TEGLUTIK

Package leaflet: Information for the user

TEGLUTIK 5mg/ml oral suspension

Riluzole
Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What TEGLUTIK is and what it is used for

What TEGLUTIK is
The active substance contained in TEGLUTIK is riluzole, which acts on the nervous system.
What TEGLUTIK is used for
TEGLUTIK is used in patients with amyotrophic lateral sclerosis (ALS).
ALS is a form of motor neuron disease in which damage to nerve cells responsible for sending signals to muscles leads to muscle weakness, loss of muscle function, and paralysis.
The destruction of nerve cells in motor neuron disease may be caused by excessive glutamate (a chemical messenger) in the brain and spinal cord. TEGLUTIK interrupts the release of glutamate, and this may help prevent damage to nerve cells.
Ask your doctor for further information about ALS and the reason why this medicine has been prescribed for you.

2. What you need to know before taking TEGLUTIK

Do not take TEGLUTIK

• if you are allergic (hypersensitive) to riluzole or to any of the other ingredients of this medicine (listed in section 6),
• if you have liver disease or increased blood levels of certain liver enzymes (transaminases),
• if you are pregnant or breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking TEGLUTIK:

• if you have liver problems: yellowing of the skin or the white part of the eye (jaundice), itching all over the body, feeling unwell, or being unwell;
• if your kidneys are not working properly;
• if you develop fever: this could be due to a decrease in white blood cells, which may increase the risk of infections.

If any of the above conditions occur, or if you are unsure, consult your doctor,
who will decide on the appropriate course of action.
Children and adolescents
If you are under 18 years of age, the use of TEGLUTIK is not recommended in children because there is
insufficient information available in this population.
Other medicines and TEGLUTIK
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines,
including those not requiring a prescription.
Pregnancy, breastfeeding and fertility
YOU MUST NOT take TEGLUTIK if you are pregnant or think you might be pregnant, or if you are breastfeeding.
If you think you may be pregnant or plan to breastfeed, consult your doctor before taking TEGLUTIK.
Driving and using machines
You may drive or operate tools or machinery unless, after taking this medicine, you feel dizzy or experience
a sensation of light-headedness.
TEGLUTIK contains liquid sorbitol (E420)
This medicine contains 4000 mg of sorbitol (E420) in 10 ml of oral suspension.
Sorbitol is a source of fructose. If your doctor has informed you that you have an intolerance to certain sugars,
or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients
cannot metabolize fructose, speak with your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per 10 ml of oral suspension, i.e.
essentially ‘sodium-free’.

3. How to take TEGLUTIK

The suspension can be administered orally or, alternatively, is also suitable for administration via an enteral feeding tube.
Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 100 mg per day (50 mg every 12 hours).
10 ml of oral suspension, containing 50 mg of riluzole, should be taken orally every 12 hours, at the same time each day (for example, in the morning and evening). The suspension is administered using a graduated dosing syringe.
The oral suspension should be shaken gently and manually for at least 30 seconds by rotating the bottle 180°, and its homogeneity should then be verified visually.

Method of administration
Instructions for oral administration:
Open the bottle: press the cap and turn counterclockwise (Figure 1).

Take the syringe, remove its cap and insert it 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 down (Figure 3), then push the plunger upward to remove any possible air bubbles (Figure 3). Pull the plunger down to the graduation mark corresponding to the amount in millilitres (ml) prescribed by your doctor (Figure 3).

Turn the bottle upright (Figure 4A). Remove the syringe from the adapter (Figure 4B).

o Administer the entire contents of the syringe orally. Dilution with water is not necessary.
o Close the bottle with the plastic cap.
o Rinse the syringe with water only and replace its cap after it has dried (Figure 5).

Instructions for administration via enteral feeding tube
Ensure that the enteral feeding tube is not obstructed before administration.

1. Flush the enteral feeding tube with 30 ml of water.
2. Administer the required dose of Teglutik oral suspension using a graduated dosing syringe.
3. Flush the enteral feeding tube with 30 ml of water.

If you take more TEGLUTIK than you should
If you take too much suspension, contact your doctor or the nearest hospital emergency department immediately.
If you forget to take TEGLUTIK
If you have forgotten to take your dose, skip the missed dose and take the next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.
If you have any doubts about how to use this product, consult your doctor or pharmacist.

4. Possible side effects

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

Important
Contact your doctor immediately

• if you develop fever (raised temperature), as TEGLUTIK may cause a decrease in the number of white blood cells. Your doctor may ask you to have a blood test to check your white blood cell count, which is important in fighting infections.
• if you experience any of the following symptoms: yellowing of the skin or the white part of the eye (jaundice), itching all over the body, feeling unwell or being sick, as these may indicate liver disease (hepatitis). Your doctor may carry out regular blood tests while you are taking TEGLUTIK to monitor for this possibility.
• if you develop cough or breathing difficulties, as these may be signs of a lung disease (called interstitial lung disease).

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

• tiredness
• malaise
• increased blood levels of certain liver enzymes (transaminases)

Common side effects (may affect more than 1 in 100 but less than 1 in 10 people)

• dizziness
• numbness or tingling of the mouth
• vomiting
• somnolence
• increased heart rate
• diarrhoea
• headache
• abdominal pain

Uncommon side effects (may affect more than 1 in 1,000 but less than 1 in 100 people)

• anaemia
• allergic reactions
• inflammation of the pancreas (pancreatitis)

Since oral suspension riluzole is absorbed more rapidly than riluzole tablets, increased frequency of fatigue, dizziness, diarrhoea and elevated transaminases cannot be excluded compared to riluzole tablets.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TEGLUTIK

Keep out of the sight and reach of children.
Do not use TEGLUTIK after the expiry date stated on the carton and on the bottle.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After opening, use the contents of the bottle within 15 days.
Do not dispose of any medicine via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TEGLUTIK contains

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

Description of the appearance of TEGLUTIK and contents of the pack
After gentle manual shaking, this medicine appears as an opaque, homogeneous, slightly brown oral suspension.
TEGLUTIK is available in 250 ml and 300 ml bottles with a graduated plastic oral dosing syringe.
The product is available in the following pack sizes:

• one or two bottles containing 250 ml of Riluzole 5 mg/ml oral suspension
• one bottle containing 300 ml of Riluzole 5 mg/ml oral suspension

The syringe is graduated in millilitres up to 10 ml.
Marketing Authorization Holder
Italfarmaco S.p.A
Viale Fulvio Testi, 330 - Milan
Tel: +39.02.64431
Fax: +39.02.644346
e-mail: [email protected]
Manufacturer and final controller
Italfarmaco S.A.
28108 Alcobendas (Madrid) (E), San Rafael, 3 – Polig. Industrial de Alcobendas
Tel: +34.916572336
Fax: +34.916572361
This leaflet was last approved