Package Insert: Information for the Patient

Oponaf 10 g powder for oral solution

Lactitol

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.

1. What is Oponaf and how is it used

2. What you need to know before starting to take Oponaf

3. How to take Oponaf

4. Possible adverse effects

5. Storage of Oponaf

6. Contents of the package and additional information

Oponaf belongs to a group of medications known as oral osmotic laxatives.

Oponaf is indicated for:

• The treatment of chronic habitual constipation.
• As part of the treatment of some symptoms of portal-systemic encephalopathy, which is a consequence of a severe liver disease.

Chronic constipation should be treated, as a first measure, with a diet rich in fiber, sufficient liquid intake, or physical exercise. If no improvement is seen with these measures, your doctor may recommend the use of Oponaf.

Especially in children, it should be taken into account that prolonged treatment with laxatives can impede the normal functioning of the defecation reflex, so it is recommended to treat constipation with appropriate hygiene and dietary measures.

Prolonged use of laxatives should be avoided.

Do not take Oponaf

• if you are allergic (hypersensitive) to lactitol;
• if you have intestinal obstruction or suspicion of organic lesions in the digestive tract;
• if you have unexplained abdominal pain or rectal bleeding;
• if you are following a galactose-free diet;
• in case of fecal stasis (prolonged retention), which should be treated previously by other means;
• if you have galactosemia;
• if you are breastfeeding a lactant with hereditary autosomal recessive fructose intolerance;
• if you have a pre-existing electrolyte imbalance in your serum.

Warnings and precautions

• in elderly patients, debilitated or dehydrated or with hypopotasemia (low potassium levels in blood), your doctor should regularly monitor blood electrolyte levels, especially in prolonged treatments;
• if you need to undergo any internal examination of the intestine, consult your doctor;
• in cases of ileostomy or colostomy (opening from the ileum or colon to the outside) Oponaf administration is not recommended;
• in case of particularly resistant constipation, consult your doctor;
• if nausea occurs, it is recommended to take Oponaf during meals;
• in babies, Oponaf should only be used after doctor's recommendation.

Administration of Oponaf with other medications

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

Certain medications may interact with Oponaf; in these cases, it may be necessary to change the dose or discontinue treatment with one of them.

It is essential to inform your doctor if you are taking or have recently taken any of the following medications:

• Anti-acids or neomycin (antibiotic) should not be administered concurrently with Oponaf in cirrhosis with hepatic encephalopathy treatments, as these medications can interfere with its mechanism of action.
• Thiazide diuretics (medications used to increase urine elimination).
• Corticosteroids (anti-inflammatory and antiallergic medications).
• Carbenoxolone (gastric mucosa protector and anti-inflammatory).
• Ampicillin B (medication for fungal infections).
• Mesalazine (anti-inflammatory medication).

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

Oponaf should not be used during the first trimester of pregnancy unless your doctor recommends otherwise.

Although the passage of lactitol to breast milk has not been studied, the use of Oponaf is considered safe for lactating mothers.

Driving and operating machinery

Oponaf has no effect on the ability to drive vehicles or operate machinery.

Oponaf contains lactitol

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Lactitol has a caloric value of 2.1 kcal/g.

Oponaf does not affect blood glucose or insulin levels, making it suitable for diabetic patients.

The use of Oponaf does not affect teeth.

Follow exactly the administration instructions for Oponaf indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Constipation

Oponaf treatment should be adapted individually to achieve a daily bowel movement.

Oponaf is administered orally in a single daily dose, either in the morning or at night, preferably mixed with food or drink and taking 1-2 glasses of liquid during meals. The patient should choose between taking the medication in the morning or at night, according to their response, as the laxative effect occurs mainly a few hours after taking it.

The first laxative response may not appear until the second or third day of treatment.

Use in children: The initial daily dose is 0.25 g/kg of body weight per day; a general schedule can be as follows:

• 1 to 6 years: 2.5 to 5 g of powder/day (¼-½ scoop)
• 6 to 12 years: 5 to 10 g of powder/day (½-1 scoop)
• 12 to 16 years: 10 to 20 g of powder/day (1-2 scoops)

Oponaf intake by children should be supervised by an adult and the doctor's instructions should be followed strictly.

Adults (including elderly patients): Oponaf is administered orally, although in hospitalized patients it can also be administered via nasogastric tube or rectal balloon catheter enema, as indicated by the doctor.

The initial daily dose should be 2 scoops (20 g of lactitol) in a single dose. After a few days, a daily dose of 1 scoop (10 g) may be sufficient for many patients.

If the initial dose is not effective, a maximum dose of 3 scoops (30 g/day) may be administered.

Hepatic encephalopathy:

Oponaf treatment should be adapted to each individual. It is essential to follow the doctor's instructions. The initial dose for adult treatment is 0.5 to 0.7 g/kg of body weight per day. The daily dose should be divided into 3 doses, taken with meals, drinking 1-2 glasses of liquid during meals.

The indicated dose may vary to achieve 2 soft bowel movements per day, depending on the severity of the disease and the response to treatment.

If you estimate that Oponaf's action is too strong or too weak, inform your doctor or pharmacist.

Your doctor will indicate the duration of your Oponaf treatment. Do not discontinue treatment before the indicated time, as irregular use or premature interruption of treatment may lead to relapse.

If you take more Oponaf than you should

If you have taken more Oponaf than you should, consult your doctor or pharmacist immediately.

The sign of Oponaf overdose is diarrhea, which may disappear by reducing the dose. If diarrhea persists, consult your doctor.

In case of accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service. Phone 91 562 04 20.

If you forget to take Oponaf

Take the next dose at the usual time.

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

If you interrupt Oponaf treatment

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

Like all medications, Oponaf can produce adverse effects, although not all people may experience them:

At the beginning of treatment, abdominal discomfort and flatulence may occur; sometimes stomach pain or spasms may be present. These effects tend to decrease or disappear after a few days of regular Emportal use

Due to individual differences, some patients may experience diarrhea at the recommended doses. This problem is resolved by reducing the dose.

Rare Adverse Effects (affects 1 to 10 patients per 10,000)

• abdominal pain
• abdominal discomfort
• diarrhea
• flatulence
• vomiting

Very Rare Adverse Effects (affects less than 1 patient per 10,000)

• nausea
• abnormal gastrointestinal sounds
• anal itching

If you experience adverse effects, consult your doctor, pharmacist, even if they are adverse effects that do not appear in this prospectus.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not store at a temperature above 86°F (30°C). Store protected from moisture.

The prepared solution should be stored preferably between 36°F and 46°F (2°C and 8°C, in a refrigerator) and should be consumed within a maximum of 2 days.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Oponaf

The active ingredient is lactitol monohydrate. A packet contains 10 g of lactitol monohydrate.

Oponaf does not contain any excipients.

Appearance of the product and content of the container

Oponaf 10 g powder for oral solution is a white, crystalline, slightly sweet-tasting powder for oral solution, presented in paper/aluminum/polyethylene sachets, 10 g, in boxes of 20 and 50 sachets.

Holder of the marketing authorization and manufacturer responsible

Holder:

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80

3rd floor, module A-Edificio Australia

08840 Viladecans, Barcelona (Spain)

Manufacturer responsible:

Lamp S. Prospero SpA

Via della Pace, 25/A

San Prospero (Módena)

Italy

or

A.C.R.A.F. S.p.A (Aziende Chimiche Riunite Angelini Francesco)

Via Vecchia Del Pinocchio, 22

60131 Ancona (AN)

Italy

This leaflet was approved in November 2015

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/