OPONAF 10 g POWDER FOR ORAL SOLUTION

Introduction

Package Leaflet: Information for the Patient

Oponaf 10 g Powder for Oral Solution

Lactitol

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package 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. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

Contents of the Package Leaflet

1. What is Oponaf and what is it used for
2. What you need to know before taking Oponaf
3. How to take Oponaf
4. Possible side effects
5. Storage of Oponaf
6. Contents of the pack and further information

1. What is Oponaf and what is it used for

Oponaf belongs to a group of medicines called oral osmotic laxatives.

Oponaf is indicated:

• For the treatment of chronic habitual constipation.
• As part of the treatment of certain symptoms of portosystemic encephalopathy, which is a consequence of severe liver disease.

2. What you need to know before taking Oponaf

Chronic constipation should be treated, as a first measure, through a high-fiber diet, sufficient fluid intake, or physical exercise. If there is no improvement 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 interfere with the normal functioning of the defecation reflex, so it is recommended to treat constipation with adequate hygiene and dietary measures.

The use of laxatives during prolonged periods should be avoided.

Do not take Oponaf

• if you are allergic (hypersensitive) to lactitol;
• if you have intestinal obstruction or there is suspicion of organic lesions in the digestive tract;
• if there is unjustified 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 baby with hereditary autosomal recessive fructose intolerance;
• if you have a pre-existing electrolyte imbalance in your serum.

Warnings and precautions

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

Taking Oponaf with other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

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

It is important that you inform your doctor if you are taking or have recently taken any of the following medicines:

• Antacids or neomycin (antibiotic) should not be administered together with Oponaf in the treatment of cirrhosis with hepatic encephalopathy, as these medicines may interfere with its mechanism of action.
• Thiazide diuretics (medicines used to increase urine elimination).
• Corticosteroids (anti-inflammatory and antiallergic medicines).
• Carbenoxolone (gastric mucosa protector and anti-inflammatory).
• Amphotericin B (medicine for the treatment of fungal infections).
• Mesalazine (anti-inflammatory medicine).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

Although it has not been studied whether lactitol passes into breast milk, the use of Oponaf is considered safe for breastfeeding mothers.

Driving and using machines

Oponaf does not affect the ability to drive vehicles or use machinery.

Oponaf contains lactitol

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

Lactitol has a caloric value of 2.1 kcal/g.

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

The use of Oponaf does not affect the teeth.

3. How to take Oponaf

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

Constipation

Treatment with Oponaf should be adapted individually, in order to achieve a daily bowel movement.

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

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 guideline may be the following:

• from 1 to 6 years: 2.5 to 5 g of powder/day (1/4 to 1/2 sachet)
• from 6 to 12 years: 5 to 10 g of powder/day (1/2 to 1 sachet)
• from 12 to 16 years: 10 to 20 g of powder/day (1 to 2 sachets)

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

Adults (including elderly patients): Oponaf is administered orally, although in hospitalized patients it can also be administered through a nasogastric tube or retention enema via a rectal balloon catheter, according to the doctor's instructions.

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

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

Hepatic encephalopathy

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

The indicated dose may vary until two soft stools per day are achieved, depending on the severity of the disease and the response to treatment.

If you think the effect of Oponaf is too strong or too weak, tell your doctor or pharmacist.

Your doctor will indicate the duration of your treatment with Oponaf. Do not stop treatment before the indicated time, as irregular use or premature interruption of treatment carries the risk of 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 overdose with Oponaf 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 Toxicology Information Service. Telephone 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 make up for forgotten doses.

If you stop taking Oponaf

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Oponaf can cause side effects, although not everybody gets them:

At the start of treatment, abdominal discomfort and flatulence may occur; sometimes stomach pain or spasms may appear. These effects tend to decrease or disappear after a few days of regular intake of Oponaf.

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

Rare side effects (affects 1 to 10 patients in every 10,000)

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

Very rare side effects (affects less than 1 patient in every 10,000)

• nausea
• abnormal gastrointestinal noises
• anal itching

If you experience side effects, talk to your doctor, pharmacist, even if it is a side effect not listed in this package leaflet.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Oponaf

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

Do not store above 30°C. Store protected from moisture.

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

Do not use Oponaf after the expiry date stated on the packaging after the abbreviation "CAD". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Oponaf

The active substance is lactitol monohydrate. One sachet contains 10 g of lactitol monohydrate.

Oponaf does not contain any excipients.

Appearance of the product and contents of the pack

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

Marketing authorization holder and manufacturer

Marketing authorization holder:

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80

3rd floor, module A-Australia Building

08840 Viladecans, Barcelona (Spain)

Manufacturer:

Lamp S. Prospero SpA

Via della Pace, 25/A

San Prospero (Modena)

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 package leaflet was approved in November 2015

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/