Broncho-Vaxom Children 30 Capsules

What is Broncho-Vaxom Children Capsules and when is it used?

Broncho-Vaxom Children Capsules is used as an immune stimulant to increase your natural defences.

Broncho-Vaxom Children Capsules can prevent recurrent respiratory infections or alleviate flare-ups of chronic bronchitis in adults and children.

When not to take Broncho-Vaxom Children Capsules?

Known hypersensitivity (allergy) to Broncho-Vaxom Children Capsules or any of its excipients (listed in the section What does Broncho-Vaxom contain?).

When is caution needed when taking/using Broncho-Vaxom Children Capsules?

If you are allergic to Broncho-Vaxom, stop treatment immediately and tell your doctor.

Broncho-Vaxom Children Capsules is not recommended for children under 6 months of age.

The use of Broncho-Vaxom to prevent pneumonia is not recommended as there are no data from clinical studies showing such an effect.

Tell your doctor, pharmacist or druggist if you or your child:

• suffer from other diseases
• have allergies or
• take other medicines (including those you bought yourself!) or use them externally

Can Broncho-Vaxom be taken during pregnancy or while breastfeeding?

Pregnancy

Although animal studies have not provided any evidence of a toxic effect, as a precautionary measure, it is not recommended to take Broncho-Vaxom during pregnancy. If you are pregnant or planning to become pregnant, you should ask your doctor for advice before using Broncho-Vaxom.

Lactation

So far, no specific studies and corresponding data are available. However, for safety reasons, the use of Broncho-Vaxom should be avoided if possible during breast-feeding.

If you are breastfeeding your child, you should ask your doctor for advice before using Broncho-Vaxom.

How do you use Broncho-Vaxom Children Capsules?

Broncho-Vaxom Children Capsules is for oral use.

Adults and young people over 12 years

For the preventive course of treatment for recurrent respiratory infections, the recommended dose is: 1 Broncho-Vaxom «Adult» capsule per day for 10 consecutive days per month for a period of 3 consecutive months.

Broncho-Vaxom is not indicated for the treatment of acute respiratory infections, but as a prophylaxis against their recurrence.

Preventive treatment can be initiated concomitantly with other treatments during the acute phase of respiratory infection.

Children between 6 months and 12 years:

For the preventive course of treatment for recurrent respiratory infections, the recommended dose is: 1 capsule of Broncho-Vaxom «Children» or 1 sachet of Broncho-Vaxom «Children» per day for 10 consecutive days per month for a period of 3 consecutive months.

Broncho-Vaxom Children Capsules is not indicated for the treatment of acute respiratory infections, but as a prophylaxis against their recurrence.

Preventive treatment can be initiated concomitantly with other treatments during the acute phase of respiratory infection.

Note: If the child has difficulty swallowing the capsule, it is also possible to open the capsule and mix the contents with a drink (water, fruit juice or milk) instead of the dosage form in the sachet. Gently stir the mixture for a few minutes until the contents are completely dissolved. Then drink the whole mixture.

Follow the dosage given in the package leaflet or prescribed by your doctor. If you think the medicine is too weak or too strong, talk to your doctor, pharmacist or druggist.

What side effects can Broncho-Vaxom Children Capsules have?

Using Broncho-Vaxom Children Capsules can cause the following side effects:

Common (affects 1 to 10 users in 100):

Headache, cough, diarrhea, abdominal pain, skin rash

Uncommon (affects 1 to 10 users in 1000):

Nausea, vomiting, hives, tiredness.

Allergic reactions including rash, redness, swelling of the eyelids, face, ankles, feet or fingers, itching, sudden shortness of breath or difficulty breathing

Rarely:

Fever

Not known:

Swelling of the skin or mucous membranes

If gastrointestinal or respiratory problems persist, please discontinue treatment and inform your doctor.

If you notice side effects, contact your doctor, pharmacist or druggist. This also applies in particular to side effects that are not listed in this leaflet.

What should also be noted?

The medicinal product may only be used up to the date marked “EXP” on the container.

Storage Notice

Store at room temperature (15-25°C) in the original packaging. Keep out of reach of children.

More information

Your doctor, pharmacist or druggist can provide you with further information. These people have the detailed information for specialists.

What is in Broncho-Vaxom?

Active Ingredients

1 Broncho-Vaxom «Adult» capsule contains 7 mg freeze-dried bacterial lysate from Haemophilus influenzae, Streptococcus (Diplococcus) pneumoniae, Klebsiella pneumoniae ssp. pneumoniae and ssp ozaenae, Staphylococcus aureus, Streptococcus pyogenes and sanguinis (viridans), Moraxella (Branhamella/Neisseria) catarrhalis .

1 capsule Broncho-Vaxom «Children» contains 3.5 mg freeze-dried bacterial lysate from Haemophilus influenzae, Streptococcus (Diplococcus) pneumoniae, Klebsiella pneumoniae ssp. pneumoniae and ssp. ozaenae, Staphylococcus aureus, Streptococcus pyogenes and sanguinis (viridans), Moraxella (Branhamella/Neisseria) catarrhalis .

Excipients

Capsules : corn starch (pregelatinized), magnesium stearate, mannitol, monosodium glutamate, antioxidant: propyl gallate (E310), titanium dioxide (E171), colour: indigo carmine (E132) and gelatin.

Granules in sachets : maize starch (pregelatinized), magnesium stearate, magnesium silicate, monosodium glutamate, mannitol, propyl gallate (E310).

Registration Number

00596 (capsules, adults) (Swissmedic).

00597 (capsules, children) (Swissmedic).

00667 (granules in bags, children) (Swissmedic).

Where can you get Broncho-Vaxom? What packs are available?

In pharmacies and drugstores, without medical prescription.

Broncho-Vaxom Adult Capsules: 10 and 30 capsules.

Broncho-Vaxom Children, Capsules: 10 and 30 capsules.

Broncho-Vaxom Children, granules in sachets: 10 and 30 sachets.

Marketing Authorization Holder

OM Pharma SA

22, Rue du Bois-du-Lan, 1217 Meyrin (Switzerland).