Package leaflet: Information for the patient

IBUM GRIP
200 mg + 30 mg, coated tablets
Ibuprofenum + Pseudoephedrini hydrochloridum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Table of contents of the leaflet

What Ibum Grip is and what it is used for
Important information before taking Ibum Grip
How to take Ibum Grip
Possible side effects
How to store Ibum Grip
Contents of the pack and other information

1. What Ibum Grip is and what it is used for

This medicine exerts a combined effect of two active substances: ibuprofen, which belongs to non-steroidal anti-inflammatory drugs (NSAIDs), and pseudoephedrine, a sympathomimetic agent. Ibuprofen has analgesic, antipyretic, and anti-inflammatory properties. Pseudoephedrine is a drug that reduces congestion of the mucous membranes of the upper respiratory tract. It clears nasal passages and sinuses and reduces mucus secretion.
This medicine is used short-term to relieve symptoms of influenza and common cold, such as:

nasal and paranasal sinus congestion,
headache,
fever,
musculoskeletal pain.

2. Important information before using Ibum Grip

When not to use Ibum Grip:

if the patient is allergic to ibuprofen or pseudoephedrine or any of the other ingredients of this medicine (listed in section 6),
in patients who have ever experienced allergic reactions such as rhinitis, urticaria or bronchial asthma after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
in patients with active or previous peptic ulcer disease of the stomach and/or duodenum, gastrointestinal perforation or bleeding, including events occurring after NSAID use,
if the patient has a bleeding tendency (haemorrhagic diathesis),
in patients with severe hepatic insufficiency, severe renal insufficiency or severe heart failure,
during pregnancy,
during breastfeeding,
in patients concurrently taking other non-steroidal anti-inflammatory drugs including COX-2 inhibitors (increased risk of adverse effects),
in patients with severe cardiovascular disorders, tachycardia, hypertension, or angina pectoris,
in patients who have experienced urinary retention,
in patients with hyperthyroidism,
in patients with narrow-angle glaucoma,
in patients who have had a haemorrhagic stroke or have risk factors increasing the risk of haemorrhagic stroke, for example due to taking vasoconstrictive drugs or other medications reducing nasal congestion, administered orally or nasally (see section "Ibum Grip and other medicines").

Warnings and precautions
Before starting treatment with Ibum Grip, consult your doctor or pharmacist.
Exercise particular caution when using Ibum Grip in patients:

with systemic lupus erythematosus or mixed connective tissue disease – due to increased risk of developing aseptic meningitis,
with gastrointestinal disorders (ulcerative colitis, Crohn's disease) – due to possible disease exacerbation,
with impaired kidney function – due to risk of further deterioration of renal function,
with impaired liver function,
with cardiac arrhythmias, hypertension, history of myocardial infarction or heart failure,
with active or past history of bronchial asthma or allergic diseases – due to possible bronchospasm,
in elderly patients – due to increased risk of adverse effects,
taking medications listed in the section "Ibum Grip and other medicines",
with diabetes,
with benign prostatic hyperplasia,
with glaucoma,
with pyloric stenosis,
with bladder neck obstruction.

Patients with a history of hypertension and/or heart failure
should exercise particular caution and consult their doctor or pharmacist before
using Ibum Grip, as fluid retention, hypertension and oedema have been reported with NSAID therapy.
Taking anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a
slight increase in the risk of myocardial infarction or stroke, particularly when used at high
doses. Do not exceed the recommended dose or duration of treatment.
Before using Ibum Grip, the patient should discuss treatment with a doctor or pharmacist if:

the patient has heart conditions such as heart failure, angina pectoris (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or history of any stroke (including mini-stroke or transient ischaemic attack - TIA),
the patient has hypertension, diabetes, high cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.

There is a risk of gastrointestinal bleeding, ulceration or perforation, which
may be fatal and may occur without warning symptoms or in patients with prior
warning signs. In case of gastrointestinal bleeding or ulceration, discontinue the medicine immediately and
contact a doctor. Patients with a history of gastrointestinal disorders,
especially elderly patients, should inform their doctor of any unusual
gastrointestinal symptoms (particularly bleeding), especially during the initial
treatment period. Such patients should use the lowest effective dose of the medicine.
During treatment with Ibum Grip, sudden abdominal pain or rectal bleeding may occur
due to inflammatory condition of the large intestine (ischaemic colitis). If such
gastrointestinal symptoms occur, discontinue use of Ibum Grip immediately and
seek medical advice or medical assistance without delay. See section 4.
Exercise caution when using the medicine in patients concurrently taking other medicines that
may increase the risk of gastrointestinal disorders or bleeding, such as corticosteroids
or anticoagulants such as warfarin or acenocoumarol, or antiplatelet agents such as
acetylsalicylic acid.
Concurrent, long-term use of analgesic medicines may lead to kidney damage
with risk of renal failure (analgesic nephropathy).
Skin reactions
Severe skin reactions associated with the use of Ibum Grip have been reported. If
any skin rash, mucosal lesions, blisters or other allergic symptoms appear, discontinue
taking Ibum Grip immediately and seek medical help promptly, as these may be early signs of a very serious skin reaction. See section 4.
As with other centrally acting stimulant medicines, there is a risk of abuse when using pseudoephedrine.
Toxic effects may occur with increased doses. Long-term use may lead to
tachyphylaxis (loss of sensitivity to the drug's effect), increasing the risk of overdose.
Sudden discontinuation of the medicine may result in depression.
The medicine should be used cautiously in patients taking tricyclic
antidepressants and other sympathomimetic medicines (medicines causing vasoconstriction of mucous membranes),
appetite suppressants, or amphetamine-like psychotropic medicines.
Effect on female fertility
Ibum Grip belongs to a group of medicines that may adversely affect fertility in women.
There is evidence that substances inhibiting cyclooxygenase (prostaglandin synthesis), including ibuprofen, may cause fertility disorders in women by affecting ovulation.
This effect is transient and resolves after discontinuation of therapy.
Children and adolescents
Do not give to children under 12 years of age.
In dehydrated patients – adolescents aged 12–18 years – there is a risk of impaired kidney function.
Elderly patients
In elderly patients, there is an increased risk of adverse effects.
To reduce the risk of adverse effects, the medicine should be taken for the shortest duration necessary to relieve symptoms.
Note for athletes: during use of pseudoephedrine, a positive result in doping tests may occur.
Consult your doctor even if the above warnings relate to conditions occurring in the past.
Ibum Grip and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Ibum Grip may affect the action of other medicines or other medicines may affect the action of
Ibum Grip. For example:

anticoagulant medicines (i.e. blood thinners/preventing clot formation), such as aspirin/acetylsalicylic acid, warfarin, ticlopidine;
acetylsalicylic acid, other non-steroidal anti-inflammatory drugs or corticosteroids (e.g. prednisolone or dexamethasone): concomitant use of these medicines with ibuprofen may increase the risk of gastrointestinal adverse effects;
antihypertensive medicines (ACE inhibitors such as captopril, beta-blockers such as medicines containing atenolol, angiotensin II receptor antagonists such as losartan);
antihypertensive medicines and diuretics: ibuprofen (like other non-steroidal anti-inflammatory drugs) may reduce the effectiveness of these medicines;
lithium (antidepressant medicine): evidence suggests a potential increase in serum lithium concentration during concomitant use of ibuprofen (similar to other non-steroidal anti-inflammatory drugs);
methotrexate (antineoplastic medicine): there is a risk of increased methotrexate serum concentration during concomitant use of ibuprofen (similar to other non-steroidal anti-inflammatory drugs);
zidovudine (antiviral medicine): evidence suggests an increased risk of joint haemorrhages and haematomas in patients with haemophilia or HIV-positive patients taking zidovudine and ibuprofen concurrently;
medicines neutralizing gastric acid increase the absorption rate of pseudoephedrine, while kaolin reduces the absorption rate of pseudoephedrine.

Before taking ibuprofen, inform your doctor if you are taking any of the above-mentioned
medicines.
Other medicines may also interact with or be affected by Ibum Grip treatment. Therefore,
always consult your doctor or pharmacist before using Ibum Grip with other medicines.
Ibum Grip should not be used concurrently with the following medicines:

monoamine oxidase inhibitors (MAOIs) or within 14 days after stopping such inhibitors. Concomitant use of MAOIs and sympathomimetic medicines may lead to hypertensive crises.

Due to increased risk of vasoconstriction and elevated blood pressure, simultaneous use of Ibum Grip (due to pseudoephedrine content) with the following medicines is not recommended:

dopamine receptor agonists, ergot alkaloid derivatives – bromocriptine, cabergoline, lisuride, pergolide;
vasoconstrictive dopaminergic medicines – dihydroergotamine, ergotamine, methylergonovine;
linezolid;
medicines reducing nasal mucosal congestion (administered orally or nasally);
phenylephrine, ephedrine, phenylpropanolamine.

Simultaneous use of the following medicines with pseudoephedrine is not recommended:

appetite suppressants (pseudoephedrine may enhance their effect);
psychostimulants of amphetamine-type (pseudoephedrine may enhance their effect);
antihypertensive medicines, alpha-methyldopa, mecamylamine, reserpine, rauwolfia alkaloids, guanethidine (pseudoephedrine may reduce their antihypertensive effect);
tricyclic antidepressants (pseudoephedrine may theoretically increase the risk of hypertension and cardiac arrhythmias).

During use of halogenated gases and inhaled general anaesthetics, concomitant use with pseudoephedrine may lead to acute hypertensive reactions in the perioperative period, similar to reactions observed when these anaesthetics are used with other indirectly acting sympathomimetic agents. Therefore, it is recommended to discontinue Ibum Grip 24 hours before planned general anaesthesia.
Taking Ibum Grip with food
Take the medicine after meals.
Pregnancy, breastfeeding and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Use of Ibum Grip in pregnant women is contraindicated.
Available data are insufficient to confirm the safety of ibuprofen use during the first six months of pregnancy. Ibuprofen must not be used during the third trimester of pregnancy, as it may inhibit uterine contractions, cause premature closure of the ductus arteriosus, neonatal hypertension, increase bleeding tendency in mother and child, and exacerbate oedema in the mother. Pseudoephedrine use reduces uterine blood flow.
Breastfeeding
Both ibuprofen and pseudoephedrine pass into breast milk. Use of the medicine in breastfeeding women is contraindicated.
Fertility
Use of Ibum Grip may adversely affect female fertility. See section "Warnings and precautions".
Driving and operating machinery
Exercise caution when driving or operating machinery during treatment with this medicine.
Ibum Grip contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should
consult a doctor before taking this medicine.
Ibum Grip contains tartrazine and quinoline yellow
The medicine may cause allergic reactions.

3. How to use Ibum Grip

This medicine should always be taken exactly as described in this patient leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine is taken orally. The recommended dose is:
Adults and adolescents over 12 years of age: 1 to 2 tablets every 4 hours after meals. Do not exceed a dose of more than 6 tablets per day (maximum daily dose: 1200 mg of ibuprofen and 180 mg of pseudoephedrine hydrochloride in divided doses).
Elderly patients: dosage adjustment is not required unless renal or hepatic function is impaired. If renal or hepatic impairment is present, the doctor should determine the dosage individually.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms.
This minimizes the risk of adverse effects.
Consult a doctor if treatment with this medicine is required for more than 3 days or if symptoms worsen.
Use in children
This medicine must not be used in children under 12 years of age.
Use of a higher than recommended dose of Ibum Grip
If a patient has taken more than the recommended dose of Ibum Grip, or if a child has accidentally ingested the medicine, seek immediate medical advice from a doctor or go to the nearest hospital to assess possible health risks and receive guidance on appropriate actions.
Symptoms may include nausea, stomach pain (epigastric pain), vomiting (possibly with blood), headache, tinnitus, disorientation, and nystagmus. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, cold sensation, breathing difficulties, increased blood pressure, and increased heart rate may occur.
In cases of acute overdose, symptoms depend on the amount ingested and the time elapsed since ingestion.
In cases of significant overdose (for ibuprofen exceeding 400 mg/kg body weight), coma, tachycardia, hyperkalemia (elevated potassium levels) with cardiac arrhythmias, metabolic acidosis, fever, respiratory disturbances, and impaired kidney function may occur.
With prolonged use, hemolytic anemia, granulocytopenia (reduced granulocyte count), and thrombocytopenia (reduced platelet count) may rarely occur. There is no specific antidote.
If pseudoephedrine is taken in a dose exceeding the maximum daily dose (adults: >240 mg; children 6–12 years: >120 mg; children 2–5 years: >60 mg; children under 2 years: any amount), hospital observation for at least 4 hours is recommended.
Gastric lavage is not recommended, as the risk of severe toxic effects is low. If the patient presents within one hour of ingestion, activated charcoal should be administered (adults: 50 g; children: 1 g/kg body weight).
Symptomatic and supportive treatment should be applied. The doctor should monitor vital signs, check electrolyte levels, and perform an electrocardiogram (ECG). If ECG changes, circulatory instability, or severe clinical symptoms (e.g., coma, seizures) occur, the doctor should perform cardiac monitoring for 12–24 hours. Seizures may be treated with diazepam. Severe hypertension may be treated with alpha-adrenergic blocking agents.
Missed dose of Ibum Grip
Do not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Uncommon (in 1 to 10 out of 1,000 patients taking the medicine):

headache, indigestion, abdominal pain, nausea, urticaria, itching.

Rare (in 1 to 10 out of 10,000 patients taking the medicine):

diarrhoea, flatulence, constipation, vomiting, gastritis, dizziness,
insomnia, restlessness, irritability and feeling tired,
oedema resulting from kidney and urinary tract disorders.

Very rare (less than 1 in 10,000 patients taking the medicine):

tarry stools, vomiting blood, ulcerative stomatitis, exacerbation of colitis and Crohn's disease,
peptic ulcer of the stomach and/or duodenum, gastrointestinal bleeding and perforation, sometimes with fatal outcome, particularly in elderly patients,
in isolated cases: depression, psychotic reactions and tinnitus, aseptic meningitis,
dysuria, reduced urine output, oedema, acute renal failure, renal papillary necrosis, increased serum urea concentration,
liver function disorders, particularly during prolonged use,
blood morphology abnormalities (anaemia, leukopenia - reduced white blood cell count, thrombocytopenia - reduced platelet count, agranulocytosis - reduced granulocyte count). Initial symptoms include: fever, sore throat, superficial ulceration of the oral mucosa, flu-like symptoms, fatigue, haemorrhagic diathesis (e.g. bruising, petechiae, purpura, nosebleeds),
erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis,
severe hypersensitivity reactions such as: facial, tongue and laryngeal swelling, shortness of breath, tachycardia (heart rhythm disturbances), hypotension (sudden drop in blood pressure), shock; exacerbation of asthma and bronchospasm,
in patients with pre-existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease), isolated cases of symptoms typical of aseptic meningitis have been reported during ibuprofen treatment, such as neck stiffness, headache, nausea, vomiting, fever, and disorientation.

Frequency not known:

Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, lymphadenopathy (swollen lymph nodes), and increased eosinophil count (a type of white blood cell).
Red, scaly rash with subcutaneous nodules and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, treatment with Ibum Grip should be discontinued immediately and medical help should be sought without delay. See also section 2.
Colitis caused by inadequate blood supply (ischaemic colitis). Treatment with high-dose NSAIDs has been associated with the occurrence of oedema, hypertension, and heart failure. Use of medicines such as Ibum Grip may be associated with a small increased risk of myocardial infarction (heart attack) or stroke.

Adverse effects due to the presence of pseudoephedrine in the medicine:
dyspepsia, gastrointestinal disturbances, skin redness and rash, nausea,
vomiting, excessive sweating, dizziness, increased thirst, tachycardia (increased heart rate),
cardiac arrhythmias, anxiety, insomnia, rarely - uncontrolled urination, muscle weakness, tremors,
anxiety, disorientation, thrombocytopenia.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Aleje Jerozolimskie 181C, 02-222 Warsaw:
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
e-mail: [email protected]
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Ibum Grip

Keep this medicine out of sight and reach of children.
Store in the original packaging to protect from light, at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Ibum Grip contains

The active substances in this medicinal product are ibuprofen and pseudoephedrine. One coated tablet contains 200 mg of ibuprofen and 030 mg of pseudoephedrine.
The other components (excipients) are: monohydrate lactose, microcrystalline cellulose, siliconized microcrystalline cellulose, sodium carboxymethyl starch, colloidal anhydrous silica, magnesium stearate, and Opadry II High Performance 85 F 23 368 Orange coating. Composition of the coating: polyvinyl alcohol, polyethylene glycol 3350, talc, sunset yellow lake (E 110), titanium dioxide (E 171), and quinoline yellow lake (E 104).

What Ibum Grip looks like and contents of the pack
Ibum Grip coated tablets are biconvex, orange in colour, and circular in shape with a diameter of 11 mm.
One pack contains 10 or 20 coated tablets in a cardboard box.
Marketing authorization holder and manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicinal product information
tel. + 48 (22) 742 00 22
e-mail: [email protected]