POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 17780/0824 .
Aprepitant Zentiva 125mg/80mg hard capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER
APREPITANT ZENTIVA 125-80mg HARD CAPSULES
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. If you are the parent of a child taking aprepitant, please read this information carefully.
What is in this leaflet:
1. What aprepitant is and what it is used for
2. What you need to know before you take or give aprepitant
3. How to take aprepitant
4. Possible side effects
5. How to store aprepitant
6. Contents of the pack and other information
1.WHAT APREPITANT IS AND WHAT IT IS USED FOR
Aprepitant contains the active substance aprepitant and belongs to a group of medicines called "neurokinin 1 (NK1) receptor antagonists". The brain has a specific area that controls nausea and vomiting. Aprepitant works by blocking signals to that area, thereby reducing nausea and vomiting.
Aprepitant capsules are used in adults and adolescents from the age of 12 years in combination with other medicines to prevent nausea and vomiting caused by medicines used in chemotherapy (cancer treatment) that are strong and moderate triggers of nausea and vomiting (such as cisplatin, cyclophosphamide, doxorubicin or epirubicin).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OR GIVE APREPITANT
Do not take aprepitant:
Tell the doctor if you or the child are taking these medicines since the treatment must be modified before you or the child start taking aprepitant.
Warnings and precautions
Talk to the doctor, pharmacist or nurse before taking aprepitant or giving this medicine to the child. Before treatment with aprepitant, tell the doctor if you or the child have liver disease because the liver is important in breaking down this medicine in the body. The doctor may therefore have to monitor the condition of your or the child's liver.
Children and adolescents
Do not give aprepitant 80 mg and 125 mg capsules to children under 12 years of age, because the 80 mg and 125 mg capsules have not been studied in this population.
Other medicines and Aprepitant
Aprepitant can affect other medicines both, during and after treatment with aprepitant. There are some medicines that should not be taken with aprepitant (such as pimozide, terfenadine, astemizole, and cisapride) or that require a dose adjustment (see also `Do not take aprepitant).
The effects of aprepitant or other medicines might be influenced if you or the child takes aprepitant together with other medicines including those listed below.
Please talk to the doctor or pharmacist if you or the child are taking any of the following medicines:
Tell the doctor or pharmacist if you or the child is taking, has recently taken or might take any other medicines.
Pregnancy and breast-feeding
This medicine should not be used during pregnancy unless clearly necessary. If you or the child are pregnant or breast-feeding, think that they may be pregnant or are planning to have a baby, ask the doctor for advice before taking this medicine.
For information regarding birth control, see 'Other medicines 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 that you tell the doctor if you or the child is breast-feeding or are planning to breast-feed before taking this medicine.
Driving and using machines
It should be taken into account that some people feel dizzy and sleepy after taking aprepitant. If you or the child feels dizzy or sleepy, avoid driving, riding a bicycle or using machines or tools after taking this medicine (see Possible side effects').
Aprepitant contains sucrose
Aprepitant capsules contain sucrose. If you or the child have been told by the doctor that you or the child has an intolerance to some sugars, contact the doctor before taking this medicine.
Aprepitant contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free'.
3. HOW TO TAKE APREPITANT
Always take this medicine or give this medicine to the child exactly as the doctor, pharmacist or nurse has told you. Check with the doctor, pharmacist or nurse if you are not sure.
Always take aprepitant together with other medicines to prevent nausea and vomiting. After treatment with aprepitant, the doctor may ask you or the child to continue taking other medicines including a corticosteroid (such as dexamethasone) and a '5HT3 antagonist' (such as ondansetron) for preventing nausea and vomiting. Check with the doctor, pharmacist or nurse if you are not sure.
The recommended dose of aprepitant is:
Day 1: one 125 mg capsule 1 hour before you start your chemotherapy session
Days 2 and 3: one 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.
This medicine is for oral use. Swallow the capsule whole with some liquid. Aprepitant can be taken with or without food.
If you take more aprepitant than you should
Do not take more capsules than prescribed by your doctor. 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.
4. POSSIBLE SIDE EFFECTS
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 notices any of the following side effects, which may be serious, and for which you or the child may need urgent medical treatment:
Other side effects
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Reporting of side effects
If you get 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE APREPITANT
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 the blister after "EXP". The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture.
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
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What aprepitant contains:
What aprepitant looks like and contents of the pack:
The 125 mg hard capsules are presented as opaque hard gelatin capsules of size No 1, with a pink cap and white body, imprinted in black ink with "125mg" on the body.
The 80 mg hard capsules are presented as opaque hard gelatin capsules of size No 2, with a white cap and white body, imprinted in black ink with "80mg" on the body.
Aprepitant is packed in a cardboard box containing the appropriate number of OPA/ALU/PVC - Aluminium foil blisters with an instruction leaflet.
Aprepitant 125 mg and 80 mg hard capsules are supplied in the following pack sizes:
The Marketing Authorisation Holder is
The manufacturer is
This leaflet was last updated in December 2019