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RIVASTIGMINE DR. REDDYS 6 MG HARD CAPSULES

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Rivastigmine 1.5 mg, 3 mg, 4.5 mg, 6 mg hard Capsules
Rivastigmine
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.

In this leaflet:
1.
What Rivastigmine is and what it is used for
2.
Before you take Rivastigmine
3.
How to take Rivastigmine
4.
Possible side effects
5.
How to store Rivastigmine
6.
Further information

1. WHAT RIVASTIGMINE IS AND WHAT IT IS USED FOR
Rivastigmine belongs to a class of substances called cholinesterase
inhibitors.
Rivastigmine is used for the treatment of

memory disorders in patients with Alzheimer's dementia.

dementia in patients with Parkinson's disease.

2. BEFORE YOU TAKE RIVASTIGMINE
Do NOT take Rivastigmine if you




are allergic (hypersensitive) to rivastigmine, other carbamate
derivatives or any of the other ingredients of Rivastigmine Capsules
such as sunset yellow FCF (E110), tartrazine (E102) in 1.5 mg and 3
mg capsules or ponceau 4R red (E124) in 3 mg capsules.
have severe liver problems.

Take special care with Rivastigmine if you







have, or have ever had impaired kidney or liver function, irregular
heartbeat, an active stomach ulcer, asthma or severe respiratory
disease, difficulties in passing urine, or seizures (fits or
convulsions).
experience gastro-intestinal reactions such as nausea (feeling sick)
and vomiting (being sick).
have a low body weight.
suffer from tremor.
if you have not taken Rivastigmine for several days, do not take the
next dose until you have talked to your doctor.

If any of these apply to you, your doctor may need to monitor you more
closely while you are on this medicine.
The use of Rivastigmine in children and adolescents (age below 18 years) is
not recommended.

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.
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.

Pregnancy and breast-feeding
It is preferable to avoid the use of Rivastigmine during pregnancy, unless
clearly necessary. Tell your doctor if you become pregnant during treatment.
Women on Rivastigmine should not breast-feed. Ask your doctor or
pharmacist for advice before taking any medicine.

Driving and using machines
Your illness may impair your ability to drive or operate machinery and you
must not carry out these activities unless your doctor tells you it is safe to do
so.
Rivastigmine may cause dizziness and somnolence, mainly at the start of
treatment or when increasing the dose. If you experience such effects, you
should not drive or operate machinery.

Important information about some of the ingredients
Sunset yellow FCF (E110) and tartrazine (E102) in Rivastigmine 1.5 mg and
3 mg capsules, and Ponceau 4R red (E124) in 3 mg Capsules may cause
allergic reactions.

3. HOW TO TAKE RIVASTIGMINE
Always take Rivastigmine exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
Swallow the capsules whole with a drink, without opening or crushing
them. You should take Rivastigmine twice a day with food (in the morning
and evening).
Your doctor will tell you what dosage of Rivastigmine to take, starting with a
low dose and gradually increasing, depending on how you respond to the
treatment. The highest dose that should be taken is 6.0 mg twice a day.
To benefit from your medicine you should take it every day.
Tell your caregiver that you are taking Rivastigmine.
This medicine should only be prescribed by a specialist and your doctor
should regularly review whether it is having the desired effect. Your doctor
will monitor your weight whilst you are taking this medicine.

If you take more Rivastigmine than you should
Tell your doctor if you find you have accidentally taken more Rivastigmine
than you are told to. You may require medical attention. Some people who
have accidentally taken too much Rivastigmine have experienced nausea,
vomiting, diarrhoea, high blood pressure and hallucinations. Slow heart beat
and fainting may also occur.

If you forget to take Rivastigmine
Rivastigmine should not be given at the same time as other medicines with
similar effects as Rivastigmine.
Rivastigmine might interfere with antiocholinergic medicines (medicines
used to

relieve stomach cramps or spasms

treat Parkinson's disease

prevent travel sickness).

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 not taken Rivastigmine for several days, do not take the next
dose until you have talked to your doctor.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Rivastigmine can cause side effects, although not
everybody gets them. You may tend to get side effects more frequently when
you start taking your medicine or increase to a higher dose.

Should such symptoms occur, contact your doctor as you may need
medical assistance. If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet, please tell your doctor
or pharmacist.

5. HOW TO STORE RIVASTIGMINE
Side effects will gradually disappear most probably as your body becomes
used to the medicine.
Should any of the following side effects occur, contact your doctor as
you may need medical assistance. If any of the side effects get serious,
or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
Very common (affects more than 1 user in 10):
 dizziness
 nausea (feeling sick)
 vomiting (being sick)
 diarrhoea
 loss of appetite
Common (affects 1 to 10 users in 100):
 agitation
 confusion
 headache
 weakness
 tremor
 stomach pain
 heartburn
 sweating
 fatigue (tiredness and feeling lack of energy)
 weight loss
 general feeling of being unwell
Uncommon (affects 1 to 10 users in 1,000):
 difficulty in sleeping
 depression
 fainting
 changes in liver function
 accidental fall
Rare (affects 1 to 10 users in 10,000):
 seizures (fits or convulsions)
 chest pain
 gastric and intestinal ulcers
 rash
Very rare (affects less than 1 user in 10,000):
 Urinary tract infection
 hallucinations
 worsening of Parkinson's disease or development of similar symptoms
(muscle stiffness, difficulty in carrying out movements)
 irregular heart beat (both fast and slow)
 high blood pressure
 gastrointestinal bleeding (blood in stools or when vomiting)
 inflammation of the pancreas (which causes severe upper stomach pain,
often with nausea and vomiting).

Keep out of the reach and sight of children.
Do not use Rivastigmine after the expiry date that is stated on the blister and
the carton. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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.

6. FURTHER INFORMATION
What Rivastigmine contains
The active substance is rivastigmine.
Rivastigmine 1.5 mg, 3 mg, 4.5 mg, 6 mg Capsules contain 1.5 mg, 3 mg,
4.5 mg, 6 mg rivastigmine as rivastigmine hydrogen tartrate, respectively.

The other ingredients are:
Capsule contents
Hypromellose 5mPas, Microcrystalline Cellulose, Silica, colloidal
anhydrous, Magnesium Stearate
Capsule shell
1.5 mg:
Titanium Dioxide (E171, Gelatin, Water purified, Sodium Laurilsulfate,
Tartrazine (E102), Sunset Yellow FCF (E110). Ink used for imprinting TekPrint SB-1018: 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 - TekPrint SB-1018: 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 - TekPrint
SB-0007P: Shellac, Sodium hydroxide, Titanium dioxide (E171) and
Povidone K16.
6 mg:
Titanium Dioxide (E171), Gelatin, Water, purified, Sodium Laurilsulfate, Iron
oxide red (E172), Iron oxide yellow (E172). Ink used for imprinting - TekPrint
SB-1018: Shellac, Sodium hydroxide, Titanium dioxide (E171), Povidone
K16 and Allura red (E129).

What Rivastigmine looks like and contents of the pack

Not known (frequency cannot be estimated from the available data):
 severe vomiting, that can lead to a rupture of the oesophagus
(swallowing tube).

Hard capsule
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.

Patients with dementia associated with Parkinson's disease experience
some side effects more frequently and also some additional side
effects, as shown below:

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.

Very common (affects more than 1 user in 10):
 tremor

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.

Common (affects 1 to 10 users in 100):
 difficulty in sleeping
 anxiety
 restlessness
 worsening of Parkinson's disease or development of similar symptoms
(muscle stiffness, difficulty in carrying out movements),
 abnormally slow or uncontrollable movements,
 slow heart beat
 too much saliva
 dehydration

6 mg: White to off-white powder in a hard gelatin capsule (size 2) with red
opaque cap and orange opaque body, imprinted “RV, 6” on body with red ink.

Uncommon (affects 1 to 10 users in 1,000):
 irregular heart beat
 poor control of movements

Rivastigmine Capsules are available in blister packs of 14, 28, 30, 56 or 112
capsules, hard.

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, 6 mg Hartkapseln
Romania: Rivastigmina Dr. Reddy’s 1.5 mg, 3 mg, 4.5 mg, 6 mg capsule
This leaflet was last approved in 10/2010.

Expand Transcript

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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