NIMVASTID Hard capsule (2022)

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Περιεχόμενα

1. Name of the medicinal product

Nimvastid 1.5 mg hard capsules. Nimvastid 3 mg hard capsules. Nimvastid 4.5 mg hard capsules. Nimvastid 6 mg hard capsule.

2. Qualitative and quantitative composition

Nimvastid 1.5 mg hard capsules: Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 1.5 mg rivastigmine. Nimvastid 3 mg hard capsules: Each hard capsule contains rivastigmine ...

3. Pharmaceutical form

Hard capsule. Nimvastid 1.5 mg hard capsules: White to almost white powder in a capsule with yellow cap and yellow body. Nimvastid 3 mg hard capsules: White to almost white powder in a capsule ...

4.1. Therapeutic indications

Symptomatic treatment of mild to moderately severe Alzheimers dementia. Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinsons disease.

4.2. Posology and method of administration

Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimers dementia or dementia associated with Parkinsons disease. Diagnosis should be made according ...

4.3. Contraindications

The use of this medicinal product is contraindicated in patients with known hypersensitivity to the active substance rivastigmine, to other carbamate derivatives or to any of the excipients listed in section ...

4.4. Special warnings and precautions for use

The incidence and severity of adverse reactions generally increase with higher doses. If treatment is interrupted for more than three days, it should be re-initiated at 1.5 mg twice daily to reduce the ...

4.5. Interaction with other medicinal products and other forms of interaction

As a cholinesterase inhibitor, rivastigmine may exaggerate the effects of succinylcholine-type muscle relaxants during anaesthesia. Caution is recommended when selecting anaesthetic agents. Possible dose ...

4.6. Fertility, pregnancy and lactation

Pregnancy In pregnant animals, rivastigmine and/or metabolites crossed the placenta. It is not known if this occurs in humans. No clinical data on exposed pregnancies are available. In peri/postnatal studies ...

4.7. Effects on ability to drive and use machines

Alzheimers disease may cause gradual impairment of driving performance or compromise the ability to use machinery. Furthermore, rivastigmine can induce dizziness and somnolence, mainly when initiating ...

4.8. Undesirable effects

Summary of the safety profile The most commonly reported adverse reactions (ADRs) are gastrointestinal, including nausea (38%) and vomiting (23%), especially during titration. Female patients in clinical ...

4.9. Overdose

Symptoms Most cases of accidental overdose have not been associated with any clinical signs or symptoms and almost all of the patients concerned continued rivastigmine treatment 24 hours after the overdose. ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: psychoanaleptics, anticholinesterases ATC code: N06DA03 Rivastigmine is an acetyl- and butyrylcholinesterase inhibitor of the carbamate type, thought to facilitate ...

5.2. Pharmacokinetic properties

Absorption Rivastigmine is rapidly and completely absorbed. Peak plasma concentrations are reached in approximately 1 hour. As a consequence of rivastigmines interaction with its target enzyme, the increase ...

5.3. Preclinical safety data

Repeated-dose toxicity studies in rats, mice and dogs revealed only effects associated with an exaggerated pharmacological action. No target organ toxicity was observed. No safety margins to human exposure ...

6.1. List of excipients

Capsule content: Microcrystalline cellulose Hypromellose Silica, colloidal anhydrous Magnesium stearate Capsule shell: Titanium dioxide (E171) Yellow iron oxide (E172) Gelatine

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

Blister pack (PVC/PVDC/Alu-foil): 14, 28, 30, 56, 60 or 112 hard capsules in a box. HDPE container: 200 or 250 hard capsules in a box. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

7. Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

8. Marketing authorization number(s)

14 hard capsules: EU/1/09/525/001 28 hard capsules: EU/1/09/525/002 30 hard capsules: EU/1/09/525/003 56 hard capsules: EU/1/09/525/004 60 hard capsules: EU/1/09/525/005 112 hard capsules: EU/1/09/525/006 ...

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 11/5/2009 Date of latest renewal: DD month YYYY

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