IBUPROM SINUS 200mg/30mg x 24 tabl
IBUPROM SINUS tab. * 12
Leaflet: user information
IBUPROM SINUS 200 mg/30 mg coated tablets
IBUPROM SINUS 200 mg/30 mg coated tablets
Ibuprofen/Pseudoephedrine Hydrochloride
(Ibuprofen/Pseudoephedrine hydrochloride)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.
Keep this leaflet. You may need to read it again.
If you need further information or advice, ask your pharmacist.
If you get any side effects, tell your doctor, pharmacist or nurse. This also includes any possible side effects not described in this leaflet. See point 4.
If after 3 days you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains
1. What IBUPROM SINUS is and what it is used for
2. What you need to know before taking IBUPROM SINUS
3. How to take IBUPROM SINUS
4. Possible side effects
5. How to store IBUPROM SINUS
6. Contents of the package and additional information
1. What IBUPROM SINUS is and what it is used for
IBUPROM SINUS is a medicinal product that reduces swelling of the nasal mucosa and the amount of secretion. It cleans the nose and paranasal cavities.
IBUPROM SINUS is an analgesic, anti-inflammatory and antipyretic medicinal product, which is indicated for the auxiliary treatment of symptoms associated with colds and flu, such as headache, pain and nasal congestion, rhinitis, high fever, sore throat, muscle pain.
If after 3 days you do not feel better or your condition worsens, you should seek medical attention.
2. What you need to know before taking IBUPROM SINUS
Do not take IBUPROM SINUS
if you are allergic to ibuprofen, pseudoephedrine, or any of the other ingredients of this medicine (listed in section 6.)
if you have evidence of hypersensitivity (rhinitis, asthma attack, urticaria) to acetylsalicylic acid or to other NSAIDs
if you are taking MAO inhibitor treatment and 2 weeks after stopping it
active or previous duodenal ulcer
severe cardiovascular disorders, severe heart failure, tachycardia, arterial hypertension, unstable angina pectoris
hyperthyroidism diabetes mellitus
pheochromocytoma
angle closure glaucoma
prostatic hyperplasia
pregnancy and breastfeeding
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking IBUPROM SINUS.
Pay special attention in case of bronchial asthma, history of peptic stomach or duodenal ulcer, liver or kidney failure, arterial hypertension, blood coagulation disorders.
If you develop reddening of large areas of the skin with increased temperature and pus bubbles, stop taking IBUPROM SINUS and contact your doctor or seek medical help immediately. See point 4.
Sudden abdominal pain or rectal bleeding may occur when using IBUPROM SINUS due to inflammation of the colon (ischemic colitis). If you develop these gastrointestinal symptoms, stop taking IBUPROM SINUS and contact your doctor or seek medical help immediately. See point 4.
Patients over 65 years of age
Medicines such as IBUPROM SINUS may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and long-term treatment. Do not exceed the recommended doses and duration of treatment - 3 days.
Use of this medicinal product in dehydrated patients increases the risk of kidney damage.
Anti-inflammatory/pain relievers such as ibuprofen may be associated with a slightly increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dosage or duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking IBUPROM SINUS if:
have heart problems, including heart failure and angina (chest pain), or have had a heart attack, bypass surgery, peripheral artery disease (impaired circulation in the legs or feet due to narrowed or blocked arteries) or any type of stroke ( including microstroke or transient ischemic attack);
you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.
Other medicines and IBUPROM SINUS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
IBUPROM SINUS may affect or be affected by some other medicines. For example:
Anticoagulant medicines (ie blood thinners/prevents clotting, eg low-dose aspirin/acetylsalicylic acid, warfarin, ticlopidine)
medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan, diuretics such as indapamide)
other drugs with analgesic and anti-inflammatory properties (including acetylsalicylic acid)
methotrexate
corticosteroid
antidepressants
zidovudine or medicinal products
Some other medicines may also affect or be affected by treatment with IBUPROM SINUS. Therefore, always before using IBUPROM SINUS with other medicines, you should consult your doctor or pharmacist.
IBUPROM SINUS with food, drink and alcohol
Food does not reduce the absorption of the active substance.
Pregnancy, lactation and fertility
Do not use this product during pregnancy.
Do not use this product when breastfeeding.
Driving and using machines
When using this product, special care should be taken when driving and operating machinery. Note that the product may cause dizziness.
IBUPROM SINUS contains sugar. If your doctor has told you that you have an intolerance to some sugars, consult him before taking this product.
The dye sunset yellow E 110 can cause allergic reactions.
3. How to take IBUPROM SINUS
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:
Adults and children over 12 years: 1-2 tablets every 4-6 hours (do not take more than 6 tablets daily).
If you have the impression that the effect of IBUPROM SINUS is too strong or too weak, inform your doctor.
If you have taken more than the required dose of IBUPROM SINUS
If you have taken more IBUPROM SINUS than the required dose or if the medicine has been accidentally taken by children, contact a doctor or the nearest hospital immediately to get an opinion on the risk and advice on what action to take.
Symptoms may include nausea, stomach pain, vomiting (bloody), headache, ringing in the ears, confusion, and rapid and involuntary eye movements. Drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, feeling cold, and trouble breathing have been reported at high doses.
You may feel an intense, distinct acceleration of the heart rate, an increase in arterial blood pressure.
If less than an hour has passed since the overdose, it is recommended to induce vomiting, gastric lavage or administration of activated charcoal. Based on numerous trials regarding the effects of an overdose of pseudoephedrine contained in combination products used for colds and allergies, gastric lavage is recommended when an amount ingested exceeds a dose equivalent to 3-4 maximum daily doses (720-960 mg ).
If you or someone else has taken more IB UP ROM SINUS than you should, tell your doctor or pharmacist immediately.
If you forget to take IBUPROM SINUS
IBUPROM SINUS is used as an aid in the treatment of pain, so it should be taken according to the instructions given in the section "How to take IBUPROM SINUS".
Do not take a double dose to make up for a missed dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects are very rare (less than 1 in 10,000 patients), but if you notice any of the effects, STOP taking this medicine immediately and consult your doctor or pharmacist:
hallucinations (especially in children);
myocardial infarction or stroke;
ulcers of the digestive tract, which are manifested by severe abdominal pain, vomiting with the presence of blood or blood in the stool, which in some cases leads to a fatal outcome, especially in elderly patients, exacerbation of ulcerative colitis and Crohn's disease, gastritis, esophagitis (inflammation of the esophagus), pancreatitis (inflammation of the pancreas), formation of intestinal, membrane-like strictures;
in patients with autoimmune diseases (e.g. systemic lupus erythematosus, mixed connective tissue diseases) who were prescribed ibuprofen, isolated cases of aseptic meningitis with manifestations of stiff neck, headache, nausea, vomiting, fever or disorientation have occurred;
severe allergic reactions with manifestations of dizziness or fainting, rapid heartbeat, swelling of the face, tongue and throat;
asthma or worsening of asthma, wheezing or difficulty breathing;
symptoms of liver damage or failure, especially with long-term use, such as yellowing of the skin or eyes;
severe skin reactions, including erythema multiforme and toxic epidermal necrolysis, exfoliative dermatitis manifested by a rash or round lesions on various parts of the body, ulceration of the mouth and lips, Stevens-Johnson syndrome;
kidney problems such as kidney damage or failure, renal papillary necrosis (especially with long-term use), decreased urine output, edema.
Other possible adverse drug reactions
The following common side effects may occur in less than 1 in 10 patients:
gastrointestinal disorders, such as heartburn, abdominal pain, nausea,
vomiting, intestinal gas, diarrhoea, constipation or mild blood loss from the digestive tract, which in isolated cases may cause anemia
The following uncommon side effects may occur in less than 1 in 100 patients:
allergic reactions: urticaria, skin rashes and itching
nervous system: headache, dizziness, insomnia, agitation, irritability or fatigue
eyes: visual disturbances
The following rare side effects may occur in less than 1 in 1,000 patients:
ears: ringing in the ears
The following very rare side effects may occur in less than 1 in 10,000 patients:
exacerbation of an existing infection
decrease in the number of blood cells which may cause pale or yellow skin, fever, sore throat, mild mouth sores, flu-like symptoms, tiredness or weakness, easy bruising or bleeding from the skin or lining of the nose
mental problems: mental reactions, depression
high blood pressure
From the available data, it is not possible to estimate the frequency of the following side effects:
increased thirst
insomnia, restlessness, agitation, dizziness, muscle weakness, tremors
fast or irregular heartbeat
dry mouth
redness of the skin, profuse sweating
urinary retention (mostly in men)
Inflammation of the colon due to insufficient blood supply (ischemic colitis)
During the first 2 days of treatment with IBUPROM SINUS, you may suddenly have a fever, reddening of the skin or multiple small pus bubbles (possible symptoms of acute generalized exanthematous pustulosis). See section 2. If you develop these symptoms, stop using IBUPROM SINUS and contact your doctor or seek medical help immediately.
A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes, and an increase in eosinophils (a type of white blood cell).
Reporting Adverse Reactions:
If you get any side effects, tell your doctor, pharmacist or nurse. This includes all possible side effects not described in this leaflet. You can also report side effects directly by:
The Medicines Executive Agency
8 Damyan Gruev St
1303 Sofia
phone: +359 2 8903417
website: www.bda.bg.
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store IBUPROM SINUS
Keep out of the reach of children.
To be stored below 25°C.
Do not use this medicine after the expiry date which is stated on the carton and inner pack after EXP. The expiration date corresponds to the last day of the specified month.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What IBULROM SINUS contains
The active substances are:
Ibuprofen 200 mg
Pseudoephedrine hydrochloride 30 mg
The other ingredients are:
Core composition: Cellulose powder (P-100), cellulose powder (F-150), corn starch, pregelatinized starch, guar, seed powder, talc, croscarmellose sodium, crospovidone (type A), silicon dioxide, colloidal hydrated , hydrogenated vegetable oil.
Shell composition: Hydroxypropyl cellulose, macrogol 400, talc, gelatin, sucrose, kaolin, calcium carbonate, gum arabic, spray dried, corn starch, Opagloss clear (carnauba wax, beeswax white, alcohol), Opalux brown (sucrose, purified water , titanium dioxide E 171, Sunset yellow varnish E 110, Allura red varnish E 129, Indigo carmine varnish E 132, povidone, sodium benzoate).
Composition of the printing ink: Opacode black (shellac, iron oxide black E 172, butyl alcohol, isopropyl alcohol, ammonium hydroxide, propylene glycol).
What IBULROM SINUS looks like and what the package contains
2 coated tablets - sachet containing 2 tablets
6 coated tablets - 3 sachets of 2 tablets in a cardboard box. Camera from laminate (paper/PE/Al/PE)
6 coated tablets in a PVC/Al foil blister
12 coated tablets in a PVC/Al foil blister
24 coated tablets — 2 PVC/Al foil blisters of 12 tablets each
Marketing Authorization Holder and Manufacturer
US Pharmacia Sp. z o.o. Poland.
