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RIVASTIGMINE DR. REDDYS 1.5 MG HARD CAPSULES

Active substance(s): RIVASTIGMINE HYDROGEN TARTRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Rivastigmine 1.5 mg, 3 mg, 4.5 mg hard Capsules
Rivastigmine
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, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet
1. What Rivastigmine is and what it is used for
2. What you need to know before you take Rivastigmine
3. How to take Rivastigmine
4. Possible side effects
5. How to store Rivastigmine
6. Contents of the pack and other information

1. What Rivastigmine is and what it is used for
The active substance of Rivastigmine Hard Capsules is rivastigmine.
Rivastigmine belongs to a class of substances called cholinesterase
inhibitors. In patients with Alzheimer’s dementia or dementia due to
Parkinson’s disease, certain nerve cells die in the brain, resulting in low
levels of the neurotransmitter acetylcholine (a substance that allows
nerve cells to communicate with each other). Rivastigmine works by
blocking the enzymes that break down acetylcholine:
acetylcholinesterase and butyrylcholinesterase. By blocking these
enzymes, Rivastigmine allows levels of acetylcholine to be increased in
the brain, helping to reduce the symptoms of Alzheimer’s disease and
dementia associated with Parkinson’s disease.
Rivastigmine is used for the treatment of
• adult patients with mild to moderately severe Alzheimer's dementia, a
progressive brain disorder that gradually affects memory, intellectual
ability and behaviour. The capsules and oral solution can also be
used for the treatment of dementia in adult patients with Parkinson’s
disease.

2.

What you need to know before you take
Rivastigmine

Do NOT take Rivastigmine

[1.5mg:]
• if you are allergic to rivastigmine, other carbamate derivatives,
sunset yellow FCF (E110), tartrazine (E102) or any of the other
ingredients of this medicine (listed in section 6)
[3mg:]
if you are allergic to rivastigmine, other carbamate derivatives, ponceau
4R red (E124), sunset yellow FCF (E110), tartrazine (E102) or any of the
other ingredients of this medicine (listed in section 6)
[4.5mg:]
• if you are allergic to rivastigmine, other carbamate derivatives or any
of the other ingredients of this medicine (listed in section 6)
• if you have had a previous skin reaction suggestive of allergic
contact dermatitis with rivastigmine patches.
If this applies to you, tell your doctor and do not take Rivastigmine.

Warnings and precautions

Talk to your doctor before taking Rivastigmine:
• if you have or have ever had, irregular or slow heartbeat
• if you have or have ever had, an active stomach ulcer
• if you have or have ever had, difficulties in passing urine
• if you have or have ever had, seizures
• if you have or have ever had, asthma or severe respiratory
disease
• if you have or have ever had, impaired kidney function
• if you have or have ever had, impaired liver function
• if you suffer from trembling
• have a low body weight
• if you have gastrointestinal reactions such as feeling sick (nausea),
being sick (vomiting) and diarrhoea. You may become dehydrated
(losing too much fluid) if vomiting or diarrhoea are prolonged.
If any of these apply to you, your doctor may need to monitor you more
closely while you are on this medicine.
If you have not taken Rivastigmine for more than three days, do not take
the next dose until you have talked to your doctor.

Children and adolescents

There is no relevant use of Rivastigmine in the paediatric population in
the treatment of Alzheimer’s disease.

Other medicines and Rivastigmine

Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.

Rivastigmine should not be given at the same time as other medicines
with similar effects to Rivastigmine, Rivastigmine might interfere with
anticholinergic medicines (medicines used to relieve stomach cramps or
spasms, to treat Parkinson’s disease or to prevent travel sickness).
Rivastigmine should not be given at the same time as metoclopramide (a
medicine used to relieve or prevent nausea and vomiting). Taking the two
medicines together could cause problems such as stiff limbs and
trembling hands.
If you have to undergo surgery whilst taking Rivastigmine, you should
inform the doctor before you are given any anaesthetics, because
Rivastigmine may exaggerate the effects of some muscle relaxants during
anaesthesia.
Caution when Rivastigmine is taken together with beta-blockers
(medicines such as atenolol used to treat hypertension, angina and other
heart conditions). Taking the two medicines together could cause
problems such as slowing of the heartbeat (bradycardia) leading to
fainting or loss of consciousness.

Pregnancy and breast-feeding

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.
If you are pregnant, the benefits of using Rivastigmine must be assessed
against the possible effects on your unborn child. Rivastigmine should not
be used during pregnancy unless clearly necessary.
You should not breast-feed during treatment with Rivastigmine.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive vehicles
and use machines safely. Rivastigmine may cause dizziness and
somnolence, mainly at the start of treatment or when increasing the dose.
If you feel dizzy or sleepy, do not drive, use machines or perform any
tasks that require your attention.

Rivastigmine 1.5 mg contains

Sunset yellow FCF (E110) and tartrazine (E102)
which may cause allergic reactions.
Rivastigmine 3 mg contains Ponceau 4R red (E124), sunset yellow
FCF (E110) and tartrazine (E102) which may cause allergic reactions.

3. How to take Rivastigmine
Always take this medicine exactly as your doctor has told you. Check with
your doctor, pharmacist or nurse if you are not sure.
How to start treatment
Your doctor will tell you what dose of Rivastigmine to take.

Treatment usually starts with a low dose.

Your doctor will slowly increase your dose depending on how you
respond to treatment.

The highest dose that should be taken is 6.0 mg twice a day.
Your doctor will regularly check if the medicine is working for you. Your
doctor will also monitor your weight whilst you are taking this medicine.
If you have not taken Rivastigmine for more than three days, do not take
the next dose until you have talked to your doctor.
Taking this medicine

Tell your caregiver that you are taking Rivastigmine.

To benefit from your medicine, take it every day.

Take Rivastigmine twice a day, in the morning and evening, with
food.

Swallow the capsules whole with a drink.

Do not open or crush the capsules.

If you take more Rivastigmine than you should

If you accidentally take more Rivastigmine than you should, inform your
doctor. You may require medical attention. Some people who have
accidentally taken too much Rivastigmine have experienced feeling sick
(nausea), being sick, vomiting, diarrhoea, high blood pressure and
hallucinations. Slow heart beat and fainting may also occur.

If you forget to take Rivastigmine

If you find you have forgotten to take your dose of Rivastigmine, wait and
take the next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
You may have side effects more often when you start taking your
medicine or when your dose is increased. Usually the side effects will
slowly go away as your body gets used to the medicine.
Very common (may affect more than 1 in 10 people):

feeling dizzy

loss of appetite

stomach problems such as feeling sick (nausea) or being sick
(vomiting), diarrhoea
Common (may affect up to 1 in 10 people):

nightmares

anxiety

sweating

headache

heartburn

weight loss

stomach pain

feeling agitated

feeling tired or weak

generally feeling unwell

trembling or feeling confused

decreased appetite

Other side effects seen with Rivastigmine transdermal patches and
which may occur with the hard capsules:
Common (may affect up to 1 in 10 people)

fever

severe confusion

urinary incontinence (inability to retain adequate urine)
Uncommon (may affect up to 1 in 100 people)

hyperactivity (high level of activity, restlessness)
Not known (frequency cannot be estimated from the available data)

allergic reaction where the patch was used, such as blisters or
skin inflammation
If you get any of these side effects, contact your doctor as you may need
medical assistance.
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 Rivastigmine

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
after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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.

t 6.

Contents of the pack and other Information

Uncommon (may affect up to 1 in 100 people):

depression

difficulty in sleeping

fainting or accidentally falling

changes in how your liver is working

Rivastigmine contains

Rare (may affect up to 1 in 1,000 people):

chest pain

rash, itching

fits (seizures)

ulcers in your stomach or intestine

Capsule contents
Hypromellose 5mPas, Microcrystalline Cellulose, Silica, colloidal
anhydrous, Magnesium Stearate.

Very rare (may affect up to 1 in 10,000 people):

high blood pressure

urinary tract infection

seeing things that are not there (hallucinations)

problems with your heart beat such as fast or slow heartbeat

bleeding in the gut - shows as blood in stools or when being sick

inflammation of the pancreas – the signs include serious upper
stomach pain, often with feeling sick (nausea) or being sick
(vomiting)

the signs of Parkinson’s disease get worse or getting similar signs
– such as stiff muscles, difficulty in carrying out movements
Not known (frequency cannot be estimated from the available data):

being violently sick (vomiting) that can cause tearing of the tube
that connects your mouth with your stomach (oesophagus)

dehydration (losing too much fluid)

liver disorders (yellow skin, yellowing of the whites of the eyes,
abnormal darkening of the urine or unexplained nausea, vomiting,
tiredness and loss of appetite)

aggression, feeling restless

uneven heartbeat
Patients with dementia and Parkinson's disease
These patients have some side effects more often. They also have some
additional side effects:
Very common (may affect more than 1 in 10 people):

trembling

fainting

accidently falling
Common (may affect up to1 in 10 people):

anxiety

feeling restless

slow and fast heartbeat

difficulty in sleeping

too much saliva and dehydration

unusually slow movements or movements you cannot control

the signs of Parkinson’s disease get worse or getting similar signs
– such as stiff muscles, difficulty in carrying out movements and
muscle weakness
Uncommon (may affect up to 1 in 1,00 people):

uneven heart beat and poor control of movements

The active substance is rivastigmine.
Rivastigmine 1.5 mg, 3 mg, 4.5 mg Capsules contain 1.5 mg, 3 mg,
4.5 mg rivastigmine as rivastigmine hydrogen tartrate, respectively.

The other ingredients are:

Capsule shell
1.5 mg:
Titanium Dioxide (E171, Gelatin, Water, purified, Sodium Laurilsulfate,
Tartrazine (E102), Sunset Yellow FCF (E110). Ink used for imprinting:
Shellac, Sodium hydroxide, Titanium dioxide (E171), Povidone K16 and
Allura red (E129).
3 mg:
Titanium Dioxide (E171), Gelatin, Water, purified, Sodium Laurilsulfate,
Brilliant Blue (E133), Ponceau 4R red (E124), Sunset Yellow FCF (E110),
Tartrazine (E102). Ink used for imprinting: Shellac, Sodium hydroxide,
Titanium dioxide (E171), Povidone K16 and Allura red (E129).
4.5 mg:
Titanium Dioxide (E171), Gelatin, Water, purified, Sodium Laurilsulfate,
Iron oxide red (E172), Iron oxide yellow (E172). Ink used for imprinting:
Shellac, Sodium hydroxide, Titanium dioxide (E171) and Povidone K16.

What Rivastigmine looks like and contents of the pack

Capsule, hard
1.5 mg: White to off-white powder in a hard gelatin capsule (size 2) with
yellow opaque cap and yellow opaque body, imprinted “RV, 1.5” on body
with red ink.
3 mg: White to off-white powder in a hard gelatin capsule (size 2) with light
orange opaque cap and light orange opaque body, imprinted “RV, 3” on
body with red ink.
4.5 mg: White to off-white powder in a hard gelatin capsule (size 2) with
red opaque cap and red opaque body, imprinted “RV, 4.5” on body with
white ink.
Rivastigmine Capsules are available in blister packs of 14, 28, 30, 56 or
112 capsules, hard. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Dr. Reddy’s Laboratories (UK) Ltd, 6 Riverview Road, Beverley,
HU17 0LD.
This medicinal product is also authorised in the Member States of
the EEA under the following names:
Germany: Rivastigmin beta 1.5 mg, 3 mg, 4.5 mg Hartkapseln
Romania: Rivastigmina Dr. Reddy’s 1.5 mg, 3 mg, 4.5 mg capsule
This leaflet was last approved in 01/2016

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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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