Aprepitant Accord 125mg/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 Hard Capsules , please read this information carefully.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you or the child 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 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. See section 4.
• The full name of this medicine is Aprepitant Hard Capsules but within this leaflet it will be referred to as Aprepitant Capsules.

What is in this leaflet

1 What Aprepitant Capsules are and what they are used for
2 What you need to know before you take or give Aprepitant Capsules
3 How to take Aprepitant Capsules
4 Possible side effects
5 How to store Aprepitant Capsules
6 Contents of the pack and other information

Do not take Aprepitant Capsules:

• if you or your child is 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 is 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 Capsules 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 takes 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 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 your child are pregnant or breast-feeding, think 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 Capsules are 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 is breast-feeding or is 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 feels 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

Aprepitant Capsules contain sucrose. If you or your child has been told by the doctor that you or your child has an intolerance to some sugars, contact the doctor before taking this medicine.

Aprepitant hard capsules contain sodium

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

If you take more Aprepitant Capsules than you should

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

If you forget to take Aprepitant Capsules

If you or your child has missed a dose, contact your doctor for advice.

Stop taking Aprepitant Capsules and see a doctor immediately if you or your child notices 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 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:

Ireland

United Kingdom

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.

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

United Kingdon

Manufacturer