Package Leaflet: Information for the user
TEGLUTIK 5 mg/mloral suspension

riluzole

Read this leaflet carefully before you start taking 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What Teglutik is and what it is used for

2. What you need to know before you start taking Teglutik

3. How to take Teglutik

4. Possible side effects

5. Storage of Teglutik

6. Contents of the pack and additional information

What isTeglutik

The active ingredient of Teglutik is riluzol which acts on the nervous system.

What is Teglutik used forTeglutik

Teglutik is used in patients with amyotrophic lateral sclerosis (ALS).

ALS is a type of motor neuron disease that affects the motor neuron cells responsible for sending signals to muscles and causes weakness, muscle wasting, and paralysis. The destruction of motor neuron cells in motor neuron diseases can be caused by excessive glutamate (a chemical messenger) in the brain and spinal cord. Teglutik stops the release of glutamate and this may help prevent damage to motor neuron cells. For further information, consult your doctor about ALS and the reason why you have been prescribed this medication.

Do not take Teglutik

• if you areallergic(hypersensitive) to riluzol or any of the other components of this medication (listed in section 6).
• if you have anyliver diseaseor elevated levels of certain liver enzymes (transaminases) in your blood.
• if you arepregnant orbreastfeeding.

Warnings and precautions.Consult your doctor or pharmacist before starting to take Teglutik:

• if you haveliver problems: yellowing of the skin or white of the eyes (jaundice), generalized itching, feeling of dizziness, nausea
• if yourkidneysdo not function correctly
• if you havefever:it may be due to having a lower number of white blood cells, which may increase the risk of infections

If you are affected by any of the circumstances mentioned above or are unsure, inform your doctor so that they can tell you what to do.

Children and adolescents:

if you are under 18 years of age, the use of Teglutik is not recommended as there is no available information in this population.

Use of Teglutik with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication

Pregnancy, breastfeeding, and fertility

You should not take Teglutik if you are pregnant or suspect you may be pregnant, nor if you are breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Driving and operating machinery

You may drive or operate tools or machinery, unless you feel dizzy or confused after taking this medication.

Teglutik contains sorbitol liquid (E420)and sodium

This medication contains 4,000 mg of sorbitol (E420) in each 10 ml of oral suspension.

Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication.

This medication contains less than 23 mg of sodium (1mmol) per 10 ml of oral suspension; it is essentially “sodium-free”.

The suspension may be administered orally and, alternatively, it is also suitable for administration via enteral feeding tube.

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

The recommended dose is 100 mg per day (50 mg every 12 hours) administered orally. Therefore, 10 ml of suspension containing 50 mg of riluzole must be taken every 12 hours and at the same time each day (for example: in the morning and at night). The suspension is administered using a graduated dosing syringe.

The oral suspension must be gently agitated manually for at least 30 seconds, continuously rotating the bottle upwards and downwards, until the Teglutik suspension is well mixed and no clear liquid is visible at the top of the suspension or any particles are seen at the bottom of the bottle.

Administration Method:

Oral Use Instructions:

Open the bottle: press the cap and turn in a counterclockwise direction (figure 1)

Take the syringe, remove the cap and insert the syringe into the opening of the adapter (figure 2). Invert the bottle (figure 3).

Fill the syringe with a small amount of suspension by pulling the plunger downwards (figure 3A), then push the plunger upwards to extract any possible bubbles (figure 3B). Pull the plunger downwards again until the graduated mark corresponding to the prescribed amount in milliliters (ml) is reached (figure 3C).

Turn the bottle over (figure 4A). Remove the syringe from the adapter (figure 4B). ·

• Take the entire contents of the syringe by mouth.
• Close the bottle with the plastic cap.
• Wash the syringe with running water and only cover it with the cap once it has dried (figure 5).

Enteral Feeding Tube Use Instructions:

Ensure that the enteral feeding tube is free of obstruction before administration.

1. Rinse the enteral tube with 30 ml of water.

2. Administer the required dose of Teglutik oral suspension using the graduated dosing syringe.

3. Rinse the enteral tube with 30 ml of water.

If you take more Teglutik than you should

Call your doctor or pharmacist immediately if you take more of this medication than prescribed by your doctor. You can also consult the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forgot to take Teglutik

If you forget to take a dose, omit it and take the next dose at the usual time.

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

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

Like all medicines, Teglutik can cause side effects, although not everyone will experience them.

IMPORTANT

Consult your doctor immediately

• if you havefever(elevated temperature) because Teglutik may cause a decrease in the number of white blood cells. Your doctor may instruct you to have blood tests to monitor the number of white blood cells, which are important in fighting infections.
• if you experience any of the following symptoms: yellowing of the skin or the white of the eyes (jaundice), generalized itching, sensation of dizziness or nausea, as they may be signs ofliver disease(hepatitis). Your doctor will recommend that you have blood tests periodically while taking Teglutik to ensure this does not occur.
• if you experience cough or difficulty breathing, as this could be a sign of alung diseasecalled interstitial lung disease.

Other side effects

Frequent side effects (may affect more than 1 in 10 people)

• fatigue
• sensation of dizziness
• elevated levels in the blood of some liver enzymes (transaminases)

Common side effects(may affect up to 1 in 10 people)

• dizziness
• numbness or tingling of the mouth
• vomiting
• drowsiness
• tachycardia
• diarrhea
• headache
• abdominal pain
• pain

Rare side effects (may affect up to 1 in 100 people)

• anemia

• allergic reactions
• inflammation of the pancreas (pancreatitis)

Side effects of unknown frequency (frequency cannot be estimated from available data)

• skin rash.

Since the oral suspension of riluzole is absorbed more rapidly than tablets, a slight increase in fatigue, dizziness, diarrhea, and transaminases should not be excluded.

Reporting of side effects:

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

• Keep this medication out of the sight and reach of children.
• Keep the container perfectly closed. Do not use Teglutik after the expiration date that appears on the container, after CAD. The expiration date is the last day of the month indicated.
• This medication does not require special conditions for conservation.
• Once opened, use within 15 days. Do not use this medication if you observe any visible sign of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

What Teglutik contains

• The active ingredient is riluzol. 1ml of oral suspension contains 5mg of riluzol.
• The other components are: liquid sorbitol (E420), magnesium aluminium silicate, xanthan gum (E415), sodium saccharin (E954), 30% simethicone emulsion, sodium lauryl sulfate, macrogol ether ester, and water.

Appearance of Teglutik and contents of the package

This medicine is presented as an oral suspension that, after being gently shaken manually, acquires a slightly brown, opaque, and homogeneous appearance.

Teglutik is presented in a 250 ml and 300 ml bottle with a graduated plastic dosing syringe.

The package sizes are:

• Carton with one or two 250 ml bottles of riluzol 5 mg/ml oral suspension
• Carton with a 300 ml bottle of riluzol 5 mg/ml oral suspension

The syringe is graduated in milliliters up to a maximum of 10 ml.

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer

Marketing authorization holder:

ITALFARMACO, S.A. San Rafael, 3 – 28108 Alcobendas (Madrid), SPAIN

Phone: 916572323

Manufacturer:

ITALFARMACO, S.A. San Rafael, 3 – 28108 Alcobendas (Madrid), SPAIN

Phone: 916572323

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Spain:Teglutik 5mg/ml oral suspension

France:Teglutik 5mg/ml oral suspension

Italy:Teglutik 5mg/ml oral suspension

Greece:Teglutik 5mg/ml

Portugal:Teglutik 5mg/ml

Austria:Teglutik 5 mg/ml oral suspension

Belgium:Teglutik 5 mg/ml oral suspension

Germany:Teglutik 5 mg/ml oral suspension

Poland:Teglutik 5 mg/ml oral suspension

United Kingdom:Teglutik 5 mg/ml oral suspension

Cyprus:Teglutik 5 mg/ml

Finland:Teglutik 5 mg/ml oral suspension

Luxembourg:Teglutik 5 mg/ml oral suspension

Netherlands:Teglutik 5mg/ml oral suspension

Norway:Teglutik 5 mg/ml oral suspension

Sweden:Teglutik 5 mg/ml oral suspension

Last review date of this leaflet:March 2023

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/