PATIENT INFORMATION LEAFLET

LAINEMA 14/3 g/100 ml rectal solution EFG

Sodium dihydrogen phosphate (monohydrate)/Disodium hydrogen phosphate (dodecahydrate)

Read this leaflet carefully before you start using the medicine.

1. What isLAINEMA 14/3 g/100 ml rectal solution EFGand what it is used for

2. Before usingLAINEMA 14/3 g/100 ml rectal solution EFG

3. How to useLAINEMA 14/3 g/100 ml rectal solution EFG

4. Possible side effects

5. Storage ofLAINEMA 14/3 g/100 ml rectal solution EFG

6. Additional information

This medication belongs to the pharmacotherapeutic group of rectal laxatives.

This medication is indicated in cases where intestinal evacuation is necessary, such as: pre- and post-surgery, childbirth and postpartum, before rectoscopy, sigmoidoscopy, and colonoscopy (techniques for exploring the large intestine), before radiological examinations, fecal impaction (accumulation of hardened feces in the rectum).

Do not use LAINEMA 14/3 g/100 ml rectal solution EFG

-If you are allergic (hypersensitive) to the active ingredients or to any of the other components of this medication

-In children under 2 years

-If there is suspicion of intestinal obstruction (impossibility of elimination of feces and gases)

-If you have megacolon (colon dilation), ileostomy (artificial anus), anal stenosis (rectal narrowing), imperforate anus (congenital absence or obstruction of the anal opening) or paralytic ileus (intestinal paralysis)

-If you have severe or moderate kidney problems

-If you have congestive heart failure (serious heart problem)

-If you have symptoms of appendicitis or intestinal perforation

-If you have undiagnosed rectal bleeding

-If you have uncontrolled high blood pressure

-If you have dehydration and, in general, in all cases where the distribution of LAINEMA in the body may be increased or its elimination decreased.

In case of doubt about any of these situations or your particular case, consult your doctor.

Be especially careful with LAINEMA 14/3 g/100 ml rectal solution EFG

If, after 10 minutes of administration of the enema, you are unable to evacuate (evacuation occurs approximately 5 minutes after administration), it is recommended to consult your doctor to perform the necessary tests to minimize the risk of severe hyperphosphatemia.

-If you are elderly, weak, have ascites (fluid accumulation in the abdomen), anal ulcers or fissures, or have kidney or heart disease.

-If you have had a colostomy (major colon surgery), consult your doctor.

-If you have pre-existing electrolyte imbalances (alteration of mineral levels in the body) as you may develop hypocalcemia (low calcium levels in the blood), hypokalemia (low potassium levels in the blood), hyperphosphatemia (high phosphorus levels in the blood), hypernatremia (high sodium levels in the blood), and acidosis.

-In case of suspected electrolyte disorders, your doctor will perform a blood test to determine the levels of these substances before administering LAINEMA.

-If you have nausea, vomiting, or abdominal pain, follow your doctor's instructions.

-Do not recommend repeated and prolonged use of LAINEMA, as it may cause habituation. Do not use if symptoms worsen or persist without consulting a doctor.

-LAINEMA should be administered following the instructions for use and handling. You should interrupt administration if you encounter resistance, as forcing its administration may cause injuries.

-If, after administration of the enema, you bleed through the rectum, do not administer more enema and consult your doctor immediately.

-Consult your doctor if signs of irritation occur.

This medication should not be used as a habitual treatment for constipation.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription, homeopathic, herbal, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

It is especially important that your doctor knows if you are taking medications for high blood pressure or angina (calcium channel blockers), medications for urinary retention (diuretics), medications for certain behavioral disorders (lithium), or other medications that may modify the balance of water or electrolytes (minerals) in the blood.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

Do not use this medication during pregnancy or lactation without consulting a doctor.

If you are breastfeeding, you should express and discard the milk produced during the 24 hours following administration of LAINEMA.

Driving and operating machinery

This medication does not affect your ability to drive or operate machinery.

Important information about some of the components of LAINEMA 14/3 g/100 ml rectal solution EFG

rectal EFG

It may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm, as it contains parahydroxybenzoate of methyl, sodium salt (E-219).

Follow exactly the medication administration instructions indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

This is a rectal medication. It should be applied at room temperature, without the need to heat it.

For self-administration of this medication, it is recommended that the patient be reclined on the left side and with both legs folded over the chest (Figure 1) or reclined with the left leg extended and the right leg folded over the chest (Figure 2).

When this medication is to be administered to the patient by another person, the recommended positions may be either those described for self-administration, or the one shown in Figure 3.

Press the cap towards one side. Thus, the seal is broken. Once the seal is broken, pull the cap and the pre-lubricated cannula upwards, and it will be free for insertion.

In the indicated positions, introduce the cannula into the rectum, carefully to avoid injuring the wall of the same, and squeeze the container, in a smooth and continuous manner, until the required amount of liquid penetrates. It is advisable for the patient to maintain this position until they feel a strong urge to defecate. Generally, 2 to 5 minutes are sufficient to achieve the desired effect. If the product is not expelled within this time, see section 4: "Possible adverse effects".

Generally, the following dose is recommended:

Children

-Infants and children under 2 years:LAINEMA should not be administered to infants and children under 2 years, its use is contraindicated.

-Children from 2 to 15 years:The recommended dose is a single dose of 5 ml/kg, or up to a maximum of 140 ml. The maximum duration of treatment will be one enema per day, for no more than 6 consecutive days.

Adults

The recommended dose is a single enema of 140 ml or 250 ml. It may be administered once a day, for a maximum of 6 consecutive days.

People over 65 years:The recommended dosage regimen is the same as for adults.

Patients with liver problems:In this case, no dose adjustment is necessary.

Patients with kidney problems:This medication should not be administered to patients with severe or moderate kidney problems.

It will be administered with caution to patients with mild kidney problems and only under medical prescription.

If you use more LAINEMA 14/3 g/100 ml rectal solution EFG than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use LAINEMA 14/3 g/100 ml rectal solution EFG

Do not use a double dose to compensate for the missed doses.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medications, LAINEMA may cause adverse effects, although not everyone will experience them.

In very rare cases, there may be instances of tetany (painful muscle spasms in the limbs) with severe hypocalcemia (low calcium levels in the blood) and hyperphosphatemia (high levels of phosphorus in the blood). Severe cases of hyperphosphatemia associated with the administration of high-phosphate laxatives have been reported. Patients with risk factors for developing hyperphosphatemia should therefore be monitored through analytical tests (see section “Be especially careful with LAINEMA 14/3 g/100 ml rectal solution EFG”)

Patients who very rarely develop severe hyperphosphatemia may present with irritability, hypotension (low blood pressure), muscle cramps, cyanosis (blue discoloration of the skin), tetany, tachycardia (increased heart rate), seizures, drowsiness, fatigue, weakness, or, potentially, a comatose state.

The following adverse effects of LAINEMA are described below and listed in order of frequency:

Very Rare Adverse Effects(affecting fewer than 1 in 10,000 patients):

-tetany

-hypocalcemia

-severe hyperphosphatemia

-blisters

-pruritus

-itching

-rectal irritation

-pain

Very Common Adverse Effects(affecting at least 1 in 10 patients)

-Transient hyperphosphatemia

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

No requires special conditions for conservation, notwithstanding in rare occasions some inorganic floculations may appear in the solution which in no way affect the integrity of the preparation.

Keep out of reach and sight of children.

Do not use LAINEMA after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown into the drains or trash. Ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help to protect the environment.

Composition of LAINEMA 14/3 g/100 ml rectal solution EFG

The active principles per milliliter are: sodium dihydrogen phosphate (monohydrate) 139 mg, disodium hydrogen phosphate (dodecahydrate) 32 mg. The other components (excipients) are: methyl parahydroxybenzoate, sodium salt (E-219) and purified water.

Appearance of the product and contents of the package

This medication belongs to a group of medications called rectal laxatives.

It is presented in the form of a rectal solution, in low-density polyethylene bottles of 80, 140, and 250 ml and a rectal applicator formed byhigh-density polyethylene stopper, EBA (ethylene-vinyl acetate copolymer) cannula already lubricated, seal and high-density polyethylene stopper..

Holder of the marketing authorization and responsible for manufacturing

LAINCO, S.A. Avda. Bizet, 8-12 - 08191 Rubí (Barcelona)

This leaflet was approved in October 2017