Atanto

PACKAGE LEAFLET

Package leaflet: information for the user

Atanto hard capsules 125 mg, hard capsules 80 mg, hard capsules 125 mg/80 mg

Aprepitant
Generic medicine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you. If you are a parent of a child who has been prescribed Atanto,
please read these instructions carefully.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you or your child only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you or your child experience any adverse reactions, including those not listed in this leaflet, you should contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Atanto is and what it is used for
2. What you need to know before taking Atanto
3. How to take Atanto
4. Possible side effects
5. How to store Atanto
6. Package contents 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 (NK ) receptor antagonists". The brain has a specific area responsible for
controlling nausea and vomiting. Atanto works by blocking signals to this area, thereby
reducing nausea and vomiting.
Atanto capsules are indicated in adults and adolescents aged 12 years and older in
combination with other medicines to prevent nausea and vomiting caused by chemotherapy
medicines (cancer treatment) that cause a high or moderate risk of nausea and vomiting (such as cisplatin, cyclophosphamide, doxorubicin or epirubicin).

2. What you need to know before taking Atanto

Do not take Atanto:

• if you or the child is allergic to aprepitant or to any of the other ingredients of this medicine (listed in section 6);
• in combination with medicines containing: pimozide (a substance used to treat certain psychiatric disorders), or terfenadine and astemizole (used for hay fever and other allergic conditions), or cisapride (used to treat digestive problems).

Inform your doctor if you or the child are currently taking any of these medicines, as treatment will need to be changed before starting Atanto.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Atanto or giving the medicine to a child.
Before treatment with Atanto, inform your doctor if you or the child have any liver disease, as the liver plays an important role in metabolizing this medicine in the body. Therefore, your doctor may need to monitor the condition of your liver or that of the child.
Children and adolescents
Do not give the 80 mg and 125 mg Atanto capsules to children under 12 years of age, as their effects have not been studied in this population.
Other medicines and Atanto
Atanto may affect other medicines, both during treatment with Atanto and even after treatment has ended. Some medicines (such as pimozide, terfenadine, astemizole, and cisapride) must not be taken with Atanto or require dose adjustments (see also "Do not take Atanto").
The effects of Atanto or other medicines may be altered if you or the child take Atanto together with other medicines, including those listed below. Talk to your doctor or pharmacist if you or the child are taking any of the following medicines:

• hormonal contraceptives, which may include pills, patches, contraceptive implants, and certain intrauterine devices (IUDs, coils) releasing hormones, which may not work as effectively when used together with Atanto. During treatment with Atanto and for two months after stopping it, use one or more additional non-hormonal contraceptive methods.
• cyclosporine, tacrolimus, sirolimus, everolimus (immunosuppressants)
• alfentanil, fentanyl (used for pain treatment)
• quinidine (used to treat irregular heartbeat)
• irinotecan, etoposide, vinorelbine, ifosfamide (medicines used to treat cancer)
• medicines containing ergot alkaloids such as ergotamine and dihydroergotamine (used to treat migraine)
• warfarin, acenocoumarol (anticoagulants; blood tests may be needed)
• rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections)
• phenytoin (a medicine used to treat seizures)
• carbamazepine (used as an antidepressant and antiepileptic)
• midazolam, triazolam, phenobarbital (sedatives or medicines used for sleep disorders)
• St. John’s wort (a herbal preparation used to treat depression)
• protease inhibitors (used to treat HIV infections)
• ketoconazole, except when used as a shampoo (used to treat Cushing's syndrome, in which the body produces excess cortisol)
• itraconazole, voriconazole, posaconazole (antifungals)
• nefazodone (used to treat depression)
• corticosteroids (such as dexamethasone and methylprednisolone)
• anxiolytic medicines (such as alprazolam)
• tolbutamide (an antidiabetic medicine)

Inform your doctor or pharmacist if you or the child are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
This medicine should not be used during pregnancy unless clearly necessary. If you or the child are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.
For information regarding contraceptive methods, see “Other medicines and Atanto”.
It is not known whether Atanto is excreted in human milk; therefore, breastfeeding is not recommended during treatment with this medicine. It is important to inform your doctor if you or the child are breastfeeding or plan to breastfeed before taking this medicine.
Driving and using machines
Keep in mind that some patients may experience dizziness and drowsiness after taking Atanto. If you or the child experience dizziness or drowsiness, avoid driving, riding a bicycle, or operating machinery or tools after taking this medicine (see "Possible side effects").
Atanto contains sucrose
Atanto capsules contain sucrose. If your doctor has diagnosed you or the child with an intolerance to certain sugars, contact your doctor before taking this medicine.
Atanto contains sodium
Each capsule of this medicine contains less than 1 mmol (23 mg) of sodium, i.e. essentially "sodium-free".

3. How to take Atanto

Take this medicine or give it to the child exactly as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
Always take Atanto together with other medicines to prevent nausea and vomiting. After treatment with Atanto, your doctor may instruct you or the child to continue taking other medicines, such as a corticosteroid (for example, dexamethasone) and a "5-HT₃ receptor antagonist" (for example, ondansetron), to prevent nausea and vomiting. If in doubt, consult your doctor, pharmacist, or nurse.

Recommended dosage of Atanto:
Day 1:

• one 125 mg capsule taken 1 hour before starting the chemotherapy session

and
Days 2 and 3:

• one 80 mg capsule each day

If chemotherapy is not administered, take Atanto in the morning.
If chemotherapy is administered, take Atanto 1 hour before starting the session.
This medicine is for oral use. Swallow the capsule whole with liquid. Atanto may be taken with or without food.

If you take more Atanto than prescribed
Do not take more capsules than prescribed by your doctor. If you or the child accidentally takes an excessive number of capsules, contact your doctor immediately.

If you forget to take Atanto
If you or the child forget a dose, ask your doctor for advice.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicinal product can cause side effects, although not everybody gets them.
Stop taking Atanto and contact a doctor immediately if you or the child experience any of the
following side effects, which could be serious and may require urgent medical treatment:

• Hives, skin rash, itching, difficulty breathing or swallowing (frequency unknown, as it 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 liver enzymes in the blood

Uncommon: may affect up to 1 in 100 people

• Dizziness, drowsiness
• Acne, skin rash
• Anxiety
• Belching, nausea, vomiting, heartburn, stomach pain, dry mouth, flatulence
• Increased frequency, pain or burning during urination
• Weakness, general malaise
• Hot flushes / flushing of the face or skin
• Fast or irregular heartbeat
• Fever with increased risk of infection, reduction in red blood cells

Rare: may affect up to 1 in 1,000 people

• Difficulty thinking, lack of energy, altered taste

• Skin sensitivity to sunlight, excessive sweating, oily skin, skin rash, itching, skin eruptions, Stevens-Johnson syndrome/toxic epidermal necrolysis (a rare, severe skin reaction)

• Euphoria (a feeling of extreme happiness), disorientation

• Bacterial infection, fungal infection

• Severe constipation, stomach ulcer, inflammation of the small intestine and colon, mouth sores, swelling

• Increased frequency of urination, abnormally large amounts of urine, presence of sugar and blood in the urine

• Chest discomfort, swelling, difficulty walking

• Cough, mucus secretion in the throat, throat irritation, sneezing, pharyngitis

• Eye discharge and itching

• Ringing in the ears

• Muscle spasms, muscle weakness

• Excessive thirst

• Slow heartbeat, heart and blood vessel disease

• Reduction in white blood cells, low levels of sodium in the blood, weight loss

Reporting of side effects
If you or the child experience any side effect, including those not listed in this leaflet, you should contact your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
Your reporting of side effects helps provide further information on the medicine's safety.

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 stated on the carton and blister after the word "EXP". The expiry date refers to the last day of that month.
Store the medicine in its original packaging to protect it from moisture.
Do not remove the capsule from the blister until you are ready to take it.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist for the correct way to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Atanto contains

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

Description of the appearance of Atanto and contents of the pack
The 125 mg hard capsules are opaque gelatin capsules of size 1, with a pink cap and a white body, marked "125mg" in black ink on the body.
The 80 mg hard capsules are opaque gelatin capsules of size 2, with a white cap and a white body, marked "80mg" in black ink on the body.
Atanto is packaged in a cardboard carton containing the appropriate number of aluminum-OPA/ALU/PVC blisters, together with a package leaflet.
The 125 mg hard capsules of Atanto are available in the following pack sizes:

• Aluminum blister containing one 125 mg capsule
• 5 aluminum blisters, each containing one 125 mg capsule

The 80 mg hard capsules of Atanto are available in the following pack sizes:

• Aluminum blister containing one 80 mg capsule
• Treatment pack for 2 days containing two 80 mg capsules
• 5 aluminum blisters, each containing one 80 mg capsule

The 125 mg and 80 mg hard capsules of Atanto are available in the following pack:

• Treatment pack for 3 days containing one 125 mg capsule and two 80 mg capsules

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Sintesy Pharma S.r.l.,
via Mazzini 20, 20123 Milano - Italy

Manufacturer
Pharmathen International S.A.,
Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece
Pharmathen SA,
6 Dervenakion str., 15351 Pallini Attiki, Greece

This medicinal product is authorized in the European Economic Area Member States under the following names:
Netherlands, Austria, Belgium, Cyprus, Denmark, Atanto
Germany, Greece, France, Iceland, Italy,
Spain, Sweden, United Kingdom