Sublivac Betulla/Nocciolo/Ontano
Italy
Table of Contents
Patient Information Leaflet
Sublivac Birch/Hazel/Alder
40,000 AUN/mL, oral mucosal drops, solution
▼ This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
For treatment of adult patients
Please read all of this leaflet carefully before taking 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 others, even if their symptoms are the same as yours, as it could 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 leaflet
- What Sublivac Birch/Hazel/Alder is and what it is used for
- What you need to know before taking Sublivac Birch/Hazel/Alder
- How to take Sublivac Birch/Hazel/Alder
- Possible side effects
- How to store Sublivac Birch/Hazel/Alder
- Contents of the pack and other information
1. What Sublivac Birch/Hazel Alder is and what it is used for
Sublivac Birch/Hazel Alder is a solution applied under the tongue. This type of treatment is known as sublingual immunotherapy. These medicines contain small amounts of substances that trigger an allergy (so-called allergens). By exposing your body to the allergens contained in this medicine, your body becomes accustomed to them, making you less sensitive or even insensitive to them.
This medicine is used to treat allergic hay fever in adults, caused by clinically proven hypersensitivity to pollen from birch and/or alder and/or hazel trees. Before starting treatment, your allergy will be diagnosed by a doctor who will perform appropriate skin and/or blood tests.
Typical symptoms of hay fever include runny or blocked nose, sneezing, and watery, burning or itchy eyes. In addition, asthma-like symptoms may occur (see section 2, point 1).
2. What you should know before taking Sublivac Birch/Hazel Alder
Do not take Sublivac Birch/Hazel Alder
■ if you suffer from uncontrolled or inadequately treated asthma with limited lung function (FEV
less than 70% of predicted)
■ if you have a severe disorder of the immune system (your body's natural defence system against
diseases), if your immune system is compromised, or if you are being treated with medicines that
suppress your natural defences
■ if you have cancer
■ if you have a severe infection in your mouth
■ if you are allergic to any of the other ingredients of this medicine listed in section 6.
Warnings and precautions
Inform your doctor if you have previously taken this type of medicine and experienced serious adverse
reactions. Also inform your doctor if you suffer from cardiovascular disease.
If you develop severe allergic symptoms after taking the medicine, such as difficulty swallowing or
breathing, throat tightness, voice changes, low blood pressure, or rapid heartbeat, stop treatment and
contact your doctor immediately (see also “Other medicines and Sublivac Birch/Hazel Alder”).
Consult your doctor if you experience persistent swallowing difficulties or stomach problems. This may
be due to inflammation of the oesophagus (eosinophilic esophagitis).
Treatment should be postponed if you develop acute fever, a severe infection, a mouth infection, or if you
have recently had a tooth extraction.
Sublivac Birch/Hazel Alder contains peppermint oil.
In sensitized patients, Sublivac Birch/Hazel Alder may trigger hypersensitivity reactions (including
respiratory distress).
Children and adolescents
The safety and efficacy in children and adolescents under 18 years of age have not yet been established.
Sublivac Birch/Hazel Alder is not authorized for the treatment of children and adolescents.
Other medicines and Sublivac Birch/Hazel Alder
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other
medicines. In particular, if you are already taking medicines to treat your symptoms, such as antihistamines,
corticosteroids, so-called mast cell stabilizers, or other medicines with antihistamine effects (e.g.
some psychoactive medicines), or anti-IgE medicines such as omalizumab, your doctor must evaluate the
use of these medicines. These may affect the tolerability of this medicine.
Tolerability fluctuations may occur if you are also exposed to tree pollen present in nature, for example
during the pollen season in spring.
Inform your doctor if you are due to receive a vaccination. Your doctor will then decide whether treatment
with this medicine can continue as planned.
You must not take this medicine if you are being treated with medicines that suppress your immune system
(your body's natural defence system).
If you experience severe allergic symptoms after taking the medicine (see “Warnings and precautions”), you
may need to receive treatment with adrenaline, an emergency medicine used to treat a severe allergic
reaction.
Inform your doctor if you are taking medicines to reduce heart rate, blood pressure, or intraocular pressure,
known as beta-blockers. These may also be available as eye drops. Beta-blockers, as well as alpha-receptor
blockers (used, for example, to reduce blood pressure or to treat prostate enlargement), may reduce the
effect of adrenaline.
The effect of adrenaline may also be increased if you are taking medicines for the treatment of
depression (tricyclic antidepressants or MAO inhibitors) or Parkinson’s disease (COMT inhibitors).
Sublivac Birch/Hazel Alder must not be used together with other immunotherapeutic medicines
containing birch allergen or other allergens from the same homologous group.
If you are being treated simultaneously with Sublivac Birch/Hazel Alder and another sublingual
immunotherapy medicine (e.g. for grass pollen), you must not take the two medicines at the same time.
An interval of at least 30 minutes is recommended.
Sublivac Birch/Hazel Alder with food, drinks and alcohol
Alcohol consumption is not expected to affect the treatment.
Inform your doctor immediately if you experience sudden mouth irritation or severe swelling of the lips
or tongue after consuming apples or nuts (e.g. walnuts).
Pregnancy and breastfeeding
Pregnancy
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding,
consult your doctor before taking this medicine.
Initial treatment with Sublivac Birch/Hazel Alder must not be started during pregnancy.
If you become pregnant during maintenance treatment, discuss with your doctor the risks associated
with continuing treatment.
Breastfeeding
It is not known whether Sublivac Birch/Hazel Alder passes into breast milk. If you are breastfeeding,
consult your doctor before starting treatment.
Driving and using machines
This medicine does not affect, or has a negligible effect on, the ability to drive and use machines.
Occasionally, you may feel slightly tired after taking the medicine. This should be taken into account if
you need to drive motor vehicles or operate machinery.
3. How to take Sublivac Birch/Hazel/Hornbeam
Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor. The dosing schedule provided serves as a guideline. However, your doctor may deviate from this guideline and recommend a different dose.
Treatment with Sublivac Birch/Hazel/Hornbeam must only be administered by physicians experienced in the treatment of allergic diseases. The first dose must be given under medical supervision, and the patient must be monitored for at least 30 minutes afterwards, so that any adverse reactions can be discussed and appropriate measures taken if necessary.
Before first use, remove the security ring from the red cap. Shake the bottle well before each use. Place the required number of drops under the tongue and hold them under the tongue for two or three minutes before swallowing. Alternatively, the drops may also be administered under the tongue using a spoon. After use, clean the blue dropper with a clean, dry paper towel. The red protective cap should then be replaced on the blue dropper.
Initial treatment
The first dose must be administered under medical supervision. On the first day of initial treatment, take one drop only. If you tolerate this dose well, increase the dose by one drop per day until reaching the maximum dose of five drops per day.
Maintenance treatment
You may then continue taking five drops per day.
If you experience any adverse effects during initial treatment, do not increase the dose and consult your doctor. If you experience any adverse effects during maintenance treatment, consult your doctor. In either case, a dose reduction may be necessary.
- 1. Remove the security ring from the red protective cap before first use.
- 2. Shake the dropper bottle briefly before each use.
- 3. Remove the red protective cap.
- 4. Place the required number of daily drops under the tongue. (Alternatively, the drops may also be administered under the tongue using a spoon.)
- 5. Hold the drops under the tongue for two or three minutes before swallowing.
- 6. Clean the blue dropper with a clean, dry paper towel. Replace the red protective cap onto the blue dropper.
It is recommended to start treatment outside the pollen season. If you have reached the maximum dose and tolerate the medicine well, you may continue taking it during the pollen season.
Treatment may also be initiated during the pollen season, provided close medical monitoring is ensured. In case of adverse effects, the dose may be temporarily reduced.
It is recommended to continue this treatment for three consecutive years.
Dose reduction in case of treatment interruptions
If treatment is temporarily interrupted for one or more weeks (e.g. due to illness), consult your doctor. Dose adjustment may be necessary.
As a general rule, the daily dose should be reduced by one drop for each week of interruption. After this reduction, the dose may be gradually increased again until the original maximum dose is reached.
If you take more Sublivac Birch/Hazel/Hornbeam than you should
Consult your doctor if you have accidentally taken too many drops during initial treatment. If you have accidentally taken too many drops during maintenance treatment, resume the correct dose the following day and continue taking that dose.
If you forget to take Sublivac Birch/Hazel/Hornbeam
Do not take a double dose to make up for the missed dose. If you have missed the dose for more than one week, dose adjustment may be necessary. Consult your doctor.
If you stop taking Sublivac Birch/Hazel/Hornbeam
It is recommended to continue this treatment for three consecutive years in order to achieve a lasting improvement. If you stop taking this medicine too early, you may experience the same allergic symptoms you had before starting treatment.
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 will experience them.
During treatment, you may be exposed to tree pollen allergens, which can cause allergic reactions. Local reactions may occur, such as swelling, itching, or pain in the throat and mouth, lips, and tongue, or itching in the ears. Nausea and abdominal pain may also occur. Allergic reactions such as runny nose, sneezing, itchy eyes, or shortness of breath may also develop. Most allergic adverse reactions occur within 30 minutes after taking the drops, but adverse reactions may also occur several hours later.
In rare cases, severe allergic reactions, known as anaphylactic reactions, may occur. Typical warning signs include:
- Widespread itching and flushing; the most commonly affected areas are the scalp, mouth, throat, palms of the hands, or soles of the feet.
- Wheezing or heavy breathing/shortness of breath
- Severe hives (urticaria)
- Swelling of the lips or throat
- Pallor or grayish skin color
- Rapid heartbeat
- Feeling of weakness or collapse
If you notice any of these warning signs, contact a doctor immediately. Treatment must be stopped immediately until your doctor advises otherwise.
Persistent difficulty swallowing or stomach pain may indicate eosinophilic esophagitis (inflammation of the esophagus), which may occur during sublingual immunotherapy (see Warnings and precautions).
The side effects observed during clinical studies and after marketing of Sublivac Birch are listed in Table 1.
For Sublivac Birch/Hazel/Alder, a comparable adverse reaction profile is expected.
Table 1: Nature and frequency of adverse reactions
| Very common (may affect more than 1 in 10 treated patients) |
|
| Common (may affect up to 1 in 10 treated patients) |
|
| Common (may affect up to 1 in 100 treated patients) |
|
| |
| Not known (frequency cannot be estimated from the available data) |
|
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist.
You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. How to store Sublivac Birch/Hazel/Alder
Keep this medicine out of the sight and reach of children.
Sublivac Birch/Hazel/Alder must be stored upright in the refrigerator (between 2 °C and
8 °C); do not freeze. Do not use this medicine after the expiry date stated on the box and on the
dropper bottle after “Exp.:”. The expiry date refers to the last day of that month.
After first opening, the contents of the dropper bottle may be used for a period of six months.
This period must not exceed the expiry date indicated on the box and on the dropper bottle. After first opening, the dropper bottle may be stored outside the refrigerator, but at a temperature below 25 °C. The dropper bottle must be stored upright.
A single dropper bottle lasts approximately three months. Please consult your doctor in advance regarding the prescription of a new pack for maintenance treatment.
Do not use this medicine if you notice particles in the dropper bottle or changes in the colour of the liquid compared to when the dropper bottle was first opened.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Package contents and other information
What Sublivac Birch/Hazel/Alder contains
The active substance is allergenic extracts from birch, alder, and hazel pollen in equal parts.
1 mL contains 40,000 AUN.
The dosage of the product is expressed in units of biological activity (AUN).
The other components are:
Glycerol
Aminocaproic acid
Disodium hydrogen phosphate
Sodium dihydrogen phosphate
Peppermint oil
Water for injections
Description of the appearance of Sublivac Birch/Hazel/Alder and contents of the pack
Clear, slightly viscous solution, colourless to yellowish-brown, with a peppermint odour. The product is
supplied in a transparent glass dropper bottle containing a 24 mL solution. It is equipped with a blue synthetic rubber dropper and sealed with a red protective cap. The dropper bottle is packaged in a carton. The single pack contains one dropper bottle, while the multiple pack contains two dropper bottles.
Marketing Authorisation Holder and Manufacturer
HAL Allergy B.V.
J.H. Oortweg 15
NL-2333 CH Leiden
The Netherlands
Tel: +31 (0)88 – 19 59 000
Fax: +31 (0)88 – 19 59 001
E-mail: [email protected]
This medicinal product is authorised in the European Economic Area Member States
under the following names:
Denmark Sublivac Træer
Finland Sublivac Puita
Germany Sublivac Bäume
Italy Sublivac Betulla/Nocciolo/Ontano
Norway Sublivac or/bjørk/hassel
Slovenia Jelša/breza/leska Sublivac 40.000 AUN/mL oralne kapljice
Sweden Sublivac Träd
Sublivac Dose Recommendation
Please detach, complete daily, and bring to every appointment with your doctor.
Dose recommendation for initial treatment and maintenance treatment with daily administration.
Dose recommendation for maintenance treatment with daily administration.
Patient's name: __________________ Batch no.: ___________
Patient's name: __________________ Batch no.: ___________
| Day | Drops | Date of administration | Notes |
| 1 | 1 | ||
| 2 | 2 | ||
| 3 | 3 | ||
| 4 | 4 | ||
| 5 | 5 | ||
| 5 drops per day | 5 | ||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| Drops | Date of administration | Notes | |
| 5 drops per day | 5 | ||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 | |||
| 5 |
One bottle lasts approximately 3 months
One bottle lasts approximately 3 months
Sublivac Dosage Recommendation
Please detach, complete daily, and bring to every medical appointment.
Dosage recommendation for the treatment of
maintenance with daily administration
Patient's name: __________________ Lot no.: ____________
| Drops | Date of intake | Notes | Drops | Date of intake | Notes | |
| 5 | 5 | |||||
| 5 | 5 | |||||
| 5 | 5 | |||||
| 5 | 5 | |||||
| 5 | 5 | |||||
| 5 | 5 | |||||
| 5 | 5 | |||||
| 5 | 5 | |||||
| 5 | 5 | |||||
| 5 | 5 | |||||
| 5 | 5 | |||||
| 5 | 5 | |||||
| 5 | 5 | |||||
| 5 | 5 | |||||
| 5 | 5 | |||||
| 5 | 5 | |||||
| 5 | 5 | |||||
| 5 | 5 | |||||
| 5 | 5 | |||||
| 5 | 5 | |||||
| 5 | 5 | |||||
| 5 | 5 | |||||
| 5 | 5 | |||||
| 5 | 5 |
One bottle lasts approximately 3 months One bottle lasts approximately 3 months