Rivastigmine Actavis
rivastigmine
rivastigmine
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.
What Rivastigmine Actavis is and what it is used for
What you need to know before you take Rivastigmine Actavis
How to take Rivastigmine Actavis
Possible side effects
How to store Rivastigmine Actavis
Contents of the pack and other information
The active substance of Rivastigmine Actavis 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 Actavis 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 Actavis 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.
if you are allergic to rivastigmine or 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 Actavis.
Talk to your doctor before taking Rivastigmine Actavis:
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.
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 Actavis 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 Actavis 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 Actavis should not be given at the same time as other medicines with similar effects to Rivastigmine Actavis. Rivastigmine Actavis might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson’s disease or to prevent travel sickness).
Rivastigmine Actavis 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 Actavis, tell your doctor before you are given any anaesthetics, because Rivastigmine Actavis may exaggerate the effects of some muscle relaxants during anaesthesia.
Caution when Rivastigmine Actavis 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.
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 Actavis must be assessed against the possible effects on your unborn child. Rivastigmine Actavis should not be used during pregnancy, unless clearly necessary.
You should not breast-feed during treatment with Rivastigmine Actavis.
Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely. Rivastigmine Actavis 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.
Always take this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.
Your doctor will tell you what dose of Rivastigmine Actavis 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 Actavis 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 Actavis.
To benefit from your medicine, take it every day.
Take Rivastigmine Actavis 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 Actavis than you should, inform your doctor. You may require medical attention. Some people who have accidentally taken too much Rivastigmine Actavis 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 Actavis, 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 or pharmacist.
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.
Feeling dizzy
Loss of appetite
Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea
Anxiety
Sweating
Headache
Heartburn
Weight loss
Stomach pain
Feeling agitated
Feeling tired or weak
Generally feeling unwell
Trembling or feeling confused
Decreased appetite
Nightmares
Depression
Difficulty in sleeping
Fainting or accidentally falling
Changes in how well your liver is working
Chest pain
Rash, itching
Fits (seizures)
Ulcers in your stomach or intestine
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
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
These patients have some side effects more often. They also have some additional side effects:
Trembling
Fainting
Accidentally falling
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
Uneven heartbeat and poor control of movements
Fever
Severe confusion
Urinary incontinence (inability to retain adequate urine)
Hyperactivity (high level of activity, restlessness)
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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 after EXP. 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.
The active substance is rivastigmine hydrogen tartrate.
The other ingredients are:
Capsule content: Magnesium stearate, colloidal anhydrous silica, hypromellose and microcrystalline cellulose.
Capsule shell: Rivastigmine Actavis 1.5 mg hard capsules: Titanium dioxide (E171), yellow iron oxide (E172) and gelatine. Rivastigmine Actavis 3 mg, 4.5 mg and 6 mg hard capsules: Red iron oxide (E172), titanium dioxide (E171), yellow iron
oxide (E172) and gelatine.
Printing ink: Shellac, propylene glycol, red iron oxide (E172). The ink may or may not contain potassium hydroxide.
Each Rivastigmine Actavis 1.5 mg capsule contains 1.5 mg of rivastigmine. Each Rivastigmine Actavis 3 mg capsule contains 3 mg of rivastigmine. Each Rivastigmine Actavis 4.5 mg capsule contains 4.5 mg of rivastigmine. Each Rivastigmine Actavis 6 mg capsule contains 6 mg of rivastigmine.
Rivastigmine Actavis 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 Actavis 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 Actavis 6 mg hard capsules, which contain off -white to slightly yellow powder, have an red cap and orange body, with red imprint “RIV 6mg” 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 Actavis Group PTC ehf. Reykjavíkurvegur 76-78
220 Hafnarfjörður Iceland
Manufacturer Pharmapath S.A. 28is Oktovriou 1
Agia Varvara, 123 51 Greece
Tjoapack Netherlands BV Nieuwe Donk 9
4879 AC Etten-Leur The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373
UAB Teva Baltics Tel: +370 52660203
Тева Фарма ЕАД
Teл: +359 24899585
Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien
Tél/Tel: +32 38207373
Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111
Teva Gyógyszergyár Zrt. Tel: +36 12886400
Teva Denmark A/S Tlf: +45 44985511
Teva Pharmaceuticals Ireland L-Irlanda
Tel: +44 2075407117
Teva Nederland B.V. Tel: +31 8000228400
UAB Teva Baltics Eesti filiaal Tel: +372 6610801
Teva Norway AS Tlf: +47 66775590
Specifar A.B.E.E.
Τηλ: +30 2118805000
ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
Teva Pharma, S.L.U. Tel: +34 913873280
Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
Teva Santé
Tél: +33 155917800
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550
Pliva Hrvatska d.o.o. Tel: +385 13720000
Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Teva Pharmaceuticals Ireland Tel: +44 2075407117
Pliva Ljubljana d.o.o. Tel: +386 15890390
Teva Pharma Iceland ehf. Sími: +354 5503300
TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911
Teva Italia S.r.l. Tel: +39 028917981
Teva Finland Oy
Puh/Tel: +358 201805900
Specifar A.B.E.E.
Ελλάδα
Τηλ: +30 2118805000
Teva Sweden AB Tel: +46 42121100
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666
Teva Pharmaceuticals Ireland Ireland
Tel: +44 2075407117