Rineffix

Package leaflet: Information for the patient

Rineffix

25 micrograms/dose + 600 micrograms/dose
Nasal spray, suspension
mometasone furoate/olopatadine
Please read this entire leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this package leaflet:

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

1. What Rineffix is and what it is used for

Rineffix contains two active substances: mometasone furoate and olopatadine.

• Mometasone furoate belongs to a group of medicines called corticosteroids (steroids) that reduce inflammation, commonly present in allergic rhinitis.
• Olopatadine belongs to a group of medicines called antihistamines. Antihistamines work by preventing the effects of substances such as histamine, which the body produces during an allergic reaction, thereby reducing the symptoms of allergic rhinitis.

Rineffix is used for the treatment of moderate to severe symptoms of seasonal allergic rhinitis (also known as
hay fever) and perennial rhinitis in adults and adolescents aged 12 years and older.
Seasonal allergic rhinitis (hay fever) is an allergic reaction occurring at certain times of the year, caused by inhaling pollen from trees, grass, weeds, as well as moulds and fungal spores.
Perennial rhinitis occurs throughout the year and symptoms may be triggered by sensitivity to various factors, including house dust mites, animal fur (or epidermal derivatives), feathers, and certain foods.
Rineffix relieves allergy symptoms such as runny nose, sneezing, itching, and nasal congestion.

2. What you need to know before using Rineffix

Do not use Rineffix

• if you are allergic to mometasone furoate, olopatadine, or any of the other ingredients of this medicine (listed in section 6).
• if you have an untreated nasal infection. Using Rineffix during an untreated nasal infection, such as herpes, may worsen the infection. You must wait until the infection has resolved before starting to use the nasal spray.
• if you have recently had nasal surgery or have injured your nose. You should not use the nasal spray until the nasal condition has healed.

Warnings and precautions
Talk to your doctor or pharmacist before using Rineffix

• if you have or have had tuberculosis
• if you have any other infection
• if you are taking other steroid medicines, either orally or by injection.

Talk to your doctor or pharmacist while using Rineffix

• if you have difficulty fighting infections (due to immune system problems) and are exposed to someone with measles or chickenpox. Avoid contact with anyone who has these infections.
• if you develop a nasal or throat infection
• if you have been using this medicine for several months or longer
• if you have persistent irritation of the nose or throat
• if you experience blurred vision or other visual disturbances.

Using steroid nasal sprays at high doses for prolonged periods may lead to unwanted effects due to absorption of the medicine into the body. These unwanted effects may include weight loss, fatigue, muscle weakness, hypoglycemia, craving for salty foods, joint pain, depression, and skin hyperpigmentation. If you experience these symptoms, your doctor may recommend an alternative medicine during periods of stress or before elective surgery.
If you are unsure whether any of the above conditions apply to you, consult your doctor or pharmacist before using Rineffix.
Children and adolescents
Rineffix is not recommended for children under 12 years of age.
Long-term use of Rineffix may cause delayed growth in children and adolescents. Your doctor will regularly monitor your child’s height and ensure they are receiving the lowest effective dose.
Other medicines and Rineffix
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are taking other steroid medicines for allergies, by mouth or by injection, your doctor may advise you to stop them when you start using Rineffix.
If you are taking other oral or topical medicines (nasal or eye drops) containing olopatadine or other antihistamines, your doctor may advise you to stop them when you start using Rineffix.
Some medicines may increase the effects of Rineffix, so your doctor may wish to monitor you closely if you are taking them (including certain HIV treatments: ritonavir, cobicistat).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.
Rineffix should not be used during pregnancy unless your doctor considers it appropriate. If you take Rineffix, your doctor will advise you whether you can breastfeed, weighing the benefit of your treatment against the benefit of breastfeeding for your baby. Do not do both simultaneously.
Driving and using machines
Dizziness, lethargy, fatigue, and drowsiness may very rarely occur. Do not drive or operate machinery if you experience these symptoms. Be aware that alcohol may worsen these effects.
Rineffix contains benzalkonium chloride
This medicine contains 0.02 mg of benzalkonium chloride per spray. Benzalkonium chloride may cause irritation or swelling inside the nose, especially with prolonged use.

3. How to use Rineffix

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Avoid contact with the eyes.
Adults and adolescents (aged 12 years and older)
The recommended dose is two sprays into each nostril in the morning and evening.
Use in children under 12 years of age
This medicine is not recommended for children under 12 years of age.
Method of administration
The spray is for nasal use only.
Read the following instructions carefully and use this medicine only as directed.
Shake the bottle for at least 10 seconds before each use.
When Rineffix is not in use, the purple dust cap must always be kept on
the white nozzle of the spray pump.
The Rineffix nasal spray bottle

Preparing the nasal spray bottle

1. Shake the bottle for at least 10 seconds, then remove the purple dust cap (see figure 1).

2. If you are using the spray for the first time, you must “prime” the bottle by actuating the pump into the air.
3. Hold the nasal spray bottle firmly upright, with your index and middle fingers on either side of the spray applicator (on the finger grip), supporting the base of the bottle with your thumb.
4. Point the spray nozzle away from you, then press and release the pump 6 times until a fine mist is produced (see figure 2).
5. The spray pump is now primed and ready for use.
6. If the spray has not been used for 14 days or more, shake the bottle well and re-prime by actuating the pump 2 times or until a fine mist is produced.

How to use the nasal spray

1. Shake the bottle for at least 10 seconds before each use (morning and evening).
2. Gently blow your nose to clear your nostrils.
3. Hold the bottle firmly, with your index and middle fingers on either side of the spray applicator (on the finger grip), supporting the base of the bottle with your thumb.
4. Close one nostril with your finger and gently insert the spray nozzle into the other, directing it slightly towards the outer wall of the nose (see figure 3).
5. Tilt your head slightly forward. Press the pump once quickly and firmly on the finger grip to activate the spray.
6. Breathe in gently through your nose while spraying. Then breathe out through your mouth (see figure 4).
7. Repeat the above steps and spray a second time into the same nostril.
8. Repeat the procedure, administering 2 sprays into the other nostril.

9. To prevent blockage, clean the spray nozzle carefully after each use with a tissue or a clean, dry cloth (see figure 5).
10. Replace the spray nozzle and put the purple dust cap back on, pressing it onto the nozzle until you hear a click (see figure 6).

How to clean the nasal spray
If the spray nozzle becomes blocked, follow the instructions below:

• Remove the spray nozzle by gently pulling it upwards (see figure 7). Remove the purple dust cap and soak only the spray nozzle in warm water.
• Do not try to unblock the nasal applicator by inserting a needle or any other sharp object,
  as this may damage the applicator and prevent the correct dose of medicine from being delivered.
• After soaking the spray nozzle in warm water for 15 minutes, rinse the spray nozzle and the purple dust cap with warm water, then allow them to dry completely.
• Replace the purple dust cap onto the spray nozzle and reattach it to the bottle.
• After following the steps to unblock the spray nozzle, refer to the section “Preparing the nasal spray bottle” above and re-prime the pump with two sprays. Replace the purple dust cap. Rineffix is now ready for use.
• Repeat the unblocking steps if necessary.

If you use more Rineffix than you should
Problems are unlikely, but if you are concerned or if you have used a higher dose than recommended for a prolonged period, inform your doctor.
If you use steroids for a long time or at high doses, they may rarely affect certain hormones. In children, this may affect growth and development.
If you forget to use Rineffix
Use the nasal spray as soon as you remember, then take the next dose at your usual scheduled time. Do not use a double dose to make up for a missed dose.
If you stop using Rineffix
It is very important that you use the nasal spray regularly. Do not stop treatment, even if you feel better, unless your doctor tells you to.
If you have any questions 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 everyone experiences them.
Immediate hypersensitivity (allergic) reactions may occur with the use of this medicine.
These reactions can be severe. You must stop using Rineffix and seek immediate medical attention if any of the following symptoms occur: swelling of the face, tongue or throat, difficulty swallowing, hives, wheezing or breathing difficulties.

Common (may affect up to 1 in 10 people):

• Bitter taste in the mouth
• Nosebleeds
• Mild irritation inside the nose

Uncommon (may affect up to 1 in 100 people):

• Dizziness
• Headache
• Drowsiness
• Dry nose
• Dry mouth
• Abdominal pain
• Nausea
• Fatigue

Rare (may affect up to 1 in 1,000 people):

• Bacterial vaginosis (bacterial infection of the vagina)
• Anxiety, depression, insomnia
• Lethargy, migraine
• Dry eyes, blurred vision, eye discomfort
• Ear pain
• Sore throat
• Sneezing
• Throat irritation
• Tongue pain
• Constipation
• Swelling and ulcers inside the nose

Not known (frequency cannot be estimated from the available data):

• Increased intraocular pressure (glaucoma) and/or cataracts causing visual disturbances
• Damage to the nasal septum separating the nostrils
• Breathing difficulties and/or wheezing
• Respiratory tract infection

Systemic side effects (side effects affecting the whole body) may occur when this medicine is used at high doses over long periods of time. It is much less likely that such effects will occur with a nasal steroid spray than with oral steroid treatment. These effects may vary between individual patients.
Nasal steroids may affect the normal production of hormones in your body, particularly if high doses are used over a long period. In children and adolescents, this side effect may cause growth retardation.

Reporting of side effects
If you experience any side effect, 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rineffix

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton after "Exp".
The expiry date refers to the last day of that month.
Do not freeze.
The bottle should be used within 2 months of first opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rineffix contains

• The active substances are: mometasone furoate (as monohydrate) and olopatadine (as hydrochloride). Each actuation (dose released from the pump) contains mometasone furoate monohydrate equivalent to 25 micrograms of mometasone furoate and olopatadine hydrochloride equivalent to 600 micrograms of olopatadine.
• The other components are: microcrystalline cellulose (E460), sodium carmellose (E 466), dibasic sodium phosphate heptahydrate (E 339), sodium chloride, benzalkonium chloride, disodium edetate, polysorbate 80 (E 433), hydrochloric acid (E 507), sodium hydroxide (E 524) and water for injections.

Description of the appearance of Rineffix and contents of the pack
Rineffix is a homogeneous white suspension.
Rineffix is contained in a white high-density polyethylene bottle fitted with a metered-dose spray pump made of polypropylene. The spray pump is protected by a purple HDPE cap.
Pack sizes:
1 bottle of 20 ml containing 56 actuations,
1 bottle of 20 ml containing 120 actuations,
1 bottle of 30 ml containing 240 actuations.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Glenmark Arzneimittel GmbH
Industriestr. 31
82194 Gröbenzell
Germany
Manufacturer:
Glenmark Pharmaceuticals s.r.o.
Fibichova 143, 566 17 Vysoke Myto
Czech Republic
This medicinal product is authorised in the EEA Member States under the following names:
Sweden: Mometasone furoate/Olopatadine Glenmark 25 micrograms/actuation and 600 micrograms/actuation Nasal Spray, suspension.
Italy: RINEFFIX