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1. Name Of The Medicinal Product

Nizoral 2% shampoo

2. Qualitative And Quantitative Composition

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

For a full list of excipients, see 6.1

3. Pharmaceutical Form

Pink viscous shampoo.

4. Clinical Particulars

4.1 Therapeutic Indications

Prevention and treatment of infections in which the yeast Malassezia (previously called Pityrosporum) is likely to be involved, such as dandruff, seborrhoeic dermatitis and tinea (pityriasis) versicolor.

4.2 Posology And Method Of Administration

For topical administration.

Adults, Elderly and Children:

Wash affected areas and leave for 3-5 minutes before rinsing.

Treatment:

Dandruff and seborrhoeic dermatitis: Wash hair twice weekly for 2-4 weeks.
Tinea versicolor: Once daily for a maximum of 5 days.

Prophylaxis:

Dandruff and seborrhoeic dermatitis: Use once every 1-2 weeks.
Tinea versicolor: Once daily for a maximum of 3 days before exposure to sunshine.

1. Name Of The Medicinal Product

NiQuitin 21 mg transdermal patches.

2. Qualitative And Quantitative Composition

Each 22 cm2 transdermal patch contains 114 mg nicotine, equivalent to 5.1 mg/cm2 of nicotine and delivering 21 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

1. Name Of The Medicinal Product

Ibuprofen 200mg Liquicaps

Nurofen Express 200mg Liquid Capsules

Nurofen 200mg Liquid Capsules

2. Qualitative And Quantitative Composition

Each capsule, soft contains Ibuprofen 200 mg.

Excipients:

Potassium hydroxide

Sorbitol

For a full list of excipients see 6.1.

3. Pharmaceutical Form

Capsule, soft.

A clear red oval soft gelatin capsule printed with an identifying logo in white.

4. Clinical Particulars

4.1 Therapeutic Indications

Adults and children over 12 years:

Ibuprofen 200mg Liquicaps are indicated for the symptomatic relief of rheumatic or muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness colds and influenza symptoms

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.

Take one or two capsules, up to three times a day as required.

Leave at least 4 hours between doses.

Do not take more than 6 capsules in any 24 hour period.

4.3 Contraindications

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

Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin

1. Name Of The Medicinal Product

Nu-Seals 300

Aspirin 300mg Gastro-resistant Tablets

2. Qualitative And Quantitative Composition

Acetylsalicylic Acid 300mg

3. Pharmaceutical Form

White, gastro-resistant tablets, coded “300” in red or “GP” in black

4. Clinical Particulars

4.1 Therapeutic Indications

Aspirin has analgesic, antipyretic and anti-inflammatory actions. It can also be used for the secondary prevention of thrombotic cerebrovascular or cardiovascular disease and following by-pass surgery (see below).

Aspirin has an anti-thrombotic action, mediated through inhibition of platelet activation, which has been shown to be useful in secondary prophylaxis following myocardial infarction, and in patients with unstable angina or ischaemic stroke including cerebral transient attacks.

Nu-Seals 300 is indicated wherever high and prolonged dosage of aspirin is required. The special coating resists dissolution in gastric juice, but will dissolve readily in the relatively less acid environment of the duodenum. Owing to the delay that the coating imposes on the release of the active ingredient, Nu-Seals 300 is unsuitable for the short-term relief of pain.

4.2 Posology And Method Of Administration

Nu-Seals 300 is for oral administration to adults only.

Analgesic, antipyretic and anti-inflammatory actions: The usual dose of aspirin is 300-900mg repeated three to four times daily according to clinical needs. In acute rheumatic disorders the dose is in the range of 4-8 g daily, taken in divided doses.

Antithrombotic action: Patients should seek the advice of a doctor before commencing therapy for the first time. The usual dosage, for long-term use following myoca

1. Name Of The Medicinal Product

NAPROXEN EC TABLETS 250mg

2. Qualitative And Quantitative Composition

Each tablet contains: 250mg Naproxen.

3. Pharmaceutical Form

Gastro-resistant tablets.

White, round, biconvex 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 effective dos

NEORAL Soft Gelatin Capsules

(ciclosporin)

This product will be called Neoral Capsules or Neoral in this leaflet.

What you need to know about Neoral Capsules

Your doctor has decided that you need this medicine to help treat your condition.

Please read this leaflet carefully before you start to take your medicine. It contains important information. Keep the leaflet in a safe place because you may want to read it again. If you have any other questions, or if there is something you don’t understand, please ask your doctor or pharmacist.

This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be 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 Neoral Capsules are and what they are used for
  • 2. Things to consider before you start to take Neoral Capsules
  • 3. How to take Neoral Capsules
  • 4. Possible side effects
  • 5. How to store Neoral Capsules
  • 6. Further information

What Neoral Capsules are and what they are used for

Neoral Capsules are available in four different strengths containing 10, 25, 50 or 100 mg of the active ingredient, ciclosporin. Ciclosporin is one of a group of drugs known as immunosuppressive agents. These drugs are used to dampen down the body's immune reactions.

Neoral Capsules can be used to treat a number of differ

1. Name Of The Medicinal Product

Nurofen 200 mg Tablets

2. Qualitative And Quantitative Composition

Ibuprofen 200 mg

For excipients, see 6.1.

3. Pharmaceutical Form

Coated Tablet

A white to off-white, biconvex, round, sugar coated tablet printed 'Nurofen' in black on one face.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of migraine-headaches, backache, dental pain, neuralgia and period pains as well as rheumatic and muscular pains.

Nurofen relieves pain and reduces inflammation and temperature as well as relieving headaches and other types of pain. It also relieves cold and flu symptoms.

4.2 Posology And Method Of Administration

For oral administration and short-term use only.

During short-term use, if symptoms persist or worsen the patient should be advised to consult a doctor.

Adults and children over 12 years:

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

Take 1 or 2 tablets with water, up to three times a day as required.

Leave at least four hours between doses.

Do not take more than 6 tablets in any 24 hour period.

Not for use by children under 12 years of age.

4.3 Contraindications

Hypersensitivity to ibuprofen or any of the excipients in the product.

Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs.

1. Name Of The Medicinal Product

Naprosyn EC 250mg Tablets

Naprosyn EC 375mg Tablets

Naprosyn EC 500mg Tablets

2. Qualitative And Quantitative Composition

Naprosyn EC 250mg Tablets:

Each tablet contains 250mg naproxen.

Naprosyn EC 375mg Tablets:

Each tablet contains 375mg naproxen.

Naprosyn EC 500mg Tablets:

Each tablet contains 500mg naproxen.

For excipients, see 6.1.

3. Pharmaceutical Form

Gastro-resistant film-coated tablets.

Naprosyn EC 250mg Tablets:

Round white tablet marked 'NPR EC 250' in black ink on one side.

Naprosyn EC 375mg Tablets:

White, oval convex tablet marked 'NPR EC 375' in black ink on one side.

Naprosyn EC 500mg Tablets:

Capsule shaped, white tablet marked 'NPR EC 500' in black ink on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

Naprosyn EC is indicated for the treatment of rheumatoid arthritis, osteoarthrosis (degenerative arthritis), ankylosing spondylitis, acute musculoskeletal disorders (such as sprains and strains, direct trauma, lumbosacral pain, cervical spondylitis, tenosynovitis and fibrositis) and dysmenorrhoea.

4.2 Posology And Method Of Administration

For oral administration.

To be taken preferably with or after food.

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

1. Name Of The Medicinal Product

Nicorette Mint 2mg Gum (or Boots NicAssist 2 mg mint gum)

2. Qualitative And Quantitative Composition

Chewing Gum containing 2mg nicotine, as nicotine resinate.

For excipients see section 6.1

3. Pharmaceutical Form

Chewing Gum

4. Clinical Particulars

4.1 Therapeutic Indications

Nicorette Mint 2mg Gum 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).

In smokers currently unable or not ready to stop smoking abruptly, the gum may also be used as part of a programme to reduce smoking prior to stopping completely.

If possible, Nicorette Mint 2mg Gum should be used in conjunction with a behavioural support programme.

4.2 Posology And Method Of Administration

Nicorette Mint 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, 2mg nicotine gum is indicated. If more that 20 cigarettes per day are smoked, 4mg nicotine gum will be needed to meet the withdrawal of the high serum nicotine levels from heavy smoking.

The chewing gums should be used whenever there is an urge to smoke according to the “chew and rest” technique described on the pack. After about 30 minutes of such use, the gum will be exhausted. Not more than 15 pieces of the chewing gum may be used each day. Absorption of nicotine is through the buccal mucosa, any nicotine which is swallowed being destroyed by the liver.

Behavioural therapy, advice and su

1. Name Of The Medicinal Product

Noradrenaline (Norepinephrine) 1:1000 or Levophed

concentrate for solution for infusion

2. Qualitative And Quantitative Composition

Noradrenaline Tartrate 2 mg/ml

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Concentrate for solution for infusion

4. Clinical Particulars

4.1 Therapeutic Indications

Norepinephrine 1:1000 is recommended for use as an emergency measure in the restoration of blood pressure in cases of acute hypotension.

4.2 Posology And Method Of Administration

Route of Administration:

For intravenous use.

Route and method of infusion:

Norepinephrine 1:1000 should be administered in a diluted solution via a central venous catheter.

The infusion should be at a controlled rate using either a syringe pump or an infusion pump or a drip counter.

Dilution instructions:

Norepinephrine 1:1000 should be diluted either with dextrose 5%, or with isotonic dextrose saline.

Adults:

Either add 2 ml of Norepinephrine 1:1000 to 48 ml 5% dextrose for administration by syringe pump, or add 20 ml of Norepinephrine 1:1000 to 480 ml 5% dextrose for administration by drip counter.

In both cases the final concentration of the infusion solution is 80 mg/litre norepinephrine tartrate, which is equivalent to 40 mg/litre norepinephrine base. If other dilutions are used check the calculation carefully before starting treatment.

Initial rate of infusion:

The

1. Name Of The Medicinal Product

NIOPAM 370, solution for injection.

2. Qualitative And Quantitative Composition

75.5% w/v Iopamidol equivalent to 370mg iodine/ml.

Each ml contains 755.3 mg Iopamidol.

For excipients, see 6.1.

3. Pharmaceutical Form

Solution for injection.

Clear aqueous solution filled into colourless glass ampoules or 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

Urography

4.2 Posology And Method Of Administration

Route of administration

Intra-arterial

Intra-venous

Intra-ventricular

Dosage

NIOPAM 370 : DOSAGE SCHEDULE

Procedure

Dosage

Peripheral Arteriography

 

Venography

Adults 20 - 50 ml *

Children **

Adults 20 - 50 ml *

1. Name Of The Medicinal Product

Neoclarityn 5 mg film-coated tablets

2. Qualitative And Quantitative Composition

Each tablet contains 5 mg desloratadine.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablets

4. Clinical Particulars

4.1 Therapeutic Indications

Neoclarityn is indicated for the relief of symptoms associated with:

- allergic rhinitis (see section 5.1)

- urticaria (see section 5.1)

4.2 Posology And Method Of Administration

Adults and adolescents (12 years of age and over): one tablet once a day, with or without a meal for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria (see section 5.1).

There is limited clinical trial efficacy experience with the use of desloratadine in adolescents 12 through 17 years of age (see sections 4.8 and 5.1).

Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than 4 weeks) should be managed in accordance with the evaluation of patient's disease history and the treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance.

In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4 weeks), continued treatment may be proposed to the patients during the allergen exposure periods.

4.3 Contraindications

Hypersensitivity to the active substance, to any of the excipients, or to loratadine.

4.4 Special Warnings And Precautions For Use

Efficacy and safety of Neoclarityn tablets in children under 12 years of

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

1. Name Of The Medicinal Product

Nicorette QuickMist 1mg/spray mouthspray

2. Qualitative And Quantitative Composition

0.07 ml contains 1 mg nicotine, corresponding to 1 mg nicotine/spray dose.

Excipient: ethanol (contains less than 100 mg of ethanol/spray dose).

For a full list of excipients see section 6.1.

3. Pharmaceutical Form

Oromucosal spray.

A clear to weakly opalescent, colourless to light yellow solution with a scent of peppermint.

4. Clinical Particulars

4.1 Therapeutic Indications

Nicorette QuickMist 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 QuickMist is indicated in pregnant and lactating women making a quit attempt.

4.2 Posology And Method Of Administration

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

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

Directions for use

If you are using Nicorette QuickMist for the first time or if you have not used the spray for 2 days, you must first prime the spray pump.

Priming

1. Point the spray safely away from you and any other adults, children or pets that are near you.

2. Press the top of the QuickMist with your index finger 3 times until a fine spray appears.

Note: priming reduces the number of sprays you may get from Nicor

1. Name Of The Medicinal Product

Nabumetone 500 mg Film-coated Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 500 mg nabumetone. For excipients, see 6.1.

3. Pharmaceutical Form

Dark red, film-coated tablets, unengraved on both sides.

4. Clinical Particulars

4.1 Therapeutic Indications

Nabumetone is a non-acidic non-steroidal anti-inflammatory agent which is a relatively weak inhibitor of prostaglandin synthesis. However, following absorption from the gastrointestinal tract it is rapidly metabolised in the liver to the principal active metabolite, 6-methoxy-2-naphthylacetic acid (6-MNA), a potent inhibitor of prostaglandin synthesis.

It is indicated for the treatment of osteoarthritis and rheumatoid arthritis requiring anti-inflammatory and analgesic treatment.

4.2 Posology And Method Of Administration

For oral administration.

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

Nabumetone 500mg film-coated tablets should be taken preferably with or after food.

Adults

The recommended daily dose is two tablets (1 g) taken as a single dose at bedtime.

For severe or persistent symptoms, or during acute exacerbations, an additional one or two tablets (500 mg-1 g) may be given as a morning dose.

Elderly

In common with many drugs, blood levels may be higher in elderly patients. The recommended daily dose of 1 g should not be exceeded in this age group and in some cases 500 mg may give satisfactory relief.

The elderly are at increased r

1. Name Of The Medicinal Product

NiQuitin 4 mg Lozenges

2. Qualitative And Quantitative Composition

Each lozenge contains 4 mg nicotine (as nicotine resinate). For excipients see Section 6.1.

3. Pharmaceutical Form

Lozenge

White, round lozenge with convex surfaces, debossed NL4 on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

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

NiQuitin Lozenges should preferably be used in conjunction with a behavioural support programme.

4.2 Posology And Method Of Administration

Directions for use:

NiQuitin 4 mg Lozenges are suitable for smokers who have their first cigarette of the day within 30 minutes of waking up.

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 20 – 30 minutes). The lozenge should not be chewed or swallowed whole.

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

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

Adults (18 years and over):

Abr

1. Name Of The Medicinal Product

Nicotinell Mint 2mg Medicated Chewing Gum

2. Qualitative And Quantitative Composition

One piece of medicated chewing gum contains 2 mg nicotine (as 10 mg nicotine – polacrilin (1:4)).

For excipients, see section 6.1

3. Pharmaceutical Form

Medicated chewing gum.

Each piece of coated chewing gum is off-white in colour and rectangular in shape.

4. Clinical Particulars

4.1 Therapeutic Indications

Nicotinell gum is indicated for the relief of nicotine withdrawal symptoms, as an aid to smoking cessation.

Concurrent counselling/behavioural support is recommended as it is likely to increase the chances of a successful quit.

4.2 Posology And Method Of Administration

Adults and elderly

Users should stop smoking completely during treatment with Nicotinell gum.

One piece of Nicotinell gum to be chewed when the user feels the urge to smoke. Normally, 8-12 pieces per day can be used, up to a maximum of 25 pieces per day.

The 2 mg chewing gum may not be well suited to smokers with a strong or very strong nicotine dependency.

The 4 mg chewing gum is intended to be used by smokers with a strong or very strong nicotine dependency and those who have previously failed to stop smoking with the aid of nicotine replacement therapy.

The optimal dosage form is selected according to the following table:

 

If an adverse event is noted when high dose forms are initiated, this should be replaced

Nu-Seals 300

aspirin (acetylsalicylic acid)

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.

The information in this leaflet has been divided into the following sections:

  • 1. What Nu-Seals 300 is and what it is taken for
  • 2. Check before you take Nu-Seals 300
  • 3. How to take Nu-Seals 300
  • 4. Possible side effects
  • 5. How to store Nu-Seals 300
  • 6. Further information

What Nu-Seals 300 is and what it is taken for

Nu-Seals 300 contains aspirin. Aspirin is used:

  • as an anti-inflammatory analgesic which can relieve pain and swelling
  • to bring down high body temperatures
  • to prevent recurrence of heart attacks or strokes by thinning the blood. If someone who has previously had a heart attack or stroke takes Nu-Seals 300 regularly, it reduces the risk of a blood clot occurring in the heart or brain. This can prevent further heart attacks or strokes.

If you take aspirin in high doses or over a long period of time, it can irritate your stomach lining. To prevent stomach irritation, these tablets have a special coating (called enteric) so that the aspirin is

NORGALAX rectal gel

Docusate Sodium

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 become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

If you need the information on this leaflet in an alternative format, such as large text, or Braille please ring from the UK: 0800 198 5000.

In this leaflet:

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

What Norgalax Is And What It Is Used For

NORGALAX softens the faeces (stools) to make your bowel movements easier. It will help you when you are constipated or can be used to empty the large intestine (gut) if the doctor wants to examine inside it.

Before You Use Norgalax

Do not use NORGALAX if:

  • You have haemorrhoids (piles) or bleeding from your rectum (back passage).
  • You have a pain in your abdomen (tummy).
  • You feel sick or are being sick.
  • Your doctor has told you that you have:
    • A blockage in your intestine (gut).
    • Sores around your anus (bottom) called anal fi

1. Name Of The Medicinal Product

Normosang 25 mg/ml, concentrate for solution for infusion.

2. Qualitative And Quantitative Composition

Human hemin ………………………………………………………………………………………..25 mg/ml.

One ampoule of 10 ml contains 250 mg human hemin.

After dilution of one 10 ml ampoule in 100 ml of 0.9% Na Cl solution, the diluted solution contains 2273 micrograms per ml of human hemin.

Excipients: ethanol 96% (1 g / 10 ml) (see section 4.4).

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Concentrate for solution for infusion.

Normosang is a dark coloured concentrate for solution for infusion.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of acute attacks of hepatic porphyria (acute intermittent porphyria, porphyria variegata, hereditary coproporphyria).

4.2 Posology And Method Of Administration

Posology

The recommended daily dose is 3 mg/kg once daily for four days, diluted in 100 ml of 0.9% sodium chloride in a glass bottle and infused intravenously over at least 30 minutes into a large antebrachial or central vein using an inline filter.

The dose should not exceed 250 mg (1 ampoule) per day.

Exceptionally, the course of the treatment may be repeated under strict biochemical surveillance if there is inadequate response after the first course of treatment.

Elderly patients

No dose adjustment is required.

Children and adolescents

Attacks of porphyria are rare in children but limited experience in tyrosinaemia suggests that it is