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KEMADRIN 5MG/ML SOLUTION FOR INJECTION

Active substance(s): PROCYCLIDINE HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET

KEMADRINTM 5 mg/ml Solution for Injection
(Procyclidine Hydrochloride)

Please read all of this leaflet carefully before taking your medicine.
•K
 eep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• T his 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 become serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet

1. What is KEMADRIN Injection and what is it used for?

2. Before you are given KEMADRIN Injection

3. How you will be given KEMADRIN Injection

4. Possible side effects

5. Storing KEMADRIN Injection

6. Further information
1. W
 hat is KEMADRIN Injection and what is it
Are you taking any of the following drugs?
used for?
• T ranquillisers (e.g. thioridazine)
• T ricyclic and related antidepressants
What is KEMADRIN Injection?
(e.g. amitriptyline)
KEMADRIN Injection belongs to a group of medicines
•M
 onoamine oxidase inhibitors, otherwise known
called anticholinergics. Anticholinergics block the
as MAOIs (used for depressive illness)
effects of a substance called acetylcholine in your
•A
 mantadine (used for parkinsonism and viral
body.
infections)
What is KEMADRIN Injection used for?
•A
 ntihistamines (used to treat allergies)
KEMADRIN Injection is used to treat and relieve
•K
 etoconazole (used as antifungals)
the symptoms of Parkinson’s disease such as stiff
• T acrine, memantine, phenothiazines and
muscles, paralysis, tremor, difficulties with speech,
neuroleptics (medicines used to treat mental
writing and walking, overproduction of saliva and
health problems including Alzheimer’s disease
dribbling, sweating, uncontrolled eye movements
and dementia)
and depression.
•C
 lozapine (used for schizophrenia)
•Q
 uinidine and disopyramide (used for arrhythmias
Some tranquillisers have side-effects like the
– too fast, too slow or irregular heart beat)
symptoms of Parkinson’s disease and they can also
•N
 efopam (used for moderate pain)
cause restlessness and abnormal head and body
 etoclopramide, cisapride and domperidone
movements. KEMADRIN Injection is also sometimes • M
(used for gastro-intestinal disorders)
used to control these side effects.
• L evodopa (used for parkinsonism)
•N
 itrate tablets that dissolve in the mouth
2. Before you are given KEMADRIN Injection
(used for angina attacks)
Do not use KEMADRIN Injection:
Your doctor may decide that you should not be given If any of the above applies to you talk to your doctor
KEMADRIN Injection if any of the points listed below or pharmacist.
applies to you:
Pregnancy and breast feeding
•H
 ave you ever had an allergy (rash, itching, and
If you are pregnant, trying to become pregnant or
shortness of breath) to KEMADRIN, procyclidine
breastfeeding, KEMADRIN Injection will only be
or lactic acid?
given to you if your doctor considers the benefit of
Special precautions to be taken:
Your doctor may decide to take special precautions
when giving you KEMADRIN Injection if any of the
points listed below applies to you:
•D
 o you experience uncontrolled movements of the
face and tongue (tardive dyskinesis)?
•D
 o you suffer from glaucoma (eye disease caused
by too much pressure within the eye)?
• If you are a man, do you suffer from an enlarged
prostate gland?
•D
 o you often suffer from stomach cramps,
abdominal pains or constipation?
•D
 o you suffer from kidney or liver disease?
If any of the above applies to you talk to your doctor
or pharmacist.
Taking other medicines
Always tell your doctor if you are taking any other
medicines because taking some medicines together
can be harmful. Remember that the doctor at the
hospital may not have been informed if you have
recently begun a course of treatment for another
illness.

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treatment outweighs the risk to the developing baby
or new born baby.
Driving and using machines
KEMADRIN Injection can cause blurred vision
and at higher doses, dizziness, confusion and
hallucinations may occur. If you are affected in this
way, do NOT drive or operate machinery while you
are receiving KEMADRIN 5 mg/ml Solution for
Injection.
3. How you will be given KEMADRIN Injection

Important:
KEMADRIN Injection will be given to you as an
injection into a vein (intravenously) or muscle
(intramuscularly). Your doctor will decide on a dose
of KEMADRIN Injection which is right for you.
Adults:
Intravenous injection:
• T he usual starting dose is 2.5mg, three times a
day, intravenously. Your doctor may then increase
this by 2.5mg to 5mg daily, every two or three
days, until the desired effect is seen. This is
known as the maintenance dose.
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• T he usual total daily maintenance dose is 15 to
30mg, however, in certain cases your doctor may
decide to prescribe more (up to a maximum of
60mg).
•A
 lthough the dose is usually taken three times
a day, your doctor may give you a fourth dose
before bedtime.
• If KEMADRIN Injection is being used to control the
side-effects of another drug, then the usual
maximum daily dose is 30mg.
•Y
 our doctor may decide to stop KEMADRIN
Injection after 3 or 4 months to see if the
side-effects return.
•G
 iven intravenously, a 5mg to 10mg dose of
KEMADRIN may relieve abnormal head and body
movements within 5 to 10 minutes. Occasionally,
a higher dose is needed and may take up to half
an hour to bring relief.
Intramuscular injection:
•K
 EMADRIN Injection may be given intramuscularly
in doses of 5 to 10mg; this may be repeated after
20 minutes, up to a daily maximum of 20mg.
Elderly:
Your doctor may decide to use a lower dose than
the above.
Children:
KEMADRIN Injection is not usually recommended for
use in children. However, in certain cases your
doctor may decide that KEMADRIN Injection is
required.
Treatment with KEMADRIN Injection should not be
stopped suddenly.
If you think you have been given too much
KEMADRIN Injection or if someone else takes
your medicine by mistake, tell a doctor or nurse
immediately.
If you think you have been given more KEMADRIN
Injection than you should:
As this medicine will be given to you whilst you are
in hospital, it is unlikely that you will be given too
little or too much, however, tell your doctor or nurse
if you have any concerns.
Symptoms of overdose: Agitation, restlessness,
confusion, sleeplessness lasting up to 24 hours
or more, hallucinations, euphoria, anxiousness,
aggressiveness, dilation of pupils and increased
heart beat.
Tell your doctor or healthcare professional if you
have any of these side effects so that he/she can
give appropriate treatment. If you have already left
the medical premises, contact your nearest hospital,
doctor or pharmacist.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines KEMADRIN Injection can cause
side effects, although not everybody gets them.
Common (more than 1 in 100 patients):
•A
 dry mouth
•B
 lurred vision
•C
 onstipation
•D
 ifficulty in passing water

Uncommon (less than 1 in 100, but more than
1 in 1000 patients):
•D
 izziness
•F
 eeling confused
•H
 earing unexpected noises or seeing unexpected
sights (hallucinations)
•N
 ausea (feeling sick) or vomiting (being sick)
•G
 ingivitis (inflammation of the gums)
•N
 ervousness
•S
 kin rash
•R
 educed concentration or memory
•A
 nxiety
•A
 gitation (feeling irritable)
Please also note that if you are taking tranquillisers,
unusual body movements, particularly of your
hands, arms and legs may occur. If you are receiving
KEMADRIN Injection to control these side effects, it
has been reported, on rare occasions, that it could
worsen these symptoms. If you find that this is
happening, tell your doctor who may decide to
change your tranquilliser dosage.
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.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme
(Website: www.mhra.gov.uk/yellowcard).
By reporting side effects, you can help provide
more information on the safety of this medicine.
5. Storing KEMADRIN Injection
Keep out of the reach and sight of children.
Do not use KEMADRIN Injection after the expiry date
on the carton. The expiry date refers to the last day
of that month.
KEMADRIN Injection should be stored below 25 ºC.
6. Further information
What KEMADRIN Injection contains:
The active substance is PROCYCLIDINE
HYDROCHLORIDE 5 mg in each 1 ml of solution.
The solution for injection also contains lactic acid
and water for injections.
Contents of the pack:
KEMADRIN Injection is supplied in cartons of five,
2 ml ampoules. Each ampoule contains 10 mg of
procyclidine hydrochloride.
Marketing authorisation holder:
Auden Mckenzie (Pharma Division) Ltd.
Mckenzie House, Bury Street,
Ruislip, Middlesex, HA4 7TL
Manufacturer:
Rotexmedica GmbH Arzneimittelwerk
Bunsenstrasse 4, Trittau, Schleswig-Holstein,
22946, Germany.
This leaflet was last approved in May 2015.
For information in large print,
on tape, on CD or in Braille,
phone 01895 627 420.

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Information for the Healthcare Professional

KEMADRINTM 5 mg/ml Solution for Injection
(Procyclidine Hydrochloride)

1. NAME OF THE MEDICINAL PRODUCT
Kemadrin 5mg/ml Solution for injection
Procyclidine Hydrochloride 5mg/ml, Solution for Injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Procyclidine Hydrochloride BP 5mg per ml (10mg in each 2ml
ampoule)
3. PHARMACEUTICAL FORM
Solution for injection
4.

CLINICAL PARTICULARS

4.1. Therapeutic Indications
Procyclidine is indicated for the treatment and symptomatic relief
of all forms of Parkinson’s disease e.g. idiopathic (paralysis
agitans), postencephalitic and arteriosclerotic disease.
Procyclidine is also used to control troublesome extra-pyramidal
symptoms induced by neuroleptic drugs including PseudoParkinsonism, acute dystonic reactions and akathisia.
4.2. Posology and Method of Administration
The variation in optimum dosage from one patient to another
should be taken into consideration by the physician.
Dosage in adults:Parkinson’s disease:Treatment is usually started at 2.5mg three times per day,
increasing by 2.5 to 5mg daily at intervals of two or three days
until the optimum clinical response is achieved.
The usual maintenance dose to achieve optimal response is
15 to 30mg procyclidine per day.
Addition of a fourth dose before retiring has been seen to be
beneficial in some patients. Doses up to 60mg procyclidine
have been well tolerated, and at the discretion of the attending
physician dosing to this level may be appropriate.
In general younger patients or those with postencephalitic
parkinsonism may require higher doses for a therapeutic response
than older patients and those with arteriosclerotic parkinsonism.
Procyclidine may be combined with levodopa or amantadine in
patients who are inadequately controlled on a single agent.
Neuroleptic-induced extrapyramidal symptoms:Treatment is usually initiated at 2.5mg procyclidine three times
per day increasing by 2.5 mg daily until symptoms are relieved.
The effective maintenance dose is usually 10 to 30 mg procyclidine
per day. After a period of 3 to 4 months of therapy, Procyclidine
should be withdrawn and the patient observed to see whether the
neuroleptic-induced extra-pyramidal symptoms recur.
If this is the case Procyclidine should be reintroduced to avoid
debilitating extra-pyramidal symptoms. Cessation of treatment
periodically is to be recommended even in patients who appear
to require the drug for longer periods.
Procyclidine Injection may be given intramuscularly in doses of
5 to 10mg, repeated after 20 minutes if necessary, up to a daily
maximum of 20mg procylidine.
In acute torsion dystonia and paroxysmal dyskinesias, doses of
5 to 10mg procyclidine intravenously are frequently effective within
5 to 10 minutes. Occasionally, patients may need more than 10 mg
procyclidine, and may require up to half an hour to obtain relief.
Dosage in children:The use of in Procyclidine this age group is not recommended.
Dosage in Elderly:Elderly patients may be more susceptible than younger adults to
the anticholinergic effects of Procyclidine and a reduced dosage
may be required (See Special Warnings and Special Precautions
for Use).

4.4. Special Warnings and Special Precautions For Use
As with all anticholinergics the benefit/risk ratio should be
assessed when prescribing in Procyclidine patients with existing
angle-closure (narrow angle) glaucoma or those considered to be
predisposed to glaucoma. Cautious prescribing is also indicated in
patients predisposed to obstructive disease of the gastro-intestinal
tract and those with urinary symptoms associated with prostatic
hypertrophy.
In a proportion of patients undergoing neuroleptic treatment,
tardive dysknesias will occur. While anticholinergic agents do not
cause this syndrome, when given in combination with neuroleptics
they may exacerbate the symptoms of tardive dyskinesia or reduce
the threshold at which these symptoms appear in predisposed
patients. In such individuals subsequent adjustment of neuroleptic
therapy or reduction in anticholinergic treatment should be
considered.
Patients with mental disorders occasionally experience a
precipitation of a psychotic episode when procyclidine is
administered for the treatment of the extrapyramidal
side effects of neuroleptics.
Elderly patients, especially those on high doses of anticholinergics
may be more susceptible to the adverse events associated with
such therapy (See ADVERSE EVENTS). Specifically, the elderly
patient may be particularly vulnerable to Central Nervous System
disturbances such as confusion, impairment of cognitive function
and memory, disorientation and hallucinations. These effects are
usually reversible on reduction or discontinuation of anticholinergic
therapy.
There is no specific information available concerning the use
of procyclidine hydrochloride in patients with impaired renal or
hepatic function. However, since procyclidine is metabolised in
the liver and excreted via the urine care should be exercised when
administering procyclidine to patients with impairment of renal or
hepatic function.
Procyclidine should not be withdrawn abruptly as rebound
Parkinsonian symptoms may occur.
Abuse
Procyclidine, along with other anticholinergic drugs, has the
potential to be abused. Although the cases of abuse are rare,
physicians should exercise caution in prescribing to Procyclidine
patients with symptoms that may not be genuine.
4.5 Interaction with other medicinal products and other forms
of interaction
Monoamine oxidase inhibitors or drugs with anticholinergic
properties, such as amantadine, memantine , antihistamines,
phenothiazines, tricyclic and related antidepressants, clozapine,
disopyramide and nefopam may increase the anticholinergic action
of procyclidine.
The use of drugs with cholinergic properties, such as tacrine,
may reduce the therapeutic response to Procyclidine. Furthermore,
drugs with anticholinergic properties may antagonise the effect of
parasympathomimetic agents.
The concomitant use of procyclidine with some neuroleptics for
the treatment of extrapyramidal symptoms has been associated
with a reduction in neuroleptic plasma concentrations. However
this reduction is unlikely to be associated with a significant
reduction in clinical effect.
Drugs with anticholinergic properties may decrease salivation
causing dry mouth and, in theory, may reduce the absorption and
therefore the therapeutic effect of sublingual or buccal nitrate
tablets.
Anticholinergics, including procyclidine, may reduce the efficacy
of levodopa by increasing gastric emptying time, resulting in
enhanced gastric degradation.

Administration:Pharmacokinetic studies have indicated that the mean plasma
elimination half life of Procyclidine is sufficient to allow twice daily
administration orally or intravenously, if more convenient.

The effect of anticholinergics such as procyclidine may antagonise
the gastrointestinal effects of cisapride, domperidone and
metoclopramide.

Oral administration may be better tolerated if associated with a
meal.

Anticholinergics may reduce the absorption of ketoconazole.

4.3. Contra-Indications
Procyclidine is contra-indicated in individuals with known
hypersensitivity to any component of the preparation, untreated
urinary retention, closed angle glaucoma and gastro-intestinal
obstruction.

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Procyclidine may potentiate the vagolytic effects of quinidine.
Exposure to high environmental temperature and humidity in
association with a phenothiazine/anticholinergic drug regimen
has rarely resulted in hyperpyrexia.
Daily administration of paroxetine increases significantly the
plasma levels of procyclidine. If anticholinergic effects are seen,
the dose of procyclidine should be reduced.

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4.6. Pregnancy and Lactation

5.

Pregnancy:The safety of using Procyclidine during pregnancy has not been
established.
However, extensive clinical use has not given any evidence that
it in any way compromises the normal course of pregnancy.
Nevertheless, as with all drugs, use should be considered only
when the expected clinical benefit of treatment for the mother
outweighs any possible risk to the developing foetus.

5.1. Pharmacodynamic Properties
Procyclidine is a synthetic anticholinergic agent which blocks the
excitatory effects of acetylcholine at the muscarinic receptor.

Lactation:No information is available on the passage of procyclidine into
human breast milk following administration of Procyclidine.
4.7. Effects on Ability to Drive and Use Machines
Adverse events of a neurological character such as blurred vision,
dizziness, confusion and disorientation have been reported with
procyclidine. Therefore, if affected, patients should be advised
not to drive or operate machinery.
4.8 Undesirable effects
For this preparation there is no modern clinical documentation
which can be used as support for determining the frequency of
adverse reactions.
The main undesirable effects are those to be expected from any
anticholinergic agent these are generally reversible on reducing
the dosage.
With high doses of procyclidine dizziness, mental confusion,
impaired cognition and memory, disorientation, anxiety, agitation
and hallucinations may occur.
Uncommon
(>1/1000 and
<1/100)

Agitation, anxiety,
nervousness,
confusion,
disorientation,
hallucinations.

Rare (<1/1000)

Psychotic disorder

Nervous system
disorders

Uncommon
(>1/1000 and
<1/100)

Dizziness, memory
impairment impaired
cognition

Eye disorders

Common (> 1/100)

Blurred vision

Gastrointestinal
disorders

Common (> 1/100)

Dry mouth,
constipation

Uncommon

(>1/1000 and
<1/100)

Nausea, vomiting,
gingivitis

Skin and
subcutaneous
tissue disorders

Uncommon
(>1/1000 and
<1/100)

Rash

Renal and
urinary disorders

Common (> 1/100)

Urinary retention

Psychiatric
disorders

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows continued monitoring of
the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse
reactions via the Yellow Card Scheme (Website: www.mhra.gov.uk/
yellowcard).
4.9 Overdose
Symptoms & Signs:
Reports of overdosage are relatively rare and no fatalities are
known. Symptoms of overdosage are agitation, restlessness
and confusion with severe sleeplessness lasting up to 24 hours
or more. Visual and auditory hallucinations have been reported.
Most subjects are euphoric but the occasional patient may be
anxious and aggressive. The pupils are widely dilated and
unreactive to light.
In recorded cases, the disorientation has lasted 1 to 4 days
and ended in a recuperative sleep. Tachycardia has also been
reported in association with cases of Procyclidine overdose.
Treatment:
If procyclidine has been ingested within the previous hour or two
(or possibly longer in view of its likely effects on gastric motility)
then gastric lavage is probably indicated. Other active measures
such as the use of cholinergic agents or haemodialysis are
extremely unlikely to be of clinical value although if convulsions
occur they should be controlled by injections of diazepam.

PHARMACOLOGICAL PROPERTIES

Idiopathic Parkinson’s disease is thought to result from
degeneration of neurones in the substantia nigra whose axons
project and inhibit cells in the corpus striatum. Blockade by
neuroleptic drugs of the dopamine released by these terminals
produces a similar clinical picture. The cell bodies in the corpus
striatum also receive cholinergic innervation which is excitatory.
Relief of the Parkinsonian syndrome can be achieved, either by
potentiation of the dopaminergic system or blockade of the
cholinergic input by anticholinergics. It is by a central action of
this latter type by which procyclidine exerts its effect.
Procyclidine is particularly effective in the alleviation of rigidity.
Tremor, akinesia, speech and writing difficulties, gait, sialorrhoea
and drooling, sweating, oculogyric crises and depressed mood are
also beneficially influenced.
5.2. Pharmacokinetic Properties
Procyclidine is adequately absorbed from the gastro-intestinal tract
with a bioavailability of 75% and disappears rapidly from the
tissues. The relatively low clearance of 68 ml/min represents a
predominantly metabolic change with a small first pass effect.
The mean plasma elimination half-life after both oral and
intravenous administration is approximately 12 hours.
No detailed information is available on the metabolic fate of
procyclidine but very little of the parent compound is excreted in
the urine unchanged. When given orally about one fifth of the dose
is known to be metabolised in the liver, principally by cytochrome
P450 and then conjugated with glucuronic acid. This conjugate
has been detected in the urine.
5.3. Pre-clinical Safety Data
Fertility:A three generation study in rats dosed at 40 mg/kg/day via the
diet before and during pregnancy showed only that the number
of viable pups was slightly decreased from the second mating.
No other parameters were affected.
Teratogenicity:No teratogenic effects were seen in rats dosed subcutaneously
with 10, 30 or 100 mg/kg/day on days 8 to 16 of pregnancy.
Maternal bodyweight gain was reduced at doses of 30 or
100 mg/kg/day, and a 10% reduction in foetal weight was
seen at 100 mg/kg/day
Mutagenicity:No data is available regarding the mutagenic potential of
procyclidine hydrochloride.
Carcinogenicity:There is no data on the carcinogenic potential of procyclidine
hydrochloride.
6.

PHARMACEUTICAL PARTICULARS

6.1. List of Excipients
Lactic acid 10μg
Lactic acid for pH 3.9 to 4.5 (quantity not fixed)
Water for Injections to 2ml
6.2. Incompatibilities
None known.
6.3. Shelf Life
5 years.
6.4. Special Precautions for Storage
Store below 25°C
6.5. Nature and Contents of Container
2ml Neutral glass ampoules
6.6. Instructions for Use, Handling and Disposal
No special instructions
7 Marketing authorisation holder
Auden Mckenzie (Pharma Division) Ltd
Mckenzie House, Bury Street, Ruislip,
Middlesex, HA4 7TL, UK
8. MARKETING AUTHORISATION NUMBER
PL 17507/0047
9. DATE OF FIRST AUTHORISATION/
RENEWAL OF AUTHORISATION
24 April 2003
10 DATE OF REVISION OF THE TEXT
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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