Formulamucol 6 mg/ml 100 ml View larger

Formulamucol jarabe 6 mg/ml 100 ml

Indicated in adults and children from 2 years old to reduce excessive bronchial viscosity that usually appears in colds and flu

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 1. Action of FormulaMucol

Formulamucol contains Ambroxol as active ingredient, a mucolytic and expectorant medicine that lowers the viscosity of bronchial secretions and increases its volume thus promoting their removal.


 2. Before taking FormulaMucol
Check with your doctor before taking FormulaMucol if:
- If you are allergic to ambroxol or to any of the excipients.
- If the patient is less than 2 years old.
- If you have fructose intolerance.
- If you have asthma.
- If the cough has persisted for a long time.
- If you have been diagnosed kidney or liver problems or stomach or duodenal ulcers
- If you have a disease called primary ciliary dyskinesia moving airway decreased.
If you notice the appearance of lesions on the skin or mucous, see a doctor immediately and stop treatment with FormulaMucol as a precaution.

Taking with other medicines FormulaMucol
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
FormulaMucol should not be taken with medicines that suppress the cough, such as codeine or dextromethorphan.
The concentrations of antibiotics in mucus FormulaMucol increase if taken with antibiotics (medicines used to treat infections) such as amoxicillin, cefuroxime or erythromycin.

Taking FormulaMucol with food and drink
FormulaMucol should be taken after meals.

Pregnancy and lactation
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, contact your doctor or pharmacist before taking this medicine.
No harmful effects have been observed during pregnancy. However, its use is not recommended during pregnancy, especially during the first 3 months.
It is not recommended to take FormulaMucol if you are breast-feeding, although adverse events are expected in the infant.

Driving and using machines
There have been no studies on the effects on the ability to drive and use machines ambroxol hydrochloride.
There is no evidence that FormulaMucol affect their ability to drive and use machines.
Important information about some of the ingredients of FormulaMucol
This medicine contains sorbitol. If your doctor has told you have an intolerance to some sugars, contact your doctor before taking this medicine.


 3. How to take FormulaMucol
Follow the instructions exactly FormulaMucol management in this leaflet or as your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
Unless prescribed differently, the recommended dose FormulaMucol are:
Adults and children over 12 years old:
During the first 2 or 3 days must be taken 5ml FormulaMucol 6 mg / ml, 3 times a day (every 8 hours), dose corresponding to 90 mg ambroxol hydrochloride per day.
Then be taken 5ml FormulaMucol 6 mg / ml, dose corresponding to 60 mg ambroxol hydrochloride per day.
Is possible to obtain more effective dose of 10 ml of the solution of 6 mg / ml 2 times daily (every 12 hours) (dose corresponding to 120 mg ambroxol hydrochloride per day).

Use in children
Children under 2 years old:
This medicine is contraindicated in children less than 2 years.
Children 2 to 5 years old:
Should be taken FormulaMucol 1.25 ml of 6 mg / ml solution 3 times a day (every 8 hours), corresponding to doses of 22.5 mg ambroxol hydrochloride per day.
Children 6 to 12 years old:
Should be taken FormulaMucol 2.5 ml of 6 mg / ml solution 2 or 3 times a day (every 12 or 8 hours), dose corresponding to 30-45 mg ambroxol hydrochloride per day.


Taking FormulaMucol
This medicine is only to be taken orally.
FormulaMucol should be taken after meals, with the help of the delivery device attached (pressure syringe adapter for the bottle).
You should drink a glass of water after administration, and drink plenty of fluids throughout the day.
Consult your doctor if symptoms do not improve or if they get worse after 5 days (before 3 days in children under 6 years old).
Carefully follow the instructions to ensure proper dosing of the oral solution.
1. Shake the closed bottle before each use
2. Remove the cap childproof the bottle
3. Fit pressing the adapter into the neck of the bottle, while holding the bottle firmly.
4. Before inserting the tip of the syringe into the bottle adapter pressure, push the plunger to bottom, until you reach the tip of the syringe. Firmly insert the tip of the syringe into the bottle adapter opening
5. Turn together the vial and syringe, put the bottle upside down.
6. Pull the plunger of the syringe to extract the correct amount (see figure below)
7. Re-flip the vial into the syringe by placing the bottle up, and remove the syringe from the adapter
8. Enter the medicine directly into the patient's mouth. Do not mix the contents of the syringe with any liquid
9. After swallowing the medicine, you should drink some liquid or juice to wipe his mouth and swallow all the medicine that is left in it
10. After each use, close the jar with the lid
11. Remove the syringe rinsing with tap water and let dry.

If you take more than you should FormulaMucol
If you take too much of this medicine, immediately consult your doctor or the emergency department of the nearest hospital.

In case of overdose or accidental ingestion, immediately seek medical center or call the poison control center (phone +34 91 562 04 20), indicating the medicine and the amount taken. Bring to the hospital or doctor this leaflet and the bottle with the remaining solution, so they know what you have taken.

If you forget to take FormulaMucol
If you forget to take a dose, take it as soon as you remember unless it is almost time for the next dose. In that case, skip the missed dose and take the next dose as planned. Do not take a double dose to make up for missed doses.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.


 4. Possible side effects
Like all medicines, FormulaMucol can cause side effects, although not everybody gets them.
If you notice any of the following serious side effects, stop taking this medicine and call your doctor immediately:
Common side effects (may affect more than 1 in 10 people):
· Diarrhea
Uncommon side effects (may affect up to 1 in 100 people):
· Stomach pain, nausea or vomiting, feel the taste of different foods to which it belongs and dry mouth
· Allergic reactions (itchy skin or rashes, difficulty breathing, rapid heartbeat, swelling of the face or throat, swelling of the skin), fever
Rare side effects (may affect up to 1 in 1,000 people):
· Heartburn
Very rare side effects (may affect up to 1 in 10,000 people):
· Constipation, increased salivation
· Serious hypersensitivity reactions, including shock. Symptoms of a hypersensitivity reaction may include fever, rash, swelling and sometimes a fall in blood pressure
· Difficulty or painful urination
· Runny nose, airway dryness
Not known (frequency can not be estimated from available data):
· Rash or itchy skin
· Numbness throat
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.


 5. Conservation of FormulaMucol
Keep this medicine out of the sight and reach of children.
FormulaMucol Do not use after the expiry date shown on the bottle label and carton after EXP. The expiry date is the last day of that month.
Do not store above 30 ° C. Keep your back upright.
Discard 6 months after first opening the bottle.
Medicines should not be disposed of via wastewater or household waste. Place containers and medicines no longer required in Point SIGRE pharmacy. If in doubt, ask your pharmacist how to dispose of medicines no longer required. This way you will help to protect the environment.


 6. Contents of the pack and other information
Composition of FormulaMucol
The active ingredient is ambroxol hydrochloride. Each milliliter of oral solution contains 6 mg of ambroxol hydrochloride.
The other ingredients are acesulfame potassium (E950), benzoic acid (E210), glycerol (E422), hydroxyethyl cellulose (E1525), propylene glycol (E1520), sorbitol (E420), raspberry flavor, vanilla flavor and purified water.

Authorization holder responsible for marketing and manufacturing
Laboratorios Vicks S.L. Avda. De Bruselas, 24
28108 Alcobendas - Madrid

Responsible for manufacturing
TEVA PHARMA, S.L.U.
C / C, n 4 Malpica Industrial Estate
(Zaragoza) - 50016 - Spain
OR
Merckle GMBH
Ludwig-Merckle-Strasse 3
D-89143 Blaubeuren, Germany
OR
TEVA CZECH INDUSTRIES s.r.o.
Ostravska 29, C.P. 305, Building No 80 Small OSD and building No 881 NOSD
747 70 Opava-Komarov, Czech Republic
OR
TEVA OPERATIONS POLAND SP.Z.O.O. Ul. Mogilska 80
31-546 Krakow, Poland


Source: Spanish Agency for Medicines and Health Products

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