Tafen nasal 32 mcg

Package leaflet: Information for the patient

Tafen Nasal 32 mcg
32 micrograms per measured dose, nasal spray, suspension
Budesonidum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

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

Contents of the leaflet

1. What Tafen Nasal 32 mcg is and what it is used for
2. Important information before using Tafen Nasal 32 mcg
3. How to use Tafen Nasal 32 mcg
4. Possible side effects
5. How to store Tafen Nasal 32 mcg
6. Contents of the pack and other information

1. What Tafen Nasal 32 mcg is and what it is used for

Tafen Nasal 32 mcg contains budesonide, a synthetic corticosteroid. Corticosteroids are a group of medicines that help reduce inflammation.
Tafen Nasal 32 mcg is used for:

• treatment and prevention of allergy symptoms such as hay fever (caused, for example, by grass pollen) and symptoms of perennial allergic rhinitis (chronic inflammation of the nasal mucosa) caused, for example, by house dust mites, in adults and children over 6 years of age;
• treatment of symptoms of nasal polyps (small growths on the nasal mucosa) in adults.

2. Important information before using Tafen Nasal 32 mcg

When not to use Tafen Nasal 32 mcg

• if the patient is allergic to budesonide or to any of the other ingredients of this medicine (listed in section 6).
• if the patient has blood clotting disorders or nosebleeds.
• if the patient has herpes-related blisters around the mouth, nose, or eyes.

Warnings and precautions
Before starting treatment with Tafen Nasal 32 mcg, discuss with a doctor or pharmacist if:

• the patient is taking other corticosteroid medicines, such as tablets, injections, or inhaled corticosteroids; do not stop taking these medicines abruptly.
• the medicine is used continuously for a long time; the doctor should examine the nasal mucosa at least once every 6 months.
• the medicine has been used in doses higher than recommended; the doctor may prescribe steroid tablets for periods of stress (such as infection) or before surgery.
• the patient has ulcers of the nasal mucosa; use of Tafen Nasal 32 mcg is not recommended.
• the patient develops infectious blisters (herpes) around the lips, nose, or eyes.
• if symptoms of infection occur, such as persistent fever.
• if the patient has diabetes, corticosteroids may increase blood sugar levels.
• nosebleeds are present; use of Tafen Nasal 32 mcg is not recommended.
• the patient has recently undergone nasal surgery or nasal injury and complete healing has not yet occurred; use of Tafen Nasal 32 mcg is not recommended.
• the patient has bacterial, viral, or fungal infections of the nose; Tafen Nasal 32 mcg may be used only if additional medicines for treating these infections are prescribed.
• if the patient has been in contact with someone who has tuberculosis, measles, or chickenpox.
• the patient has liver function disorders, as budesonide levels in the body may increase; the doctor may recommend liver function tests and may reduce the dose depending on the results.
• the patient has adrenal gland disorders and the doctor has changed their medication from another form to a nasal spray.
• the doctor has diagnosed the patient with respiratory tract infections or pulmonary tuberculosis—these are infections affecting lung function.
• in rare cases, locally administered corticosteroids may cause systemic adverse effects. These usually depend on dose, duration of treatment, concomitant or prior use of corticosteroids, and individual factors. Nasally administered corticosteroids may cause the following adverse effects: Cushing's syndrome, cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataracts, and increased intraocular pressure (glaucoma). Psychiatric symptoms and behavioral changes, such as psychomotor hyperactivity, sleep disturbances, anxiety, depression, or aggression (especially in children), occur less frequently.

If the patient experiences blurred vision or any other visual disturbances, or if any symptoms occur, persist, or worsen during treatment with this medicine, contact a doctor immediately.
For the medicine to be effective, the nostrils must be clear. Therefore, blow the nose before each dose.
The effect on symptoms may only become apparent after several days of treatment.
If nasal congestion (blocked nose) persists despite starting treatment, consult a doctor for re-evaluation of therapy.
Athletes should exercise caution, as this medicine contains an active ingredient that may lead to a positive result in anti-doping tests.

Children and adolescents
The long-term effects of locally administered corticosteroids in children are not fully known.
If a child is receiving high doses of this medicine for a prolonged period, the doctor will regularly monitor their growth.

Tafen Nasal 32 mcg and other medicines
This medicine may affect the action of other medicines or be affected by them.
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including those available without a prescription.
Ensure that the doctor is informed about the use of:
medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, or voriconazole),
cyclosporine, an immunosuppressive medicine used, for example, in connection with organ transplants,
ethinylestradiol, a medicine used for contraception,
antibacterial medicines (such as erythromycin, clarithromycin, telithromycin, ciprofloxacin, levofloxacin, troleandomycin, and others),
boceprevir (a medicine used to treat hepatitis C, a liver disease caused by infection with hepatitis C virus),
non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. containing acetylsalicylic acid), used to reduce pain, fever, and inflammation,
heparin and oral anticoagulants (medicines preventing blood clots),
antiepileptic medicines used to treat epilepsy (such as carbamazepine, phenobarbital, phenytoin, sodium valproate),
cobimetinib (a medicine used to treat certain types of skin and mucosal cancers called melanomas),
medicines affecting liver metabolism, known as enzyme inducers (such as St. John's wort),
medicines containing activated charcoal, used to relieve stomach discomfort, gastroesophageal reflux, or to reduce intestinal gas.

Some medicines may enhance the effect of Tafen Nasal 32 mcg, and the doctor may wish to closely monitor the patient taking such medicines (including certain HIV medicines: saquinavir, atazanavir, indinavir, nelfinavir, ritonavir, cobicistat).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not use Tafen Nasal 32 mcg during pregnancy unless specifically advised by a doctor.
If the patient becomes pregnant while using this medicine, she should consult her doctor.
Budesonide passes into breast milk, but at normally used doses, it should not affect the infant. Mothers who are breastfeeding may use Tafen Nasal 32 mcg, but only if, in the doctor's opinion, the benefits to the mother outweigh the risks to the breastfed infant. If a woman is breastfeeding, she should inform her doctor immediately.
Prolonged treatment during breastfeeding is not recommended.

Driving and operating machinery
Tafen Nasal 32 mcg may cause blurred vision. If this occurs, the patient should not drive or operate machinery.

Tafen Nasal 32 mcg contains potassium sorbate
Tafen Nasal 32 mcg contains potassium sorbate, which may cause skin or mucous membrane irritation (e.g. contact dermatitis).

3. How to use Tafen Nasal 32 mcg

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Tafen Nasal 32 mcg is intended for intranasal administration , according to the instructions for use
described below.
Dosage
The dose should be adjusted to the individual needs of the patient. The lowest effective dose that
controls symptoms should be used.
Allergic rhinitis
Initial dose
Adults, adolescents (aged 12 years and older), and children above 6 years of age:
The recommended initial dose is 8 sprays of 32 micrograms per spray of Tafen Nasal 32 mcg aerosol (256 micrograms) per day .
The medicine can be used:
once daily – 4 sprays into each nostril in the morning
or
twice daily – 2 sprays into each nostril in the morning and 2 sprays into each nostril in the evening.
Children should be supervised by an adult during treatment.
If treatment in children lasts longer than 2 months within one year, consultation with a pediatrician is required.
It is best to start treatment up to 14 days before the expected onset of symptoms.
For example, if a patient suffers from hay fever, treatment should begin approximately 2 weeks before the usual pollen season starts and should be discontinued after the pollen season ends.
Maintenance dose
The therapeutic effect of the medicine occurs after 7 to 14 days. After this period, the doctor may reduce the dose.
Nasal polyps
Adults:
The recommended initial dose is 8 sprays of 32 micrograms per spray of Tafen Nasal 32 mcg aerosol (256 micrograms) per day .
The medicine can be used:
once daily – 4 sprays into each nostril in the morning
or
twice daily – 2 sprays into each nostril in the morning and 2 sprays into each nostril in the evening.
Once the effect is achieved, the lowest dose that controls symptoms should be used.
Using more than 8 recommended sprays of Tafen Nasal 32 mcg will not increase the effectiveness of the medicine.
Duration of treatment
Your doctor will inform you how long treatment with Tafen Nasal 32 mcg should last. The medicine must be used regularly; otherwise, it will not be effective. Do not stop treatment without medical advice, even if you feel better.
If no immediate improvement is noticed, continue using the medicine regularly, as the onset of therapeutic effect may take several days.
Instructions for use

1. If necessary, gently blow your nose to clear the nasal passages.
2. Shake the bottle. Remove the protective cap (Fig. 1).

Fig. 1

3. Hold the bottle as shown in Fig. 2. Before first use of Tafen Nasal 32 mcg, the pump must be primed (i.e. filled with medicine). Press the pump several times (5–10 times) to spray the medicine into the air until a fine mist appears. Priming is sufficient for approximately 24 hours. If more than 24 hours elapse before the next dose, the pump must be re-primed. If the interval between uses of Tafen Nasal 32 mcg is shorter, simply spray once into the air.

Fig. 2

4. Insert the applicator tip into one nostril as shown in Fig. 3 and spray once (or more times, if directed by your doctor). Repeat the same procedure for the other nostril. Note: Inhalation is not required during spraying.

Fig. 3

5. Wipe the applicator with a clean tissue and replace the protective cap.
6. Store the bottle in an upright position.

Cleaning the applicator
The plastic applicator should be cleaned regularly and whenever the medicine does not spray properly.
First, check whether the pump is primed (see above). If the pump still does not work after re-priming, clean the applicator as follows:

• Remove the plastic applicator using a clean tissue and wash it with warm (not hot) water.
• Rinse thoroughly, dry completely, and reattach to the bottle.
• Never use a pin or any sharp object to unblock the applicator.
• After cleaning, the pump must be re-primed (i.e. refilled with medicine) before reuse.

Use of a higher than recommended dose of Tafen Nasal 32 mcg
It is important that the patient uses the medicine exactly as prescribed by the doctor. Use only the amount prescribed. Using a higher or lower dose than recommended may worsen symptoms.
If a higher dose of Tafen Nasal 32 mcg has been used by mistake, continue treatment according to the usual dosing schedule. No health problems are expected.
However, if a dose exceeding 8 sprays of Tafen Nasal 32 mcg per day has been used for more than one month, contact your doctor immediately.
Missed dose of Tafen Nasal 32 mcg
If a dose is missed at the usual time, take it as soon as possible, then return to the regular dosing schedule. Do not use a larger dose than recommended to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The medicine generally only treats symptoms affecting the nose (e.g. nasal congestion or nasal discharge).
If the patient previously received steroids in tablet form or steroids administered by injection, but the doctor has now prescribed Tafen Nasal 32 μg instead, worsening of certain other symptoms may be expected (such as redness and itching of the eyes). In such cases, the doctor will treat these symptoms separately.
Allergic reactions have been reported after using this medicine: urticaria, itching, skin rash, angioedema manifesting as swelling of the face, lips, tongue and (or) throat, accompanied by difficulty breathing and swallowing, and a general feeling of discomfort.
If these symptoms occur after administration of Tafen Nasal 32 μg, treatment with Tafen Nasal 32 μg should be discontinued immediately and medical advice must be sought without delay.
The following adverse reactions may occur during treatment with Tafen Nasal 32 μg:
Common adverse reactions (may affect fewer than 1 in 10 people)
These reactions may occur immediately after administration of the medicine:
occasional sneezing, dryness or stinging sensation in the nose
small amount of bloody nasal discharge
nosebleeds (immediately after administration)
pain in the mouth and (or) throat
Uncommon adverse reactions (may affect fewer than 1 in 100 people)
skin redness
skin irritation
muscle spasms
Rare adverse reactions (may affect fewer than 1 in 1000 people)
anaphylactic reaction
bone fragility (after long-term use of the medicine)
bruising or contusions
increased intraocular pressure
blurred vision
sores or painful erosions in the nasal cavity
perforation of the nasal septum (the partition separating the nostrils)
voice disorders
slowed growth rate in children and adolescents, especially after prolonged use of high doses
adrenal suppression. This may cause loss of appetite, abdominal pain, weight loss, nausea, headache, vomiting, altered consciousness, low blood sugar levels, and seizures. Situations that may potentially trigger an adrenal crisis include: trauma, infections, surgical procedures, or sudden dose reduction.
If any of these symptoms occur, seek immediate medical advice.
Unknown frequency (cannot be estimated from available data):
glaucoma (eye pain, redness of the eye, blurred vision)
cataract (clouding of the eye lens)
headache
nasal, oral and pharyngeal candidiasis (difficulty eating and (or) swallowing, thrush (white patches in the mouth, throat or on the tongue))
Candidiasis:
With prolonged treatment, nasal candidiasis (fungal infection) may occasionally occur. Medical advice should be sought to discuss appropriate treatment. In such cases, discontinuation of treatment until resolution of the infection is recommended.
Systemic effects:
Intranasal corticosteroids, when used in high doses and for prolonged periods, may have systemic effects. The following symptoms may occur:

• hypercortisolism (manifesting as weight gain, moon face, fatigue and (or) increased abdominal girth)

The excipient in this medicine, potassium sorbate, may cause local irritation of the skin or mucous membranes, e.g. nasal mucosa.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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,
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tafen Nasal 32 mcg

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following EXP.
The expiry date refers to the last day of the stated month.
Do not store above 30 °C.
Do not freeze.
After 3 months of opening, the bottle containing the remaining suspension should be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Tafen Nasal 32 μg contains
The active substance is budesonide. One metered dose of 0.05 ml nasal aerosol suspension contains 32 micrograms (μg) of budesonide.
The other ingredients are: dispersible cellulose (microcrystalline cellulose and sodium carmellose (89:11 w/w)), polysorbate 80, potassium sorbate (E 202), anhydrous glucose, disodium edetate, concentrated hydrochloric acid, ascorbic acid (E 300), water for injections.

What Tafen Nasal 32 μg looks like and contents of the pack
Tafen Nasal 32 μg is a white or almost white, homogeneous suspension.
Tafen Nasal 32 μg is available in an amber glass bottle with a plastic metering pump spray and a polypropylene nasal applicator: 1 x 120 doses.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
tel. 22 209 70 00

Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: Budesonid Sandoz 32 Mikrogramm/Sprühstoß Nasenspray, Suspension
Denmark: Budesonid "Sandoz"
Norway: Budesonid Sandoz 32 mikrogram/dose nesespray, suspensjon
Poland: Tafen Nasal 32 μg
Sweden: Desonix 32 mikrogram/dos nässpray, suspension