Diplorin

Patient Information Leaflet

Diplorin

137 micrograms/50 micrograms per spray
Nasal spray, suspension
Azelastine hydrochloride / fluticasone propionate
Please read this leaflet carefully before using this medicine because 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 pass it on to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Diplorin is and what it is used for

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

• Azelastine hydrochloride belongs to the pharmacotherapeutic class of antihistamines. Antihistamines work by blocking the effects of substances such as histamine, which the body produces during an allergic reaction, thereby reducing the symptoms of allergic rhinitis.
• Fluticasone propionate belongs to the pharmacotherapeutic class of corticosteroids, which reduce inflammation. Diplorin is used to relieve symptoms of moderate to severe seasonal or perennial allergic rhinitis when treatment with either an antihistamine alone or an intranasal corticosteroid alone is considered insufficient. Seasonal or perennial allergic rhinitis are allergic reactions to substances such as pollen (hay fever), house dust mites, moulds, dust, or pets. Diplorin relieves allergy symptoms such as excessive nasal mucus production, runny nose, sneezing, nasal itching, or nasal congestion.

2. What you need to know before using Diplorin

Do not use Diplorin:

• if you are allergic to azelastine hydrochloride or fluticasone propionate or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before using Diplorin:
• if you have recently had nasal surgery
• if you have had a nasal infection. Nasal airway infections should be treated with an antibacterial or antifungal medicine. If you have been prescribed a medicine for a nasal infection, you may continue using Diplorin for the treatment of your allergies
• if you suffer from tuberculosis or from an untreated infection
• if you have experienced vision problems or if you have a history of increased intraocular pressure, glaucoma and/or cataracts. If any of these conditions apply to you, you will be closely monitored during treatment with Diplorin
• if you suffer from impaired adrenal function. Extreme caution is required

when switching from systemic corticosteroid therapy to Diplorin

• if you have severe liver disease. Your risk of experiencing systemic undesirable effects is higher.

In these cases, your doctor will decide whether or not you can use Diplorin.
It is important that you take your dose as indicated in section 3 below or as advised by your doctor. Treatment with inhaled corticosteroid doses higher than recommended
may cause adrenal suppression, a condition that can lead to weight loss, fatigue,
muscle weakness, low blood sugar levels, craving for salty foods, joint pain, depression and darkening of the skin. If these symptoms occur,
your doctor may recommend an alternative medicine during periods of stress or prior to elective surgery.
To avoid adrenal suppression, your doctor will advise you to take the lowest dose capable of effectively controlling your rhinitis symptoms.
When taken for prolonged periods, inhaled corticosteroids (such as Diplorin) may cause
slowed growth in children and adolescents. Your doctor will regularly monitor your child's height and ensure they are taking the lowest effective dose possible.
Contact your doctor if blurred vision or other visual disturbances occur.
If you are unsure whether any of the above conditions apply to you, discuss this with your doctor or
pharmacist before using Diplorin.
Children
The use of this medicine is not recommended in children under 12 years of age.
Other medicines and Diplorin
Inform your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including medicines obtained without a prescription.
Some medicines may increase the effects of Diplorin and your doctor may wish to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat, and medicines for fungal infections: ketoconazole).
Do not use if you are taking sedatives or central nervous system depressants.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding,
please consult your doctor or pharmacist before taking Diplorin.
Driving and using machines
Diplorin has negligible influence on the ability to drive and use machinery.
Very rarely, fatigue or dizziness may occur, either due to the underlying disease or to the use of Diplorin. In such cases, avoid driving or operating machinery. You should be aware that alcohol consumption may worsen these effects.
Diplorin contains benzalkonium chloride
This medicine contains 14 micrograms of benzalkonium chloride per spray.
Benzalkonium chloride may cause irritation and swelling inside the nose,
especially if used for prolonged periods. Consult your doctor or pharmacist if you experience discomfort during use of the spray.

3. How to use Diplorin

Use Diplorin exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
It is essential to use Diplorin regularly to achieve full therapeutic benefit.
Avoid contact with the eyes.

Adults and adolescents (from 12 years of age)

• The recommended dose is one spray into each nostril in the morning and evening.

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 renal or hepatic impairment

• There are no data available in patients with renal or hepatic impairment.

Method of administration
For nasal inhalation use only.
Read the information provided in this leaflet and follow the instructions carefully.

INSTRUCTIONS FOR USE
Preparing the spray

1. Gently shake the bottle for 5 seconds, tilting it downwards and upwards, then remove the protective cap (see Figure 1).
   Figure 1

The first time you use the nasal spray, you must prime the pump by spraying the product into the air.

3. Prime the pump by placing two fingers on both sides of the spray pump and your thumb on the base of the bottle.
4. Press down and release the pump 6 times, until a fine mist appears (see Figure 2).
5. The pump is now primed and ready for use.
   Figure 2

If the nasal spray has not been used for more than 7 days, you must re-prime the pump by pressing and releasing it once.

Using the spray

1. Gently shake the bottle for about 5 seconds, tilting it downwards and upwards, then remove the protective cap (see Figure 1).
2. Blow your nose to clear the nostrils.
3. Keep your head tilted slightly forward (downward). Do not tilt your head backward.
4. Hold the bottle upright and gently insert the spray tip into one nostril.
5. Close the other nostril with a finger, press down quickly once, and at the same time inhale gently (see Figure 3).
6. Breathe out through your mouth.
   Figure 3

Repeat the same procedure for the other nostril.

8. Breathe in gently without tilting your head backward after administration. This will help prevent the medicine from running down your throat and causing an unpleasant taste (see Figure 4).

Figure 4

9. After each use, wipe the spray tip with a tissue or clean cloth and replace the protective cap.
10. Do not pierce the nozzle if no spray is produced. Clean the spray tip with water.
    It is important that you take your dose as prescribed by your doctor. Use only the amount recommended by your doctor.

Duration of treatment
Diplorin is indicated for long-term use. The duration of treatment should correspond to the period during which allergy symptoms occur.

If you use more Diplorin than you should
It is unlikely that you will experience any problems if you spray an excessive dose of this medicine into your nose. If you are concerned, or if you have used higher than recommended doses for a prolonged period, contact your doctor.
In case of accidental ingestion of Diplorin, especially by a child, contact your doctor or the nearest hospital emergency department immediately.

If you forget to use Diplorin
Use the nasal spray as soon as you remember, then take the next dose at your usual time. Do not use a double dose to make up for a forgotten dose.

If you stop using Diplorin
Do not stop using Diplorin without first consulting your doctor, as this may jeopardize the success of treatment.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Diplorin can cause side effects, although not everyone experiences them.

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

• Nosebleeds

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

• Headache
• Bitter taste in the mouth, especially if you tilt your head backwards when using the nasal spray. This should disappear quickly if you sip a non-alcoholic drink for a few minutes after using this medicine
• Unpleasant smell

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

• Mild irritation inside the nose. This may cause mild burning, itching or sneezing
• Dry nose, cough, dry throat or throat irritation

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

• Dryness of the mouth

Very rare side effects (may affect up to 1 in 10,000 people):

• Dizziness or drowsiness
• Cataract, glaucoma or increased intraocular pressure, leading to loss of vision and/or red, painful eyes. These side effects have been reported after prolonged treatment with fluticasone propionate nasal sprays.
• Skin damage and damage to the nasal mucous membrane
• Nausea, exhaustion, tiredness or weakness
• Skin rash, itching or redness of the skin, raised itchy welts
• Bronchospasm (narrowing of the airways in the lungs)

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• Blurred vision
• Nasal ulcers

Seek immediate medical help if you notice any of the following symptoms:

• Swelling of the face, lips, tongue or throat, which may cause difficulty in swallowing or breathing, and sudden onset of skin rash.
  These could be signs of a severe allergic reaction.
  Note: This occurrence is very rare.

Systemic side effects (side effects affecting the whole body) may occur when this medicine is used at high doses over a long period. It is much less likely that such effects will occur with a corticosteroid nasal spray than with oral corticosteroids. These effects may vary between individual patients and between different corticosteroid preparations (see section 2). Nasal corticosteroids may affect the body's normal hormone production, particularly if high doses are used for a prolonged period. In children and adolescents, this side effect may cause a slowing of growth. In rare cases, reduced bone density (osteoporosis) has been observed when inhaled corticosteroids have been administered over a long period.

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:
http://www.agenziafarmaco.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 Diplorin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the bottle and on the
carton, following "Exp.". The expiry date refers to the last day of that month.
Do not refrigerate or freeze.
Usable period after first opening: Discard any unused medicine 6 months after first
opening of the nasal spray.
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 Diplorin contains
The active substances are: azelastine hydrochloride and fluticasone propionate.
Each gram of suspension contains 1,000 micrograms of azelastine hydrochloride and 365
micrograms of fluticasone propionate.
Each spray (0.14 g) delivers 137 micrograms of azelastine hydrochloride (equivalent to 125
micrograms of azelastine) and 50 micrograms of fluticasone propionate.
The other components are: disodium edetate, glycerol (E422), microcrystalline cellulose, sodium carmellose,
polysorbate 80, benzalkonium chloride, phenylethyl alcohol, and purified water.
Description of the appearance of Diplorin and contents of the pack
Diplorin is a white, homogeneous suspension.
Diplorin is supplied in an amber glass bottle equipped with a spray pump, an applicator, and a protective cap.
The 25 ml bottle contains 23 g of nasal spray, suspension (providing at least 120 sprays).
Each pack contains 1 bottle with 23 g of nasal spray, suspension, or multiple packs comprising
3 bottles, each containing 23 g of nasal spray, suspension.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Drugs Minerals and Generics Italia S.r.l.
Via Laurentina Km. 26.700
00071 Pomezia (Roma)
Manufacturer
Teva Czech Industries s.r.o.
Ostravská 305/29, 747 70 Opava-Komárov,
Czech Republic
This medicinal product is authorized in the Member States of the European Economic Area
under the following names:
Diplorin