Solafid

Package leaflet: Information for the user

Solafid
(137 micrograms + 50 micrograms)/dose nasal spray
nasal spray, suspension
Azelastini hydrochloridum + Fluticasoni propionas
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for possible future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Solafid is and what it is used for

Solafid contains two active substances: azelastine hydrochloride and fluticasone propionate.

• Azelastine hydrochloride belongs to a group of medicines called antihistamines. Antihistamines work by preventing the action of substances such as histamine, which the body produces as part of an allergic reaction, thereby reducing the symptoms of allergic rhinitis.
• Fluticasone propionate belongs to a group of medicines called corticosteroids, which reduce inflammation.

Solafid is used to relieve symptoms of moderate to severe seasonal and perennial allergic rhinitis when treatment with other intranasal medicinal products containing either an antihistamine or a corticosteroid alone is considered insufficient.
Seasonal and perennial allergic rhinitis is a type of allergic reaction to substances such as: pollen (hay fever), house dust mites, mould spores, dust, or animal dander.
Solafid relieves allergy symptoms such as nasal discharge, postnasal drip, sneezing, itching, and nasal congestion.

2. Important information before using Solafid

When not to use Solafid

• If the patient is allergic to azelastine hydrochloride or fluticasone propionate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Solafid, discuss this with your doctor or pharmacist:

• If the patient has recently undergone nasal surgery.
• If the patient has a nasal infection. Infections of the nasal passages should be treated with antibacterial or antifungal medications. Patients who have been treated for nasal infection may continue allergy treatment with Solafid.
• If the patient has tuberculosis or untreated infection.
• If the patient has experienced changes in vision or has previously been diagnosed with increased intraocular pressure, glaucoma, and/or cataracts. Such patients will be closely monitored during treatment with Solafid.
• If the patient has adrenal gland disorders. Caution should be exercised when switching from systemic steroid therapy to treatment with Solafid.
• If the patient has severe liver disease. In this case, the risk of systemic adverse effects increases.

In these cases, the decision on whether Solafid can be used will be made by the treating physician.
It is important that the patient uses the medicine at the dose indicated below in section 3 or as directed by the treating physician. Intranasal corticosteroids used in doses higher than recommended may suppress adrenal function, a condition in which weight loss, fatigue, muscle weakness, low blood sugar, increased salt craving, joint pain, depression, and darkening of the skin may occur. In such cases, the doctor may recommend taking another medicine during periods of stress or before planned surgical procedures.
To avoid adrenal suppression, the doctor may recommend using the lowest dose of Solafid that still effectively controls symptoms of nasal mucosal inflammation.
If the patient experiences blurred vision or other visual disturbances, medical advice should be sought.
If in doubt whether any of the above conditions apply, consult a doctor or pharmacist before starting treatment with Solafid.

Children and adolescents
This medicine is not recommended for children under 12 years of age.
Long-term intranasal corticosteroid use (such as Solafid) in children and adolescents may suppress growth rate. The doctor will regularly monitor the child's growth and ensure that the lowest effective dose is used.

Solafid with other medicines
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, including over-the-counter medicines.
Some medicines may increase the effect of Solafid, and the doctor may recommend careful monitoring if the patient is taking such medicines (including certain HIV medications: ritonavir, cobicistat, and antifungal agents such as ketoconazole). Solafid should not be used if the patient is taking sedatives or medicines acting on the central nervous system.

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

Driving and operating machinery
Solafid has a minor influence on the ability to drive and operate machinery.
Very rarely, fatigue and dizziness may occur, which may be caused by the disease itself or by the use of Solafid. In such cases, driving and operating machinery should be avoided. Be aware that alcohol consumption may worsen these effects.

Solafid contains benzalkonium chloride
This medicine contains 14 micrograms of benzalkonium chloride per spray. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a prolonged period.

3. How to use Solafid

This medicine should always be used exactly as directed by the doctor. In case of doubt, consult
your doctor or pharmacist.
For the treatment to be most effective, Solafid must be used regularly.
Avoid contact with the eyes.

Use in adults and adolescents (aged 12 years and older)
One dose into each nostril in the morning and evening is recommended.

Use in children under 12 years of age
This medicine is not recommended for use in children under 12 years of age.

Use in patients with impaired kidney or liver function
There is no data available on the use of this medicine in patients with impaired kidney or liver function.

Method of administration
For nasal use only.
Please read the following instructions carefully and use the medicine strictly as directed.

INSTRUCTIONS FOR USE

Preparing the aerosol

1. Gently shake the bottle up and down for 5 seconds, then remove the protective cap.
2. If the nasal spray is used for the first time, prime the pump by releasing a dose into the air.
3. Prime the pump by placing two fingers on either side of the pump and the thumb on the bottom of the bottle.
4. Press and release the pump 6 times until a fine mist is produced (see figure a).

a

5. The pump is now primed and ready for use.
6. If the nasal spray has not been used for more than 7 days, re-prime the pump by pressing and releasing it once.

Using the aerosol

1. Gently shake the bottle up and down for 5 seconds, then remove the protective cap.
2. Blow your nose to clear the nostrils.
3. Keep your head tilted forward toward your toes. Do not tilt your head backward.
4. Hold the bottle vertically and gently insert the nozzle into one nostril.
5. Close the other nostril with a finger, press the pump quickly once, and at the same time inhale gently (see figure b).

b

6. Breathe out through the mouth.
7. Repeat the same procedure for the other nostril.
8. After administering the medicine, take gentle breaths and do not tilt your head backward. This helps prevent the medicine from running down the throat and causing an unpleasant taste.
9. After each use, wipe the nozzle with a clean tissue or cloth and replace the protective cap.
10. If the nozzle becomes blocked, do not pierce it or use a sharp object to unblock it. Clean the nozzle with water.

It is important to use the dose prescribed by your doctor. Always follow the dosage instructions
given by your doctor.

Duration of treatment
Solafid may be used long-term. The duration of treatment should correspond to the period during
which allergy symptoms occur.

Use of more than the recommended dose of Solafid
If too much nasal spray is used, the risk of adverse effects is low. However, if you are concerned or
if a higher than recommended dose has been used for a prolonged period, consult your doctor. If
anyone, especially a child, accidentally swallows Solafid, contact a doctor or the nearest hospital
emergency department immediately.

Missed dose of Solafid
Use the nasal spray as soon as you remember, then continue with the next dose at the usual time.
Do not use a double dose to make up for a missed dose.

Stopping Solafid
Do not stop using Solafid without consulting your doctor, due to the risk of ineffective treatment.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Very common adverse effects (may affect more than 1 in 10 people):

• Nasal bleeding

Common adverse effects (may affect fewer than 1 in 10 people):

• Headache
• Bitter taste in the mouth, especially if the patient tilts their head backwards while administering the nasal spray. This taste should disappear if the patient drinks a non-alcoholic beverage a few minutes after using the medicine
• Unpleasant odour

Uncommon adverse effects (may affect fewer than 1 in 100 people):

• Mild irritation inside the nose. This may cause mild stinging, itching or sneezing
• Dryness in the nose, cough, dry throat or sore throat

Rare adverse effects (may affect fewer than 1 in 1,000 people):

• Dryness in the mouth

Very rare adverse effects (may affect fewer than 1 in 10,000 people):

• Dizziness or drowsiness
• Cataract, glaucoma or increased eye pressure, which may lead to loss of vision and (or) redness and eye pain. These adverse effects have been reported after long-term use of nasal spray containing fluticasone propionate
• Skin and nasal mucosa damage
• Malaise, feeling of fatigue, exhaustion or weakness
• Rash, itching or redness of the skin, itchy blisters on the skin
• Bronchospasm (narrowing of the lower airways)

Seek immediate medical help if any of the following symptoms occur:

• Swelling of the face, lips, tongue or throat, which may cause difficulty in swallowing and (or) breathing, and sudden onset of skin rash. These may be symptoms of a severe allergic reaction. Note: these symptoms are very rare.

Adverse effects with unknown frequency (frequency cannot be determined from available data):

• Blurred vision
• Nasal mucosal ulceration

When the medicine is used in high doses over a long period of time, systemic adverse effects (affecting the whole body) may occur. The likelihood of such effects is much lower with corticosteroids administered as a nasal spray than with oral corticosteroid treatment. These effects may vary between individual patients and depending on the corticosteroid medicine used (see section 2). Intranasal corticosteroids may affect normal hormone production processes in the body, especially when used long-term at high doses. In children and adolescents, these adverse effects may lead to slowed growth rate. In rare cases, reduced bone density (osteoporosis) has been observed following prolonged intranasal administration of corticosteroids.

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Solafid

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the bottle and outer carton
following: Expiry (EXP). The expiry date refers to the last day of the specified month.
Do not store in the refrigerator or freeze.
Duration of use after first opening: Unused medicine should be discarded 6 months after
first opening of the nasal aerosol.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures help protect the
environment.

6. Contents of the package and other information

What Solafid contains

• The active substances are: azelastine hydrochloride and fluticasone propionate. Each gram of suspension contains 1000 micrograms of azelastine hydrochloride and 365 micrograms of fluticasone propionate.

Each spray actuation (0.14 g) delivers 137 micrograms of azelastine hydrochloride (= 125 micrograms of azelastine) and 50 micrograms of fluticasone propionate.

• Other ingredients are: disodium edetate, glycerol, microcrystalline cellulose, sodium croscarmellose, polysorbate 80, benzalkonium chloride, phenylethyl alcohol, and purified water.

What Solafid looks like and contents of the pack
Solafid is a white or almost white, homogeneous suspension.
Solafid is available in a 25 mL amber glass bottle with a spray pump, applicator, and protective cap, packed in a cardboard box.
The 25 mL bottle contains 23 g of nasal suspension (providing at least 120 doses).
Solafid is available in:
packs containing 1 bottle with 23 g of nasal suspension.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SUBSTIPHARM
24 rue Erlanger
75016 Paris
France

Manufacturers
FARMEA
10, rue Bouché Thomas
ZAC d’Orgemont
49007 Angers
France
FARMACLAIR
440 Avenue Du Général De Gaulle
14200 Hérouville-Saint-Clair
France

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: Solafid
Sweden: Solafid