ATOLAXANT 13.7 g POWDER FOR ORAL SOLUTION

Introduction

Patient Information: Summary of Product Characteristics

Atolaxant 13.7 g powder for oral solution

macrogol 3350/sodium chloride/sodium hydrogen carbonate/potassium chloride

Read the entire patient information leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this patient information leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this patient information leaflet. See section 4.

Contents of the Patient Information Leaflet:

1. What is Atolaxant and what is it used for
2. What you need to know before taking Atolaxant
3. How to take Atolaxant
4. Possible side effects
5. Storage of Atolaxant
6. Package contents and additional information

1. What is Atolaxant and what is it used for

Atolaxant is a laxative used for the treatment of constipation (especially long-lasting constipation) in adults, adolescents, and elderly patients. It is not recommended for children under 12 years of age.

It is also used for the treatment of hard stools that have accumulated in the intestine as a result of long-lasting constipation (this is known as fecal impaction).

The active ingredient Macrogol 3350 softens the stools, making them pass more easily, relieving constipation. The electrolytes (salts) help maintain normal sodium, potassium, and water levels in your body while you are being treated for constipation.

2. What you need to know before taking Atolaxant

Do not take Atolaxant

• if you are allergic to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride, or any of the other ingredients of this medication (listed in section 6),
• if you have a perforation in the intestinal wall,
• if you have an intestinal blockage (intestinal obstruction, ileus),
• if you have a severe inflammatory bowel disease, such as ulcerative colitis, Crohn's disease, or toxic megacolon.

Consult your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Atolaxant.

Before taking Atolaxant to treat symptoms of fecal impaction, your doctor must have confirmed that you have this condition.

If you have heart disease and are taking a product for fecal impaction, follow the special instructions indicated in section 3.

If you develop side effects such as swelling, difficulty breathing, fatigue, dehydration (symptoms including increased thirst, dry mouth, and weakness), or heart problems, you should stop taking Atolaxant and contact your doctor immediately.

If you experience sudden abdominal pain or rectal bleeding while taking Atolaxant for intestinal preparation, contact your doctor or go to a doctor immediately.

Children

It is not indicated for children under 12 years of age.

Other medications and Atolaxant

Tell your doctor or pharmacist if you are taking or have recently taken any other medication.

Some medications, such as antiepileptics, may not be as effective when administered with Atolaxant. Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

If you need to thicken fluids to swallow them safely, macrogol may counteract the effect of the thickener.

Pregnancy and breastfeeding

Atolaxant can be taken during pregnancy and breastfeeding.If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

Atolaxant does not affect the ability to drive or use machines.

Atolaxant contains sodium, sorbitol, and potassium.

This medication contains 188 mg of sodium (main component of table salt/cooking salt) per sachet. This is equivalent to 9.4% of the maximum daily sodium intake recommended for an adult.

Consult your doctor or pharmacist if you need 3 or more sachets per day for an extended period, especially if you have been advised to follow a low-sodium diet.

The maximum daily dose of this medication in patients with chronic constipation contains 564 mg of sodium. This is equivalent to 28.2% of the maximum daily sodium intake recommended by the WHO.

Atolaxant has a high sodium content, which should be taken into account in patients with low-sodium diets.

The maximum daily dose of this medication in patients with fecal impaction contains 1504 mg of sodium. This is equivalent to 75.2% of the maximum daily sodium intake recommended by the WHO.

Consult your doctor or pharmacist if you need 3 or more sachets per day for an extended period, especially if you have been advised to follow a low-sodium diet.

Patients with renal insufficiency or low-potassium diets should note that this medication contains 24.4 mg (0.6 mmol) of potassium per sachet.

The lemon-lime flavoring of this medication contains 0.8 mg of sorbitol (E420) per sachet.

3. How to take Atolaxant

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Constipation:

The dose of Atolaxant is one sachet dissolved in 125 ml (1/4 water). Take this 1 to 3 times a day, depending on the severity of your constipation.

Treatment with this medication usually lasts 2 weeks. If you need to take this medication for a longer period, consult your doctor. If your constipation is caused by a disease such as Parkinson's or multiple sclerosis (MS), or if you are taking medications that cause constipation, your doctor will recommend that you do not take this medication for more than 2 weeks. If you need to take this medication for a longer period, consult your doctor. Normally, for long-term treatment, the dose should be reduced to 1 or 2 sachets per day.

Fecal impaction

Before taking this medication for fecal impaction, it must be confirmed that you have this condition. A dose of 8 sachets per day of Atolaxant is needed for the treatment of fecal impaction. Each sachet should be dissolved in 125 ml (1/4 water) of water. The 8 sachets should be taken every 6 hours for 3 days if necessary. If you have heart disease, do not take more than 2 sachets in one hour.

Method of administration

Open the sachet and pour the contents into a glass. Add 125 ml of water or a quarter of water to the glass. Stir well until the powder is dissolved and the solution is clear or slightly cloudy, and then drink it.

If you are being treated for fecal impaction, you can dissolve the contents of eight sachets in a large container (in one liter of water).

This medication should be taken orally.

Children

Do not administer this medication to children under 12 years of age.

If you take more Atolaxant than you should

You may experience severe abdominal pain and inflammation (stomach) or vomiting (nausea) or diarrhea. Excessive diarrhea can lead to dehydration. If this occurs, stop taking this medication and drink plenty of fluids. If you experience these symptoms, consult your doctor or pharmacist.

If you have taken more Atolaxant than you should, consult your doctor, pharmacist, or call the Toxicology Information Service immediately, indicating the medication and the amount used.

If you forget to take Atolaxant

Take your dose as soon as you remember.

.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If you experience any of the following side effects, stop taking Atolaxant and go to your doctor immediately:

• Signs of allergy such as eczema, itching, redness of the skin, shortness of breath or difficulty breathing, or swelling of the face, lips, tongue, or throat.
• Signs of changes in your body's fluids or electrolyte levels, such as swelling (mainly in the ankles), weakness, dehydration, increased fatigue, or increased thirst with headache. These symptoms may be a sign that your potassium levels are higher or lower than normal.

Other side effects include:

• swelling of hands, feet, and ankles,
• headache,
• indigestion, stomach pain, cramps,
• feeling bloated, belching, feeling nauseous or vomiting,
• anal pain (anus),
• diarrhea (when starting to take this medication),
• changes in your body's fluid or electrolyte levels (low sodium levels).

These side effects usually improve if you reduce the amount of Atolaxant you take.

The frequency of these side effects is not known (cannot be estimated from available data).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this patient information leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Atolaxant

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

Do not use this medication after the expiration date stated on the packaging and sachet after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Once Atolaxant is reconstituted in water, keep it covered and store it in the refrigerator (between 2°C and 8°C), and it must be taken within 24 hours. After 24 hours, any remaining reconstituted solution should be discarded.

Do not use this medication if you notice any signs of deterioration in the sachet.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Atolaxant

• The active ingredients are:

Each sachet contains:

macrogol 3350 13.125 g

sodium chloride 0.3507 g

sodium hydrogen carbonate 0.1785 g

potassium chloride 0.0466 g

The other ingredients (excipients) are: colloidal anhydrous silica, sodium saccharin, orange flavoring (the orange flavoring contains: flavoring substances and flavoring preparations, maltodextrin, gum arabic (E 414), and alpha-tocopherol (E 307)), and lemon-lime flavoring (the lemon-lime flavoring contains: natural lemon oil, natural lemon powder, lime powder, maltodextrin, mannitol (E 421), gluconolactone (E 575), sorbitol (E 420), gum arabic (E 414), and colloidal anhydrous silica (E 551))

Appearance of the product and package contents

Atolaxant is a white crystalline powder.

The sachet is composed of PAP/ALU/PE.

Each sachet contains 13.7 g of powder for oral solution and is presented in cardboard boxes containing 2, 6, 8, 10, 20, 30, 50, 60 (2x30), and 100 (2x50) sachets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Klocke Pharma-Service GmbH

Strassburger Strasse 77,

77767 Appenweier

Germany

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1, 39179 Barleben

Germany

or

Hermes Pharma Ges.m.b.H.

Schwimmschulweg 1a

9400 Wolfsberg

Austria

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany Macrogol Hexal plus Elektrolyte Pulver zur Herstellung einer Lösung zum Einnehmen

Austria Laxoglam-Pulver zur Herstellung einer Lösung zum Einnehmen

Belgium Macrogol+electrolytes Sandoz poeder voor drank

Denmark Gangiden

Netherlands Macrogol en elektrolyten Sandoz 13,8 g poeder voor drank

Ireland Macrolief 13.125g + 351mg + 179mg + 47mg sachet, powder for oral solution

Italy MACROGOL SANDOZ 13.125 g + 351 mg + 179 mg + 47 mg polvere per soluzione orale

Luxembourg Macrogol+electrolytes Sandoz poudre pour solution buvable

Sweden Laxiriva pulver till oral lösning, i dospåse

United Kingdom Compound Macrogol 13.8g Powder for Oral Solution

Malta Macrolief 13.8g sachet, powder for oral solution

Date of the last revision of this patient information leaflet:February 2022

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