Modafen Extra Grip

Leaflet accompanying the packaging: information for the user

MODAFEN EXTRA GRIP

200 mg + 30 mg, coated tablets

Ibuprofen + Pseudoephedrine hydrochloride

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.
The medicine should always be used exactly as described in this 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 doctor or pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

• 1. What is Modafen Extra Grip and what is it used for
• 2. Important information before taking Modafen Extra Grip
• 3. How to take Modafen Extra Grip
• 4. Possible side effects
• 5. How to store Modafen Extra Grip
• 6. Contents of the pack and other information

1. What is Modafen Extra Grip and what is it used for

Modafen Extra Grip is used to relieve the symptoms of flu and colds, such as:

• fever,
• headache,
• nasal congestion (runny nose) and sinusitis,
• musculoskeletal pain.

Modafen Extra Grip is a pain reliever, anti-inflammatory, and antipyretic, reducing congestion of mucous membranes. It clears the nose and sinuses.

2. Important information before taking Modafen Extra Grip

When not to take Modafen Extra Grip

• if the patient is allergic to ibuprofen, pseudoephedrine, or any of the other ingredients of this medicine (listed in section 6), or to other non-steroidal anti-inflammatory drugs,
• in patients who have had allergic reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) in the past, such as nasal mucosal inflammation, hives, or asthma,
• in case of active stomach or duodenal ulcer, or a history of ulcers, perforation, or bleeding, also occurring after taking NSAIDs,
• in case of severe cardiovascular disease, such as ischemic heart disease, tachycardia,
• if the patient has very high blood pressure (severe hypertension) or uncontrolled hypertension,
• in case of narrow-angle glaucoma,
• in case of severe liver failure,
• if the patient has severe acute (sudden) or chronic (long-term) kidney disease or kidney failure,
• in case of concomitant use of other NSAIDs, including COX-2 inhibitors (increased risk of adverse reactions),
• in case of urinary retention,
• in case of hyperthyroidism,
• in case of bleeding disorders,
• in case of a history of hemorrhagic stroke or risk factors that may increase the likelihood of a hemorrhagic stroke, such as patients taking vasoconstrictor medications or other medications that reduce congestion, taken orally or nasally,
• if the patient is severely dehydrated (dehydration caused by vomiting, diarrhea, or insufficient fluid intake).

The medicine is contraindicated in pregnancy and breastfeeding.

Warnings and precautions

Before taking Modafen Extra Grip, the patient should discuss the treatment with a doctor or pharmacist if:

• the patient has systemic lupus erythematosus and mixed connective tissue disease or liver inflammation,
• the patient has gastrointestinal disease, such as ulcerative colitis, Crohn's disease,
• the patient has an inherited disorder of porphyrin metabolism (e.g., acute intermittent porphyria),
• the patient has heart diseases, such as heart failure, angina pectoris (chest pain), the patient has had a heart attack, coronary artery bypass grafting, or has peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or has had any stroke (including mini-stroke or transient ischemic attack - TIA),
• the patient has hypertension or arrhythmias, diabetes, increased cholesterol levels, a family history of heart disease or stroke, or if the patient smokes,
• the patient has kidney function disorders,
• the patient has liver function disorders,
• the patient has asthma or a history of allergic reactions (the medicine may cause bronchospasm),
• the patient has neurological symptoms (nausea, headaches),
• the patient has urethral stricture,
• the patient has pyloric stenosis,
• the patient has benign prostatic hyperplasia,
• the patient has glaucoma,
• the patient has chickenpox, it is recommended to avoid taking Modafen Extra Grip.
• the patient has an infection - see "Infections" below.

In case of fever with generalized redness of the skin and pustular rash, Modafen Extra Grip should be discontinued and medical advice should be sought immediately. See section 4.
If the patient has any of the above conditions, they should consult a doctor before taking the medicine.
During ibuprofen treatment, symptoms of allergic reactions to this medicine have been reported, including respiratory disorders, facial and neck edema (angioedema), chest pain.
If these symptoms are observed, Modafen Extra Grip should be discontinued and a doctor or emergency department should be consulted immediately.
In patients with asthma associated with chronic rhinitis, chronic sinusitis, and (or) nasal polyps, there is a higher risk of allergic reactions when taking acetylsalicylic acid and (or) NSAIDs. Symptoms of allergic reactions may occur as edema or Quincke's edema. Administration of Modafen Extra Grip may precipitate an acute asthma attack; especially in some patients sensitive to acetylsalicylic acid or NSAIDs.
Severe acute hypersensitivity reactions (e.g., anaphylactic shock) have been observed very rarely. After the first signs of hypersensitivity reaction after taking or administering Modafen Extra Grip, treatment should be discontinued and medical help should be sought immediately.
Ibuprofen, the active substance of Modafen Extra Grip, may temporarily inhibit platelet function (platelet aggregation). Therefore, patients with platelet disorders should be regularly monitored.
In case of long-term treatment with ibuprofen, liver and kidney function parameters should be regularly controlled, and blood morphology with a smear should be performed.
Long-term use of any type of pain relievers for headache treatment may exacerbate these headaches. If symptoms occur or are suspected, medical advice should be sought and treatment should be discontinued. Headache caused by medication overuse may occur in patients who frequently or daily experience headache despite (or due to) regular use of pain relievers.
Taking pain relievers, especially in combination with several active pain relievers, may lead to permanent kidney damage with a risk of kidney failure (analgesic nephropathy). This risk may increase with physical exertion associated with salt loss and dehydration, so it should be avoided.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and does not necessarily have to be preceded by warning signs or may occur in patients who have had such warning signs. In case of gastrointestinal bleeding or ulceration, the medicine should be discontinued and a doctor should be consulted immediately.
Patients with a history of gastrointestinal diseases, especially the elderly, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), especially during the initial treatment period.
During Modafen Extra Grip treatment, sudden abdominal pain or rectal bleeding may occur due to inflammatory bowel disease (ischemic colitis). If such gastrointestinal symptoms occur, Modafen Extra Grip treatment should be discontinued and medical help should be sought immediately. See section 4.
Taking anti-inflammatory/pain relievers, such as ibuprofen, may be associated with a slight increase in the risk of heart attack or stroke, particularly when used in high doses. The recommended dose should not be exceeded, and the treatment duration should not be prolonged. If symptoms persist, worsen, or new symptoms occur, a doctor should be consulted.
Concomitant long-term use of different pain relievers may lead to kidney damage with a risk of kidney failure.
Very rarely, in patients treated with NSAIDs, severe skin reactions have been reported, some of which were fatal, including blistering and exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. The risk of these reactions seems to be highest at the beginning of treatment, and in most cases, symptoms occurred within the first month of treatment. The medicine should be discontinued in case of skin rash, mucosal lesions, or any other symptoms of hypersensitivity.
Pseudoephedrine and its main metabolite, norpseudoephedrine, are on the list of substances prohibited for use by athletes (doping).
As with other central nervous system stimulants, there is a risk of abuse when taking pseudoephedrine. When taking increased doses, toxic effects may occur. Long-term use may lead to the development of tolerance, with an increased risk of overdose. After sudden withdrawal of the medicine, depression may occur.
During Modafen Extra Grip treatment, a decrease in blood flow in the optic nerve may occur. If sudden vision loss occurs, Modafen Extra Grip treatment should be discontinued and medical help should be sought immediately. See section 4.
After taking pseudoephedrine-containing medicines, cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported. PRES and RCVS are rare conditions that may be associated with reduced blood flow to the brain.
In case of symptoms that may be symptoms of PRES or RCVS, Modafen Extra Grip treatment should be discontinued immediately and medical help should be sought immediately (symptoms, see section 4 "Possible side effects").

Severe skin reactions

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported with ibuprofen. If the patient experiences any of the symptoms associated with these severe skin reactions described in section 4, Modafen Extra Grip should be discontinued and medical help should be sought immediately.

Infections

Modafen Extra Grip may mask the symptoms of infection, such as fever and pain. Therefore, it is possible that Modafen Extra Grip may delay appropriate treatment of the infection, which may lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an infection, and the symptoms of the infection persist or worsen, they should consult a doctor immediately.

Children and adolescents

This medicine is not intended for use in children under 12 years of age.
There is a risk of kidney function disorders in dehydrated children and adolescents.

Modafen Extra Grip and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Modafen Extra Grip may affect the action of other medicines or other medicines may affect the action of Modafen Extra Grip. For example:

• anticoagulant medicines (i.e., blood thinners/preventing blood clots, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine).
• blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan).

Modafen Extra Grip should not be taken with monoamine oxidase inhibitors or within 14 days after their administration (hypertensive crises may occur).
Due to the increased risk of vasoconstriction and increased blood pressure, it is not recommended to take Modafen Extra Grip (due to the presence of pseudoephedrine in the medicine) with the following medicines:
dopamine receptor agonists, ergot alkaloid derivatives - bromocriptine, cabergoline, lisuride, pergolide,
dopaminergic vasoconstrictor medicines - dihydroergotamine, ergotamine, methylergometrine, linezolid,
medicines reducing nasal congestion (taken orally or nasally) - phenylephrine, ephedrine, phenylpropanolamine.
Additionally, it is not recommended to take pseudoephedrine with the following medicines:
appetite suppressants (pseudoephedrine may enhance their action),
psychostimulant medicines of the amphetamine type (pseudoephedrine may enhance their action),
antihypertensive medicines, 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).
Care should be taken when taking Modafen Extra Grip with the following medicines:
acetylsalicylic acid, excluding acetylsalicylic acid in low doses (no more than 75 mg per day) on a doctor's prescription, due to the increased risk of adverse reactions,
other non-steroidal anti-inflammatory medicines, due to the increased risk of adverse reactions,
antihypertensive medicines: NSAIDs may reduce the effectiveness of blood pressure-lowering medicines,
diuretics: there is limited evidence of reduced effectiveness of diuretics,
anticoagulant medicines: NSAIDs may enhance the effect of medicines reducing blood coagulability, such as warfarin (acenocoumarol),
lithium and methotrexate: it has been shown that non-steroidal anti-inflammatory medicines may increase the serum levels of both lithium and methotrexate; monitoring of lithium levels in serum is recommended,
zydovudine: there is evidence of prolonged bleeding time in patients treated with ibuprofen and zidovudine concomitantly,
corticosteroids: increased risk of adverse reactions in the gastrointestinal tract, including gastrointestinal bleeding and ulceration.
Phenobarbital accelerates the metabolism of ibuprofen.
Ibuprofen increases the serum levels of digoxin and phenytoin, increases the toxicity of baclofen.
Ibuprofen reduces the excretion of uric acid in the urine under the influence of probenecid and sulfinpyrazone.
Concomitant use of potassium-sparing diuretics may lead to hyperkalemia.
Antacids increase the absorption rate of pseudoephedrine, while kaolin reduces the absorption rate of pseudoephedrine.
When taking Modafen Extra Grip with inhaled anesthetics, a sudden hypertensive reaction may occur during the perioperative period, similar to concomitant use of these medicines with other indirectly acting sympathomimetic medicines. Therefore, it is recommended to discontinue Modafen Extra Grip 24 hours before scheduled general anesthesia.
Also, some other medicines may be affected or may affect Modafen Extra Grip treatment. Therefore, before taking Modafen Extra Grip with other medicines, a doctor or pharmacist should always be consulted.
Concomitant use of pseudoephedrine with beta-adrenergic blockers may reduce the hypotensive effect of these medicines.

Modafen Extra Grip with food, drink, and alcohol

Adverse reactions when consuming alcohol and taking Modafen Extra Grip may be exacerbated.

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 a doctor or pharmacist before taking this medicine.
Modafen Extra Grip is contraindicated in pregnancy and breastfeeding.

Pregnancy

Modafen Extra Grip should not be taken during pregnancy, as it may harm the unborn child or cause complications during delivery. Modafen Extra Grip may cause kidney and heart disorders in the unborn child. It may increase the risk of bleeding in the mother and child and cause prolonged or delayed labor. Taking Modafen Extra Grip for more than a few days, starting from the 20th week of pregnancy, may cause kidney function disorders in the unborn child, leading to low amniotic fluid levels (oligohydramnios) or narrowing of the arterial duct (ductal constriction) in the child's heart.

Breastfeeding

Modafen Extra Grip should not be taken during breastfeeding.

Fertility

The medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may adversely affect female fertility. This effect is temporary and reverses after the end of treatment.

Driving and using machines

During treatment, caution should be exercised when driving vehicles and operating machines.

Modafen Extra Grip contains lactose

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

Modafen Extra Grip contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take Modafen Extra Grip

The medicine should be taken orally.
Adults and adolescents over 12 years of age:the initial dose is 2 tablets, then, if necessary, 1 to 2 tablets every 4 to 6 hours. The maximum daily dose is 6 tablets.
The medicine should not be taken in children under 12 years of age.
Elderly patients:dose adjustment is not necessary unless there is liver or kidney function disorder. In these patients, the dose should be determined individually.
The lowest effective dose should be used for the shortest time necessary to relieve symptoms.
In case of infection, a doctor should be consulted immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
The medicine should not be taken for more than 3 days without a doctor's recommendation. If it is necessary to take the medicine for more than 3 days or if symptoms worsen, a doctor should be consulted.
The coated tablets should be swallowed whole, without chewing, and washed down with a sufficient amount of water.

Taking a higher dose of Modafen Extra Grip than recommended

If the patient has taken a higher dose of Modafen Extra Grip than recommended or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to get an opinion on possible health risks and advice on what to do in such a case.
Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see also section 4 below), diarrhea, 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 have occurred. Additionally, blood in the urine, low potassium levels in the blood, feeling cold, and respiratory disorders may occur. Furthermore, the prothrombin time/INR may be prolonged, probably due to the disruption of circulating clotting factors. Acute kidney failure and liver damage may occur. In asthmatics, asthma may worsen. Additionally, low blood pressure and shallow breathing may occur.
After ibuprofen overdose, central nervous system disorders - headaches, dizziness, nystagmus, seizures, which can lead to loss of consciousness, may occur. Gastrointestinal disorders, such as stomach pain, nausea, and vomiting, may also occur. In severe cases, low blood pressure, acidosis, respiratory failure, and cyanosis have been observed. Additionally, after pseudoephedrine overdose, a hypertensive crisis (hypertensive emergency) may occur.
In case of overdose or accidental ingestion of a larger number of tablets, a doctor should be consulted. The doctor will provide symptomatic and supportive treatment. Within the first hour of taking the medicine, activated charcoal (adults: 50 g; children: 1 g/kg body weight) can be administered.
In all cases with symptoms of overdose, electrolyte levels should be checked, and an electrocardiogram should be performed.

Missing a dose of Modafen Extra Grip

A double dose of the medicine should not be taken 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.
Modafen Extra Grip treatment should be discontinued and medical help should be sought immediately if symptoms indicating posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) occur. These include:

• severe headache with a sudden onset,
• nausea,
• vomiting,
• confusion,
• seizures,
• changes in vision. If the patient experiences any of the following symptoms, they should stop taking Modafen Extra Grip and seek medical help immediately:
• Red, non-raised, target-like or circular patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome).
• Red, scaly rash with nodules under the skin and blisters, often with fever at the beginning of treatment (acute generalized exanthematous pustulosis).

Frequent side effects (in less than 1 in 10 patients, but more than 1 in 100 patients):

drowsiness, dizziness, heartburn.

Uncommon side effects (in less than 1 in 100 patients, but more than 1 in 1,000 patients):

allergic reactions, such as: hives and itching; anxiety, insomnia, restlessness, hallucinations, headaches; fainting; taste disorders; palpitations; stomach pain, nausea, and indigestion.

Rare side effects (in less than 1 in 1,000 patients, but more than 1 in 10,000 patients):

blurred vision, disorders of tear secretion; diarrhea, bloating, constipation, vomiting.

Very rare side effects (in less than 1 in 10,000 patients and in individual cases):

changes in blood counts - anemia, leukopenia (reduced white blood cell count), thrombocytopenia (reduced platelet count), pancytopenia (reduced count of all blood cell types, i.e., white, red, and platelets), agranulocytosis (significant reduction in the number of a certain type of white blood cell - granulocytes or absence of granulocytes in the blood) - the first symptoms are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, or subcutaneous bleeding; in patients with autoimmune diseases (such as systemic lupus erythematosus, mixed connective tissue disease) during ibuprofen treatment, individual cases of aseptic meningitis have occurred, with symptoms such as neck stiffness, headache, nausea, vomiting, fever, disorientation; severe hypersensitivity reactions - facial edema, tongue and pharynx edema, dyspnea, tachycardia, hypotension (reduced blood pressure), anaphylactic reaction, angioedema, or severe shock; exacerbation of asthma and bronchospasm; rapid muscle fatigue; hypertension, tachycardia, vasodilation; black stools, bloody vomiting, ulcerative stomatitis, exacerbation of ulcerative colitis and Crohn's disease; gastric and duodenal ulcer, perforation, or gastrointestinal bleeding; liver function disorders (especially during long-term treatment); severe skin reactions, such as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis; painful or difficult urination; reduced urine output, edema, acute kidney failure, renal papillary necrosis (especially during long-term treatment), increased serum urea levels.

Side effects with unknown frequency (frequency cannot be estimated from available data):

manic symptoms, such as insomnia, elevated mood or irritability, increased self-esteem, increased activity or restlessness, racing thoughts, accelerated speech rate, concentration disorders, tachycardia, urinary retention, increased skin sensitivity to sunlight, inflammatory bowel disease (ischemic colitis), red scaly rash with nodules under the skin and blisters, mainly in skin folds, on the torso and upper limbs, with fever at the beginning of treatment (acute generalized exanthematous pustulosis), reduced blood flow in the optic nerve (ischemic optic neuropathy), chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome, severe vascular disorders affecting the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). If such symptoms occur, Modafen Extra Grip treatment should be discontinued and medical help should be sought immediately. See also section 2.
In case of the above symptoms, Modafen Extra Grip treatment should be discontinued and medical help should be sought immediately.
NSAID treatment has been associated with edema, hypertension, and heart failure.
Taking medicines like ibuprofen may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke.
Due to the presence of pseudoephedrine in the medicine, gastrointestinal disorders, indigestion, nausea, vomiting, ischemic colitis, excessive sweating, dizziness, increased thirst, palpitations, arrhythmias, anxiety, and insomnia may occur. Rarely, urinary disorders, muscle weakness, tremors, anxiety, disorientation, thrombocytopenia may occur. Unknown frequency (frequency cannot be estimated from available data): urinary retention may occur, mainly in men with benign prostatic hyperplasia.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Modafen Extra Grip

Store in a temperature below 30°C, in the original packaging.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Modafen Extra Grip contains

The active substances of the medicine are ibuprofen and pseudoephedrine hydrochloride. One coated tablet contains 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride.
Other ingredients are: microcrystalline cellulose, lactose monohydrate, corn starch, pregelatinized starch, sodium lauryl sulfate, povidone 25, stearic acid, sodium carboxymethylcellulose (type C), anhydrous colloidal silica; coating:hypromellose, talc, titanium dioxide (E 171), macrogol 6000, simethicone emulsion SE4.

What Modafen Extra Grip looks like and contents of the pack

Modafen Extra Grip is in the form of coated tablets.
The tablets are white or almost white, round, and biconvex.
Pack sizes: 12, 24 coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Manufacturer
Zentiva k.s.,
U kabelovny 130,
Dolni Mecholupy,
102 37 Prague 10,
Czech Republic
To obtain more detailed information about this medicine, the representative of the marketing authorization holder should be contacted:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

Date of last revision of the leaflet: