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The product code for this leaflet is: PL 00142/0312

 

Prochlorperazine Tablets BP 5mg

Company Details

Actavis UK Ltd


Whiddon ValleyBarnstapleDevonEX32 8NS
Telephone:
Fax:
Medical Information Direct Line:
Medical Information e-mail:medinfo@actavis.co.uk
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PATIENT INFORMATION LEAFLET

Prochlorperazine 5mg tablets

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.

Index

1 What Prochlorperazine tablets are and what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information

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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
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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)

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
  • 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.

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 sulphate, 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.

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 breast-feeding 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.

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.

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3 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.

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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.

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

If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.

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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.

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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
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Date of last revision November 2011

Actavis
Barnstaple
EX32 8NS
UK

AAAC8558 50618992


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