Aprepitant 125 mg hard capsules

• 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.
• 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.

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

• if you or the 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 the child is taking these medicines since the treatment must be modified before you or the child start taking Aprepitant capsules.

Talk to the doctor, pharmacist or nurse before you take or give this medicine to the child.

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

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.

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 the child take Aprepitant capsules 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 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 using 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 (an 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 the child are taking, have recently taken, or might take any other medicines.

This medicine should not be used during pregnancy unless clearly necessary. If you or the child are pregnant or breast-feeding, 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 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 to tell the doctor if you or the child are breast-feeding or are planning to breast-feed before taking this medicine.

It should be taken into account that some people feel dizzy and sleepy after taking Aprepitant capsules. 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 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 capsules contain less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

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

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

• 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) are:

• 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) are:

• 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 to 1 in 1,000 people) are:

• 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.

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 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.

• The active substance is aprepitant. Each 125 mg capsule contains 125 mg of aprepitant. Each 80 mg capsule contains 80 mg of aprepitant.
• The other ingredients are: hydroxypropylcellulose, sodium laurilsulfate, sucrose, cellulose microcrystalline, titanium dioxide (E 171), gelatin, shellac, ammonia solution, concentrated, propylene glycol, potassium hydroxide, black iron oxide (E 172). The 125 mg capsule also contains red iron oxide (E 172).

The 125 mg capsule is size 1 capsule and has an opaque pink cap and an opaque white body, printed with “125 mg” in black ink.

The 80 mg capsule is size 2 capsule and has an opaque white cap and an opaque white body printed with “80 mg” in black ink.

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

• PA/Aluminium/PVC/Aluminium blister containing one 125 mg capsule
• PA/Aluminium/PVC/Aluminium blister containing five 125 mg capsules

Aprepitant 80 mg capsules are supplied in the following pack size:

• PA/Aluminium/PVC/Aluminium blister containing one 80 mg capsule
• 2-day treatment pack containing two 80 mg capsules
• PA/Aluminium/PVC/Aluminium blister containing five 80 mg capsules

Aprepitant 125 mg and 80 mg capsules are supplied in the following pack size:

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: