Інструкція із застосування OMMUNAL
Зміст інструкції
- OMMUNAL Adults 7 mg hard capsules, Children 3.5 mg hard capsules, Children 3.5 mg granules in sachet
- OMMUNAL and consult your doctor (see section 4 “Possible side effects”). The
OMMUNAL Adults 7 mg hard capsules, Children 3.5 mg hard capsules, Children 3.5 mg granules in sachet
Lyophilized bacterial lysate
Read this leaflet carefully before taking or giving this medicine to your child 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 or your child only. Do not give it to other people, even if they have the same symptoms as you or your child, as it could be harmful.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What OMMUNAL is and what it is used for
- 2. What you need to know before you take OMMUNAL
- 3. How to take OMMUNAL
- 4. Possible side effects
- 5. How to store OMMUNAL
- 6. Contents of the pack and other information
1. What is OMMUNAL and what is it used for
OMMUNAL is a preparation that works by stimulating the body to produce antibodies (proteins that protect it
against germs that cause infectious diseases).
OMMUNAL is used in adults to prevent recurrent respiratory tract infections.
OMMUNAL is used in children and adolescents (ages between 1 and 17 years) to prevent recurrent
infections of the upper airways.
Consult your doctor if you/the child do not feel better or if you feel worse.
2. What you need to know before taking/giving OMMUNAL to the child
Do not take OMMUNAL
- If you are allergic to the active ingredients or to any of the other ingredients of this medicine (listed in section 6).
- If the child is under 1 year of age.
- If you suffer from autoimmune diseases (diseases of the immune system that react against organs and tissues of your own body).
- If you have acute intestinal infections.
Warnings and precautions
Consult your doctor or pharmacist before taking/giving OMMUNAL to the child:
- If you/the child develops a fever, especially at the beginning of treatment: stop taking OMMUNAL and consult your doctor. If you develop a high fever above 39°C (see section 4 “Possible side effects”), stop treatment and do not restart it. The doctor will assess whether this fever is related to taking the medicine or to your/your child's underlying condition.
- If you/the child are taking other medicines with nonspecific immunostimulating activity such as those containing bacterial extracts, do not take/give OMMUNAL to the child as well.
- In some cases, the onset of asthma attacks has been observed in predisposed patients after taking medicines containing bacterial extracts. In this case, OMMUNAL adults/children should no longer be taken.
- If you/the child has an allergic reaction. Stop taking immediately.
OMMUNAL and consult your doctor (see section 4 “Possible side effects”). The
treatment with OMMUNAL should not be restarted.
- The use of OMMUNAL for the prevention of pneumonia is not recommended because there are no data from clinical studies demonstrating such effect.
- OMMUNAL is not indicated for the treatment of acute respiratory infections but exclusively for the prevention of recurrences; however, it is not necessary to suspend the recurrence prophylaxis of respiratory infections during the treatment of an ongoing respiratory tract infection.
Children
Do not give OMMUNAL to children under 1 year of age.
Other medicines and OMMUNAL
Inform your doctor or pharmacist if you/the child is taking, has recently taken or might
take any other medicine.
No interaction studies with other drugs or vaccines have been conducted.
The immune response may be inhibited in subjects with congenital or acquired immunodeficiency, in
immunosuppressive therapy or with corticosteroids.
OMMUNAL with food and drink
See section 3 How to take OMMUNAL.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy or if you are breastfeeding with milk
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Data relating to the use of OMMUNAL in pregnant women are limited. Animal studies
do not indicate any direct or indirect harmful effects regarding reproductive toxicity. As a precautionary
measure, it is preferable to avoid the use of OMMUNAL during pregnancy.
Breastfeeding
Regarding breastfeeding, no specific studies have been conducted and no data are available. Therefore, as a
precautionary measure, it is preferable to avoid the use of the product during breastfeeding.
Fertility
OMMUNAL has not shown effects on fertility.
Driving and operating machinery
OMMUNAL does not influence or negligibly influences the ability to drive vehicles or use
machinery.
OMMUNAL contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially
‘sodium-free’.
3. How to take OMMUNAL
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults and adolescents over 12 years of age:
One hard capsule (7 mg) daily on an empty stomach, for 10 consecutive days in a month, for 3 months
consecutively.
The prophylactic treatment cycle can be repeated if necessary.
Use in children aged between 1 and 12 years:
One hard capsule or 1 sachet (3.5 mg) daily on an empty stomach, for 10 consecutive days in a month, for
3 consecutive months.
The prophylactic treatment cycle can be repeated if necessary.
Method of administration
Oral
The contents of the sachet should be poured into a beverage (water, fruit juice, milk etc.) before
administration.
If you/the child has difficulty swallowing the capsule, you can open the capsule and pour its contents into
a beverage (water, fruit juice, milk, etc.) before administration, in the same way as the sachet.
The mixture dissolves by stirring it gently. Then take the entire mixture within a few minutes and
always stir it just before drinking.
If you take more OMMUNAL than you should
If you have taken too much OMMUNAL, contact your doctor or go to hospital immediately.
If you forget to take OMMUNAL
Do not take a double dose to make up for a missed dose.
If you stop taking OMMUNAL
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you/the child experiences
- stomach and intestinal disorders
- long-lasting respiratory disorders
- allergic reactions stoptreatment. If you/the child experiences skin reactions stoptreatment, as they may be a symptom of an allergic reaction.
Other side effects reported for OMMUNAL are listed below according to frequency:
common (may affect up to 1 in 10 people)
- headache
- cough
- diarrhea
- abdominal pain
- skin rash uncommon (may affect up to 1 in 100 people)
- allergic reactions (erythematous rash, generalized rash, erythema, edema, eyelid edema, facial edema, peripheral edema, swelling, facial swelling, itching, generalized itching, dyspnea)
- urticaria
- fatigue rare (may affect up to 1 in 1,000 people)
- fever not known (frequency cannot be estimated based on available data)
- rapid swelling of the skin and mucous membranes (angioedema)
- vomiting
- nausea.
Reporting of side effects
If you/the child experiences any side effect, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly through 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 OMMUNAL
Keep this medicine out of the sight and reach of children.
Store at a temperature below 30°C.
Store in the original package to protect the medicine from light.
Do not use this medicine after the expiry date which is stated on the package after SCAD.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to eliminate the
medicines that you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What OMMUNAL contains
OMMUNAL Adults 7 mg hard capsules
- The active ingredients contained in one hard capsule are 7 mg of OM-85 lyophilized bacterial lysate of Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae ssp. pneumoniae and ssp.ozaenae, Staphylococcus aureus, Streptococcus pyogenes and sanguinis, Moraxella (Branhamella)catarrhalis.
- The other ingredients are Corn starch (pregelatinized), mannitol, anhydrous propyl gallate (E 310), anhydrous sodium glutamate, magnesium stearate. Capsule shell composition: gelatin, titanium dioxide (E 171), indigotin (E 132).
OMMUNAL Children 3.5 mg hard capsules
- The active ingredients contained in one hard capsule are 3.5 mg of OM-85 lyophilized bacterial lysate of Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae ssp. pneumoniae and ssp. ozaenae, Staphylococcus aureus, Streptococcus pyogenes and sanguinis, Moraxella (Branhamella) catarrhalis.
- The other ingredients are Corn starch (pregelatinized), mannitol, anhydrous propyl gallate (E 310), anhydrous sodium glutamate, magnesium stearate. Capsule shell composition: gelatin, titanium dioxide (E 171), indigotin (E 132). OMMUNAL Children 3.5 mg granules in sachet
- The active ingredients contained in one sachet are 3.5 mg of OM-85 lyophilized bacterial lysate of Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae ssp. pneumoniae and ssp. ozaenae, Staphylococcus aureus, Streptococcus pyogenes and sanguinis, Moraxella (Branhamella) catarrhalis.
- The other ingredients are pregelatinized corn starch, mannitol, magnesium silicate, anhydrous propyl gallate (E310), anhydrous sodium glutamate, magnesium stearate
Description of the appearance of OMMUNAL and contents of the pack
OMMUNAL Adults 7 mg hard capsules are presented as opaque capsules, with a blue body and cap,
containing a powder from white to light beige.
It is available in packs of 10 and 30 hard capsules.
OMMUNAL Children 3.5 mg hard capsules are presented as opaque capsules, with a white body and
blue cap, containing a powder from white to light beige.
It is available in packs of 10 and 30 hard capsules.
OMMUNAL Children 3.5 mg granules in sachet are presented as light beige granules.
It is available in packs of 10 and 30 sachets.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Marketing authorisation holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia 70 - 00181 Roma
Manufacturer
FLAVINE PHARMA FRANCE
3 voie d’Allemagne,
13127 Vitrolles, France

- Країна реєстрації
- Лікарська формаHard capsule, 7 MG
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до OMMUNALЛікарська форма: Powder and solvent for injectable solution, 0,5 MLДіюча речовина: haemophilus influenzae B, combinations with toxoidsВиробник: SANOFI WINTHROP INDUSTRIEПотрібен рецептЛікарська форма: Injectable suspension in pre-filled syringe, 0.5MLДіюча речовина: meningococcus B, multicomponent vaccineВиробник: GLAXOSMITHKLINE VACCINES S.R.L.Рецепт не потрібенЛікарська форма: Injectable suspension, 0.5 MLДіюча речовина: pertussis, purified antigen, combinations with toxoidsВиробник: GLAXOSMITHKLINE S.P.A.Рецепт не потрібен
Аналоги OMMUNAL в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог OMMUNAL у Польща
Аналог OMMUNAL у Україна
Лікарі онлайн щодо OMMUNAL
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на OMMUNAL онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
OMMUNAL потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
OMMUNAL виробляється компанією AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO A.C.R.A.F. S.P.A.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування OMMUNAL з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати OMMUNAL у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною () включають AKTIB, BEXSERO, BOOSTRIX. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
















