Patient Information Leaflet: Instructions for the User

FROBEN COLD

0.05% NASAL SPRAY, SOLUTION
Generic Medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.

Keep this leaflet. You may need to read it again.
For further information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice improvement, or if your symptoms worsen after 4 days.

Contents of this leaflet:

What Froben Cold is and what it is used for
What you need to know before using Froben Cold
How to use Froben Cold
Possible side effects
How to store Froben Cold
Contents of the pack and other information

1. What Froben Cold is and what it is used for

Froben Cold, a nasal medicinal product, provides prolonged relief from nasal congestion associated with
the common cold by acting to constrict the blood vessels in the nasal mucosa (nasal decongestant).
Froben Cold is indicated for adults and children over 12 years of age.
Consult your doctor if you do not feel better after 4 days.

2. What you should know before taking Froben Cold

Do not use Froben Cold

if you are allergic to the active substance (oxymetazoline) or to any of the other ingredients of this medicine (listed in section 6);
if you are taking or have taken within the last 2 weeks antidepressant medicines (e.g. monoamine oxidase inhibitors, MAOIs);
if you have an enlarged prostate (prostatic hypertrophy);
if you have heart disease or severely high blood pressure (severe arterial hypertension);
if you have eye diseases with high intraocular pressure that may cause vision problems (glaucoma);
if you have high levels of thyroid hormones (hyperthyroidism);
if you have inflammation or lesions of the mucous membrane of the mouth or of the 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 Cold if:

you are 65 years of age or older, as you may have difficulty urinating (urinary retention);
you suffer or have previously suffered from heart or circulatory diseases, such as coronary artery disease or high blood pressure (hypertension).

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

a burning or dry sensation in the nose (sensitization phenomena);
worsening of congestion symptoms after discontinuation (rebound effect);
reduced effectiveness or duration of action of the medicine (tachyphylaxis);
drug dependence: in such cases, discontinue treatment and consult your doctor, who will initiate appropriate therapy. To avoid the conditions listed above, do not exceed the recommended doses or duration of treatment (see section 3).

If symptoms persist or worsen, or new symptoms appear, stop using the medicine and consult a doctor.
If you do not notice any improvement within the first 4 days of using Froben Cold, consult your doctor.
Do not use the medicine orally. This medicine may be harmful if accidentally swallowed or taken in high doses over a long period.
Avoid contact of the liquid with the eyes.
Attention for athletes: The product contains substances prohibited in doping. Any use differing from the recommended dosage regimen or route of administration is prohibited.
Children and adolescents
Do not give Froben Cold to your child if they are under 12 years of age.
Froben Cold may have a pronounced sedative effect if accidentally ingested.
Other medicines and Froben Cold
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use Froben Cold if you are taking or have taken within the last 2 weeks antidepressant medicines (e.g. monoamine oxidase inhibitors, MAOIs), as concomitant use may cause an increase in blood pressure (see "Do not use Froben Cold").
Oxymetazoline may reduce the effectiveness of certain medicines used to treat high blood pressure (beta-blockers or antihypertensives).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy or breastfeeding unless the potential benefit to the mother outweighs the possible risks to the developing fetus or nursing 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 or operate machinery are known.

3. How to use Froben Cold

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Do not exceed the recommended doses or duration of treatment without medical advice.

Adults and children over 12 years of age
One spray per nostril every 6–12 hours, if needed.
Do not use for more than 4 days unless otherwise advised by a doctor.
Consult your doctor if you do not notice any improvement or if your symptoms worsen.
Do not use Froben Cold in children under 12 years of age.

Method of administration
Administer Froben Cold nasally, following these instructions: remove the plastic cap, insert the nozzle into one nostril and press quickly and firmly, while breathing deeply through that nostril. Repeat the procedure for the other nostril.

If you use more Froben Cold than you should
Contact your doctor immediately or go to the nearest hospital.
If you accidentally use too much Froben Cold or ingest the contents of the bottle, the following symptoms may occur: increased blood pressure (arterial hypertension), increased heart rate (tachycardia), light sensitivity causing pain (photophobia), severe headache (intense cephalalgia), and chest tightness.

In children, the following symptoms may occur: excessive drop in body temperature (hypothermia), profound drowsiness (marked sedation) due to severe depression of the central nervous system.

Oral ingestion, especially in children, may cause symptoms such as nausea, vomiting, lethargy (deep sleep state), increased or decreased heart rate (tachycardia or bradycardia), reduced breathing, high or low blood pressure (hypertension or hypotension), sedation, drowsiness, pupil dilation (mydriasis), stupor, low body temperature (hypothermia), salivation, coma.

These symptoms require immediate emergency measures; therefore, seek medical help without delay.

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

If you stop using Froben Cold
If you have any questions about using 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.
The following side effects have been reported 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);
- slowed heart rate (reflex bradycardia);
- rise in 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 sensation of nasal burning or dryness (sensitization phenomena) and nasal congestion with swelling of the mucosa (rebound congestion).
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Froben Cold

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle label and on the carton after "EXP". The expiry date refers to the last day of that month.
After first opening the bottle, you must use the product within 4 weeks; after this period, any remaining product should be discarded.
Store below 25°C.
Do not store in the refrigerator or refrigerate.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Contents of the pack and other information

What Froben Cold 0.05% nasal spray, solution contains
The active substance is oxymetazoline hydrochloride. 100 ml of solution contain 50 mg of oxymetazoline hydrochloride.
One spray corresponds to 0.1 ml of solution and contains 0.05 mg of oxymetazoline.
The other components are: sorbitol, potassium dihydrogen phosphate, disodium phosphate dodecahydrate, chlorhexidine diacetate, purified water.
Description of the appearance of Froben Cold and contents of the pack
Froben Cold is presented as a solution for nasal spray.
The pack contains one 15 ml bottle of solution.
Marketing Authorization Holder
Cooper Consumer Health B.V.
Verrijn Stuartweg 60 – 1112 AX Diemen
(The Netherlands)
Manufacturer responsible for batch release
Alfasigma S.p.A.
Via Enrico Fermi, 1
65020 Alanno (PE)