Memantine Hydrochloride 10mg/ml Oral Solution

  • Name:

    Memantine Hydrochloride 10mg/ml Oral Solution

  • Company:
    info
  • Active Ingredients:

    Memantine hydrochloride

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/06/16

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Summary of Product Characteristics last updated on medicines.ie: 23/8/2018

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Gerard Laboratories

Gerard Laboratories

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1 - 0 of 116 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 23 August 2018 SmPC

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 21 June 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 June 2016 PIL

Reasons for updating

  • Change to date of revision
  • Change to product name
  • Addition of information on reporting a side effect.

Updated on 27 August 2015 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2:  Qualitative and Quantitative composition
Pump: Each pump actuation of the pump (one downward pump) delivers 0.5 ml of solution containing which contains 5 mg of memantine hydrochloride which is equivalent to 4.16 mg of memantine.

Section 4.1 Therapeutic Indications
Treatment of adult patients with moderate to severe Alzheimer's disease

Section 4.2 Posology and method of administration 

This medicinal product should be taken once daily at the same time each day. The solution must not be poured, pumped or pipetted into the mouth directly from the bottlepump or pipette, but should be dosed onto a spoon or into a glass of water using the pump or pipette.

For detailed instructions on the preparation and handling of the product see section 6.6.

The solution can be taken with or without food.

Adults:

Dose titration

The maximum daily dose is 20 mg daily. In order to reduce the risk of undesirable effects, the maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows:

(a)Pump pack of 5 mg/pump:

Week 1 (day 1 7):
The patient should take 0.5 ml solution (5 mg) equivalent to one downward pump actuation, per day for 7 days.

Week 2 (day 8 14):
The patient should take 1 ml solution per day (10 mg) equivalent to two downward pumps actuations, per day for 7 days.
Week 3 (day 15 21):
The patient should take 1.5 ml solution per day (15 mg) equivalent to three downward pumps actuations, per day for 7 days.
From Week 4 on:
The patient should take 2 ml solution per day (20 mg) equivalent to four downward pumps actuations, once a day.

Elderly: On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (2 ml solution, equivalent to four downward pumps actuations) as described above.

Children and adolescents under the age of 18 years: This medicinal product is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Paediatric population:
No data available
Renal impairment:
In patients with mildly impaired renal function (creatinine clearance 50 – 80 ml/min) no dosage dose adjustment is required. In patients with moderate renal impairment (creatinine clearance 30 - 49 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two downward pumps actuations) per day. 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 (1 ml solution, equivalent to two downward pumps actuations) 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 this medicinal product is not recommended in patients with severe hepatic impairment.
Paediatric population:
No data available

Method of administration

This medicinal product should be taken orally once daily at the same time each day. The solution can be taken with or without food. The solution must not be poured, pumped or pipetted into the mouth directly from the bottle, pump or pipette, but should be dosed onto a spoon or into a glass of water using the pump or pipette.

For detailed instructions on the preparation and handling of the product see section 6.6.

Section 4.6 Fertility, pregnancy and lactation
Fertility
No adverse reactions of memantine were noted on male and female fertility.

Section 4.7 Effects on ability to drive and use machines
Furthermore, this medicinal product has minor or moderate influence on the ability to drive or use machines, such that outpatients should be warned to take special care.

Section 4.8 Undesirable effects 
Tabulated list of adverse reactions
The following Adverse Drug Reactions listed in the Table below have been accumulated in clinical studies with this memantine hydrochloride and since its introduction in the market. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Adverse reactions are ranked according to system organ class, using the following convention: very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100), rare ( 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 


Nervous system disorders
uncommon common Balance disorders
Uncommon Gait abnormal
Very Rare Seizures 





 


 

Updated on 27 August 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 18 August 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to improve clarity and readability
  • Change due to harmonisation of PIL

Updated on 26 May 2015 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Appendix V approved details entered to replace text Appendix V

Updated on 11 May 2015 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 13 April 2015 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In Section 6.3 Shelf life has been changed from 24-36 months following variation approval

Updated on 13 October 2014 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 4 September 2014 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 4 September 2014 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided