Detam 10 mg film-coated tablets EFG
SpainTable of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Detam 10 mg film-coated tablets EFG
memantine hydrochloride
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you personally and must not be given to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Detam is and what it is used for
- What you need to know before taking Detam
- How to take Detam
- Possible adverse effects
- How to store Detam
- Contents of the pack and other information
1. What Detam is and what it is used for
Detam contains the active substance memantine hydrochloride. It belongs to a group of medicines known as anti-dementia medications.
Memory loss in Alzheimer's disease is due to disturbances in brain signaling. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors, which are involved in the transmission of nerve signals important for learning and memory. Memantine belongs to a group of medicines called NMDA receptor antagonists. Memantine works on these receptors, improving the transmission of nerve signals and memory.
Detam is used in the treatment of patients with moderate to severe Alzheimer's disease.
2. What you need to know before starting to take Detam
Do not take Detam:
? If you are allergic to memantine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Detam:
? If you have a history of epileptic seizures.
? If you have recently had a myocardial infarction (heart attack), if you suffer from congestive heart disease, or if you have uncontrolled high blood pressure (hypertension).
In the above situations, treatment must be carefully monitored, and your doctor should regularly re-evaluate the clinical benefit of Detam.
You must inform your doctor if you have recently changed or intend to substantially change your diet (for example, from a normal diet to a strict vegetarian diet), or if you have renal tubular acidosis (RTA, excess acid-producing substances in the blood due to renal dysfunction (kidney problem)) or severe urinary tract infections (the structure that carries urine), as your doctor may need to adjust the dose of the medicine.
If you have renal impairment (kidney problems), your doctor must closely monitor kidney function and, if necessary, adjust the doses of memantine.
The use of memantine together with other medicines such as amantadine (used to treat Parkinson's disease), ketamine (a drug generally used as an anaesthetic), dextromethorphan (a cough medicine), and other NMDA antagonists should be avoided.
Children and adolescents
The use of this medicine is not recommended in children and adolescents under 18 years of age.
Other medicines and Detam
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Specifically, administration of Detam may cause changes in the effects of the following medicines, so your doctor may need to adjust the dose:
? amantadine, ketamine, dextromethorphan,
? dantrolene, baclofen,
? cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine,
? hydrochlorothiazide (or any combination containing hydrochlorothiazide),
? anticholinergics (substances generally used to treat movement disorders or intestinal spasms),
? anticonvulsants (substances used to prevent and stop seizures),
? barbiturates (substances generally used to induce sleep),
? dopaminergic agonists (substances such as L-dopa, bromocriptine),
? neuroleptics (substances used in the treatment of mental illnesses),
? oral anticoagulants.
If you are admitted to hospital, inform your doctor that you are taking Detam.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
The use of memantine is not recommended in pregnant women.
Breastfeeding
Women taking Detam must not breastfeed.
Driving and using machines
Your doctor will advise you whether your condition allows you to drive and use machines safely.
Furthermore, Detam may affect your reaction ability, so driving or operating machinery may be inappropriate.
Detam contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Detam
Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.
The recommended dose for adults and elderly patients is 20 mg administered once daily.
To reduce the risk of adverse effects, this dose is reached gradually according to the following daily treatment schedule:
Week 1 | half a 10 mg tablet |
Week 2 | one 10 mg tablet |
Week 3 | one and a half 10 mg tablets |
Week 4 and onwards | two 10 mg tablets once daily |
The usual starting dose is half a 10 mg tablet once daily (1 x 5 mg) during the first week. This is increased to one 10 mg tablet daily (1 x 10 mg) in the second week, and to one and a half 10 mg tablets once daily (1 x 15 mg) in the third week. From the fourth week onwards, the usual dose is two 10 mg tablets (1 x 20 mg), administered once daily.
The tablet may be divided into equal doses.
Use in patients with renal impairment
If you have kidney problems, your doctor will decide the appropriate dose for your condition. In this case, your doctor should periodically monitor your kidney function.
Administration
Detam must be administered orally once daily. To get the maximum benefit from your medication, you should take it every day at the same time. The tablets should be swallowed with some water. The tablets may be taken with or without food.
Duration of treatment
Continue taking Detam for as long as it benefits you. Your doctor should periodically evaluate your treatment.
If you take more Detam than you should
? In general, taking an excessive amount of Detam should not cause you any harm. You may experience an increase in the symptoms described in section 4, “Possible side effects”.
? In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Detam
? If you realize you have forgotten to take your dose of Detam, wait and take the next dose at the usual time.
? Do not take a double dose to make up for the missed dose.
If you have any other questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
In general, adverse effects are classified as mild to moderate.
Common (may affect up to 1 in 10 people):
? headache,
? drowsiness,
? constipation,
? elevated liver function tests,
? dizziness,
? impaired balance,
? difficulty breathing,
? high blood pressure,
? hypersensitivity to the medicine.
Uncommon (may affect up to 1 in 100 people):
? fatigue,
? fungal infections,
? confusion,
? hallucinations,
? vomiting,
? impaired gait,
? heart failure and formation of blood clots in the venous system (venous thrombosis/venous thromboembolism).
Very rare (may affect up to 1 in 10,000 people):
? seizures.
Frequency not known (frequency cannot be estimated from available data):
? inflammation of the pancreas,
? inflammation of the liver (hepatitis),
? psychotic reactions.
Alzheimer's disease has been associated with depression, suicidal ideation, and suicide. These events have been reported in patients treated with memantine.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Detam
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 packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage temperature conditions.
Store the blister in the outer packaging to protect it from light.
Medicines must not be disposed of via wastewater drains or household waste. Unused medicines and waste materials, including packaging, should be taken to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Detam
? The active substance is memantine hydrochloride. Each tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.
? The other components are: microcrystalline cellulose, crospovidone type B, colloidal anhydrous silica, magnesium stearate, monohydrate lactose (see section 2 “Detam contains”), hypromellose 6cP, macrogol 400 and titanium dioxide (E171).
Appearance of the product and contents of the pack
Detam 10 mg is a film-coated tablet, white in colour, oblong, biconvex, 9.5 mm by 4.5 mm, with a break line on both sides.
Detam 10 mg tablets are available in packs of 112 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Devon Farmacéutica, S.A.
C/ José Rizal Nº 84
28043 Madrid
Spain
Manufacturer
Zaklady Farmaceutyczne POLPHARMA SA
(Pharmaceutical Works POLPHARMA SA)
19, Pelplinska Street
83-200 Starogard Gdanski
Poland
Date of the most recent revision of this package leaflet: July 2018
Other sources of information
Detailed information on this medicinal product is available on the website of the {Spanish Agency of Medicines and Medical Devices (AEMPS)} (http://www.aemps.gob.es/)}