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RIVASTIGMINE 6 MG HARD CAPSULE

Active substance(s): RIVASTIGMINE HYDROGEN TARTRATE

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B. PACKAGE LEAFLET

Package leaflet:Information for the user.
Rivastigmine 1.5 mg hard capsules
Rivastigmine 3 mg hard capsules
Rivastigmine 4.5 mg hard capsules
Rivastigmine 6 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.
What is in this leaflet:
1. What Rivastigmine hard capsules are and what they are used for
2.
What you need to know before you take Rivastigmine hard capsules
3. How to take Rivastigmine hard capsules
4.
Possible side effects
5.
How to store Rivastigmine hard capsules
6.
Contents of the pack and other information

1.

What Rivastigmine hard capsules are and what they are used for.

The active substance of Rivastigmine hard capsules is rivastigmine.
Rivastigmine belongs to a class of substances called cholinesterase inhibitors.
Rivastigmine hard capsules are used for the treatment of memory disorders in patients with
Alzheimer’s disease. They are also used for the treatment of dementia in patients with
Parkinson’s disease.
2.

What you need to know before you take Rivastigmine Hard Capsules

Do not take Rivastigmine hard capsules
- if you are allergic to rivastigmine (the active substance in Rivastigmine hard capsules) or
to any of the other ingredients of this medicine (listed in section 6).
- if you have a skin reaction spreading beyond the patch size, if there is a more intense
local reaction (such as blisters, increasing skin inflammation, swelling) and if it does not
improve within 48 hours after removal of the transdermal patch.
If this applies to you, tell your doctor and do not take Rivastigmine hard capsules.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Rivastigmine Hard Capsules
- if you have, or have ever had, irregular 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
if you 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 hard capsules for several days, do not take the next dose until
you have talked to your doctor.
Children and adolescents
The use of Rivastigmine hard capsules in children and adolescents (age below 18 years) is not
recommended.
Other medicines and Rivastigmine Hard Capsules
Tell your doctor or pharmacist if you are taking have recently taken or might take any other
medicines,.
Rivastigmine hard capsules should not be given at the same time as other medicines with similar
effects to Rivastigmine hard capsules. Rivastigmine hard capsules might interfere with
anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat
Parkinson’s disease or to prevent travel sickness).
If you have to undergo surgery whilst taking Rivastigmine hard capsules,tell your doctor before
you are given any anesthetics , because Rivastigmine hard capsules may exaggerate the effects of
some muscle relaxants during anaesthesia.
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.
It is preferable to avoid the use of Rivastigmine hard capsules during pregnancy, unless clearly
necessary. Tell your doctor if you become pregnant during treatment.
You should not breast-feed during treatment with Rivastigmine hard capsules.
Driving and using machines
Your doctor will tell you whether your illness allows you to drive vehicles and use machines
safely.
Rivastigmine hard capsules 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 hard capsules contain lecithin

Rivastigmine 1.5 mg, 3 mg and 6 mg hard capsules contain lecithin made from soya oil. If you
are allergic to peanuts or soya, consult your doctor or pharmacist.
3.

How to take Rivastigmine Hard Capsules

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
How to start treatment
Your doctor will tell you what dose of Rivastigmine hard capsules 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 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 hard capsules for several 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 hard capsules. To benefit from your
medicine, take it every day. Take Rivastigmine hard capsules 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 hard capsules than you should
If you accidentally take more Rivastigmine hard capsules than you should, inform your doctor.
You may require medical attention. Some people who have accidentally taken too much
Rivastigmine hard capsules 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 hard capsules
If you find you have forgotten to take your dose of Rivastigmine hard capsules, 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 medicine, ask your doctor, pharmacist or
nurse.
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 your medicine or when your dose is
increased. Usually, the side effects will slowly go away as your body gets used to the medicine.
The frequencies are defined as:
Very common (affects more than 1 patient in 10)
Common (affects 1 to 10 patients in 100)
Uncommon (affects 1 to 10 patients in 1,000)
Rare (affects 1 to 10 patients in 10,000)
Very rare (affects less than 1 patient in 10,000)

Not known (frequency cannot be estimated from the available data)

Very common
• Feeling dizzy
• Loss of appetite
• Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea
Common
• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Stomach pain
• Feeling agitated
• Feeling tired or weak
• Generally feeling unwell
• Trembling or feeling confused
Uncommon
• Depression
• Difficulty in sleeping
• Fainting or accidentally falling
• Changes in how well your liver is working
Rare
• Chest pain
• Rash, itching
• Fits (seizures)
• Ulcers in your stomach or intestine
Very rare
• High blood pressure
• Urinary tract infection
• Seeing things that are not there (hallucinations)
• Problems with your heartbeat 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
• 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 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
• Trembling
• Fainting
• Accidentally falling
Common
• 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
• Uneven heartbeat and poor control of movements
Other side effects seen with Rivastigmine transdermal patches and which may occur with
the hard capsules:
Common
• Fever
• Severe confusion
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects
not listed in this leaflet.
5.

How to store Rivastigmine Hard Capules

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., blister or capsule
container. The expiry date refers to the last day of that month.
Do not store above 25°C.
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 Rivastigmine hard capsules contain

1.5 mg 3 mg, and 6 mg:
The active substance is rivastigmine hydrogen tartrate.
The other ingredients are:
Capsule content: Magnesium stearate, colloidal anhydrous silica, hypromellose and
microcrystalline cellulose.
Capsule shell: Titanium dioxide (E171), yellow iron oxide (E172) and gelatine.
3 mg & 6 mg also contains Red iron oxide (E172)
Printing ink:
Red ink on capsules - Shellac glaze, Iron oxide red (E172), N-butyl
alcohol, Purified water, Industrial methylated spirit 74 OP, Lecithin
(soya)E322, Antifoam DC 1510-US
4.5 mg:
The active substance is rivastigmine hydrogen tartrate.
The other ingredients are:
Capsule content: Magnesium stearate, colloidal anhydrous silica, hypromellose and
microcrystalline cellulose.
Capsule shell: Red iron oxide (E172), titanium dioxide (E171), yellow iron oxide
(E172) and gelatine.
Printing ink:
White ink on capsules-- Shellac glaze Titanium dioxide (E171), Isopropyl
alcohol, Ammonia solution, butyl alcohol Propylene glycol , Antifoam
DC 1510-US,
Each Rivastigmine 1.5 mg hard capsule contains 1.5 mg of rivastigmine.
Each Rivastigmine 3 mg hard capsule contains 3 mg of rivastigmine.
Each Rivastigmine 4.5 mg hard capsule contains 4.5 mg of rivastigmine.
Each Rivastigmine 6 mg hard capsule contains 6 mg of rivastigmine.
What Rivastigmine hard capsules looks like and contents of the pack
Rivastigmine 1.5 mg hard capsules, which contain off-white to slightly yellow powder, have a
yellow cap and yellow body, with red imprint “RIV 1.5mg” on body.
Rivastigmine 3 mg hard capsules, which contain off-white to slightly yellow powder, have an
orange cap and orange body, with red imprint “RIV 3.0mg” on body.
Rivastigmine 4.5 mg hard capsules, which contain off-white to slightly yellow powder, have a red
cap and red body, with white imprint “RIV 4.5mg” on body.
Rivastigmine 6 mg hard capsules, which contain off -white to slightly yellow powder, have a red
cap and orange body, with red imprint “RIV 6.0mg” on body.
The capsules are packed in blisters available in three different pack sizes (28, 56 and 112
capsules) and capsule containers of 250 capsules, but these may not all be available in your
country.
Marketing Authorisation Holder
Aptil Pharma Limited
9th Floor, CP House
97-107 Uxbridge Road, Ealing

London
W5 5TL
Manufacturer
Actavis hf.
Reykjavíkurvegi 76-78
IS-222 Hafnarfjörður
Iceland
This leaflet was last updated in 01/2013

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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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