FROBEN 0.05 % Nasal spray, solution

Зміст інструкції

1. FROBEN RAFFREDDORE
   1. What is Froben Raffreddore and what is it used for?
   2. What you need to know before you take Froben Raffreddore
   3. How to use Froben Raffreddore
   4. Possible side effects
   5. How to store Froben Raffreddore
   6. Contents of the pack and other information

FROBEN RAFFREDDORE

0.05% NASAL SPRAY, SOLUTION
Equivalent Medicinal Product
Read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.
Keep this leaflet. You may need to read it again.
If you want more information or advice, ask your pharmacist.
If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
See a doctor if you do not feel better or if your symptoms worsen after 4 days.

• Keep this leaflet. You may need to read it again.
• If you desire more information or advice, consult your pharmacist.
• If any undesirable effects occur, including effects not listed in this leaflet, consult your doctor or pharmacist. See paragraph 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 4 days.

Contents of this leaflet:

• 1. What Froben Raffreddore is and what it is used for
• 2. What you need to know before you use Froben Raffreddore
• 3. How to use Froben Raffreddore
• 4. Possible side effects
• 5. How to store Froben Raffreddore
• 6. Contents of the pack and other information

1. What is Froben Raffreddore and what is it used for?

Froben Raffreddore, a medicine for nasal use, provides prolonged relief from nasal congestion in case of
a cold, as it works by constricting the blood vessels in the nasal mucosa (nasal decongestant).
Froben Raffreddore is indicated for adults and children over 12 years of age.
See a doctor if you do not feel better after 4 days.

2. What you need to know before you take Froben Raffreddore

Do not useFroben Raffreddore

• if you are allergic to the active ingredient (oxymetazoline) or to any of the other ingredients of this medicine (listed in section 6);
• if you are taking or have taken in the last 2 weeks medicines against depression (antidepressants), such as monoamine oxidase inhibitors (MAOIs);
• if you suffer from enlarged prostate (prostatic hypertrophy);
• if you suffer from heart disease or very high blood pressure (severe arterial hypertension);
• if you suffer from eye diseases with high pressure in the eye with possible vision problems (glaucoma);
• have high levels of thyroid hormones (hyperthyroidism);
• have inflammation or injury to the mucous membrane of the mouth or skin around the nostrils.

Do not give this medicine to your child if they are under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Froben Raffreddore if:

• you are 65 years of age or older because you may have difficulty urinating (urinary retention);
• you suffer from or have suffered in the past from heart and circulatory diseases, such as coronary arteries and high blood pressure (hypertension);

If you have thyroid disease, diabetes, or difficulty urinating due to enlarged prostate, you should not
take Froben Raffreddore unless otherwise indicated by your doctor.
The use of Froben Raffreddore may cause temporary discomfort such as burning, tingling, sneezing, or increased nasal secretion.
Prolonged or frequent use of Froben Raffreddore may be harmful as it may alter the normal
function of the nasal and paranasal sinus mucosa, leading to:

• a sensation of burning or dryness in the nose (sensitization phenomena);
• worsening of congestion symptoms after discontinuation (rebound effect);
• a reduction in the effectiveness or duration of the medicine's effect (habituation);
• drug dependence: in this case, stop treatment and consult your doctor who will establish appropriate therapy. To avoid the conditions listed above, do not exceed the recommended doses and duration of treatment (see section 3).

If symptoms persist or worsen, or new symptoms appear, stop using it and consult a doctor.
If you do not notice any improvement within the first 4 days with Froben Raffreddore, see a doctor.
Do not use the medicine orally. This medicine may be harmful if swallowed accidentally or if taken
for a long period at high doses.
Avoid contact of the liquid with your eyes.
Caution for those who play sports: the product contains substances prohibited for doping. Taking it
in a manner different from the dosage regimen and route of administration specified is prohibited.

Children and adolescents
Do not give Froben Raffreddore to your child if they are under 12 years of age.
Froben Raffreddore may have a pronounced sedative effect if accidentally ingested.

Other medicines and Froben Raffreddore
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Do not use Froben Raffreddore if you are taking or have taken in the last 2 weeks medicines against depression
(antidepressants), such as monoamine oxidase inhibitors (MAOIs) as the concurrent use
may cause an increase in blood pressure (see “Do not use Froben Raffreddore”).
Oxymetazoline may reduce the effectiveness of some medicines that are used to treat high
blood pressure (beta-blockers or antihypertensives)

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
This medicine should not be used during pregnancy or breastfeeding unless the potential benefit
of the treatment for the mother is greater than the possible risks to the developing fetus or breastfeeding infant.
It is not known whether oxymetazoline and its metabolites pass into human milk.

Driving and using machines
No effects on the ability to drive and operate machinery have been reported.

3. How to use Froben Raffreddore

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or
pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Do not exceed the dosage and duration of treatment indicated without your doctor’s advice.

Adults and children over 12 years
One spray per nostril every 6-12 hours, if necessary.

Do not exceed 4 days of treatmentunless otherwise indicated by your doctor.
Consult your doctor if you do not notice any improvement or if your symptoms worsen.

Do not use Froben Raffreddore in children under 12 years of age.
Method of administration
Administer Froben Raffreddore nasally, following these instructions: remove the plastic cap, insert the
end of the bottle into the nostril and press quickly and firmly, breathing deeply through the same
nostril. Repeat the operation for the other nostril.

If you use more Froben Raffreddore than you should
Notify your doctor immediately or go to the nearest hospital.
If you should accidentally use an excessive dose of Froben Raffreddore or ingest the contents of the bottle,
the following symptoms may occur: increased blood pressure (arterial hypertension), increased
heart rate (tachycardia), painful sensation caused by light (photophobia), severe headache (severe
headache), feeling of tightness in the chest.
In your child, the following symptoms may instead occur: excessive lowering of body temperature (hypothermia), deep sleepiness (marked sedation) due to severe depression of the central nervous
system.
Oral ingestion, especially in children, can cause symptoms such as nausea, vomiting, lethargy (deep sleep
state), increased or decreased heart rate (tachycardia or bradycardia) decreased breathing,
high or low blood pressure (hypertension or hypotension), sedation, drowsiness, dilation of the pupil
of the eye (mydriasis), stupor, low body temperature (hypothermia), salivation, coma.
These symptoms require the adoption of adequate emergency measures, so consult your doctor immediately.

If you forget to use Froben Raffreddore
Do not use a double dose to make up for a missed dose.

If you stop using Froben Raffreddore
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Below are listed the side effects identified during post-marketing experience:

• Rare (may affect up to 1 in 1,000 people):
• eye irritation, discomfort or redness;
• Very rare (may affect up to 1 in 10,000 people):
• increased heart rate (tachycardia, palpitations);
• slowing of the heart rate (reflex bradycardia);
• increased blood pressure;
• insomnia;
• nervousness;
• tremor;
• anxiety, agitation, irritability;
• headache;
• nausea;
• difficulty urinating;
• nosebleed (epistaxis);
• nasal discomfort;
• throat irritation and dry mouth;
• sneezing.

This medicine may cause a burning or dryness sensation in the nose (sensitization phenomena) and
nasal congestion with swelling of the mucous membrane (rebound congestion).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or
pharmacist. You can also report side effects directly through the national reporting system
at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help to
provide more information on the safety of this medicine.

5. How to store Froben Raffreddore

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 label of the bottle and on the carton after
“EXP”. The expiry date refers to the last day of that month.
After the first opening of the bottle, you must use the product within 4 weeks; after this period you must
dispose of any excess product.
Store at a temperature below 25°C.
Do not store in a refrigerator or freeze.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Froben Raffreddore 0.05% nasal spray, solution contains
The active ingredient is oxymetazoline hydrochloride. 100 ml of solution contains 50 mg of oxymetazoline hydrochloride.
One spray corresponds to 0.1 ml of solution and contains 0.05 mg of oxymetazoline.
The other ingredients are: sorbitol, dipotassium hydrogen phosphate, disodium phosphate dodecahydrate, chlorhexidine
diacetate, purified water.

Description of the appearance of Froben Raffreddore and contents of the pack
Froben Raffreddore is presented in the form of a nasal spray solution.
The pack contains a 15 ml bottle of solution.

Marketing Authorisation Holder
Cooper Consumer Health B.V.
Verrijn Stuartweg 60 – 1112 AX Diemen
(Netherlands)

Manufacturer responsible for batch release
Alfasigma S.p.A.
Via Enrico Fermi, 1
65020 Alanno (PE)