Rasagiline Sandoz® Tablets

Rasagiline Sandoz® Tablets

Active ingredient: rasagiline (as mesilate)

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Consumer Medicine Information (CMI)

This leaflet provides important information about using Rasagiline Sandoz. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Rasagiline Sandoz.

Where to find information in this leaflet:

1. Why am I using Rasagiline Sandoz?
2. What should I know before I use Rasagiline Sandoz?
3. What if I am taking other medicines?
4. How do I use Rasagiline Sandoz?
5. What should I know while using Rasagiline Sandoz?
6. Are there any side effects?
7. Product details

1. Why am I using Rasagiline Sandoz?

Rasagiline Sandoz contains the active ingredient rasagiline (as mesilate). Rasagiline Sandoz works by increasing and maintaining the level of dopamine in your brain which will decrease symptoms of Parkinson’s disease.

Rasagiline Sandoz is used to treat the symptoms of Parkinson’s disease. It can be taken with or without dopamine agonist or levodopa therapy.

Parkinson’s disease is a condition of the brain that mainly affects body movement. The three main symptoms of Parkinson’s disease are:

• Shaking (tremor)
• Muscle stiffness
• Slow and unsteady movement.

In Parkinson’s disease, there is a loss of cells producing dopamine in certain areas in the brain.

2. What should I know before I use Rasagiline Sandoz?

Warnings

Do not use Rasagiline Sandoz if:

• You are allergic to rasagiline, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
• You are taking monoamine oxidase inhibitors (MAOI), whether used to treat depression, Parkinson’s disease or any other condition.
• You are taking other medicinal and natural product without prescription which have MAOI activity (e.g. St. John’s Wort).
• You are taking pethidine, a strong pain killer.
• You are taking ciprofloxacin, an antibiotic used to treat infection.

Check with your doctor if you:

• Have a problem with your liver.
• Smoke. Nicotine can affect the amount of rasagiline that is in your body.
• Are pregnant or intend to become pregnant.
• Are breastfeeding or plan to breastfeed.
• Notice any unusual skin lumps or moles which are or have changed.
• Take any medicines for any other condition.
• Have allergies to any substances, such as foods, preservatives, or dyes.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant. Your doctor can discuss with you the risks and benefits involved.

Talk to your doctor if you are breastfeeding or intend to breastfeed. Your doctor can discuss with you the risks and benefits involved.

Use in children

• Rasagiline Sandoz should not be given to children under 18 years of age as there is not specific information about such use.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

The following medicines require specific medical advice before being taken together with Rasagiline Sandoz:

• Medicines used to treat depression, anxiety, panic disorder, obsessive compulsive disorder or pre-menstrual dysphoric disorders. Examples of such medicines include selective serotonin reuptake inhibitors (SSRIs), tricyclic and tetracyclic antidepressants.
• Other medicines used to treat depression called fluoxetine and fluvoxamine. Wait at least 5 weeks between stopping fluoxetine treatment and starting treatment with Rasagiline Sandoz, and 14 days between stopping Rasagiline Sandoz treatment and starting treatment with fluoxetine or fluvoxamine.
• Dextromethorphan, a medicine for cough.
• Substances with sympathomimetic activity such as those present in ‘cold and flu’ oral tablets and nasal drops containing ephedrine or pseudoephedrine.
• Clozapine, a medicine used to treat schizophrenia.
• Other medicines used to treat symptoms of Parkinson’s disease.

Your doctor or pharmacist can tell you what to do if you are taking this or any other medicines.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Rasagiline Sandoz.

4. How do I use Rasagiline Sandoz?

How much to take

• Your doctor will tell you how much Rasagiline Sandoz to take each day. Take the amount your doctor tells you to.
• The usual dose of Rasagiline Sandoz is one tablet of 1 mg taken orally once a day.
• Follow the instructions provided and use Rasagiline Sandoz until your doctor tells you to stop.
• If you do not understand the instructions on the box, ask your doctor or pharmacist for help

When to take Rasagiline Sandoz

• Take your medicine at about the same time each day.
  Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

How to take Rasagiline Sandoz

• Swallow the tablet whole with a full glass of water.
• Rasagiline Sandoz can be taken with or without food.

If you forget to use Rasagiline Sandoz

Rasagiline Sandoz should be used regularly at the same time each day. If you miss your dose at the usual time, take it as soon as you remember, and then go back to taking your medicine as you would normally. If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you use too much Rasagiline Sandoz

If you think that you have used too much Rasagiline Sandoz, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Rasagiline Sandoz?

Things you should do

• Remind any doctor, dentist or pharmacist you visit that you are using Rasagiline Sandoz.
• If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking Rasagiline Sandoz.

Call your doctor straight away if you:

• Become pregnant while taking Rasagiline Sandoz.

Things you should not do

• Do not give Rasagiline Sandoz to anyone else, even if their symptoms seem similar to yours.
• Do not take Rasagiline Sandoz to treat any other complaints unless your doctor tells you to.
• Do not stop using this medicine without first checking with your doctor.

Melanoma

• Scientific evidence suggests that Parkinson’s disease is associated with a higher risk of skin cancer (including melanoma). During the development (placebo-controlled clinical trials), melanoma was observed in both rasagiline- and placebo-treated patients (around 0.5% vs 0.2% respectively). People with Parkinson’s disease, including those taking Rasagiline Sandoz, should undergo periodic examination of the skin.

Tyramine

• Eating excessive amounts of food rich in tyramine (e.g. aged cheese, red wine) while you are taking Rasagiline Sandoz could very rarely cause an increase in your blood pressure and should be avoided. If you eat these foods while you are taking Rasagiline Sandoz and do not feel well, you should contact your treating doctor. Your treating doctor or pharmacist can advise you on what foods are rich in tyramine and what your risk of having a reaction may be.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Rasagiline Sandoz affects you.

Rasagiline Sandoz may cause you to feel sleepy in the daytime during daily activities.

Do not drive, operate machinery or work at heights during treatment if you have fallen asleep without warning, prior to the use of Rasagiline Sandoz.

Drinking alcohol

Be careful when drinking alcohol while you are taking Rasagiline Sandoz.

Looking after your medicine

• Keep Rasagiline Sandoz tablets in a cool dry place where the temperature stays below 25°C.
• Keep your tablets in the original packaging until it is time to take them.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink or stove
• in the car or on a window sill.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects	What to do
Headache Flu syndrome Malaise Neck pain Indigestion Joint pain Depression Eye inflammation Abdominal pain Accidental injury (primarily falls) Dizziness when you stand up due to low blood pressure Constipation Vomiting Weight loss Difficulty in moving normally Obsessive thoughts or impulsive behaviour	Speak to your doctor if you have any of these less serious side effects and they worry you. They are generally mild and do not cause patients to stop taking Rasagiline Sandoz.

Serious side effects

Serious side effects	What to do
Allergic reactions which may be serious including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. If you have an allergic reaction, stop taking Rasagiline Sandoz and call your doctor right away.	Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What Rasagiline Sandoz contains

Active ingredient (main ingredient)	Each Rasagiline Sandoz tablet contains 1 mg rasagiline (as mesilate)
Other ingredients (inactive ingredients)	microcrystalline cellulose maize starch colloidal silicon dioxide anhydrous citric acid pregelatinised starch talc stearic acid purified water
Potential allergens	N/A

Do not take this medicine if you are allergic to any of these ingredients.

What Rasagiline Sandoz looks like

Rasagiline Sandoz tablet 1 mg – White to off-white, round, flat, bevelled tablets, debossed with “C13” on one side and plain on the other side. Pack size of 30 tablets
(AUST R 356090).

Who distributes Rasagiline Sandoz

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park, NSW 2113
Tel: 1800 726 369

This leaflet was prepared in December 2021.