Patient leaflet - Aprepitant 80 mg and 125 mg hard capsules
What Aprepitant is and what it is used for
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- alfentanil, fentanyl (used to treat pain),
- quinidine (used to treat an irregular heart beat),
- irinotecan, etoposide, vinorelbine, ifosfamide (medicines used to treat cancer),
Always take this medicine or give this medicine to the child exactly as the doctor, pharmacist or nurse has told you. You should check with the Aprepitant contains the active substance
aprepitant and belongs to a group of
- medicines containing ergot alkaloid derivatives such as ergotamine and diergotamine (used for
medicines called “neurokinin 1 (NK1) receptor
antagonists”. The brain has a specific area
that controls nausea and vomiting. Aprepitant
treating migraines),
works by blocking signals to that area, thereby
- warfarin, acenocoumarol (blood thinners; blood tests may be required),
reducing nausea and vomiting. Aprepitant are
used in adults and adolescents from the age
- rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections),
of 12 years
in combination with other medicines to
- phenytoin (a medicine used to treat seizures),
prevent nausea and vomiting caused by
chemotherapy (cancer treatment) that are
- carbamazepine (used to treat depression and epilepsy),
strong and moderate triggers of nausea and
vomiting (such as cisplatin, cyclophosphamide,
- midazolam, triazolam, phenobarbital (medicines used to produce calmness or help you sleep),
doxorubicin or epirubicin).
What you need to know before you take or give Aprepitant
- St. John’s Wort (an herbal preparation used to treat depression),
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- protease inhibitors (used to treat HIV infections)
- ketoconazole except shampoo (used to treat Cushing’s syndrome - when the body produces an excess of cortisol),
Do not take Aprepitant:
if you or the child is allergic to aprepitant or
any of the other ingredients of this medicine
- itraconazole, voriconazole, posaconazole (antifungals),
(listed in section 6).
with medicines containing pimozide (used
- nefazodone (used to treat depression),
to treat psychiatric illnesses), terfenadine
- corticosteroids (such as dexamethasone and methylprednisolone),
and astemizole (used for hay fever
and other allergic conditions), cisapride
- anti-anxiety medicines (such as alprazolam),
(used for treating digestive problems).
- tolbutamide (a medicine used to treat diabetes)
Tell the doctor if you or the child is taking
these medicines since the treatment must
be modified before you or the child start
Tell the doctor if you or the child are taking, have recently taken, or might take any other medicines.
taking Aprepitant.
Warnings and precautions
Pregnancy and breast-feeding
Talk to the doctor, pharmacist before you take
This medicine should not be used during pregnancy unless clearly necessary. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Aprepitant or give this medicine to the child.
Before treatment with Aprepitant, tell the doctor
if the patient has liver disease because the liver
is important in breaking down the medicine in
the body. The doctor may therefore have to
monitor the condition of patient’s liver.
For information regarding birth control, see ‘Other medicines and Aprepitant’.
Children and adolescents
Do not give Aprepitant 80 mg and Aprepitant
It is not known whether Aprepitant is excreted in human milk; therefore, breast-feeding is not recommended during treatment with this medicine. It is important to tell the doctor if you are breast-feeding or are planning to breast-feed before taking this medicine.
125 mg to children under 12 years of age,
because the Aprepitant 80 mg and Aprepitant
125 mg capsules have not been studied in this
population.
Other medicines and Aprepitant
Aprepitant can affect other medicines both
Driving and using machines
during and after treatment with aprepitant (the
It should be taken into account that some people feel dizzy and sleepy after taking Aprepitant.
active substance of Aprepitant). There are
some medicines that should not be taken with
Aprepitant (such as pimozide, terfenadine,
If you or the child feels dizzy or sleepy, avoid driving, riding a bicycle or using machines or tools after taking Aprepitant (see ‘Possible side effects’).
astemizole, and cisapride) or that require
a dose adjustment (see also ‘Do not take
Aprepitant’).
The effects of Aprepitant or other medicines
Aprepitant contains sucrose
might be influenced if you or the child take
Aprepitant capsules contain sucrose. If you or the child have been told by your doctor that you or the child have an intolerance to some sugars, contact the doctor before taking this medicine.
Aprepitant together with other medicines
including those listed below. Please talk to the
doctor or pharmacist if you or the child is taking
any of the following medicines:
birth control medicines which can include
birth control pills, skin patches, implants,
and certain Intrauterine devices (IUDs) that
How to take Aprepitant
release hormones may not work adequately
when taken together with Aprepitant.
Another or additional non-hormonal form of
birth control should be used during
treatment with Aprepitant and for up to 2
months after using Aprepitant,
The recommended oral dose of Aprepitant is Day 1:
one Aprepitant 125 mg capsule 1 hour before you start your chemotherapy session
and
Days 2 and 3:
- one Aprepitant 80 mg capsule each day
- If no chemotherapy is given, take Aprepitant in the morning.
- If chemotherapy is given, take Aprepitant 1 hour before you start your chemotherapy session.
Aprepitant can be taken with or without food. Swallow the capsule whole with some liquid.
If you take more Aprepitant than you should
Do not take more Aprepitant than the doctor recommends.
If you or the child has taken too many capsules, contact your doctor immediately.
If you forget to take Aprepitant
If you or the child has missed a dose, contact your doctor for advice.
If you have any further questions on the use of this medicine, ask the doctor or pharmacist.
Possible side effects 4
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Aprepitant and see a doctor immediately if you or the child notice any of the following side effects, which may be serious, and for which you or the child may need urgent medical treatment:
- Hives, rash, itching, difficulty breathing or swallowing (frequency not known, cannot be estimated from the available data); these are signs of an allergic reaction. Other side effects that have been reported are listed below.
Common side effects (may affect up to 1 in 10 people):
- constipation, indigestion,
- headache,
- tiredness,
- loss of appetite,
- hiccups,
- increased amount of liver enzymes in your blood.
Uncommon side effects (may affect up to 1 in 100 people):
- dizziness, sleepiness,
- acne, rash,
- anxiousness,
- burping, nausea, vomiting, heartburn, stomach pain, dry mouth, passing wind,
- increased painful or burning urination,
- weakness, generally feeling unwell,
- hot flush/reddening of the face or skin,
- fast or irregular heartbeats,
- fever with increased risk of infection, lowering of red blood cells.
Rare side effects (may affect up to1 in 1,000 people):
- difficulty thinking, lack of energy, taste disturbance,
- sensitivity of the skin to sun, excessive sweating, oily skin, sores on skin, itching rash, Stevens-Johnson syndrome/ toxic epidermal necrolysis (rare severe skin reaction),
- euphoria (feeling of extreme happiness), disorientation,
- bacterial infection, fungal infection,
- severe constipation, stomach ulcer, inflammation of the small intestine and colon, sores in mouth, bloating,
- frequent urination, passing more urine than normal, presence of sugar or blood in urine,
- chest discomfort, swelling, change in the manner of walking,
- cough, mucus in back of throat, throat irritation, sneezing, sore throat,
- eye discharge and itching,
- ringing in the ear,
- muscle spasms, muscle weakness,
- excessive thirst,
- slow heartbeat, heart and blood vessel disease,
lowering of white blood cells, low sodium levels in the blood, weight loss.
Reporting of side effects
If you or the child gets any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov. uk/yellowcard) or search for MHRA Yellow Card in Google play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store Aprepitant 5
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 after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not remove the capsule from its blister until you are ready to take it.
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 protect the environment.
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Contents of the pack and other infomation
What Aprepitant contains
- The active substance is aprepitant.
Aprepitant 80 mg hard capsules
Each hard capsule contains 80 mg of aprepitant.
Aprepitant 125 mg hard capsules
Each hard capsule contains 125 mg of aprepitant.
The other ingredients are: sucrose, cellulose microcrystalline sphere 500 (E 460), hydroxypropylcellulose (HPC-SL) (E 463), sodium laurilsulfate, gelatin, titanium dioxide (E 171); the 125 mg hard capsule also contains red iron oxide (E 172).
What Aprepitant looks like and contents of the pack
Aprepitant 80 mg hard capsules
Opaque with a white body and cap, containing white to off-white pellets.
Aprepitant 80 mg hard capsules are supplied in the following pack sizes:
- Aluminium-OPA/Alu/PVC blister containing one 80 mg capsule
- Aluminium-OPA/Alu/PVC blister containing two 80 mg capsules
- 3 Aluminium-OPA/Alu/PVC blisters each containing one 80 mg capsule
- 5 Aluminium-OPA/Alu/PVC blisters each containing one 80 mg capsule
Aprepitant 125 mg hard capsules
Opaque with a white body and pink cap, containing white to off-white pellets. Aprepitant 125 mg hard capsules are supplied in the following pack sizes:
- Aluminium-OPA/Alu/PVC blister containing one 125 mg capsule
- Aluminium-OPA/Alu/PVC blister containing two 125 mg capsules
- 3 Aluminium- OPA/Alu/PVC blisters each containing one 125 mg capsule
- 5 Aluminium-OPA/Alu/PVC blisters each containing one 125 mg capsule
Aprepitant 80 mg and 125 mg hard capsules
- 3-day treatment pack containing one blister of 125 mg capsule and one blister of 80 mg capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Limited
Park View, Riverside Way
Watchmoor Park
Camberley, Surrey
GU15 3YL
United Kingdom
Manufacturer
Rontis Hellas Medical, P.O. Box 3012 Larissa Industrial Area, Larissa, 41500, Greece or
Lek Pharmaceuticals d.d., Verovškova ulica 57 Ljubljana 1526, Slovenia
This leaflet was last revised in 02/2024
SZ96401LT02A 0102802