Package leaflet: Information for the user

ENEMAC 16.1g/100ml + 6g/100ml

Rectal solution
Monosodium phosphate monohydrate + disodium phosphate heptahydrate
Please read this leaflet carefully before using this medicine because it contains
important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you want more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.
Contact your doctor if you do not notice improvement or if you notice worsening of symptoms.

Contents of this leaflet:

What ENEMAC is and what it is used for
What you need to know before using ENEMAC
How to use ENEMAC
Possible side effects
How to store ENEMAC
Package contents and other information

1. What ENEMAC is and what it is used for

ENEMAC contains the active substances monosodium phosphate monohydrate and disodium phosphate heptahydrate and
belongs to the class of medicines used to facilitate the elimination of faeces (intestinal evacuant).
ENEMAC is indicated for the treatment of constipation and to promote intestinal evacuation
prior to radiological examinations or other diagnostic tests.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using ENEMAC

Do not use ENEMAC

if you are allergic to monosodium phosphate monohydrate, disodium phosphate heptahydrate, or any of the other ingredients of this medicine (listed in section 6).
in case of abdominal pain, nausea, and vomiting.
in case of anorectal disorders.

Warnings and precautions
Talk to your doctor or pharmacist before using ENEMAC.

Administer ENEMAC to children under two years of age only after consulting a doctor and evaluating with him the risk/benefit ratio. Consult your doctor if constipation persists.
If you use laxatives for a prolonged period, you may develop tolerance or other types of damage.
If you use laxatives for a prolonged period, you may develop dehydration.
Use ENEMAC only for occasional administration.
If you have celiac disease, you can take this medicine without risk.

Other medicines and ENEMAC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
To date, no interactions with other drugs have been reported.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
You may use ENEMAC during pregnancy and breastfeeding.

Driving and using machines
ENEMAC does not affect the ability to drive vehicles or operate machinery.

ENEMAC contains sodium as part of the active ingredient in the amount stated in the composition. This should be taken into consideration in individuals with impaired renal function or those following a low-sodium diet.

ENEMAC also contains sodium methyl parahydroxybenzoate. It may cause allergic reactions (including delayed reactions).

3. How to use ENEMAC

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Administer the medicine rectally only.
Adults
The recommended dose is 1 bottle per day as a single administration.
Children over 2 years of age
The recommended dose is from one-quarter to one-half of a bottle, administered once. Any remaining solution must be discarded. In children over two years of age, the rectal cannula should not be inserted more than halfway.
Instructions for use:

Before using ENEMAC, push the cannula cap downward until the safety seal on the bottle breaks.
Remove the protective cap from the rectal cannula.
Hold the bottle and lubricate the cannula with a few drops of ENEMAC.
Lie on your left side and gently insert the cannula into the rectum.
Squeeze the bottle to release the solution. A small amount of solution is expected to remain in the bottle. After administration, while still squeezing the bottle, withdraw the cannula.
Remain lying down and retain the liquid until you feel a strong urge to defecate (approximately 5 minutes): it is not necessary to retain the liquid longer than 10–15 minutes.
The rectal solution is intended for single use only. Discard any remaining solution.
Warning: bottle is not reusable.
Do not exceed the recommended doses without consulting your doctor.
Use the medicine only for short-term treatment. Consult your doctor if the condition (constipation) recurs frequently or if you have noticed any recent changes in bowel habits.
If you use more ENEMAC than you should
No cases of overdose have been reported to date.
In case of accidental ingestion, inform your doctor immediately or go to the nearest hospital, showing the packaging.

4. Possible side effects

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

Prolonged use may lead to a state of dehydration. This side effect is generally temporary. However, if it occurs, you should consult your doctor or pharmacist.

Other side effects:

high levels of phosphate in the blood (hyperphosphataemia),
low levels of potassium in the blood (hypokalaemia),
high levels of sodium in the blood (hypernatraemia),
low levels of calcium in the blood (hypocalcaemia)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioniavverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ENEMAC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
Do not store above 30°C.
During cold seasons, it is recommended to warm the product to room temperature by heating in a water bath.
It is important to always keep the medicine information available; therefore, retain the packaging and the leaflet.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ENEMAC contains

The active substances are: monosodium phosphate monohydrate and disodium phosphate heptahydrate. 1 ml contains 0.161 g of monosodium phosphate monohydrate and 0.060 g of disodium phosphate heptahydrate.
The other components are: methyl p-hydroxybenzoate sodium and purified water Ph. Eur.

Description of the appearance of ENEMAC and contents of the pack
ENEMAC is a ready-to-use rectal solution (enema). The pack contains 130 ml.
Marketing Authorization Holder
Eurospital S.p.A., via Flavia 122 – 34147 Trieste
Manufacturer
Zeta Farmaceutici S.p.A., via Galvani 10, 36066 Sandrigo (VI)