TEGLUTIK 5mg/ml ORAL SUSPENSION

Using Teglutik with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy, breastfeeding, and fertility

Do not take Teglutik if you are pregnant or think you may be pregnant, or if you are breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before taking this medicine.

Driving and using machines

You can drive or use tools or machines, unless you feel dizzy or confused after taking this medicine.

Teglutik contains sorbitol liquid (E420)and sodium

This medicine 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 some sugars, or you 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 medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per 10 ml of oral suspension; this is essentially "sodium-free".

3. How to take Teglutik

The suspension can be administered orally and, alternatively, is also suitable for administration through an enteral feeding tube.

Follow the administration instructions of this medicine exactly as indicated by your doctor. If in 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 should be taken every 12 hours and at the same time every day (e.g., in the morning and at night). The suspension is administered using a graduated dosing syringe.

The oral suspension should be gently shaken manually for at least 30 seconds, continuously turning the bottle upside down and back, until the Teglutik suspension is well mixed and no clear liquid is visible on top of the suspension or any particles at the bottom of the bottle.

Method of administration:

Instructions for oral use:

Open the bottle: press the cap and turn it counterclockwise (figure 1)

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

Fill the syringe with a small amount of suspension by pulling the plunger down (figure 3A), then push the plunger up to remove any possible bubbles (figure 3B). Pull the plunger down again to the graduated mark corresponding to the prescribed amount in milliliters (ml) by your doctor (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).

Instructions for use with an enteral feeding tube:

Make sure the enteral feeding tube is free from obstruction before administration.

1. Rinse the enteral tube with 30 ml of water.
2. Administer the required dose of Teglutik oral suspension with 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 medicine than prescribed by your doctor. You can also contact the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget 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 make up for forgotten doses.

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

4. Possible side effects

Like all medicines, Teglutik can cause side effects, although not everybody gets them.

IMPORTANT

Consult your doctor immediately

• if you have a fever(increase in temperature) because Teglutik may cause a decrease in the number of white blood cells. Your doctor may recommend that you 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 whites of the eyes (jaundice), generalized itching, feeling of dizziness, or nausea, as these may be signs of liver disease(hepatitis). Your doctor will recommend that you have periodic blood tests while taking Teglutik to ensure this does not occur.
• if you experience coughing or difficulty breathing, as this could be a sign of a lung diseasecalled interstitial lung disease.

Other side effects

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

• fatigue
• dizziness
• high levels of certain liver enzymes (transaminases) in the blood

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

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

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

• anemia

• allergic reactions
• inflammation of the pancreas (pancreatitis)

Rare side effects (frequency cannot be estimated from the available data)

• skin rash.

Since the oral suspension of riluzole is absorbed more quickly than tablets, a slight increase in fatigue, dizziness, diarrhea, and transaminases cannot be ruled out.

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 leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Teglutik

• Keep this medicine out of the sight and reach of children.
• Keep the container tightly closed. Do not use Teglutik after the expiration date stated on the container, after EXP. The expiration date is the last day of the month indicated.
• This medicine does not require special storage conditions.
• Once opened, use within 15 days. Do not use this medicine if you notice any visible signs of deterioration.

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

6. Contents of the pack and further information

What Teglutik contains

• The active substance is riluzole. 1 ml of oral suspension contains 5 mg of riluzole.
• The other ingredients are: sorbitol liquid (E420), magnesium aluminum silicate, xanthan gum (E415), sodium saccharin (E954), 30% simethicone emulsion, sodium lauryl sulfate, cetostearyl ether macrogol, water.

Appearance of Teglutik and contents of the pack

This medicine is presented as an oral suspension that, after being gently shaken manually, has 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 pack sizes are:

• Box with one or two 250 ml bottles of riluzole 5 mg/ml oral suspension
• Box with one 300 ml bottle of riluzole 5 mg/ml oral suspension

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

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

Tel.: 916572323

Manufacturer:

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

Tel.: 916572323

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Spain: Teglutik 5mg/ml oral suspension

France: Teglutik 5mg/ml suspension buvable

Italy: Teglutik 5mg/ml suspensione orale

Greece: Teglutik 5mg/ml π?σιμο εναι?ρημα

Portugal: Teglutik 5mg/ml

Austria: Teglutik 5 mg/ml suspension zum Einnehmen

Belgium: Teglutik 5 mg/ml suspension buvable

Germany: Teglutik 5 mg/ml suspension zum Einnehmen

Poland: Teglutik 5 mg/ml Zawiesina doustna

United Kingdom: Teglutik 5 mg/ml oral suspension

Cyprus: Teglutik 5 mg/ml π?σιμο εναι?ρημα

Finland: Teglutik 5 mg/ml oraalisuspensio

Luxembourg: Teglutik 5 mg/ml suspension buvable

Netherlands: Teglutik 5mg/ml, suspensie voor oraal gebruik

Norway: Teglutik 5 mg/ml mikstur, suspensjon

Sweden: Teglutik 5 mg/ml oral suspension

Date of last revision of this leaflet:March 2023

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