OXOTICA-O Nasal Spray

1. What OXOTICA-O is and what it is used for

OXOTICA-O is a nasal spray that contains two active substances:

Fluticasone Furoate – a corticosteroid that helps reduce inflammation in the nose
Oxymetazoline Hydrochloride – a decongestant that helps relieve nasal blockage

OXOTICA-O is used for the treatment of symptoms of allergic rhinitis with nasal congestion.

Symptoms may include:

blocked nose / nasal congestion
sneezing
runny nose
itchy nose

2. What you need to know before you use OXOTICA-O

Do not use OXOTICA-O if you:

are allergic (hypersensitive) to Fluticasone Furoate, Oxymetazoline Hydrochloride, or any of the other ingredients of this medicine
are below 12 years of age
have undergone recent trans-nasal surgery
have chronic nasal inflammation with very dry nasal passages (rhinitis sicca or atrophic rhinitis)
have cardiovascular disease
have hyperthyroidism
have angle-closure glaucoma
have prostatic enlargement

Warnings and precautions
Talk to your doctor or pharmacist before using OXOTICA-O if you:

are using or have recently used other corticosteroid medicines
have or have had eye problems, including blurred vision, cataract, or glaucoma
have symptoms suggestive of visual disturbance
are taking medicines containing ritonavir, cobicistat, or other strong CYP3A4 inhibitors
are taking ketoconazole
are taking monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, or non-selective beta blockers
have previously been treated with systemic (oral/injectable) steroids
are pregnant, think you may be pregnant, or are breast-feeding

Keep the spray away from the eyes.
Do not spray into the mouth or eyes.

Systemic corticosteroid effects
Although the amount absorbed into the body is low, systemic effects of nasal corticosteroids may occur, especially when used:

at high doses, or
for prolonged periods

These may include:

adrenal suppression
Cushing's syndrome / Cushingoid features
cataract
glaucoma
mood or behavioural changes
sleep disturbances

Always use the lowest dose that controls your symptoms.

Children and adolescents

Do not use this medicine in children below 12 years of age.
Long-term use of nasal corticosteroids in children and adolescents may affect growth.

Other medicines and OXOTICA-O
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor if you are taking:

ritonavir
cobicistat-containing medicines
ketoconazole
monoamine oxidase inhibitors (MAOIs)
tricyclic antidepressants
non-selective beta blockers
other corticosteroids

Some medicines may increase the effects of OXOTICA-O and your doctor may wish to monitor you carefully.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

There are no adequate data on the use of this medicine in pregnant women.
It is not known whether Fluticasone Furoate or Oxymetazoline Hydrochloride passes into human breast milk.

Your doctor will decide whether you should use this medicine.

Driving and using machines
OXOTICA-O has no or negligible effect on the ability to drive and use machines.

3. How to use OXOTICA-O

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Recommended dose
Adults and adolescents (12 years and older):

Two sprays in each nostril once daily

Once symptom control is achieved, the dose may be reduced to:

One spray in each nostril once daily for maintenance, if advised by your doctor

Children below 12 years of age:

Do not use in children below 12 years of age

Elderly patients (65 years and above):

No dose adjustment is required

Patients with kidney or liver problems:

No dose adjustment is required

Method of administration
For intranasal use only.

Shake the bottle well before each use.
Remove the protective cap.
Gently blow/clean your nose before use.
Insert the nozzle into one nostril while closing the other nostril.
Aim the spray towards the outer side of the nostril, away from the nasal septum (the cartilage in the middle of the nose).
Press the pump to release the spray while breathing in gently through the nose.
Breathe out through the mouth.
Repeat in the other nostril as prescribed.
Avoid deep inhalation, as this may cause the medicine to pass into the throat and reduce local effect.
Wipe the nozzle clean after use and replace the cap.

Important advice

Do not spray into the eyes or mouth
Do not share the bottle with anyone else
Clean the nozzle regularly

If you use more OXOTICA-O than you should
If you accidentally use more than prescribed, contact your doctor or pharmacist.
Overuse may cause:

local nasal irritation
rebound nasal congestion

Treatment is usually symptomatic.

If you forget to use OXOTICA-O
If you forget a dose, use it as soon as you remember.
Then continue as before.
Do not use a double dose to make up for a forgotten dose.

If you stop using OXOTICA-O
Do not stop using this medicine without talking to your doctor, even if you feel better.

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.

Common side effects

Nosebleeds (epistaxis)
Nasal dryness or discomfort
Sneezing
Headache

Other side effects reported

nasal ulceration
pain in the nose (rhinalgia)
local irritation
dry mouth
dry throat
stomatitis
blurred vision
transient eye-related changes
nasal septum perforation
nausea
sleep problems (insomnia)
anxiety
irritability
sedation
restlessness
somnolence
fatigue
increased blood pressure (hypertension)
irregular heart rate
increased heart rate
hypersensitivity reactions including:
- rash
- urticaria
- swelling (angioedema)
- severe allergic reaction (anaphylaxis)

Prolonged use may cause:

rebound congestion
rhinitis medicamentosa (worsening nasal blockage due to overuse of decongestant sprays)

Frequency not known

dysphonia (voice change)
aphonia (loss of voice)
dysgeusia (altered taste)
ageusia (loss of taste)
anosmia (loss of smell)

Seek medical help immediately if you notice:

swelling of the face, lips, tongue, or throat
difficulty breathing
severe rash or allergic reaction
sudden visual changes

Reporting of side effects
If you get 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 suspected side effects directly via email at: medico@zorvia.com
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store OXOTICA-O

• Store below 30°C
• Shake well before each use
• Keep out of the sight and reach of children

Do not use this medicine after the expiry date stated on the pack.

6. Contents of the pack and other information

What OXOTICA-O contains

Active ingredients
Each actuation delivers:

Fluticasone Furoate EP – 27.5 mcg
Oxymetazoline Hydrochloride – 50 mcg

Other ingredients

Benzalkonium Chloride Solution IP (preservative)
other excipients q.s.

What OXOTICA-O looks like and contents of the pack

OXOTICA-O Nasal Spray is a white to off-white suspension in a pre-filled intranasal sprayer.

Pack size:

7 g container
70 metered doses

Marketing Authorization Holder