NUROMOL Film-coated tablet (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Nuromol 200mg/500mg tablets.

2. Qualitative and quantitative composition

Each tablet contains ibuprofen 200 mg and paracetamol 500 mg. For a full list of excipients see section 6.1

3. Pharmaceutical form

Film-coated tablets. (tablets) White to off-white, oval shaped, pearlescent tablets de-bossed with an identifying helix.

4.1. Therapeutic indications

For the temporary relief of mild to moderate pain associated with migraine, headache, backache, period pain, dental pain, rheumatic and muscular pain, pain of non-serious arthritis, cold and flu symptoms, ...

4.2. Posology and method of administration

Posology For short term-use only. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). The patient should consult a doctor if the symptoms ...

4.3. Contraindications

This product is contraindicated: In patients with a known hypersensitivity to ibuprofen, paracetamol or any other excipients in the product. In concomitant use with other Paracetamol-containing products ...

4.4. Special warnings and precautions for use

Do not exceed the recommended dose. If symptoms persist consult your doctor. Keep out of the sight and reach of children. Paracetamol The hazards of paracetamol overdose are greater in patients with non-cirrhotic ...

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

This product (like any other paracetamol containing products) is contraindicated in combination with other paracetamol containing products – increased risk of serious adverse effects (see Section 4.3). ...

4.6. Pregnancy and lactation

Pregnancy There is no experience of use of this product in humans during pregnancy. A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies ...

4.7. Effects on ability to drive and use machines

Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected patients should not drive or operate machinery.

4.8. Undesirable effects

Clinical trials with this product have not indicated any other undesirable effects other than those for ibuprofen or paracetamol alone. The following table lists adverse effects from pharmacovigilance ...

4.9. Overdose

Paracetamol Liver damage is possible in adults who have taken 10 g (equivalent to 20 tablets) or more of paracetamol. Ingestion of 5 g (equivalent to 10 tablets) or more of paracetamol may lead to liver ...

5.1. Pharmacodynamic properties

ATC Code: M01AE51 – Musculoskeletal system, anti-inflammatory and antirheumatic products, non-steroids, propionic acid derivatives. Ibuprofen combinations. The pharmacological actions of ibuprofen ...

5.2. Pharmacokinetic properties

Ibuprofen is well absorbed from the gastrointestinal tract and is extensively bound to plasma proteins. Ibuprofen diffuses into the synovial fluid. Plasma levels of ibuprofen from this product are detected ...

5.3. Preclinical safety data

The toxicological safety profile of ibuprofen and paracetamol has been established in animal experiments and in humans from extensive clinical experience. There are no new preclinical data of relevance ...

6.1. List of excipients

Tablet: Croscarmellose sodium Microcrystalline cellulose Colloidal anhydrous silica Magnesium stearate Stearic acid Film Coat: Polyvinyl alcohol Titanium Dioxide Talc Macrogol Potassium aluminium ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions

6.5. Nature and contents of container

Opaque, white PVC with PVdC (polyvinylidene chloride), heat-sealed to aluminium foil, blister pack containing: 4, 6, 8, 10, 12, 16, 20, 24, 32 film-coated tablets. Not all pack sizes may be marketed. ...

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Reckitt Benckiser Healthcare (UK) Ltd, Slough, SL1 3UH, UK

8. Marketing authorization number(s)

PL 00063/0649

9. Date of first authorization / renewal of the authorization

17/06/2011

10. Date of revision of the text

24/03/2021

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