Rivastigmine Dr. Reddys 4.5 Mg Hard Capsules
Out of date information, search anotherPACKAGE LEAFLET: INFORMATION FOR THE USER Rivastigmine 1.5 mg, 3 mg, 4.5 mg hard Capsules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.
• 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 1.5mg 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.
Rivastigmine should not be given at the same time as other medicines with similar effects as Rivastigmine.
Rivastigmine might interfere with anticholinergic medicines (medicines used to
• relieve stomach cramps or spasms
• treat Parkinson's disease
• prevent travel sickness).
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 3mg 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
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.
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).
Not known (frequency cannot be estimated from the available data):
• severe vomiting, that can lead to a rupture of the oesophagus (swallowing tube).
Patients with dementia associated with Parkinson's disease experience some side effects more frequently and also some additional side effects, as shown below:
Very common (affects more than 1 user in 10):
• tremor
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
Uncommon (affects 1 to 10 users in 1,000):
• irregular heart beat
• poor control of movements
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
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 Capsules contain 1.5 mg, 3 mg, 4.5 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.
What Rivastigmine looks like and contents of the pack
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.
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.
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 This leaflet was last approved in 10/2010.