GALNORA 8 mg Extended-Release Hard Capsule

Зміст інструкції

1. GALNORA 8 mg prolonged-release hard capsules, 16 mg prolonged-release hard capsules, 24 mg prolonged-release hard capsules
   1. What is GALNORA and what is it used for
   2. What you need to know before taking GALNORA
   3. How to take GALNORA
   4. Possible side effects
   5. How to store GALNORA
   6. Package contents and other information

GALNORA 8 mg prolonged-release hard capsules, 16 mg prolonged-release hard capsules, 24 mg prolonged-release hard capsules

Galantamine
Generic medicine

Read this leaflet carefully before you start taking this medicine, as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is GALNORA and what is it used for

GALNORA contains the active substance “galantamine” which is an antidementia drug. It is used in adults for the
symptomatic treatment of mild to moderately severe Alzheimer's dementia, a type of dementia that alters
brain functions.
Alzheimer's disease causes increased memory loss, confusion and behavioral changes, which
make it increasingly difficult to perform normal daily activities.
These effects are believed to be caused by a lack of “acetylcholine”, a substance responsible for sending
signals between neurons. GALNORA increases the amount of acetylcholine in the brain and improves the symptoms of the disease.
The capsules are in the form of prolonged-release capsules. This means that they release the drug slowly.

2. What you need to know before taking GALNORA

Do not take GALNORA

• if you are allergic to galantamine or any of the other ingredients of this medicine (listed in section 6).
• if you have a severe liver or kidney disease.

Warnings and precautions
Talk to your doctor or pharmacist before taking GALNORA
This medicine is used only for Alzheimer's disease and is not recommended for other types of memory loss or
confusion.

Serious adverse effects
Galnora can cause serious skin reactions, heart problems, seizures (convulsions). You should be
aware of these adverse effects while taking Galnora. See section 4 “Be aware of
serious adverse effects”.
Before taking Galnora, tell your doctor if you have or have had the following:

• liver or kidney problems;
• heart condition (such as chest pain often caused by physical activity, heart attack, heart failure, slow or irregular heartbeat);
• changes in the levels of "electrolytes" (natural chemicals present in the blood, such as potassium);
• Peptic ulcer (stomach);
• blockage of the stomach or intestines;
• nervous system diseases (such as epilepsy or Parkinson's disease);
• respiratory diseases or infections affecting breathing (such as asthma, chronic obstructive pulmonary disease, pneumonia);
• Problems with urination.

The doctor will decide if Galnora is suitable for you, or if the dose needs to be changed.

Also tell your doctor if you have recently had surgeryto the stomach, intestine or
bladder. The doctor may decide if Galnora is suitable for you.
Galnora can cause weight loss. The doctor will check your weight regularly while you are taking Galnora.

Children and adolescents
Galnora is not recommended in children and adolescents

Other medicines and GALNORA
Tell your doctor or pharmacist if you are taking, have recently taken or might take other medicines.
GALNORA must not be taken with medicines that work in a similar way, such as:

• donepezil or rivastigmine (for Alzheimer's disease);
• ambenonium, neostigmine or pyridostigmine (for severe muscle weakness);
• pilocarpine (when taken orally for dry mouth or dry eyes). Some medicines can cause adverse effects more frequently in people taking Galnora. These include:
• paroxetine or fluoxetine (antidepressants),
• quinidine (for irregular heartbeat),
• ketoconazole (an antifungal),
• erythromycin (an antibiotic),
• ritonavir (for the human immunodeficiency virus or 'HIV').
• non-steroidal anti-inflammatory drugs (such as ibuprofen) which increase the risk of ulcers;
• medicines taken for heart conditions or high blood pressure (such as digoxin, amiodarone, atropine, beta-blockers, calcium channel blockers). If you are taking medicines for an irregular heartbeat, your doctor may assess your heart condition by performing an electrocardiogram (ECG).

The doctor may give you a lower dose of Galnora if you are also taking one of these medicines.
Galnora can affect some anesthetics. If you are about to have surgery with general anesthesia, tell your doctor that
you are taking Galnora, well in advance.
If you have any doubts, ask your doctor or pharmacist.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
You must not take GALNORA if you are breastfeeding.

Driving and using machines
GALNORA can make you feel dizzy and sleepy, especially in the first few weeks of treatment.
Do not drive or use tools or machines if you experience these symptoms.

3. How to take GALNORA

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or
pharmacist.
If you are currently taking galantamine tablets or oral solution and your doctor has advised you to
switch to galantamine prolonged-release capsules, carefully read the instructions in this paragraph
“Switching from taking galantamine tablets or oral solution to Galnora capsules”.

Amount to take
You will start treatment with Galnora at a low dose. The usual starting dose is 8 mg once a day. Your doctor
may gradually increase the dose, every 4 weeks or more, to reach a dose that is right for you. The maximum
dose is 24 mg once a day.
Your doctor will explain with which dose to start and when the dose should be increased. If you are not sure what to do or
if you feel that the effect of GALNORA is too strong or too weak, tell your doctor or pharmacist.
Your doctor will need to see you regularly to check if the medicine is working and to discuss how you
feel.

If you have liver problems or kidney problems, your doctor may give you a reduced dose of Galnora, or may decide that
this medicine is not suitable for you.

Switching from taking galantamine tablets or oral solution to Galnora capsules
If you are taking galantamine tablets or oral solution, your doctor may decide that you should switch to
Galnora prolonged-release capsules. If this happens:

• take your last dose of galantamine tablets or oral solution in the evening;
• the next morning, take your first dose of Galnora prolonged-release capsule.

Do not take more than one capsule in a day. While you are taking Galnora capsules once a day, do not
take galantamine tablets or oral solution.
How to take GALNORA
GALNORA capsules must be swallowed whole and not chewed or crushed. If you have difficulty swallowing the
capsules, you can empty the capsules and swallow the entire contents. Do not chew or crush the contents.
Take your dose of Galnora once a day in the morning, with water or other liquids. Try to take Galnora with
food. Drink plenty of fluids while taking Galnora, to stay hydrated.

If you take more GALNORA than you should
If you take too much GALNORA, contact your doctor or hospital immediately. Bring the remaining capsules and the container. Signs
of overdose include:

• severe nausea and vomiting,
• muscle weakness, slowed heartbeat, seizures (convulsions) and loss of consciousness.

If you forget to take GALNORA
If you forget to take a dose, do not take the missed dose and take the next one at the scheduled time. Do
not take a double dose to make up for the missed dose.
If you forget to take more than one dose, contact your doctor.

If you stop taking GALNORA
Talk to your doctor before stopping treatment with GALNORA. It is important to continue taking
this medicine to treat your condition.
If you have any further questions on the use of 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.
Pay attention to serious adverse effects
Stop taking the medicine and see a doctor or go immediately to the nearest emergency room if
you experience the following.

Skin reactions, including:

• Severe skin rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).
• red rashes covered with small bumps filled with pus that can spread all over the body, sometimes with fever (acute generalized exanthematous pustulosis).
• Skin rash that may cause blisters, with spots that look like small marks. These skin reactions are rare in people taking galantamine (may affect up to 1 in
• 1,000).

Heart problemsincluding changes in heartbeat (such as a slow heartbeat, an extra beat) or
palpitations (feeling a fast or irregular heartbeat). Heart problems may highlight an abnormality on an
electrocardiogram (ECG) tracing, and may be common in people taking Galnora (may affect up to 1 in 10 people);

Seizures (convulsions). These are uncommon in people taking Galnora (may affect up to 1
person in 100).

You must stop taking Galnora and seek help immediatelyif you notice the onset of any of
the side effects mentioned above.

Other side effects:
Very common side effects (may affect more than 1 in 10 people):
Nausea and vomiting.
These side effects are more likely to occur in the first few weeks of treatment or when the dose is
increased. These tend to disappear gradually as the body gets used to the treatment and generally
do not last more than a few days. If you experience these effects, your doctor may advise you to drink more fluids and may
prescribe a medicine to relieve your discomfort.

Common side effects (may affect up to 1 in 10 people):

• Weight loss, decreased appetite.
• Seeing, hearing or perceiving things that are not real (hallucinations).
• Depression.
• Feeling dizzy or fainting.
• Muscle tremors or spasms.
• Headache.
• Feeling very tired, weak or generally unwell.
• Feeling very sleepy with little energy.
• High blood pressure.
• Stomach pain or discomfort.
• Diarrhea.
• Indigestion.
• Falls.
• Injuries

Uncommon side effects (may affect up to 1 in 100 people):

• Allergic reaction.
• Excessive water loss from the body (dehydration).
• Tingling or numbness of the skin (pins and needles).
• Changes in the sense of taste.
• Daytime sleepiness.
• Blurred vision.
• Sounds or ringing in the ears (tinnitus).
• Low blood pressure.
• Flushing.
• Feeling sick to your stomach (nausea).
• Excessive sweating.
• Muscle weakness.
• Increased liver enzymes in the blood.

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

• Inflammation of the liver (hepatitis).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist. You can also report side effects directly through the national reporting system at
http:// www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting
side effects you can help provide more information on the safety of this medicine.

5. How to store GALNORA

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 blister and the box after EXP. The expiry date refers to the last day of that month.
Do not store at a temperature above 30 °C.
Store in the original package to protect the medicine from moisture.
Do not dispose of any medicine in 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 GALNORA contains

• The active ingredient is galantamine. 8 mg: each prolonged-release hard capsule contains 8 mg of galantamine (as bromhydrate). 16 mg: each prolonged-release hard capsule contains 16 mg of galantamine (as bromhydrate). 24 mg: each prolonged-release hard capsule contains 24 mg of galantamine (as bromhydrate).
• The excipients contained in the core of the prolonged-release capsules are sodium lauryl sulfate, ammonium methacrylate copolymer (type B), hypromellose, carbomers, hydroxypropylcellulose, magnesium stearate and talc.
• The excipients contained in the coating of the 8 mg capsules are gelatin, titanium dioxide (E171) and black ink (shellac, propylene glycol, concentrated ammonia solution, black iron oxide (E172), potassium hydroxide).
• The excipients contained in the coating of the 16 mg and 24 mg capsules are gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172) and black ink (shellac, propylene glycol, concentrated ammonia solution, black iron oxide (E172), potassium hydroxide).

Description of the appearance of GALNORA and package contents

8 mg: White capsules size 2 (capsule length: 17.6 - 18.4 mm) with “G8” imprinted on the head of the
capsule. The capsule content is an oval, white, prolonged-release tablet core.

16 mg: Pink capsules size 1 (capsule length: 19.0 - 19.8 mm) with “G16” imprinted on the head of the
capsule. The capsule content is two oval, white, prolonged-release tablet cores.

24 mg: Pink-orange capsules size 0 (capsule length: 23.8 - 24.6 mm) with “G24” imprinted on the
head of the capsule. The capsule content is three oval, white, prolonged-release tablet cores.
The capsules are available in boxes containing blisters of 10, 14, 28, 30, 56, 60, 84, 90 and 100 prolonged-release hard
capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturers responsible for batch release
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Local Representative for Italy
KRKA Farmaceutici Milano S.r.l., Viale Achille Papa 30, 20149 Milano, Italy

This medicinal product is authorised in the Member States of the European Economic Area with the following
names: