Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - memantine

Document Subject

Generated Narrative: MedicinalProductDefinition mp78817b35263746b79687cd6c5a122f9f

identifier: http://ema.europa.eu/identifier/EU/1/13/836/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Memantine ratiopharm 10 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-78817b35263746b79687cd6c5a122f9f

identifier: http://ema.europa.eu/identifier/EU/1/13/836/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - memantine

Attesters

What is in this leaflet

1. What Memantine ratiopharm is and what it is used for
2. What you need to know before you take Memantine ratiopharm
3. How to take Memantine ratiopharm
4. Possible side effects
5. How to store Memantine ratiopharm
6. Contents of the pack and other information

How does Memantine ratiopharm work Memantine ratiopharm 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. Memantine ratiopharm belongs to a group of medicines called NMDA-receptor antagonists. Memantine ratiopharm acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

What is Memantine ratiopharm used for Memantine ratiopharm is used for the treatment of patients with moderate to severe Alzheimer s disease.

Do not take Memantine ratiopharm if you are allergic to memantine hydrochloride, peanut or soya or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions Talk to your doctor or pharmacist before taking Memantine ratiopharm 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 Memantine ratiopharm 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.

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

Other medicines and Memantine ratiopharm Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.

In particular, Memantine ratiopharm may change the effects of the following medicines and their dose may need to be adjusted by your doctor: amantadine, ketamine, dextromethorphan dantrolene, baclofen cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine hydrochlorothiazide (or any combination with hydrochlorothiazide) 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 (substances such as L-dopa, bromocriptine) neuroleptics (substances used in the treatment of mental disorders) oral anticoagulants

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

Memantine ratiopharm 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) or 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), 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.

The use of memantine in pregnant women is not recommended.

Women taking Memantine ratiopharm 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, Memantine ratiopharm may change your reactivity, making driving or operating machinery inappropriate.

Memantine ratiopharm contains lactose and soya lecithin This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This medicine contains soya lecithin. If you are allergic to peanut or soya, do not take this medicinal product.

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

Dosage The recommended dose of Memantine ratiopharm for adults and older patients is 20 mg once a day. In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme:

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 beyond two 10 mg tablets once a day

The usual starting dose is half a tablet once a day (1x 5 mg) for the first week. This is increased to one tablet once a day (1x 10 mg) in the second week and to one and a half tablets once a day in the third week. From the fourth week on, the usual dose is two tablets once a day (1x 20 mg).

The tablet can be divided into equal doses.

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 Memantine ratiopharm 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 should be swallowed with some water. The tablets can be taken with or without food.

Duration of treatment Continue to take Memantine ratiopharm as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.

If you take more Memantine ratiopharm than you should In general, taking too much Memantine ratiopharm 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 Memantine ratiopharm, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take Memantine ratiopharm If you find you have forgotten to take your dose of Memantine ratiopharm, 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.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In general, the observed side effects are mild to moderate. Common (affects 1 to 10 users in 100): Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity

Uncommon (affects 1 to 10 users in 1,000): Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism)

Very Rare (affects less than 1 user in 10,000): Seizures

Not known (frequency cannot be estimated from the available data): Inflammation of the pancreas, inflammation of the liver (hepatitis) and 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 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 pack after EXP. The expiry date refers to the last day of that month.

Blister packs Do not store above 25 C.

HDPE bottles This medicinal product does not require any special storage conditions. Shelf life after first opening of the container: 6 months

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.

What Memantine ratiopharm contains

• The active substance is memantine hydrochloride. Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
• The other ingredients are: Tablet core Cellulose microcrystalline (E 460), starch pregelatinised (E 1404), lactose, colloidal anhydrous silica (E 551), magnesium stearate (E 470b). Coating Polysorbate 80 (E 433), polyvinyl alcohol (E 1203), titanium dioxide (E 171), talc (E 553b), soya lecithin (E 322), xanthan gum (E 415).

What Memantine ratiopharm looks like and contents of the pack White to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with 10 on the other side.

Memantine ratiopharm is available in packs of 10, 14, 21, 28, 30, 42, 50, 56, 98, 100 and 112 film- coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder ratiopharm GmbH Graf-Arco-Stra e 3 89079 Ulm Germany

Manufacturer Merckle GmbH Ludwig-Merckle-Stra e 3 89143 Blaubeuren Germany

TEVA Pharmaceutical Works Private Limited Company Pallagi t 13, 4042 Debrecen Hungary

HBM Pharma s.r.o. Slabinsk 30, 03680 Martin Slovakia

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG T l/Tel: +32 38207Lietuva UAB Teva Baltics Tel: +370 52660

: +359 24899Luxembourg/Luxemburg ratiopharm GmbH Allemagne/Deutschland T l/Tel: +49 73140 esk republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007Magyarorsz g Teva Gy gyszergy r Zrt. Tel: +36 12886Danmark Teva Denmark A/S Tlf: +45 44985Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407Deutschland ratiopharm GmbH Tel: +49 73140Nederland Teva Nederland B.V. Tel: +31 8000228Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610Norge Teva Norway AS Tlf: +47 66775
Specifar A.B.E.E. : +30 2118805 sterreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970Espa a Teva Pharma, S.L.U. Tel: +34 913873Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459France Teva Sant
T l: +33 155917Portugal ratiopharm - Com rcio e Ind stria de Produtos Farmac uticos, Lda. Tel: +351 214767Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720Rom nia Teva Pharmaceuticals S.R.L. Tel: +40 212306Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890 sland Alvogen ehf. S mi: +354 5222Slovensk republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267Italia Teva Italia S.r.l. Tel: +39 028917Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805
Specifar A.B.E.E.

: +30 2118805Sverige Teva Sweden AB Tel: +46 42121Latvija UAB Teva Baltics fili le Latvij
Tel: +371 67323United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: