or very cold weather to reduce the risk of an extreme rise or fall in body temperature.

  • have had any heart disorders (heart attack, angina)

  • have ever abused alcohol

  • are not eating properly

  • have a low white blood cell count

  • have a low blood concentration of potassium (hypokalaemia), calcium (hypocalcaemia) or magnesium (hypomagnesaemia)

  • are taking other medicines such as:

    • medicines to relieve pain (eg morphine, codeine phosphate, dextropropoxyphene, dihydrocodeine, tramadol),
    • antacids or kaolin preparations,
    • medicines to relieve depression (eg amitriptyline, dosulepin, imipramine),
    • medicines to treat narcolepsy (a tendency to fall asleep during the day, eg dexamfetamine sulphate),
    • medicines to treat hayfever or other allergies (eg terfenadine),
    • medicines taken by mouth to treat diabetes (eg chlorpropamide, gliclazide),
    • medicines to treat high blood pressure (eg clonidine, doxazosin, guanethidine, prazosin, indoramin, nifedipine, verapamil),
    • medicines to treat Parkinson’s disease and some mental illnesses (eg benzatropine mesilate, bromocriptine, cabergoline, procyclidine, levodopa, pramipexole, ropinirole, apomorphine, lisuride, pergolide),
    • lithium (used to treat severe depression and mania),
    • medicines to treat bladder and bowel problems or high blood pressure (eg hyoscine, atropine, oxybutynin or other anticholinergic medicines),
    • ritonavir (used to treat HIV (human immunodeficiency virus)),
    • medicines used to treat anxiety and difficulty sleeping (eg diazepam, alprazolam, chlordiazepoxide, lorazepam, oxazepam, barbiturates),
    • sotalol (used to prevent and treat some heart conditions),
    • desferrioxamine (used to treat iron poisoning),
    • metoclopramide (used to prevent and treat nausea and vomiting),
    • sibutramine (used in the treatment of weight loss),
    • tetrabenazine (used to treat movement disorders),
    • cimetidine (used to treat stomach ulcers),
    • adrenaline (epinephrine),
    • phenobarbital or carbamazepine (used to treat epilepsy)
    • medicines to treat irregular heart beat (e.g. amiodarone, flecainide)
    • antibiotics or cancer treatments that may affect blood cell production and including any that you can buy without prescription.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product, as it contains lactose.


You are advised NOT to drink alcohol with this medicine. Taking alcohol with Prochlorperazine Tablets may make your breathing difficult and increase the chance of other side effects, including drowsiness.


If you are pregnant, think you may be pregnant or are breast-feeding, check with your doctor that this medicine is suitable for you before taking any.


Prochlorperazine Tablets may make you feel drowsy. If so, do not drive a car or operate machinery.


If you see another doctor or go into hospital, especially if you are to have an anaesthetic, let them know what medicines you are taking.




Taking Your Medicine


Your doctor has decided the dose which is best for you. Always follow your doctor's instructions exactly, and those on the pharmacy label. If you do not understand anything, ask your doctor or pharmacist.


The usual dosage(s) are described below:


  • Elderly: Use with caution, your doctor may prescribe a lower dose.



  • Dizziness:

  • Adults: 5mg (one tablet) to be taken 3 times daily, increasing if necessary to a maximum of 30mg (six tablets) daily. Your doctor may gradually reduce to 5-10mg (one to two tablets) daily after several weeks of therapy.



  • Nausea and vomiting:

  • Adults: Prevention: 5-10mg (one to two tablets) two or three times daily
    Treatment: 20mg (four tablets) immediately, followed if necessary by 10mg (two tablets) two hours later.

  • Children:

  • (Over 10kg only) 250 micrograms/kg 2-3 times daily.



  • Migraine:

  • Adults: Prevention: 5mg (one tablet) three or four times daily. If associated with emotional disturbances, 5-10mg (one to two tablets) should be given before the event and repeated, if necessary, to prevent the attack.Treatment: 20mg (four tablets) immediately, followed if necessary by 10mg (two tablets) two hours later.



  • To help with the treatment of anxiety:

  • Adults: 15-20mg (three to four tablets) daily in divided doses. Your doctor may increase the dose to a maximum of 40mg (eight tablets) daily in divided doses.



  • Mental illness:

  • Adults: 75-100mg (15-20 tablets) daily, but patients vary widely in response. Suggested dosages: Initially 12.5mg (two and a half tablets) twice daily for seven days, rising by 12.5mg increments (two and a half tablets) at four to seven day intervals. Your doctor will decide on a dose suitable for you.

  • Children: Not recommended to children under 12 years of age.

These tablets should be taken as instructed - followed by a glass of water. Continue to take them for as long as your doctor tells you to as it may be dangerous to stop without their advice.


If you forget to take a dose, take another as soon as you remember and then your next dose at the usual time. However, if it is almost time for your next dose, skip the missed dose and continue as usual. NEVER take two doses at the same time.


If you are elderly, it is particularly important to take this medicine exactly as directed by the doctor.


If you accidentally take more than your prescribed dose, contact your nearest hospital casualty department, or tell your doctor, immediately. Take any remaining tablets and the container with you.




After Taking Your Medicine


Like many medicines, Prochlorperazine Tablets may occasionally cause side-effects in some patients, particularly when you first start taking it. These may include:



Effects on the blood: Rarely your medicine may cause a potentially life-threatening reduction in certain blood cells, which can present as sore throat, mouth ulcers and a tendency to infection or bleeding or bruising easily. If you notice any of these effects you should consult your doctor immediately who might want to give you a blood test.



Effects on the endocrine system: An increase in prolactin levels which may cause milk production, development of breasts in males, irregular or loss of menstrual periods in women and reduced sexual potency in men have been reported.



Effects on the central nervous system: Agitation and difficulty sleeping. Movement disorders such as tremor, rigidity, involuntary movements especially of the face, mouth and tongue may occur after weeks or months of treatment. It is common just for tremor to occur. Abnormal and repetitive movements (eg grimacing, tongue protrusion, lip smacking and pursing, rapid movements of the arms and legs) may occur usually but not always after prolonged or high doses. Difficulty in controlling movements and jerky movements (which is usually temporary and more common in children and young adults, and usually occurs within 4 days of treatment or after dose increases). When you first start taking prochlorperazine a large dose may cause restlessness. This medicine may cause “Neuroleptic Malignant Syndrome”. Symptoms include high temperature, drowsiness, rigid muscles, rapid breathing, restlessness and uncontrolled movements.



Effects on the eye: Although never reported for prochlorperazine, difficulty in focussing or loss of sight has been experienced in some patients who have taken similar medicines for several years. These effects could occur with prochlorperazine.



Effects on the heart: Irregular heartbeats, heart block or fast racing heart have been reported. These effects are more likely if you already suffer from heart problems, are elderly, have low levels of potassium in the blood or are taking medicines known as tricyclic antidepressants. Low blood pressure, which may cause dizziness and feeling faint especially when you stand up, commonly occurs. Although changes in the electrical activity of the heart may occur, these are usually harmless and would be detected by a test called an ECG.



Effects on the lungs, chest and airway: A blocked nose is a minor side effect. Difficulty breathing is possible in susceptible patients.



Effects on the stomach and intestines: A dry mouth is a minor side effect.



Effects on the liver: Jaundice (yellowing of the skin and/or whites of the eyes) occurs in a very small number of patients and is usually temporary in nature. If you develop a sudden fever (high temperature) 1-3 weeks after starting the tablets, followed by jaundice and possibly a rash, you should contact your GP immediately.



Effects on the skin and tissues: Do not handle the tablets more than you need to as you may develop sore, red or blistered skin. Although never reported for prochlorperazine, greyish-mauve colouration of exposed skin has been experienced in some patients, especially women, who have taken similar medicines for several years. Patients taking high doses may develop sensitivity to sunlight. If this occurs you should avoid sun lamps and direct sunlight. Your doctor may advise you to use a sunscreen. Skin rashes have also been reported.


If you get these or any other unusual effects, tell your doctor or pharmacist immediately and seek advice.




Storing Your Medicine


Do not use the tablets after the expiry date shown on the product packaging. Keep the tablets stored below 25°C in a dry place, protected from light, and in the original packaging. KEEP THEM IN A SECURE PLACE WHERE CHILDREN CANNOT GET AT OR SEE THEM. REMEMBER, this medicine is for YOU only. NEVER give it to anyone else. It may harm them, even if their symptoms are the same as yours. Unless your doctor tells you to, do not keep medicines that you no longer need - give them back to your pharmacist for safe disposal.



Date of last revision: September 2007




Actavis

Barnstaple

EX32 8NS

UK


50134787





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