ALMEIDA

Package leaflet: Information for the user

Almeida 1.875 mg/0.5 ml + 0.375 mg/0.5 ml nebuliser solution, 0.375% + 0.075% nebuliser solution

Salbutamol and ipratropium bromide
Equivalent medicine
Please read all of this leaflet carefully before you start using this medicine because 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Almeida is and what it is used for
2. What you need to know before using Almeida
3. How to use Almeida
4. Possible side effects
5. How to store Almeida
6. Contents of the pack and other information

1. What Almeida is and what it is used for

Almeida is a medicinal product containing two active substances for the treatment of obstructive (narrowing) bronchial diseases: salbutamol (a beta-agonist) and ipratropium bromide (an anticholinergic).
Almeida is indicated for the treatment of bronchospasm (contraction of the bronchial muscles) in adult patients with chronic obstructive pulmonary disease (a condition that makes it difficult to empty air from the lungs).

2. What you should know before taking Almeida

Do not take Almeida

• if you are allergic to salbutamol and/or ipratropium bromide or to any of the other components of this medicine (listed in section 6);
• if you are allergic to atropine or to active substances similar to atropine;
• if you have severe heart disease;
• if you have glaucoma (an eye disease affecting the optic nerve);
• if you have prostatic hypertrophy (enlargement of the prostate gland);
• if you have urinary retention (inability of the bladder to empty);
• if you have intestinal obstruction (blockage preventing the passage of intestinal contents).

Warnings and precautions
Talk to your doctor or pharmacist before taking Almeida if:

• you have obstruction of the blood vessels supplying the heart (coronary artery disease);
• you have an irregular heartbeat;
• you have high blood pressure (hypertension);
• you have an overactive thyroid gland (hyperthyroidism);
• you have phaeochromocytoma, a tumour that produces chemicals causing high blood pressure and rapid heartbeat;
• you have diabetes (a condition characterized by high blood glucose levels due to reduced insulin production by the pancreas);
• you have cystic fibrosis. Treatment with Almeida may increase the risk of gastrointestinal disorders.

Contact your doctor if you experience chest pain, severe breathing difficulties with increased wheezing or shortness of breath, or visual disturbances such as eye pain, blurred vision, coloured images, pupil dilation, or if you notice a worsening of your general health condition, especially if:

• you have ischaemic heart disease (a heart condition caused by reduced blood flow due to narrowing of the coronary arteries);
• you have tachyarrhythmia (rapid and irregular heartbeat);
• you have severe heart failure (inability of the heart to pump sufficient blood to meet the body's needs).

Treatment with Almeida may cause a decrease in blood potassium levels (hypokalaemia), which can be severe. Therefore, your doctor will prescribe periodic monitoring.
A condition known as lactic acidosis has been reported in association with high therapeutic doses of
salbutamol, particularly in patients treated for acute bronchospasm (see sections 3 and 4). Increased plasma
lactate levels may lead to shortness of breath and hyperventilation, even if your wheezing improves. If you
think the medicine is no longer effective and you need to use the nebulizer more often than prescribed by
your doctor, contact your doctor immediately.
During treatment, immediate hypersensitivity reactions may occur, rarely including urticaria, angioedema, paradoxical bronchospasm (sudden involuntary contraction of the airways and difficulty breathing), and anaphylaxis.
Be careful not to spray the solution into the eyes, especially if you are at risk of glaucoma (an eye condition caused by increased intraocular pressure). Isolated cases of ocular complications (such as mydriasis, blurred vision, visual halos or coloured images, increased intraocular pressure, closed-angle glaucoma, eye pain) have been reported when ipratropium bromide (one of the active substances in Almeida) has come into contact with the eye.

Use in children and adolescents
Almeida is not indicated for use in children and adolescents (under 18 years of age).

For athletes
Using this medicine without a medical need constitutes doping and may result in a positive anti-doping test.

Other medicines and Almeida
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines, including those without a prescription.
Inform your doctor if you are taking:

• beta-blockers, such as propranolol (medicines used for heart conditions and to lower blood pressure);
• xanthine derivatives, e.g. theophylline and aminophylline (medicines that relax bronchial muscles);
• corticosteroids (medicines used to treat inflammatory conditions);
• diuretics (medicines that lower blood pressure);
• antidepressants (tricyclic antidepressants and monoamine oxidase inhibitors);
• anticholinergic medicines;
• digoxin – a medicine used to treat heart failure;
• if you are scheduled for surgery. Some anaesthetics may affect the actions of Almeida. If you are undergoing surgery, inform your doctor, dentist, or anaesthetist that you are being treated with Almeida.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Your doctor will prescribe Almeida only if clearly necessary.

Driving and using machines
During treatment, dizziness, difficulty focusing vision, pupil dilation (mydriasis), and blurred vision may occur. If this happens, avoid driving or operating machinery.

Almeida (the solution in the multidose vial) contains para-hydroxybenzoates. These may cause allergic reactions (including delayed reactions) and, exceptionally, bronchospasm (narrowing of the airways).

3. How to take Almeida

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Use with nebulizers
Adults
Inhalation using electric nebulizers, for outpatient or home use:
Dilute 5 drops with 2 ml of distilled water or sterile physiological solution;
Nebulization duration: 10–15 minutes, to be repeated 2–3 times daily.
Inhalation using electric respirators (Intermittent Positive Pressure Breathing), for hospital use:
Dilute 2 drops with 1 ml of distilled water or sterile physiological solution: 6 breaths;
Alternatively, dilute 2 drops with 5 ml of distilled water or sterile physiological solution: inhalation duration 2 minutes;
or dilute 1 drop with 5 ml of distilled water or sterile physiological solution: inhalation duration 10 minutes.
Adults
The recommended dose is: 10 drops, 3–4 times daily.
Use in children and adolescents
Almeida is not indicated in children and adolescents (under 18 years of age).
Instructions for use
Single-dose containers:
To open the single-dose container, twist the cap.
Multi-dose bottle:
To prevent the bottle from being easily opened, a dropper has been used which requires a non-instinctive but rational movement to open.
To open the bottle, simultaneously press down on the dropper ring and turn counterclockwise. To close the bottle, screw the ring back on clockwise, as usual.
If you take more Almeida than you should
If you ingest or take an excessive dose of Almeida, contact your doctor or go to the nearest
hospital immediately.
In case of overdose, symptoms such as tremors, increased heart rate, increased respiratory rate (tachypnea), and metabolic acidosis (alteration of blood acidity) may occur.
If you forget to take Almeida
Do not take a double dose to make up for the missed dose.
If you stop using Almeida
Do not stop using this medicine without first consulting your doctor.
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 gets them.
Conditions you should pay attention to

• Chest pain
• Severe breathing difficulties
• Eye pain with blurred vision, pupil dilation → Contact your doctor immediately if you experience any of these symptoms and stop treatment

Rare side effects - (may affect up to 1 in 1,000 people)

• Headache, tension, dizziness (sensation of movement or spinning), drowsiness, muscle tremors, agitation, psychomotor hyperactivity
• Dry mouth, nausea, irritation of the mouth and throat, gastrointestinal motility disorders (diarrhea, constipation, and vomiting), stomatitis
• Hypersensitivity, anaphylaxis, and angioedema
• Visual accommodation disorders (blurred vision), pupil dilation (mydriasis), eye pain, dilation of superficial ocular blood vessels (conjunctival hyperemia), glaucoma, increased eye pressure
• Peripheral vasodilation (red, warm skin) at high doses

Very rare side effects - (may affect up to 1 in 10,000 people)

• Cardiac arrhythmias (irregular heartbeat), including atrial fibrillation, supraventricular tachycardia, and extrasystoles
• Myocardial ischemia (reduced oxygen supply to the heart)
• Angina (chest pain)

Side effects frequency not known - (frequency cannot be estimated from the available data):

• Irritability
• Hypokalaemia (reduced potassium levels in the blood)
• Paradoxical bronchospasm (bronchial constriction), hyperventilation (increased respiratory rate immediately after inhalation)
• Cough, dysphonia, throat irritation, sore throat
• Increase in systolic blood pressure / decrease in diastolic blood pressure
• Asthenia
• Urticaria, pruritus, excessive sweating (hyperhidrosis)
• Muscle pain, cramps, muscle weakness, urinary retention
• A condition known as lactic acidosis which may cause stomach ache, hyperventilation, shortness of breath despite improvement of wheezing, cold hands and feet, irregular heartbeat, or thirst.

Following the instructions provided in the package leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.
You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Almeida

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. The expiry date applies to the product in its original packaging, correctly stored.
Store below 25°C.
The contents of a single-dose container must be used immediately after opening; discard any remaining amount.
After opening the aluminium pouch containing the single-dose containers, these must be used within 7 days; after this period, discard any remaining single-dose containers.
The contents of the multidose bottle may be used within 28 days after first opening the bottle; after this period, discard any remaining amount.

6. Package contents and other information

What Almeida contains
Almeida 1.875 mg/0.5 ml + 0.375 mg/0.5 ml nebulising solution (in single-dose containers)

• The active substances are: salbutamol and ipratropium bromide. Each single-dose container contains 1.875 mg of salbutamol (2.25 mg as salbutamol sulfate) and 0.375 mg of ipratropium bromide.
• The other component is: water for injections.

One 0.5 ml container corresponds to 10 drops. One drop (0.05 ml) contains: 187.5 micrograms of
salbutamol and 37.5 micrograms of ipratropium bromide.
Almeida 0.375% + 0.075% nebulising solution (in multi-dose bottle)

• The active substances are: salbutamol and ipratropium bromide. 100 ml of solution contain 0.375 g of salbutamol (0.450 g as salbutamol sulfate) and 0.075 g of ipratropium bromide.
• Other components are: ethyl p-hydroxybenzoate, methyl p-hydroxybenzoate, water for injections.

Description of the appearance of Almeida and contents of the pack
Nebulising solution. The solution may be pale yellow in colour.

• Carton containing 30 single-dose containers of 0.5 ml
• Multi-dose bottle of 15 ml

Marketing Authorisation Holder
I.B.N. Savio S.r.l. - Via del Mare 36, Pomezia (RM)
Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)