APREPITANT ETHYPHARM 80 MG AND 125 MG HARD CAPSULES - patient leaflet, side effects, dosage

- 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.

What is in this leaflet

• 1. What Parpilan is and what it is used for

• 2. What you need to know before you take or give Parpilan

• 3. How to take Parpilan

• 4. Possible side effects

• 5. How to store Parpilan

• 6. Contents of the pack and other information

1. what parpilan is and what it is used for

Parpilan 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. Parpilan works by blocking signals to that area, thereby reducing nausea and vomiting. Parpilan 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 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 parpilan- 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 Parpilan.

Warnings and precautions

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

Before treatment with Parpilan, 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.

Children and adolescents

Do not give Parpilan 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 Parpilan

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

The effects of Parpilan or other medicines might be influenced if you or the child take Parpilan 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 Parpilan. Another or additional non-hormonal form of birth control should be used during treatment with Parpilan and for up to 2 months after using Parpilan,

• – 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.

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, 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 Parpilan.

It is not known whether Parpilan 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 or the 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 Parpilan. 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’).

Parpilan contains sucrose

Parpilan 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.

3. how to take parpilan

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 doctor, pharmacist or nurse if you are not sure. Always take Parpilan together with other medicines, to prevent nausea and vomiting. After treatment with Parpilan, 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 oral dose of Parpilan is

Day 1:

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

and

Day 2 and 3:

• – one 80 mg capsule each day

• – If no chemotherapy is given, take Parpilan in the morning

• – If chemotherapy is given, take Parpilan 1 hour before you start your chemotherapy session

Parpilan can be taken with or without food.

Swallow the capsule whole with some liquid.

If you take more Parpilan than you should

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 forget to take Parpilan

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.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Parpilan 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) 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.

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store parpilan

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.

6. contents of the pack and other information- 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).

What Parpilan looks like and contents of the pack

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.

Parpilan 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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Ethypharm

194, Bureaux de la Colline, Batiment D

92213 Saint-Cloud cedex

France

Manufacturer

Ethypharm

Chemin de la Poudriere

76120 Le Grand Quevilly

France

Ethypharm

Z.I. de Saint Arnoult

28170 Chateauneuf en Thymerais

France

This medicinal product is authorised in the Member States of the EEA under the following names:

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

This leaflet was last revised in 05/2018.