Donepezil-Genepharm

Donepezil HCl.

The active substance is donepezil hydrochloride.
Donepezil HCL Genepharm Orodispersible Tablets are available in two presentations: Tablets of 5mg, which contains 5 mg of donepezil hydrochloride.
Tablets of 10mg, which contains 10 mg of donepezil hydrochloride.
Excipients/Inactive Ingredients: The other ingredients are: Polacrilin Potassium, Microcrystalline cellulose, Lactose monohydrate (Spray Dried), Monosodium citrate anhydrous, Aspartame, Croscarmellose sodium, Silica colloidal anhydrous, Magnesium Stearate, Hydrochloric acid for pH adjustments and purified water.

Donepezil HCL Genepharm Orodispersible Tablets (donepezil hydrochloride) belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil increases the levels of a substance (acetylcholine) in the brain involved in memory function by slowing down the breakdown of acetylcholine.

It is used to treat the symptoms of dementia in people diagnosed as having mild and moderately severe Alzheimer's disease. The symptoms include increasing memory loss, confusion and behavioural changes. As a result, sufferers of Alzheimer's disease find it more and more difficult to carry out their normal daily activities.
Donepezil HCL Genepharm Orodispersible Tablets is for use in adult patients only.

How much Donepezil HCL Genepharm Orodispersible Tablets should the patient take?: Always take this medicine exactly as the doctor or pharmacist has instructed. Check with the doctor or pharmacist if not sure.
Initially, the recommended dose is 5 mg every night before going to bed. After one month, the doctor may tell to take 10 mg every night before going to bed.
The tablet strength to be taken may change depending on the length of time that the patient has been taking the medicine and on what the doctor recommends.
The maximum recommended dose is 10 mg each night.
Always follow the doctor's, or pharmacist's advice about how and when to take the medicine.
Do not alter the dose without the doctor's advice.
How to take the medicine: The tablet should be placed on the tongue and allowed to disintegrate before swallowing, with or without water, according to the preference.
Use in Children and adolescents: Donepezil HCL Genepharm Orodispersible Tablets is not recommended for use in children and adolescents (younger than 18 years of age).
If the patient forgets to take Donepezil HCL Genepharm Orodispersible Tablets: If the patient forgets to take the medicine, take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet. If the patient forgets to take the medicine for more than one week, call the doctor before taking any more medicine.
If the patient stops taking Donepezil HCL Genepharm Orodispersible Tablets: Do not stop taking the tablets unless told to do so by the doctor. If the patient stops taking Donepezil HCL Genepharm Orodispersible Tablets, the benefits of the treatment will gradually fade away. If there are any further questions on the use of this medicine, ask the doctor or pharmacist.
For how long should the patient take Donepezil HCL Genepharm Orodispersible Tablets?: The doctor or pharmacist will advise on how long the patient should continue taking the tablets. The patient will need to see the doctor from time to time to review the treatment and assess the symptoms.

If the patient takes more Donepezil HCL Genepharm Orodispersible Tablets than necessary: Contact the doctor or the nearest hospital emergency department immediately if the patient takes more of the medicine than necessary. Take any remaining tablets.
Overdose symptoms may include feeling and being sick, drooling, sweating, slow heart rate, low blood pressure (light-headedness or dizziness when standing), breathing problems, losing consciousness and seizures (fits) or convulsions.

Do NOT take Donepezil HCL Genepharm Orodispersible Tablets: if the patient is allergic (hypersensitive) to donepezil hydrochloride, or to piperidine derivatives, or any of the other ingredients of Donepezil HCL Genepharm Orodispersible Tablets listed in Description.

Tell the doctor or pharmacist before starting to take Donepezil HCL Genepharm Orodispersible Tablets if the patient has or has had: Stomach or duodenal ulcers.
Seizures (fits) or convulsions.
A heart condition (irregular or very slow heart beat).
Asthma or other long term lung disease.
Liver problems or hepatitis.
Difficulty passing urine or mild kidney disease.
Also tell the doctor if the patient is pregnant or thinks she might be pregnant.
Neuroleptic Malignant Syndrome (NMS): There have been very rare post-marketing reports of NMS in patients treated with donepezil with or without concomitant antipsychotic medication. NMS is a potentially life-threatening condition characterized by hyperthermia, muscle rigidity, autonomic instability (e.g., irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia), altered consciousness and elevated serum creatine phosphokinase (CPK) levels. If a patient develops symptoms indicative of NMS, or presents with unexplained high fever in the absence of additional clinical manifestations of NMS, donepezil therapy should be discontinued.
Rhabdomyolysis (Muscle Effects): Rare cases of rhabdomyolysis (including acute renal failure) have been reported in patients treated with donepezil, particularly in the days following dose initiation and dose increase. Majority of these cases occurred independently of the occurrence of NMS. Patients should be carefully monitored for muscle pain, tenderness or weakness and darkened urine, particularly if accompanied by malaise or fever. Blood creatine phosphokinase (CPK) levels should be assessed in patients experiencing these symptoms.
Donepezil therapy should be discontinued if markedly elevated CPK levels are measured and/or if the patient develops symptoms indicative of rhabdomyolysis. Caution should be particularly exercised in prescribing donepezil to patients with risk factors such as prior history of muscular disorders, uncontrolled hypothyroidism, hepatic or renal impairment, and in patients who are receiving concomitant medications that can cause rhabdomyolysis (e.g., statins, antipsychotics, selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor).
Driving and using machines: Alzheimer's disease may impair the ability to drive or operate machinery and the patient must not perform these activities unless the doctor tells that it is safe to do so. Also, the medicine can cause tiredness, dizziness and muscle cramp. If any of these effects were experienced, the patient must not drive or operate machinery.
Use in Children and adolescents: Donepezil HCL Genepharm Orodispersible Tablets is not recommended for use in children and adolescents (younger than 18 years of age).

If the patient is pregnant or breast-feeding, thinks may be pregnant, or planning to have a baby, ask the doctor or pharmacist for advice before taking any medicine.
Donepezil Genepharm should not be used while breastfeeding.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported by people taking Donepezil.
Tell the doctor if the patient has any of these effects while taking Donepezil HCL Genepharm Orodispersible Tablets.
Serious side effects: Tell the doctor immediately if the patient notices these serious side effects mentioned. The patient may need urgent medical treatment.
Liver damage e.g. hepatitis. The symptoms of hepatitis are feeling or being sick, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, and dark coloured urine (may affect up to 1 in 1,000 people).
Stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) felt between the navel and the breast bone (may affect up to 1 in 100 people).
Bleeding in the stomach or intestines. This may cause the patient to pass black tar like stools or visible blood from the rectum (may affect up to 1 in 100 people).
Seizures (fits) or convulsions (may affect up to 1 in 100 people).
Fever with muscle stiffness, sweating or a lowered level of consciousness (a disorder called "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people).
Muscle weakness, tenderness or pain and particularly, if at the same time, feeling unwell, have a high temperature or have dark urine. They may be caused by an abnormal muscle breakdown which can be life threatening and lead to kidney problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 people).
Very common side effects (affects more than 1 in 10 people): diarrhoea, feeling sick, headaches.
Common side effects (may affect up to 1 in 10 people): muscle cramp, tiredness, difficulty in sleeping (insomnia), the common cold, loss of appetite, hallucinations (seeing or hearing things that are not really there), unusual dreams including nightmares, agitation, aggressive behaviour, fainting, dizziness, stomach feeling uncomfortable, rash, itching, passing urine uncontrollably, pain, accidents (patients may be more prone to falls and accidental injury).
Uncommon side effects (May affect up to 1 in 100 people): slow heart beat, salivary hypersecretion.
Rare side effects (may affect up to 1 in 1000 people): stiffness, shaking or uncontrollable movement especially of the face and tongue but also of the limbs.
Reporting side effects: If the patient gets any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed.

Please tell the doctor or pharmacist if the patient is taking, might take, or has recently taken, any other medicine. This includes medicines that the doctor has not prescribed but have been bought from a chemist/pharmacist. It also applies to medicines that may be taken sometime in the future if the patient continues to take Donepezil HCL Genepharm Orodispersible Tablets. This is because these medicines may weaken or strengthen the effects of Donepezil HCL Genepharm Orodispersible Tablets.
In particular, it is important to tell the doctor if taking any of the following types of medicines: Other Alzheimer's disease medicines, e.g. galantamine.
Pain killers or treatment for arthritis e.g. aspirin, non-steroidal anti-inflammatory (NSAID) drugs such as ibuprofen, or diclofenac sodium.
Anticholinergics medicines, e.g. tolterodine.
Antibiotics e.g. erythromycin, rifampicin.
Anti-fungal medicine e.g. ketoconazole.
Anti-depressants e.g. fluoxetine.
Anticonvulsants e.g. phenytoin, carbamazepine.
Medication for a heart condition e.g. quinidine, beta-blockers (propanolol and atenolol).
Muscle relaxants e.g. diazepam, succinylcholine.
General anaesthetic.
Medicines obtained without a prescription e.g. herbal remedies.
If the patient is going to have an operation that requires having a general anaesthetic, tell the doctor and the anaesthetist that the patient is taking Donepezil HCL Genepharm Orodispersible Tablets. This is because the medicine may affect the amount of anaesthetic needed.
Donepezil HCL Genepharm Orodispersible Tablets can be used in patients with kidney disease or mild to moderate liver disease. Tell the doctor first if the patient has kidney or liver disease. Patients with severe liver disease should not take Donepezil HCL Genepharm Orodispersible Tablets.
Tell the doctor or pharmacist the name of the caregiver. The caregiver will help the patient to take the medicine as it is prescribed.
Donepezil HCL Genepharm Orodispersible Tablets with food drink and Alcohol: Food will not influence the effect of Donepezil HCL Genepharm Orodispersible Tablets.
Donepezil HCL Genepharm Orodispersible Tablets should not be taken with alcohol because alcohol may change its effect.

Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer used. These measures will help to protect the environment.

Neurodegenerative Disease Drugs

N06DA02 - donepezil ; Belongs to the class of anticholinesterases. Used in the management of dementia.

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