SOLVERA 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Solvera 5 mg Orodispersible Tablets EFG

Donepezil, Hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Solvera and what is it used for
2. What you need to know before taking Solvera
3. How to take Solvera
4. Possible side effects
5. Storage of Solvera
6. Package Contents and Additional Information

1. What is Solvera and what is it used for

Solvera is a specific and reversible inhibitor of acetylcholinesterase, the predominant cholinesterase in the brain.

It is used for the symptomatic treatment of mild to moderately severe Alzheimer's disease.

2. What you need to know before taking Solvera

Do not take Solvera:

• If you are allergic to donepezil or any of the components of Solvera (listed in section 6).
• If you are pregnant or breastfeeding.

Warnings and Precautions

• Consult your doctor, pharmacist, or nurse before starting to take Solvera.
• Before starting treatment with Solvera, you should inform your doctor if you have or have had stomach ulcers, heart conditions (such as irregular or slow heartbeats, heart failure, myocardial infarction), seizures, asthma, chronic obstructive pulmonary disease, or difficulty urinating.
• If you have or have had a heart condition called "prolonged QT interval" or a history of certain abnormal heart rhythms called torsades de pointes, or if a family member has "prolonged QT interval".
• If you have low levels of magnesium or potassium in your blood.
• In the event of surgery with general anesthesia, you should inform your doctor that you are taking Solvera.
• The use of Solvera is not recommended in children.
• You should avoid taking Solvera with other acetylcholinesterase inhibitors and other agonists or antagonists of the cholinergic system.
• If you have vascular dementia (loss of brain function due to a series of small strokes).

Interaction of Solvera with Other Medications

Tell your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medication, especially if you are taking any of the following medications:

• medications for heart rhythm problems, such as amiodarone or sotalol
• medications for depression, such as citalopram, escitalopram, amitriptyline, fluoxetine
• medications for psychosis, such as pimozide, sertindole, or ziprasidone
• medications for bacterial infections, such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungal medications, such as ketoconazole
• other medications for Alzheimer's disease, such as galantamine
• analgesics or arthritis treatment, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or diclofenac sodium
• anticholinergic medications, such as tolterodine
• anticonvulsants, such as phenytoin, carbamazepine
• medications for heart conditions, such as quinidine, beta-blockers (propranolol and atenolol)
• muscle relaxants, such as diazepam, succinylcholine
• general anesthetics
• over-the-counter medications, such as herbal remedies

Taking Solvera with Food and Drinks

Place the tablet on the tongue and let it dissolve. Swallow with or without water.

Taking Solvera with alcohol may reduce the absorption of this medication.

Pregnancy, Breastfeeding, and Fertility

Consult your doctor or pharmacist before using any medication.

Do not take Solvera if you are pregnant.

Do not take Solvera if you are breastfeeding your child.

Driving and Using Machines

Your illness may affect your ability to drive or use machinery, and you should not perform these activities unless your doctor tells you it is safe to do so. Solvera 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 machinery.

Important Information about Some of the Components of Solvera

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

3. How to Take Solvera

Follow your doctor's or pharmacist's instructions for taking Solvera exactly. If you are unsure, consult your doctor or pharmacist again.

Solvera is administered orally. The tablet should be placed on the tongue and allowed to dissolve before swallowing with or without water.

Treatment with Solvera starts with a 5 mg tablet, taken once a day, at night, immediately before bedtime. After a month of treatment, your doctor may recommend increasing the dose to 10 mg, once a day, at night. The maximum recommended dose is 10 mg/day.

If you have abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend taking donepezil in the morning.

If you have mild or moderate liver or kidney impairment, you may follow a similar dosing schedule as indicated above.

If you take more Solvera than you should

If you have taken more Solvera than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Solvera

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

If you stop taking Solvera

If you have any further questions about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medications, Solvera can cause side effects, although not everyone will experience them.

Severe side effects:

Consult your doctor immediately if you experience these severe side effects. You may need urgent medical treatment.

• Weakness, sensitivity, or muscle pain, especially if you feel unwell, have a fever, or your urine is dark in color. This may be due to abnormal muscle destruction, which can be life-threatening and cause kidney problems (a condition called rhabdomyolysis).

Very common (may affect more than 1 in 10 people):

• Diarrhea
• Nausea
• Headache

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

• Cold
• Loss of appetite
• Hallucinations, agitation, aggressive behavior
• Fainting, dizziness, difficulty sleeping
• Vomiting, abdominal discomfort
• Urinary incontinence
• Rash, itching
• Muscle cramps
• Fatigue, pain
• Accidents

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

• Seizures
• Decreased heart rate
• Gastrointestinal bleeding, stomach and duodenal ulcers
• Increased levels of a type of enzyme (creatine kinase) in the blood

Rare (may affect up to 1 in 1000 people):

• Extrapyramidal symptoms (such as tremors or rigidity of the hands or feet)
• Alterations in cardiac conduction
• Liver function disorders, including hepatitis

Frequency not known (cannot be estimated from available data):

• Changes in cardiac activity that can be observed in an electrocardiogram (ECG) called "prolonged QT interval".
• Fast and irregular heartbeat, fainting that can be symptoms of a potentially life-threatening disorder known as torsades de pointes.
• Increased libido, hypersexuality.
• Pisa syndrome (a condition involving involuntary muscle contraction with abnormal flexion of the body and head to one side).

If you consider any of the side effects you experience to be serious, or if you notice any side effect not listed in this package leaflet, inform your doctor or pharmacist.

Other Side Effects in Children and Adolescents

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet.

5. Storage of Solvera

Keep out of the reach and sight of children.

This medication does not require special storage conditions.

Do not use Solvera after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Solvera

• The active ingredient is donepezil hydrochloride. Each tablet contains 5 mg of donepezil hydrochloride.

Other components (excipients) are:Polacrilin potassium, microcrystalline cellulose, lactose monohydrate (Spray Dried), anhydrous monosodium citrate, croscarmellose sodium, aspartame (E-951), magnesium stearate, hydrochloric acid, and purified water.

Appearance of the Product and Package Contents

• Solvera is presented in orodispersible tablets, which dissolve in the mouth. The tablets are white or off-white, flat with rounded edges, and engraved with a "5" on one side and smooth on the other side.
• Solvera is available in three package sizes with transparent blisters formed by PVC/PCTFE (Aclar)/aluminum and aluminum/aluminum. Each package may contain 28, 56, or 120 (clinical package) tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder

Devon Farmacéutica, S.A.

C/ José Rizal Nº 84

28043 Madrid

Spain

Manufacturer

GENEPHARM, S.A.

Marathonos Avenue 18 Th Km

Pallini. Attikis – 153 51

Greece

This package leaflet was approved in December 2022

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

http://www.aemps.gob.es/