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RISPERIDONE 1 MG/ML ORAL SOLUTION

Active substance(s): RISPERIDONE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SZ00000LT000

Risperidone 1 mg/ml Oral Solution

Risperidone
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the
same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See
section 4.

What is in this leaflet:
1. What Risperidone Oral Solution is and what it is used for
2. What you need to know before you take Risperidone Oral
Solution
3. How to take Risperidone Oral Solution
4. Possible side effects
5. How to store Risperidone Oral Solution
6. Contents of the pack and other information

1

The following medicines may reduce the effect of risperidone
• Rifampicin (a medicine for treating some infections)
• Carbamazepine, phenytoin (medicines for epilepsy)
• Phenobarbital.
If you start or stop taking such medicines you may need a different
dose of risperidone.

What Risperidone Oral Solution is and what it
is used for

Risperidone Oral Solution belongs to a group of medicines called
‘anti-psychotics’.

The following medicines may increase the effect of risperidone
• Quinidine (used for certain types of heart disease)
• Antidepressants such as paroxetine, fluoxetine, tricyclic
antidepressants
• Medicines known as beta blockers (used to treat high blood
pressure)
• Phenothiazines (e.g. used to treat psychosis or to calm down)
• Cimetidine, ranitidine (blockers of the acidity of stomach)
• Itraconazole and ketoconazole (medicines for treating fungal
infections)
• Certain medicines used in the treatment of HIV/AIDS, such as
ritonavir
• Verapamil, a medicine used to treat high blood pressure and/or
abnormal heart rhythm.
• Sertraline and fluvoxamine, medicines used to treat depression
and other psychiatric disorders.
If you start or stop taking such medicines you may need a different
dose of risperidone.

Risperidone Oral Solution is used to treat the following:
• Schizophrenia, where you may see, hear or feel things that are
not there, believe things that are not true or feel unusually
suspicious, or confused
• Mania, where you may feel very excited, elated, agitated,
enthusiastic or hyperactive. Mania occurs in an illness called
“bipolar disorder”
• Short-term treatment (up to 6 weeks) of long-term aggression in
people with Alzheimer’s dementia, who harm themselves or
others. Alternative (non-drug) treatments should have been
used previously
• Short-term treatment (up to 6 weeks) of long-term aggression in
intellectually disabled children (at least 5 years of age) and
adolescents with conduct disorder.
Risperidone can help alleviate the symptoms of your disease and
stop your symptoms from coming back.

2

If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before using Risperidone Oral Solution.

What you need to know before you take
Risperidone Oral Solution

Taking Risperidone Oral Solution with food, drink and alcohol
You can take this medicine with or without food. You should avoid
drinking alcohol when taking Risperidone Oral Solution.
Risperidone Oral Solution must not be mixed with tea.

Do not take Risperidone Oral Solution:
• If you are allergic to risperidone or any of the other ingredients
of this medicine (listed in section 6).

Pregnancy, breast-feeding and fertility
• If you are pregnant or breast-feeding,think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist
for advice before taking this medicine. Your doctor will decide if
you can take it
• The following symptoms may occur in newborn babies, of
mothers who have used Risperidone 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.
• Risperidone Oral Solution can raise your levels of a hormone
called "prolactin" that may impact fertility (see section 4
“Possible side effects”).

If you are not sure if the above applies to you, talk to your doctor
or pharmacist before using Risperidone Oral Solution.

Warnings and precautions
Talk to your doctor or pharmacist before taking Risperidone Oral
Solution if:
• You have a heart problem. Examples include an irregular heart
rhythm or if you are prone to low blood pressure or if you are using
medicines for your blood pressure. Risperidone Oral Solution
may cause low blood pressure. Your dose may need to be adjusted
• You know of any factors which would favour you having a
stroke, such as high blood pressure, cardiovascular disorder or
blood vessel problems in the brain
• You have ever experienced involuntary movements of the
tongue, mouth and face
• You have ever had a condition whose symptoms include high
temperature, muscle stiffness, sweating or a lowered level of
consciousness (also known as Neuroleptic Malignant Syndrome)
• You or someone else in your family has a history of blood clots,
as medicines like this have been associated with formation of
blood clots
• You have Parkinson’s disease or dementia
• You know that you have had low levels of white blood cells in the
past (which may or may not have been caused by other medicines).
• You are diabetic
• You have epilepsy
• You are a man and you have ever had a prolonged or painful
erection.
• You have problems controlling your body temperature
or overheating
• You have kidney problems
• You have liver problems
• You have an abnormally high level of the hormone prolactin in
your blood or if you have a possible prolactin dependent tumour.

Driving and using machines
Dizziness, tiredness, and vision problems may occur during
treatment with Risperidone Oral Solution. Do not drive or use any
tools or machines without talking to your doctor first.

3

How to take Risperidone Oral Solution

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose is as follows:

For the treatment of schizophrenia
Adults
• The usual starting dose is 2 ml oral solution (2 mg risperidone)
per day, this may be increased to 4 ml oral solution (4 mg
risperidone) per day on the second day.
• Your dose may then be adjusted by your doctor depending on
how you respond to the treatment.
• Most people feel better with daily doses of 4 to 6 ml oral
solution (4 to 6 mg risperidone).
• This total daily dose can be divided into either one or two doses
a day. Your doctor will tell you which is the best dose for you.

If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before using Risperidone Oral Solution.

As dangerously low numbers of a certain type of white blood cell
needed to fight infection in your blood has been seen very rarely
with patients taking Risperidone Oral Solution, your doctor may
check your white blood cell counts.

Elderly people
• Your starting dose will normally be 0.5 ml oral solution (0.5 mg
risperidone) twice a day.
• Your dose may then be gradually increased by your doctor to
1 to 2 ml oral solution (1 to 2 mg risperidone) twice a day.
• Your doctor will tell you which is the best for you.

Risperidone Oral Solution may cause you to gain weight.
Significant weight gain may adversely affect your health. Your
doctor should regularly measure your body weight.

As diabetes mellitus or worsening of pre-existing diabetes mellitus
have been seen with patients taking Risperidone Oral Solution, your
doctor should check for signs of high blood sugar. In patients with
pre-existing diabetes mellitus blood glucose should be monitored
regularly.
Risperidone Oral Solution commonly raises levels of a hormone
called "prolactin". This may cause side effects such as menstrual
disorders or fertility problems in women, breast swelling in men
(see section 4 “Possible side effects”). If such side effects occur,
evaluation of the prolactin level in the blood is recommended.

During an operation on the eye for cloudiness of the lens (cataract),
the pupil (the black circle in the middle of your eye) may not increase
in size as needed. Also, the iris (the coloured part of the eye) may
become floppy during surgery and that may lead to eye damage. If
you are planning to have an operation on your eye, make sure you
tell your eye doctor that you are taking this medicine.
Elderly people with dementia
In elderly patients with dementia, there is an increased risk of stroke.
You should not take risperidone if you have dementia caused by
stroke.
During treatment with risperidone you should frequently see your
doctor.
Medical treatment should be sought straight away if you or your
care-giver notice a sudden change in your mental state or sudden
weakness or numbness of your face, arms or legs, especially on
one side, or slurred speech, even for a short period of time. These
may be signs of a stroke.

Children and adolescents
Before treatment is started in conduct disorder, other causes of
aggressive behaviour should have been ruled out. Before treatment
is started your or your child’s body weight may be measured and it
may be regularly monitored during treatment.
If during treatment with risperidone tiredness occurs, a change in
the time of administration might improve attention difficulties.
A small and inconclusive study has reported an increase in height
in children who took risperidone, but whether this is an effect of
the drug or due to some other reason is not known.

For the treatment of mania
Adults
• Your starting dose will usually be 2 ml oral solution (2 mg
risperidone) once a day.
• Your dose may then be gradually adjusted by your doctor
depending on how you respond to the treatment.
• Most people feel better with doses of 1 to 6 ml oral solution (1
to 6 mg risperidone) once a day.

Elderly people
• Your starting dose will usually be 0.5 ml oral solution (0.5 mg
risperidone) twice a day.
• Your dose may then be gradually adjusted by your doctor to 1 to
2 ml oral solution (1 to 2 mg risperidone) twice a day depending
on how much you respond to the treatment.

For the treatment of long-standing aggression in people with
Alzheimer’s dementia
Adults (including elderly people)
• Your starting dose will normally be 0.25 ml oral solution
(0.25 mg risperidone) twice a day.
• Your dose may then be gradually adjusted by your doctor
depending on how you respond to the treatment.
• Most people feel better with 0.5 ml oral solution (0.5 mg
risperidone) twice a day. Some patients may need 1 ml oral
solution (1 mg risperidone) twice a day.
• Treatment duration in patients with Alzheimer’s dementia should
be not more than 6 weeks.
Use in children and adolescents
• Children and adolescents under 18 years old should not be
treated with Risperidone for schizophrenia or mania.
For the treatment of conduct disorder
The dose will depend on your child’s weight:

For children who weigh less than 50 kg
• The starting dose will normally be 0.25 ml oral solution (0.25 mg
risperidone) once a day.
• The dose may be increased every other day in steps of 0.25 ml
oral solution (0.25 mg risperidone) per day.
• The usual maintenance dose is 0.25 to 0.75 ml oral solution
(0.25 to 0.75 mg risperidone) once a day.

Other medicines and Risperidone Oral Solution
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.

For children who weigh 50 kg or more
• The starting dose will normally be 0.5 ml oral solution (0.5 mg
risperidone) once a day.
• The dose may be increased every other day in steps of 0.5 ml
oral solution (0.5 mg risperidone) per day.
• The usual maintenance dose is 0.5 to 1.5 ml oral solution (0.5
to 1.5 mg risperidone) once a day.

It is especially important to talk to your doctor or pharmacist if you
are taking any of the following:
• Medicines that work on your brain such as to help you calm
down (benzodiazepines) or some medicines for pain (opiates),
medicines for allergy (some antihistamines), as risperidone may
increase the sedative effect of all of these
• Medicines that may change the electrical activity of your heart,
such as medicines for malaria, heart rhythm problems, allergies
(anti-histamines), some antidepressants or other medicines for
mental problems
• Medicines that cause a slow heart beat
• Medicines that cause low blood potassium (e.g. certain
diuretics)
• Medicines to treat elevated blood pressure. Risperidone Oral
Solution can lower blood pressure
• Medicines for Parkinson's disease (such as levodopa)
• Water tablets (diuretics) used for heart problems or swelling of
parts of your body due to a build up of too much fluid (such as
furosemide or chlorothiazide). Risperidone Oral Solution taken
by itself or with furosemide, may have an increased risk of
stroke or death in elderly people with dementia.

Treatment duration in patients with conduct disorder should be not
more than 6 weeks.
Children under 5 years old should not be treated with Risperidone
Oral Solution for conduct disorder.
People with kidney or liver problems
Regardless of the disease to be treated, all starting doses and
following doses of risperidone should be halved. Dose increases
should be slower in these patients.
Risperidone should be used with caution in this patient group.

Method of administration
For oral use.

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Opening the bottle and handling the dosing pipette
A dosing pipette is supplied with each bottle. The bottle has a
child-proof screw cap.

of Risperidone may be needed
• Sudden loss of blood supply to brain (stroke or "mini" stroke)
• Unresponsive to stimuli, Loss of consciousness, Low level of
consciousness
• Convulsion (fits), Fainting
• A restless urge to move parts of your body, Balance disorder,
Abnormal coordination, Dizziness upon standing, Disturbance
in attention, Problems with speech, Loss or abnormal sense of
taste, Reduced sensation of skin to pain and touch, A sensation
of tingling, pricking, or numbness skin
• Oversensitivity of the eyes to light, Dry eye, Increased tears,
Redness of the eyes
• Sensation of spinning (vertigo), Ringing in the ears, Ear pain
• Atrial fibrillation (an abnormal heart rhythm), An interruption in
conduction between the upper and lower parts of the heart,
Abnormal electrical conduction of the heart, Prolongation of the
QT interval from your heart, Slow heart rate, Abnormal electrical
tracing of the heart (electrocardiogram or ECG), A fluttering or
pounding feeling in your chest (palpitations)
• Low blood pressure, Low blood pressure upon standing
(consequently, some people taking taking Risperidone may feel
faint, dizzy, or may pass out when they stand up or sit up
suddenly, Flushing
• Pneumonia caused by inhaling food, Lung congestion,
Congestion of breathing passages, Crackly lung sounds,
Wheezing, Voice disorder, Breathing passage disorder
• Stomach or intestinal infection, Stool incontinence, Very hard
stool, Difficulty swallowing, Excessive passing of gas or wind
• Hives (or "nettle rash"), Itching, Hair loss, Thickening of skin,
Eczema, Dry skin, Skin discoloration, Acne, Flaky, itchy scalp or
skin, Skin disorder, Skin lesion
• An increase of CPK (creatine phosphokinase) in your blood, an
enzyme which is sometimes released with muscle breakdown
• Abnormal posture, Joint stiffness, Joint swelling, Muscle
weakness, Neck pain
• Frequent passing of urine, Inability to pass urine, Pain when
passing urine
• Erectile dysfunction, Ejaculation disorder
• Loss of menstrual periods, Missed menstrual periods or other
problems with your cycle (females)
• Development of breasts in men, Leakage of milk from the
breasts, Sexual dysfunction, Breast pain, Breast discomfort,
Vaginal discharge
• Swelling of the face, mouth, eyes, or lips
• Chills, An increase in body temperature
• A change in the way you walk
• Feeling thirsty, Feeling unwell, Chest discomfort, Feeling "out of
sorts", Discomfort
• Increased liver transaminases in your blood, Increased GGT (a
liver enzyme called gamma-glutamyltransferase) in your blood,
Increased liver enzymes in your blood
• Procedural pain.

1. Open the screw cap by pressing it firmly downwards and
turning it anticlockwise as shown in Figure 1.

2. Insert the pipette into the bottle. In order to measure the dose
hold the pipette tightly with one hand by the lower ring and with
the other hand pull the upper ring of the pipette until the correct
quantity of the medicine is visible from the barrel of the pipette
(ml or mg for example) as shown in Figure 2.

3. Draw the pipette carefully from the bottle holding it tightly by the
lower ring as shown in Figure 3. Transfer the quantity of
medicine drawn into the pipette into a glass containing a drink
(not alcohol or tea) by pressing the upper ring of the pipette.
Drink the contents of the glass.
4. Close the bottle and rinse the empty pipette with water.

Fig. 1
1

Fig. 2

2

0
0.5
1
1.5
2
2.5
3

Fig. 3
0
0.5
1
1.5
2
2.5
3

If you take more Risperidone Oral Solution than you should
• See a doctor right away. Take the medicine pack with you
• In case of overdose you may feel sleepy or tired, or have
abnormal body movements, problems standing and walking,
feel dizzy due to low blood pressure, or have abnormal heart
beats or fits.

Rare (may affect up to 1 in 1,000 people):
• Infection
• Inappropriate secretion of a hormone that controls urine volume
• Sugar in the urine, Low blood sugar, High blood triglycerides (a fat)
• Lack of emotion, Inability to reach orgasm
• Neuroleptic malignant syndrome (confusion, reduced or loss of
consciousness, high fever, and severe muscle stiffness)
• Blood vessel problems in the brain
• Coma due to uncontrolled diabetes
• Shaking of the head
• Glaucoma (increased pressure within the eyeball), Problems
with movement of your eyes, Eye rolling, Eyelid margin crusting
• Eye problems during cataract surgery. During cataract surgery,
a condition called intraoperative floppy iris syndrome (IFIS) can
happen if you take or have taken Risperidone. If you need to
have cataract surgery, be sure to tell your eye doctor if you take
or have taken this medicine.
• Dangerously low numbers of a certain type of white blood cell
needed to fight infection in your blood
• Severe allergic reaction characterised by fever, swollen mouth,
face, lip or tongue, shortness of breath, itching, skin rash and
sometimes drop in blood pressure
• Dangerously excessive intake of water
• Irregular heart beat
• Blood clot in the legs, Blood clot in the lungs
• Trouble breathing during sleep (sleep apnea), Fast, shallow
breathing
• Inflammation of the pancreas, A blockage in the bowels
• Swollen tongue, Chapped lips, Rash on skin related to drug
• Dandruff
• Breakdown of muscle fibers and pain in muscles (rhabdomyolysis)
• A delay in menstrual periods, Enlargement of the glands in your
breasts, Breast enlargement, Discharge from the breasts
• Increased insulin (a hormone that controls blood sugar levels)
in your blood
• Priapism (a prolonged penile erection that may require surgical
treatment)
• Hardening of the skin
• Decreased body temperature, Coldness in arms and legs
• Symptoms of drug withdrawal
• Yellowing of the skin and the eyes (jaundice).

If you forget to take Risperidone Oral Solution
• If you forget to take a dose, take it as soon as you remember it.
However, if it is almost time for your next dose, skip the missed
dose and continue as usual. If you miss two or more doses,
contact your doctor
• Do not take a double dose (two doses at the same time) to
make up for a forgotten dose.
If you stop taking Risperidone Oral Solution
You should not stop taking this medicine unless told to do so by
your doctor. Your symptoms may return. If your doctor decides to
stop this medicine, your dose may be decreased gradually over a
few days.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

4

Possible side effects

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

Tell your doctor immediately if you:
• Experience 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.
• Have dementia and experience a sudden change in your mental
state or sudden weakness or numbness of your face, arms or
legs, especially on one side, or slurred speech, even for a short
period of time. These may be signs of a stroke.
• Experience fever, muscle stiffness, sweating or a lowered level
of consciousness (a disorder called “neuroleptic malignant
syndrome”). Immediate medical treatment may be needed.
• Are a man and experience prolonged or painful erection. This is
called priapism. Immediate medical treatment may be needed.
• Experience involuntary rhythmic movements of the tongue,
mouth and face. Withdrawal of risperidone may be needed.
• Experience severe allergic reaction characterised by fever,
swollen mouth, face, lip or tongue, shortness of breath, itching,
skin rash or drop in blood pressure.

Very rare (affects less than 1 user in 10,000):
• Life threatening complications of uncontrolled diabetes.
• Serious allergic reaction with swelling that may involve the
throat and lead to difficulty breathing
• Lack of bowel muscle movement that causes blockage.

• The following side effect has been seen with the use of
another medicine called paliperidone that is very similar to
risperidone, so these can also be expected with
Risperidone: Rapid heartbeat upon standing.

The following side effects may happen:

Very Common (may affect more than 1 in 10 people):
• Difficulty falling or staying asleep
• Parkinsonism: This condition may include: slow or impaired
movement, sensation of stiffness or tightness of the muscles
(making your movements jerky), and sometimes even a
sensation of movement “freezing up” and then restarting. Other
signs of parkinsonism include a slow shuffling walk, a tremor
while at rest, increased saliva and/or drooling, and a loss of
expression on the face.
• Feeling sleepy, or less alert
• Headache

Additional side effects in children and adolescents
In general, side effects in children are expected to be similar to
those in adults.
The following side effects were reported more often in children
and adolescents (5 to 17 years) than in adults: feeling sleepy, or
less alert, fatigue (tiredness), headache, increased appetite,
vomiting, common cold symptoms, nasal congestion, abdominal
pain, dizziness, cough, fever, tremor (shaking), diarrhoea, and
incontinence (lack of control) of urine.

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
(www.mhra.gov.uk/yellowcard). By reporting side effects you can
help provide more information on the safety of this medicine.

Common (may affect up to 1 in 10 people):
• Pneumonia, Infection of the chest (bronchitis), Common cold
symptoms, Sinus infection Urinary tract infection, Ear infection,
Feeling like you have the flu
• Raised levels of a hormone called "prolactin" found in a blood
test (which may or may not cause symptoms). Symptoms of
high prolactin occur uncommonly and may include in men
breast swelling, difficulty in getting or maintaining erections,
decreased sexual desire or other sexual dysfunction. In women
they may include breast discomfort, leakage of milk from the
breasts, missed menstrual periods, or other problems with your
cycle or fertility problems.
• Weight gain, Increased appetite, Decreased appetite
• Sleep disorder, Irritability, Depression, Anxiety, Restlessness
• Dystonia: This is a condition involving slow or sustained
involuntary contraction of muscles. While it can involve any part
of the body (and may result in abnormal posture), dystonia
often involves muscles of the face, including abnormal
movements of the eyes, mouth, tongue or jaw.
• Dizziness
• Dyskinesia: This is a condition involving involuntary muscle
movements, and can include repetitive, spastic or writhing
movements, or twitching.
• Tremor (shaking)
• Blurry vision, Eye infection or "pink eye"
• Rapid heart rate, High blood pressure, Shortness of breath
• Sore throat, Cough, Nosebleeds, Stuffy nose
• Abdominal pain, Abdominal discomfort, Vomiting, Nausea,
Constipation, Diarrhea, Indigestion, Dry mouth, Toothache
• Rash, Skin redness
• Muscle spasms, Bone or muscle ache, Back pain, Joint pain
• Incontinence (lack of control) of urine
• Swelling of the body, arms or legs, Fever, Chest pain,
Weakness, Fatigue (tiredness), Pain
• Fall.

5

How to store Risperidone Oral Solution

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on
the carton and on the label of the bottle after “EXP”. The expiry
date refers to the last day of that month.

Do not freeze.
Do not use Risperidone Oral Solution after 6 months have elapsed
from first opening of the bottle.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

6

Contents of the pack and other information

What Risperidone Oral Solution contains
- The active substance is risperidone. Each ml of Oral Solution
contains 1 mg risperidone.
- The other ingredients are benzoic acid (E 210); water, purified.

What Risperidone Oral Solution looks like and contents of the
pack
Risperidone 1 mg/ml Oral Solution is a clear and colourless
Solution.
It is available in brown glass bottles with a white plastic child
resistant closure containing 30 ml, 60 ml, 100 ml or 120 ml Oral
Solution.
A dosing pipette including pipette holder is enclosed.
Not all pack sizes may be marketed.

Uncommon (may affect up to 1 in 100 people):
• Infection of the breathing passages, Bladder infection, ‘Eye
infection, Tonsillitis, Fungal infection of the nails, Infection of the
skin, An infection confined to a single area of skin or part of the
body, Viral infection, Skin inflammation caused by mites
• Decrease in the type of white blood cells that help to protect
you against infection, White blood cell count decreased,
Decrease in platelets (blood cells that help you stop bleeding),
Anemia, Decrease in red blood cells, Increase in eosinophils (a
type of white blood cell) in your blood
• Allergic reaction
• Diabetes or worsening of diabetes, High blood sugar, Excessive
drinking of water
• Weight loss, Loss of appetite resulting in malnutrition and low
body weight
• Increased cholesterol in your blood
• Elated mood (mania), Confusion, Decreased sexual drive,
Nervousness, Nightmares
• Tardive dyskinesia (twitching or jerking movements that you
cannot control in your face, tongue, or other parts of your body).
Tell your doctor immediately if you experience involuntary
rhythmic movements of the tongue, mouth and face. Withdrawal

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey,
GU16 7SR, UK.
Manufacturers
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1,
39179 Barleben, Germany or
LEK Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana,
Slovenia.
This leaflet was last revised in 11/2017.

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Date prepared:
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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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