Boehringer Ingelheim BoxaGrippal 200 mg/30 mg - 20 tablets

The ibuprofen in BoxaGrippal has a pain-relieving, fever-reducing and anti-inflammatory effect. The use of anti-inflammatory ibuprofen makes sense when you have a cold because a cold is an inflammatory process.
The second component of BoxaGrippal®, PSE, decongests the mucous membranes in the nose and sinuses. Result: Ventilation is improved and inflammatory secretions can drain off unhindered. In addition, breathing becomes easier again and the mucous membrane can heal. The mode of action of PSE can be imagined as a "decongestant nasal spray from the inside". The great thing: In contrast to most nasal sprays, the PSE inBoxaGrippal® can also reach the mucous membranes of the sinuses

field of use

BoxaGrippal 200 mg/30 mg film-coated tablets are used for the symptomatic relief of nasal congestion accompanied by headaches and/or fever associated with flu-like infections in adults and adolescents aged 15 and over.

You should only use this combination medicine if you have both nasal congestion 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 do not feel better or if you feel worse after 5 days, contact your doctor

Contraindications

BoxaGrippal 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 under 15 years old;
• during pregnancy and lactation;
• if you have previously had 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 insufficiently 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 had seizures in the past;
• in unexplained disorders of blood formation;
• if you suffer from increased pressure in the eye (narrow-angle glaucoma);
• if you have problems urinating due to prostate problems;
• if you suffer from systemic lupus erythematosus (SLE), a disease caused by the immune system that causes joint pain, skin changes and other symptoms;
• if you are taking the following medicines:
  other vasoconstrictor medicines taken or used in the nose to treat swelling of the lining of the nose (e.g. medicines containing the active substances 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

BoxaGrippal may affect or be affected by other medicines. For example:

• Medicines that have an anticoagulant effect (i.e. thin the blood/prevent clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine)
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as medicines containing atenolol, angiotensin II receptor antagonists such as losartan)

Some other medicines can also affect or be affected by treatment with BoxaGrippal 200 mg/30 mg film-coated tablets. You should therefore always seek the advice of your doctor or pharmacist before using BoxaGrippal 200 mg/30 mg film-coated tablets with other medicines.

In particular, tell your doctor or pharmacist if you are taking 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 doses of acetylsalicylic acid;
• Herzglycoside (z. B. 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 to treat hypertension (high blood pressure);
• medicines for migraines (including ergot alkaloids);
• zidovudine (a medicine used to treat HIV/AIDS);
• Preparations containing ginkgo biloba.

BoxaGrippal 200 mg/30 mg film-coated tablets must not be used in combination with the following medicines:

• other vasoconstrictive medicines taken or used in the nose to treat congestion in the lining of the nose (e.g. medicines containing the active substances phenylpropanolamine, phenylephrine and ephedrine), or methylphenidate;
• non-selective monoamine oxidase inhibitors (MAOIs such as iproniazid) prescribed to treat certain major depressive disorders.

After taking pseudoephedrine hydrochloride, an acute increase in blood pressure can occur during an operation. Therefore, stop treatment with BoxaGrippal 200 mg/30 mg film-coated tablets a few days before you plan to have surgery and tell your anesthesiologist about it.

Taking BoxaGrippal with food, drink and alcohol
Do not take the tablet with alcoholic drinks.

Pregnancy, breast-feeding and fertility
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.

BoxaGrippal 200 mg/30 mg film-coated tablets must not be used during pregnancy and breastfeeding.

Athletes
The use of the drug BoxaGrippal 200 mg/30 mg film-coated tablets can lead to positive results in doping controls. 

BoxaGrippal contains lactose
Please only take BoxaGrippal 200 mg/30 mg film-coated tablets after consulting your doctor if you know that you suffer from a sugar intolerance. 

application

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

This medicine is for short-term use only. You should take the lowest dose for the shortest time needed to treat your symptoms. Do not take BoxaGrippal 200 mg/30 mg film-coated tablets for more than 5 days without medical advice.

The recommended dose is:
Adults and adolescents 15 years and older take 1 tablet, if necessary every 6 hours. For more severe symptoms, take 2 tablets, every 6 hours if necessary.

A maximum daily dose of 6 tablets (equivalent to 1,200 mg ibuprofen and 180 mg pseudoephedrine hydrochloride) must not be exceeded under any circumstances.

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

Use in children and adolescents
BoxaGrippal 200 mg/30 mg film-coated tablets must not be used in children and adolescents under 15 years of age.
If adolescents require this medicine for more than 3 days or if symptoms worsen, a doctor should be consulted.

side effects

Like all medicines, BoxaGrippal 200 mg/30 mg film-coated tablets can have side effects, although not everyone gets them.

Stop taking BoxaGrippal and seek medical advice immediately if you notice any of 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 severe allergic reaction such as B. severe skin rashes, peeling, flaking or blistering of the skin, swelling of the face, unexplained wheezing, shortness of breath, easy bruising
• A severe skin reaction known as DRESS syndrome can occur.
  - Symptoms of DRESS include a rash, fever, swollen lymph nodes and
  an increase in eosinophils (a type of white blood cell).

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

Frequency "Not known"

• Sudden onset of fever, reddening of the skin or many small pustules (possible signs of acute generalized exanthematous pustulosis - AGEP) can occur within the first 2 days of treatment with BoxaGrippal. See section 2.
• Inflammation of the large intestine due to insufficient blood supply (ischemic colitis)

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

Common (affects 1 to 10 users in 100):

• indigestion
• stomach pain
• nausea
• Vomit
• gas
• Diarrhea
• constipation

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

• headache
• dizziness
• weariness
• sleep disorders
• restlessness
• irritability
• fatigue
• visual disturbances
• Gastrointestinal ulcers, sometimes with bleeding and perforation
• Worsening of colitis (inflammation of the colon) and Crohn's disease
• skin rashes

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

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

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

• Impaired production of blood cells; this may manifest itself as an increased tendency to bruise or be more susceptible to infections
• severe allergic reactions
• psychotic reactions
• Depression
• high blood pressure
• palpitations
• Heart attack
• liver dysfunction
• severe skin reactions
• kidney damage
• difficulty urinating

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

• increased sun sensitivity of the skin 

composition

The active ingredients are: 1 film-coated tablet contains 200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride.

The other ingredients are:
Tablet
core lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), anhydrous colloidal anhydrous silica, magnesium stearate,
tablet
coating polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc