Atolaxant 13.7 g powder for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Atolaxant 13.7 g powder for oral solution

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

Read the entire leaflet carefully before starting to take this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Atolaxant is and what it is 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 prolonged constipation (this is known as fecal impaction).

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

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

Do not take Atolaxant

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

Consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to 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 a heart condition and are taking a product for fecal impaction, follow the special instructions provided in section 3.

If you develop side effects such as swelling, difficulty breathing, fatigue, dehydration (symptoms 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 immediate medical attention.

Children

Not recommended for children under 12 years of age.

Other medicines and Atolaxant

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

Some medicines, such as antiepileptics, may be less effective when taken together with Atolaxant. Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicines.

If you need to thicken liquids to swallow them safely, macrogol may counteract the thickening agent's effect.

Pregnancy and breastfeeding

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

Driving and using machines

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/cooking salt) per sachet. This corresponds to 9.4% of the maximum daily recommended sodium intake for an adult.

Consult your doctor or pharmacist if you need 3 or more sachets daily over a prolonged period, especially if you have been advised to follow a low-salt (low-sodium) diet.

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

Atolaxant has a high sodium content and should therefore be taken into account in patients on low-sodium diets.

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

Consult your doctor or pharmacist if you need 3 or more sachets daily over a prolonged period, especially if you have been advised to follow a low-salt (low-sodium) diet.

Patients with renal impairment or those on potassium-restricted diets should note that this medicine contains 24.4 mg (0.6 mmol) of potassium per sachet.

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

3. How to take Atolaxant

Follow exactly the administration instructions for this medicine 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 pint) of water. Take this 1 to 3 times a day, depending on the severity of your constipation.

Treatment with this medicine usually lasts 2 weeks. If you need to take this medicine for longer, 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 medicines that cause constipation, your doctor will advise you not to take this medicine for longer than 2 weeks. If you need to take this medicine for a longer period, consult your doctor. For long-term treatment, the dose is usually reduced to 1 or 2 sachets per day.

Faecal impaction

Before taking this medicine for faecal impaction, it must be confirmed that you have this condition. A dose of 8 sachets per day of Atolaxant is required for the treatment of faecal impaction. Each sachet should be dissolved in 125 ml (1/4 pint) of water. The 8 sachets should be taken every six hours over 3 days if necessary. If you have a heart condition, 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 a pint of water to the glass. Stir well until the powder is dissolved and the solution becomes clear or slightly cloudy, then drink it.

If you are being treated for faecal impaction, you may dissolve the contents of eight sachets in a large container (in one litre of water).

This medicine should be taken orally.

Children

Do not give this medicine to children under 12 years of age.

If you take more Atolaxant than you should

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

If you have taken more Atolaxant than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Atolaxant

Take your dose as soon as you remember.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

If you experience any of the following adverse effects, stop taking Atolaxant and contact your doctor immediately:

• Signs of allergy such as: eczema, itching, skin redness, shortness of breath or difficulty breathing, or 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 tiredness, or increased thirst accompanied by headache. These symptoms may indicate that blood potassium levels are either higher or lower than normal.

Other adverse effects include:

• swelling of hands, feet and ankles,
• headache,
• indigestion, stomach pain, cramps,
• feeling bloated, experiencing excessive air swallowing (aerophagia), dizziness or vomiting,
• pain in the anus,
• diarrhea (when starting this medicine),
• changes in fluid or electrolyte levels in your body (low sodium levels).

These adverse effects generally improve if the dose of Atolaxant is reduced.

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

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Atolaxant

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

Do not use this medicine after the expiry date stated on the pack and sachet after EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C.

After reconstituting Atolaxant in water, keep it covered and store in a refrigerator (between 2°C and 8°C) and use within 24 hours. After 24 hours, any remaining reconstituted solution must be discarded.

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

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to your pharmacy’s SIGRE point. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atolaxant

• The active substances 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 components (excipients) are: anhydrous colloidal silica, sodium saccharin, orange flavouring (the orange flavouring contains: flavouring substances and flavouring preparations, maltodextrin, arabic gum (E 414), and alpha-tocopherol (E 307), and lime-lemon flavouring (the lime-lemon flavouring contains: natural lemon oil, natural powdered lemon flavouring, powdered lime flavouring, maltodextrine, mannitol (E 421), gluconolactone (E 575), sorbitol (E 420), arabic gum (E 414), and anhydrous colloidal silica (E 551)).

Nature of the product and contents of the pack

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 packages containing 2, 6, 8, 10, 20, 30, 50, 60 (2x30), and 100 (2x50) sachets.

Only certain 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 medicinal product 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 most recent review of this summary: February 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/