Patient leaflet - Aprepitant Accord 80 mg hard capsules

1 What Aprepitant Capsules are and what they are used for

Aprepitant Capsules contain 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 Capsules work 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 Capsules

Do not take Aprepitant Capsules:

if you or your child are allergic to aprepitant or any of the other ingredients of this medicine (listed in section 6).
with medicines containing:
- pimozide (used to treat psychiatric illnesses)
- terfenadine and astemizole (used for hay fever and other allergic conditions)
- cisapride (used for treating digestive problems).

Tell the doctor if you or your child are taking these medicines since the treatment must be modified before you or your child starts taking Aprepitant Capsules.

Warnings and precautions

Talk to the doctor, pharmacist or nurse before taking Aprepitant Capsules or giving this medicine to your child.

Before treatment with Aprepitant Capsules, tell the doctor if you or your child has 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 your child’s liver.

Children and adolescents

Do not give Aprepitant 80mg and 125mg Capsules to children under 12 years of age, because the 80mg and 125mg capsules have not been studied in this population.

Other medicines and Aprepitant Capsules

Aprepitant Capsules can affect other medicines both during and after treatment with Aprepitant Capsules. There are some medicines that should not be taken with Aprepitant Capsules (such as pimozide, terfenadine, astemizole, and cisapride) or that require a dose adjustment (see also ‘Do not take Aprepitant Capsules ’).

The effects of Aprepitant Capsules or other medicines might be influenced if you or your child are taking Aprepitant Capsules together with other medicines including those listed below. Please talk to the doctor or pharmacist if you or your child are taking any of the following medicines:

birth control medicines which can include birth control pills, skin patches, implants, and certain Intrauterine devices (IUDs) that release hormones may not work adequately when taken together with Aprepitant Capsules . Another or additional non-hormonal form of birth control should be used during treatment with Aprepitant Capsules and for up to 2 months after taking Aprepitant Capsules
cyclosporine, tacrolimus, sirolimus, everolimus (immunosuppressants)
alfentanil, fentanyl (used to treat pain)
quinidine (used to treat an irregular heart beat)
irinotecan, etoposide, vinorelbine, ifosfamide (medicines used to treat cancer)
medicines containing ergot alkaloid derivatives such as ergotamine and diergotamine (used for treating migraines)
warfarin, acenocoumarol (blood thinners; blood tests may be required)
rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections)
phenytoin (a medicine used to treat seizures)
carbamazepine (used to treat depression and epilepsy)
midazolam, triazolam, phenobarbital (medicines used to produce calmness or help you sleep)
St. John’s Wort (a herbal preparation used to treat depression)
protease inhibitors (used to treat HIV infections)
ketoconazole, except shampoo (used to treat Cushing’s syndrome - when the body produces an excess of cortisol)
itraconazole, voriconazole, posaconazole (antifungals)
nefazodone (used to treat depression)
corticosteroids (such as dexamethasone and methylprednisolone)
anti-anxiety medicines (such as alprazolam)
tolbutamide (a medicine used to treat diabetes).

Tell the doctor or pharmacist if you or your child are taking, have 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 your child are pregnant or breast-feeding, think that you/they may be pregnant or planning to have a baby, ask the doctor for advice before taking this medicine.

For information regarding birth control, see ‘Other medicines and Aprepitant Capsules ’.

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 your child are 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 Capsules. If you or your child feel dizzy or sleepy, avoid driving, riding a bicycle or using machines or tools after taking this medicine (see ‘Possible side effects’).

Aprepitant Capsules contain sucrose

If you or your child have been told by the doctor that you or your child have an intolerance to some sugars, contact the doctor before taking this medicine.

Information on sodium content

This medicine contains less than 1 mmol sodium (23mg) per capsule, that is to say essentially ‘sodium-free’.

3 How to take Aprepitant Capsules

Always take this medicine or give this medicine to your 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 Capsules together with other medicines to prevent nausea and vomiting. After treatment with Aprepitant Capsules, the doctor may ask you or your child to continue taking other medicines including a corticosteroid (such as dexamethasone) and a ‘5HT₃antagonist’ (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 Capsules is:

Day 1:

one 125mg capsule 1 hour before you start your chemotherapy session

and

Days 2 and 3:

one 80mg capsule each day

If no chemotherapy is given, take Aprepitant Capsules in the morning.

If chemotherapy is given, take Aprepitant Capsules 1 hour before you start your chemotherapy session.

This medicine is for oral use. Swallow the capsule whole with some liquid. Aprepitant Capsules can be taken with or without food.

If you take more Aprepitant Capsules than you should

Do not take more capsules than prescribed by your doctor. If you or your child have taken too many capsules, contact your doctor immediately.

If you forget to take Aprepitant Capsules

If you or your child have 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 Capsules and see a doctor immediately if you or your child notice any of the following side effects, which may be serious, and for which you or your 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

Common: 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: 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: may affect up to 1 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 your child get 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 Website: 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 Capsules

Keep this medicine out of the sight and reach of children.

Do not take 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 Capsules contain

The active substance is aprepitant. Each 125mg capsule contains 125mg of aprepitant.
Each 80mg capsule contains 80mg of aprepitant.
The other ingredients are hypromellose, poloxamer, sucrose, microcrystalline cellulose, gelatin, sodium laurilsulfate (E487), titanium dioxide (E171), shellac, iron oxide black (E172), propylene glycol (E1520). The 125mg capsule also contains iron oxide red (E172).

What Aprepitant Capsules look like and contents of the pack

The 125mg 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 80mg 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 Capsules are packed in a cardboard box containing the appropriate number of OPA/ALU/PVC - Aluminium foil blisters with an instruction leaflet.

Aprepitant Capsules 125mg hard capsules are supplied in the following pack sizes:

5 Aluminium blisters each containing one 125mg capsule

Aprepitant Capsules 80mg hard capsules are supplied in the following pack sizes:

2-day treatment pack containing two 80mg capsules
5 Aluminium blisters each containing one 80mg capsule

Aprepitant Capsules 125mg and 80mg hard capsules are supplied in the following pack sizes:

3-day treatment pack containing one 125mg capsule and two 80mg capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Accord Healthcare Limited

Sage House

319 Pinner Road

North Harrow

Middlesex

HA1 4HF

United Kingdom

Manufacturers

Pharmathen International S.A

Sapes Industrial Park Block 5

Rodopi

69300

Greece

Pharmathen S.A

6, Dervenakion Str

Pallini, Attiki

15351