Prospect: information for the user

Galantamine RATIO 16 mg prolonged-release hard capsules EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, including those not listed in this prospect.

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

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

3. How to take Galantamine Ratio 16 mg prolonged-release hard capsules

4. Possible adverse effects

5. Storage of Galantamine Ratio 16 mg

6. Contents of the pack and additional information

Galantamina Ratio is an antidementia medication used to treat the symptoms of mild to moderateAlzheimer's disease, a condition in which brain function is altered.

The symptoms of Alzheimer's disease include memory loss, increased confusion, and changes inbehavior. As a result, it becomes increasingly difficult to perform everyday routine activities.

It is believed that these symptoms are due to a lack of acetylcholine, a substance responsible fortransmitting messages between brain cells. Galantamina Ratio increases the amount of acetylcholinein 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 medicationgradually.

Do not take Galantamine Ratio

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

Warnings and precautions

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

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

• liver or kidney problems
• a heart condition (for example, angina, heart attack, heart failure, slow or irregular heartbeat, prolonged QTc interval)
• electrolyte imbalance (for example, 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 or infection that interferes with breathing (such as asthma, chronic obstructive pulmonary disease, or pneumonia)
• if you have recently had surgery in the intestine or bladder
• if you have difficulty urinating.

If you are to undergo a general anaesthetic operation, inform your doctor that you are taking Galantamine Ratio.

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

Use of other medicines

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

Galantamine Ratio should not be taken with medicines that act in the same way, including:

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

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, including:

• non-steroidal anti-inflammatory analgesics (for example, ibuprofen) which may increase the risk of ulcers
• medicines for certain heart problems or high blood pressure (for example, digoxin, amiodarone, atropine, beta-blockers, or calcium channel blockers). If you take medicines due to an irregular heartbeat, your doctor may consider performing an electrocardiogram (ECG)
• medicines that affect the QTc interval.

If you are to undergo a general anaesthetic operation, 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.

During treatment with Galantamine Ratio, you should take a sufficient amount of 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 if you are pregnant, may be pregnant, or are planning to become pregnant.

You should not breastfeed while taking Galantamine Ratio.

Driving and operating machinery

Your condition may affect your ability to drive or operate machinery and you should not do so unless your doctor tells you it is safe to do so. Galantamine may cause dizziness and drowsiness, mainly at the start of treatment or when increasing the dose. If you experience these effects, you should not drive or operate machinery.

Follow exactly the administration instructions for Galantamina Ratio indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

How to take Galantamina Ratio capsules

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

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

1. Treatment begins 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, your doctor may decide to increase the dose again as soon as possible.
3. You will then take the 24 mg capsule once a day.

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

If you estimate that the action of Galantamina Ratio is too strong or too weak, inform your doctor or pharmacist.

Your doctor needs to see you regularly to check that this medication is suitable for you and comment on how you feel. The doctor will also regularly monitor your weight during treatment with Galantamina Ratio.

Liver or kidney disease

• If you have mild liver or kidney disease, treatment begins with the 8 mg capsule once a day in the morning.
• If you have moderate liver or kidney disease, treatment begins with the 8 mg capsule every other day in the morning. After a week, 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 Galantamina Ratio.

If you take more Galantamina Ratio than you should

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

If you forget to take Galantamina Ratio

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

Do not take a double dose to compensate for missed doses

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

If you interrupt treatment with Galantamina Ratio

Consult your doctor before interrupting treatment with Galantamina Ratio. It is essential to continue taking this medication to treat your disease.

How can I change from Galantamina tablets or oral solution to Galantamina prolonged-release capsules?

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

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

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

Use in children

Galantamina Ratio is not recommended for children.

Like all medications, Galantamina Ratio may cause side effects,although not everyone will experience them. Some of these side effects may be due to theunderlying disease.

If you consider any of the side effects you are experiencing to be severe or if you notice anyside effect not mentioned in this leaflet, inform your doctor or pharmacist.

Stop taking your medication and consult your doctor immediatelyif you experience:

• Heart problems including changes in heart rhythm (slow or irregular)
• Palpitations (heart beating irregularly)
• Other alterations such as fainting
• An allergic reaction. Symptoms may include rash, difficulty swallowing or breathing, or swelling of the lips, face, throat, or tongue.

The side effects include:

Very common: affects more than 1 in 10 patients

• Unpleasant feeling with nausea and/or vomiting. If these unwanted 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 the treatment and usually pass within a few days. If you experience these effects, your doctor may recommend that you drink more liquids and, if necessary, may prescribe a medication to help you feel better.

Common: affects between 1 and 10 in 100 patients

• Weight loss
• Loss of appetite
• Decreased appetite
• Slow heart rate
• Feeling weak
• Dizziness
• Trembling
• Headache
• Drowsiness
• Abnormal fatigue
• Abdominal pain or discomfort
• Diarrhea
• Constipation (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)
• Sensation of sadness (depression)

Rare: affects between 1 and 10 in 1000 patients

• Increased liver enzymes in the blood (the laboratory test result shows if your liver is working correctly)
• Possible abnormal heart rhythm
• Alteration of the mechanism of conduction of impulses in the heart
• Sensation of abnormal heartbeats (palpitations)
• Prickling, pinching, or numbness of the skin
• Change in sense of taste
• Excessive sleep
• Blurred vision
• Ringing or buzzing in the ears (tinnitus)
• Sensation of need 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 patients

• Liver inflammation (hepatitis)

Consult your doctor or pharmacist if you are concerned or believe that Galantamina Ratio iscausing you a problem. If you experience any side effect not described in this leaflet, pleaseconsult your doctor.

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

No special storage conditions are required.

Do not use Galantamina Ratio after the expiration date that appears on the packagingafter “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging andany unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing soyou will help protect the environment.

Composition of Galantamina Ratio

• The active principle is galantamine. Each capsule contains 16 mg of galantamine (equivalent to 20,504 mg of galantamine hydrobromide)
• The other components are microcrystalline cellulose, hypromellose, ethylcellulose, and magnesium stearate. The capsule components are gelatin, titanium dioxide (E-171), and iron oxide red (E172).

Appearance of the product and content of the packaging

Galantamina Ratio 16 mg prolonged-release hard capsules are of a meat color.

16 mg capsules come in packs of 28 capsules.

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B 1st Floor, Alcobendas

28108 Madrid. Spain

Responsible for manufacturing

Pharmathen International S.A

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

Rodopi 69300 (Greece)

Last review date of this leaflet: March 2021

Detailed and updated information on this medication is available on the website of the

Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/