Solvera 5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Solvera 5 mg orodispersible tablets EFG

Donepezil, Hydrochloride

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

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Solvera is and what it is 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 starting to take Solvera

Do not take Solvera:

• If you are allergic to donepezil or to 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 ulcer, heart condition (such as irregular or very slow heartbeat, heart failure, myocardial infarction), seizures, asthma, chronic obstructive pulmonary disease, or difficulty urinating.
• If you have or have had a heart condition called "QT interval prolongation" or a history of certain abnormal heart rhythms known as torsade de pointes, or if anyone in your family has "QT interval prolongation".
• If you have low levels of magnesium or potassium in your blood.
• If you are undergoing surgery with general anesthesia, you must inform your doctor that you are taking Solvera.
• The use of Solvera is not recommended in children.
• You should avoid taking Solvera together 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 Medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, especially if you are taking any of the following:

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

Taking Solvera with food and drinks

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

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

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

Do not take Solvera if you are pregnant.

Do not take Solvera if you are breastfeeding your child.

Driving and using machines

Your medical 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, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you should not drive or operate machinery.

Important information about some of the components of Solvera

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine may be harmful for people with phenylketonuria because it contains aspartame, a source of phenylalanine.

3. How to take Solvera

Follow exactly the instructions for administering Solvera given 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 starts with one 5 mg tablet taken once daily, at night, immediately before going to bed. After one month of treatment, your doctor may instruct you to increase the dose to 10 mg once daily 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 that you take donepezil in the morning.

If you have mild or moderate hepatic impairment (liver disease) or renal impairment (kidney disease), you may follow a dosing regimen similar to that described above.

If you take more Solvera than you should

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

If you forget to take Solvera

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

If you stop taking Solvera

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

4. Possible adverse effects

Like all medicines, Solvera may produce adverse effects, although not everyone experiences them.

Serious adverse effects:

Consult your doctor immediately if you experience any of the following serious adverse effects. You may require urgent medical treatment.

• Muscle weakness, tenderness or pain, particularly if you also feel unwell, have a fever or your urine is dark-colored. This may be due to abnormal muscle breakdown, which can be life-threatening and may lead to 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 symptoms
• 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)
• Increase in a type of enzyme (muscle creatine kinase) in the blood

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

• Extrapyramidal symptoms (such as tremor or stiffness of the hands or legs)
• Cardiac conduction disturbances
• Liver function abnormalities, including hepatitis

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

• Changes in heart activity that may be observed on an electrocardiogram (ECG), known as "QT interval prolongation".
• Rapid and irregular heartbeat, fainting, which may be symptoms of a potentially life-threatening condition known as torsade de pointes.
• Increased libido, hypersexuality.
• Pisa syndrome (a condition involving involuntary muscle contractions with abnormal flexion of the body and head to one side).

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

Other adverse effects in children and adolescents

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

5. Storage of Solvera

Keep out of the reach and sight of children.

This medicine does not require any special storage conditions.

Do not use Solvera after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Solvera

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

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

Appearance of the medicine and contents of the pack

• Solvera is available as orodispersible tablets, i.e. tablets that dissolve in the mouth. The tablets are white or almost white, flat with rounded edges, marked with a "5" on one side and smooth on the other.
• Solvera is available in three pack sizes with transparent blisters made of PVC/PCTFE (Aclar)/aluminum and aluminum/aluminum. Each pack may contain 28, 56 or 120 tablets (clinical pack).

Only certain pack 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 leaflet was approved in December 2022

"Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/"