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Document: leaflet MAH GENERIC_PL 04425-0593 change

• leaflet MAH BRAND_PL 04425-0593
• leaflet MAH GENERIC_PL 04425-0593

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Prochlorperazine Maleate 5mg Tablets

Prochlorperazine maleate

PATIENT INFORMATION LEAFLET

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

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

•    Your doctor may have given you this medicine before from another company. It may have looked slightly different. However, either brand will have the same effect.

In this leaflet:

1.    What prochlorperazine is and what it is used for

2.    Before you take prochlorperazine

3.    How to take prochlorperazine

4.    Possible side effects

5.    How to store prochlorperazine

6.    Further information

1. WHAT PROCHLORPERAZINE IS AND WHAT IT IS USED FOR

The name of your medicine is Prochlorperazine Maleate 5mg Tablets (called prochlorperazine in this leaflet). It belongs to a group of medicines called ‘phenothiazine antipsychotics’.

It works by blocking the effects of a chemical in the brain.

Prochlorperazine can be used to:

•    Treat balance problems or dizziness (vertigo). This includes problems of the inner ear such as ‘Meniere’s Syndrome’ or ‘labyrinthitis’

•    Stop you feeling sick (nausea) or being sick (vomiting). This can be from any cause including migraines

•    Treat schizophrenia

•    Treat over-active behaviour or thoughts (mania)

•    Treat anxiety in the short-term, when used in addition to other medicines

2. BEFORE YOU TAKE PROCHLORPERAZINE

Do not take this medicine and tell your

doctor if:

•    You are allergic (hypersensitive) to prochlorperazine maleate or any of the other ingredients of prochlorperazine (listed in Section 6 below)

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

Take special care and check with your

doctor or pharmacist before taking

prochlorperazine if:

•    You are allergic to phenothiazine medicines such as chlorpromazine

•    You have heart problems or a family history of heart problems

•    You have ever had a stroke

•    You have liver or kidney problems

•    You have thyroid problems

•    You have an enlarged prostate gland.

This means you may have problems when passing water (urine)

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

•    You have Parkinson’s disease

•    You have dementia

•    You have epilepsy or have ever had fits (seizures)

•    You have depression

•    You have a tumour on your adrenal gland called ‘phaeochromocytoma’

•    You have a type of muscle weakness called ‘myasthenia gravis’

•    You have or have ever had glaucoma (signs include painful eyes with blurred vision)

•    You have or have ever had a low number of white blood cells (agranulocytosis). This would lead you to get infections more easily than usual

•    You have low blood levels of potassium, calcium and magnesium. Your doctor may perform blood tests to check on these

•    You are not eating properly or are very under-weight

•    You have a history of alcohol problems

•    You are elderly (65 years of age or older).

•    The person is a child. This is because children may develop unusual face and body movements (dystonic reactions)

•    You are diabetic or have high levels of sugar in your blood (hyperglycaemia). Your doctor may want to monitor you more closely

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking prochlorperazine.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because prochlorperazine can affect the way some other medicines work. Also some medicines can affect the way prochlorperazine works.

In particular, tell your doctor if you are taking any of the following:

•    Medicines to help you sleep (sedatives, barbiturates)

•    Other medicines used to calm emotional and mental conditions

•    Medicines used for depression

•    Medicines used for Parkinson’s disease such as levodopa

•    Medicines for fits (epilepsy) such as carbamazepine

•    Medicines used to control your heartbeat such as amiodarone, disopyramide, propanolol or quinidine

•    Medicines for high blood pressure such as doxazosin, terazosin, guanethidine or clonidine

•    Medicines used for diabetes

•    Medicines used for cancer (cytotoxics)

•    Medicines used for infections (antibiotics)

•    Medicines for indigestion and heartburn (antacids)

•    Anticholinergic medicines - includes some medicines used for irritable bowel syndrome, asthma or incontinence

•    Amphetamines - used for Attention Deficit Hyperactivity Disorder (ADHD)

•    Adrenaline - used for life threatening allergic reactions

•    Desferroxamine - used when you have too much iron in your blood

•    Lithium - used for some types of mental illness

Taking prochlorperazine with food and drink

•    Do not drink alcohol while you are taking prochlorperazine.

•    This is because alcohol can add to the effects of prochlorperazine and can cause serious breathing difficulties.

Pregnancy and breast-feeding

Do not take prochlorperazine if:

•    You are pregnant, might become pregnant or think you might be pregnant

•    You are breast-feeding or planning to breast-feed

The following symptoms may occur in newborn babies of mothers that have used prochlorperazine 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.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

You may feel sleepy after taking this medicine. If this happens, do not drive or use any tools or machines.

Important information about some of the ingredients of prochlorperazine • Lactose: This medicine contains lactose, a type of sugar. If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before having this medicine.

3. HOW TO TAKE PROCHLORPERAZINE

Always take prochlorperazine exactly as your

doctor has told you. You should check with

your doctor or pharmacist if you are not sure

Taking this medicine

•    Take this medicine by mouth

•    Do not give to children under 1 year of age or who weigh less than 10 kg

•    You should not let the tablets touch your skin for very long, as you may get skin redness, swelling and itching (contact skin sensitisation)

•    If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor

How much to take Adults:

Treatment of balance problems or

dizziness (vertigo):

•    The usual dose is 5 mg three times each day

•    This may be increased to a total daily dose of 30 mg each day

•    After several weeks treatment, your doctor may decide to gradually lower your daily dose to 5 to 10 mg each day

Stopping you feeling sick or being sick:

•    The usual dose is 5 or 10 mg

•    This may be taken two or three

times each day    2

Treatment of feeling sick or being sick:

•    To begin with you will usually take 20 mg

•    This may be followed by 10 mg two hours later

Treatment of schizophrenia and overactive behaviour or thoughts (mania):

•    The starting dose is usually 12.5 mg twice each day for seven days

•    Your doctor may increase your dose up to a total daily dose of 75 to 100 mg each day

•    After several weeks of treatment, your doctor may then lower your dose to a total daily dose of 25 to 50 mg each day

Short-term treatment of anxiety:

•    The starting dose will be 15 to 20 mg each day in divided doses

•    Your doctor may then increase your dose to a total daily dose of 40 mg each day

Elderly:

•    Your doctor may prescribe a lower dose

•    You should be careful during very hot or very cold weather to make sure that you do not get too hot or too cold.

Children (over 1 year of age and weighing more than 10 kg):

Stopping your child feeling sick or being sick:

•    Your doctor will decide the dose according your child’s weight

•    A dose of 0.25 mg for each kilogram of your child’s weight is usually given

•    This dose may be given two or three times a day

If you take more prochlorperazine than you should

If you take more prochlorperazine than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. Taking too much prochlorperazine may cause symptoms such as feeling sleepy or dizzy, increased or rapid heartbeat, feeling very cold and confused, writhing movements, feeling restless, stiffness or shaking. You may lose consciousness.

If you forget to take prochlorperazine

If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking prochlorperazine

Keep taking prochlorperazine until your doctor tells you to stop. Do not stop taking prochlorperazine just because you feel better. If you stop, your illness may come back and you may have other effects such as feeling or being sick or difficulty sleeping. Your doctor will gradually stop your medicine to prevent these effects happening.

Exposure to sunlight

Prochlorperazine can cause your skin to be more sensitive to sunlight. You should avoid exposure to direct sunlight while taking this medicine.

Tests

Your doctor may do regular tests while you are taking this medicine. These might include blood tests and an ECG to check your heart is working properly.

If you have any further questions about taking prochlorperazine ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, prochlorperazine can

cause side effects, although not everybody

gets them.

Stop taking prochlorperazine and see a

doctor or go to a hospital straight away if:

•    You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

•    You have an unusually pale complexion, sweating, high temperature, fast heartbeat, stiff muscles, fast breathing and feel confused, drowsy or agitated. These could be signs of a serious side effect called ‘neuroleptic malignant syndrome’

•    You have frequent infections such as fever, sore throat or mouth ulcers. These could be signs of a blood problem called leucopenia

•    You may get infections more easily than usual. This could be because of a blood disorder (agranulocytosis)

•    You have yellowing of your skin or eyes (jaundice). These could be signs of liver problems

•    You have a very fast, uneven or forceful

heartbeats (palpitations) and experience breathing problems such as wheezing, shortness of breath, tightness in the chest and chest pain    3

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