Name
RINAZINA DOUBLE ACTION 0.5 mg/ml + 0.6 mg/ml nasal spray, solution
Xylometazoline hydrochloride/Ipratropium bromide


What it is and what it is used for
RINAZINA DOPPIA AZIONE is a combination medicine consisting of two different substances.
One of the active substances helps against a runny nose, the other has a decongestant effect.
RINAZINA DOPPIA AZIONE is used for the treatment of nasal congestion with a runny nose (rhinorrhea) associated with common colds.


What you need to know before taking the medicine
Do not use RINAZINA DOUBLE ACTION:
- in children under 18 years of age, as adequate information on safety and efficacy is not available
- if you are allergic to xylometazoline hydrochloride or ipratropium bromide or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to atropine or atropine-like substances such as hyoscyamine and scopolamine
- if you have had your pituitary gland removed through your nose
- if you have had brain surgery where the operation was performed through your nose or mouth
- if you suffer from glaucoma (increased pressure in the eyes)
- if you have a very dry nose (inflammatory nasal dryness, dry rhinitis or atrophic rhinitis).


Warnings and precautions
RINAZINA DOUBLE ACTION may cause sleep disturbances, dizziness, tremor, irregular heart rhythm or high blood pressure if you are sensitive to medicines for the relief of a stuffy nose.
Consult your doctor if these symptoms occur and are bothersome.
Contact your doctor or pharmacist before using RINAZINA DOPPIA AZIONE if you suffer from:

- heart disease (e.g., long QT syndrome)
- increased blood pressure
- diabetes
- overactive thyroid gland (hyperthyroidism)
- difficulty urinating and/or enlarged prostate
- angle-closure glaucoma
- tendency to have nosebleeds
- intestinal obstruction (paralytic ileus)
- cystic fibrosis
- benign tumor of the adrenal gland that produces high amounts of adrenaline and noradrenaline (pheochromocytoma) or a particular sensitivity to adrenaline and noradrenaline.

Immediate hypersensitivity (allergic reaction) may occur. This may manifest as a red itchy rash with raised skin inflammation (hives), difficulty breathing or speaking, difficulty swallowing due to swelling of the lips, face or throat. These symptoms may appear individually or all combined as a severe allergic reaction. If this occurs, stop using RINAZINA DOPPIA AZIONE immediately (see section 4).

RINAZINA DOPPIA AZIONE should not be used for more than 7 consecutive days. If symptoms persist, consult your doctor. Prolonged or excessive use may cause the return or worsening of stuffy nose and swelling of the nasal mucosa.

Avoid spraying RINAZINA DOPPIA AZIONE in or around your eyes. If this happens, rinse your eyes thoroughly with cold water. Your vision may become temporarily blurred and your eye may become irritated, painful and red. If this happens, contact your doctor for advice.
Worsening of narrow-angle glaucoma may also occur.

Children and adolescents
The use of RINAZINA DOPPIA AZIONE is not recommended in children and adolescents under 18 years of age as adequate information on safety and efficacy is not available.


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

Stop using RINAZINA DOPPIA AZIONE and seek medical help immediately if you have any of the following symptoms:
- Palpitations and increased heart rate (affects less than 1 in 100 people).
- Signs of an allergic reaction such as difficulty breathing, speaking or swallowing: swelling of the face, lips, tongue or throat; severe itching of the skin, with red rash or raised bumps (frequency not known, cannot be estimated from the available data).
- Vision disturbances (including blurred vision, worsening of glaucoma or increased pressure in the eye), rainbow-coloured circles/halos around bright lights and/or eye pain (frequency not known cannot be estimated from the available data).

The most common side effects are nosebleeds and nasal dryness. Many of the reported side effects are also symptoms of the common cold.

Very common side effects (may affect more than 1 in 10 people):
• nosebleeds (epistaxis)

Common side effects (may affect up to 1 in 10 people):
• nasal discomfort, nasal congestion, dry nose, nose pain
• dry mouth, dry or irritated throat
• altered sense of taste, headache, dizziness, local burning sensation
• nausea

Uncommon (may affect up to 1 in 100 people):
• nasal ulcer, sneezing, sore throat, cough, hoarseness
• stomach problems
• altered sense of smell, tremors
• discomfort, tiredness
• insomnia
• eye irritation, dry eyes, eye swelling, eye redness
• palpitations, increased heart rate

Rare (may affect up to 1 in 1,000 people):
• runny nose

Very rare (may affect up to 1 in 10,000 people):
• reaction to the medicine such as swelling, rash, itching
• vision impairment

Frequency not known (frequency cannot be estimated from the available data):
• urticaria
• discomfort around the nose
• difficulty swallowing
• chest discomfort, thirst
• sudden spasm of the throat, swelling of the throat
• irregular heart rhythm
• difficulty focusing with the eyes, dilation of the pupils, seeing flashes of light, increased pressure in the eye, glaucoma, blurred vision, halos around bright lights and eye pain
• difficulty emptying the bladder.

In order to minimize the risk of side effects, it is recommended to stop treatment with RINAZINA DOPPIA AZIONE as soon as your symptoms improve.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.