IBUM 200 mg/30 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. IBUM GRIP
3. 200 mg + 30 mg, coated tablets
   1. It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Ibum Grip and what is it used for
5. Important information before taking Ibum Grip
   1. When not to take Ibum Grip:
   2. Warnings and precautions
   3. Ibum Grip and other medicines
   4. Using Ibum Grip with food
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Ibum Grip contains lactose
   8. Ibum Grip contains orange and quinoline yellow dyes
6. How to take Ibum Grip
   1. Use in children
   2. Taking a higher dose of Ibum Grip than recommended
   3. Missing a dose of Ibum Grip
7. Possible side effects
   1. Side effects due to pseudoephedrine in the medicine:
   2. Reporting side effects
8. How to store Ibum Grip
9. Package contents and other information
   1. What Ibum Grip contains
   2. What Ibum Grip looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Medicine information
   5. Date of last revision of the leaflet: 12-2019

Leaflet accompanying the packaging: patient information

IBUM GRIP

200 mg + 30 mg, coated tablets

Ibuprofen + Pseudoephedrine hydrochloride

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Ibum Grip and what is it used for
• 2. Important information before taking Ibum Grip
• 3. How to take Ibum Grip
• 4. Possible side effects
• 5. How to store Ibum Grip
• 6. Package contents and other information

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

The medicine has a combined effect of two components: ibuprofen, a non-steroidal anti-inflammatory drug, and pseudoephedrine, a sympathomimetic drug. Ibuprofen has analgesic, antipyretic, and anti-inflammatory effects. Pseudoephedrine is a drug that reduces congestion of the mucous membranes of the upper respiratory tract. It clears the nose and paranasal sinuses, reducing the amount of discharge.

The medicine is used to temporarily relieve the symptoms of flu and colds, such as:

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

2. Important information before taking Ibum Grip

When not to take 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 had allergic symptoms (such as rhinitis, urticaria, or bronchial asthma) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
• in patients with active or recurrent peptic ulcer, perforation, or bleeding, also occurring after NSAID use,
• if the patient has a bleeding disorder (tendency to bleed),
• in patients with severe liver, kidney, or heart failure,
• during pregnancy,
• during breastfeeding,
• in patients taking other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (increased risk of side effects),
• in patients with severe cardiovascular disorders, tachycardia, hypertension, angina pectoris,
• in patients who have had urinary retention,
• in patients with hyperthyroidism,
• in patients with narrow-angle glaucoma,
• in patients with a history of hemorrhagic stroke or risk factors that may increase the risk of hemorrhagic stroke, such as taking vasoconstrictor medications or other decongestants used orally or nasally (see "Ibum Grip and other medicines").

Warnings and precautions

Before starting treatment with Ibum Grip, the patient should discuss it with their doctor or pharmacist.

Particular caution should be exercised when using Ibum Grip in patients:

• with systemic lupus erythematosus and mixed connective tissue disease - due to the increased risk of developing aseptic meningitis,
• with gastrointestinal diseases (ulcerative colitis, Crohn's disease) - due to the possibility of exacerbating the disease,
• with impaired renal function - due to the risk of further deterioration of renal function,
• with impaired liver function,
• with arrhythmias, hypertension, myocardial infarction, or heart failure in their medical history,
• with asthma, allergic diseases - due to the possibility of bronchospasm,
• in the elderly - due to the risk of increased side effects,
• taking medications listed in the "Ibum Grip and other medicines" section,
• with diabetes,
• with benign prostatic hyperplasia,
• with glaucoma,
• with pyloric stenosis,
• with urethral stricture.

Patients who have had hypertension and/or heart failure should exercise particular caution and consult their doctor or pharmacist before taking the medicine, as NSAID treatment has been associated with fluid retention, hypertension, and edema.

Taking anti-inflammatory/pain-relieving medications, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. The recommended dose should not be exceeded, and the duration of treatment should be as short as possible.

Before taking Ibum Grip, the patient should discuss their treatment with their doctor or pharmacist if:

• they have heart disease, such as heart failure, angina pectoris (chest pain), have had a heart attack, coronary artery bypass grafting, have peripheral arterial disease (poor circulation in the legs due to narrowing or blockage of arteries), or have had any stroke (including mini-stroke or transient ischemic attack - TIA),
• they have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or smoke.

There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and may not be preceded by warning symptoms or may occur in patients who have had such warning symptoms. In the event of gastrointestinal bleeding or ulceration, the medicine should be discontinued, and medical advice should be sought immediately.

Patients with a history of gastrointestinal diseases, especially the elderly, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), particularly during the initial treatment period. Such patients should use the lowest effective dose.

During treatment with Ibum Grip, sudden abdominal pain or rectal bleeding may occur due to inflammatory bowel disease (ischemic colitis). If such gastrointestinal symptoms occur, the use of Ibum Grip should be discontinued, and medical advice should be sought immediately. See section 4.

Caution should be exercised when using the medicine in patients taking other medications that may increase the risk of gastrointestinal disorders or bleeding, such as corticosteroids or anticoagulant medications, such as warfarin or acenocoumarol, or antiplatelet agents, such as acetylsalicylic acid.

Long-term concurrent use of pain-relieving medications may lead to kidney damage with a risk of kidney failure (analgesic nephropathy).

Skin reactions

Severe skin reactions have been reported with the use of Ibum Grip. If a skin rash, mucosal lesions, blisters, or other signs of hypersensitivity occur, the use of Ibum Grip should be discontinued, and medical advice should be sought immediately, as these may be the first signs of a severe skin reaction. See section 4.

As with other central nervous system stimulants, there is a risk of abuse when using pseudoephedrine. Taking increased doses may lead to toxic effects. Long-term use may result in the development of tolerance (loss of effect) with an increased risk of overdose. After sudden withdrawal, depression may occur.

The medicine should be used with caution in patients taking tricyclic antidepressants and other sympathomimetic medications (vasoconstrictor medications), appetite suppressants, amphetamine-like psychostimulants.

Effect on fertility in women

Ibum Grip belongs to a group of medications that may adversely affect female fertility.

There is evidence that cyclooxygenase inhibitors (prostaglandin synthesis inhibitors), to which ibuprofen belongs, may cause fertility disorders in women by affecting ovulation.

This effect is reversible and disappears after the end of therapy.

Children and adolescents

Not to be given to children under 12 years of age.

In dehydrated patients - adolescents aged 12-18 years, there is a risk of renal impairment.

Elderly patients

In elderly patients, there is an increased risk of side effects.

To minimize the risk of side effects, the medicine should be taken for the shortest period necessary to relieve symptoms.

Attention for athletes: when using pseudoephedrine, a positive result in doping tests may occur.

It is necessary to consult a doctor, even if the above warnings refer to past situations.

Ibum Grip and other medicines

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.

Ibum Grip may affect the action of other medications or other medications may affect the action of Ibum Grip. For example:

• anticoagulant medications (i.e., blood thinners/preventing blood clots, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• acetylsalicylic acid, other non-steroidal anti-inflammatory drugs, or corticosteroids (e.g., prednisolone or dexamethasone): concurrent use of these medications with ibuprofen may increase the risk of gastrointestinal side effects;
• blood pressure-lowering medications (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan);
• antihypertensive medications and diuretics: ibuprofen (like other non-steroidal anti-inflammatory drugs) may reduce the effect of these medications;
• lithium (antidepressant medication): there is evidence of a potential increase in lithium plasma concentration during concurrent use with ibuprofen (like other non-steroidal anti-inflammatory drugs);
• methotrexate (anticancer medication): there is a risk of increased methotrexate plasma concentration during concurrent use with ibuprofen (like other non-steroidal anti-inflammatory drugs);
• zydovudine (antiviral medication): there is evidence of an increased risk of bleeding into the joints and hematomas in patients with hemophilia, HIV-positive, taking zydovudine and ibuprofen concurrently;
• antacids increase the absorption rate of pseudoephedrine, while kaolin decreases the absorption rate of pseudoephedrine.

Before taking ibuprofen, the patient should inform their doctor about taking any of the above medications.

Other medications may also be affected or have an effect on Ibum Grip treatment. Therefore, before taking Ibum Grip with other medications, the patient should always consult their doctor or pharmacist.

Ibum Grip should not be taken concurrently with the following medications:

• monoamine oxidase inhibitors and for 14 days after stopping the inhibitor. Concurrent use of monoamine oxidase inhibitors and sympathomimetic medications may cause hypertensive crises.

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

• dopamine receptor agonists, ergot alkaloid derivatives - bromocriptine, cabergoline, lisuride, pergolide;
• dopaminergic vasoconstrictor medications - dihydroergotamine, ergotamine, methylergonovine;
• linezolid;
• nasal decongestants (used orally or nasally)
• phenylephrine, ephedrine, phenylpropanolamine.

Concurrent use of the following medications with pseudoephedrine is not recommended:

• appetite suppressants (pseudoephedrine may increase their effect);
• psychostimulant medications of the amphetamine type (pseudoephedrine may increase their effect);
• antihypertensive medications, alpha-methyldopa, mecamylamine, reserpine, ergot alkaloids, guanethidine (pseudoephedrine may reduce their antihypertensive effect);
• tricyclic antidepressants (pseudoephedrine may theoretically increase the risk of hypertension and arrhythmias).

When using halogenated anesthetics, inhaled general anesthetics, in combination with pseudoephedrine, a severe hypertensive reaction may occur during the perioperative period, similar to the use of these medications in combination with other indirect sympathomimetic medications. Therefore, it is recommended to discontinue Ibum Grip 24 hours before scheduled general anesthesia.

Using Ibum Grip with food

The medicine should be taken after meals.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

Use of Ibum Grip in pregnant women is contraindicated.

There is insufficient data to confirm the safety of ibuprofen use during the first six months of pregnancy. Ibuprofen should not be used during the last trimester of pregnancy, as it may inhibit uterine contractions, cause premature closure of the ductus arteriosus, hypertension in the newborn, increase the risk of bleeding in the mother and child, and exacerbate the formation of edema 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

Ibum Grip use may adversely affect female fertility. See "Warnings and precautions" section.

Driving and using machines

Caution should be exercised when driving vehicles and operating machinery while taking the medicine.

Ibum Grip contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Ibum Grip contains orange and quinoline yellow dyes

The medicine may cause allergic reactions.

3. How to take Ibum Grip

This medicine should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist.

In case of doubt, the patient should consult their doctor or pharmacist.

The medicine is taken orally. The recommended dose is:

Adults and adolescents over 12 years:1 to 2 tablets every 4 hours after meals. The dose should not exceed 6 tablets per day (maximum daily dose of 1200 mg ibuprofen and 180 mg pseudoephedrine in divided doses).

Elderly patients:no dose adjustment is required unless there is impaired renal or hepatic function. If there is impaired renal or hepatic function, the doctor should determine the dose individually.

The patient should use the smallest effective dose for the shortest period necessary to relieve symptoms.

This will minimize the risk of side effects.

The patient should consult their doctor if it is necessary to take the medicine for more than 3 days or if symptoms worsen.

Use in children

The medicine should not be used in children under 12 years of age.

Taking a higher dose of Ibum Grip than recommended

If the patient has taken a higher dose of Ibum Grip than recommended or if a child has accidentally taken the medicine, they should always consult their doctor or go to the nearest hospital to assess the potential risk to their health and receive advice on what to do.

Symptoms may include nausea, stomach pain (abdominal pain), vomiting (which may contain blood), headache, ringing in the ears, disorientation, and nystagmus. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness may occur, as well as blood in the urine, feeling cold, breathing difficulties, increased blood pressure, and increased heart rate.

In case of acute overdose, symptoms depend on the amount of medicine taken and the time elapsed since ingestion.

In case of significant overdose (for ibuprofen above 400 mg/kg body weight), coma, tachycardia, hyperkalemia (elevated potassium levels) with arrhythmias, metabolic acidosis, fever, respiratory disorders, and kidney function disorders may occur.

After long-term use, hemolytic anemia, granulocytopenia (reduced granulocyte count), and thrombocytopenia (reduced platelet count) may rarely occur. There is no specific antidote.

In case of pseudoephedrine overdose, hospital observation is recommended for at least 4 hours.

Gastric lavage is not recommended, as the risk of severe toxic effects is low. If the patient seeks medical attention within 1 hour of ingestion, activated charcoal (50 g for adults, 1 g/kg body weight for children) should be administered.

Supportive and symptomatic treatment should be used. The doctor should monitor vital signs, check electrolyte levels, and perform an electrocardiogram. If there are changes in the electrocardiogram, cardiovascular instability, or severe clinical symptoms (e.g., coma, seizures), the doctor will use cardiac monitoring for 12-24 hours. Seizures can be treated with diazepam. Severe hypertension can be treated with alpha-adrenergic blockers.

Missing a dose of Ibum Grip

A double dose should not be taken to make up for a missed dose.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ibum Grip can cause side effects, although not everybody gets them.

Uncommon(in 1 to 10 out of 1000 patients taking the medicine):

• headache, nausea, abdominal pain, rash, itching.

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

• diarrhea, bloating, constipation, vomiting, gastritis, dizziness,
• insomnia, agitation, irritability, and fatigue,
• edema resulting from renal and urinary disorders.

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

• black stools, bloody vomiting, oral mucosal ulceration, exacerbation of colitis and Crohn's disease,
• peptic ulcer disease and/or duodenal ulcer, gastrointestinal bleeding, and perforation, sometimes with a fatal outcome, especially in the elderly,
• in individual cases, the following have been reported: depression, psychotic reactions, and tinnitus, aseptic meningitis,
• dysuria, reduced urine output, edema, acute renal failure, renal papillary necrosis, increased urea levels in the blood,
• liver function disorders, especially during long-term use,
• blood count abnormalities (anemia, leukopenia, thrombocytopenia, agranulocytosis). The first symptoms are: fever, sore throat, superficial oral mucosal ulcers, flu-like symptoms, fatigue, bleeding tendency (e.g., bruising, petechiae, purpura, nosebleeds),
• erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis,
• severe hypersensitivity reactions, such as: facial edema, tongue and pharyngeal edema, dyspnea, tachycardia, hypotension, shock; exacerbation of asthma and bronchospasm,
• in patients with existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) during ibuprofen treatment, individual cases of symptoms of aseptic meningitis have been reported, such as neck stiffness, headache, nausea, vomiting, fever, disorientation.

Frequency not known:

• Severe skin reactions known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling, and an increased number of eosinophils (a type of white blood cell).
• A red scaly rash with thickening under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever occurring at the beginning of treatment (acute generalized pustular psoriasis). If such symptoms occur, the use of Ibum Grip should be discontinued, and medical advice should be sought immediately. See also section 2.
• Inflammatory bowel disease (ischemic colitis). Large doses of NSAIDs have been associated with edema, hypertension, and heart failure. Taking medications like Ibum Grip may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Side effects due to pseudoephedrine in the medicine:

nausea, gastrointestinal disorders, redness, rash, vomiting, excessive sweating, dizziness, increased thirst, tachycardia, arrhythmias, anxiety, insomnia, rarely - uncontrolled urination, muscle weakness, tremors, anxiety, disorientation, thrombocytopenia.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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]

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ibum Grip

The medicine should be stored 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 month.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Ibum Grip contains

• The active substances of the medicine are ibuprofen and pseudoephedrine. One coated tablet contains 200 mg of ibuprofen and 30 mg of pseudoephedrine.
• The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose, siliconized microcrystalline cellulose, sodium carboxymethylcellulose, colloidal anhydrous silica, magnesium stearate, and Opadry II High Performance 85 F 23 368 Orange coating. The coating contains: polyvinyl alcohol, macrogol 3350, talc, orange yellow dye (E 110), titanium dioxide (E 171), quinoline yellow dye (E 104).

What Ibum Grip looks like and contents of the pack

Ibum Grip coated tablets are biconvex, orange in color, and have a diameter of 11 mm.

One pack of the medicine 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

Medicine information

tel. +48 (22) 742 00 22

e-mail: [email protected]

Date of last revision of the leaflet: 12-2019