ALZMENDA 5 MG 14 TAB

24.00 EGP

Each 5 mg film-coated tablet contains 5 mg of memantine hydrochloride equivalent to 4.155 mg memantine.

ALZMENDA 5 MG 14 TAB; memantine, antidementia agents .

ACTIVE-INGREDIENT OF ALZMENDA 5 MG 14 TAB

Each 5 mg film-coated tablet contains 5 mg of memantine hydrochloride equivalent to 4.155 mg memantine.

INDICATION OF ALZMENDA 5 MG 14 TAB

Treatment of patients with moderate to severe Alzheimer’s disease.

DOSAGE OF ALZMENDA 5 MG 14 TAB

Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet

Ask your pharmacist or doctor for help if you do not understand the instructions on the box .

The recommended dose is : –

Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’s dementia. Therapy should only be started if a caregiver is available who will reqularly monitor the intake of the medicinal product by the patient. Diagnosis should be made according to current guidlines. The tolerance and dosing of memantine should be reassessed on a regular basis, preferably within three months after start of treatment. The reafter, the clinical benefit of memantine and the patient’s tolerance of treatment should be reassessed on a regular basis according to current clinical guidlines. Maintenance treatment can be continued for as long as a therapeutic benefit is favourable and the patient tolerates treatment with memantine. Discontinuation of memantine should be considered when evidence of a therapeutic benefit is favourable and the patient tolerates treatment with memantine. Discontinution of memantine should be considered when evidence of a therapeutic effect is no longer present or if the patient does no tolerate treatment. Alzemenda tablets should be administered once a day and should be taken at the same time every day. Film-coated tablets can be taken with or without food. Adults: Dose titration: Treatment initiation pack: The recommended starting dose is 5 mg per day, which is stepwise increased over the first 4 weeks of treatment reaching the recommended maintenance dose as follows: Week 1 (day1-7): The patient should take one 5 mg film-coated tablet per day for 7 days. Week 2 (day 8-14): The patient should take one 10 mg film-coated tablet per day for 7 days. Week 3 (day15-21 ): The patient should take 15 mg film-coated tablet per day for 7 days. From week 4 on: The patient should take 20 mg film-coated tablet per day for 7 days. The maximum daily dose is 20 mg per day. Tablets packs of 10 mg and 20 mg. The maximum daily dose is 20 mg daily. In order to reduce the risk of undesirable effects the maintenance dose is achieved bu upward titration of 5 mg per week over the first 3 weeks as follows: Week 1 (day1-7): The patient should take half a 10 mg film-coated tablet per day for 7 days. Week 2 (day 8-14): The patient should take one 10 mg film-coated tablet per day for 7 days. Week 3 (day15-21 ): The patient should take one 5 mg tab and one 10 mg tab = 15 mg per day for 7 days. From week 4 on: The patient should take 20 mg film-coated tablet/two 10 mg film-coated tablets once a day. Maintenance dose: The recommended maintenance dose is 20 mg per day. Elderly: On the basis of clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (one 20 mg film-coated tablet/two 10 mg film-coated tablets). Children and adolescents under the age of 18 years: Alzmenda is not recommended for use in children below 18 years due to a lack of data on safety and efficacy. Renal impairment : In patients with mildly impaired renal function (creatinine clearance 50 – 80 ml/min.) no dosage adjustment is required. In patients with moderate renal impairment (creatinine clearance 30 – 40 ml/min.) daily dose should be 10 mg. if tolerated well after at least 7 days of treatment, the dose could be increased up to 20 mg/day according to standard titration scheme. In patients with severe renal impairment (creatinine clearance 5 – 29 ml/min.) daily dose should be 10 mg per day . Hepatic impairment: In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B ) no dosage adjustment is needed. No data on the use of memantine in patients with severe hepatic impairment are available. Administration of Alzmenda is not recommended in patients with severe hepatic impairment. The recommended maintenance dose is 20 mg per day. Elderly: On the basis of clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (one 20 mg film-coated tablet/two 10 mg film-coated tablets). Children and adolescents under the age of 18 years: Alzmenda is not recommended for use in children below 18 years due to a lack of data on safety and efficacy. Renal impairment : In patients with mildly impaired renal function (creatinine clearance 50 – 80 ml/min.) no dosage adjustment is required. In patients with moderate renal impairment (creatinine clearance 30 – 40 ml/min.) daily dose should be 10 mg. if tolerated well after at least 7 days of treatment, the dose could be increased up to 20 mg/day according to standard titration scheme. In patients with severe renal impairment (creatinine clearance 5 – 29 ml/min.) daily dose should be 10 mg per day . Hepatic impairment: In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B ) no dosage adjustment is needed. No data on the use of memantine in patients with severe hepatic impairment are available. Administration of Alzmenda is not recommended in patients with severe hepatic impairment.

OVER-DOSAGE OF ALZMENDA 5 MG 14 TAB

Only limited experience with overdose is available from clinical studies and post-marketing experience . Symptoms: Relatively large doses (200 mg and 105 mg/day for 3 days, respectively) have been associated with either only symptoms of tiredness, weakness and/or diarrhoea or no symptoms. In the overdose cases below 140 mg or unkown dose the patients revealed symptoms from central nervous system (confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination, and gait disturbance) and/or gastrointestinal origin (vomiting and diarrhea). In the most extreme case of overdose, the patient survived the oral intake of a total of 2000 mg memantine with effects on the central nervous system ( coma for 10 days, and later diplopia and agitation). The patient recieved symptomatic treatment and plasmapheresis. The patient recovered without permenant sequelae. In another case of a large overdose, the patient also survived and recovered. The patient had recieved 400 mg memantine orally. The patient experienced central nervous system symptoms such as restlessness, psychosis, visual hallucination, proconvulsiveness, somnolence, stupor, and unconsciousness. Treatment: In the event of overdosage, treatment should be symptomatic. No specific antidote for intoxication or overdose is available. Standard clinical procedures to remove active substance material, e.g. gastric lavage, carbo medicinalis ( interruption of potential entero-hepatic recirculation), acidification of urine, forced diuresis should be used as appropriate. In case of signs and symptoms of general CNS overstimulation, careful symptomatic clinical treatment should be considered.

CONTRA-INDICATION OF ALZMENDA 5 MG 14 TAB

Hypersensitivity to the active substance or to any of the excipients.

STORAGE OF ALZMENDA 5 MG 14 TAB

This medicinal product does not require any special storage conditions. Store at temperature not exceeding 30 °C in a dry place.
PACK OF ALZMENDA 5 MG 14 TAB
Carton box containing 1,2,3 or 4 strips each of 7 tablets & insert leaflet ( for Almenda 5 mg ).
ALZMENDA 5 MG 14 TAB MANUFACTURED BY
Marcyrl Pharmaceutical Industries E; Obour City – Egypt.

https://www.webmd.com/drugs/2/drug-77932-377/memantine-oral/memantine-oral/details

https://www.drugbank.ca/drugs/DB01043

https://www.gardeniapharmacy.com/category/medicine-2/

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