Glytrin

WHAT YOU SHOULD KNOW ABOUT GLYTRIN Spray

(Glyceryl Trinitrate)

Please read this carefully before you start to use Glytrin Spray. If you have any questions or are not sure about anything ask your doctor or pharmacist.

What Is In Your Medicine?

Your medicine is called Glytrin Spray.

It is a metered aerosol which delivers 400 micrograms of glyceryl trinitrate, the active ingredient, each time the button is pressed.

It contains the following inactive ingredients: peppermint oil, 1,1,1,2-tetrafluoroethane, ethanol.

Each aerosol can contains 200 doses.

Glyceryl trinitrate is one of a group of medicines called nitrates which relax the muscle walls of the blood vessels and reduce the workload of the heart.

Marketing Authorisation Holder:

Ayrton Saunders Ltd

Reeds Lane

Moreton

Wirral

CH46 1DW

UK

Manufactured by:

Pharmasol Limited

North Way

Andover

Hants

SP10 5AZ

UK

Distributed by:

Sanofi-Synthelabo

PO Box 597

Guildford

Surrey

Sanofi-Synthelabo Ireland

United Drug House

Belgard Road

Tallaght

Dublin 24

Ireland

What Is Your Medicine For?

You may use Glytrin Spray to relieve the pain of an angina attack as soon as it has started

or

to prevent it starting by using immediately before events which may set off your angina, for instance physical effort, emotional stress or exposure to cold.

Before Using Your Medicine

If you can answer yes to any of the following questions, do not use Glytrin Spray without first talking to your doctor:

• 1. Are you hypersensitive to nitrates?


• 2. Are you pregnant or likely to become so?


• 3. Are you breast-feeding your baby?


• 4. Do you have any of the following: low blood pressure or heart rate; severe anaemia or a condition called glucose-6-phosphate-dehydrogenase (G6PD) deficiency which can cause anaemia; a heart valve disorder; angina caused by a disease of the heart muscle; bleeding from the brain; fluid on the lungs?


• Have you had: shock caused by very low blood pressure, blood circulation problems or heart failure; a head injury; heart attack or heart failure?


• 5. Do you suffer from any of the following: a condition called pericardial tamponade in which fluid surrounding the heart puts pressure on the heart; problems controlling blood pressure when standing up which may cause dizziness, faintness or blurred vision; a disease which is accompanied by increased pressure on the brain; glaucoma; an underactive thyroid gland; liver or kidney disorders?


• 6. Are you taking any other medication, particularly medicines used to treat heart or blood pressure problems (including other nitrates and diuretics, or water tablets), anxiety, depression or migraine, or medication used to thin the blood?

If Viagra (sildenafil-for male erectile dysfunction) is used by patients taking nitrate preparations such as Glytrin Spray, a severe and possibly dangerous fall in blood pressure can occur. This would result in collapse, unconsciousness and could be fatal. You should not take Viagra whilst on Glytrin Spray.

Continuous use of nitrates may result in reduced effectiveness of Glytrin Spray and other nitrate medications.

You may wish to use Glytrin Spray urgently or in the dark, so if you have never used it before, practise spraying a few puffs into the air.

Never use Glytrin Spray near a naked flame e.g., cigarette.

Glytrin Spray should not be taken with alcohol.

Driving or using machines should be avoided during use of Glytrin Spray.

Using Your Medicine

Always check the label for directions on how to take your medicine. Your pharmacist will help if you are not sure.

If possible, it is recommended that you sit down to use your medicine.

Remove the cap. Hold the canister upright with forefinger on top of the white button. There is no need to shake the canister.

Open your mouth and bring the Glytrin Spray nozzle as close as possible, aiming it under your tongue.

Press the button firmly, directing the spray UNDER YOUR TONGUE while holding your breath. Keep the button held down until all the dose has been released. Close your mouth immediately but do not inhale the spray.

If necessary, repeat for a second time following the steps above. No more than three doses are recommended at one time.

Always replace the cap after use.

If you use Glytrin Spray during an attack, sit down and rest until the pain disappears.

If you accidentally take more than the recommended dose of Glytrin Spray tell your doctor or go to the nearest
hospital casualty department immediately. Remember to take your spray with you.

After Using Your Medicine

Glytrin Spray may occasionally cause headache, facial flushing, weakness, dizziness and faintness, particularly on standing up, light-headedness, abnormal heart rate, and nausea. There have been reports of tongue blistering. Rarely an allergic skin rash, fainting or a drop in blood pressure with an increase in the symptoms of angina may occur. You may only need to consult your doctor if these symptoms become troublesome. These symptoms may be made worse if you have been drinking alcohol or are taking prescribed medicine for high blood pressure.

If you experience any other ill effects or find that your medicine is becoming less effective, tell your doctor or pharmacist immediately and ask if you should continue with your medication.

Keeping Your Medicine Safe

Store below 25°C. Keep Glytrin Spray away from frost and direct sources of heat including sunlight.

Do not use this medicine after the month shown on the pack.

Keep Glytrin Spray out of the reach of children.

Do not attempt to puncture, break or burn the canister, even if it appears to be empty.

Make sure you have a Glytrin Spray with you at all times.

Make sure you get a new one before the old one runs out. Ideally, keep a spare handy.

REMEMBER this medicine is for you. Never give it to others. It may harm them even if their symptoms are the same as yours.

Date of revision of leaflet: September 2006.

MP00608

Glypressin Injection

1. Name Of The Medicinal Product

Glypressin^® Injection

2. Qualitative And Quantitative Composition

Each vial contains 1mg Terlipressin Acetate

For excipients, see 6.1

3. Pharmaceutical Form

Powder and solvent for solution for injection

Vial contains white, freeze-dried powder.

Ampoule contains solvent.

4. Clinical Particulars

4.1 Therapeutic Indications

Glypressin^® is indicated in the treatment of bleeding oesophageal varices.

4.2 Posology And Method Of Administration

In acute variceal bleeding, 2mg Glypressin^® should be administered by intravenous bolus, followed by 1 - 2mg every 4 - 6 hours until bleeding is controlled, up to a maximum of 72 hours.

Administration is by intravenous injection.

4.3 Contraindications

Pregnancy

4.4 Special Warnings And Precautions For Use

Since Glypressin^® has antidiuretic and pressor activity it should be used with great caution in patients with hypertension, atherosclerosis, cardiac dysrhythmias or coronary insufficiency. Constant monitoring of blood pressure, serum sodium and potassium and fluid balance is essential.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

Glypressin^® may stimulate contraction of smooth muscle and is therefore contraindicated in pregnancy. There is no data concerning its use in lactation.

4.7 Effects On Ability To Drive And Use Machines

Not applicable

4.8 Undesirable Effects

Glypressin^® is only recommended for the short-term treatment of bleeding oesophageal varices, so few side effects have been reported. Those noted have included abdominal cramps, headache, transient blanching and increased arterial blood pressure.

4.9 Overdose

Increase in blood pressure in patients with known hypertension has been controlled with clonidine, 150mcg iv.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Glypressin^® may be regarded as a circulating depot of lysine vasopressin. Following intravenous injection, three glycyl moieties are enzymatically cleaved from the N-terminus to release lysine vasopressin.

The slowly released vasopressin reduces blood flow in the splanchnic circulation in a prolonged manner, thereby helping to control bleeding from ruptured oesophageal varices.

5.2 Pharmacokinetic Properties

Glypressin^® is administered by bolus iv injection. It shows a biphasic plasma level curve which indicates that a two compartment model can be applied.

The half-life of distribution is about 8 -10 minutes.

The half-life of elimination is about 50 -70 minutes.

Lysine vasopressin reaches maximum plasma levels about 1 - 2 hours following iv administration and has a duration of activity of 4 - 6 hours.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Vial:

Mannitol

Hydrochloric Acid 1M

Solvent Ampoule:

Sodium Chloride

Hydrochloric Acid 1M

Water for Injection

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Do not store above 25ºC. Keep container in the outer carton.

6.5 Nature And Contents Of Container

Powder: Type I glass vial

Solvent: Type I glass ampoule

Pack size: Cartons containing 5 packs, each with one vial of powder and one ampoule of 5ml solvent.

6.6 Special Precautions For Disposal And Other Handling

Prior to injection, the powder should be reconstituted with the solvent provided. Use immediately after reconstitution.

7. Marketing Authorisation Holder

Ferring Pharmaceuticals Limited, The Courtyard, Waterside Drive, Langley, Berkshire SL3 6EZ (UK)

8. Marketing Authorisation Number(S)

PL 3194/0018

9. Date Of First Authorisation/Renewal Of The Authorisation

18^th July 2001

10. Date Of Revision Of The Text

June 2002

11. Legal Category

POM

Glycerin, Lemon and Honey with Glucose

1. Name Of The Medicinal Product

Glycerin, Lemon and Honey with Glucose or

Honey, Lemon and Glycerine

2. Qualitative And Quantitative Composition

Each 5ml of solution contains:-

1.36g Glycerol BP

Excipients: Each 5ml contains Syrup (sucrose) 1.7g, Liquid Glucose 280.0mg

For full list of excipients see section 6.1

3. Pharmaceutical Form

Linctus

4. Clinical Particulars

4.1 Therapeutic Indications

A soothing preparation for relief of the symptoms of coughs and sore throats.

4.2 Posology And Method Of Administration

Oral.

Recommended doses

Adults: two 5ml spoonfuls.

Children over 1 year: one 5ml spoonful.

Dosage schedule

May be repeated every 4 hours if required.

The product may be taken for up to 5 days, following which, if symptoms persist, medical advice should be sought.

Shake the bottle.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Keep all medicines out of the reach and sight of children.

Not suitable for children under 1 year.

Not suitable for use in diabetics.

If symptoms persist, consult your doctor

Patients with rare glucose-galactose malabsorption should not take this medicine

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No adverse effects are considered likely if this product is used in the above conditions, however, as with all medicines, its use should be avoided unless recommended by a doctor.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

None anticipated at the recommended dosage.

4.9 Overdose

Overdose with this preparation is unlikely to occur, however, large doses of glycerin may cause thirst, headache, nausea, vomiting, diarrhoea, hyperglycaemia, dehydration, dizziness and mental confusion. Cardiac arrhythmias have been reported. Treatment should be symptomatic.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Glycerol acts as a demulcent to soothe the passage of the upper respiratory tract.

5.2 Pharmacokinetic Properties

Glycerol is readily absorbed from the intestine and is metabolised to carbon dioxide and glycogen.

5.3 Preclinical Safety Data

None known.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lemon soluble essence

Syrup

Purified water

Lemon juice

Citric acid monohydrate

Honey

Liquid glucose

6.2 Incompatibilities

None stated.

6.3 Shelf Life

100ml: 24 months unopened.

200ml: 24 months unopened.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

100ml: glass bottle with plastic cap or polypropylene child-resistant cap with a saranex faced EPE liner or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner.

200ml: glass bottle with plastic cap or polypropylene child-resistant cap with a saranex faced EPE liner or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

L.C.M. Ltd

Linthwaite Laboratories

Huddersfield

HD7 5QH

England

8. Marketing Authorisation Number(S)

PL 12965/0013

9. Date Of First Authorisation/Renewal Of The Authorisation

06.04.99

10. Date Of Revision Of The Text

24/08/2009

Glycerin Suppositories BP 2g Children's Size

1. Name Of The Medicinal Product

Glycerin Suppositories BP 2g Children's Size.

2. Qualitative And Quantitative Composition

Glycerol BP 70% w/w.

3. Pharmaceutical Form

Suppositories.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of occasional constipation.

4.2 Posology And Method Of Administration

Route of administration:	Rectal.
Dose:	One suppository.
Dosage Schedule:	As required.

The suppository should be dipped in water before insertion.

The suppositories are defined as children's size, therefore there is no infants' or adults' recommendation

4.3 Contraindications

Contraindicated in patients with known hypersensitivity to glycerol. Children's Suppositories are not suitable for use by infants (under 1 year).

4.4 Special Warnings And Precautions For Use

Keep all medicines away from children.

Not to be swallowed.

Suppositories must not be taken by mouth.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Not applicable.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

May cause irritation.

4.9 Overdose

Glycerol has a mildly laxative action, however, if the product is accidentally swallowed it is unlikely to cause such effects and it is unlikely that active measures will be required. Accidental ingestion of a large number of suppositories may cause headache, nausea and vomiting; less frequently diarrhoea, thirst, dizziness, mental confusion and cardiac arrhythmias can occur.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Glycerol by the rectal route promotes peristalsis and evacuation of the lower bowel by virtue of its irritant action.

5.2 Pharmacokinetic Properties

No information available.

5.3 Preclinical Safety Data

None.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Gelatin BP, Purified Water BP, Purified Water BP QS.

6.2 Incompatibilities

None known.

6.3 Shelf Life

18 months unopened.

6.4 Special Precautions For Storage

Store below 25°C in a dry place.

6.5 Nature And Contents Of Container

12's: Sealed, PVC/PE laminate inside a cardboard carton.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Thornton & Ross Ltd.

Linthwaite Laboratories

Huddersfield

HD7 5QH.

8. Marketing Authorisation Number(S)

PL 00240/6101R

9. Date Of First Authorisation/Renewal Of The Authorisation

01.08.86 / 22.04.93, 25.11.98

10. Date Of Revision Of The Text

18.04.02

11 DOSIMETRY

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

Not Applicable

Gaviscon Advance (Forum Health Products Limited )

1. Name Of The Medicinal Product

Gaviscon Advance Oral suspension.

2. Qualitative And Quantitative Composition

1 ml contains sodium alginate 100 mg and potassium hydrogen carbonate 20 mg.

Excipients: methylparahydroxybenzoate (E218) and propylparahydroxybenzoate (E216).

For a full list of excipients, see Section 6.1.

3. Pharmaceutical Form

Oral suspension

Off-white, viscous suspension.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion (related to reflux), for example, following meals, or during pregnancy, or in patients with symptoms related to reflux oesophagitis.

4.2 Posology And Method Of Administration

Adults and children 12 years and over: 5-10 ml after meals and at bedtime.

Children under 12 years: Should be given only on medical advice.

Elderly: No dose modification is required for this age group.

If symptoms do not improve after seven days, the clinical situation should be reviewed

Shake well before use. Check that the cap seal is unbroken before first taking the product.

4.3 Contraindications

This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients.

4.4 Special Warnings And Precautions For Use

Each 10 ml dose has a sodium content of 106 mg (4.6 mmol) and a potassium content of 78 mg (2.0 mmol). This should be taken into account when a highly restricted salt diet is recommended, e.g. in some cases of congestive cardiac failure and renal impairment or when taking drugs which can increase plasma potassium levels.

Each 10 ml contains 200 mg (2.0 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.

There is a possibility of reduced efficacy in patients with very low levels of gastric acid.

Treatment of children younger than 12 years of age is not generally recommended, except on medical advice.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

An open, uncontrolled study in 146 pregnant women did not demonstrate any significant adverse effects of this product on the course of pregnancy or on the health of the foetus/new-born child. Based on this and previous experience this product may be used during pregnancy and lactation, however it is recommended to limit the treatment duration as much as possible.

4.7 Effects On Ability To Drive And Use Machines

No studies have been performed.

4.8 Undesirable Effects

Very rarely (<1/10,000) patients may develop allergic manifestations such as urticaria or bronchospasm, anaphylactic or anaphylactoid reactions.

4.9 Overdose

In the event of overdosage symptomatic treatment should be given. The patient may notice abdominal distension.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic classification: A02E AO1 Anti-regurgitant

On ingestion the suspension reacts with gastric acid to form a raft of alginic acid gel having a near-neutral pH and which floats on the stomach contents effectively (up to 4 hours) impeding gastro-oesophageal reflux. In severe cases the raft itself may be refluxed into the oesophagus in preference to the stomach contents and exert a demulcent effect.

5.2 Pharmacokinetic Properties

The mode of action of this product is physical and does not depend on absorption into the systemic circulation.

5.3 Preclinical Safety Data

No preclinical findings of relevance to the prescriber have been reported.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Calcium carbonate

Carbomer 974P

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Saccharin sodium

Fennel flavour

Sodium hydroxide (for pH adjustment)

Purified water

Ingredients of fennel flavour:

Fennel anethol

Benzyl alcohol

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Shelf life: 2 years.

Shelf life after opening: 6 months.

6.4 Special Precautions For Storage

Do not refrigerate.

6.5 Nature And Contents Of Container

Amber glass bottles with moulded polypropylene cap having a tamper evident strip and lined with an expanded polyethylene wad and containing 80, 100, 125, 140, 150, 180, 200, 250, 300, 400, 500, 560 or 600 ml suspension.

Or

Amber glass bottles with moulded polypropylene cap having a tamper evident strip and lined with an expanded polyethylene wad with either a measuring device (natural polypropylene) containing 5, 10, 15 and 20 ml graduations, or a measuring spoon (crystal polystyrene) containing 2.5 ml and 5 ml measure and containing 80, 100, 125, 140, 150, 180, 200, 250, 300, 400, 500, 560 or 600 ml suspension.

Not all pack sizes may be marketed. The carton and measuring device or spoon may not be made available in all markets/pack sizes.

6.6 Special Precautions For Disposal And Other Handling

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited,

Dansom Lane,

Hull,

HU8 7DS,

United Kingdom

8. Marketing Authorisation Number(S)

PL 00063/0097

9. Date Of First Authorisation/Renewal Of The Authorisation

31/10/1996 / 30/09/2006

10. Date Of Revision Of The Text

11/11/2008

Galfer Syrup

1. Name Of The Medicinal Product

Galfer Syrup

2. Qualitative And Quantitative Composition

Active Ingredient:

Ferrous Fumarate 140mg/5ml*

(*Equivalent to 45mg of elemental iron).

For excipients, see 6.1

3. Pharmaceutical Form

Oral solution.

A viscous brown coloured liquid with a peppermint/chocolate odour.

4. Clinical Particulars

4.1 Therapeutic Indications

This product is indicated in the prophylaxis and treatment of iron deficiency anaemia.

4.2 Posology And Method Of Administration

For oral administration:

a) Prevention of iron deficiency:

Adults, the elderly and children over 12 years:

Two 5ml spoonfuls (10ml) taken once daily.

Children (under 12 years):

Full term infants and young children: 0.5ml/kg/day administered in 2 - 3 divided doses daily. The maximum total daily dose should not exceed 20ml (180mg elemental iron).

Premature infants: 0.5ml/day in infants weighing up to 3kgs.

Iron supplementation in premature infants is only recommended in those of low birth weight who are solely breast fed, and in these cases, supplementation should be commenced 4-6 weeks after birth and continued until mixed feeding is established.

b) Treatment of iron deficiency:

Adults, the elderly and children over 12 years:

Two 5ml spoonfuls (10ml) taken once or twice daily.

Children (under 12 years):

Full term infants and young children: 0.5ml/kg/day administered in 2 - 3 divided doses daily. The maximum total daily dose should not exceed 20ml (180mg elemental iron).

Administration to infants and children should take place under medical advice.

Medical advice should be sought if symptoms do not improve after four weeks of use of this product as these symptoms may reflect an underlying disease process.

4.3 Contraindications

Known hypersensitivity to the product or ingredients.

Haemosiderosis, haemochromatosis, haemoglobinopathies, inflammatory bowel disease, intestinal strictures and diverticulae, active peptic ulcer, repeated blood transfusions, regional enteritis and ulcerative colitis and anaemias not produced by iron deficiency unless iron deficiency is also present.

Concomitant use with parenteral iron.

Concomitant use with dimercaprol.

4.4 Special Warnings And Precautions For Use

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Iron preparations colour the faeces black, which may interfere with tests used for detection of occult blood in the stools. Oral liquid preparations containing iron salts may blacken the teeth. To help prevent this, the mouth may be rinsed with water after use to minimise exposure.

Prolonged or excessive use in children without medical supervision may lead to toxic accumulation.

Some post-gastrectomy patients have poor absorption of iron. Caution is advised when prescribing iron preparations to individuals with a history of peptic ulcers. Duration of treatment should generally not exceed 3 months after correction of the anaemia has been achieved. Patients with microcytic anaemia resistant to therapy with iron alone should be screened for vitamin B₁₂ or foliate deficiency, since anaemia due to combined deficiencies may be microcytic in type. Iron deficiency in male patients warrants careful investigation to determine its cause.

The label will state:

“Important warning: Contains iron. Keep out of the reach and sight of children, as overdose may be fatal.”

This will appear on the front of the pack within a rectangle in which there is no other information.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Iron and tetracyclines reduce the absorption of each other. Iron reduces absorption of zinc, and absorption of oral iron is reduced by zinc.

Iron reduces the absorption of penicillamine, fluoroquinolones, levodopa, carbidopa, entacapone, bisphosphonates, mycophenolate and levothyroxine.

Absorption of iron is reduced with calcium, magnesium and other mineral supplements, bicarbonates, carbonates, zinc and trientine and impaired by antacids, cholestyramine, tea, eggs or milk, but may be increased by ascorbic or citric acid.

Chloramphenicol delays plasma iron clearance, incorporation of iron into red blood cells and interferes with erythropoiesis.

Reduced hypotensive effect of methyldopa.

4.6 Pregnancy And Lactation

Galfer Syrup is suitable for use during pregnancy and lactation. However, administration of drugs during the first trimester of pregnancy requires careful assessment of potential risks versus benefits to be gained.

4.7 Effects On Ability To Drive And Use Machines

Galfer Syrup does not affect the ability to drive or operate machinery.

4.8 Undesirable Effects

Oral liquid preparations containing iron salts may blacken the teeth. To help prevent this, the mouth may be rinsed with water after use to minimise exposure.

Anorexia, nausea, vomiting, gastro-intestinal discomfort, constipation, diarrhoea, darkening of the stools and allergic reactions occur rarely. Gastro-intestinal side effects may be reduced by taking the syrup after food or by beginning with a small dose and increasing gradually. Iron preparations can be particularly constipating in older patients and occasionally lead to faecal impaction. Iron preparations can also exacerbate diarrhoea in patients with inflammatory bowel disease; care should be taken with patients who have intestinal strictures or diverticular disease.

Haemosiderosis may occur as a result of excessive or mistaken therapy.

4.9 Overdose

All those who have recently ingested more than 20mg/kg should be referred to hospital.

In the first phase of acute iron overdosage, which occurs up to 6 hours after oral ingestion, gastrointestinal toxicity, notably nausea, vomiting, abdominal pain and diarrhoea, predominates. Haematemesis and rectal bleeding may also occur. Other effects may include cardiovascular disorders, such as hypotension and tachycardia, metabolic changes, including acidosis and hyperglycaemia, and CNS depression ranging from lethargy to coma. Patients with only mild to moderate poisoning do not generally progress past this phase. The second phase may occur at 6 to 24 hours after ingestion and is characterised by a temporary remission or clinical stabilisation. In the third phase, which occurs between 12 and 48 hours after ingestion, gastrointestinal toxicity recurs together with shock, metabolic acidosis, convulsions, coma, hepatic necrosis and jaundice, hypoglycaemia, coagulation disorders, oliguria or renal failure, and pulmonary oedema. Patients may also experience severe lethargy and myocardial dysfunction. The fourth phase may occur several weeks after ingestion and is characterised by gastrointestinal obstruction and possibly late hepatic damage.

Gastric lavage should be considered only within 1 hour of a life-threatening amount being ingested within 1 hour, if the airway can be protected adequately. Desferrioxamine mesilate (5 to 10 g in 50 to 100 ml of water) may be given by mouth, or by stomach tube, to chelate any iron left in the stomach and prevent further absorption following gastric lavage, as activated charcoal is ineffective. To eliminate iron already absorbed, desferrioxamine mesilate should be given intramuscularly, or if the patient is hypotensive or in shock, intravenously by slow infusion. The dose and route of parenteral administration should be adjusted according to the severity of the poisoning.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

B03A A02 - Iron bivalent, oral preparations

Elemental iron in the ferrous form is effective as prophylaxis against iron deficiency and as replacement therapy in mild to moderate iron deficiency anaemia. Good serum rise and haemoglobin response are obtained. Gastro-intestinal disturbance is low as ferrous fumarate has low irritant characteristics.

5.2 Pharmacokinetic Properties

Iron is irregularly and incompletely absorbed from the gastro-intestinal tract, the main sites of absorption being the duodenum and jejunum. Absorption is aided by the acid secretions of the stomach or dietary acids, and is more readily effected when the iron is in the ferrous state. Absorption is also increased in conditions of iron deficiency or in the fasting state but is decreased if body stores are overloaded.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Nipasept Sodium

Citric Acid Monohydrate

Aluminium Magnesium Silicate (Veegum HS)

Chocolate flavour (17.42.5444)

Peppermint flavour (17.40.1951)

Liquid Maltitol

Purified water

6.2 Incompatibilities

None stated.

6.3 Shelf Life

24 months from the date of manufacture.

6.4 Special Precautions For Storage

Store in a cool place.

Keep out of reach of children.

6.5 Nature And Contents Of Container

Amber glass bottles with polypropylene caps.

Pack sizes: 100 and 300ml.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Thornton & Ross Ltd.

Linthwaite Laboratories

Huddersfield

HD7 5QH.

8. Marketing Authorisation Number(S)

PL: 00240/0106

9. Date Of First Authorisation/Renewal Of The Authorisation

8 June 2002

10. Date Of Revision Of The Text

04/02/2010

11 DOSIMETRY (IF APPLICABLE)

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Not Applicable

Gyno-Pevaryl 1 Vaginal Pessary

Gyno-Pevaryl 1 vaginal pessary

Econazole nitrate

Gyno-Pevaryl is a registered trademark

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 you get side effects and they become serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

In this leaflet

• 1. What Gyno-Pevaryl 1 is and what it is used for


• 2. Before you use Gyno-Pevaryl 1


• 3. How to use Gyno-Pevaryl 1


• 4. Possible side effects


• 5. How to store Gyno-Pevaryl 1


• 6. Further information

What Gyno-Pevaryl 1 is and what it is used for

The name of your medicine is Gyno-Pevaryl 1 vaginal pessary. It is called ‘Gyno-Pevaryl 1’ in this leaflet.

Gyno-Pevaryl 1 is a solid, bullet-shaped pessary (vaginal suppository). When inserted into the vagina it releases a medicine called econazole. This belongs to a group of medicines called ‘antifungals’.

Gyno-Pevaryl 1 is used for infections of the vagina and the skin around the vagina. The infections are caused by fungi and yeasts such as thrush (Candida).

Before you use Gyno-Pevaryl 1

Do not use Gyno-Pevaryl 1 if:

• You are allergic to anything in Gyno-Pevaryl 1 (listed in section 6 below)


• You are allergic to any other medicine used to treat thrush or other fungal infections


• You are under 16 years old

Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Gyno-Pevaryl 1.

Take special care with Gyno-Pevaryl 1

Check with your doctor or pharmacist before using this medicine if:

• You are using a ‘barrier’ method of contraception. This includes condoms or diaphragms. This is because Gyno-Pevaryl 1 can damage the rubber and stop them working properly. Talk to your doctor about using another type of contraception while you are using this medicine

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines.

In particular tell your doctor if you are taking:

• Medicines to thin the blood (anticoagulants) such as warfarin or acenocoumarol

Pregnancy and breast-feeding

Please tell your doctor before using Gyno-Pevaryl 1 if you are pregnant, think you may be pregnant or might become pregnant.

You may still be able to use Gyno-Pevaryl 1 if your doctor thinks you need to.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

This medicine is not likely to affect you being able to drive or use any tools or machines.

How to use Gyno-Pevaryl 1

Always use this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Using the pessary

• Use the pessary just before going to bed. This helps it to stay in place


• Do not swallow the pessary

Inserting the pessary with the applicator

• Remove the pessary from the plastic packet using the easy open tab


• Pull the plunger of the applicator out until it sticks


• Gently push the pessary into the cup. Do not force it because it might stick


• Lie down with your knees bent and spread apart. Insert the applicator high into your vagina, pessary first


• Push the plunger to release the pessary


• Remove the applicator and dispose of it safely in your household waste

If you swallow Gyno-Pevaryl 1

If the pessary is eaten or swallowed talk to a doctor or go to the nearest hospital casualty department straight away.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Gyno-Pevaryl 1 can cause side effects, although not everybody gets them.

Stop using Gyno-Pevaryl 1 and tell your doctor straight away if you notice the following. You may need urgent medical treatment.

• Sudden swelling of the face or throat. Hives (also known as nettle rash or urticaria), severe irritation, reddening or blistering of your skin. These may be signs of a severe allergic reaction (affects less than 1 in 10,000 people)

Other side effects:

• Itchy and red skin around or inside the vagina. This is much milder than an allergic reaction. Tell your doctor or pharmacist if this feeling lasts for more than a few minutes or gets worse (rash, burning or swelling)

If you get side effects and they become serious or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Gyno-Pevaryl 1

Keep out of the reach and sight of children. Store in the original container. Do not store above 30°C. Keep away from heat and sunlight.

Do not use Gyno-Pevaryl 1:

• After the expiry date which is stated on the label. The expiry date refers to the last day of that month


• If the plastic packet is broken or missing


• If the pessary is not light beige in colour

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 protect the environment.

Further information

The active substance in Gyno-Pevaryl 1 is econazole nitrate. The pessary contains 150mg econazole nitrate.

The other ingredients are polygel, colloidal silicon dioxide, Witepsol H 19, Wecobee FS, stearyl heptanoate.

What Gyno-Pevaryl 1 looks like and contents of the pack

Gyno-Pevaryl 1 comes in a plastic strip containing one pessary. It is bullet-shaped and light beige in colour.

The product licence is held by:

JANSSEN-CILAG LTD

50-100 Holmers Farm Way

High Wycombe

Bucks

HP12 4EG

UK

Gyno-Pevaryl 1 is made by:

Janssen Pharmaceutica NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

OR

McGregor Cory Ltd

Middleton Close

Banbury

Oxfordshire

OX16 8RS

UK

For information in large print, tape, CD or Braille, telephone 0800 7318450.

This leaflet was last approved in August 2008.