Exelon (Rivastigmine) 28 Capsules

Keep these instructions for use. You can need to read again.

• If you have other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed for you personally, please do not give it to others.

• When using this medicine, tell your doctor that you are taking this medicine when you go to a doctor or hospital.

• Follow the instructions in this manual. Do not use high or low doses other than the recommended dose for the drug.

In these Instructions for Use:

1. What is EXELON and what is it used for?

2. Things to consider before using

3. EXELONHow to use EXELON?

4. What are the possible side effects?

5. The EXELON Storage

Headers are included.

What is EXELON and what is it used for?

EXELON is a white-light yellow powder with a yellow hull and a yellow hood, in a capsule with a red print on its hull that says "EXELON 1.5 mg". Each capsule contains rivastigmine 1.5 mg rivastigmine in the form of hydrogen tartrate.

EXELON is presented in packages containing 2 strips (= 28 capsules) from blister strips containing 14 capsules.

EXELON is included in the class of substances called cholinesterase inhibitors. It is used to treat memory impairment in patients with Alzheimer's or Parkinson's disease.

How to use EXELON?

Carefully follow all instructions given to you by your doctor, even if they differ from the information in this manual.

Instructions for proper use and dose / frequency of administration

• Your doctor will tell you how much EXELON you will use, starting with a low dose and depending on how you respond to treatment, by gradually increasing the dose.

• The highest dose should be 6 mg twice a day.

• You should use it every day to benefit from your medication.

• Tell your healthcare provider that you are using EXELON. Also, if you have not taken the medication for a few days, please inform the person concerned.

• The prescription of this medicine requires expert advice and periodic evaluation of the benefits of treatment.

• Your doctor will follow your weight while you are taking this medicine.

Method and method of

administration • Swallow the capsules with a drink without opening or crushing.

• You should take EXELON twice a day with your breakfast and once with dinner once a day.

Different age groups

Use in children Use in the

elderly Use in the

elderly Use in

elderly

Special use cases

There is no special dosage recommendation in patients with renal or hepatic impairment. Unless your doctor recommends otherwise follow these instructions. Do not forget to take your medication in time.

Your doctor will tell you how long your treatment will take with EXELON. Do not cut the treatment early because you cannot get the desired result.

If you have an impression that EXELON's effect is too strong or too weak, talk to your doctor or pharmacist.

If you use more EXELON than you should use EXELON,

talk to a doctor or pharmacist if you have used more than you should use.

Tell your doctor if you find that you received more than one EXELON in the accident. You may need medical attention. Some people who took too much EXELON by accident experienced nausea, vomiting, diarrhea, high blood pressure, and hallucinations. The heartbeat may decelerate and faint.

forgot to use

If youEXELON If you have not received EXELON for several days, do not take the next dose until you talk to your doctor.

If you find that you forgot to take a dose of EXELON, wait and take the next dose at the usual time. Do not take double doses to compensate for the forgotten dose.

Do not take double doses to compensate for forgotten doses.

When treatment with EXELON is terminated,

do not discontinue treatment with EXELON. Your doctor will tell you how long to use EXELON.

Things to consider before using

EXELON DO NOT use EXELON

if:You

•are hypersensitive (allergic) to the excipients of Rivastigmine or,if you

EXELON•have an allergic reaction to the same type of medicines as EXELON • your

problems with your liver There

is,tell your doctor before using Exelon in this case.

USE EXELON CAUTION

:

• If you have an irregular heartbeat or if you have experienced this type of condition in the past,

• If you have active gastric ulcers or have experienced such a situation in the past,

• If you have difficulties in urination or in the past a situation lived If y'all

• If seizures (seizures or convulsions) spends If you or past ye have experienced such a situation,

• If you have asthma or severe respiratory disease or in the past in such a situation lived If y'all

• digestion if you like nausea or to vomit If ye live system related reactions,

chills • If you have a complaint

If you have any of these applications, your doctor when you are using this medicine may need to follow you more closely.

If you have not used EXELON for a few days, do not take a new dose without consulting your doctor.

Please consult your doctor if these warnings are valid for you, even at any time in the past.

Using EXELON with food and drink You can get

EXELON twice a day, once with your breakfast and once with dinner. Remove capsules with or without a drink.

Pregnancy

Consult your doctor or pharmacist before using the medicine.

pregnancy

was pregnant during yourtreatmentGDIIf you notice your  from your doctor or pharmacistevilyourthen.

Breastfeeding

Consult your doctor or pharmacist before using the medicine. Do not suckle your baby during treatment with EXELON.

Usingmachine and machine

yourYour doctor will tell you if your disease allows you to use vehicles and machines safely. EXELON may cause dizziness and drowsiness at the beginning of the treatment or when the dose is increased. Therefore, you should expect to find out what effects the drug may cause before you engage with such activities.

Important information about some excipients contained in

EXELON If you do not have an extreme sensitivity to the excipients contained within EXELON, no adverse effects due to these substances are to be expected.

Use with other drugs

If you take one of the following medications, you may need to change the dose and / or take other measures:

• Other drugs (cholinomimetic agents) or anticholinergic drugs with similar effects by EXELON.

• If you have to undergo EXELON surgery, you should inform your doctor before any anesthesia is given because EXELON may increase the effects of some muscle relaxants during anesthesia.

What are the possible side effects?

As with all medicines, there may be side effects in people who are sensitive to the substances contained in the content of EXELON.

The drug may cause you to see more side effects at the beginning of the treatment or when the dose is increased. Side effects are likely to disappear gradually as your body gets used to the drug.

Side effects are as follows:

Nausea, vomiting, diarrhea, dizziness and loss of appetite-related effects such as anorexia are very common side effects (more than 1 patient in 10 patients). Other common side effects (less than 1 patient in 10 patients less than 1 patient): Restlessness (agitation), confusion, headache, drowsiness, tremor, stomach aches, discomfort in the stomach after eating, sweating, fatigue , weakness, general feeling of not being well and weight loss.

If you have any of the following, stop using EXELON and IMMEDIATELY tell your doctor or contact the emergency department of the nearest hospital:

Uncommon (less than 1 patient in 100 patients but more than 1 patient in 1000 patients):

• Depression

• Fainting

Sparse (1 in 1000 patients) less than 1 patient in 10,000 patients:

• Seizures (crises or convulsions)

• Chest pain

• Heart attack (crushing chest pain)

• Stomach and duodenal ulcers Very rare (less than 1 patient in 10,000 patients):

• Delusions,

• Heart rhythm problems (slow and fast),

• Digestive system bleeding (blood in feces or vomiting)

• Pancreas inflammation (severe upper stomach pain, often with nausea and vomiting)

• Severe vomiting that can cause damage to the esophagus These are all very serious side effects.

If you have one of these, you may need emergency medical care or hospitalization.

Tell your doctor if you notice any of the following:

Uncommon (less than 1 patient in 100 patients but more than 1 patient in 1000 patients):

• Difficulty in sleep

• Changes in liver function tests

• Accidents with accidents

Sparse (less than 1 patient in 1000 patients but in 10,000 patients 1 more than the patient):

• Redness

• Itching.

Very rare (less than 1 patient in 10,000 patients):

• High blood pressure

• Urinary tract infection

•Parkinson's disease symptoms or the development of similar findings (such as muscle stiffness, difficulty in completing movements)

Worsening ofThese are usually mild to moderate side effects of EXELON. Most of these effects are temporary and usually decrease over time.

4.6. Pregnancy and lactation

General advice

Pregnancy category: B.

Women with childbearing potential / contraception (contraception)

HealthHealth professionals who prescribe EXELON should describe the potential risks of these agents to women who have the potential to have children.

Pregnancy period In

animal studies, rivastigmine has no teratogenic effect. However, the safety of EXELON has not been confirmed in human pregnancy and EXELON should only be used to pregnant women if the benefit to be obtained from treatment is greater than the potential risk to the fetus.

Lactation

Women, who do not know whether or not Rivastigmine has passed into human milk, should not use rivastigmine.

Reproductive ability / Fertility

4.7. Effects ondrive and use machines

ability toAlzheimer's disease may cause a gradual deterioration in vehicle driving performance and impair the ability to operate the machine. Rivastigmine can induce dizziness and drowsiness at baseline and initiation of tre