Burinex 5 mg Tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Bumetanide
Available from:
Leo Laboratories Limited
ATC code:
C03CA; C03CA02
INN (International Name):
Bumetanide
Dosage:
5 milligram(s)
Pharmaceutical form:
Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Sulfonamides, plain; bumetanide
Authorization status:
Not marketed
Authorization number:
PA0046/016/003
Authorization date:
1978-04-01

Package leaflet: Information for the user

Burinex

5 mg Tablets

bumetanide

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

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 only. Do not pass it on to others. It may harm

them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible

side effects not listed in this leaflet. See section 4.

In this leaflet Burinex

5 mg Tablets will be called Burinex.

What is in this leaflet

What Burinex

is and what it is used for

What you need to know before you take Burinex

How to take Burinex

Possible side effects

How to store Burinex

Contents of the pack and other information

1. What Burinex

is and what it is used for

Burinex 5 mg tablets contain the active substance bumetanide. It is a diuretic (water tablet).

It works by removing any excess water from your body. It will make you go to the toilet more

often.

Burinex is used in adults to treat oedema which occurs as a result of heart, kidney or liver

problems. Oedema means that there is too much water in parts of your body. Oedema can

cause symptoms such as swollen ankles or trouble breathing.

2. What you need to know before you take Burinex

Do not take Burinex

If you are allergic (hypersensitive) to bumetanide or any of the other ingredients in this

medicine (listed in section 6).

If you have been told that you have very low levels of potassium, sodium or chloride in your

blood.

If you cannot pass water (urine) at all.

If you have severe liver problems or are in a coma caused by this (hepatic encephalopathy).

Warnings and precautions

Talk to your doctor or pharmacist before taking Burinex

If you have severe liver problems.

If you have low blood pressure.

If you have been told that you have abnormal levels of potassium in your blood. Your doctor

may test your blood regularly.

If you are taking proton pump inhibitors as this may cause magnesium levels in your blood

to fall.

If you have gout.

If you have kidney problems or a blockage of your kidney or bladder.

If you have diabetes. Your doctor may test your blood and urine regularly.

If you are allergic (hypersensitive) to medicines called sulphonamides.

If you have an intolerance to lactose (please see the end of section 2).

Burinex is banned for use in sports and will cause disqualification for sports persons as it will

be detected in urine during routine tests.

Extra tests that may be required when taking Burinex

Most people taking Burinex will have regular tests to check the levels of water and other

substances (e.g. salts such as potassium) in their blood.

If you are diabetic, you will have tests to check the amount of glucose in your blood and urine

as Burinex can affect your glucose levels.

Children and adolescents

Do not give this medicine to children or adolescents because limited information is available

and it is not known if it is safe to use.

Other medicines and Burinex

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines. This includes any medicines which you have bought without a prescription.

You must tell your doctor or pharmacist if you are taking any of the following:

Medicines for heart conditions (e.g. digoxin), as they may make you feel or get sick or

experience changes in your heart rate.

Medicines for heart conditions (e.g. amiodarone), as they may cause dizziness, confusion,

muscle weakness, twitching, tiredness, a sudden loss of consciousness, very fast heart beat or

heart attack.

Lithium, as Burinex will increase the lithium level in your blood and your dose may need to

be changed.

Non-steroidal anti-inflammatory drugs e.g. ibuprofen, for arthritis or aches and pains, as

they may damage your kidneys.

Medicines for depression (e.g. tricyclic antidepressants), as they may make you dizzy.

Medicines for high blood pressure, as they may make you dizzy.

Probenecid, a treatment for gout.

Medicines to treat certain bacterial infections (e.g. neomycin), as it might damage your

hearing.

Medicines for diabetes as your dose may need to be changed.

Medicines that relax your muscles. If you are to be given a muscle relaxant (usually given

by injection, before a general anaesthetic), please tell your hospital doctor that you are taking

Burinex.

Any medicine that affects the amount of potassium in your blood e.g. some diuretics.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a

baby, ask your doctor or pharmacist for advice before taking this medicine.

This medicine should not be used in pregnancy unless clearly necessary. It may only be used

in case your heart stops working and when the benefit outweighs the risk to the unborn child.

Tell your doctor if you become pregnant while taking this medicine.

Breast-feeding

Do not take this medicine if you are breast-feeding.

Driving and using machines

This medicine should not have any effect on your ability to drive or use machinery. However,

dizziness may occur when taking Burinex and this could affect you.

Check with your doctor if you get any side effects that may affect your driving or using

machinery.

Burinex contains lactose monohydrate. This is a type of sugar. If you have been told by

your doctor that you have an intolerance to some sugars, contact your doctor before taking

this medicinal product.

3. How to take Burinex

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your

doctor or pharmacist if you are not sure.

How much Burinex to take

Your doctor will tell you how many tablets to take. You should take the tablets in the

morning. This will help to stop you getting up in the night to go to the toilet. To remind you to

take your medicine, it may help to take it when you do another regular activity such as

brushing your teeth.

Remember to always take this medicine with a glass of water.

If you are taking more than one tablet a day, you may be told to take them in two or more

doses.

The score line is only there to help you break the tablet if you have difficulty swallowing it

whole.

Adults

To treat oedema:

The recommended starting dose for Burinex 5 mg Tablets is 1 tablet a day.

Your doctor may change your dose depending on how the medicine works for you.

If you take more Burinex than you should

Tell your doctor straight away. You may need to stop taking this medicine. Signs that you

have taken too much include dry mouth, thirst, weakness, drowsiness, muscle pain and

confusion. You may also feel sick or pass a very large amount of water (urine) e.g. 2-3 litres.

If you forget to take Burinex

If the dose is less than 12 hours late, take it immediately. If it is more than 12 hours late, leave

it out. Take your next dose at the usual time. Do not take a double dose to make up for a

forgotten tablet.

If you keep forgetting to take your tablets, speak to your doctor.

If you have any further questions on the use of this medicine, please ask your doctor or

pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In clinical trials, approximately 12 out of every 100 patients got a side effect.

Important side effects to look out for:

Although allergic reactions are not known to happen with Burinex, it could happen with

any medicine. You must get medical help straight away if you have any of the following

symptoms. You may be having a severe allergic reaction.

You have difficulty breathing.

Your lips and mouth start to tingle or swell.

Your face or throat swell.

Your skin develops a severe rash.

Important side effects that can also become serious. You should tell your doctor as soon

as possible:

Common (may affect up to 1 in 10 people)

Low potassium levels in your blood; possible signs of this are muscle weakness, twitching

or an abnormal heart rate.

Low sodium levels in your blood; this could cause tiredness, confusion, muscle twitching,

fits or coma.

High potassium levels in your blood which may cause an irregular heartbeat.

Uncommon (may affect up to 1 in 100 people)

You may become more sensitive to light.

You may pass little or no urine and your kidneys may stop working completely.

You may have problems with your bone marrow or blood, the signs of this are:

º Feeling tired, dizzy, short of breath or looking pale.

º You may get infections more often such as a sore throat or mouth ulcers.

º You may bleed or bruise more easily than normal.

Other possible side effects which are usually less serious can occur:

Common (may affect up to 1 in 10 people)

Low chloride levels in your blood; you usually will not notice this.

Dizziness especially when standing up due to low blood pressure or problems with your

balance (vertigo).

You may feel sleepy, unusually weak, lack energy or have a general feeling of being unwell.

Headache.

You may feel sick, get pain or discomfort in your stomach.

You may experience pain, aching muscles not caused by exercise and muscle spasms.

You may need to go to the toilet very often, during the night or pass very large amounts or

very small amounts of water (urine).

Uncommon (may affect up to 1 in 100 people)

You may lose too much water from your body and feel tired and sick.

You may have low or high sugar levels in your blood.

The signs of low sugar levels are confusion, blurred vision, slurred speech, aggression, loss

of consciousness, fast or irregular heartbeat, tremor, anxiety, sweating and hunger.

The signs of high sugar levels are excessive thirst and hunger, needing to pass water (urine)

often, blurred vision, sleepiness, weight loss and a dry mouth.

You may experience high uric acid levels in your blood which may cause painful swollen

joints (gout).

Fainting.

Problems with your hearing.

Chest pain and discomfort.

Low blood pressure. This might make you feel dizzy.

Shortness of breath or a cough.

Vomiting.

Diarrhoea or constipation.

Dry mouth or feel thirsty.

Skin problems such as a rash with raised lumps or pimples, hives.

Itching of the skin often including blisters that weep and become crusted.

Swelling of hands, ankles or feet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. You can also report side effects directly via HPRA

Pharmacovigilance, Earlsfort Terrace, IRL-Dublin 2;

Tel: +353 1 6764971; Fax: + 353 1 6762517. Website: www.hpra.ie; E-mail:

medsafety@hpra.ie. By reporting side effects you can help provide more information on the

safety of this medicine.

5. How to store Burinex

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister

(EXP). This expiry date refers to the last day of that month.

Keep the blisters in the outer carton in order to protect from light.

Burinex 5 mg Tablets: Store below 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist

how to throw away medicines you no longer use. These measures will help protect the

environment.

6. Contents of the pack and other information

What Burinex contains

The active substance is bumetanide.

The other ingredients are: maize starch, lactose monohydrate, colloidal anhydrous silica,

povidone, polysorbate 80, agar powder, talc and magnesium stearate.

You can find important information about some of the ingredients in your medicine near the

end of section 2 of this leaflet.

What Burinex looks like and contents of the pack

Burinex 5 mg Tablets are a white, flat, circular, uncoated, bevelled edge tablet marked with a

score line and ‘5 mg’ on one face.

Burinex comes in blister packs of 30 and 56 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: LEO Laboratories Limited, Cashel Road, Dublin 12.

Manufacturer: Laboratoires LEO, 39 Route de Chartres, 28500 Vernouillet, France.

This leaflet was last revised in July 2017.

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Burinex 5 mg Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 5 mg of Bumetanide.

Excipient with known effect: Each tablet contains 92 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Tablet

A white, flat, circular, uncoated, bevelled-edge tablet marked with a score line and ‘5 mg’ on one face.

The score line is only to facilitate breakup for ease of swallowing and not to divide into equal doses.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Burinex 5 mg Tablets are indicated in adults in the management of oedema due to congestive heart failure, hepatic

cirrhosis and renal disease, including nephrotic syndrome, where high dose diuretic is required.

4.2 Posology and method of administration

Posology

The dose should be carefully adjusted according to response. As a general rule, dosage should be started at 5 mg daily

and then increased by 5 mg every 12-24 hours until the required response is obtained or side effects appear.

Consideration should be given to a twice daily dosage, rather than a once daily dosage.

Paediatric population

The medicinal product is not recommended for children as there is limited information on safety, efficacy and dosage

in children.

Elderly

The dosage recommendations for adults apply, but in the elderly bumetanide is generally eliminated more slowly.

Dosage should be titrated until the required response is achieved.

Patients with liver or renal insufficiency

Depending on the liver or renal function, the dose should be titrated according to the patient’s response and required

therapeutic effect (see section 4.4).

Method of administration

For oral administration.

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4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Severe electrolyte depletion.

Persisting anuria.

Hepatic encephalopathy including coma.

4.4 Special warnings and precautions for use

Hepatic Impairment

Caution is advised if bumetanide is to be administered to patients with severe hepatic impairment.

Hypotension

Caution should be exercised when bumetanide is used in patients with hypotension.

Electrolyte Imbalance

Electrolyte and fluid imbalance may occur and replacement therapy should be instituted where indicated. Serum

potassium concentrations should be monitored regularly.

Hypomagnesaemia

Administration of proton pump inhibitors has been associated with development of hypomagnesaemia.

Hypomagnesaemia may be exacerbated with co-administration of bumetanide and particular attention to magnesium

levels should be given when this combination is used.

Hyperuricaemia

As with other diuretics, bumetanide may cause an increase in blood uric acid.

Urinary tract obstruction

Bumetanide should be used with caution in patients with potential obstruction of the urinary tract.

Renal Impairment

In patients with severe chronic renal failure treated with high doses of bumetanide, there have been reports of severe

generalised musculoskeletal pain sometimes associated with muscle spasm, occurring one or two hours after

administration and lasting for up to 12 hours. Occasionally analgesic medication has been required to treat the pain. All

patients recovered fully and there was no deterioration in their renal function. The cause of this pain is uncertain but

may be a result of varying electrolyte gradients at the cell membrane level. Experience suggests that the incidence of

such reactions is reduced by initiating treatment at 5-10 mg daily and titrating upwards, using a twice daily dosage

regimen at doses of 20 mg per day or more. When using more than 10 mg per day expert advice should be sought.

Patients with chronic renal failure on high doses of bumetanide should remain under constant hospital supervision.

Caution is advised if bumetanide is to be administered to patients with severe or progressive renal impairment or with

elevated urea/Blood Urea Nitrogen (BUN) or creatinine.

Diabetic patients

Periodic monitoring of urine and blood glucose should be made in diabetics and patients suspected of latent diabetes

since this preparation may induce hyperglycaemia (see sections 4.5 and 4.8).

Hypersensitivity

If known hypersensitivity to sulphonamides, there may be a potential risk of hypersensitivity to bumetanide.

Athletes

Bumetanide found in urine by doping tests is a cause for disqualification of athletes.

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Excipients warning

Burinex tablets contain lactose as an excipient and patients with rare hereditary problems of galactose intolerance, the

Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

4.5 Interaction with other medicinal products and other forms of interaction

Dose adjustment of hypoglycaemic agents may be necessary in patients with diabetes mellitus.

Digitalis glycosides

Hypokalaemia increases the sensitivity to digitalis glycosides which might result in digitalis toxicity (nausea, vomiting,

and arrhythmias). Potassium level and signs for digitalis toxicity should be monitored. Potassium supplementation and

lower digitalis glycoside dose should be considered.

Non-depolarising neuromuscular blocking agents

Hypokalaemia increases the sensitivity to non-depolarising neuromuscular blocking agents.

Lithium

Bumetanide reduces lithium clearance resulting in high serum levels of lithium, therefore concomitant therapy requires

close monitoring of serum lithium levels. Lower lithium doses may be required.

Antiarrhythmics

Concomitant use of bumetanide and class III antiarrhythmic drugs may result in increased risk of electrolyte imbalance

and subsequent cardiotoxicity (QT prolongation, torsades de pointes, cardiac arrest). Patients’ electrolyte levels should

be monitored as should symptoms of arrhythmias.

NSAIDs

Non-steroidal anti-inflammatory drugs (NSAID) inhibit the effect of bumetanide. The effects of concurrent use should

be monitored (e.g. blood pressure, signs of renal failure). Diuretics may enhance the nephrotoxicity of NSAIDs.

Antihypertensive agents and medicinal products inducing postural hypotension.

Bumetanide may potentiate the effect of antihypertensive agents including diuretics and drugs inducing postural

hypotension (e.g. tricyclic antidepressants). First-dose hypotension may occur.

Potassium depleting agents

The potassium depleting effect of bumetanide may be increased by other potassium depleting agents.

Aminoglycosides

The ototoxic effects of aminoglycosides may be increased by concomitant administration of potent diuretics such as

bumetanide.

Probenecid

Probenecid inhibits the renal tubular secretion of bumetanide leading to a diminished natriuresis.

4.6 Fertility, pregnancy and lactation

Pregnancy

Bumetanide may cause harmful

pharmacological

effects during pregnancy,

to the foetus or

to the newborn child.

Bumetanide should not be used during pregnancy unless the clinical condition of the woman requires treatment with

bumetanide.

may be used only in case of heart

failure when the potential

benefit

justifies the potential

risk to the

foetus.

Breast-feeding

Bumetanide should not be used during breast-feeding.

Fertility

There are no clinical studies with bumetanide regarding fertility.

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4.7 Effects on ability to drive and use machines

Bumetanide has no or negligible direct influence on the ability to drive and use machines. However, the patient should

be informed that dizziness may occur during treatment and take this into account while driving or using machines.

4.8 Undesirable effects

The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical studies

and spontaneous reporting.

Based on pooled data from clinical studies including more than 1000 patients who received bumetanide,

approximately 12% of patients can be expected to experience an undesirable effect.

The most frequently reported adverse reactions during treatment are headache and electrolyte imbalance (including

hypokalaemia, hyponatraemia, hypochloraemia and hyperkalaemia) occurring in approximately 4% of the patients,

followed by dizziness (including orthostatic hypotension and vertigo) and fatigue occurring in approximately 3% of

patients.

Electrolyte disturbances can occur especially during long term treatment.

Renal failure has been reported in post-marketing safety surveillance.

Undesirable effects are listed by MedDRA system organ class (SOC) and the individual undesirable effects are listed

starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the

order of decreasing seriousness.

Very common

1/10

Common

1/100 and <1/10

Uncommon

1/1,000 and <1/100

Rare

1/10,000 and <1/1,000

Very rare <1/10,000

Blood and lymphatic system disorders

Uncommon

1/1,000 and <1/100)

Bone marrow failure and pancytopenia

Thrombocytopenia

Leukopenia including neutropenia

Anaemia

Metabolism and nutrition disorders

Common:

1/100 and <1/10)

Electrolyte imbalance (including

hypokalaemia, hyponatraemia,

hypochloraemia and hyperkalaemia)

Uncommon:

1/1,000 and <1/100)

Dehydration

Glucose metabolism disorder

Hyperuricaemia and gout

Nervous system disorders

Common:

1/100 and <1/10)

Dizziness (including orthostatic

hypotension and vertigo)

Fatigue (including lethargy,

somnolence, asthenia and malaise)

Headache

Uncommon:

1/1,000 and <1/100)

Syncope

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Paediatric population

The safety profile of Bumetanide has not been established in the paediatric population.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any

suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;

Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

Ear and labyrinth disorders

Uncommon:

1/1,000 and <1/100)

Hearing disturbances

Cardiac disorders

Uncommon

1/1,000 and <1/100)

Chest pain and discomfort

Vascular disorders

Uncommon:

1/1,000 and <1/100)

Hypotension

Respiratory, thoracic and mediastinal disorders

Uncommon:

1/1,000 and <1/100)

Dyspnoea

Cough

Gastrointestinal disorders

Common:

1/100 and <1/10)

Abdominal pain and discomfort

Nausea

Uncommon:

1/1,000 and <1/100)

Vomiting

Diarrhoea

Constipation

Dry mouth and thirst

Skin and subcutaneous tissue disorders

Uncommon:

1/1,000 and <1/100)

Rash*

Dermatitis and eczema

Urticaria

Pruritus

Photosensitivity

*Various types of rash reactions such as

erythematous, maculo-papular and

pustular have been reported

Musculoskeletal and connective tissue disorders

Common:

1/100 and <1/10)

Muscle spasms

Pain and myalgia

Renal and urinary disorders

Common:

1/100 and <1/10)

Micturition disorder

Uncommon:

1/1,000 and <1/100)

Renal impairment (including renal

failure)

General disorders and administration site conditions

Uncommon:

1/1,000 and <1/100)

Oedema peripheral

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4.9 Overdose

In high doses and during long-term treatment loop diuretics may cause electrolyte imbalance, dehydration and polyuria.

Symptoms of electrolyte imbalance include dry mouth, thirst, weakness, lethargy, drowsiness, confusion,

gastrointestinal disturbances, restlessness, muscle pain and cramps and seizures.

Treatment is adjustment of the fluid and electrolyte imbalance.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Sulphonamides, plain

ATC code: C03CA 02

Bumetanide is a potent loop diuretic.

Bumetanide exerts an inhibiting effect on the reabsorption mechanism of salts in the ascending limb of the loop of

Henle and in the renal proximal tubules. Bumetanide thereby causes the diuretic and natriuretic action observed.

5.2 Pharmacokinetic properties

Bumetanide is nearly totally absorbed from the gastro-intestinal tract. After peroral administration, a bioavailability of

between 80

95% is observed. Diuresis begins within ½

1 hour with a peak effect between 1 and 2 hours. The diuretic

effect lasts up to about 4 hours. Bumetanide is eliminated with half-life ranging from between 1 to 2 hours after oral

administration of a dose of 0.5

2 mg. It is strongly bound to plasma proteins and renal excretion of unchanged drug

accounts for about half of the total clearance. The hepatic metabolism and biliary excretion accounts for the other half.

The primary metabolites are conjugated alcohols of bumetanide. No active metabolites have been found. Bumetanide

has a steep dose response curve.

In neonates and infants, elimination appears slower than in older paediatric patients and adults, possibly because of

immature renal and hepatobiliary functions. Mean serum elimination half-life decreases during the first month of life

from 6 hours in neonates to 2.4 hours in infants 1 month of age.

Mean serum elimination half-life is 2.5 and 1.5 hours in infants younger than 2 months of age and in those 2–6 months

of age, respectively. The apparent elimination half-life may be prolonged to approximately 6 hours (with a range up to

15 hours) after IV administration in premature or full-term neonates with respiratory disorders. Data for younger

children, including neonates and infants, is not sufficient to allow for dosing recommendations, see 4.2.

5.3 Preclinical safety data

There are no preclinical 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

Maize starch

Lactose monohydrate

Povidone

Polysorbate 80

Colloidal anhydrous silica

Agar powder

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Talc

Magnesium stearate.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Keep the blisters in the outer carton in order to protect from light.

Store below 25°C.

6.5 Nature and contents of container

PVC/aluminium blister packs of 14 (physician’s sample), 30 and 56 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements. Any unused product or waste material should be disposed of in accordance with local

requirements.

7 MARKETING AUTHORISATION HOLDER

LEO Laboratories Ltd.

Cashel Road

Dublin 12

Ireland

8 MARKETING AUTHORISATION NUMBER

PA0046/016/003

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 01 April 1978

Date of latest renewal: 01 April 2008

10 DATE OF REVISION OF THE TEXT

November 2017

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