Rivastigmine Dr. Reddy's 3 mg hard Capsules

• 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.

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

• if you are allergic to rivastigmine or 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 these apply to you, tell your doctor and do not take Rivastigmine.

Talk to your doctor before taking Rivastigmine:

• if you have, or have ever had, a heart condition such as an irregular or slow heartbeat, QTc prolongation, a family history of QTc prolongation, torsade de pointes, or have a low blood level of potassium or magnesium.
• 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.

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

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.

Caution when Rivastigmine is taken together with other medicines that can affect your heart rhythm or the electrical system of your heart (QT prolongation).

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.

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.

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.

• 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 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 heartbeat and fainting may also occur.

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.

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 100 people):

• uneven heart beat and poor control of movements

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.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

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.

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: 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.

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.