Package Insert: Information for the User

Solvera 5 mg Bucodispersable Tablets EFG

Donepezil Hydrochloride

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What Solvera is and for what it is used

2. What you need to know before starting to take Solvera

3. How to take Solvera

4. Possible adverse effects

5. Storage of Solvera

6. Contents of the package and additional information

Solverais 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.

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 must inform your doctor if you have or have a history of stomach ulcers, heart disease (such as irregular or very slow heartbeats, heart failure, myocardial infarction), seizures, asthma, chronic obstructive pulmonary disease, or difficulty urinating.

- If you have a heart condition called "prolongation of the QT interval" or a history of certain abnormal heart rhythms called torsades de pointes, or if someone in your family has "prolongation of the QT interval."

- If you have low levels of magnesium or potassium in your blood.

- In case of surgical intervention with general anesthesia, you must inform your doctor that you are taking Solvera.

- Do not recommend the use of Solvera in children.

- You should avoid taking Solvera with other acetylcholinesterase inhibitors and other cholinergic agonists or antagonists.

- If you have vascular dementia (loss of brain function due to a series of small strokes).

Interaction of Solvera with other Medications

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

• Medications for heart rhythm problems, for example, amiodarone or sotalol
• Medications for depression, for example, citalopram, escitalopram, amitriptyline, fluoxetine
• Medications for psychosis, for example, pimozide, sertindole, or ziprasidone
• Medications for bacterial infections, for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• Antifungal medications, such as ketoconazole
• Other medications for Alzheimer's disease, for example, galantamine
• Analgesics or arthritis treatment, for example, aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium
• Anticholinergic medications, for example, tolterodine
• Anticonvulsants, for example, phenytoin, carbamazepine
• Medications for heart disease, for example, quinidine, beta-blockers (propranolol and atenolol)
• Muscle relaxants, for example, diazepam, succinylcholine
• General anesthetic
• Over-the-counter medications, for example, herbal remedies

Taking Solvera with food and drinks

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

The taking of 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 operating machinery

Your condition may affect your ability to drive or operate machinery and you should not perform these activities unless your doctor tells you it is safe to do so. Solvera may cause dizziness and drowsiness, mainly at the beginning of treatment or when increasing the dose. If you experience these effects, do not drive or operate 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 him before taking this medication.

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

Follow exactly the administration instructions for Solvera indicated by your doctor or pharmacist. If in doubt, 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 begins with a 5 mg tablet, taken once a day, at night, immediately before going to bed. After a month of treatment, your doctor may recommend an increase in the dose to 10 mg, once a day and at night. The maximum recommended dose is 10 mg/day.

If you experience 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 disease (a disease that affects the liver) or kidney disease (a disease that affects the kidney), you can 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 Toxicological 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 compensate for the missed doses.

If you interrupt treatment with Solvera

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

Like all medications, Solvexa 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.

• Muscle weakness, sensitivity, or pain, particularly if you also feel unwell, have a fever, or your urine is dark. This can be due to abnormal muscle destruction that can be fatal 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):

• Common 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 (a part of the intestine)
• Increased levels of a certain enzyme (creatine kinase muscle) in the blood

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

• Extrapyramidal symptoms (such as tremors or stiffness of the hands or legs)
• Alterations in heart conduction
• Liver function impairment, including hepatitis

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

• Changes in heart activity that can be seen on an electrocardiogram (ECG) called "prolongation of the QT interval".
• Fast and irregular heartbeat, fainting that may be symptoms of a potentially fatal condition called torsade 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 severe or if you notice any side effects not mentioned in this 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 not listed in this leaflet.

Keep out of reach and sight of children.

This medication does not require special storage conditions.

Do not use Solvera after the expiration date that appears on the packaging after 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 packaging and unused medicines at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Solvera

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

hydrochloride of donepezil.

- The other components (excipients) are: Potassium polacrilex, microcrystalline cellulose, lactose monohydrate (Spray Dried), anhydrous sodium citrate, sodium croscarmellose aspartame (E-951), magnesium stearate, hydrochloric acid, and purified water.

Appearance of the product and contents of the packaging

- Solvera is presented in buccal dispersible tablets, i.e., that dissolve in the mouth. The tablets are white or off-white, flat with rounded edges and engraved with a “5” on one face and smooth on the other face.

- Solvera is available in three sizes of packaging with transparent blisters formed by PVC/PCTFE (Aclar)/aluminum and aluminum/aluminum. Each package may contain 28, 56, or 120 (clinical package) tablets.

You may only find some sizes of packaging marketed.

Holder of the marketing authorization

Devon Farmacéutica, S.A.

C/ José Rizal Nº 84

28043 Madrid

Spain

Responsible for manufacturing

GENEPHARM, S.A.

Marathonos Avenue 18 Th Km

Pallini. Attikis – 153 51

Greece

This leaflet was approved in December 2022

“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/