Detam 20 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Detam 20 mg film-coated tablets EFG
memantine hydrochloride
Read the entire leaflet carefully before you start taking this medicine, because 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 only, and you should not give it to other people, even if they have the same symptoms as you, since it may 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 side 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 drugs.
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 acts 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 taking 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
Talk to your doctor or pharmacist before taking Detam:
• If you have a history of epileptic seizures.
• If you have recently had a myocardial infarction (heart attack), if you have congestive heart disease, or if you have uncontrolled hypertension (high blood pressure).
In the above situations, treatment must be carefully monitored, and your doctor should regularly reassess 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 (structures that carry 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 medicine used to treat cough), 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
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Specifically, the 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.
In addition, 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 instructions for use of this medicine provided 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 daily treatment schedule outlined below. Tablets with different strengths are available to adjust the dose.
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 | one 20 mg tablet or 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 or one 20 mg tablet (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 should be administered orally once daily. To get the maximum benefit from your medication, you must take it every day at the same time. The tablets should be swallowed with some water. 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, contact 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 further 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,
? gait disturbance,
? 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 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 or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.
6. Contents of the pack and other information
Composition of Detam
? The active substance is memantine hydrochloride. Each tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.
? The other components are: microcrystalline cellulose, crospovidone type B, anhydrous colloidal silica, magnesium stearate, monohydrate lactose (see section 2 “Detam contains”), hypromellose 6cP, macrogol 400, titanium dioxide (E171) and red iron oxide (E172).
Nature of the product and pack contents
Detam 20 mg is a pink, film-coated, oblong, biconvex tablet, 12.5 mm by 5.6 mm, with a break line on both sides.
Detam 20 mg tablets are available in packs containing 56 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 review of this 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 Health Products (AEMPS)} (http://www.aemps.gob.es/)}