Film-coated tablets for oral use based on the active ingredient ibuprofen and pseudoephedrine hydrochloride.
Therapeutic indications
ZerinoDek film-coated tablets are indicated for the symptomatic treatment of nasal congestion associated with headache and / or fever in adults and adolescents over 15 years of age suffering from the common cold. You should only take this combination if you have a blocked nose with pain or fever. If you have any of these symptoms you should consult your pharmacist or doctor about using ibuprofen or pseudoephedrine alone. Talk to your doctor if you don't feel better or if you feel worse after 5 days.
Ibuprofen belongs to a class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by reducing pain and lowering fever. Pseudoephedrine belongs to a class of drugs called vasoconstrictors, which work on the blood vessels inside the nose to relieve nasal congestion.
Dosage and posology
The recommended dose is:
- Adults and adolescents aged 15 years and over: 1 tablet every 6 hours as needed. For more severe symptoms, take 2 tablets every 6 hours as needed. Never exceed the maximum daily dose of 6 tablets per day (corresponding to 1200 mg of ibuprofen and 180 mg of pseudoephedrine hydrochloride). The tablets should be taken without chewing them with a glass of water, preferably with meals.
- Use in children and adolescents: ZerinoDek should not be given to children and adolescents under the age of 15 years. If the use of the medicine is necessary for more than 3 days in adolescents, or in the case of worsening of symptoms, the doctor should be consulted.
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. This product should only be used for short periods of treatment. You should take the lowest dose for the shortest time necessary to relieve symptoms. Do not take the product for more than 5 days, unless prescribed by your doctor.
Overdose
If you take more ZerinoDek than you should Stop the treatment and consult your doctor immediately, even if you feel well.
Contraindications
Do not take ZerinoDek if:
- if you are allergic to ibuprofen or pseudoephedrine hydrochloride or any of the other ingredients of this medicine
- is under 15 years old
- you are a pregnant or breastfeeding woman
- have ever had a previous allergic reaction or asthma, rash, runny itchy nose or facial swelling while taking this product, ibuprofen, acetylsalicylic acid or other similar medicines
- have a history of recurrent gastric or duodenal ulcer or have had gastrointestinal bleeding related to previous NSAID therapy
- suffer from severe liver or kidney disease
- have heart problems (such as coronary insufficiency)
- have a history of heart attack (myocardial infarction)
- suffer from uncontrolled high blood pressure
- have had a stroke or have been told in the past that you are at risk of having a stroke
- have a history of fits (seizures)
- suffer from disturbances in the production of blood components of unknown origin
- suffer from increased intraocular pressure (narrow-angle glaucoma)
- suffer from difficulty urinating related to prostate problems
- You have been diagnosed with systemic lupus erythematosus (SLE), a disease that affects the immune system and causes joint pain, skin changes and other problems
- if you are taking: other nasal decongestants (vasoconstrictors) administered orally or nasally (e.g. phenylpropanolamine, phenylephrine, ephedrine, xylometazoline or oxymetazoline) or methylphenidate, medicines for depression, such as non-selective monoamine oxidase inhibitors (known as MAOIs e.g. iproniazid) or if you have taken them in the past 14 days.
Side effects
Like all medicines, ZerinoDek can cause side effects, although not everybody gets them. Stop taking ZerinoDek immediately and see your doctor right away if any of the following occur:
- Signs of bleeding from the gut such as: bright red stools (excrements), black stools, vomit containing blood or dark coffee-grounds-like particles
- Signs of severe allergic reaction such as: severe rash, peeling or peeling or blistering of the skin, facial swelling, shortness of breath of unknown origin, shortness of breath, bruising easily.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. ZerinoDek is contraindicated during pregnancy and breastfeeding.
Special warnings
You should discuss your therapy with your doctor or pharmacist before taking ZerinoDek:
- if you suffer from asthma; the use of this drug can cause an asthma attack
- if you have a history of gastrointestinal disease (such as hiatus hernia, gastrointestinal bleeding, peptic or duodenal ulcer)
- if you have heart problems including heart attack, angina (chest pain) or if you have a history of heart attack, coronary artery bypass grafting, peripheral arterial disease (poor circulation in the legs or feet due to narrowing or blocked arteries) or any type of stroke (including 'mini stroke' or "TIA", transient ischemic attack)
- if you have high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker
- if you suffer from hyperthyroidism (overactive thyroid)
- if you are taking drugs that interact with Ibuprofen and pseudoephedrine. Anti-inflammatory / pain-relieving drugs such as ibuprofen may be associated with a modest increased risk of heart attack or stroke, especially when given in high doses. Do not exceed the recommended dose or duration of treatment.
ZerinoDek contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Expiry and retention
Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Store below 25 ° C.
Warning : do not use the medicine after the expiry date indicated on the package.
Composition
Each ZerinoDek tablet contains:
Active principles
Ibuprofen 200 mg pseudoephedrine hydrochloride 30 mg.
Excipients
Core: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), colloidal anhydrous silica, magnesium stearate.
Coating: alcohol, polyvinyl titanium dioxide (E 171), macrogol type 3350, talc.