BoxaGrippal forte 400 mg/60 mg 12 film-coated tablets

BoxaGrippal forte 400 mg/60 mg - film-coated tablets contain two active ingredients: ibuprofen and pseudoephedrine hydrochloride.

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Non-steroidal anti-inflammatory drugs have analgesic and antipyretic effects. Pseudoephedrine hydrochloride belongs to the group of medicines known as vasoconstrictors, whose vasoconstricting effect causes the nasal mucosa to swell.

BoxaGrippal forte 400 mg/60 mg - film-coated tablets are used for the symptomatic relief of nasal congestion accompanied by headaches and/or fever in flu-like infections in adults and adolescents aged 15 and over.

You should only use this combination medicine if you have both a stuffy nose and pain or fever. If you only have one of these symptoms, please talk to your doctor or pharmacist about treatment with ibuprofen or pseudoephedrine hydrochloride only.

If you don't feel better or feel worse after 5 days, contact your doctor.

Contraindications

BoxaGrippal forte must not be taken

• if you are allergic to ibuprofen, pseudoephedrine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if you are younger than 15 years old;
• during pregnancy and breastfeeding;
• if you have previously experienced an allergic reaction or asthma, skin rash, itchy, runny nose or facial swelling after taking this medicine, ibuprofen, acetylsalicylic acid or similar medicines;
• if you have a history of stomach or duodenal ulcers or gastrointestinal bleeding associated with previous treatment with non-steroidal anti-inflammatory drugs (NSAIDs);
• in case of severe liver or kidney disease;
• if you have heart problems (such as coronary insufficiency);
• if you have had a myocardial infarction (heart attack);
• with inadequately controlled high blood pressure;
• if you have had a stroke or have been diagnosed with risk factors for a stroke in the past;
• if you have suffered from seizures in the past;
• if you have unexplained blood formation disorders;
• if you suffer from increased intraocular pressure (narrow-angle glaucoma);
• if you have difficulty urinating due to prostate problems;
• if you suffer from systemic lupus erythematosus (SLE); a disease triggered by the immune system that causes joint pain, skin changes and other problems;
• if you use the following medicines:
• other vasoconstrictors that are taken to treat swelling of the nasal mucosa or applied directly in the nose (e.g. medicines with the active ingredients phenylpropanolamine, phenylephrine, ephedrine, xylometazoline or oxymetazoline), or methylphenidate;
• Medicines for depression, such as non-selective monoamine oxidase inhibitors (MAOIs, e.g. tranylcypromine) - even if you have used them in the last 14 days.

Interactions

In particular, tell your doctor or pharmacist if you are using the following medicines:

• Platelet aggregation inhibitors and oral anticoagulants (have a blood thinning/anticoagulant effect, e.g. acetylsalicylic acid, warfarin, ticlopidine);
• other non-steroidal anti-inflammatory drugs (NSAIDs) including high-dose acetylsalicylic acid;
• cardiac glycosides (e.g. digoxin);
• corticosteroids;
• heparin injections;
• certain medicines used to treat depression (e.g. lithium, selective serotonin reuptake inhibitors, monoamine oxidase A inhibitors);
• High-dose methotrexate (more than 20 mg per week);
• Quinolone-type antibiotics (used to treat a variety of infections);
• ciclosporin, tacrolimus and trimethoprim;
• Medicines used to treat hypertension (high blood pressure);
• Anti-migraine medicines (including ergot alkaloids);
• zidovudine (a medicine used to treat HIV/AIDS);
• preparations containing Ginkgo biloba;
• CYP2C9 inhibitors (e.g. voriconazole or fluconazole);
• Mifepristone (used to terminate pregnancy).

BoxaGrippal forte 400 mg/60 mg - film-coated tablets must not be used in combination with the following medicines:

• other vasoconstrictor medicines that are taken to treat swelling of the nasal mucosa or applied directly into the nose (e.g. medicines containing the active ingredients phenylpropanolamine, phenylephrine and ephedrine), or methylphenidate;
• non-selective monoamine oxidase inhibitors (MAOIs such as tranylcypromine), which are prescribed to treat certain depressive conditions.

After taking pseudoephedrine hydrochloride, an acute increase in blood pressure may occur during surgery. Therefore, stop treatment with BoxaGrippal forte 400 mg/60 mg film-coated tablets a few days before a planned surgical procedure and inform your anesthetist about this.

Taking BoxaGrippal forte 400 mg/60 mg - film-coated tablets with food, drinks and alcohol
. Do not take the tablets with alcoholic drinks.

Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding ,
think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine
should not be used during pregnancy or breastfeeding.

Athletes
The use of the drug BoxaGrippal forte 400 mg/60 mg - film-coated tablets can lead to positive results in doping controls.

Ability to drive and use machines
BoxaGrippal forte 400 mg/60 mg - film-coated tablets can cause dizziness and/or blurred vision; The ability to drive a vehicle and operate machines may therefore be temporarily restricted.

Caution: This medicine can impair your ability to react and drive

Application

This medicine is for short-term use only. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2). Do not take BoxaGrippal forte 400 mg/60 mg film-coated tablets for longer than 5 days without medical advice.

The recommended dose is:
Adults and adolescents aged 15 years and over take 1 tablet if the symptoms are severe, every 6 hours if necessary.
For less severe symptoms, taking 1 tablet of a lower-dose drug containing 200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride may be sufficient; if necessary every 6 hours.

A maximum daily dose of 3 tablets of BoxaGrippal forte 400 mg/60 mg - film-coated tablets (corresponding to 1200 mg ibuprofen and 180 mg pseudoephedrine hydrochloride) must not be exceeded under any circumstances.

Take the film-coated tablets whole with a glass of water, preferably with meals.

Do not use for long periods of time or in higher concentrations or doses than recommended without a doctor's advice.

Use in children and adolescents
BoxaGrippal forte 400 mg/60 mg - film-coated tablets must not be used in children and adolescents under 15 years of age.

If this medicine is needed for more than 3 days in adolescents or if symptoms worsen, consult a doctor.

Side effects

Like all medicines, BoxaGrippal forte 400 mg/60 mg - film-coated tablets can cause side effects, although not everyone gets them.
Stop taking BoxaGrippal forte 400 mg/60 mg - film-coated tablets immediately and seek medical advice immediately if you notice the following:

• Signs of gastrointestinal bleeding such as: B. bright red stools, black stools (tarry stools), vomiting blood, or vomit that looks like coffee grounds
• Signs of a serious allergic reaction such as: B. severe rashes, peeling, peeling or blistering of the skin, facial swelling, unexplained wheezing, shortness of breath, tendency to bruise
• A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include rash, fever, swollen lymph nodes, and an increase in eosinophils (a form of white blood cells).

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

Frequency “Not known”

• At the start of treatment, a red, scaly, widespread rash with bumps under the skin and blisters accompanied by fever, primarily on the skin folds, trunk and upper extremities (acute generalized pustular rash). Stop using BoxaGrippal forte if you develop these symptoms and seek medical treatment immediately. See also section 2.
• Inflammation of the colon due to insufficient blood supply (ischemic colitis)
• Reduced blood supply to the optic nerve (ischemic optic neuropathy)

If you experience these symptoms, stop taking BoxaGrippal and contact a doctor immediately.

Common (affects 1 to 10 people in 100):

• Indigestion
• stomach pain
• nausea
• Vomit
• Flatulence
• Diarrhea
• constipation

Uncommon (affects 1 to 10 people in 1,000):

• Headache
• dizziness
• sleep disorders
• restlessness
• irritability
• fatigue
• Vision problems
• Ulcers in the gastrointestinal area, sometimes with bleeding and perforation
• Worsening of chronic inflammatory bowel diseases (e.g. colitis and Crohn's disease)
• Rashes

Rare (affects 1 to 10 people in 10,000):

• Tinnitus (ringing in the ears)
• Kidney tissue damage

Very rare (affects less than 1 in 10,000 people):

• impaired production of blood cells; This can manifest itself in an increased tendency to bruises or susceptibility to infections
• severe allergic reactions
• psychotic reactions
• depression
• high blood pressure
• heart palpitations
• Heart attack
• Inflammation of the blood vessels (vasculitis)
• Liver dysfunction
• severe skin reactions
• Kidney damage
• Difficulty urinating

Not known (frequency cannot be estimated from available data):

• increased skin sensitivity to the sun

composition

The active ingredients are: 1 film-coated tablet contains 400 mg ibuprofen and 60 mg pseudoephedrine hydrochloride.

The other components are:

• Tablet core
  lactose monohydrate, microcrystalline cellulose, carboxymethyl starch sodium (type A), colloidal silicon dioxide, magnesium stearate
• Tablet coating
  polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc

Usually ships out within 3-4 business days