RIVASTIGMINA 1.5 mg Kapsułki twarde

Treść ulotki

1. Rivastigmina Actavis 1.5 mg hard capsules, 3 mg hard capsules, 4.5 mg hard capsules, 6 mg hard capsules
   1. What is Rivastigmina Actavis and what is it used for
   2. What you need to know before taking Rivastigmina Actavis
   3. How to take Rivastigmina Actavis
   4. Possible side effects
   5. How to store Rivastigmina Actavis
   6. Package Contents and Other Information

Rivastigmina Actavis 1.5 mg hard capsules, 3 mg hard capsules, 4.5 mg hard capsules, 6 mg hard capsules

rivastigmina

Read this leaflet carefully before you start taking this medicine asit contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Rivastigmina Actavis is and what it is used for
• 2. What you need to know before you take Rivastigmina Actavis
• 3. How to take Rivastigmina Actavis
• 4. Possible side effects
• 5. How to store Rivastigmina Actavis
• 6. Contents of the pack and other information

1. What is Rivastigmina Actavis and what is it used for

Rivastigmina Actavis contains the active substance rivastigmine.
Rivastigmine belongs to a class of substances called cholinesterase inhibitors.
In patients with Alzheimer's dementia or dementia associated with Parkinson's disease, some cells
in the brain die, resulting in low levels of 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, Rivastigmina Actavis
increases the levels of acetylcholine in the brain, improving the symptoms of Alzheimer's disease or
dementia associated with Parkinson's disease.
Rivastigmina Actavis is used for the treatment of adult patients with Alzheimer's dementia of mild
to moderate severity, a progressive disorder of the central nervous system that gradually affects
memory, learning ability and behavior. The hard capsules and oral solution
can also be used for the treatment of dementia in adult patients with Parkinson's disease.

2. What you need to know before taking Rivastigmina Actavis

Do not take Rivastigmina Actavis

• 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 that spreads beyond the area where the patch was applied, if you have a more intense local reaction (such as blisters, increased skin inflammation, swelling) and if it does not improve within 48 hours of removing the patch.

If this is the case, tell your doctor and do not take Rivstigmina Actavis.

Warnings and precautions
Talk to your doctor before taking Rivastigmina Actavis:

• if you have or have ever had a heart condition such as irregular or slow heartbeat, prolonged QT interval, a family history of prolonged QT interval, torsade de pointes, or have a low level of potassium or magnesium in your blood.
• if you have or have ever had an active stomach ulcer.
• if you have or have ever had difficulty urinating.
• if you have or have ever had seizures (convulsions).
• if you have or have ever had asthma or severe respiratory disorders.
• if you have or have ever had impaired kidney function.
• if you have or have ever had impaired liver function.
• if you suffer from tremors.
• if you weigh little.
• if you experience gastrointestinal disorders such as nausea, vomiting and diarrhoea. If vomiting and diarrhoea are persistent, you may become dehydrated (excessive fluid loss).

If you recognise yourself in any of these conditions, your doctor may visit you more frequently
during therapy with this medicine.
If you have not taken Rivastigmina Actavis for more than three days, consult your doctor before resuming
treatment.

Children and adolescents
There is no indication for specific use of Rivastigmina Actavis in the paediatric population
in the treatment of Alzheimer's disease

Other medicinesand Rivastigmina Actavis
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Rivastigmina Actavis must not be administered together with other medicines that have similar effects.
Rivastigmina Actavis can interfere with anticholinergic medicines (medicines used to relieve
cramps or spasms in the stomach, for the treatment of Parkinson's disease or to prevent travel
sickness).
Rivastigmina Actavis must not be administered at the same time as metoclopramide (a
medicine used to relieve or prevent nausea and vomiting). Taking the two medicines together can
cause disorders such as rigidity of the limbs and tremors in the hands.
If you are to undergo surgery and are taking Rivastigmina Actavis, tell your
doctor before being given anaesthesia, as Rivastigmina Actavis may increase the
effects of some muscle relaxants during anaesthesia.
Caution is recommended when Rivastigmina Actavis is taken together with beta-blockers (medicines
such as atenolol, used for the treatment of hypertension, angina and other heart diseases).
Taking the two medicines together can cause disorders such as slowing of the heartbeat
(bradycardia) which can lead to fainting or loss of consciousness.
Caution is recommended when Rivastigmina Actavis is taken together with other medicines that
can affect the heart rate or the electrical system of the heart (prolongation of the QT interval).

Pregnancy, breastfeedingand fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, the benefits of using Rivastigmina Actavis must be weighed against the possible
effects on the unborn child. Rivastigmina Actavis should not be used during pregnancy unless
strictly necessary.
You must not breastfeed during treatment with Rivastigmina Actavis.

Driving and using machines
Your doctor will tell you if your illness allows you to drive and use machines safely. Rivastigmina Actavis can cause dizziness and drowsiness, especially at the beginning of treatment
or when the dose is increased. If you feel dizzy or sleepy, do not drive, do not use machines and do not
perform any other activity that requires vigilance

3. How to take Rivastigmina Actavis

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor, pharmacist or nurse.

How to start treatment
Your doctor will tell you which dose of Rivastigmina Actavis to take.

• Treatment usually starts with a low dose.
• Your doctor will slowly increase the dose based on your response to treatment.
• The highest dose that can be taken is 6.0 mg twice a day.

Your doctor will regularly check if the medicine is working. Your doctor will also monitor your
weight while you are taking this medicine.
If you have not taken Rivastigmina Actavis for several days more than three, consult your doctor before
resuming treatment.

Taking the medicine

• Inform the person who is taking care of you that you are being treated with Rivastigmina Actavis.
• To benefit from the treatment, take the medicine every day.
• Take Rivastigmina Actavis twice a day, in the morning and in the evening, with food.
• Swallow the capsules whole with a drink.
• Do not open or break the capsules.

If you take more Rivastigmina Actavis than you should
If you accidentally take more Rivastigmina Actavis than you should, inform your doctor. You may need
medical attention. Some people who have accidentally taken an excessive amount of Rivastigmina
Actavis have experienced nausea, vomiting, diarrhea, high blood pressure and hallucinations.
Slow heartbeat and fainting may also occur.

If you forget to take Rivastigmina Actavis
If you discover that you have forgotten to take your dose of Rivastigmina Actavis, wait and take the next
dose at the scheduled time. Do not take a double dose to make up for a missed dose.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may be more frequent when you start taking the medicine or when
you increase the dose. Generally, side effects will gradually disappear as your
body gets used to the medicine.

Very common(may affect more than 1 in 10 people)

• Feeling dizzy
• Loss of appetite
• Stomach discomfort such as feeling nauseous, vomiting, diarrhoea

Common(may affect up to 1 in 10 people)

• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Stomach pain
• Feeling restless
• Feeling tired or weak
• General feeling of being unwell
• Tremors or feeling confused
• Loss of appetite
• Nightmares
• Drowsiness

Uncommon(may affect up to 1 in 100 people)

• Depression
• Sleep disorders
• Fainting or accidental falls
• Changes in your liver function

Rare(may affect up to 1 in 1,000 people)

• Chest pain
• Skin rash, itching
• Convulsions (seizures)
• Ulcer in the stomach or intestine

Very rare(may affect up to 1 in 10,000 people)

• High blood pressure
• Urinary tract infection
• Seeing things that are not there (hallucinations)
• Heart rhythm disorders, such as a fast or slow heartbeat
• Bleeding from the intestine - this manifests with blood in the stools or vomit
• Inflammation of the pancreas - this manifests with severe pain in the upper part of the stomach, often accompanied by nausea or vomiting
• The signs of Parkinson's disease worsen or symptoms similar to it develop - such as muscle stiffness, difficulty performing movements

Not known(frequency cannot be estimated from the available data)

• Severe vomiting that can lead to rupture of the tract connecting the mouth to the stomach (oesophagus)
• Dehydration (excessive fluid loss)
• Liver disorders (yellowing of the skin and the white of the eye, abnormally dark urine or unexplained nausea, vomiting, fatigue and loss of appetite)
• Aggression, feeling restless
• Irregular heartbeat
• Pisa syndrome (a condition involving involuntary muscle contraction with abnormal flexion of the body and head to one side)

Patients with dementia and Parkinson's disease
These patients more frequently experience some side effects. They also experience some
additional side effects:

Very common(may affect more than 1 in 10 people)

• Tremors
• Accidental falls

Common(may affect up to 1 in 10 people)

• Anxiety
• Feeling restless
• Fast and slow heartbeat
• Sleep disorders
• Excessive salivation and dehydration
• Unusual slowing down of movements or movements that cannot be controlled
• The signs of Parkinson's disease worsen or symptoms similar to it develop - such as muscle stiffness, difficulty performing movements and muscle weakness
• Seeing things that are not there (hallucinations)
• Depression
• High blood pressure

Uncommon(may affect up to 1 in 100 people)

• Irregular heartbeat and poor control of movements
• Low blood pressure

Not known(frequency cannot be estimated from the available data)

• Pisa syndrome (a condition involving involuntary muscle contraction with abnormal flexion of the body and head to one side)
• Skin rash

Other side effects observed with rivastigmine transdermal patches and which may
occur with the capsules:
Common(may affect up to 1 in 10 people)

• Fever
• Severe confusion
• Urinary incontinence (inability to adequately retain 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 reactions at the patch application site, such as blisters or skin inflammation
If any of these symptoms occur, contact your doctor as you may need
medical assistance
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed
in Annex V. By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Rivastigmina Actavis

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 package, on the blister or on the bottle
of capsules after Exp.. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Rivastigmina Actavis contains

• The active ingredient is rivastigmine hydrogen tartrate.
• The other ingredients are: Capsule contents: Magnesium stearate, anhydrous colloidal silicon dioxide, hypromellose and microcrystalline cellulose. Capsule shell: Rivastigmina Actavis 1.5 mg hard capsules: Titanium dioxide (E171), yellow iron oxide (E172) and gelatin. Rivastigmina Actavis 3 mg, 4.5 mg and 6 mg hard capsules: Red iron oxide (E172), Titanium dioxide (E171), and Yellow iron oxide (E172) and gelatin.

Each Rivastigmina Actavis 1.5 mg capsule contains 1.5 mg of rivastigmine.
Each Rivastigmina Actavis 3 mg capsule contains 3 mg of rivastigmine.
Each Rivastigmina Actavis 4.5 mg capsule contains 4.5 mg of rivastigmine.
Each Rivastigmina Actavis 6 mg capsule contains 6 mg of rivastigmine.

Description of the appearance of Rivastigmina Actavis and contents of the pack

• Rivastigmina Actavis 1.5 mg hard capsules, which contains a near-white to slightly yellow powder, has a yellow cap and a yellow body.
• Rivastigmina Actavis 3 mg hard capsules, which contains a near-white to slightly yellow powder, has an orange cap and an orange body.
• Rivastigmina Actavis 4.5 mg hard capsules, which contains a near-white to slightly yellow powder, has a red cap and a red body.
• Rivastigmina Actavis 6 mg hard capsules, which contains a near-white to slightly yellow powder, has a red cap and an orange body.

The capsules are packaged in blisters available in three different packs (28, 56 and 112 capsules) and plastic bottles
of 250 capsules, but these may not all be available in your country.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland
Manufacturer
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Poland
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Teл.: +359 24899585

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Magyarország
Teva Gyógyszergyár Zrt.
Tel.: +36 12886400

Danmark
Teva Denmark A/S
Tlf.: +45 44985511

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117

Deutschland
ratiopharm GmbH
Tel: +49 73140202

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
TEVA HELLAS Α.Ε.
Τηλ: +30 2118805000

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

España
Teva Pharma, S.L.U.
Tel: +34 915359180

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel.: +48 223459300

France
Teva Santé
Tél: +33 155917800

Portugal
Teva Pharma - Produtos Farmacêuticos,
Lda.
Tel: +351 214767550

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Teva Pharma Iceland ehf.
Sími: +354 5503300

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος
TEVA HELLAS Α.Ε.
Ελλάδα
Τηλ: +30 2118805000

Sverige
Teva Sweden AB
Tel: +46 42121100

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu .