Tafen Nasal 64 mcg

Leaflet attached to the packaging: patient information

Tafen Nasal 64 μg

64 micrograms/dose, nasal spray, suspension

Budesonide

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor. See section 4.

Table of contents of the leaflet

• 1. What Tafen Nasal 64 μg is and what it is used for
• 2. Important information before using Tafen Nasal 64 μg
• 3. How to use Tafen Nasal 64 μg
• 4. Possible side effects
• 5. How to store Tafen Nasal 64 μg
• 6. Contents of the packaging and other information

1. What Tafen Nasal 64 μg is and what it is used for

Tafen Nasal 64 μg contains budesonide, a synthetic corticosteroid. Corticosteroids are a group of medicines that help fight inflammation. Tafen Nasal 64 μg is used for: the treatment and prevention of allergy symptoms, such as hay fever (caused by grass pollen) and symptoms of year-round, allergic rhinitis (chronic rhinitis), caused by house dust, in adults and children over 6 years old, treatment of nasal polyps (small growths on the nasal mucosa) in adults.

2. Important information before using Tafen Nasal 64 μg

When not to use Tafen Nasal 64 μg

Warnings and precautions

Before starting treatment with Tafen Nasal 64 μg, discuss it with your doctor or pharmacist if: you are taking other corticosteroid medicines, such as tablets or injections, do not stop taking them suddenly. if the medicine is used continuously for a long time, the doctor will examine the nasal mucosa at least every 6 months; if the medicine was used in higher doses than recommended, the doctor may prescribe steroid tablets for use during stressful periods (such as infection) or before surgery; if the patient has nasal mucosa ulcers, using Tafen Nasal 64 μg is not recommended; if the patient has infectious blisters (herpes) around the mouth, nose, or eyes; if symptoms of infection occur, such as persistent fever; if the patient has diabetes, corticosteroids may increase blood sugar levels; if the patient has nosebleeds, using Tafen Nasal 64 μg is not recommended; if the patient has recently undergone nose surgery or injury and has not yet fully recovered, using Tafen Nasal 64 μg is not recommended; if the patient has a bacterial, viral, or fungal infection of the nose; Tafen Nasal 64 μg can only be used if medicines for the treatment of these infections are also prescribed; if the patient has had contact with a person with tuberculosis, measles, or chickenpox if the patient has liver function disorders, as the budesonide concentration in the body may increase; the doctor may recommend a liver test and, depending on the result, reduce the dose of the medicine; if the patient has adrenal function disorders and the doctor has changed the medicine to a nasal spray; if the doctor has diagnosed a respiratory tract infection or pulmonary tuberculosis - these are infections that affect lung function; in rare cases, locally administered corticosteroids may cause side effects that affect the whole body. Most often, they depend on the dose, duration of use, additional concurrent or previous use of corticosteroids, and individual factors. Corticosteroids used intranasally may cause the following side effects: Cushing's syndrome, cushingoid features, adrenal insufficiency, growth retardation in children and adolescents, cataracts, and increased intraocular pressure (glaucoma). Less common are psychological symptoms and behavioral changes, including excessive psychomotor activity, sleep disturbances, anxiety, depression, or aggression (especially in children).

If the patient experiences blurred vision or other vision disturbances, or if any symptoms occur, persist, or worsen during treatment with this medicine, they should contact their doctor. For the medicine to be effective, the nostrils must be cleaned. Therefore, before taking a dose, blow your nose. The effect of the medicine on symptoms may only appear after a few days of treatment. If nasal congestion (feeling of a blocked nose) persists despite starting treatment, consult your doctor to reassess the treatment. Athletes should be cautious, as this medicine contains an active ingredient that may cause a positive result in doping tests.

Children and adolescents

The long-term effects of locally administered corticosteroids in children are not fully known. If the patient is a child receiving large doses of the medicine for a long time, the doctor will regularly monitor their growth.

Tafen Nasal 64 μg and other medicines

This medicine may affect the action of other medicines or be affected by other medicines. Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those available without a prescription. Make sure your 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 transplants, ethinyl estradiol, a medicine used to prevent pregnancy, antibacterial medicines (such as erythromycin, clarithromycin, telithromycin, ciprofloxacin, levofloxacin, troleandomycin, and others), boceprevir (a medicine used to treat hepatitis, a liver disease caused by hepatitis C virus infection), non-steroidal anti-inflammatory medicines (NSAIDs) (e.g., containing acetylsalicylic acid), used to reduce pain, fever, and inflammation, heparin and oral anticoagulants (medicines that prevent 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 mucous membrane cancer, called melanoma), medicines that affect liver metabolism, called enzyme inducers (such as St. John's Wort), medicines containing activated carbon, used to relieve stomach pain, reflux, or reduce gas in the intestines.

• Some medicines may enhance the effect of Tafen Nasal 64 μg, and your doctor may want to monitor your condition closely while taking such medicines (including some HIV medicines: saquinavir, atazanavir, indinavir, nelfinavir, ritonavir, cobicistat).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine. Do not useTafen Nasal 64 μg during pregnancyunless previously agreed with your doctor. If you become pregnant during treatment, consult your doctor. Budesonide passes into breast milk, but at the usual doses, it should not affect the baby. Breastfeeding mothers may useTafen Nasal 64 μg, but only if the doctor believes the benefits of treatment for the mother outweigh the risk to the breastfed child. If you are breastfeeding, inform your doctor immediately. It is recommended to avoid breastfeeding during long-term treatment.

Driving and using machines

Tafen Nasal 64 μg may cause blurred vision. If this occurs, do not drive or operate machinery.

Tafen Nasal 64 μg contains potassium sorbate

Tafen Nasal 64 μg contains potassium sorbate. It may cause skin or mucous membrane irritation (e.g., contact dermatitis).

3. How to use Tafen Nasal 64 μg

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist. Tafen Nasal 64 μg is intended for intranasal use, as described below.

Dosage

The dose should be adjusted to the patient's needs. Use the smallest dose that relieves the symptoms. Allergic rhinitisInitial doseAdults, adolescents (from 12 years old), and children over 6 years old: The recommended initial dose of the medicine is 4 dosesof 64 micrograms/dose aerosolTafen Nasal 64 μg (256 micrograms) per day. The medicine can be used: once a day, 2 doses of aerosol into each nostril in the morning ortwice a day, 1 dose of aerosol into each nostril in the morning and 1 dose of aerosol into each nostril in the evening. Children should be treated under adult supervision. If used in children for more than 2 months in a year, a pediatrician's consultation is necessary. It is best to start using the medicine 14 days before the expected onset of symptoms. For example, if the patient has hay fever, treatment should start about 2 weeks before the pollen season and stop after the end of the pollen season. Maintenance doseThe effect of the medicine occurs after 7 to 14 days. After this time, the doctor may reduce the dose. Nasal polypsAdults: The recommended initial dose of the medicine is 4 dosesof 64 micrograms/dose aerosolTafen Nasal 64 μg (256 micrograms) per day. The medicine can be used: once a day, 2 doses of aerosol into each nostril in the morning ortwice a day, 1 dose of aerosol into each nostril in the morning and 1 dose of aerosol into each nostril in the evening. After achieving the effect, use the smallest dose of the medicine that relieves the symptoms. Using more than the recommended 4 dosesof Tafen Nasal 64 μg per daywill not increasethe effectiveness of the medicine.

Duration of treatment

The doctor will inform the patient how long the treatment with Tafen Nasal 64 μg will last. The medicine must be used regularly; otherwise, it will not be effective. Do not stop treatment without the doctor's advice, even if you feel better. If using the medicine does not bring immediate improvement, continue taking the medicine regularly, as the onset of the therapeutic effect may occur after a few days.

Method of administration

• 1. If necessary, gently blow your nose to clean the nostrils.
• 2. Shake the bottle. Remove the protective cap (Fig. 1).

Fig. 1

• 3. Hold the bottle as shown in Figure 2. Before using the medicine for the first time, prime the pump (i.e., introduce the medicine into it). To do this, perform the pumping action by moving the plunger up and down several times (5-10 times), spraying the medicine into the air until a visible mist is obtained. Priming is sufficient for about 24 hours. If more time passes before taking the next dose, prime the pump again. If the breaks in using Tafen Nasal 64 μg are shorter, it is enough to spray the medicine into the air once.

Fig. 2

• 4. Insert the applicator tip into the nostril, as shown in Figure 3, and spray once (or more, if your doctor has instructed you to do so). Use the same method to administer the aerosol to the other nostril. Note: During spraying, it is not necessary to inhale.

Fig. 3

• 5. Wipe the applicator with a clean tissue and put on the protective cap.
• 6. Store the bottle upright.

Cleaning the applicatorThe plastic applicator should be cleaned at regular intervals and every time the medicine cannot be sprayed properly. In this case, first check if the pump is primed (see above). If the pump still does not work after re-priming, clean the applicator according to the following instructions:

• Remove the plastic applicator using a clean tissue and wash it in warm (not hot) water.
• Rinse the applicator thoroughly, dry, and reattach it to the bottle.
• Never use a needle or other sharp object to unclog the applicator.
• After cleaning the applicator, prime the pump (fill the applicator with medicine) before reusing it.

Using a higher dose of Tafen Nasal 64 μg than recommended

It is essential to use the medicine as directed by the doctor. Use exactly the amount of medicine prescribed by the doctor. Using a higher or lower dose of the medicine may worsen the symptoms of the disease. If a higher dose of Tafen Nasal 64 μg than recommended is used, continue using the medicine according to the usual dosing schedule. No health problems are expected. However, if a dose higher than the recommended 4 dosesof Tafen Nasal 64 μg per dayis used for more than a month, contact your doctor immediately.

Missing a dose of Tafen Nasal 64 μg

If a dose is missed at the right time, use it as soon as possible, and then return to the usual dosing schedule. Do not use a higher dose than recommended to make up for the missed dose.

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The medicine usually only treats symptoms that occur in the nose (e.g., congestion or discharge). If you have previously taken steroids in tablet form or steroids for injection, but your doctor has now prescribed Tafen Nasal 64 μg instead, you may expect some other symptoms to worsen (such as redness and itching of the eyes). In this case, your doctor will treat these symptoms separately. After using this medicine, allergic reactions have been reported: hives, itching, skin rash, angioedema (swelling of the face, lips, tongue, and/or throat) with difficulty breathing and swallowing, and a general feeling of discomfort. If you experience these symptoms after using Tafen Nasal 64 μg, stop using the medicine and consult your doctor immediately. During treatment with Tafen Nasal 64 μg, the following side effects may occur:

Common side effects (may occur in less than 1 in 10 people)

These effects may occur immediately after using the medicine: occasional sneezing, dryness, or tingling in the nose a small amount of bloody discharge from the nose nosebleeds (immediately after administration) pain in the mouth and/or throat

Uncommon side effects (may occur in less than 1 in 100 people)

skin redness skin irritation muscle cramps

Rare side effects (may occur in less than 1 in 1000 people)

anaphylactic reaction bone fragility (after long-term use of the medicine) bruising or bruising increased eye pressure blurred vision ulcers or painful sores in the nasal cavity perforation of the nasal septum (nasal septum) voice disorders slower growth rate in children and adolescents, especially after using high doses for a long time adrenal insufficiency. This can cause loss of appetite, abdominal pain, weight loss, nausea, headaches, vomiting, changes in consciousness, decreased blood sugar levels, and seizures. Situations that can potentially trigger an adrenal crisis include injury, infection, surgery, or sudden reduction in dose. If you experience such symptoms, contact your doctor immediately.

Unknown frequency (cannot be estimated from the available data)

glaucoma (eye pain, eye redness, blurred vision) cataract (clouding of the eye lens) headache oral thrush and throat (difficulty eating and/or swallowing, thrush (white spots in the mouth, throat, or tongue))

Thrush:

During long-term treatment, thrush (fungal infection) of the nose may occasionally occur. Consult your doctor to discuss appropriate treatment. In this case, it is recommended to discontinue treatment until the infection is cured.

Systemic effects:

Intranasal corticosteroids in high doses and used for a long time may affect the body. The following symptoms may occur:

• hyper cortisolism (occurring with symptoms such as weight gain, moon face, fatigue, and/or increased abdominal girth)

The ingredient of this medicine, potassium sorbate, may cause local skin or mucous membrane irritation, e.g., nasal mucosa irritation. Reporting side effects If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 64 μg

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

6. Contents of the packaging and other information

What Tafen Nasal 64 μg contains

The active substance of the medicine is budesonide. One dose of 0.05 ml of nasal spray suspension contains 64 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), and water for injection.

What Tafen Nasal 64 μg looks like and contents of the pack

Tafen Nasal 64 μg is a white or almost white, homogeneous suspension. Tafen Nasal 64 μg is available in a brown glass bottle with a plastic spray pump and a polypropylene nasal applicator: 1 x 120 doses.

Marketing authorization holder and manufacturer

Marketing authorization holder Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl, Austria phone: 22 209 70 00 Manufacturer Lek Pharmaceuticals d.d. Verovškova 57 1526 Ljubljana, Slovenia

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom under the following names:

Germany: Budesonide Sandoz 64 Mikrogramm/Sprühstoß Nasenspray, Suspension Denmark: Budesonide "Sandoz" France: BUDESONIDE SANDOZ 64 microgrammes/dose, suspension pour pulvérisation nasale Norway: Budesonid Sandoz 64 mikrogram/dose nesespray, suspensjon Poland: TAFEN NASAL 64 µg Sweden: Desonix 64 mikrogram/dos nässpray, suspension United Kingdom: Budesonide 64 micrograms/actuation aqueous nasal spray Date of last revision of the leaflet:11/2024 {Sandoz logo}