115B/BST128/1

FOR SINGLE RECTAL USE ONLY

P

115B/BLT128/1

Phosphates Enema BP Formula B Long Tube

READY-TO-USE DISPOSABLE SINGLE-DOSE ENEMA

Phosphates Enema BP Formula B

READY-TO-USE DISPOSABLE SINGLE-DOSE ENEMA

FOR SINGLE RECTAL USE ONLY

128 ml

Essential Generics,

7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB

SEE CARTON FOR FULL DIRECTIONS

ACTIVE INGREDIENTS:

sodium dihydrogen phosphate

dihydrate 10.0 % w/v    ^

disodium phosphate    §

dodecahydrate 8.0 % w/v    ^

Also contains disodium edetate, benzalkonium chloride, and purified water

DO NOT STORE ABOVE 25°C

2

KEEP OUT OF THE REACH    ^

AND SIGHT OF CHILDREN    §

NOT TO BE TAKEN BY MOUTH

E

PL 17736/0115

Phosphates Enema BP

Formula B

LONG TUBE VERSION

128 ml

SIDE EFFECTS:

STOP using the enema and seek medical help immediately if you have any of the following allergic reactions:

•    difficulty breathing or swallowing, swelling of the face, lips, tongue or throat

•    severe itching of the skin, with a red rash or raised lumps.

Tell your doctor as soon as possible if you:

•    faint after using the enema. This may happen to elderly patients.

Other side effects:

•    rectal irritation (redness, itching).

Long term use of the enema may irritate the anal passage, or the bowel may become lazy. It may also affect the amount of salts in your blood, your doctor may check for this.

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 the Yellow Card Scheme at www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

CONTENTS: The rectal solution is a clear liquid in a plastic bottle with a separate application tube for a single dose use. Text revised: December 2014 Manufacturer: Purna Pharmaceuticals NV, Rijksweg 17, 2870 Puurs, Belgium

E

PL 17736/0115 MA Holder:

Chemidex Pharma Ltd trading as Essential Generics 7 Egham Business Village Crabtree Road, Egham Surrey TW20 8RB

ESSENTIAL GENERICS

Phosphates

. Enema BP

• ••

•• Formula B

_#    sodium dihydrogen phosphate dihydrate

•    _f disodium phosphate dodecahydrate

.• READY-TO-USE ENEMA

•    FOR SINGLE RECTAL USE ONLY

i'LOMG TUBE VERSION

•    •

128 ml

• •• ••

Phosphates Enema BP Formula B

RECTAL SOLUTION CONTAINING: Active ingredients:

•    sodium dihydrogen phosphate dihydrate 10 % w/v

•    disodium phosphate dodecahydrate 8 % w/v

Other ingredients:

•    disodium edetate

•    benzalkonium chloride

•    purified water

NOT TO BE TAKEN BY MOUTH

FOR SINGLE RECTAL USE ONLY

HOW TO STORE:

•    Keep out of the reach and sight of children

•    Do not use after the expiry date

•    Do not store above 25°C

•    Do not throw it away with your household waste or in water. Return all the unwanted medicine to your pharmacist. This will help to protect the environment.

128 ml

EAN CODE

5050204100629

WHATTHIS MEDICINE IS:

Phosphates enema is a bowel cleanser which acts by drawing water into the bowel, making the stools softer and encouraging evacuation. It is used:

•    to evacuate and clean the bowel before and after certain operations

•    before childbirth

•    before diagnostic procedures such as colonoscopy or x-ray examination

•    to treat constipation.

DO NOT USE if you:

•    are allergic to any of the ingredients

•    have inflammation or ulcers of the large bowel (the colon),unless advised by your doctor

•    have a condition of increased absorption from the colon, such as in Hirschsprung's disease

•    have any unexplained stomach or intestinal (gut) problems.

Tell your doctor before using if you:

•    suffer from electrolyte disturbances (change of salt levels in the body)

•    have a blockage in the gut (bowel obstruction)

•    are elderly,frail (debilitated) or have a neurological disorder such as paralysis of the lower part of the body or a stroke

•    are taking other medicines

•    are pregnant or breast-feeding.

Important information about some of the ingredients:

•    sodium. Speak to your doctor or pharmacist if you are on a sodium controlled diet. Each enema contains 3.2 g of sodium.

•    benzalkonium chloride. This may cause irritation.

HOW TO USE:

For rectal use only

Adults and elderly: Use one enema as required.

Children 3 to 12 years: Reduce the dose in proportion to the child's weight, i.e.for a 35 kg (515 stone) child give half the contents of the bottle. If unsure, check with your doctor or pharmacist.

Under 3 years: Not recommended.

1.    Warm the bottle before use, in warm water.

2.    Remove the cap, and screw on the application tube. If required, apply a lubricant (e.g. petroleum jelly) to the nozzle.

3.    Lie on a towel, on your side with both knees bent towards the chest.

4.    Insert the full length of the nozzle into the rectum and squeeze the bottle gently until empty. For a young child, the nozzle should only be inserted to half its length. Do not use force especially in children, the elderly or frail, if the lower body is paralysed, or in stroke patients.

5.    Put the used bottle back into the carton for disposal.

After using the enema, if you have not had a bowel movement (usually

within 15 to 30 minutes), contact your doctor for advice. Do NOT use

another enema.

If you use too much or swallow some by mistake, seek medical advice.

Batch No: Expiry:

115B/CST128/m/6

HOWTO USE:

For rectal use only

Adults and elderly: Use one enema as required.

Children 3 to 12 years: Reduce the dose in proportion to the child's weight, i.e. for a 35 kg {5'A stone) child give half the contents of the bottle. If unsure, check with your doctor or pharmacist. Under 3 years: Not recommended.

1.    Warm the bottle before use, in warm water.

2.    Remove the cap. If required, apply a lubricant (e.g. petroleum jelly) to the nozzle.

3.    Lie on the towel, on your side with both knees bent towards the chest.

4.    Insert the full length of the nozzle into the rectum and squeeze the bottle gently until empty. For a young child, the nozzle should only be inserted to half its length. Do not use force especially in children, the elderly or frail, if the lower body is paralysed, or in stroke patients.

5.    Put the used bottle back into the carton for disposal.

After using the enema. If you have not had a bowel movement (usually within 15 to 30 minutes), contact your doctor for advice. Do NOT use another enema. If you use too much or swallow some by mistake, seek medical advice.

SIDE EFFECTS:

STOP using the enema and seek medical help immediately if you have any of the following allergic reactions:

•    difficulty breathing or swallowing, swelling of the face, lips, tongue or throat

•    severe itching of the skin, with a red rash or raised lumps.

Tell your doctor as soon as possible if

you:

•    faint after using the enema. This may happen to elderly patients.

Other side effects:

•    rectal irritation (redness, itching).

Long term use of the enema may irritate the anal passage, or the bowel may become lazy. It may also affect the amount of salts in your blood, your doctor may check for this.

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellow-card

By reporting side effects you can help provide more information on the safety of this medicine.

FOR SINGLE RECTAL USE ONLY

FOR SINGLE RECTAL USE ONLY