Prochlorperazine Tablets Bp 5mg
Read all of this leaflet carefully before you
start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• are not eating properly
• have low blood concentrations of potassium (hypokalaemia), calcium (hypocalcaemia) or magnesium (hypomagnesaemia)
• or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots
• suffer with dementia
• have ever had a stroke.
Index
T| What Prochlorperazine tablets are and what they are used for 2 Before you take ^ How to take 4| Possible side effects How to store "6 Further information
_1 What Prochlorperazine tablets are and what they are used for
Prochlorperazine tablets belong to a group of medicines called phenothiazine tranquillisers. They may be used to treat:
• dizziness due to ear diseases (such as Meniere's syndrome or labyrinthitis), or due to other causes
• nausea and vomiting including during a migraine
• mental illnesses (such as schizophrenia and mania)
• anxiety in the short term
2 Before you take
Do not take Prochlorperazine tablets and tell your doctor if you have:
• an allergy (hypersensitivity) to prochlorperazine meleate, phenothiazines or any of the other ingredients (see section 6)
• high blood pressure due to a tumour near the kidney (phaeochromocytoma)
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription. Especially:
• strong painkillers (eg morphine, codeine phosphate)
• antacids or kaolin preparations
• medicines to treat depression such as lithium or tricyclics (eg amitriptyline, dosulepin, imipramine)
• terfenadine (to treat allergies)
• medicines to treat diabetes (eg chlorpropamide, gliclazide)
• medicines to treat high blood pressure (eg clonidine, doxazosin, guanethidine, nifedipine, verapamil),
• medicines to treat Parkinson's disease and some mental illnesses such as bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, apomorphine, lisuride, pergolide
• anticholinergics (eg atropine sulfate, oxybutynin)
• medicines used to treat anxiety and difficulty sleeping (eg diazepam, chlordiazepoxide)
• sotalol (to prevent and treat some heart conditions)
• desferrioxamine (to treat iron poisoning)
• sibutramine (used for weight loss)
• adrenaline (epinephrine)
• amphetamine
• antipsychotics (e.g. chlorpromazine, trifluoperazine)
• medicines to treat epilepsy (e.g. phenobarbital)
• medicines to treat irregular heart beat (e.g. amiodarone, flecainide)
• if you are about to undergo surgery or dentistry where an
anaesthetic will be used
• ritonavir (for HIV infection)
• cimetidine (to treat stomach ulcers)
Alcohol
You are advised not to drink alcohol with this medicine as it may cause difficulty breathing and increase the chance of other side effects, including drowsiness.
Check with your doctor or pharmacist before taking Prochlorperazine tablets if you:
• liver or kidney problems or have ever had jaundice (yellowing or the skin or whites of the eyes)
• epilepsy
• muscle weakness (myasthenia gravis)
• an underactive thyroid gland
• Parkinson's disease
• increased pressure in the eye (glaucoma)
• an enlarged prostate gland
• 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 disease
• have ever abused alcohol Continued top of next column AAAG9479 50776894
Pregnancy and breast-feeding
This medicine is not recommended for women who are pregnant or breast-feeding.
If you are pregnant, planning to become pregnant or are breastfeeding ask your doctor or pharmacist for advice before taking any medicine.
The following symptoms may occur in newborn babies, of mothers that have used prochlorperazine 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.
Driving and using machines
Prochlorperazine tablets may cause drowsiness. Make sure you are not affected before you drive or operate machinery.
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Sugar intolerance
If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains a type of sugar called lactose.
How to take
Always take Prochlorperazine tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Swallow the tablets with water. Do not handle the tablets more than you need to as you may develop sore, red or blistered skin.
Doses:
Adults
• Dizziness:
5mg three times a day, up to a maximum of 30mg a day. Your doctor may gradually reduce to 5-10mg a day after several weeks.
• Nausea and vomiting:
Prevention: 5-10mg two or three times a day.
Treatment: 20mg immediately, followed if necessary by 10mg two hours later.
• To help with the treatment of anxiety:
15-20mg a day (divided throughout the day). Up to a maximum of 40mg a day (divided throughout the day).
• Mental illness:
75-100mg a day, depending on response.
Start with 12.5mg twice a day for seven days, rising by 12.5mg every four to seven days.
Elderly: Your doctor may prescribe a lower dose.
Children: Not recommended to children under 12 years of age.
If you take more than you should
If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include drowsiness, loss of consciousness, low blood pressure, fast or irregular heart rate, low body temperature.
If you forget to take the tablets
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.
If you stop taking the tablets
Contact your doctor before stopping Prochlorperazine tablets as you may develop withdrawal effects such as feeling or being sick, sweating, difficulty sleeping, or involuntary movements. Your doctor will reduce your dose gradually to reduce the risk of developing withdrawal effects.
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
• Nervous system:
- Parkinsonian effects (tremor, rigidity, loss of normal muscle movement)
- tardive dyskinesia (lip smacking or puckering; puffing of cheeks, rapid or worm-like movements of tongue, uncontrolled chewing movements, uncontrolled movements of arms and legs)
- difficulty in controlling movements and jerky movements and muscle spasms (more common in children and young adults)
- trouble in sleeping, agitation
• Eye: visual disturbances
• Heart; dizziness and feeling faint especially when you stand up, irregular or fast heartbeats, heart block (these 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), changes in the electrical activity of the heart or heart attack.
• Chest and airways: blocked nose, difficulty breathing
• Stomach and intestines: dry mouth
• Skin and tissues: greyish-mauve discolouration of skin (following direct contact with the tablets), sensitivity to sunlight (if this occurs you should avoid sun lamps and direct sunlight, you may be advised to use a sunscreen), skin rashes
• Reproductive system: raised blood levels of the hormone prolactin which can cause breast milk production, breast tenderness and swelling or changes in periods, reduced sexual potency in men
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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5| How to store
Keep out of the reach and sight of children.
Store below 25°C in a dry place, protected from light, and in the original packaging.
Do not use Prochlorperazine tablets after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.
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.
4 Possible side effects
Like all medicines, Prochlorperazine tablets can cause side effects, although
not everybody gets them.
In elderly people with dementia, a small increase in the number of deaths
has been reported for patients taking antipsychotics compared with those
not receiving antipsychotics.
Contact your doctor immediately if you experience the following :
• Blood: this medicine may alter the numbers and types of your blood cells, you may notice increased bruising, nosebleeds, sore throats or infections. Your doctor may want to give you a blood test.
• 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.
• Liver: a sudden fever 1-3 weeks after starting the tablets, followed by jaundice (yellowing of the skin or whites of the eyes) and possibly a rash.
• Neuroleptic Malignant Syndrome: excessive temperature, drowsiness, rigid muscles, rapid breathing, restlessness and uncontrolled movements.
6| Further information
What Prochlorperazine tablets contain
• The active substance (the ingredient that makes the tablet work) is 5mg of prochlorperazine maleate.
• The other ingredients are lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose (E460).
What Prochlorperazine tablets look like and contents of the pack
Prochlorperazine tablets are white, circular, uncoated tablets
Pack sizes are 28 and 84 tablets
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK
Date of last revision April 2014
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^actavis
Actavis, Barnstaple, EX32 8NS, UK
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