INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo MEMINIST 10 film-coated tablets

SCHEDULING STATUS
S4

PROPRIETARY NAME
(and dosage form)

MEMINIST 10 film-coated tablets

COMPOSITION
Active ingredient:
Each film-coated tablet contains 10 mg
memantine hydrochloride
Inactive ingredients:
Colloidal anhydrous silica, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified talc and titanium dioxide.
Sugar-free.

PHARMACOLOGICAL CLASSIFICATION
A 5.11 Medicines affecting autonomic function. Others.

PHARMACOLOGICAL ACTION
Pharmacodynamic properties
Memantine is a voltage dependant, moderate-affinity non-competitive antagonist of the NMDA-type glutamate receptor. It blocks the effects of pathologically elevated tonic levels of glutamate that may lead to neuronal dysfunction. Memantine interacts with the Mg2+ binding site of the channel to prevent excessive activation, while sparing normal function. Increasing evidence suggests that malfunctioning of glutamatergic neurotransmission, in particular at N-methyl-D-aspartate (NMDA)-receptors, contributes to both expression of symptoms and disease progression in neurodegenerative dementia.
Pharmacokinetic properties
Absorption:
Memantine has an absolute bioavailability of approximately 100%. Peak plasma concentrations are achieved between 3-8 hours. There is no indication that food influences the absorption of memantine.
Linearity:
The pharmacokinetics of memantine are linear in the dose range between 10 - 40 mg.
Distribution:
The volume of distribution is approximately 10 L/kg. About 45% of memantine is bound to plasma protein.
Biotransformation:
Approximately 80% of the circulating memantine-related material is present as the parent compound. The main metabolites are N-3,5-dimethylgludantan, the isomeric mixture of 4- and 6-hydroxy-memantine, and 1-nitroso-3,4-dimethyl-adamantane. None of these metabolites exhibits NMDAantagonistic activity, and in vitro no P450 catalysed metabolism has been detected.
Elimination:
Memantine is eliminated in a monoexponential manner, with a terminal half-life of 60-100 hours. The total clearance of memantine amounts to 170 mL/min/1,73 m2, and part of total renal clearance is achieved by tubular secretion. Renal handling involves tubular reabsorption and is probably mediated by cation transport proteins. Alkaline urine conditions may reduce renal elimination of memantine (see WARNINGS AND SPECIAL PRECAUTIONS).
Special populations:
Renal impairment:
A significant correlation between creatinine clearance and total renal clearance of memantine has been observed in elderly patients with normal and reduced renal function (creatine clearance of 50-100 mL/min/1,73 m2) (see DOSAGE AND DIRECTIONS FOR USE).
Hepatic impairment:
The effects of liver impairment on the pharmacokinetics of memantine have not been evaluated. As memantine is metabolised only to a minor extent, and into metabolites with no NMDA-antagonistic activity, the pharmacokinetics of memantine are not expected to produce clinically significant changes in patients with mild to moderate hepatic impairment.

INDICATIONS
MEMINIST 10
is indicated for the treatment of patients with moderately severe to severe Alzheimer’s disease. Efficacy has not been established beyond 6 months.

CONTRAINDICATIONS
Hypersensitivity to memantine or to any of the excipients in MEMINIST 10 (see COMPOSITION).
Children and adolescents under the age of 18 years, as safety and efficacy have not been established.
WARNINGS AND SPECIAL PRECAUTIONS
MEMINIST 10
therapy is not recommended for patients with severe renal impairment (creatinine clearance less than 9 mL/min/1,73 m2) as no data are available (see DOSAGE AND DIRECTIONS FOR USE).
Under alkaline conditions the rate of elimination of MEMINIST 10 is reduced (see Pharmacokinetic properties). Factors that may raise urine pH therefore may necessitate careful monitoring of the patient. These factors include drastic changes in diet, e.g. from a diet rich in meat products to a vegetarian diet, or a massive ingestion of alkalising gastric buffers. Urine pH may also be elevated by states of renal tubular acidosis (RTA) or severe infections of the urinary tract with Proteus bacteria.
Caution is recommended in patients at risk of convulsions.
Concomitant use of N-methyl-D-aspartate (NMDA)-antagonists, such as amantadine, ketamine or dextromethorphan, with MEMINIST 10 should be avoided. These compounds act at the same receptor system as MEMINIST 10, and therefore side effects (mainly central nervous system (CNS)-related) may be more frequent or more pronounced (see INTERACTIONS). Limited data are available on patients with recent myocardial infarction, congestive heart failure (NYHA III-IV) and uncontrolled hypertension. These patients should be closely supervised.

Effects on ability to drive and use machines
MEMINIST 10
may change reactivity and outpatients should be warned to take special care when driving a vehicle or operating machinery. Moderately severe to severe Alzheimer’s disease also usually causes impairment of driving performance and compromises the ability to use machinery.

INTERACTIONS
The effects of L-dopa, dopaminergic agonists and anticholinergics may be enhanced by concomitant treatment with MEMINIST 10.
The effects of barbiturates and neuroleptics may be reduced during concomitant treatment with MEMINIST 10.
MEMINIST 10 may alter the effects of the antispasmodic medicines dantrolene and baclofen, and a dosage adjustment may be necessary.
Use of other NMDA antagonists such as amantadine, ketamine or dextromethorphan with MEMINIST 10 should be avoided, as it may increase the incidence and severity of pharmatoxic psychosis.
Medicines such as cimetidine, ranitidine, procainamide, quinidine, quinine and nicotine, that use the same renal cationic transport system as amantadine, may interact with MEMINIST 10 leading to a potential risk of increased plasma levels.
MEMINIST 10 decreases the area under the curve (AUC) and peak plasma concentration (Cmax) of hydrochlorothiazide by 20%.

PREGNANCY AND LACTATION
The safety and efficacy of MEMINIST 10 have not been established in pregnant and lactating women.

DOSAGE AND DIRECTIONS FOR USE
Treatment should be initiated and supervised by a medical practitioner experienced in the diagnosis and treatment of Alzheimer’s dementia. Therapy should only be started if a caregiver is available who will regularly monitor medicine intake by the patient. Diagnosis should be made according to current guidelines.
Adults:
The maximum daily dose is 20 mg per day.
In order to reduce the risk of side effects, the maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows:
Treatment should be started with 5 mg per day (half a tablet in the morning) during the 1st week. In the 2nd week 10 mg per day (half a tablet twice a day), and in the 3rd week 15 mg per day is recommended (one tablet in the morning and half a tablet in the afternoon). From the 4th week on, treatment can be continued with the recommended maintenance dose of 20 mg per day (one tablet twice a day).
The tablets can be taken with or without food.
Elderly:
The recommended dose for patients >65 years of age is 20 mg per day (10 mg twice a day) as described above.
Renal impairment:
In patients with normal to mildly impaired renal function (serum creatinine levels of up to 130 micromol/L) no dose reduction is needed.
In patients with moderate renal impairment (creatinine clearance 40-60 mL/min/1,73 m2) the dose should be reduced to 10 mg per day.
No data are available for patients with severely reduced kidney function (see WARNINGS AND SPECIAL PRECAUTIONS).
Hepatic impairment:
There are no data on the use of MEMINIST 10 in patients with hepatic impairment.

SIDE EFFECTS
Blood and the lymphatic system disorders
Frequency unknown: Thrombocytopenia
Endocrine disorders
Frequency unknown: Acute pancreatitis, hypoglycaemia
Metabolism and nutrition disorders
Less frequent: Anorexia
Frequency unknown: Hyperlipidaemia
Psychiatric disorders
Frequent: Agitation, hallucinations, insomnia
Less frequent: Depression, somnolence
Nervous system disorders
Frequent: Confusion, dizziness, headache
Less frequent: Anxiety, abnormal gait
Frequency unknown: Dyskinesia, grand mal convulsions, neuroleptic malignant syndrome, tardive dyskinesia, carpal tunnel syndrome, restlessness
Cardiac disorders
Frequency unknown: Atrioventricular block, prolonged QT interval, supraventricular tachycardia, tachycardia
Vascular disorders
Less frequent: Hypertension
Frequency unknown: Cerebral infarction, intracranial haemorrhage, claudication
Respiratory, thoracic and mediastinal disorders
Frequent: Coughing
Less frequent: Bronchitis, dyspnoea, upper respiratory tract infection
Frequency unknown: Aspiration pneumonia
Gastrointestinal disorders
Less frequent: Vomiting, constipation, diarrhoea, nausea
Frequency unknown: Ileus, colitis, dysphagia, gastritis, gastro-oesophageal reflux
Hepatobiliary disorders
Frequency unknown: Hepatic failure
Skin and subcutaneous tissue disorders
Frequency unknown: Stevens-Johnson syndrome
Musculoskeletal, connective tissue and bone disorders
Less frequent: Hypertonia (increased muscle tone), arthralgia, back pain
Frequency unknown: Bone fracture
Renal and urinary disorders
Frequent: Urinary incontinence
Less frequent: Cystitis, urinary tract infection
Frequency unknown: Acute renal failure
Reproductive system and breast disorders
Less frequent: Increased libido
Frequency unknown: Impotence
General disorders and administrative site conditions
Frequent: Inflicted injury
Less frequent: Peripheral oedema, tiredness, fatigue, influenza-like syndrome, pain
Frequency unknown: Chest pain, malaise

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See SIDE EFFECTS.
Treatment of overdosage should be symptomatic and supportive.

IDENTIFICATION
Off-white, capsule shaped, biconvex, film-coated tablets, debossed with “M” and 10 on either side of the break line on one side and break line on other side.

PRESENTATION
Clear transparent triplex (PVC/PE/PVDC) film blister strips with aluminium foil containing 10 tablets. Six blister strips are packed in an outer carton.

STORAGE INSTRUCTIONS
Store at or below 25°C.
Keep blister strips in outer carton until required for use.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
46/5.11/0427

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
Unichem S.A. (Pty) Ltd.
1st Floor, Pinewood Park, Lonsdale Road, Pinelands, Cape Town 7405
MARKETED BY
Forrester Pharma (Pty) Ltd.
13 Pasita Street, Rosen Heights, Rosen Park, Bellville, 7530

DATE OF PUBLICATION OF THE PACKAGE INSERT
18 February 2016

PATIENT INFORMATION LEAFLET FOR MEMINIST 10
SCHEDULING STATUS
Schedule 4

PROPRIETARY NAME AND DOSAGE FORM
MEMINIST 10
film-coated tablets
Please read all of this leaflet carefully before taking MEMINIST 10
Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or your pharmacist.
MEMINIST 10 has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.

1. WHAT MEMINIST 10 CONTAINS
Active ingredient:
Each film-coated tablet contains 10 mg memantine hydrochloride.
Inactive ingredients:
Colloidal anhydrous silica, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified talc and titanium dioxide.
Sugar-free.

2. WHAT MEMINIST 10 IS USED FOR
Alzheimer’s disease is a form of dementia which is a brain disorder that negatively affects a person’s ability to carry out daily activities.
MEMINIST 10 is used to treat the symptoms of Alzheimer’s disease such as memory loss.

3. BEFORE YOU TAKE MEMINIST 10
Do not take MEMINIST 10:
If you are allergic (hypersensitive) to memantine or to any of the ingredients of MEMINIST 10 (see WHAT MEMINIST 10 CONTAINS).
MEMINIST 10 should not be used in children and adolescents under the age of 18 years.

Take special care with MEMINIST 10:
Before you take MEMINIST 10 tell your doctor:
If you have a severe kidney disorder.
If you have recently changed or intend to change your diet significantly (such as from normal diet to vegetarian diet), if you suffer from a condition called renal tubular acidosis or RTA (an excess of acid-forming substances in the blood due to a kidney disorder) or if you suffer from severe infections of the urinary tract, as your doctor may need to adjust the dose of MEMINIST 10.
If you suffer from epilepsy or have a history of seizures or fits.
If you recently had a heart attack or have a heart disorder.
If you have a history of high and uncontrolled blood pressure.

Taking MEMINIST 10 with food or drink:
MEMINIST 10
may be taken with or without food.

Pregnancy and breastfeeding:
If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional before taking MEMINIST 10.
Do not take MEMINIST 10 if you are pregnant, suspect you are pregnant or planning to become pregnant. Contact you doctor immediately.
Do not take MEMINIST 10 if you are breastfeeding your baby.

Driving and using machinery:
MEMINIST 10
may impair your ability to drive a vehicle and use machinery.
Do not drive a vehicle, operate machinery or perform any activities that require concentration until you know how MEMINIST 10 affects you.

Taking other medicines with MEMINIST 10:
Always tell your healthcare professional if you are taking any other medicine (this includes complementary or traditional medicines).
In particular, tell your doctor if you are taking any of the following medicines:
Dextromethorphan (a type of cough medicine).
Dantrolene, baclofen (used as muscle relaxants).
Cimetidine, ranitidine (used to treat stomach ulcers or heartburn).
Hydrochlorothiazide (water pill or any medicine used to manage high blood pressure that is in combination with hydrochlorothiazide).
Anticholinergics (used to treat movement disorders or intestinal cramps).
Anticonvulsants (used to prevent and relieve seizures or fits).
Barbiturates (used to induce sleep).
Dopaminergic agonists, such as L-dopa (used to treat Parkinson’s disease) or bromocriptine (used to treat high levels of the hormone prolactin in your body).
Neuroleptics (used in the treatment of mental disorders).
Amantadine (used to treat Parkinson’s disease).
Ketamine (used as anaesthetic during surgery).
Procainamide or quinidine (used to treat an abnormal heartbeat).
Quinine (used to reduce fever and treat malaria).
Nicotine (used as an aid to stop smoking and prevent withdrawal symptoms).
Not all medicines that may interact with MEMINIST 10 are included in this leaflet.

4. HOW TO TAKE MEMINIST 10
Do not share medicines prescribed for you with any other person.
Your caregiver will help you take your medication exactly as directed by your doctor. You should check with your doctor or pharmacist if you are unsure.
When starting your treatment your doctor will start off with a small dose and gradually increase the dose. This allows your doctor to make sure that you have the right dose that helps your condition and avoids any unwanted symptoms.
The usual dose is:
Week 1: 5 mg per day (half a tablet in the morning).
Week 2: 10 mg per day (half a tablet twice a day).
Week 3: 15 mg per day (one tablet in the morning and half a tablet in the afternoon).
Week 4: 20 mg per day (one tablet twice a day).
The maximum dose is 20 mg per day.
Your doctor will adjust your dose accordingly if you are elderly or suffer from moderate kidney problems.
Make sure to take MEMINIST 10 at the same time each day and try to avoid missing any doses.
Your doctor will tell you how long your treatment with MEMINIST 10 will last. If you have the impression that the effects of MEMINIST 10 is too strong or too weak, tell your doctor or pharmacist.

If you take more MEMINIST 10 than you should:
In the event of overdosage, consult your doctor or pharmacist as soon as possible. If neither is available, contact the nearest hospital or poison centre.
Take this leaflet and any remaining tablets with you, so that the doctor knows what you have taken.

If you forget to take MEMINIST 10:
If you have missed your dose by only a few hours, take the missed dose as soon as you remember and then continue with your normal schedule.
However, if it is almost time for your next dose, skip the missed dose and take your next dose at the usual time. Do not take a double dose to make up for a missed dose.

5. POSSIBLE SIDE EFFECTS
MEMINIST 10
can have side effects.
Not all side effects reported for MEMINIST 10 are included in this leaflet. Should your general health worsen or you experience any untoward effects while taking MEMINIST 10, please consult your doctor, pharmacist or other healthcare professional for advice.
If any of the following happens, stop taking MEMINIST 10 and tell your doctor immediately or go to the casualty department at your nearest hospital:
Swelling of your hands, feet, ankles, face, mouth or throat, which may cause difficulty in swallowing or breathing.
Rash or itching.
Fainting.
These are all very serious side effects. If you have them, you may have had a serious allergic reaction to MEMINIST 10. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
The following side effects occur frequently:
Shortness of breath.
Loss of bladder control.
The following side effect occurs less frequently:
Bladder infection (painful or burning urination, frequent urge to urinate).
The following side effects can occur but the frequencies are not known:
Yellowing of your skin and eyes, also called jaundice or liver failure.
Chest pain.
Changes in the way your heart beats (beating faster than normal).
Stroke (weakness, loss of sensation, slurred speech, difficult movement, loss of sight).
Unexplained bruising, pin point bleeds on your skin, nosebleeds or bleeding gums.
Inhalation of foreign material (such as food, mucus or saliva) causing infection of your lungs (chest pain, shortness of breath, wheezing, cough with sputum, blood or odour).
Seizures.
Neuroleptic malignant syndrome (NMS) (fever, tight/stiff muscles, altered mental status (feeling confused, agitated or disoriented), changes in the way your heart beats, changes in your pulse rate or blood pressure and increased sweating).
Tardive dyskinesia (uncontrolled and repetitive movements of your lips, tongue, face, arms or legs, or excessive blinking of your eyes).
Severe, painful, blistering skin rash known as Stevens-Johnson syndrome.
Kidney failure (weakness, tiredness, nausea, vomiting or changes in the amount of urine).
These are all serious side effects. You may need urgent medical attention.

Tell your doctor as soon as possible if you notice any of the following:
The following side effects occur more frequently:
Feeling confused or agitated.
Hallucinations (seeing, hearing or sensing things that are not real).
Difficulty sleeping (insomnia).
Headache or dizziness.
Coughing.
Inflicted injury.
The following side effects occur less frequently:
Anorexia (severe weight loss).
Feeling depressed or anxious.
Drowsiness.
Changes in the way you walk.
Involuntary muscle movements.
Carpal tunnel syndrome (numbness, pain or tingling in your hand or arm).
Restlessness.
High blood pressure.
Claudication (pain or cramping in your lower legs while walking or exercising).
Nausea (feeling sick) or vomiting (being sick).
Constipation or diarrhoea.
Increased muscle tone or spams.
Joint or back pain.
Increased sex drive.
Swelling of your hands, feet, arms or legs due to water retention.
Tiredness.
Flu-like symptoms (headache, aching muscles, tiredness).
Generalised pain.
The following side effects can occur but the frequencies are not known:
High fat levels in your blood when tests are done.
Pancreatitis (pain of your stomach are radiating to your back).
Low blood sugar levels (confusion, dizziness, headaches, pale skin and increased heartrate).
Intestinal obstruction caused by slow bowel movements (cramping, bloating, inability to go to the bathroom, nausea or vomiting).
Stomach upset.
Difficulty swallowing.
Heartburn.
Bone fracture.
Inability to develop or maintain an erection.
General discomfort.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

6. STORING AND DISPOSING OF MEMINIST 10
Store at or below 25°C.
Keep blister strips in outer carton until required for use.
STORE ALL MEDICINES OUT OF REACH OF CHILDREN.
Do not use after the expiry date printed on the label or carton.
Return all unused medicine to your pharmacist.
Do not dispose unused medicine in drains and sewerage systems (e.g. toilets).

7. PRESENTATION OF MEMINIST 10
Clear transparent triplex (PVC/PE/PVDC) film blister strips with aluminium foil containing 10 tablets. Six blister strips are packed in an outer carton.

8. IDENTIFICATION OF MEMINIST 10
Off white, capsule shaped, biconvex, film-coated tablets, debossed with “M” and 10 on either side of the break line on one side and break line on other side.

9. REGISTRATION NUMBER
46/5.11/0427

10. NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
Unichem S.A. (Pty) Ltd.
1st Floor, Pinewood Park, Lonsdale Road, Pinelands, Cape Town 7405, +27 21 531 0436

11. MARKETED BY
Forrester Pharma (Pty) Ltd.
13 Pasita Street, Rosen Heights, Rosen Park, Bellville, 7530

12. DATE OF PUBLICATION

New addition to this site: November 2016
Source: Pharmaceutical Industry

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