5 mg, 10 mg, 15 mg, 20 mg film-coated tablets
memantine hydrochloride

What Memantine ratiopharm is and what it is used for

How Memantine Ratiopharm works
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 NMDA receptors (N-methyl-D-aspartate) that are involved in the transmission of nerve signals that are important for learning and memory. Memantine Ratiopharm belongs to a group of medicines called NMDA receptor antagonists. Memantine Ratiopharm acts on these NMDA receptors by improving the transmission of nerve signals and memory.

What Memantine Ratiopharm is used for
Memantine Ratiopharm is used for treating patients with moderate to severe Alzheimer’s disease.

What you need to know before you take Memantine ratiopharm

Do not use Memantine ratiopharm

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

Warnings and cautions

Talk to your doctor or pharmacist before taking Memantine Ratiopharm:

  • if you have a history of epileptic seizures.
  • if you have recently had a myocardial infarction (heart attack) or if you suffer from untreated heart failure or uncontrolled hypertension (high blood pressure ).

In these situations, treatment should be closely monitored and the clinical benefit of Memantine Ratiopharm should be regularly assessed by your physician.

If you suffer from impaired kidney function (kidney problems), your doctor should closely monitor your kidney function and, if necessary, adjust the memantine doses accordingly.

Concomitant use of drugs containing

  • amantadine (for the treatment of Parkinson’s disease )
  • ketamine (a substance commonly used as an anesthetic)
  • dextromethorphan (generally used to treat cough)
  • other NMDA antagonist er

should be avoided.

Children and young people

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

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.

Memantine Ratiopharm may in particular affect the effects of the following medicines and these doses may need to be changed by your doctor:

  • amantadine, ketamine, dextromethorphan
  • dantrolen, baklofen
  • cimetidine, ranitidine, procainamide , quinidine , quinine, nicotine
  • hydrochlorothiazide (or any combination with hydrochlorothiazide)
  • anticholinergics (substances commonly used to treat movement disorders or intestinal cramps)
  • antiepileptics (substances used to prevent and relieve seizures)
  • barbiturates (substances commonly used for insomnia)
  • dopaminergic agonists (substances such as L-dopa , bromocriptine)
  • neuroleptics (substances used in the treatment of mental illness)
  • oral anticoagulants

If you are hospitalized, tell your doctor that you are taking Memantine Ratiopharm.

Memantine ratiopharm with food and drink

You should tell your doctor if you have recently changed or intend to change your diet significantly (eg from a regular diet to a vegetarian diet only) or if you suffer from a condition of renal tubular acidosis (RTA, an excess on acid-forming substances in the blood due to kidney dysfunction (impaired kidney function)) or severe urinary tract infections, as your doctor may need to adjust the dose of your medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 breastfeed.

Driving and using machines

Your doctor will tell you if your illness allows you to drive and use machines safely.
Memantine Ratiopharm may also alter your ability to react, making it unsuitable to drive or use machines.

Memantine ratiopharm contains lactose and soy 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 medicine.
This medicine contains soy lecithin. If you are allergic to peanuts or soy, do not use this medicine.

How to use Memantine ratiopharm

Memantine Ratiopharm packaging for the start of treatment should only be used at the beginning of treatment with Memantine Ratiopharm.

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Dosage
The recommended treatment dose of 20 mg per day is achieved by gradually increasing the dose of Memantine Ratiopharm during the first 3 weeks of treatment. Take one tablet once a day.

Week 1 (day 1-7):
Take a 5 mg tablet once a day (white to off-white, capsule-shaped, biconvex, smooth on one side, and debossed with “5” on the other side) for 7 days.

Week 2 (day 8-14):
Take a 10 mg tablet once a day (white to off-white, capsule-shaped, biconvex, with a scoreline on one side and debossed with “10” on the other side) for 7 days.

Week 3 (day 15-21):
Take one 15 mg tablet once daily (white to off-white, capsule-shaped, biconvex, smooth on one side, and debossed with “15” on the other side) for 7 days.

Week 4 (day 22-28):
Take a 20 mg tablet once daily (white to off-white, capsule-shaped, biconvex, with a scoreline on one side and debossed with “20” on the other side) for 7 days.

week 1 5 mg tablet
week 2 10 mg tablet
week 3 15 mg tablet
week 4 and thereafter 20 mg tablets once a day

Maintenance
dose The recommended daily dose is 20 mg once a day. To continue treatment, consult your doctor.

Dosage in patients with renal impairment
If you have renal impairment, your doctor will prescribe a dose that suits your condition. In this case, your doctor should examine your kidney function at certain intervals.

Administration
Memantine Ratiopharm should be taken orally once a day. For you to benefit from your medicine, you must take it regularly every day at the same time of day.
The tablets should be swallowed with a little water. The tablets can be taken with or without food.

Treatment
time Continue to take Memantine Ratiopharm for as long as you benefit from it. Your doctor should regularly evaluate your treatment.

If you take more Memantine ratiopharm than you should

  • In general, it should not harm you if you take too much Memantine ratiopharm. You may experience increased symptoms as described in section 4. “Possible side effects”.
  • If you are taking a large overdose of Memantine ratiopharm, contact your doctor or seek medical advice, as you may need care.

If you forget to take Memantine ratiopharm

  • If you find that 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 product, ask your doctor or pharmacist.

Possible side effects

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

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

Common (affects 1 to 10 users in 100):

  • Headache, drowsiness, 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):

  • Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disorders, heart failure and blood clots in veins

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

  • Cramps

No known frequency (can not be calculated from the available data):

  • Pancreatitis, 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.

How to store Memantine ratiopharm

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 blister after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

The active substance is memantine hydrochloride.
Each film-coated tablet contains 5 mg memantine hydrochloride equivalent to 4.15 mg memantine.
Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
Each film-coated tablet contains 15 mg memantine hydrochloride equivalent to 12.46 mg memantine.
Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.

The other ingredients are:
Tablet core
Microcrystalline cellulose (E 460), pregelatinized starch (E 1404), anhydrous 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), soy lecithin (E 322), xanthan gum (E 415).

What the medicine looks like and contents of the pack

The 5 mg film-coated tablets are white to off-white, capsule-shaped, biconvex tablets that are smooth on one side and debossed with “5” on the other side.
The 10 mg film-coated tablets are white to off-white, capsule-shaped, biconvex tablets with a scoreline on one side and debossed with “10” on the other side.
The 15 mg film-coated tablets are white to off-white, capsule-shaped, biconvex tablets that are smooth on one side and debossed with “15” on the other side.
The 20 mg film-coated tablets are white to off-white, capsule-shaped, biconvex tablets with a scoreline on one side and debossed with “20” on the other side.

Memantine ratiopharm is available in packs of 28 (7 + 7 + 7 + 7) film-coated tablets.

Marketing Authorisation Holder

ratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm
Germany

Manufacturer
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany

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

HBM Pharma sro
Slabinská 30, 03680 Martin
Slovakia

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienTeva Pharma Belgium NV / SA / AGTel: +32 3 820 73 73 LithuaniaUAB “Sicor Biotech”Tel: +370 5 266 0203
BulgariaTeva Pharmaceuticals Bulgaria ЕООДTel: +359 2 489 95 82 Luxembourg / Luxemburgratiopharm GmbHGermany / GermanyTel: +49 731 402 02
Czech RepublicTeva Pharmaceuticals CR, sroTel: +420 251 007 111 HungaryTeva Gyógyszergyár Zrt.Tel .: +36 1 288 64 00
DenmarkTeva Denmark A / STel: +45 44 98 55 11 MaltaTeva Pharmaceuticals IrelandL-IrelandTel: +353 51 321 740
Germanyratiopharm GmbHTel: +49 731 402 02 The NetherlandsTeva Nederland BVTel: +31 800 0228 400
EestiUAB “Sicor Biotech” Eesti subsidiaryTel: +372 661 0801 NorwayTeva Norway ASTel: +47 66 77 55 90
GreeceTeva Αλλάς Α.Ε.:Ηλ: +30 210 72 79 099 Austriaratiopharm Arzneimittel Vertriebs ‑ GmbHTel: +43 1 97 007 0
Spainratiopharm Spain, SATel: +34 91 567 29 70 PolandTeva Pharmaceuticals Polska Sp. z ooTel .: +48 22 345 93 00
FranceTeva HealthTel: +33 1 55 91 78 00 Portugalratiopharm, Commerce and Industry of Pharmaceutical Products, LdaTel: +351 21 476 75 50
CroatiaPliva Hrvatska dooTel: + 385 1 37 20 000 RomaniaTeva Pharmaceuticals SRLTel: +40 21 230 65 24
IrelandTeva Pharmaceuticals IrelandTel: +353 51 321740 SloveniaPliva Ljubljana dooTel: +386 1 58 90 390
IcelandAlvogen ehf.Phone: +354 522 2900 Slovak RepublicTEVA Pharmaceuticals Slovakia sroTel: +421 2 57 26 79 11
ItalyTeva Italia SrlTel: +39 02 89 17 98 1 Finland / Finlandratiopharm OyPuh / Tel: +358 20 180 5900
.ΠροςTeva Αλλάς Α.Ε., .λλάδα:Ηλ: +30 210 72 79 099 SwedenTeva Sweden ABTel: +46 42 12 11 00
LatviaUAB “Sicor Biotech” affiliates LatvijāTel: +371 673 23 666 United KingdomTeva UK LimitedTel: +44 1977 628500

Muhammad Nadeem

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