FROBEN COLD*15ML 0.05%

FROBEN COLDCURE
0.05% NASAL SPRAY, SOLUTION
Equivalent Medicine

What it is and what it is used for
Froben Coldcure, a medicine for nasal use, provides prolonged relief from nasal obstruction in cases of common cold, as it acts by constricting the blood vessels in the nasal lining (nasal decongestant).
Froben Coldcure is indicated for adults and children over 12 years of age.

Consult your doctor if you do not feel better after 4 days.

What you need to know before taking the medicine
Do not use Froben Coldcure
- if you are allergic to the active substance (oxymetazoline) or any of the other ingredients of this medicine (listed in paragraph 6);
- if you are taking or have taken antidepressants (such as monoamine oxidase inhibitors (MAOIs)) in the last 2 weeks;
- if you suffer from an enlarged prostate (benign prostatic hyperplasia);
- if you suffer from heart disease or very high blood pressure (severe arterial hypertension);
- if you suffer from eye diseases with high intraocular pressure with possible vision problems (glaucoma);
- if you have high thyroid hormone levels (hyperthyroidism);
- if you have inflammation or lesions of the oral mucosa or 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 Coldcure if:

• you are 65 years of age or older because you may have difficulty urinating (urinary retention);
• you suffer 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 an enlarged prostate, you should not take Froben Coldcure, unless otherwise directed by your doctor.

The use of Froben Coldcure may cause temporary discomfort such as burning, stinging, sneezing, or increased nasal secretion.

Prolonged or frequent use of Froben Coldcure can be harmful as it can alter the normal function of the nasal and paranasal sinus mucosa, leading to:
– burning sensation or dryness of the nose (sensitization phenomena);
– worsening of congestion symptoms after discontinuation (rebound effect);
– a reduction in the effectiveness or duration of the medicine's effect (tolerance);
– drug dependence: in this case, stop the treatment and consult your doctor who will establish an appropriate therapy.

To avoid the occurrence of the above conditions, do not exceed the recommended doses and duration of treatment (see paragraph 3).

If symptoms persist or worsen, or new symptoms appear, discontinue use and consult a doctor.
If you do not notice any improvement within the first 4 days with Froben Coldcure medicine, consult your doctor.

Do not use the medicine orally. This medicine can be harmful if accidentally swallowed or if taken for a long period at high doses.

Avoid contact of the liquid with the eyes.

Attention for those who engage in sports activities: the product contains substances prohibited for doping. Any administration different from those reported in terms of dosage regimen and route of administration is prohibited.

Children and adolescents
You should not give Froben Coldcure to your child if they are under 12 years of age.
Froben Coldcure can have a marked sedative effect if accidentally ingested.

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

The following are 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);
• slowed 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 can cause a burning sensation or dryness of the nose (sensitization phenomena) and nasal congestion with swelling of the mucosa (rebound congestion).