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Symptomatic treatment of cough forms not accompanied by expectoration (irritative cough, nervous cough) for adults and adolescents from 12 years old
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1. What it is FORMULATUS and what it is used.
FormulaTus 7.33 mg lozenges honey flavor contains dextromethorphan as the active ingredient, a cough suppressant that inhibits the cough reflex.
It is indicated for the symptomatic treatment of cough forms not accompanied by expectoration (irritative cough, nervous cough) for adults and adolescents from 12 years old.
You should consult a doctor if worsens or does not improve after 7 days of treatment.
2. What you need to know before you start taking FORMULATUS
Not take FormulaTus if:
- If you are allergic to dextromethorphan or any of the other ingredients of this medicine (listed in section 6).
- If you have severe lung disease.
- If you have difficulty breathing.
- If you have asthmatic cough.
- If you have a cough accompanied by abundant secretions
- If you are being treated or if it has been during the previous two weeks with medication monoamine oxidase inhibitor (MAOI) used for depression treatment for Parkinson's disease or other diseases as well as other medicines inhibiting reuptake serotonin used to treat depression as fluoxetine and paroxetine; or with bupropion is a medicine used to stop smoking or linezolid is an antibacterial medicine (see section Taking other medicines).
Children under 12 years old can not take this medicine.
Warnings and Precautions
Should consult their doctor or pharmacist before you start taking this medicine patients:
- With chronic, such as due to persistent cough or snuff. Especially in children chronic cough could be an early symptom of asthma.
- With liver disease
- With atopic dermatitis (inflammatory skin disease characterized by erythema, itching, oozing, crusting and scaling, which begins in childhood allergic individuals with hereditary predisposition)
- Who they are sedated, debilitated or bedridden.
They have been reported cases of abuse with medications containing dextromethorphan by adolescents therefore should be taken into account this possibility, because they can cause serious adverse effects (see section FormulaTus If you take more than you should).
Taking FormulaTus with other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Taking FormulaTus with food, drink and alcohol
should not drink alcohol during treatment because it can cause adverse effects. Not be taken together with grapefruit juice, orange or bitter because they may increase the adverse effects of this medicine.
Taking food or drink does not affect the effectiveness of the medicine.
Pregnancy, lactation and fertility.
If you are pregnant or breast feeding, or think you might be pregnant or planning to become pregnant, ask your doctor or pharmacist before using this medicine.
Pregnant or lactating women should not take this medicine without consulting a doctor
Driving and using machines.
On rare occasions, during treatment, you may appear mild drowsiness and dizziness, so if noticing these symptoms you should not drive a car or operate hazardous machinery.
FormulaTus contains sucrose and glucose:
If your doctor has told you have an intolerance to some sugars, contact your doctor before taking this medicine.
Patients with diabetes mellitus should be aware that this medicine contains 2.2 g of sucrose and 1.1 g of glucose per tablet. It can cause tooth decay.
3. How to take FORMULATUS
Follow exactly the instructions of medicine administration in this leaflet or as your doctor or pharmacist. If in doubt, ask your doctor or pharmacist. The recommended dose is:
Adults and adolescents from 12 years old: 2 tablets dissolved in the mouth, one after the other. Repeat every 6-8 hours as needed, in no case more than 8 pills taken within 24 hours
Do not exceed the recommended dose.
Use in Children: This medicine is contraindicated in children under 12 years old.
How to take
FormulaTus is taken by mouth
Remove the tablet from the blister pack, place it in your mouth and let it dissolve completely. Do not chew or swallow.
Do not take with grapefruit juice or bitter orange or with alcohol (see section Taking FormulaTus with food, drinks and alcohol)
If it gets worse, or if symptoms persist for more than 7 days of treatment, or if accompanied by high fever, rash or persistent headache, consult your doctor.
If you take more than you should FormulaTus
If you take more than the recommended FormulaTus you may notice: confusion, excitability, restlessness, nervousness and irritability.
Taking very high amounts of this medicine in children can produce a state of torpor, nervousness, nausea, vomiting or changes in gait.
There have been instances of abuse with medicines containing dextromethorphan, serious adverse effects may appear: anxiety, panic, memory loss, tachycardia (accelerated heartbeat), lethargy, hypertension or hypotension (high or low voltage) mydriasis (dilation of the pupil of the eye), agitation, dizziness, gastrointestinal disturbances, slurred speech, nystagmus (uncontrolled, involuntary eye movement), fever, tachypnea (rapid, shallow breathing), brain damage, ataxia (uncoordinated movements) seizures, respiratory depression, unconsciousness, arrhythmias (irregular heartbeat) and death.
In case of overdose or accidental ingestion, seek medical attention or call poison control center (phone +34 91 562 04 20), indicating the medicine and the amount taken.
4. Possible side effects
Like all FormulaTus medicines can cause side effects, although not everybody gets them.
During the period of use of dextromethorphan, they have observed the following side effects whose frequency has not been able to establish exactly:
- In some cases drowsiness, lightheadedness, dizziness, constipation, gastrointestinal discomfort, nausea, vomiting.
- In more rare: mental confusion and headache.
If you experience side effects talk to your doctor or pharmacist, even if it comes to possible side effects not listed in this leaflet.
5. Conservation of FORMULATUS
Keep this medicine out of the sight and reach of children. Store in the original container in a dry place to protect from moisture. Do not store above 25 ° C.
Do not use this medicine after the expiry date on the carton after "Expiry". The expiry date is the last day of that month.
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. Other information
Composition of FormulaTus
⋅ The active ingredient is dextromethorphan. Each lozenge contains 7.33 mg of dextromethorphan.
⋅ The (excipients) other ingredients are: sucrose, glucose syrup, menthol, honey, aroma of honey, cream-caramel flavor.
Holder of the marketing authorization:
Laboratorios Vicks, S.L.
Avda. De Bruselas, 24 28108 Alcobendas. Madrid
Responsible of Manufacture:
Procter & Gamble GmbH
Procter & Gamble Strasse
64521 Gross Gerau
Source: Spanish Agency for Medicines and Health Products