PATIENT PACKAGE INSERT

PATIENT INFORMATION

NAMENDA XR [Nuh-MEN-dah Eks-Are]

(memantine hydrochloride) Extended Release Capsules

What is NAMENDA XR and what is it used for?

NAMENDA XR belongs to a class of substances called NMDA antagonists. It is used for the treatment of patients with Alzheimer's disease.

Do not take NAMENDA XR in the following cases:

If you know that you are allergic (hyper-sensitive) to memantine (the active substance in NAMENDA XR) or to any of the other ingredients of NAMENDA XR [see Description (11)].

Take special care with NAMENDA XR if:

You have, or ever had seizures.
You have, or ever had difficulty passing urine.
If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.

NAMENDA XR with food and drink:

NAMENDA XR may be taken with or without food. NAMENDA XR capsules may be opened and sprinkled on applesauce before swallowing, but the contents of the entire capsule should be taken and the dose should not be divided. Except when opened and sprinkled on applesauce, NAMENDA XR capsules must be swallowed whole and never crushed, divided or chewed [see Dosage and Administration (2)].

NAMENDA XR and older people:

NAMENDA XR can be used by patients over the age of 65, as well as by patients with Alzheimer's Disease who are aged 65 years or younger.

NAMENDA XR and children:

The use of NAMENDA XR in children is not recommended.

Pregnant women:

Tell your doctor if you are pregnant or planning to become pregnant. In the event of pregnancy, the benefits of NAMENDA XR must be assessed against the possible effects on your unborn child. Ask your doctor or pharmacist for advice before taking any medicine during pregnancy.

Breast-feeding mothers:

You should not breast-feed during treatment with NAMENDA XR. Ask your doctor or pharmacist for advice before taking any medicine while you are breast-feeding.

Taking other medicines:

Tell your doctor or pharmacist about any other medicines you are taking or have recently taken, including any you have taken without a prescription.

How to use NAMENDA XR:

Follow all instructions given to you by your doctor carefully, even if they differ from the ones given in this leaflet.

How to start treatment:

Treatment begins at a low dose (7 mg, once a day) and is gradually increased until the target dose (28 mg, once a day) is reached. To be effective, NAMENDA XR must be taken correctly, according to the following schedule:

Week 1: Start on Day 1

Take one 7 mg capsule each day.

Week 2: Start on Day 8

Take one 14 mg capsule each day.

Week 3: Start on Day 15

Take one 21 mg capsule each day.

Week 4: Start on Day 22

Take one 28 mg capsule each day.

Once the target dose (28 mg, once a day) has been reached, you can continue with that daily schedule unless told otherwise by your healthcare professional. (For patients with severe renal impairment, 14 mg once a day is the recommended dose.)

During the course of treatment, your healthcare professional may change the dose to suit your individual needs.

If you are currently taking another formulation of memantine, talk to your healthcare professional about how to switch to NAMENDA XR.

What to do if you take more NAMENDA XR capsules than you should:

If you accidentally take more NAMENDA XR capsules than you should, inform your healthcare professional that you have accide