Emcitate – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Emcitate, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of 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 further questions, ask your doctor or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 1. What Emcitate is and what it is used for
Emcitate contains the active substance tiratricol and belongs to a group of medicines called thyroid hormones.
Emcitate is used for the treatment of thyrot oxicosis in patients with MCT8 deficiency (Allan -Herndon- Dudley Syndrome) .
Thyrotoxicosis in MCT8 deficiency happens because a protein in the body, called MCT8 , is not working as it should. Because of this, thyroid hormones cannot move in and out of cells in the body, which can cause problems in the body and brain. The active substance in Emcitate, tiratricol, is very similar to a natural thyroid hormone in the body called T3 . Unlike natural T3, tiratrico l does not need MCT8 to move in and out of cells and this helps to get the different types of thyroid hormones in the body to the right levels .
⚠️ 2. What you need to know before you take Emcitate
Do not take Emcitate
- If you are allergic to tiratricol or any of the other ingredients of this medicine (listed in section 6).
- If you have a condition called hyperthyroidism (an overactive thyroid gland) that is not caused by MCT8 deficiency .
- If you are pregnant (see section 2, Pregnancy and breast -feeding ).
Do not take Emcitate if this applies to you. If you are not sure, talk to your doctor or nurse before taking Emcitate.
Warnings and precautions
Talk to your doctor or nurse before taking Emcitate if:
- You have diabetes
- You have problems with your heart
- You have problems with your liver or kidneys 23 If any of the above apply to you (or you are not sure), talk to your doctor or nurse before taking Emcitate.
Emcitate can cause some side effects called hypermetabolic symp toms (see section 4, Possible side effects) . If you experience any of these symptoms and they persist, your doctor may adjust your dose of Emcitate. However, do not change the dose without talking to your doctor first.
Emcitate must not be taken for weight -loss. It can cause s erious or life -threatening side effects, especially when taken together with orlistat for weight -loss.
Other medicines and Emcitate
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Do not take Emcitate, and tell your doctor or nurse , if you are taking any of the following medicines:
- Medicines for thyroid conditions that wor k like thyroid hormones, such as levoth yroxine, proplythiouracil and carbimazole . Taking them with Emcitate could make your thyroid hormone levels to o high or too low.
- Psychostimulants (substances that increase brain activity ), such as methylphenidate, amphetamines and caffeine. Taking them with Emcitate can raise your heart rate and blood pressure.
If any of the above apply to you (or you are not sure), do not take Emcitate and tell your doctor or nurse .
Some medicines should be taken well before or after you take Emcitate because they may lower how much Emcitate is absorbed in the body. Talk to your doctor or pharmacist before you take Emcitate if you are taking any of the following medicines:
- Antacids
- Charcoal tablets
- Calcium or iron medicines
- Sucralphate, a medicine for stomach problems
- Sevelamer carbonate, a medicine for kidney problems.
These should be taken at least 2 hours before or after you take Emcitate .
- Cholestyramine, a medicine to lower cholesterol Take Emcitate at least 1 hour before or 4 hours after .
If you are not sure if the above applies to you, talk to your doctor or pharmacist before taking Emcitate .
Also tell your doctor or pharmacist if you are taking:
- Medicines for diabetes – Emcitate may lower blood glucose levels. This means that your doctor may decide to adjust the dose of diabetes medicines.
- Blood-thinning medicines – Emcitate may increase the effect of blood -thinning medicines. This may make you bleed more often. The dose of these medicines may have to be changed .
- Some medicines for epilepsy (such as phenytoin and carbamazepine, phenobarbital and phenytoin) – These may increase how fast your body breaks down Emcitate . Your doctor may need to regularly check your blood levels of T3 if you are starting, changing or stopping treatment with these medicines. The dose of Emcitate may need to be changed .
- Proton pump inhibitors (such as omeprazole, esomeprazole, pantoprazole, rabeprazole and lansoprazole) used to lower the amount of acid produced by the stomach – These may lower the amount of Emcitate that is absorbed by your body. The dose of Emcitate may need to be changed.
- Antimalarial medicines (such as chloroquine, proguanil) – These may cause hypothyroidism when used together with Emcitate. Your doctor may need to regularly check your blood levels of T3 and adjust the dose of Emcitate during and after treatment with antimalarial medicines.
24 – Antibiotic medicines (used for the treatment of bacterial infections) such as rifampicin and rifabutin. The dose of Emcitate may need to be changed .
- Anti-inflammatory medicines, corticosteroids (such as hydrocortisone ) and pain medicines (such as salicylates, acetylsalicylic acid or naproxen, phenyl butazone and asp irin) – These may lower blood levels of Emcitate.
- Herbal medicines (such as St. John’s wort (Hypericum perforatum)) – This may increase how fast your body breaks down Emcitate . Your doctor may need to regularly check your blood levels of T3 if you are starting, changing or stopping treatment with this medicine.
- Immunosuppressants , medicines used after an organ transplantation (such as ciclosporin, everolimus, sirolimus and tacrolimus ) – Emcitate may change how fast these are broken down by your body .
- Medicines for lowering blood cholesterol (such as atorvastatin, lovastatin and simvastatin ) – Emcitate may change how fast these are broken down by your body.
- If you are taking oestrogen or products containing oestrogen (such as hormone replacement therapy , but not contraceptives ), you may need a higher dose of tiratricol.
- The weight -loss medicine orlistat may lower the amount of tiratricol your body takes in, which can lead to low thyroid hormone levels. Your doctor may need to check your thyroid function if you are taking orlistat with tiratricol.
If any of the above appl ies to you (or you are not sure), talk to your doctor or nurse before taking Emcitate.
Pregnancy and breast -feeding You must not take Emcitate if you are pregnant, as it is not known if it will be harmful to an unborn baby.
You must not become pregnant while taking Emcitate. If you are able to have a baby , you must use effective contraception (birth control) while taking Emcitate.
If you do become pregnant during your treatment with Emcitate, you must stop treatment and inform your doctor immediately.
Talk to your doctor before taking this medicine if you are breast -feeding. This is because it is not known if it passes into breast milk. You and your doctor must decide whether to stop breast -feeding or to stop taking Emcitate , considering the benefit of breast -feeding for your child and the benefit of Emcitate for you.
Driving and using machines
Emcitate does not affect your ability to drive, cycle or use any tools or machines.
If you think this medicine might be affecting your ability to drive or use machines, do not drive, cycle or use any tools or machines until symptoms have improved.
Emcitate contains lactose
Emcitate contains lactose, a type of sugar . If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product .
💊 3. How to take Emcitate
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor, or pharmacist or nurse if you are not sure.
Treatment will be started and monitored by doctors who are experienced in treating people with rare genetic diseases such as MCT8 deficiency.
How much Emcitate to take Your doctor will decide what dose is right for you. Your dose of Emcitate depends on your thyroid hormone levels and body weight .
25 – Your dose will be increased every two weeks until your levels of T3 are right for your situation .
- When you are taking a stable dose of Emcitate, y our blood levels of T3 will be checked regularly. If levels change and are no longer right for you, your doctor may decide to adjust your dose.
- Do not change the dose without talking to your doctor first.
When to take Emcitate When you start taking 2 or more tablets a day, spread the doses over the day – such as morning, midday and evening.
How to take Emcitate Emcitate dispersible tablets should always be dispersed in water before use. The dispersion should be given by mouth or through a gastroenteral feeding tube.
To give by mouth 1. Make the dispersion in a small glass. This glass should not be used for anything else.
- Mix the tablet or tablets (not more than 4 tablets at once) in 30 mL of drinking water.
Only use drinking water – do not use any other liquids.
- If you need half a tablet – break the tablet along the score line in the middle of the tablet.
- Stir with a teaspoon for 1 minute. The dispersion should look cloudy white. The teaspoon should not be used for anything else.
2. Use a syringe to pull up the dispersion from the glass. The syringe should only be used for Emcitate.
3. Slowly and gently push the plunger down to gently squirt the medicine into the inside of your cheek and swallow it.
4. Then put 10 mL more drinking water into the glass to mix any remaining medicine
- Stir with the teaspoon for around 5 seconds to make sure any dispersion left is mixed in.
- Pull up the dispersion from the glass with the same syringe.
5. Take Emcitate as described under step 3.
To give through a gastroenteral feeding tube 1. Make the dispersion in a small glass. This glass should not be used for anything else.
- Mix the tablet or tablets (not more than 4 tablets at once) in 30 mL of drinking water.
Only use drinking water – do not use any other liquids.
- If you need half a tablet – break the tablet along the score line in the middle of the tablet.
- Stir with a teaspoon for 1 minute. The dispersion should look cloudy white . The teaspoon should not be used for anything else.
2. Use a syringe to pull up the dispersion from the glass. The syringe should only be used for Emcitate.
3. Please read instructions on the use of the feeding tube carefully before giving Emcitate and use the tube exactly as prescribed.
4. Then put 10 mL more drinking water into the glass to mix any remaining medicine
- Stir with the teaspoon for around 5 seconds to make sure any dispersion left is mixed in.
- Pull up the dispersion from the glass with the same syringe.
5. Give Emcitate as prescribed for the tube.
6. Flush and rinse as prescribed for the tube. A 3 mL flush volume (water) is recommended.
If you take more Emcitate than you should
If you take more Emcitate than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
The following effects may happen: fast heartbeat, sweating, body overheating, feeling nervous, not being able to sleep or diarrhoea (signs of a hypermetabolic state).
- Your doctor may lower your dose or pause treatment.
If you forget to take Emcitate
- If you forget a dose, you can take it if there are more than 4 hours to the next dose.
26 – If the next dose is planned within 4 hours, skip the missed dose and t ake your next dose at the usual time.
- Do not take a double dose to make up for a forgotten dose.
If you stop taking Emcitate
Do not stop taking Emcitate without talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
❗ 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may happen with this medicine:
Common (may affect up to 1 in 10 people )
- feeling irritable
- anxiety
- nightmares
- diarrhoea
- excessive sweating (hyperhidrosis)
Not known (frequency cannot be estimated from the available data)
- trouble sleeping (insomnia)
- a faster heartbeat (tachycardia)
- feeling too warm (hyperthermia) Emcitate can cause so -called hypermetabolic symptoms when starting treatment or when the dose is changed. The symptoms usually do not last more than a few days, but you should inform your doctor immediately if you have symptoms that could be a sign of h ypermetabolism such as feeling irritable, anxiety, nightmares , excessive sweating , trouble sleeping, feeling too warm, a faster heartbeat, temporary rises in blood pressure , or diarrh oea. See section 2, Warnings and precautions .
Tell your doctor or nurse if you notice any of the side effects listed above. Also tell them if you think you have any other side effects not in this list.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effec ts you can help provide more information on the safety of this medicine. Like all medicines, this medicine can cause side effects, although not everybody gets them.
🌡️ 5. How to store Emcitate
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister foil. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C).
Store in the original pac kage in order to protect from light.
After dispersion :
27 The 30 mL dispersion can be stored below 25 °C for up to 4 hours in the glass, and then be resuspended by stirring for 1 minute with a teaspoon prior to administration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment .
📦 6. Contents of the pack and other information
What Emcitate contains
- Each tablet contains 350 micrograms of the active substance tiratricol.
- The other ingredients are lactose monohydrate (see section 2, ‘Emcitate contains lactose’) , calcium hydrogen phosphate, maize starch, and magnesium stearate.
What Emcitate looks like and contents of the pack
Emcitate is a white, oblong tablet (size: 10 mm long, 5 mm wide) with score lines on both sides.
Emcitate is supplied in PVC/aluminium blisters, inserted into an outer carton .
Emcitate is available in p acks containing 60 dispersi ble tablets.
Marketing Authorisation Holder
Rare Thyroid Therapeutics International AB Klara Norra Kyrkogata 26 111 22 Stockholm Sweden
Manufacturer
Cenexi 17 Rue De Pontoise 95529 Osny France
This leaflet was last revised i n
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu . There are also links to other websites about rare diseases and treatments.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Emcitate (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/24/1897).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.