Rivastigmine 1 A Pharma 2 mg/ml oral solution

Rivastigmine 1 A Pharma belongs to a class of substances called cholinesterase inhibitors.

Rivastigmine 1 A Pharma is used for the treatment of memory disorders in patients with Alzheimer?s disease.

Rivastigmine 1 A Pharma is used for the treatment of dementia in patients with Parkinson?s disease.

Before taking Rivastigmine 1 A Pharma it is important that you read the following section and discuss any questions you might have with your doctor.

Do not take Rivastigmine 1 A Pharma

• if you are allergic (hypersensitive) to rivastigmine or any of the other ingredients of Rivastigmine 1 A Pharma.
• if you have severe liver problems.

Take special care with Rivastigmine 1 A Pharma

• if you have, or have ever had impaired 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 1 A Pharma 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 1 A Pharma 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 1 A Pharma, you should inform the doctor before you are given any anaesthetics, because Rivastigmine 1 A Pharma may exaggerate the effects of some muscle relaxants during anaesthesia.

Rivastigmine 1 A Pharma should not be given at the same time as other medicines with similar effects to Rivastigmine 1 A Pharma. Rivastigmine 1 A Pharma might interfere with anticholinergic 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 1 A Pharma during pregnancy, unless clearly necessary. Tell your doctor if you become pregnant during treatment. Women on Rivastigmine 1 A Pharma 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 that it is safe to do so. Rivastigmine 1 A Pharma 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.

Important information about some of the ingredients of Rivastigmine 1 A Pharma

One of the inactive ingredients in Rivastigmine 1 A Pharma oral solution is sodium benzoate. Benzoic acid is a mild irritant to the skin, eyes and mucous membranes.

Always take Rivastigmine 1 A Pharma exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Remove the oral dosing syringe provided from its protective case. Using this syringe, withdraw the prescribed amount of Rivastigmine 1 A Pharma oral solution from the container. Each dose of Rivastigmine 1 A Pharma oral solution may be swallowed directly from the syringe.

You should take Rivastigmine 1 A Pharma twice a day with food (in the morning and evening).

Your doctor will tell you what dosage of Rivastigmine 1 A Pharma 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 mg twice a day. If you have not taken Rivastigmine 1 A Pharma 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 1 A Pharma.

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 1 A Pharma than you should

Tell your doctor if you find you have accidentally taken more Rivastigmine 1 A Pharma than you are told to. You may require medical attention. Some people who have accidentally taken too much Rivastigmine 1 A Pharma have experienced nausea, vomiting, diarrhoea, high blood pressure and hallucinations. Slow heart beat and fainting may also occur.

If you forget to take Rivastigmine 1 A Pharma

If you find you have forgotten to take your dose of Rivastigmine 1 A Pharma, 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 1 A Pharma can cause side effects, although not everybody gets them.

You may tend to get side effects most 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.
Very common side effects (affects more than 1 patient in 10) are dizziness, nausea (feeling sick), vomiting (being sick), diarrhoea, and loss of appetite.
Common side effects (affects 1 to 10 patients in 100) are: heartburn, stomach pain, headache, agitation, confusion, weakness, fatigue, sweating, a general feeling of being unwell, weight loss and trembling.
Uncommonly (affects 1 to 10 patients in 1,000), patients have complained of depression, difficulty in sleeping, changes in liver function, fainting or accidentally falling.
Rarely (affects 1 to 10 patients in 10,000), patients have experienced chest pain, seizures (fits or convulsions), rash, itching, gastric and intestinal ulcers.
Very rarely (affects less than 1 patient in 10,000), patients have experienced gastrointestinal haemorrhage (blood in stools or when vomiting), urinary tract infection, inflammation of the pancreas (severe upper stomach pain, often with nausea and vomiting), problems with heart rhythm (both fast and slow), high blood pressure, hallucinations, worsening of Parkinson?s disease or development of similar symptoms (muscle stiffness, difficulty in carrying out movements).
Not known (frequency cannot be estimated from the available data): severe vomiting that can lead to a rupture of the oesophagus (the tube that connects the mouth with the stomach).

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).

Additional side effects which have been reported with rivastigmine transdermal patches: severe confusion, anxiety, fever (common).

Should such symptoms occur, contact your doctor as you may need medical assistance.

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.

Keep out of the reach and sight of children.

Do not use Rivastigmine 1 A Pharma after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not store above 30°C. Do not refrigerate or freeze.

Store in an upright position.

Use Rivastigmine 1 A Pharma oral solution within 1 month of opening the bottle.

What Rivastigmine 1 A Pharma contains

• The active substance is rivastigmine hydrogen tartrate. Each ml contains rivastigmine hydrogen tartrate corresponding to rivastigmine base 2.0 mg.
• The other ingredients are sodium benzoate, citric acid, sodium citrate, quinoline yellow WS dye (E104) and purified water.

What Rivastigmine 1 A Pharma looks like and contents of the pack

Rivastigmine 1 A Pharma oral solution is supplied as 50 ml or 120 ml of a clear, yellow solution (2.0 mg/ml base) in an amber glass bottle with a child-resistant cap, foam liner, dip tube and self aligning plug. The oral solution is packaged with an oral dosing syringe in a plastic tube container.

Marketing Authorisation Holder

1 A Pharma GmbH
Keltenring 1 + 3
D-82041 Oberhaching
Germany

Manufacturer

Novartis Pharma S.A.S.
26, rue de la Chapelle
F-68333 Huningue
France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

1 A Pharma GmbH
Keltenring 1 + 3
D-82041 Oberhaching
Tel: +49 89 6138825 - 0
E-mail: medwiss@1apharma.com

This leaflet was last approved in

Instructions for Use: Rivastigmine 1 A Pharma oral solution

1. Remove oral dosing syringe from its protective case. Push down and turn child resistant closure to open bottle.

2. Insert nozzle of syringe into opening of white stopper.

3. Withdraw prescribed amount of Rivastigmine 1 A Pharma oral solution from bottle.

4. Before removing syringe containing prescribed dose from bottle, expel any large bubbles by depressing and withdrawing plunger a few times. The presence of a few tiny bubbles is of no importance and will not affect the dose in any way.

5. Swallow Rivastigmine 1 A Pharma oral solution directly from the syringe or first mix in a small glass with water. Stir and drink the entire mixture.

6. After use, wipe outside of syringe with a clean tissue and replace it in its protective case. Close bottle using child resistant closure.