GALANTAMINE RATIO 16 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Galantamine RATIO 16 mg prolonged-release hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

1. What is Galantamine RATIO 16 mg and what is it used for
2. What you need to know before you take Galantamine RATIO 16 mg
3. How to take Galantamine RATIO 16 mg prolonged-release hard capsules
4. Possible side effects
5. Storage of Galantamine RATIO 16 mg
6. Contents of the pack and other information

1. What is Galantamine RATIO 16 mg and what is it used for

Galantamine RATIO is an anti-dementia medicine used to treat the symptoms of mild to moderate dementia of the Alzheimer type, a disease in which the brain function is impaired.

The symptoms of Alzheimer's disease include memory loss, increased confusion, and changes in behavior. As a result, it becomes more and more difficult to perform daily routine activities.

It is thought that these symptoms are due to a lack of acetylcholine, a substance responsible for transmitting messages between brain cells. Galantamine RATIO increases the amount of acetylcholine in the brain, which may improve the symptoms of the disease.

The capsules are in the form of "prolonged release". This means that they release the medicine gradually.

2. What you need to know before you take Galantamine RATIO 16 mg

Do not take Galantamine RATIO

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

Warnings and precautions

Galantamine RATIO should be used in Alzheimer's disease and not in other forms of memory loss or confusion.

Medicines are not always suitable for everyone. Before starting treatment with Galantamine RATIO, your doctor should know if you suffer or have suffered from any of the following disorders:

• liver or kidney problems
• a heart disorder (e.g. angina, heart attack, heart failure, slow or irregular pulse, prolonged QTc interval)
• electrolyte imbalance (e.g. high or low potassium levels in the blood)
• peptic ulcer (stomach)
• acute abdominal pain
• a nervous system disorder (such as epilepsy or Parkinson's disease) a respiratory disease that interferes with breathing (such as asthma, chronic obstructive pulmonary disease, or pneumonia)
• if you have had recent surgery on the intestine or bladder
• if you have difficulty urinating.

If you are going to have an operation with general anesthesia, inform your doctor that you are taking Galantamine RATIO.

Galantamine RATIO.

Your doctor will decide if treatment with Galantamine RATIO is suitable for you and if the dose needs to be changed.

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Galantamine RATIO should not be taken with medicines that work in the same way, these include:

• donepezil or rivastigmine (for Alzheimer's disease)
• ambenonium, neostigmine, or pyridostigmine (for severe muscle weakness)
• pilocarpine (for dry eyes or mouth) if taken orally

Some medicines may alter the effects of Galantamine RATIO, or Galantamine RATIO may reduce the effectiveness of other medicines when taken together. These include:

• paroxetine or fluoxetine (antidepressants)
• quinidine (for heart rhythm disorders)
• ketoconazole (antifungal)
• erythromycin (antibiotic)
• ritonavir (antiviral - HIV protease inhibitor).

Your doctor may prescribe a lower dose of Galantamine RATIO if you are also taking any of the above-mentioned medicines.

Some medicines may increase the number of side effects caused by Galantamine RATIO, these include:

• non-steroidal anti-inflammatory painkillers (e.g. ibuprofen) that may increase the risk of ulcers
• medicines for certain heart problems or high blood pressure (e.g. digoxin, amiodarone, atropine, beta-blockers, or calcium channel blockers). If you are taking medicines for an irregular heartbeat, your doctor may consider it necessary to perform an electrocardiogram (ECG)
• medicines that affect the QTc interval.

If you are going to have an operation with general anesthesia, inform your doctor that you are taking Galantamine RATIO.

Consult your doctor or pharmacist if you have any doubts.

Use of Galantamine RATIO with food and drink

It is recommended to take Galantamine RATIO with food.

While taking Galantamine RATIO, you should drink enough liquids to stay hydrated. See section 3 of this leaflet for more information on how to take this medicine.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Before taking Galantamine RATIO, consult your doctor to advise you in case you are pregnant, may be pregnant, or are planning to become pregnant.

You should not breastfeed while taking Galantamine RATIO.

Driving and using machines

Your illness may affect your ability to drive or use machines, and you should not perform these activities unless your doctor tells you it is safe to do so. Galantamine may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose. If you experience these effects, do not drive or use machines.

3. How to take Galantamine RATIO 16 mg

Follow the instructions for administration of Galantamine RATIO indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

If you are taking Galantamine tablets or oral solution and your doctor has told you that you will be switched to Galantamine prolonged-release capsules, read the instructions carefully at the end of this section.

How to take Galantamine RATIO capsules

Galantamine RATIO capsules should be swallowed whole, DO NOT chew or crush. Galantamine RATIO should be taken in the morning, with water or other liquids, and preferably with food.

Galantamine RATIO prolonged-release capsules are available in three strengths: 8 mg, 16 mg, and 24 mg. Treatment with Galantamine RATIO starts with a low dose. Your doctor may gradually increase the dose (concentration) of Galantamine RATIO you are taking, until the most suitable dose for you is found.

1. Treatment starts with the 8 mg capsule once a day. After 4 weeks of treatment, the dose is increased.
2. You will then take the 16 mg capsule once a day. After another 4 weeks of treatment, at the earliest, your doctor may decide to increase the dose again.
3. You will then take the 24 mg capsule once a day.

Your doctor will explain which dose you should start with and when and how you should increase it.

If you think the action of Galantamine RATIO is too strong or too weak, tell your doctor or pharmacist.

Your doctor needs to see you regularly to check that this medicine is working for you and to discuss with you how you feel. The doctor will also monitor your weight regularly during treatment with Galantamine RATIO.

Liver or kidney disease

• If you have mild liver or kidney disease, treatment starts with the 8 mg capsule once a day in the morning.
• If you have moderate liver or kidney disease, treatment starts with the 8 mg capsule every other day in the morning. After one week, you start taking the 8 mg capsule once a day in the morning. Do not take more than 16 mg per day
• If you have severe liver or kidney disease, do not take Galantamine RATIO.

If you take more Galantamine RATIO than you should

If you take too much Galantamine RATIO, consult your doctor or go to the hospital. Bring the package with the remaining capsules. The signs and symptoms of an overdose may include: severe nausea, vomiting, muscle weakness, slow heart rate, seizures, and loss of consciousness.

If you forget to take Galantamine RATIO

If you forget to take a dose, skip that dose and continue treatment as usual with the next scheduled dose.

Do not take a double dose to make up for forgotten doses

If you forget to take more than one dose, you should consult your doctor.

If you stop taking Galantamine RATIO

Consult your doctor before stopping treatment with Galantamine RATIO. It is important to continue taking this medicine to treat your illness.

How can I switch from Galantamine tablets or oral solution to Galantamine prolonged-release capsules?

If you are currently taking Galantamine tablets or oral solution, your doctor may decide to switch you to Galantamine prolonged-release capsules.

• Take the last dose of Galantamine tablets or oral solution at night
• The next morning, take the first dose of Galantamine prolonged-release capsules.

DO NOT take more than one capsule per day. While taking Galantamine capsules once a day, DO NOT take Galantamine tablets or oral solution.

Use in children

Galantamine RATIO is not recommended for use in children.

4. Possible side effects

Like all medicines, Galantamine RATIO can cause side effects, although not everybody gets them. Some of these side effects may be due to the disease itself.

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Stop taking your medicine and consult your doctor immediatelyif you:

• have heart problems including changes in heart rate (slow or irregular)
• have palpitations (pounding heartbeat)
• have other disorders such as fainting
• have an allergic reaction. The signs can include rash, swallowing or breathing problems, or swelling of the lips, face, throat, or tongue.

Side effects include:

Very common: affects more than 1 in 10 people

• Feeling sick with nausea and/or vomiting. If these undesirable effects occur, they are mainly experienced at the beginning of treatment or when the dose is increased. They usually disappear gradually as the body adapts to treatment and generally pass within a few days. If you experience these effects, your doctor may recommend drinking more liquids and if necessary, may prescribe a medicine to prevent you from feeling sick.

Common: affects between 1 and 10 in 100 people

• Weight loss
• Lack of appetite
• Decreased appetite
• Slow heart rate
• Feeling weak
• Dizziness
• Tremors
• Headache
• Somnolence
• Abnormal fatigue
• Abdominal pain or discomfort
• Diarrhea
• Indigestion (with a feeling of acidity)
• Increased sweating
• Muscle contractions
• Falls
• Increased blood pressure
• Feeling weak
• General feeling of discomfort
• Seeing, feeling, or hearing things that are not real (hallucinations)
• Feeling sad (depression)

Uncommon: affects between 1 and 10 in 1000 people

• Increased liver enzymes in the blood (the laboratory test result shows if your liver is working properly)
• Possible heart rate anomaly
• Disorder of the conduction mechanism of impulses in the heart
• Feeling of abnormal heartbeats (palpitations)
• Numbness, tingling, or prickling sensation of the skin
• Change in sense of taste
• Excessive sleepiness
• Blurred vision
• Ringing or buzzing in the ears (tinnitus)
• Feeling of needing to vomit
• Muscle weakness
• Excessive loss of water in the body
• Decreased blood pressure
• Redness of the face
• Allergic reaction

Rare side effects: affects between 1 and 10 in 10,000 people

• Liver inflammation (hepatitis)

Consult your doctor or pharmacist if you are concerned or think that Galantamine RATIO is causing you a problem. If you experience any side effects not described in this leaflet, please consult your doctor.

5. Storage of Galantamine RATIO 16 mg

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use Galantamine RATIO after the expiry date which is stated on the package after "EXP". The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return the packages and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of packages and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Galantamine RATIO

• The active substance is galantamine. Each capsule contains 16 mg of galantamine (equivalent to 20.504 mg of galantamine hydrobromide)
• The other ingredients are microcrystalline cellulose, hypromellose, ethylcellulose, and magnesium stearate. The capsule ingredients are gelatin, titanium dioxide (E-171), and red iron oxide (E172).

Appearance of the product and pack contents

Galantamine RATIO 16 mg prolonged-release hard capsules are flesh-colored.

The 16 mg capsules come in packs of 28 capsules.

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B 1ª Planta, Alcobendas

28108- Madrid. Spain

Manufacturer

Pharmathen International S.A

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

Rodopi 69300 (Greece)

Date of last revision of this leaflet: March 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/