EQUIMET 0.5 mg/ml Nasal spray, solution

Зміст інструкції

1. Equimet 0.5 mg/ml nasal spray, solution
   1. What is Equimet and what is it used for
   2. What you need to know before using Equimet
   3. How to use Equimet
   4. Possible side effects
   5. How to store Equimet
   6. Contents of the pack and other information

Equimet 0.5 mg/ml nasal spray, solution

oxymetazoline hydrochloride

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.

• 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 of treatment.

Contents of this leaflet:

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

1. What is Equimet and what is it used for

Equimet is a medicine that contains oxymetazoline, a decongestant substance effective for local (topical) use which determines a prolonged relief from nasal obstruction.
Equimet is used as a nasal mucosa decongestant (clears a stuffy nose), especially in case of
a cold.
See your doctor if you do not feel better or if you feel worse after 4 days of treatment.

2. What you need to know before using Equimet

Do not use Equimet

• if you are allergic to oxymetazoline or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from enlarged prostate (prostatic hypertrophy);
• if you have heart disease and/or very high blood pressure (severe arterial hypertension);
• if you have a disease of the optic nerve (glaucoma);
• if you have excessive production of thyroid hormones (hyperthyroidism);
• if you are being treated with medicines against depression (antidepressants) or within two weeks after such therapy;
• if you suffer from inflammation or lesions of the oral mucosa or the skin around the nostrils.
• if you are under 12 years of age (see “Children”).

Warnings and precautions
Consult your doctor or pharmacist before using Equimet.
Prolonged use of medicines that constrict blood vessels (vasoconstrictors) may alter the
normal function of the nasal and paranasal sinus mucosa, also inducing tolerance to
the medicine (habituation). Repeating applications for long periods may be harmful.
Patients with thyroid disorders, diabetes, or difficulty urinating due to enlarged
prostate should not take oxymetazoline, unless otherwise indicated by the doctor.
Temporary discomforts such as burning, stinging, sneezing or increased nasal secretion
may occur.
The use, especially prolonged, of topical products may give rise to allergic reactions
(sensitization); in this case, stop treatment and consult your doctor to establish appropriate
therapy. However, if you do not notice considerable improvement within a few days, consult your doctor.
Do not prolong treatment for more than 4 days to avoid a rebound effect and drug-induced rhinitis.
Do not use this medicine by mouth. The medicine, if accidentally ingested or if used for
a long period in excessive doses, may determine toxic phenomena. Keep Equimet out of the
reach of children, as accidental ingestion may cause marked sedation (see “If you use
more Equimet than you should”).
Avoid contact of the liquid with the eyes.

Pay particular attention with Equimet:

• If you suffer from heart and circulatory (cardiovascular) diseases, especially if you have high blood pressure (hypertension); consult your doctor each time.
• If you are an elderly person, due to the risk of urinary retention (difficulty urinating). Consult your doctor also in cases where such disorders have occurred in the past.
• If you are pregnant or during the breastfeeding period (see “Pregnancy and breastfeeding”).

For those who play sports: the medicine contains substances prohibited for doping. An intake different from that reported for treatment scheme and route of administration is prohibited.

Children
Equimet should not be used by children under 12 years of age.

Other medicines and Equimet
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not use this medicine during and within two weeks following therapy with medicines against
depression (antidepressants) (see “Do not use Equimet”).
Oxymetazoline may reduce the effectiveness of beta-blockers, methyl
dopa other drugs or antihypertensive drugs. Hypertension and arrhythmias may occur when tricyclic
antidepressants are administered with sympathomimetic drugs such as oxymetazoline. Increased
cardiovascular toxicity may occur when sympathomimetic drugs are
administered in conjunction with antiparkinsonian drugs such as bromocriptine.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, you should not use this medicine. Always ask your doctor or pharmacist for advice
before using this medicine.
During pregnancy, especially in the first months, and during breastfeeding, use Equimet only after
consulting your doctor and evaluating with him the risk/benefit ratio in your case.

3. How to use Equimet

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.

The recommended dosefor adults and children over 12 years of age is one spray (nebulization) per nostril every 6-12 hours, if necessary.

Instructions for use:remove the plastic cap; insert the end of the bottle into the nostril and press with a quick and firm motion, breathing deeply through your nose.

Caution: do not exceed the indicated doses.
Do not exceed 4 days of treatment unless indicated by your doctor.
Consult your doctor if the disorder occurs repeatedly or if you notice any recent change in its characteristics.

If you use more Equimet than you should
In case of ingestion/accidental intake of an excessive dose of Equimet, immediately inform your doctor or go to the nearest hospital.
In case of overdose, alternating periods of stimulation and depression of the cardiopulmonary and central nervous system may occur, causing symptoms such as, but not limited to, increased blood pressure (arterial hypertension), rapid heartbeat (tachycardia), painful sensation caused by light (photophobia), severe headache (intense cephalalgia), feeling of chest tightness and, in children, excessive lowering of body temperature (hypothermia) and severe depression of the central nervous system with excessive calmness (marked sedation), which require the adoption of adequate emergency measures.
Oral ingestion, especially in children, can cause symptoms such as nausea, vomiting, lethargy, tachycardia, decreased breathing, bradycardia, hypotension, hypertension, sedation, drowsiness, mydriasis, stupor, hypothermia, salivation, coma.
In the most serious cases, intubation and artificial respiration are required.

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

If you stop treatment with Equimet
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.
The medicine may locally determine allergic phenomena and worsening of the sensation of
nasal congestion.
Due to the rapid absorption of the medicine through the inflamed mucous membranes, general effects on the
body (systemic) may occur, such as increased blood pressure (arterial hypertension), reduced heart rate
(reflex bradycardia), headache, difficulty urinating (urinary disorders), eye irritation, discomfort or
redness, epistaxis (nosebleed), discomfort or irritation of the nose, mouth or throat, sneezing,
tachycardia (accelerated heartbeat), palpitations, increased blood pressure, reflex bradycardia (decreased
heart rate), insomnia, nervousness, tremor, anxiety, agitation, irritability and headache, nausea.).
Following the instructions contained in the package leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please
consult your doctor or pharmacist. You can also report side effects directly through the
national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse..
Reporting side effects can help provide more information on the safety of
this medicine.

5. How to store Equimet

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 after “EXP”.
The expiry date refers to the last day of that month. The indicated expiry date refers to the product in intact packaging, correctly stored.
After the first opening of the bottle, the medicine must be used within 4 weeks; after this period, dispose of any excess product.
Do not refrigerate.
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 Equimet contains

• The active ingredient is oxymetazoline hydrochloride. 100 ml contain 0.050 g of oxymetazoline hydrochloride. One spray corresponds to 0.1 ml of solution and contains 0.05 mg of oxymetazoline.
• The other ingredients are: Benzalkonium chloride, Dipotassium phosphate, Disodium hydrogen phosphate anhydrous, Purified water.

Description of the appearance of Equimet and contents of the pack
Equimet is presented as a nasal spray.
The pack contains a 15 ml bottle of solution.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Tecnigen S.r.l.
Via Galileo Galilei, 40

• 20092 - Cinisello Balsamo (MI)

Manufacturer
Laboratorios Alcalà Farma, S.L.
Avenida de Madrid, 82
28802 Alcalà de Henares (Madrid)
Spain