Rivastigmine Actavis

Package leaflet: Information for the user

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

rivastigmine
Read this entire leaflet carefully before taking this medicine because it 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Rivastigmina Actavis contains the active substance rivastigmine.
Rivastigmine belongs to a class of substances known as cholinesterase inhibitors.
In patients with Alzheimer's dementia or dementia associated with Parkinson's disease, certain brain cells die, resulting in low levels of acetylcholine (a substance that enables nerve cells to communicate with each other). Rivastigmine works by inhibiting the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By inhibiting these enzymes, Rivastigmina Actavis increases acetylcholine levels in the brain, thereby 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 mild to moderate Alzheimer's dementia, a progressive disorder of the central nervous system that gradually affects memory, learning ability, and behaviour. The hard capsules and oral solution may 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 to 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), or if it does not improve within 48 hours after removing the patch.

If this applies to you, inform your doctor and do not take Rivastigmina 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 QTc interval, family history of prolonged QTc interval, torsades de pointes, or if you have low levels 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 (epileptic fits).
• 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 are underweight.
• if you experience gastrointestinal disorders such as nausea, vomiting, and diarrhea. If vomiting and diarrhea are persistent, you may become dehydrated (excessive loss of fluids).

If any of these conditions apply to you, your doctor may decide to monitor you more frequently during treatment 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 the specific use of Rivastigmina Actavis in the pediatric population for the treatment of Alzheimer's disease.
Other medicines and Rivastigmina Actavis
Inform 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 may interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, for the treatment of Parkinson’s disease, or to prevent motion sickness).
Rivastigmina Actavis must not be taken at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking both medicines together may cause side effects such as stiffness of the limbs and hand tremors.
If you are scheduled for surgery and are being treated with Rivastigmina Actavis, inform your doctor before receiving anesthesia, as Rivastigmina Actavis may enhance the effects of certain muscle relaxants during anesthesia.
Caution is recommended when Rivastigmina Actavis is taken together with beta-blockers (medicines such as atenolol, used to treat hypertension, angina, and other heart conditions).
Taking both medicines together may cause side effects such as slowing of the heartbeat (bradycardia), which may lead to fainting or loss of consciousness.
Caution is recommended when Rivastigmina Actavis is taken together with other medicines that may affect heart rhythm or the heart's electrical system (prolongation of the QT interval).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant, the benefits of using Rivastigmina Actavis must be weighed against the possible risks to the unborn child. Rivastigmina Actavis should not be used during pregnancy unless clearly necessary.
You must not breastfeed during treatment with Rivastigmina Actavis.
Driving and using machines
Your doctor will advise you whether your condition allows you to drive or operate machinery safely. Rivastigmina Actavis may cause dizziness and drowsiness, especially at the beginning of treatment or when the dose is increased. If you feel dizzy or drowsy, do not drive, do not use machines, and do not perform any other activity that requires alertness.

3. How to take Rivastigmina Actavis

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor, pharmacist, or nurse.
Starting treatment
Your doctor will tell you what 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 daily.

Your doctor will regularly check whether 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 more than three days, consult your doctor before restarting treatment.
Taking the medicine

• Inform the person caring for you that you are being treated with Rivastigmina Actavis.
• To benefit from treatment, take the medicine every day.
• Take Rivastigmina Actavis twice daily, in the morning and 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 treatment. Some people who accidentally took an excessive amount of Rivastigmina Actavis experienced nausea, vomiting, diarrhoea, high blood pressure, and hallucinations.
A slowed heartbeat and fainting may also occur.
If you forget to take Rivastigmina Actavis
If you realize you have forgotten to take your dose of Rivastigmina Actavis, wait and take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use 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 first start taking this medicine or when the dose is increased.
Generally, side effects will gradually disappear as your body gets used to the medicine.

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

• Dizziness
• Loss of appetite
• Stomach disturbances such as nausea, vomiting, diarrhoea

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

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

• Chest pain
• Rash, itching
• Seizures (epileptic fits)
• Stomach or intestinal ulcer

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 fast or slow heartbeat
• Intestinal bleeding –表现为 blood in the stool or vomit
• Inflammation of the pancreas –表现为 severe pain in the upper stomach, often accompanied by nausea or vomiting
• Worsening of Parkinson’s disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty moving

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

• Severe vomiting that may lead to tearing of the tube connecting the mouth to the stomach (oesophagus)
• Dehydration (excessive loss of body fluids)
• Liver problems (yellowing of the skin and whites of the eyes, abnormally dark urine, or unexplained nausea, vomiting, tiredness and loss of appetite)
• Aggression, feeling restless
• Irregular heartbeat
• Pisa syndrome (a condition involving involuntary muscle contractions causing abnormal sideways bending of the body and head)

Patients with dementia and Parkinson’s disease
These patients experience certain side effects more frequently. They may also experience 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
• Slow and fast heartbeat
• Sleep disorders
• Excessive salivation and dehydration
• Unusual slowing of movements or uncontrollable movements
• Worsening of Parkinson’s disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty moving 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 contractions causing abnormal sideways bending of the body and head)
• 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 properly control 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 you experience any of these symptoms, 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 via 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 carton, blister pack, or bottle
of capsules after Exp.. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater 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 Rivastigmine Actavis contains

• The active substance is rivastigmine hydrogen tartrate.
• The other components are: Capsule contents: Magnesium stearate, anhydrous colloidal silica, hypromellose and microcrystalline cellulose. Capsule coating: Rivastigmine Actavis 1.5 mg hard capsules: Titanium dioxide (E171), yellow iron oxide (E172) and gelatin. Rivastigmine Actavis 3 mg, 4.5 mg and 6 mg hard capsules: Red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172) and gelatin.

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

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

• Rivastigmine Actavis 1.5 mg hard capsules, containing a powder from almost white to slightly yellow, with a yellow cap and a yellow body.
• Rivastigmine Actavis 3 mg hard capsules, containing a powder from almost white to slightly yellow, with an orange cap and an orange body.
• Rivastigmine Actavis 4.5 mg hard capsules, containing a powder from almost white to slightly yellow, with a red cap and a red body.
• Rivastigmine Actavis 6 mg hard capsules, containing a powder from almost white to slightly yellow, with a red cap and an orange body.

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

Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./AG
Teл.: +359 24899585 Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel.: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf.: +45 44985511 L-Irlanda
Tel: +44 2075407117

Deutschland Nederland
ratiopharm GmbH Teva Nederland B.V.
Tel: +49 73140202 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
TEVA HELLAS Α.Ε. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 915359180 Tel.: +48 223459300

France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
TEVA HELLAS Α.Ε. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

This Patient Information Leaflet was last updated on

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