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1. Name Of The Medicinal Product

Nootropil 1200 mg film-coated Tablets

Nootropil 800 mg film-coated Tablets

Nootropil 33 % Oral Solution

2. Qualitative And Quantitative Composition

Piracetam - 1200 mg per tablet

Piracetam - 800 mg per tablet

Piracetam 33% w/v

3. Pharmaceutical Form

Tablet for oral administration.

Solution for oral administration.

4. Clinical Particulars

4.1 Therapeutic Indications

NOOTROPIL is indicated for patients suffering from myoclonus of cortical origin, irrespective of aetiology, and should be used in combination with other anti-myoclonic therapies.

4.2 Posology And Method Of Administration

Adults :

The dosage regime shows important interindividual variability, requiring an individualised dose finding approach. A reasonable protocol would be to introduce piracetam at a dosage of 7.2 g/day, increasing by 4.8 g/day every 3 to 4 days up to a maximum of 20g/day, given in either 2 or 3 divided doses while keeping other antimyoclonic drugs unchanged at their optimal dosage. If possible, depending on clinical benefit, an attempt should be made to subsequently reduce the dosage of other antimyoclonic drugs.

4.3 Contraindications

Piracetam is contra-indicated in patients with severe renal impairment (renal creatinine clearance of less than 20 ml per minute), hepatic impairment and to those under 16 years of age. It is also contraindicated in patients with cerebral haemorrhage, Huntington's Chorea and in those with hypersensitivity to piracetam, other pyrrolidone derivatives or any of the excipients .

4.4 Special Warnings And Preca

1. Name Of The Medicinal Product

Nabilone Capsules

2. Qualitative And Quantitative Composition

Nabilone Capsules contain 1.0mg Nabilone per capsule.

3. Pharmaceutical Form

Blue and white capsules imprinted "CL 3101.

4. Clinical Particulars

4.1 Therapeutic Indications

Nabilone is indicated for the control of nausea and vomiting, caused by chemotherapeutic agents used in the treatment of cancer, in patients who have failed to respond adequately to conventional antiemetic treatments.

4.2 Posology And Method Of Administration

Nabilone is for administration to adults only. It is not recommended for use in children younger than 18 years of age as safety and efficacy have not been established.

The usual adult dosage is 1mg or 2mg twice a day. To minimise side-effects, it is recommended that the lower starting dose is used and that the dose is increased as necessary. The first dose should be administered the night before initiation of chemotherapy, and the second dose should be given one to three hours before the first dose of the oncolytic agent is administered.

The maximum daily dose should not exceed 6mg, given in three divided doses.

Nabilone may be administered throughout each cycle of chemotherapy and, if necessary, for 48 hours after the last dose of each cycle. Data on the chronic use of nabilone are not available.

The elderly: as for adults (see 'precautions').

4.3 Contraindications

Nabilone is contra-indicated in patients with a known allergy to cannabinoid agents and when the nausea and vomiting arises from any cause other than cancer chemotherapy.

4.4 Special Warnings And Precautions For Use

As nabilone i

1. Name Of The Medicinal Product

Nicorette Icy White 2 mg Gum

Boots NicAssist Ice Mint 2 mg Gum.

2. Qualitative And Quantitative Composition

Chewing Gum containing 2 mg nicotine, as nicotine resinate.

For excipients, see 6.1.

3. Pharmaceutical Form

Medicated Chewing Gum

A square, coated, white coloured piece of gum

4. Clinical Particulars

4.1 Therapeutic Indications

Nicorette Icy White 2 mg Gum relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.

Nicorette Icy White 2 mg Gum is indicated in pregnant and lactating women making a quit attempt.

4.2 Posology And Method Of Administration

Adults and Children over 12 years of age

Nicorette Icy White 2 mg Gum should be chewed slowly according to the instructions.

The strength of gum to be used will depend on the smoking habits of the individual. In general, if the patient smokes 20 or less cigarettes a day, 2 mg nicotine gum is indicated. If more than 20 cigarettes per day are smoked, 4 mg nicotine gum will be needed to meet the withdrawal of the high serum nicotine levels from heavy smoking.

Nicorette Icy White 2 mg Gum should be used whenever the urge to smoke is felt or to prevent cravings in situations where these are likely to occur.

Smokers willing or able to stop smoking immediately should initially replace all their cigarettes with the Gum and as soon as they are able, reduce the number o

1. Name Of The Medicinal Product

NORPROLACTablets 25 micrograms

NORPROLACTablets 50 micrograms

NORPROLACTablets 75 micrograms

2. Qualitative And Quantitative Composition

Quinagolide, as the hydrochloride, 25, 50 and 75 micrograms

3. Pharmaceutical Form

Tablet for oral administration

4. Clinical Particulars

4.1 Therapeutic Indications

Hyperprolactinaemia (idiopathic or originating from a prolactin-secreting pituitary microadenoma or macroadenoma).

4.2 Posology And Method Of Administration

Since dopaminergic stimulation may lead to symptoms of orthostatic hypotension, the dosage of NORPROLAC should be initiated gradually with the aid of the 'starter pack', and given only at bedtime.

Adults

The optimal dose must be titrated individually on the basis of the prolactin-lowering effect and tolerability.

With the 'starter pack' treatment begins with 25 micrograms/day for the first 3 days, followed by 50 micrograms/day for a further 3 days. From day 7 onwards, the recommended dose is 75 micrograms/day.

If necessary, the daily dose may then be increased stepwise until the optimal individual response is attained. The usual maintenance dosage is 75 to 150 micrograms/day.

Daily doses of 300 micrograms or higher doses are required in less than one-third of the patients.

In such cases, the daily dosage may be increased in steps of 75 to 150 micrograms at intervals not shorter than 4 weeks until satisfactory therapeutic effectiveness is achieved or reduced tolerability, requiring the discontinuation of treatment, occurs.

Eld

1. Name Of The Medicinal Product

Nurofen for Children Strawberry Baby

Nurofen for Children 3 months to 9 years Strawberry

2. Qualitative And Quantitative Composition

Ibuprofen 100 mg/5ml (equivalent to 2.0% w/v).

For excipients, see 6.1.

3. Pharmaceutical Form

Oral suspension.

An off-white, strawberry-flavoured, syrupy suspension.

4. Clinical Particulars

4.1 Therapeutic Indications

Prescription and OTC: For the fast and effective reduction of fever, including post immunisation pyrexia and the fast and effective relief of the symptoms of colds and influenza and mild to moderate pain, such as a sore throat, teething pain, toothache, headache, minor aches and sprains.

4.2 Posology And Method Of Administration

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

For pain, fever and symptoms of cold and infuenza: The daily dosage of Nurofen For Children is 20-30 mg/kg bodyweight in divided doses. Using the spoon or syringe dosing device provided this can be achieved as follows:

Infants 3 - 6 months weighing more than 5kg: One 2.5ml dose may be taken 3 times in 24 hours.

Infants 6 - 12 months: One 2.5ml dose may be taken 3 to 4 times in 24 hours.

Children 1 - 3 years: One 5ml dose may be taken 3 times in 24 hours.

Children 4 - 6 years: 7.5ml (5ml +2.5ml spoonful) may be taken 3 times in 24 hours.

Children 7 - 9 years: Two 5ml doses may be taken 3 times in 24 hours.

Children 10 12 years: Three 5ml doses may be taken 3 times in 24 hours.

Doses should be given approximately ever

1. Name Of The Medicinal Product

NAPROXEN TABLETS BP 500mg

2. Qualitative And Quantitative Composition

Each tablet contains 500mg Naproxen PhEur.

3. Pharmaceutical Form

Yellow uncoated tablets.

Yellow, capsule-shaped, biconvex uncoated tablets impressed C on one face, and the identifying letters N and D on either side of a central division line across the minor axis on the reverse.

4. Clinical Particulars

4.1 Therapeutic Indications

Naproxen is indicated for the treatment of:

1) Rheumatoid arthritis.

2) Osteoarthritis (degenerative arthritis).

3) Ankylosing spondylitis.

4) Acute gout.

5) Acute musculoskeletal disorders such as cervical spondylitis, lumbosacral pain, direct trauma, strains and sprains, fibrositis and tenosynovitis.

4.2 Posology And Method Of Administration

Posology

Adults:

Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis: 500mg-1g daily in two doses at twelve hour intervals, or alternatively, as a single administration of two tablets, morning or evening.

A loading dose of 750mg-1g daily for the acute phase is recommended in the following cases:

a) Patients reporting severe night time pain and/or morning stiffness.

b) Patients commencing naproxen therapy following a switch from a high dose of another antirheumatic compound.

c) Osteoarthritis where pain is the predominant symptom.

For patients requiring 750mg or 1g daily, the size of the morning and evening doses may be adjusted on the basis of the predominant symptoms eg night t

Nutraplus

urea

CREAM

Nutraplus 10% Cream

Urea

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use Nutraplus carefully to get the best results from it.

  • Keep this leaflet. You may need to read it again.
  • Ask your pharmacist if you need more information or advice.
  • You must contact a doctor if your symptoms worsen or do not improve.
  • If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

  • 1. What Nutraplus is and what it is used for
  • 2. Before you use Nutraplus
  • 3. How to use Nutraplus
  • 4. Possible side effects
  • 5. How to store Nutraplus
  • 6. Further information

What Nutraplus is and what it is used for

  • Nutraplus is an emollient, a moisturising and protective cream for the treatment of dry or damaged skin.
  • The active substance in this product is urea, a natural substance found in healthy skin.
  • The presence of urea in the cream moisturises the skin. This helps bring back soft and supple skin.

Before you use Nutraplus

Do not use Nutraplus

  • If you are allergic (hyper

1. Name Of The Medicinal Product

NEXIUM 20 mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains: 20mg esomeprazole (as magnesium trihydrate).

For excipients see 6.1.

3. Pharmaceutical Form

Gastro-resistant tablet

20 mg: A light pink, oblong, biconvex, film-coated tablet engraved 20 mg on one side and

4. Clinical Particulars

4.1 Therapeutic Indications

NEXIUM tablets are indicated for:

Gastroesophageal Reflux Disease (GERD)

treatment of erosive reflux esophagitis

long-term management of patients with healed esophagitis to prevent relapse

symptomatic treatment of gastroesophageal reflux disease (GERD)

In combination with an appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori and

healing of Helicobacter pylori associated duodenal ulcer and

prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcers.

4.2 Posology And Method Of Administration

The tablets should be swallowed whole with liquid. The tablets should not be chewed or crushed.

Gastroesophageal Reflux Disease (GERD)

treatment of erosive reflux esophagitis

40 mg once daily for 4 weeks.

An additional 4 weeks treatment is recommended for patients in whom esophagitis has not healed or who have persistent symptoms.

long-term management of patients with healed esophagitis to preven

1. Name Of The Medicinal Product

Nurofen Express 256 mg Caplets

2. Qualitative And Quantitative Composition

Ibuprofen 200 mg (as sodium dihydrate).

Also contains the following excipients:

carmellose sodium

xylitol

sucrose

For a full list of excipients, see Section 6.1.

3. Pharmaceutical Form

Tablet

A white to off-white, biconvex, oval sugar coated tablet printed with an identifying logo in black on one face.

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of mild to moderate pain, such as headache, backache, period pain, dental pain, neuralgia, rheumatic and muscular pain, migraine, cold and flu symptoms, sore throat and fever.

4.2 Posology And Method Of Administration

For oral administration and short-term use only.

Adults, the elderly and children over 12 years:

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days.

Adults and children over 12 years: Initial dose, 200mg to 400mg, up to three times a day as required.

Leave at least four hours between doses and do not take more than 1200mg in any 24 hour period.

Not for use by children under 12 years of age.

Elderly: No special dosage modifications are required (see Section 4.4).

4.3 Contraindications

Patients with a known hypersensitivity to ibuprofen or any other constituent of the medicinal product.

Patients who have previously shown hypersensitivity r

NutropinAq

10 mg/2 ml (30 IU), solution for injection

Somatropin

Read all of this leaflet carefully before you start using this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

  • 1. What NutropinAq is and what it is used for
  • 2. Before you use NutropinAq
  • 3. How to use NutropinAq
  • 4. Possible side effects
  • 5. How to store NutropinAq
  • 6. Further Information

WHAT NutropinAq IS AND WHAT IT IS USED FOR

Somatropin has effects that are equivalent to human growth hormone of pituitary origin. Growth hormone exerts significant effects directly on the production of other hormones, e.g. IGF-1, and on metabolic actions. The anabolic and growth-promoting effects of somatropin are to some part indirect effects mediated by IGF-1.

NutropinAq is indicated for:

  • Long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion.
  • Long-term treatment of growth failure associated with Turner syndr

1. Name Of The Medicinal Product

NIOPAM 340, solution for injection

2. Qualitative And Quantitative Composition

69.4% w/v Iopamidol equivalent to 340mg iodine/ml.

Each ml contains 694 mg Iopamidol.

For excipients, see 6.1.

3. Pharmaceutical Form

Solution for injection.

Clear aqueous solution filled into colourless glass bottles.

4. Clinical Particulars

4.1 Therapeutic Indications

X-ray contrast medium for use in peripheral arteriography, angiocardiography and left ventriculography, coronary arteriography, aortography - retrograde, selective renal arteriography, selective visceral angiography, digital subtraction angiography, computer tomography enhancement, urography and arthrography.

4.2 Posology And Method Of Administration

Route of administration

Intra-ventricular

Intra-arterial

Intravenous

Intra-articular

Dosage

NIOPAM 340 : DOSAGE SCHEDULE

Procedure

Dosage

Peripheral arteriography and venography

Adults 10 - 50 ml

Children: **

Angiocardiography and left ventriculography

1. Name Of The Medicinal Product

NEVANAC 1 mg/ml eye drops, suspension

2. Qualitative And Quantitative Composition

1 ml of suspension contains 1 mg nepafenac.

Excipients: benzalkonium chloride 0.05 mg.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Eye drops, suspension (eye drops)

Light yellow to dark yellow uniform suspension, pH 7.4 (approximately).

4. Clinical Particulars

4.1 Therapeutic Indications

Prevention and treatment of postoperative pain and inflammation associated with cataract surgery (see section 5.1).

4.2 Posology And Method Of Administration

Use in adults, including the elderly

The dose is one drop of NEVANAC in the conjunctival sac of the affected eye(s) 3 times daily beginning 1 day prior to cataract surgery, continued on the day of surgery and for the first 2 weeks of the postoperative period. Treatment can be extended to the first 3 weeks of the postoperative period, as directed by the clinician. An additional drop should be administered 30

Paediatric patients

NEVANAC is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.

Use in hepatic and renal impairment

NEVANAC has not been studied in patients with hepatic disease or renal impairment. Nepafenac is eliminated primarily through biotransformation and the systemic exposure is very low following topical ocular administration. No dose adjustment is warranted in these patients.

Method of administration

For ocular use.

Instruct pat

1. Name Of The Medicinal Product

Nicorette 10mg Patch or Boots NicAssist 10 mg Patch

2. Qualitative And Quantitative Composition

Nicotine, 10mg released over 16 hours use. Each patch is 20 sq.cm, containing nicotine 0.83mg/sq.cm.

For excipients see section 6.1

3. Pharmaceutical Form

Transdermal Patch

4. Clinical Particulars

4.1 Therapeutic Indications

Nicorette Patch is indicated for the relief of nicotine withdrawal symptoms as an aid to smoking cessation in adults and children over 12 years of age. It is also indicated in pregnant and lactating women (see section 4.6).

If possible, Nicorette Patch should be used in conjunction with a behavioural support programme.

4.2 Posology And Method Of Administration

The patient should make every effort to stop smoking completely during treatment with Nicorette Patch.

Behavioural therapy, advice and support will normally improve the success rate.

Nicorette Patch should be applied to clean, dry intact areas of hairless skin, for example on the hip, upper arm, or chest. These areas should be varied each day and the same site should not be used on consecutive days.

There is no clinically significant difference in bioavailability of nicotine when the patch is applied to either the hip, upper arm or chest.

Adults (over 18 years of age)

The daily dose is one patch delivering 15mg, 10mg or 5mg nicotine as appropriate, with application limited to 16 hours in a 24 hour period in each case.

Daily treatment commences with one 15mg (30cm2) patch, applied on waking (usually in the morning) and removed 16 hours later (usually at be

1. Name Of The Medicinal Product

Nizoral 2% cream

2. Qualitative And Quantitative Composition

Ketoconazole 2% w/w (each gram of cream contains 20mg).

Excipients;

propylene glycol, 20%w/w (each gram of cream contains 200mg).

stearyl alcohol, 7.5%w/w (each gram of cream contains 75mg).

cetyl alcohol, 2.0%w/w (each gram of cream contains 20mg).

For a full list of excipients, see 6.1.

3. Pharmaceutical Form

Cream

4. Clinical Particulars

4.1 Therapeutic Indications

For topical application in the treatment of dermatophyte infections of the skin such as tinea corporis, tinea cruris, tinea manus and tinea pedis infections due to Trichophyton spp, Microsporon spp and Epidermophyton spp. Nizoral 2% cream is also indicated for the treatment of cutaneous candidosis (including vulvitis), tinea (pityriasis) versicolor and seborrhoeic dermatitis caused by Malassezia (previously called Pityrosporum) spp.

4.2 Posology And Method Of Administration

Tinea pedis:

Nizoral 2% cream should be applied to the affected areas twice daily. The usual duration of treatment for mild infections is 1 week. For more severe or extensive infections (eg involving the sole or sides of the feet) treatment should be continued until a few days after all signs and symptoms have disappeared in order to prevent relapse.

For other infections:

Nizoral 2% cream should be applied to the affected areas once or twice daily, depending on the severity of the infection.

The treatment should be continued until a few days after the disappearance of all signs

1. Name Of The Medicinal Product

NAVELBINE 10 mg / ml concentrate for solution for infusion

2. Qualitative And Quantitative Composition

Vinorelbine 10 mg/ml as vinorelbine tartrate

Each 1ml vial contains 10 mg Vinorelbine as vinorelbine tartrate

Each 4ml vial contains 40 mg Vinorelbine as vinorelbine tartrate

Each 5ml vial contains 50 mg Vinorelbine as vinorelbine tartrate

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Concentrate for solution for infusion.

Navelbine is a clear colourless to pale yellow solution with a pH range from 3.3 to 3.8.

4. Clinical Particulars

4.1 Therapeutic Indications

- As a single agent or in combination for the first line treatment of stage 3 or 4 non small cell lung cancer.

- Treatment of advanced breast cancer stage 3 and 4 relapsing after or refractory to an anthracycline containing regimen.

4.2 Posology And Method Of Administration

Strictly intravenous administration after appropriate dilution

Intra-thecal administration of Navelbine may be fatal.

Navelbine must only be administered by the intravenous route as an infusion over 6 10 minutes.

Instructions for use and handling: see section 6.6.

Administration

- It is recommended to infuse Navelbine over 6 to 10 minutes after dilution in a 50 ml infusion bag with sodium chloride 9 mg/ml (0.9%) solution for injection or in 5% glucose solution for injection.

- Administration should always be followed with at least 250 ml of a normal saline infusion to flush the vein.

- The infusion time of 6 to 10 minut

Nitrazepam 5mg tablets

Read all of this leaflet carefully before you start taking this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

  • 1 What Nitrazepam tablets are and what they are used for
  • 2 Before you take
  • 3 How to take
  • 4 Possible side effects
  • 5 How to store
  • 6 Further information

What Nitrazepam tablets are and what they are used for

Nitrazepam belongs to a group of medicines called benzodiazepines. Nitrazepam tablets may be used for the short term treatment of sleeplessness, which is severe, disabling or distressing, and when sleepiness during the day is acceptable.

Before you take

Do not take Nitrazepam tablets and tell your doctor if you

  • are allergic (hypersensitive) to Nitrazepam or to other benzodiazepine medicines or to any of the other ingredients in your tablets (see section 6)
  • are breathless or have difficulty breathing
  • have a phobia (a fear of a particular object or situation), obsession or other mental illness
  • have myasthenia gravis (a condition which causes muscles to weaken and tire easily)

1. Name Of The Medicinal Product

Nutrizym 10

2. Qualitative And Quantitative Composition

Each capsule contains Pancreatin BP 155mg with not less than the following activities.

Lipase 10,000 BP Units, Protease 500 BP Units and Amylase 9000 BP Units.

3. Pharmaceutical Form

Hard gelatin capsule containing enteric coated pancreatin minitablets for oral administration.

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of pancreatic exocrine insufficiency such as in fibrocystic disease of the pancreas and chronic pancreatitis.

4.2 Posology And Method Of Administration

Adults (including the elderly) and children:

1-2 capsules with meals and 1 capsule with snacks.

Since the individual response to pancreatin supplements is variable, the number of capsules taken may need to be titrated to the individual according to symptoms and at the discretion of the physician. Dose increase, if required should be added slowly with careful monitoring of response and symptomatology.

Colonic damage has been reported in patients with cystic fibrosis taking in excess of 10,000 units of lipase/kg/day. The dose of Nutrizym 10 should usually not exceed this dose.

Capsules should be swallowed whole with water. Where swallowing of capsules proves to be difficult, the minitablets may be removed and taken with water or mixed with a small amount of soft food and swallowed immediately without chewing.

Adequate patient hydration should be ensured at all times whilst treating with Nutrizym 10.

4.3 Contraindications

Known hypersensitivity to the active ingredient (porcine pancreatin) or any of the excipients.

1. Name Of The Medicinal Product

NAPROXEN EC TABLETS 500mg

2. Qualitative And Quantitative Composition

Each tablet contains: 500mg Naproxen.

3. Pharmaceutical Form

Gastro-resistant tablets.

White, oval, biconvex, deep concave, enteric-coated tablets.

4. Clinical Particulars

4.1 Therapeutic Indications

Naproxen is indicated for the treatment of:

1) Rheumatoid arthritis.

2) Osteoarthritis (degenerative arthritis).

3) Ankylosing spondylitis.

4) Juvenile rheumatoid arthritis.

5) Acute gout.

6) Acute musculoskeletal disorders.

7) Dysmenorrhoea.

4.2 Posology And Method Of Administration

Posology

Adults:

Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis: 500mg-1g daily in two doses at twelve hourly intervals, or alternatively, if 1g daily is needed this can be administered as two 500mg doses or as a single dose. The size of the morning and evening doses can be adjusted on the basis of the predominant symptoms (ie night time pain or morning stiffness)

Acute gout: Initially 750mg followed by 250mg every 8 hours until the attack has passed.

Acute musculoskeletal disorders and dysmenorrhoea: Initially 500mg followed by 250mg every 6-8 hours as necessary to a maximum of 1250mg daily after the first day.

Children over 5 years: For juvenile rhematoid arthritis 10mg/kg a day taken in two doses every 12 hours.

Elderly: The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest

1. Name Of The Medicinal Product

NiQuitin Minis Mint 1.5 mg Lozenges.

2. Qualitative And Quantitative Composition

Each lozenge contains 1.5 mg nicotine (as nicotine resinate).

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Compressed Lozenge (lozenge)

White to off white oval tablet with convex surfaces; one surface bearing a debossed L logo.

4. Clinical Particulars

4.1 Therapeutic Indications

NiQuitin Minis 1.5 mg Lozenges relieve and/or prevent craving and nicotine withdrawal symptoms associated with tobacco dependence. They are indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.

NiQuitin Minis 1.5 mg Lozenges are indicated in pregnant and lactating women making a quit attempt.

NiQuitin Minis Mint 1.5 mg Lozenges should preferably be used in conjunction with a behavioural support programme.

4.2 Posology And Method Of Administration

Directions for use:

The strength of lozenge to be used will depend on the smoking habits of the individual.

NiQuitin Minis Mint 1.5 mg Lozenges are suitable for smokers who smoke 20 cigarettes or less a day.

One lozenge should be placed in the mouth and allowed to dissolve. Periodically, the lozenge should be moved from one side of the mouth to the other, and repeated, until the lozenge is completely dissolved (approximately 10 minutes). The lozenge should not be chewed or swallowed whole.

Users should not eat or drink while a lozenge is in the mouth.

Be

1. Name Of The Medicinal Product

NiQuitin 14 mg transdermal patches.

2. Qualitative And Quantitative Composition

Each 15 cm2 contains 78 mg nicotine, equivalent to 5.1 mg/cm2 of nicotine and delivering 14 mg over 24 hours.

For excipients, see section 6.1.

3. Pharmaceutical Form

Transdermal patch.

Each patch is rectangular and is comprised of an outer matt pinkish tan-coloured layer, a middle silver layer and an outer clear layer which is removed prior to use.

4. Clinical Particulars

4.1 Therapeutic Indications

NiQuitin patches relieve and/or prevent craving and nicotine withdrawal symptoms associated with tobacco dependence. They are indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.

NiQuitin patches are indicated in pregnant and lactating women making a quit attempt.

If possible, when stopping smoking, NiQuitin patches should be used in conjunction with a behavioural support programme.

4.2 Posology And Method Of Administration

NiQuitin patches should be applied once a day, at the same time each day and preferably soon after waking, to a non-hairy, clean, dry skin site and worn continuously for 24 hours. The NiQuitin patch should be applied promptly on removal from its protective sachet.

Avoid applying to any skin which is broken, red or irritated. After 24 hours the used patch should be removed and a new patch applied to a fresh skin site. The patch should not be left on for longer than 24 hours. Skin sites should not be reused for at least seven days. Only one patch should be worn at a time.