Sudafed spray ha comfort

Patient Information Leaflet

Sudafed Spray HA Comfort, 1 mg/ml, nasal spray, solution
Xylometazolini hydrochloridum
Please read the entire leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine exactly as described in this Patient Information Leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days of treatment, or if you feel worse, consult your doctor.

Table of contents:

1. What is Sudafed Spray HA Comfort and what is it used for
2. Important information before using Sudafed Spray HA Comfort
3. How to use Sudafed Spray HA Comfort
4. Possible side effects
5. How to store Sudafed Spray HA Comfort
6. Contents of the pack and other information

1. What is Sudafed Spray HA Comfort and what is it used for

Xylometazoline is a vasoconstrictor agent that reduces swelling of the nasal mucosa. The onset of action occurs within 2 minutes after administration. Reduction of mucosal swelling facilitates nasal breathing and promotes drainage of secretions.
Sudafed Spray HA Comfort contains hyaluronic acid in the form of sodium salt as an excipient, which protects and moisturizes the nasal mucosa.
Sudafed Spray HA Comfort is intended for use in adults and children over 6 years of age.
Indications
Reduction of nasal mucosal swelling in acute rhinitis, vasomotor rhinitis, and allergic rhinitis.
Facilitation of mucus drainage in acute sinusitis and in otitis media with Eustachian tube dysfunction associated with the common cold.

2. Important information before using Sudafed Spray HA Comfort

When not to use Sudafed Spray HA Comfort:

• if the patient is allergic to xylometazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• do not use in children under 6 years of age;
• do not use in patients after pituitary gland removal or after other surgical procedures involving exposure of the dura mater.

Warnings and precautions
This medicine should only be used after careful consideration by a physician of the benefit-risk ratio in patients:

• being treated with monoamine oxidase inhibitors (MAO inhibitors) or other medicinal products that may increase blood pressure;
• with increased intraocular pressure, especially in patients with narrow-angle glaucoma;
• with severe cardiovascular disorders (e.g. ischemic heart disease, hypertension, long QT syndrome);
• with pheochromocytoma;
• with metabolic disorders (e.g. hyperthyroidism, diabetes);
• with benign prostatic hyperplasia;
• with hypersensitivity to substances with effects similar to xylometazoline, manifested by insomnia, tremor, dizziness, cardiac arrhythmias, and elevated blood pressure.

This medicine is intended for short-term use only. Use of xylometazoline in doses higher than recommended or for longer than recommended periods may lead to reactive hyperaemia of the nasal mucosa. This causes nasal congestion, leading to frequent and prolonged use of the medicine by the patient. As a result, this may lead to rhinitis medicamentosa and atrophy of the nasal mucosa.

Consult a doctor if symptoms do not improve or worsen, or if new symptoms occur.

Other medicines and Sudafed Spray HA Comfort
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

When administered intranasally, the likelihood of interactions with other medicines appears to be low; however, such interactions cannot be ruled out.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
No influence of Sudafed Spray HA Comfort, when used at recommended doses, on the ability to drive or operate machinery has been demonstrated.

3. How to use Sudafed Spray HA Comfort

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Sudafed Spray HA Comfort is intended for nasal use only (including in cases of Eustachian tube inflammation).
Adults and children over 6 years of age
1 spray dose into each nostril up to 3 times daily.
Do not administer more than 3 doses into each nostril per day.
Do not use in infants and children under 6 years of age.
Do not exceed the recommended dose.
Sudafed Spray HA Comfort should not be used for longer than 7 days unless otherwise advised by a doctor. Repeated use may be resumed after a break of several days.
For information on the duration of treatment in children, consult a doctor.
For hygienic reasons, one package of the medicine should be used by only one patient.

Instructions for use
Remove the plastic cap.
Before first use, press the pump several times until a fine, uniform spray is produced (Fig. 1). This primes the spray for use.
To administer the nasal spray, insert the applicator tip into the nostril and press the pump once while inhaling through the nose (Fig. 2). The bottle should be held in an upright or near-upright position during administration. Replace the plastic cap after use.

Accidental overdose of Sudafed Spray HA Comfort
In case of overdose or accidental ingestion, the following symptoms may occur:
dilated pupils, nausea, vomiting, cyanosis (bluish discoloration of the skin and mucous membranes), fever, convulsions, tachycardia (increased heart rate), cardiac arrhythmias, circulatory collapse, cardiac arrest, arterial hypertension, pulmonary edema (fluid accumulation in the lungs, manifesting as breathlessness), respiratory disturbances, and psychiatric disturbances.
The following symptoms may also occur: central nervous system depression with drowsiness, decreased body temperature, bradycardia (slowed heart rate), drop in arterial blood pressure resembling shock, apnea, and coma.
Keep the medicine out of the reach of children.
In case of overdose, seek immediate medical help. The physician may take appropriate measures such as administering activated charcoal. In justified cases, gastric lavage and oxygen therapy may be necessary. To lower arterial blood pressure, the physician may administer phentolamine 5 mg in 0.9% sodium chloride solution as a slow intravenous infusion or 100 mg orally.
Vasoconstrictor agents are contraindicated.
If necessary, antipyretic and anticonvulsant medications should be used.

If you forget to use Sudafed Spray HA Comfort
Do not use a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The frequency of adverse effects is presented according to the following classification:
Commonly occurs in less than 1 in 10 patients
Uncommonly occurs in less than 1 in 100 patients
Rarely occurs in less than 1 in 1,000 patients

Irritation symptoms (such as burning or dryness of the nasal mucosa) and sneezing may commonly occur, especially in sensitive patients. After discontinuation of the medicine, rebound congestion (reactive hyperemia) of the nasal mucosa may occur.

Uncommonly, local nasal administration may cause:

• symptoms related to systemic effects of the medicine, such as palpitations, increased heart rate, elevated blood pressure,
• nosebleeds.

Nausea, visual disturbances, allergic reactions, headache, insomnia, or fatigue may occur rarely.
Prolonged or frequent use, as well as administration in doses higher than recommended, may lead to rebound congestion with medicamentosa rhinitis, characterized by nasal stuffiness, nasal discharge, nasal itching, and sneezing. This effect may occur as early as after 5 days of treatment and, if continued use persists, may lead to chronic atrophic rhinitis.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl

Adverse effects can also be reported to the Marketing Authorization Holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Sudafed Spray HA Comfort

Keep this medicine out of the sight and reach of children.
Store below 25°C.
The shelf life after first opening the bottle is 12 months. Do not use this medicine after
the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Sudafed Spray HA Comfort contains

• The active substance is xylometazoline hydrochloride. 1 ml of Sudafed Spray HA Comfort solution contains 1 mg of xylometazoline hydrochloride.
• Other ingredients: sodium hyaluronate, sorbitol, glycerol, disodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, water for injections.

What Sudafed Spray HA Comfort looks like and contents of the pack
The Sudafed Spray HA Comfort package consists of a white HDPE bottle with a metering pump (3K system), containing 10 ml of solution (minimum 55 doses), in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
McNeil Healthcare (Ireland) Limited
Office 5, 6 & 7, Block 5
High Street, Tallaght
Dublin 24, D24 YK8N
Ireland
Manufacturer:
Famar Health Care Services Madrid, S.A.U.
Avda. Leganés, 62
28923 Alcorcón-Madrid
Spain
For further information, please contact:
email: [email protected]