Memantine Hydrochloride 20 mg soluble tablets – patient leaflet, side effects, dosage

1. What Cognomem is and what it is used for

Cognomem contains the active substance memantine hydrochloride. It belongs to a group of medicines known as anti-dementia medicines. Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory. Cognomem belongs to a group of medicines called NMDA-receptor antagonists. Cognomem acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

Cognomem is used for the treatment of patients with moderate to severe Alzheimer’s disease.

2. What you need to know before you take Cognomem

Do not take Cognomem

• if you are allergic to memantine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Cognomem:

• if you have a history of epileptic seizures
• if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure). In these situations the treatment should be carefully supervised, and the clinical benefit of Cognomem reassessed by your doctor on a regular basis. If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.

If you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function) or severe infections of the urinary tract (structure that carries urine), your doctor may need to adjust the dose of your medicine.

The use of medicinal products called amantadine (for the treatment of Parkinson’s disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.

Children and adolescents

Cognomem is not recommended for children and adolescents under the age of 18 years.

Other medicines and Cognomem

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, Cognomem may change the effects of the following medicines and their dose may need to be adjusted by your doctor:

• amantadine (substance used in the treatment of Parkinson’s disease)
• ketamine (an anaesthetic)
• dextromethorphan (substance used to treat coughs)
• dantrolene (substance used as a muscle relaxant)
• baclofen (substance used to relieve muscle spasms occurring in various illnesses such as cerebral palsy and multiple sclerosis)
• cimetidine, ranitidine (substances used in the treatment of indigestion, heartburn and gastric ulcers)
• procainamide, quinidine (substances used to treat irregular heartbeats)
• quinine (substance used to treat night time leg cramps)

• nicotine (substance used to help you stop smoking)

  • hydrochlorothiazide (or any combination with hydrochlorothiazide – substances used in the treatment of water retention and high blood pressure)
  • anticholinergics (substances generally used to treat movement disorders or intestinal cramps)
  • anticonvulsants (substances used to prevent and relieve seizures)
  • barbiturates (substances generally used to induce sleep)
  • dopaminergic agonists (such as L-dopa and bromocriptine which are used in Parkinson’s disease to stimulate your nerve cells)
  • neuroleptics (substances used in the treatment of mental health disorders)
  • oral anticoagulants (such as warfarin used to thin the blood)

If you go into hospital, let your doctor know that you are taking Cognomem.

Cognomem with food and drink

You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet), as your doctor may need to adjust the dose of your medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The use of this medicine in pregnant women is not recommended.

Breast-feeding

Women taking this medicine should not breast-feed.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, Cognomem may change your reactivity, making driving or operating machinery inappropriate.

Cognomem contains sodium and sodium benzoate

This medicine contains 50.68 mg sodium (main component of cooking/table salt) in each soluble tablet. This is equivalent to 2.53% of the recommended maximum daily dietary intake of sodium for an adult.

This medicine contains 10 mg benzoate salt in each tablet.

Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).

3. How to take Cognomem

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended treatment dose of 20 mg per day is achieved by a gradual increase of Cognomem dose during the first 3 weeks of treatment. The treatment scheme is also indicated on the treatment initiation pack. Take one tablet once a day.

The usual starting dose is one 5 mg tablet once a day for the first week. This is increased to one 10 mg tablet once a day in the second week and to one 15 mg tablet once a day in the third week. From the fourth week on, the usual dose is 20 mg once a day (two tablets of 10 mg or 1 tablet of 20 mg). Dosage in patients with impaired kidney function

If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In this case, monitoring of your kidney function should be performed by your doctor at specified intervals. Administration

• This medicine should be administered orally once a day.
• To benefit from your medicine you should take it regularly every day at the same time of the day.
• The tablets can be taken with or without food.
• The tablets are best taken dissolved in half a glass of water, however, they can also be taken whole, with a drink of water.
• Dissolve the tablet, that your doctor has told you to take, in a glass of water, and then drink all of it immediately.

Duration of treatment

Continue to take this medicine as long as it is of Package leaflet: Information for the user

Cognomem 20 mg soluble tablets

Memantine hydrochloride

Drug Product:

Name of Document:

CONFIDENTIAL

MEMANTINE HYDROCHLORIDE 5 mg + 10 mg + 15 mg + 20 mg (LICENCE LAMDA) Sol

Module 1 Page 1 benefit to you. Your doctor should assess your treatment on a regular basis.

If you take more Cognomem than you should

• In general, taking too much Cognomem than you have been prescribed should not result in any harm to you. You may experience increased symptoms as described in section 4. “Possible side effects”.
• If you take a large overdose of Cognomem, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take Cognomem

• If you find you have forgotten to take your dose of Cognomem, wait and take your next dose at the usual time.
• Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any of the following serious side effects, seek immediate medical attention:

§ Blood clots in blood vessels (thrombosis/ thromboembolism) where signs may include pain and swelling of a limb, rapid breathing, feeling faint, fast heart-rate and shortness of breath. § Allergic reaction (drug hypersensitivity) where signs may include shortness of breath, wheezing, rash or itching skin, swelling of the mouth, lips, tongue or throat etc.

§ Seizures or Heart failure (may appear as shortness of breath, chest pains, dizziness with a persistent cough)

§ Inflammation of the liver (hepatitis) where signs include nausea, abdominal pain and yellowing of the eyes or skin

Other side effects

In general, the observed side effects are mild to moderate.

Common (may affect up to 1 in 10 people):

• Headache, sleepiness, constipation
• Dizziness, problems with your balance
• Elevated liver function shown on blood tests
• Shortness of breath, high blood pressure Uncommon (may affect up to 1 in 100 people):
• Tiredness, confusion, hallucinations
• Fungal infections, being sick (vomiting), abnormal gait

Not known (frequency cannot be estimated from the available data):

• Inflammation of the pancreas
• Psychotic reactions.

Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. These events have been reported in patients being treated with Cognomem.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Cognomem

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month. This medicinal product does not require any special temperature storage conditions.

Store in the original package in order to protect from moisture.

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

6. Contents of the pack and other information

What Cognomem contain

• The active substance is memantine

  hydrochloride. Each soluble tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.

• The other ingredients are:

Disodium Hydrogen Citrate

Citric Acid Anhydrous

Mannitol

Sodium Bicarbonate

Sodium Benzoate

Macrogol 6000 (PEG 6000)

Brilliant Blue FCF (E 133)

What Cognomem look like and contents of the pack

Memantine hydrochloride soluble tablets 20 mg are blue-coloured round, flat tablets, of diameter 11.0 mm ± 0.2 mm,packed in PA/Al/PVC/Al blisters. Each blister contains 7 tablets. The colour of the

blister is blue.

Pack size of 28 tablets i.e. four blisters of 7 tablets. Marketing Authorisation Holder

Zentiva Pharma UK Limited,

12 New Fetter Lane,

London,

EC4A 1JP, United Kingdom

Manufacturer

RAFARM S.A.

Thesi Pousi-Xatzi, Agiou Louka, Paiania, Attiki, TK 19002, Greece.

This leaflet was last revised in October 2020.

1065021330 Drug Product:

Name of Document:

CONFIDENTIAL

MEMANTINE HYDROCHLORIDE 5 mg + 10 mg + 15 mg + 20 mg (LICENCE LAMDA) Sol

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