Description

Ibuprom Zatoki Sprint is a medication intended for children over 12 years of age and adults for the short-term relief of flu and cold symptoms, including pain, fever, nasal and sinus congestion. The medication contains ibuprofen and pseudoephedrine hydrochloride.

Composition

The active substance is ibuprofen ( Ibuprofenum ) and pseudoephedrine hydrochloride ( Pseudoephedrini hydrochloridum ).

1 soft capsule contains:
Ibuprofen ( Ibuprofenum ) 200 mg
Pseudoephedrine hydrochloride ( Pseudoephedrini hydrochloridum ) 30 mg

Excipients: macrogol 600; potassium hydroxide; purified water; gelatin; sorbitol, liquid, partially dehydrated; purified water; natural Beta Carotene 10% CWD, powder, composition (natural beta carotene (E160), modified food starch (E1450), dl-Alpha tocopherol (E307)); printing ink, composition (shellac, iron oxide, black (E172), N-butyl alcohol, propylene glycol, ammonium hydroxide 28%).

Dosage

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you have any questions, ask your doctor or pharmacist.

The drug should only be taken orally and for a short time.

The lowest possible effective doses should be used to reduce the risk of side effects.

Children over 12 years of age, adults and the elderly:

1 to 2 capsules every 4 to 6 hours, maximum dose is 6 capsules per day.

Action

The medicinal product Ibuprom Zatoki Sprint has analgesic, antipyretic, anti-inflammatory properties and reduces nasal congestion.

Indications

Ibuprom Sinus Sprint is used to relieve symptoms associated with nasal congestion or sinus headache, fever, and joint and muscle pain associated with colds and flu.

Contraindications

Apart from contraindications related to use with other drugs, the drug should not be used in case of hypersensitivity to the active substances or to any of the excipients.

This medicinal product is not recommended for use in patients with hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, active or recurrent peptic ulcer or gastrointestinal bleeding, a history of hemorrhagic stroke, severe heart failure (NYHA class IV), renal failure, or hepatic failure. It should not be used in patients with heart disease, circulatory system disease, hypertension, prostatic hyperplasia, coronary artery disease, angina pectoris, tachycardia, or a hemorrhagic diathesis.

More information in the leaflet provided with the medicine.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (affects 1 to 10 patients in 100 taking the medicine): Indigestion, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, loss of appetite, slight blood loss from the gastrointestinal tract, in rare cases leading to anemia.

Uncommon (affects 1 to 10 users in 1,000): Hypersensitivity reactions: hives, itching and asthma attacks (with drop in blood pressure), central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or fatigue, visual disturbances, stomach ulcer with bleeding and/or perforation, gastritis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease, various skin rashes.

Rare (in 1 to 10 out of 10,000 patients taking the medicine): tinnitus, worsening of asthma or hypersensitivity reactions with bronchospasm, kidney tissue damage (renal papillary necrosis) and increased uric acid levels in the blood.

More information in the leaflet provided with the medicine.

Warnings and precautions

Ibuprom Zatoki Sprint should only be used if you experience nasal congestion along with headache, pain, and/or fever. It should not be used if you have only one of these symptoms.

This medicine contains 63 mg of sorbitol per capsule. Consult your doctor before taking this medicine if you have an intolerance to some sugars.

One capsule of Ibuprom Zatoki Sprint contains 21 mg of potassium. This should be taken into account in patients with reduced kidney function and in patients who are monitoring the potassium content in their diet.

Use of other medications

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken or might take.

You should not use this medicine if you are taking: other non-steroidal anti-inflammatory drugs (NSAIDs); decongestant medicines (nasal or oral); in the past or within the last two weeks, antidepressants known as
monoamine oxidase inhibitors (MAOIs); tricyclic antidepressants (used to treat depression).

You should tell your doctor if you are taking:

• medicines that have an anticoagulant effect (i.e. thin the blood/prevent clots, such as warfarin, ticlopidine, aspirin/acetylsalicylic acid);
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as medicines containing atenolol, angiotensin II receptor antagonists
• cardiac glycosides such as digoxin (digitalis) or quinidine used to treat heart conditions; − phenytoin (a medicine used to treat epilepsy);
• lithium (used to treat mood disorders);
• methotrexate (used to treat arthritis);
• antacids (drugs used to treat symptoms of stomach ulcers, e.g. heartburn);
• cyclosporines (used to weaken the body's immune system, e.g. after a transplant);
• mifepristone (used to terminate pregnancy);
• quinolone antibiotics (used to treat a wide range of infections);
• tacrolimus (a drug used after transplantation);
• medicines known as sulfonylureas, such as glibenclamide (used to treat diabetes);
• corticosteroids (a type of anti-inflammatory drug, e.g. hydrocortisone);
• selective serotonin reuptake inhibitors (SSRIs, e.g., fluoxetine) (drugs used to treat depression);
• aminoglycosides (e.g., gentamicin or amikacin) (drugs used to treat infections);
• the antibacterial drug furazolidone (drugs used to treat infections);
• zidovudine (used to treat HIV infection);
• guanethidine, reserpine or methyldopa (drugs used to treat heart and circulatory system diseases);
• sulfinpyrazone and probenecid (drugs used to treat gout);
• potassium-sparing diuretics (drugs used to treat heart disease);
• ergot derivatives (drugs used to treat migraines);
• dopamine receptor agonists (drugs used to treat symptoms of Parkinson's disease);
• heparin, Ginkgo biloba (used to treat blood clots).

More information in the leaflet provided with the medicine.

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.

The use of Ibuprom Zatoki Sprint is contraindicated during pregnancy and breastfeeding.

Impact on fertility

If you are having problems getting pregnant, tell your doctor that you are taking this medicine.

Use of the drug in children and adolescents

The medicinal product Ibuprom Zatoki Sprint is contraindicated for use in children under 12 years of age.

Driving and operating machinery

This medicinal product has minor or moderate influence on the ability to drive and use machines. Caution should be exercised.