ATANTO 80 MG HARD CAPSULES - patient leaflet, side effects, dosage

Patient leaflet - ATANTO 80 MG HARD CAPSULES

What is in this leaflet

1. What Atanto is and what it is used for
2. What you need to know before you take or give Atanto
3. How to take Atanto
4. Possible side effects
5. How to store Atanto
6. Contents of the pack and other information

1. what atanto is and what it is used for

Atanto 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. Atanto works by blocking signals to that area, thereby reducing nausea and vomiting.

Atanto 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 atanto- 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:

o pimozide (used to treat psychiatric illnesses)

o terfenadine and astemizole (used for hay fever and other allergic conditions)

o 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 starts taking Atanto.

Warnings and precautions

Talk to the doctor, pharmacist or nurse before taking Atanto or giving this medicine to the child.

Before treatment with Atanto, tell the doctor if you or the 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 the child’s liver.

Children and adolescents

Do not give Atanto 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 Atanto

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

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

– 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 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 is pregnant or breast-feeding, think that may be pregnant or is planning to have a baby, ask the doctor for advice before taking this medicine.

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

It is not known whether Atanto 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 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 Atanto. 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’).

Atanto contains sucrose

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

Atanto 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 atanto

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 Atanto together with other medicines to prevent nausea and vomiting. After treatment with Atanto, 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

Day 1:

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

and

Days 2 and 3:

– one 80 mg capsule each day

If no chemotherapy is given, take Atanto in the morning.

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

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

If you take more Atanto 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 Atanto

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 Atanto 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:

– 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

– 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 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 Yellow Card Scheme, website: 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 atanto

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- 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 hypromellose, poloxamer, sucrose, microcrystalline cellulose, gelatin, sodium laurilsulfate (E487), titanium dioxide (E171), shellac, iron oxide black (E172), propylene glycol (E1520). The 125 mg capsule also contains iron oxide red (E172).

What Atanto 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.

Atanto is packed in a cardboard box containing the appropriate number of OPA/ALU/PVC -Aluminium foil blisters with an instruction leaflet.

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

– Aluminium blister containing one 125 mg capsule
– 5 Aluminium blisters each containing one 125 mg capsule

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

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

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

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Pharmathen SA, 6 Dervenakion str., 15351 Pallini Attiki, Greece

Manufacturer

Pharmathen International S.A., Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece