Rivastigmine Hexal
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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Rivastigmine HEXAL is and what it is used for
What you need to know before you take Rivastigmine HEXAL
How to take Rivastigmine HEXAL
Possible side effects
How to store Rivastigmine HEXAL
Contents of the pack and other information
The active substance of Rivastigmine HEXAL 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 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 HEXAL 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 (the active substance in Rivastigmine HEXAL) or any of the other ingredients of this medicine (listed in section 6).
if you have had a previous skin reaction suggestive of allergic contact dermatitis with rivastigmine.
If this applies to you, tell your doctor and do not take Rivastigmine HEXAL.
Talk to your doctor before taking Rivastigmine HEXAL
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 HEXAL 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 HEXAL 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 Hexal should not be given at the same time as other medicines with similar effects to Rivastigmine HEXAL. Rivastigmine HEXAL might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson’s disease or to prevent travel sickness).
Rivastigmine Hexal 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 HEXAL, tell your doctor before you are given any anaesthetics, because Rivastigmine HEXAL may exaggerate the effects of some muscle relaxants during anaesthesia.
Caution when Rivastigmine HEXAL 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 HEXAL must be assessed against the possible effects on your unborn child. Rivastigmine HEXAL should not be used during pregnancy unless clearly necessary.
You should not breast-feed during treatment with Rivastigmine HEXAL.
Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely. Rivastigmine HEXAL 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 or pharmacist if you are not sure.
Your doctor will tell you what dose of Rivastigmine HEXAL 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 HEXAL 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 HEXAL.
To benefit from your medicine, take it every day.
Take Rivastigmine HEXAL 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 HEXAL than you should, inform your doctor. You may require medical attention. Some people who have accidentally taken too much Rivastigmine HEXAL 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 HEXAL, 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
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
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 or pharmacist. 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 Rivastigmine HEXAL after the expiry date which is stated on the blister, bottle label and carton after “EXP”. The expiry date refers to the last day of that month.
Do not store above 30°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.
The other ingredients are: hypromellose, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica, gelatin, yellow iron oxide red iron oxide, titanium dioxide, and shellac.
Each Rivastigmine HEXAL 1.5 mg capsule contains 1.5 mg of rivastigmine. Each Rivastigmine HEXAL 3 mg capsule contains 3 mg of rivastigmine. Each Rivastigmine HEXAL 4.5 mg capsule contains 4.5 mg of rivastigmine. Each Rivastigmine HEXAL 6 mg capsule contains 6 mg of rivastigmine.
Rivastigmine HEXAL 1.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a yellow cap and yellow body, with a red imprint “RIV 1.5 mg” on the body.
Rivastigmine HEXAL 3 mg hard capsules, which contain an off-white to slightly yellow powder, have an orange cap and orange body, with a red imprint “RIV 3 mg” on the body.
Rivastigmine HEXAL 4.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and red body, with a white imprint “RIV 4.5 mg” on the body.
Rivastigmine HEXAL 6 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and orange body, with a red imprint “RIV 6 mg” on the body.
They are packed in blisters available in three different pack sizes (28, 56 or 112 capsules) and plastic bottles of 250 capsules, but these may not all be available in your country.
HEXAL AG
Industriestraße 25
D-83607 Holzkirchen Germany
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764 08013 Barcelona
Spain
Novartis Pharma GmbH Roonstrasse 25
90429 Nürnberg Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Sandoz N.V.
Telecom Gardens, Medialaan 40 B-1800 Vilvoorde
Tél/Tel: + 32 (0)2 722 97 97
Hexal AG Industriestraße 25
D-83607 Holzkirchen Tel: + 49 8024 908 0
Сандоз България КЧТ Бул.“Никола Вапцаров“ No. 55 сгр. 4, ет. 4
1407 София
Teл.: + 359 2 970 47 47
E-mail: info.hungary@sandoz.com
Sandoz s.r.o.
Na Pankráci 1724/129
CZ-14000 Praha 4 - Nusle
E-mail: office.cz@sandoz.com Tel: +420 225 775 111
V.J. Salomone Pharma Limited Upper Cross Road
Marsa MRS 1542
Malta
Tel: 00356 22983143
Sandoz A/S
Edvard Thomsens Vej 14 DK-2300 København S
E-mail: info.danmark@sandoz.com
NL-1327 AH Almere Tel: + 31 36 5241600
E-mail: info.sandoz-nl@sandoz.com
D-83607 Holzkirchen Tel: + 49 8024 908 0
Sandoz A/S
Edvard Thomsens Vej 14 DK-2300 København S
E-mail: info.danmark@sandoz.com
Sandoz d.d. Eesti filiaal Pärnu mnt 105
EE-11312 Tallinn Tel: +372 6652400
HEXAL Pharma GmbH Stella-Klein-Löw-Weg 17 A-1020 Wien
Tel: + 43 (0)1 486 96 22
Novartis (Hellas) S.A.C.I./Sandoz division Εθνική Οδός No 1 (12ο km) Μεταμόρφωση
GR-144 51 Αθήνα
Τηλ: +30 210 2811712
Sandoz Polska Sp.z o.o. ul. Domaniewska 50 C PL-02-672 Warszawa Tel: + 48 22 549 15 00
Sandoz Farmacéutica, S.A Centro Empresarial Parque Norte
C/ Serrano Galvache Nº 56, Edificio Roble E-28033 Madrid
Tel: +34 91 602 30 62
Sandoz Farmacêutica Lda.
Avenida Professor Doutor Cavaco Silva, n.º 10E Taguspark
2740-255 Porto Salvo Portugal
Tel: +351 211 964 000
Sandoz SAS
49, avenue Georges Pompidou F-92593 Levallois-Perret Cedex Tél: + 33 1 4964 4800
SC Sandoz S.R.L. Str Livezeni nr. 7A,
Targu Mures, 540472 Romania
Phone: +40 21 310 44 30
IE-Bantry Co. Cork P75 V009
Tel: +353 27 50077
Lek Pharmaceuticals d.d.
Verovśkova 57
SI-1526 Ljubljana Tel: + 386 1 5802111
Sandoz A/S
Edvard Thomsens Vej 14 DK-2300 København S
E-mail: info.danmark@sandoz.com
Sandoz d.d. - organizačná zložka
Žižkova 22B
SK-811 02 Bratislava
Tel: +421 2 48 200 600
Sandoz S.p.a
Largo Umberto Boccioni 1 I-21040 Origgio (VA)
Tel: + 39 02 96541
Sandoz A/S
Edvard Thomsens Vej 14
DK-2300 Kööpenhamina S/Köpenhamn S E-mail: info.suomi@sandoz.com
Π.T.Χατζηγeωργίου εταιρεία Ltd Γιλντίζ31-3042 Λεμεσός Τηλέφωνο: 00357 25372425
Φαξ: 00357 25376400
e-mail: hapanicos@cytanet.com.cy
Sandoz A/S
Edvard Thomsens Vej 14 DK-2300 Köpenhamn S
E-mail: info.sverige@sandoz.com
Sandoz d.d. Latvia filiāle K.Valdemāra Str. 33 – 29 LV-1010 Riga
Tel: + 371 67892006
Sandoz Ltd
Frimley Business Park
Frimley Camberley Surrey GU16 7SR Tel: +44 1276 69 8020
E-mail: uk.drugsafety@sandoz.com
Sandoz Pharmaceuticals d.d., Branch Office Lithuania
Seimyniskiu Str. 3A LT-09312 Vilnius Tel: + 370 5 2636037
10 000 Zagreb
Tel: +38512353111
E-mail: upit.croatia@sandoz.com