Tafen Nasal

Package Leaflet: Information for the Patient

Tafen Nasal, 50 µg/dose nasal spray, suspension

Budesonide

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Tafen Nasal and what is it used for

Tafen Nasal contains budesonide, a synthetic corticosteroid. Corticosteroids are a group of medicines that help prevent inflammation.
Tafen Nasal is used to treat:

• in adults and children over 6 years: symptoms of seasonal allergic rhinitis (e.g. hay fever); perennial allergic rhinitis (e.g. house dust allergy); nasal polyps (growth of nasal mucous membrane),
• in adults: symptoms of non-allergic rhinitis (e.g. caused by irritants in the air, infection, food and drinks).

2. Important information before using Tafen Nasal

When not to use Tafen Nasal

• if you are allergic (hypersensitive) to budesonide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Tafen Nasal, discuss with your doctor or pharmacist if:
you are a child and are taking the medicine in high doses for a long time, your doctor will regularly check your growth.
you have taken higher than recommended doses of the medicine, your doctor may recommend taking steroid tablets during periods of stress (e.g. during infection) or before surgery.
you have a fungal, bacterial or viral infection of the respiratory tract that requires appropriate treatment.
you have been diagnosed with tuberculosis (an infection that usually affects the lungs).
you have a nasal mucous membrane ulcer.
you have had nasal surgery or a nasal injury that has not fully healed.
you have severe liver disease.
before using Tafen Nasal, you have been taking oral corticosteroids due to increased risk of systemic side effects (such as Cushing's syndrome, cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataracts, glaucoma, excessive psychomotor activity, sleep disturbances, anxiety, depression, and aggression, especially in children).
See also section 4.
In patients with asthma, rapid reduction of oral corticosteroid doses may cause severe exacerbation of the disease.
The medicine will not provide immediate relief, as its effect may start after a few days.
You should use the medicine regularly.
if you experience eye symptoms that may require additional treatment.
if you use Tafen Nasal for a long time, your doctor will recommend examining the nasal mucous membrane once or twice a year.
If you experience blurred vision or other vision disturbances, you should contact your doctor.

Tafen Nasal and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.
Particularly, inform your doctor about taking:

• ketoconazoleor itraconazole(medicines used to treat fungal infections).

Some medicines may enhance the effect of Tafen Nasal and your doctor may want to monitor your condition closely while taking such medicines (including some HIV medicines: ritonavir, cobicistat).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Tafen Nasal can be used during pregnancy only on the advice of a doctor.
Tafen Nasal can be used during breastfeeding if your doctor thinks it is necessary.

Driving and using machines

Tafen Nasal does not affect the ability to drive or use machines.

Tafen Nasal contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, and propylene glycol

Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possible late reactions) and, exceptionally, bronchospasm.
The medicine contains 5 mg of propylene glycol in each dose, which corresponds to 1 g in 10 ml of suspension.

3. How to use Tafen Nasal

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

Dosage

The medicine is intended for adults and children over 6 years.
Usually, at the beginning of treatment, 2 sprays (50 μg each) are used in each nostril twice a day. After improvement, your doctor will recommend a maintenance dose, usually 1 spray in each nostril twice a day or 2 sprays in each nostril once a day, in the morning. As a maintenance dose, your doctor will recommend the smallest effective dose that controls the symptoms of the disease.
Tafen Nasal has an anti-inflammatory effect, so it is very important to use it regularly without interruption, even if you feel better.
It may take a few days or even up to 2 weeks for the medicine to start working. However, you should use it regularly, even if it does not provide immediate relief.
In the treatment of seasonal allergic rhinitis, you should start using Tafen Nasal before the allergens appear.
Your doctor will determine how long you need to use Tafen Nasal. The treatment may last up to 3 months.

How to use Tafen Nasal

Proper use of Tafen Nasal reduces side effects and improves its effectiveness.

• 1. Clean your nostrils carefully, if possible with a 0.9% sodium chloride solution.

• 2. Remove the cap from the bottle.

• 3. Shake the bottle.

• 4. If the bottle is used for the first time, release a few sprays into the air by pressing the actuator several times until a fine mist appears. If Tafen Nasal has not been used for several days, repeat this step. If the nozzle is clogged, carefully remove it and clean it (see: Cleaning procedure).
• 5. Tilt your head forward so that you can see your feet. With your right hand, insert the actuator into your left nostril and direct it towards the outer wall of your nose.

• 6. Press the actuator, release one spray into your nose, and take a deep breath through your nose.
• 7. With your left hand, insert the actuator into your right nostril and direct it towards the outer wall of your nose. Release one spray into your nose and take a deep breath through your nose.
• 8. After use, wipe the actuator with a clean handkerchief and put the cap back on. When not in use, the actuator should be covered with the cap. Store the bottle upright.

Cleaning procedure

The actuator and cap should be cleaned regularly. To do this, carefully remove them, wash them with warm and rinse with cold water, and dry them in the air. Carefully put the actuator back and cover it with the cap. If the actuator is clogged, soak it in warm water, then clean it as described above. Do not use a needle or any other sharp object.

Using a higher dose of Tafen Nasal than recommended

If you use more Tafen Nasal than recommended, return to the previous dosage. It is unlikely that occasional overdose will cause any medical problems. However, if you take high doses for a long time, you should consult your doctor immediately.

Missing a dose of Tafen Nasal

Take the missed dose as soon as possible, without changing the dosing schedule. Never take a double dose at the same time to make up for a missed dose.

Stopping treatment with Tafen Nasal

Do not stop using Tafen Nasal without your doctor's advice, even if you feel better. Your doctor will carefully explain how to gradually reduce the dose of the medicine to avoid withdrawal symptoms of corticosteroids.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe side effects that occur not very often(may occur less often than in 1 in 100 people):
swelling of the lips, face, throat
If you experience such a severe side effect, immediatelycontact your doctor. These may be symptoms of an allergic reaction.

Other possible side effects

Common side effects(may occur less often than in 1 in 10 people):
sneezing, dryness of the nasal mucous membrane or tingling in the nose
nasal discharge stained with blood
nasal bleeding (immediately after using the medicine)
cough
dry mouth
dry throat
Uncommon side effects(may occur less often than in 1 in 100 people):
hives (itchy rash)
rash
itching
skin rash with blisters
angioedema (skin swelling, sometimes mucous membrane swelling, without itching, mainly on the face)
muscle cramps
Rare side effects(may occur less often than in 1 in 1000 people):
systemic corticosteroid effects*
osteoporosis (in case of long-term treatment)
ulceration of the nasal mucous membrane (painful sores in the nose)
anaphylactic reaction (acute, generalized allergic reaction)
perforation (hole) of the nasal septum
voice disorders
injuries
blurred vision
Side effects with unknown frequency(frequency cannot be estimated from the available data):
glaucoma and cataracts (in case of long-term treatment)
* If you take high doses of the medicine for a long time, you may experience systemic effects, including adrenal suppression (causing symptoms such as weight loss, dehydration, weakness, disorientation, low blood pressure, nausea, diarrhea, vomiting), growth retardation in children and adolescents (reported after using intranasal corticosteroids in recommended doses), bone fragility, excessive production of adrenal cortex hormones (with symptoms such as weight gain, moon face, skin changes, weakness, central obesity - so-called cushingoid features). If you experience any of these symptoms, contact your doctor immediately.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tafen Nasal

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use Tafen Nasal after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month.
The batch number on the packaging is marked as "Lot".
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Tafen Nasal contains

• The active substance of the medicine is budesonide. Each dose contains 50 micrograms (μg) of budesonide.
• The other ingredients are: microcrystalline cellulose and sodium carboxymethylcellulose, disodium edetate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, polysorbate 80, simethicone emulsion, propylene glycol, sucrose, hydrochloric acid (to adjust pH) and purified water.

What Tafen Nasal looks like and contents of the pack

Tafen Nasal is a white, homogeneous suspension. The bottle in the carton contains 200 doses of 50 micrograms (μg) of budesonide.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
To obtain more detailed information, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00

Date of last revision of the leaflet:

{Logo Sandoz}