What is it and how is it used?

Rivastigmine Teva belongs to a class of substances called cholinesterase inhibitors.

Rivastigmine Teva is used for the treatment of memory disorders in patients with Alzheimer?s dementia.

Rivastigmine Teva is used for the treatment of dementia in patients with Parkinson?s disease.

What do you have to consider before using it?

Before taking Rivastigmine Teva it is important that you read the following section and discuss any questions you might have with your doctor.

Do NOT take Rivastigmine Teva

  • If you are allergic (hypersensitive) to rivastigmine or any of the other ingredients of Rivastigmine Teva
  • If you have severe liver problems.
Take special care with Rivastigmine Teva

  • if you have, or have ever had imparied kidney or liver function, irregular heartbeat, an active stomach ulcer, asthma or severe respiratory disease, difficulties in passing urine, or seizures (fits or convulsions).
  • If you have not taken Rivastigmine Teva for several days, do not take the next dose until you have talked to your doctor.
  • If you experience gastro-intestinal reactions such as nausea (feeling sick) and vomiting (being sick).
  • If you have a low body weight.
  • If you suffer from trembling.

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 Teva 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 Teva, you should inform the doctor before you are given any anaesthetics, because Rivastigmine Teva may exaggerate the effects of some muscle relaxants during anaesthesia.

Rivastigmine Teva should not be given at the same time as other medicines with similar effects to Rivastigmine Teva. Rivastigmine Teva might interfere with antiocholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson?s disease or to prevent travel sickness).

Pregnancy and breast-feeding

It is preferable to avoid the use of Rivastigmine Teva during pregnancy, unless clearly necessary. Tell your doctor if you become pregnant during treatment. Women on Rivastigmine Teva 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 Teva 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.

How is it used?

Always take Rivastigmine Teva 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 Teva twice a day with food (in the morning and evening).

Your doctor will tell you what dosage of Rivastigmine Teva 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. If you have not taken Rivastigmine Teva for several days, do not take the next dose until you have talked to your doctor.

To benefit from your medicine you should take it every day.

Tell your caregiver that you are taking Rivastigmine Teva.

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 Teva than you should
Tell your doctor if you find you have accidentally taken more Rivastigmine Teva than you are told to. You may require medical attention. Some people who have accidentally taken too much Rivastigmine Teva have experienced nausea, vomiting, diarrhoea, high blood pressure and hallucinations. Slow heart beat and fainting may also occur.

If you forget to take Rivastigmine Teva

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.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, Rivastigmine Teva 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.

The following side effects have been reported at the approximate frequencies shown:

Very common affects more than 1 user in 10 Common affects 1 to 10 users in 100 Uncommon affects 1 to 10 users in 1,000 Rare affects 1 to 10 users in 10,000 Very Rare affects less than 1 user in 10,000 Unknown frequency cannot be estimated from the available data

Very common:

  • Dizziness
  • Nausea (feeling sick)
  • Vomiting (being sick)
  • Diarrhoea
  • Loss of appetite
Common:

  • Agitation
  • Confusion
  • Headache
  • Weakness
  • Somnolence (Sleepiness)
  • Tremor
  • Abdominal pain and indigestion
  • Heartburn
  • Increased sweating
  • Tiredness (fatigue) and lack of energy (lethargy)
  • Weight loss
  • General feeling of being unwell
Uncommon:

  • Insomnia
  • Depression
  • Fainting
  • Changes in liver function
  • Accidental fall
Rare:

  • Seizures (fits or convulsions)
  • Chest pain
  • Gastric and intestinal ulcers
  • Rash
  • Itching
Very rare:

  • Urinary tract infection
  • Hallucinations
  • Impairment of voluntary movement i.e. tremors, tics, changes in muscle tone, slowness of movement, worsening of Parkinson?s disease
  • Irregular heart beat
  • 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).

Unknown:

Some cases of severe vomiting were associated with rupture of the gullet (swallowing tube).

Patients with dementia associated with Parkinson?s disease experience some side effects more frequently and also some additional side effects: trembling (very common), 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 and dehydration (common), irregular heart beat and poor control of movements (uncommon).

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.

How should it be stored?

Keep out of the reach and sight of children.

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.

Further information

What Rivastigmine Teva contains

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:
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).

What Rivastigmine Teva looks like and contents of the pack

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.

Marketing Authorisation Holder

Teva Pharma B.V.
Computerweg 10, 3542 DR Utrecht
The Netherlands

Manufacturer

TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13,
4042 Debrecen,
Hungary

Or:
TEVA Pharmaceutical Works Private Limited Company
H-2100 Gödöll-,
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,
Postbus 552,
2003 RN Haarlem
The Netherlands

Or:
TEVA Santé Sa,
Rue Bellocier, 89107,
Sens,
France

Or

IVAX Pharmaceuticals 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:

BelgiëBelgiqueBelgien Teva Pharma Belgium N.V.S.A. TelTél 32 3 820 73 73 LuxembourgLuxemburg Teva Pharma Belgium S.A. TélTel 32 3 820 73 73

Te 359 2 489 95 82 Magyarország Teva Magyarország Zrt Tel. 36 1 288 64 00 eská republika Teva Pharmaceuticals CR, s.r.o. Tel 420 251 007 111 Malta Teva .. el 30 210 72 79 099 Danmark Teva Denmark AS Tlf 45 44 98 55 11 Nederland Teva Nederland B.V. Tel 31 0 800 0228400 Deutschland Teva Generics GmbH Tel 49 351 834 0 Norge Teva Sweden AB Tlf 46 42 12 11 00 Österreich Teva Generics GmbH Tel 49 351 834 0 Eesti Teva Eesti esindus UAB Sicor Biotech Eesti filiaal Tel 372 611 2409 Teva .. 30 210 72 79 099 Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel. 48 22 345 93 00

España Teva Genéricos Española, S.L.U Tél 34 91 387 32 80 Portugal Teva Pharma - Produtos Farmacêuticos Lda Tel 351 214 235 910 France Teva Santé Tél 33 1 55 91 7800 România Teva Pharmaceuticals S.R.L Tel 4021 230 65 24 Ireland Teva Pharmaceuticals Ireland Tel 353 042 9395 892 Slovenija Pliva Ljubljana d.o.o. Tel 386 1 58 90 390 Ísland Teva UK Limited Sími 44 1323 501 111. Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Tel 421 2 5726 7911 Italia Teva Italia S.r.l. Tel 39 0289179805 SuomiFinland Teva Sweden AB PuhTel 46 42 12 11 00 Teva .. 30 210 72 79 099 Sverige Teva Sweden AB Tel 46 42 12 11 00 Latvija UAB Sicor Biotech filile Latvij Tel 371 67 784 980 United Kingdom Teva UK Limited Tel 44 1323 501 111 Lietuva UAB Sicor Biotech Tel 370 5 266 02 03

This leaflet was last approved in {MM/YYYY}.

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