5 mg/ml oral suspension
riluzole
What Teglutik is and what it is used for
What Teglutik is
The active substance 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 type of motor neuron disease where attacks on the nerve cells responsible for sending instructions to the muscles lead to weakness, muscle atrophy, and paralysis.
The breakdown of nerve cells in a motor neuron disease can be due to too much glutamate (a chemical messenger) in the brain and spinal cord. Teglutik stops the release of glutamate and this can help prevent nerve cells from being destroyed.
Ask your doctor for additional information about ALS and why you have been prescribed this medication.
Riluzole contained in Teglutik may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Teglutik
Do not take Teglutik:
- if you are allergic to riluzole or any of the other ingredients of this medicine (listed in section 6),
- if you have any liver disease or elevated 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: skin or whites of the eyes have turned yellow (jaundice), itching all over the body, feeling sick, vomiting
- if your kidneys are not working very well
- if you have a fever: it may be due to a low number of white blood cells, which may cause an increased risk of infection
If any of the above applies to you or if you are unsure, contact the doctor who will then decide what to do.
Children and young people
If you are younger than 18 years, the use of Teglutik is not recommended, as there is no data for this patient group.
Other medicines and Teglutik
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding, and fertility
You should not take Teglutik if you are pregnant, think you are pregnant, or if you are breastfeeding.
If you think you may be pregnant or if you intend to breastfeed, consult your doctor before taking this medicine.
Driving ability and use of machinery
You can drive and use tools or machines unless you feel dizzy or light-headed after taking this medicine.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Teglutik contains liquid sorbitol (E420) and sodium.
This medicine contains 4000 mg of sorbitol (E420) in 10 ml of oral suspension.
Sorbitol is a source of fructose. If you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare, inherited disease that makes it impossible to break down fructose, consult a doctor before using this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per 10 ml of oral suspension, i.e. it is almost “sodium-free”.
How to take Teglutik
Suspension one can be given orally. Alternatively, it is also suitable for use via an enteral tube (feeding tube).
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The recommended daily dose is 100 mg (50 mg every 12 hours). 10 ml of oral suspension, containing 50 mg of riluzole, should be taken by mouth every 12 hours at the same time every day (eg morning and evening). Suspension is given/taken with a graduated dosing syringe.
The oral suspension should be gently shaken by hand for at least 30 seconds by continuously turning the bottle upside down until the Teglutik suspension is well mixed and you do not see any clear liquid at the top of the suspension or any particles at the bottom of the bottle.
User manual:
Instructions for use by mouth :
Open the bottle: push the cap down and turn it counterclockwise (picture 1).
Take the dosing syringe, remove the tip cover and place the syringe in the adapter opening (picture 2). Turn the bottle upside down (picture 3).
Fill the syringe with a small amount of suspension by pulling down on the syringe plunger (Figure 3A), then push up on the syringe plunger to remove any bubbles (Figure 3B). Pull the syringe plunger down to the graduation that corresponds to the number of milliliters (ml) your doctor prescribed (Figure 3C).
Turn the bottle to an upright position (Figure 4A). Detach the dosing syringe from the adapter (picture 4B).
- Give/take the entire contents of the syringe by mouth.
- Close the bottle with the plastic screw cap.
- Rinse the syringe with water only and replace the tip cover when the syringe is dry (picture 5).
Instructions for use via enteral tube :
Ensure that there is no blockage in the enteral tube before administration.
- Flush the enteral tube with 30 ml of water.
- Give/take the prescribed dose of Teglutik oral suspension with the graduated dosing syringe.
- Flush the enteral tube with 30 ml of water.
If you have taken too much Teglutik
If you have ingested too much medicine or if, for example, if a child has ingested the medicine by mistake, immediately contact a doctor or hospitaview l
for an assessment of the risk and advice.
If you forget to take Teglutik
If you forget to take a dose, skip that dose and take the next dose as usual.
Do not take a double dose to make up for a missed dose.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Important
Tell your doctor immediately
- if you develop a fever (elevated temperature) because Teglutik can reduce the number of white blood cells. The doctor may want to take a blood test to check the number of white blood cells, which are important for fighting infection.
- if you experience any of the following symptoms: skin or whites of the eyes turn yellow (jaundice), itching all over the body, nausea or vomiting, as these may be signs of liver disease ( hepatitis ). Doctors may need to do regular blood tests while you are taking Teglutik, to check that this does not happen.
- if you develop a cough or difficulty breathing, this may be a sign of lung disease (called interstitial lung disease).
Other side effects are
Very common side effects ( may affect more than 1 in 10 users)
- fatigue
- nausea
- increased blood levels of certain liver enzymes ( transaminases )
Common side effects ( may affect up to 1 in 10 users)
- dizziness
- numbness or tingling in the mouth
- vomiting
- somnolence
- increase in pulse a
- diarrhea
- headache
- stomach pains
- pain
Uncommon side effects ( may affect up to 1 in 100 users)
- blood deficiency ( anemia )
- allergic reactions
- inflammation of the pancreas ( pancreatitis )
Since riluzole oral suspension is absorbed more quickly than riluzole tablets, a small increase in fatigue, dizziness, diarrhea and elevated blood levels of certain liver enzymes cannot be excluded.
How to store Teglutik
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton and bottle after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Shelf life after opening: 15 days.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is riluzole. 1 ml of oral suspension contains 5 mg of riluzole.
- Other ingredients are liquid sorbitol (E420), aluminum magnesium silicate, xanthan gum (E415), saccharin sodium (E954), simethicone emulsion 30%, and sodium lauryl sulfate, macrogol cetostearyl ether, water.
Appearance and package sizes of the medicine
The oral suspension is slightly brown, opaque, and homogeneous after being shaken gently by hand.
Teglutik is available in bottles of 250 ml and 300 ml. A plastic graduated dosing syringe is included in the package.
Package sizes:
- carton containing one or two 250 ml bottles of riluzole 5 mg/ml oral suspension
- carton containing a 300 ml bottle of riluzole 5 mg/ml oral suspension.
The syringe is graduated in milliliters up to 10 ml.
Not all pack sizes may be marketed.
Italfarmaco SA
San Rafael 3
28108 Alcobendas (Madrid)
Spain