Prospect: information for the patient

Atolaxant 13.7 g powder for oral solution

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

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to other people, 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 prospect. See section 4.

• 1. What is Atolaxant and what is it used for
• 2. What you need to know before starting to take Atolaxant
• 3. How to take Atolaxant
• 4. Possible adverse effects
• 5. Storage of Atolaxant
• 6. Contents of the package and additional information

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 prolonged constipation (this is known as fecal impaction).

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

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 medicine (listed in section 6),
• if you have a perforation in the wall of the intestine,
• if you suffer from intestinal obstruction (intestinal blockage, ileus),
• if you suffer from a severe inflammatory intestinal disease, such as ulcerative colitis, Crohn's disease, or toxic megacolon.

Consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Atolaxant.

Your doctor must have confirmed that you have this condition before taking Atolaxant to treat the symptoms of fecal impaction.

If you have any heart disease and take 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 that include increased thirst, dry mouth, and weakness) or heart problems, stop taking Atolaxant and contact your doctor immediately.

If you experience sudden abdominal pain or rectal bleeding while taking Atolaxant for bowel preparation, contact your doctor or seek medical attention immediately.

Children

Not indicated in children under 12 years of age.

Other medicines and Atolaxant

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicine.

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

If you need to thicken fluids to swallow 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 intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

Atolaxant does not affect the ability to drive or operate machinery.

Atolaxant contains sodium, sorbitol, and potassium.

This medicine contains 188 mg of sodium (main component of table salt/for cooking) in each 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 a prolonged period, especially if you have been recommended a low-sodium diet.

The maximum daily dose of this medicine 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. Therefore, it should be taken into account in patients with low-sodium diets.

The maximum daily dose of this medicine 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 a prolonged period, especially if you have been recommended a low-sodium diet.

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

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

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

Constipation:

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

The 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 disease 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 is 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 a heart condition, do not take more than 2 sachets in an hour.

Administration form:

Open the sachet and pour the contents of the same into a glass. Add 125 ml of water or a quarter of water to the glass. Stir well until the powder has dissolved and the solution is clear or slightly turbid, 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 a 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 or inflammation or vomiting 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forgot to take Atolaxant:

Take your dose as soon as you remember.

.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

If you experience any of the following adverse effects, stop taking Atolaxant and seek immediate medical attention:

• Allergic signs such as: eczema, itching, skin redness, shortness of breath or difficulty breathingor swelling of the face, lips, tongue, or throat.
• Signs of changes in your body fluids or electrolyte levels (salt levels), such as: swelling (mainly in the ankles), weakness, dehydration, increased fatigue or increased sensation of thirst with headache. These symptoms may indicate that your blood potassium levels are higher or lower than normal.

Other adverse effects include:

• Swelling of hands, feet, and ankles,
• Headache,
• Indigestion, stomach pain, cramps,
• Feeling bloated, experiencing belching, feeling dizzy or vomiting,
• Pain in the anus (rectum),
• Diarrhea (when starting to take this medication),
• Changes in your body fluid or electrolyte levels (low sodium levels).

These adverse effects generally improve if you reduce the amount of Atolaxant you take.

The frequency of these adverse effects is unknown (cannot be estimated from available data).

Reporting Adverse Effects

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

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and the overwrap 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), it must be taken within 24 hours. After 24 hours, any remaining solution of the reconstituted product must be discarded.

Do not use this medication if you observe any sign of deterioration in the overwrap.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications that you do not need atthe SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you do not need. In this way, you will help protect the environment.

Composition of Atolaxant

• The active principles are:

Each sachet contains:

macrogol 335013,125 g

sodium chloride0,3507 g

sodium hydrogen carbonate0,1785 g

potassium chloride0,0466 g

The other components (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, powdered natural lemon flavoring, powdered lime flavoring, 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 contents of the package

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 are presented in carton containers that contain 2, 6, 8, 10, 20, 30, 50, 60 (2x30) and 100 (2x50) sachets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Klocke Pharma-Service GmbH

Strassburger Strasse 77,

77767 Appenweier

Germany

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1, 39179 Barleben

Germany

or

Hermes PharmaGes.m.b.H.

Schwimmschulweg 1a

9400 Wolfsberg

Austria

This medicine is authorized in the member states of the European Economic Area with the following names:

GermanyMacrogol Hexal plus Elektrolyte Pulver zur Herstellung einer Lösung zumEinnehmen

AustriaLaxoglam-Pulver zur Herstellung einer Lösung zum Einnehmen

BelgiumMacrogol+electrolytes Sandoz poeder voor drank

DenmarkGangiden

NetherlandsMacrogol en elektrolyten Sandoz 13,8 g poeder voor drank

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

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

LuxembourgMacrogol+electrolytes Sandoz poudre pour solution buvable

SwedenLaxiriva pulver till oral lösning, i dospåse

United KingdomCompound Macrogol 13.8g Powder for Oral Solution

MaltaMacrolief 13.8g sachet, powder for oral solution

Last review date of thisleaflet:February 2022

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