Rivastigmine Teva
rivastigmine
Rivastigmine
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.
What Rivastigmine Teva is and what it is used for
Before you take Rivastigmine Teva
How to take Rivastigmine Teva
Possible side effects
How to store Rivastigmine Teva
Further information
Medicinal product no longer authorised
The active substance of Rivastigmine Teva is rivastigmine
Rivastigmine belongs to a class of substances called cholinesterase inhibitors.
Rivastigmine Teva is used for the treatment of memory disorders in patients with Alzheimer’s disease. It is also used for the treatment of dementia in patients with Parkinson’s disease.
If you are allergic (hypersensitive) to rivastigmine (the active substance in Rivastigmine Teva) or to any of the other ingredients of Rivastigmine Teva listed in section 6 of this leaflet
If this applies to you, tell your doctor and do not take Rivastigmine Teva.
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) and being sick (vomiting) and diarrhoea. You may become dehydrated (losing too much fluid) if vomiting or diarhoea 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 Teva for several days, do not take the next dose until you have talked to your doctor.
The use of Rivastigmine Teva in children and adolescents (age below 18 years) is not recommended.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Rivastigmine Teva should not be given at the same time as other medicines with similar effects to Rivastigmine Teva. Rivastigmine Teva 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 Teva, tell your doctor before you are given any anaesthetics, because Rivastigmine Teva may exaggerate the effects of some muscle relaxants during anaesthesia.
Medicinal product no longer authorised
Tell your doctor if you become pregnant during treatment. It is preferable to avoid the use of Rivastigmine Teva during pregnancy, unless clearly necessary.
You should not breast-feed during treatment with Rivastigmine Teva. Ask your doctor or pharmacist for advice before taking any medicine.
Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.. Rivastigmine Teva 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 Rivastigmine Teva exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Your doctor will tell you what dose of Rivastigmine Teva to take.
Treatment usually starts with a low dose.
Your doctor will slowly increase your dose depending on how you respond to the 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 Teva 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 Teva.
To benefit from your medicine, take it every day.
Take Rivastigmine Teva 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 Teva than you should, inform your doctor. You may require medical attention. Some people who have accidentally taken too much Rivastigmine Teva have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations. Slow heart beat and fainting may also occur.
If you find you have forgotten to take your dose of Rivastigmine Teva, wait and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
Like all medicines, Rivastigmine Teva 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 slowly go away as your body gets used to the medicine.
The frequencies are defined as:
Medicinal product no longer authorised
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)
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
Depression
Difficulty in sleeping
Fainting or accidentally falling
Changes in how 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 eyes, abnormal darkening of the urine or unexplained nausea, vomiting, tiredness and loss of appetite)
Aggression , feeling restless
Uneven heartbeat
Medicinal product no longer authorised
These patients have some side effects more often. They also have some additional side effects:
Trembling
Anxiety
Feeling restless,
Slow 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
Uneven heartbeat and poor control of movements
Other side effects seen with Rivastigmine transdermal patches and which may occur with hard capsules:
Fever
Severe confusion
If you get any of these side effects, contact your doctor as you may need medical assistance.
If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Do not use Rivastigmine Teva after the expiry date that is stated on 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.
The active substance is rivastigmine
Rivastigmine Teva 1.5 mg hard capsules contains 1.5 mg rivastigmine as rivastigmine hydrogen tartrate
Rivastigmine Teva 3 mg hard capsules contains 3 mg rivastigmine as rivastigmine hydrogen tartrate Rivastigmine Teva 4.5 mg hard capsules contains 4.5 mg rivastigmine as rivastigmine hydrogen tartrate
Rivastigmine Teva 6 mg hard capsules contains 6 mg rivastigmine as rivastigmine hydrogen tartrate
The other ingredients are:
Medicinal product no longer authorised
Capsule contents - microcrystalline cellulose, hypromellose, colloidal silicon dioxide, magnesium stearate.
Capsule shell – titanium dioxide (E171), gelatin and ink used for imprinting Black S-1-17822/S-1- 17823 (shellac glaze-45% in ethanol containing iron oxide black, N-butyl alcohol, isopropyl alcohol, propylene alcohol and ammonium hydroxide). In addition, Rivastigmine Teva 3 mg, 4.5 mg and 6 mg hard capsules contain red iron oxide (E172) and yellow iron oxide (E 172).
Hard capsule
Rivastigmine Teva 1.5 mg hard capsules: White cap imprinted with “R” & white body imprinted with “1.5”
Rivastigmine Teva 3 mg hard capsules: Flesh colour cap imprinted with “R” & flesh colour body imprinted with “3”
Rivastigmine Teva 4.5 mg hard capsules: Orange colour cap imprinted with “R” & orange colour body imprinted with “4.5”
Rivastigmine Teva 6 mg hard capsules: Orange cap imprinted with “R” & flesh colour body imprinted with “6”
Rivastigmine Teva hard capsules are available in blister packs of 28, 56 and 112 capsules, perforated blisters containing 50 x 1 capsules, and bottles containing 250 capsules.
Teva Pharma B.V.
Computerweg 10, 3542 DR Utrecht The Netherlands
TEVA Pharmaceutical Works Private Limited Company Pallagi út 13,
4042 Debrecen, Hungary
Or:
TEVA Pharmaceutical Works Private Limited Company H-2100 Gödöllő,
Táncsics Mihály út 82 Hungary
Or:
TEVA UK Ltd
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG
United Kingdom
Or:
Pharmachemie B.V. Swensweg 5,
2031 GA Haarlem The Netherlands
Medicinal product no longer authorised
Or:
TEVA Santé,
Rue Bellocier, 89100, Sens,
France
Or:Teva Czech Industries s.r.o. Ostravska 29, c.p. 305
747 70 Opava-Komarov Czech Republic
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharma Belgium N.V./S.A./AG Tel/Tél: +32 3 820 73 73
Тева Фармасютикълс България ЕООД
Teл: +359 2 489 95 82
Teva Pharmaceuticals CR, s.r.o. Tel: +420 251 007 111
Teva Denmark A/S Tlf: +45 44 98 55 11
Teva Magyarország Zrt Tel.: +36 1 288 64 00
Drugsales Ltd
Tel: +356 21 419 070/1/2
Teva Nederland B.V.
Tel: +31 (0) 800 0228400
Teva GmbH
Tel: + 49 731 402 08
Teva Eesti esindus UAB Sicor Biotech Eesti filiaal
Tel: +372 6610801
Teva Ελλάς Α.Ε.
Τηλ: +30 210 72 79 099
Teva Pharma, S.L.U Tél: +(34) 91 387 32 80
Teva Santé
Tél: +(33) 1 55 91 7800
Teva Pharmaceuticals Ireland Tel: +353 (0)42 9395 892
Teva UK Limited
Sími: +(44) 1323 501 111.
Teva Italia S.r.l.
Tel: +(39) 0289179805
Medicinal product no longer authorised
Teva Ελλάς Α.Ε.
Τηλ: +30 210 72 79 099
UAB Sicor Biotech filiāle Latvijā Tel: +371 67 784 980
UAB “Sicor Biotech” Tel: +370 5 266 02 03
Teva Norway AS Tlf: +46 66 77 55 90
ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97 007
Teva Pharmaceuticals Polska Sp. z o.o. Tel.: +(48) 22 345 93 00
Teva Pharma - Produtos Farmacêuticos Lda Tel: (351) 214 235 910
Teva Pharmaceuticals S.R.L Tel: +4021 230 65 24
Pliva Ljubljana d.o.o. Tel: +386 1 58 90 390
Teva Pharmaceuticals Slovakia s.r.o. Tel: +(421) 2 5726 7911
ratiopharm Oy
Puh/Tel: +(46) 42 12 11 00
Teva Sweden AB
Tel: +(46) 42 12 11 00
Teva UK Limited
Tel: +(44) 1323 501 111