Meman/donepz 28-10mg ER Capsules

Memantine is a low to moderate affinity, uncompetitive (open-channel) N-methyl-D-aspartate (NMDA) receptor antagonist. It binds to the NMDA receptor-operated cation channels, blocking the effects of abnormally elevated tonic levels of glutamate, which may contribute to neuronal dysfunction in Alzheimer's disease. Donepezil is a reversible inhibitor of the enzyme acetylcholinesterase, which catalyzes the hydrolysis of acetylcholine. This inhibition leads to an increase in acetylcholine concentration at cholinergic synapses in the central nervous system, thereby enhancing cholinergic function.

Serious Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Urination problems
Severe dizziness or fainting
Fever, chills, or sore throat
New or worsening breathing difficulties
Seizures
Stomach pain or heartburn
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material
Slow heartbeat
Abnormal heartbeat
Bruising

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor:

Diarrhea
Upset stomach or vomiting
Decreased appetite
Dizziness or headache
Muscle cramps
Fatigue or weakness
* Sleep disturbances

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.

It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. While this drug can help manage symptoms, it is not a cure for Alzheimer's disease, and you should continue to receive regular care from your doctor. If you are pregnant, planning to become pregnant, or are breast-feeding, be sure to discuss this with your doctor, as you will need to carefully weigh the potential benefits and risks of this medication to both you and your baby.

• Anticholinergic agents (e.g., atropine, scopolamine): May antagonize the effects of donepezil.
• Other cholinesterase inhibitors (e.g., rivastigmine, galantamine): Increased risk of cholinergic adverse effects.
• Drugs that increase gastric acid secretion (e.g., NSAIDs): Increased risk of GI bleeding with donepezil.

• Drugs that alter urinary pH (e.g., carbonic anhydrase inhibitors, sodium bicarbonate): May alter memantine excretion.
• CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine): May increase donepezil exposure.
• CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): May increase donepezil exposure.
• CYP2D6/3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital): May decrease donepezil exposure.
• Succinylcholine, other neuromuscular blocking agents: Donepezil may exaggerate neuromuscular blockade.
• Beta-blockers, other agents that slow heart rate: Increased risk of bradycardia and syncope with donepezil.

• Nausea
• Vomiting
• Diarrhea
• Dizziness
• Headache
• Confusion
• Agitation
• Hallucinations
• Bradycardia
• Syncope (fainting)
• Urinary incontinence/obstruction
• Muscle cramps
• Fatigue
• Anorexia/weight loss

Category C. There are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.

Donepezil is excreted in human milk. It is not known if memantine is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness have not been established in pediatric patients. Not indicated for use in children.

This medication is primarily used in the geriatric population. No specific dosage adjustment is required based solely on age, but dosage adjustments are necessary for renal and severe hepatic impairment, which are more common in the elderly.

• This fixed-dose combination is intended for patients with moderate to severe Alzheimer's disease who are already stabilized on donepezil 10 mg and memantine 10 mg BID (or memantine ER 28 mg). It is not for initial treatment.
• The extended-release formulation allows for once-daily dosing, which may improve patient adherence.
• Counsel patients and caregivers on the importance of swallowing the capsule whole and not crushing or chewing it.
• Monitor for common side effects such as nausea, vomiting, diarrhea, dizziness, and headache, especially during the initial weeks of therapy.
• Be vigilant for signs of bradycardia or syncope, particularly in patients with pre-existing cardiac conditions, due to the donepezil component.
• Renal function should be assessed before initiating therapy and monitored periodically, as memantine dosage adjustment is required in renal impairment.

• Donepezil (Aricept) monotherapy
• Memantine (Namenda) monotherapy
• Rivastigmine (Exelon)
• Galantamine (Razadyne)

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further guidance. To ensure your safety and the safety of others, never share your medication with anyone else, and do not take medication that has been prescribed to someone else.

All medications should be stored in a secure location, out of the reach of children and pets, to prevent accidental ingestion. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or the medication's packaging. Instead, consult with your pharmacist to determine the best disposal method, as some communities have drug take-back programs in place.

In some cases, medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, it is crucial to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will aid healthcare professionals in providing appropriate treatment.