Prontinal
Italy
Table of Contents
Patient Information Leaflet: Information for the User
PRONTINAL 800 micrograms suspension for nebuliser
Beclometasone dipropionate
Please read this leaflet carefully before using 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 other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Prontinal is and what it is used for
- What you need to know before using Prontinal
- How to use Prontinal
- Possible side effects
- How to store Prontinal
- Contents of the pack and other information
1. What Prontinal is and what it is used for
Prontinal contains the active substance beclometasone dipropionate. It belongs to a group of medicines called corticosteroids, which have an anti-inflammatory action that reduces swelling and irritation in the walls of the airways (e.g. nose, lungs), thereby alleviating respiratory problems.
Prontinal is indicated for the treatment of asthma in adults and children up to 18 years of age when the use of pressurized metered-dose inhalers or dry powder inhalers is unsatisfactory or inadequate.
Prontinal is also indicated for the treatment of recurrent wheezing (wheeze) in children up to 5 years of age.
2. What you need to know before using Prontinal
Do not use Prontinal:
- if you are allergic to the active substance 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 Prontinal if any of the following
conditions apply to you:
- You are, or have previously been, undergoing treatment for tuberculosis.
- Your condition seems to be worsening. You notice that wheezing or shortness of breath have worsened, or that your inhaler is less effective.
- Your doctor may need to increase your dose of Prontinal, prescribe a course of oral corticosteroids, or change your overall treatment.
- You have a chest infection. Your doctor may prescribe a course of antibiotics.
- If you develop a nasal or paranasal sinus infection, you should be treated with appropriate therapies, although this does not specifically contraindicate the use of Prontinal.
- If you experience an immediate increase in wheezing, shortness of breath, or coughing after using Prontinal, stop using Prontinal immediately and contact your doctor.
Contact your doctor if you experience blurred vision or other visual disturbances.
Rinse your mouth with water immediately after inhalation to reduce the frequency of fungal infections in the mouth.
Switching from oral corticosteroids to Prontinal
Switching from oral corticosteroids to inhaled corticosteroid therapy
may cause you to feel generally unwell or you may develop a skin rash, eczema, runny nose, or sneezing (rhinitis).
If you experience these symptoms, contact your doctor as soon as possible. Do not stop treatment with Prontinal unless your doctor tells you to.
If you have taken oral corticosteroids at high doses or for a prolonged period of time, the dose may be gradually reduced approximately one week after starting treatment with Prontinal. During this period, your doctor will regularly monitor steroid levels in your body.
If you have been treated for a prolonged period with high doses of inhaled corticosteroids, you may require additional corticosteroid treatment during periods of stress, for example:
- during hospitalization following a serious accident,
- before surgery,
- or if you develop a chest infection or other serious illness.
Your doctor will decide whether you need a course of oral corticosteroids or possibly a corticosteroid injection, and will also advise you on how long you should take the oral corticosteroids and how to taper them as you begin to feel better.
Children and adolescents
If the child is under 5 years of age and has been using Prontinal for a long time to treat recurrent wheezing, the doctor will regularly monitor the child's height to assess for any potential growth retardation and may consider interrupting treatment.
Other medicines and Prontinal
Tell your doctor if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Some medicines may increase the effects of Prontinal, and your doctor may wish to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).
Inform your doctor if you are taking, have recently taken, or may take any other corticosteroid-containing medicines, as these drugs may interact with Prontinal and worsen any potential side effects.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Since during pregnancy prolonged treatment with corticosteroids (such as beclometasone dipropionate contained in Prontinal) cannot exclude the possibility of growth retardation or fetal harm, in such cases the decision to use Prontinal lies with your doctor.
Corticosteroids pass into breast milk in small amounts. To date, no harm has been reported in breastfed infants. Nevertheless, as a precautionary measure, if high doses of beclometasone dipropionate are inhaled, breastfeeding should be avoided for 4 hours following administration of the drug.
Driving and using machines
It is unlikely that Prontinal will affect your ability to drive or operate machinery. However, if you experience side effects such as dizziness and/or tremor, your ability to drive or use machinery may be impaired.
3. How to use Prontinal
Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The initial dose must be prescribed by the doctor according to the frequency and severity of the disease. The dose may then be adjusted by the doctor until effective symptom control is achieved.
Recommended initial doses are:
Adults and adolescents (from 12 years of age):
- 800–1600 micrograms twice daily, corresponding to a total daily dose of 1600 or 3200 micrograms.
Children (up to 11 years of age):
- 400–800 micrograms twice daily, corresponding to a total daily dose of 800 or 1600 micrograms.
The daily dose should normally not exceed 1600 micrograms in children up to 11 years of age and 3200 micrograms in adults and adolescents.
In asthma, Prontinal must be used regularly on a daily basis. Your doctor will determine the duration of treatment.
If the child suffers from recurrent wheezing (wheeze), the duration of treatment should not exceed 3 months, unless otherwise prescribed by the paediatrician.
The Prontinal 800 microgram vial may be used to obtain 400 micrograms (half the content) by using the half-dose marking as described below.
Instructions for use:
The vial must be used according to the following instructions:
- Bend the vial forward and backward to loosen it from the strip (Figure A).
- Carefully separate the vial from the strip, starting from the top, then the middle (Figure B), leaving the other vials in the pouch.
- Shake the vial vigorously and turn it upside down to mix the suspension. Repeat this step until the entire content is completely dissolved and uniformly mixed (Figure C).
- Open the vial by twisting the opening tabs in the direction of the arrow (Figure D).
- Gently squeeze the vial and pour the contents into the nebulizer chamber (Figure E).
The vial must be opened immediately before administration.
If only half the dose of Prontinal 800 micrograms is required, turn the vial upside down, ensure the half-dose marking is clearly visible, and apply gentle pressure. While holding the vial squeezed, allow the contents to be dispensed until the suspension level reaches the half-dose mark (do not exceed this level). Once half the content has been poured out, close the vial again by pressing the cap firmly onto it. The vial closed in this way must be stored at 2°C–8°C (in the refrigerator), and the remaining amount must be used within 12 hours of the first opening.
Dilution:
Your doctor may decide that the dose should be diluted.
In this case, empty the vial contents into the nebulizer chamber, then add the amount of sterile sodium chloride solution 9 mg/ml (0.9%, physiological saline) prescribed by your doctor.
After closing the chamber, gently shake to mix the contents.
Dilution of the dose may be necessary to achieve a final volume suitable for the specific nebulizer used, to assist in administering small volumes, or if a prolonged administration time is preferred.
During nebulization:
Place the mask or mouthpiece.
Turn on the nebulizer.
Breathe normally. Nebulization should not last longer than 10–15 minutes.
After nebulization:
Remember to rinse your mouth, lips, and the area of the face covered by the mask with water.
After inhalation, any unused suspension remaining in the nebulizer chamber must be discarded.
Cleaning:
For cleaning the nebulizer, follow the manufacturer’s instructions. It is important that the nebulizer is kept clean.
If you use more Prontinal than you should
It is important to use the dose as recommended by your doctor. Do not increase or decrease the dose without consulting your doctor.
If you have used more Prontinal than you should, inform your doctor as soon as possible. Your doctor may decide to monitor corticosteroid levels in the blood, and a blood sample may therefore be required.
If you forget to use Prontinal
If you forget to take a dose, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose; simply take the next dose at the scheduled time. Do not use a double dose to make up for a forgotten dose.
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 experiences them.
The following side effects have been reported. Inform your doctor as soon as possible if you notice any of these side effects, but do not stop treatment unless instructed to do so. Your doctor will try to avoid these side effects by prescribing Prontinal at the lowest effective dose possible.
Very common side effects (may affect more than 1 in 10 people):
- Sore throat (pharyngitis, laryngitis). Gargling with water immediately after inhalation may help prevent this effect.
Common side effects (may affect up to 1 in 10 people):
- Cough
- Nausea and stomach ache
- Oral thrush (in the mouth, on the tongue and in the throat). Rinsing the mouth or gargling with water immediately after inhalation may help prevent these effects.
Uncommon side effects (may affect up to 1 in 100 people):
- Headache
- Throat irritation, hoarseness
- Worsening of shortness of breath, cough and wheezing (known as paradoxical bronchospasm). In this case, do not take another dose of Prontinal. Contact your doctor immediately. Your doctor may decide to reassess asthma or recurrent wheezing and, if necessary, start another treatment regimen. You may be advised not to use Prontinal again.
Rare side effects (may affect up to 1 in 1,000 people):
- Cold sores (herpes simplex), painful blisters on the lips and in the mouth
- Tremor (involuntary trembling)
- Tiredness
- Allergic reaction (swelling of the eyes, face, lips and throat leading to severe breathing difficulties, skin rash, hives, itching or redness).
Side effects not known (frequency cannot be estimated from available data):
- Blurred vision
The following effects may additionally occur more frequently in children:
- Sleep problems, depression or anxiety, restlessness, nervousness, overexcitement or irritability.
With high doses over a long period of time, Prontinal may alter the normal production of corticosteroids in the body. In children and adolescents, this may result in delayed growth; therefore, it is important that their height is regularly monitored by a doctor. Bone thinning and eye problems such as clouding of the eye's lens (cataract) and increased pressure in the eye (glaucoma) have also been reported.
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 www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Prontinal
Keep this medicine out of the sight and reach of children.
Do not use Prontinal after the expiry date stated on the box,
pouch, and vial.
Store the vials upright in their original packaging (cardboard box) to
protect the medicine from light.
After first opening the pouch, write the date in the designated space on the pouch. Do not use the vials more than 3 months after the pouch has been first opened.
After first opening the vial, store in the refrigerator (2 °C–8 °C). The remaining amount must be used within 12 hours of first opening.
Do not use Prontinal if you notice that the packaging is damaged.
Do not dispose of any medicine via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect
the environment.
6. Contents of the pack and other information
What Prontinal contains
The active substance is beclometasone dipropionate.
Each 2 ml vial contains 800 micrograms of beclometasone dipropionate.
Each vial has a mid-dose line on one side (corresponding to 400 micrograms).
The other excipients are: polysorbate 20; sorbitan laurate; sodium chloride; water for
injections.
Description of the appearance of Prontinal and contents of the pack
Prontinal is a white or almost white suspension for nebuliser.
The Prontinal suspension is supplied in polyethylene vials containing 2 ml. Strips of 5 vials are packed in a sealed pouch, with pack sizes of 20 vials (4 pouches).
Marketing Authorisation Holder and Manufacturer
Dompè farmaceutici S.p.A. – Via San Martino 12 – 20122 Milano
Chiesi Farmaceutici S.p.A. – Parma facility, Via San Leonardo 96, 43122 Parma