Modafen extra grip: detailed information

Patient Information Leaflet

MODAFEN EXTRA GRIP
200 mg + 30 mg, coated tablets
Ibuprofen + Pseudoephedrine hydrochloride
Please read the entire leaflet carefully before using this 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 for future reference.
If you need advice or further information, consult your doctor or pharmacist.
If you experience any adverse reactions, including any 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

What Modafen Extra Grip is and what it is used for
What you should know before taking Modafen Extra Grip
How to take Modafen Extra Grip
Possible side effects
How to store Modafen Extra Grip
Contents of the pack and other information

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

Modafen Extra Grip is used for the temporary relief of symptoms of influenza and the common cold, such as:

fever,
headache,
nasal congestion (stuffy nose) and sinus congestion,
musculoskeletal pain.

Modafen Extra Grip is an analgesic, anti-inflammatory and antipyretic medicine that reduces mucosal congestion. It helps clear the nasal passages and sinuses.

2. Information before using Modafen Extra Grip

When not to use 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 (NSAIDs),
in patients who have previously experienced allergic symptoms such as rhinitis, urticaria, or asthma after taking acetylsalicylic acid or other NSAIDs,
in case of active or past history of peptic ulcer or duodenal ulcer, gastrointestinal perforation or bleeding, including events associated with previous NSAID use,
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 renal failure,
when taking other NSAIDs, including COX-2 inhibitors (increased risk of adverse effects),
in case of urinary retention,
in case of hyperthyroidism,
in case of hemorrhagic diathesis,
in case of history of hemorrhagic stroke or presence of risk factors increasing the likelihood of hemorrhagic stroke, for example in patients taking vasoconstrictive drugs or other drugs reducing congestion administered orally or nasally,
if the patient is severely dehydrated (dehydration caused, for example, by vomiting, diarrhea, or insufficient fluid intake).

The medicine is contraindicated during pregnancy and breastfeeding.
Warnings and precautions
Before using Modafen Extra Grip, the patient should discuss treatment with a doctor or pharmacist if:

the patient has systemic lupus erythematosus or mixed connective tissue disease or hepatitis,
the patient has gastrointestinal disorders such as ulcerative colitis or Crohn's disease,
the patient has a congenital metabolic disorder of porphyrins (e.g. acute intermittent porphyria),
the patient has heart diseases such as heart failure, angina pectoris (chest pain), history of myocardial infarction, coronary bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or if the patient has had any stroke (including mini-stroke or transient ischemic attack - TIA),
the patient has hypertension or cardiac arrhythmias, diabetes, elevated cholesterol levels, family history of heart disease or stroke, or if the patient smokes,
the patient has impaired kidney function,
the patient has impaired liver function,
the patient has bronchial asthma or a history of allergic reactions (the medicine may cause bronchospasm),
the patient has neurological symptoms (nausea, headaches),
the patient has bladder outlet obstruction,
the patient has pyloric stenosis,
the patient has benign prostatic hyperplasia,
the patient has glaucoma,
the patient has chickenpox, use of Modafen Extra Grip is not recommended.
the patient has an infection – see section "Infections" below.

If fever occurs with generalized skin redness and blistering rash, treatment with Modafen Extra Grip should be discontinued immediately and medical advice sought. See section 4.
If the patient has any of the above-mentioned conditions, they should consult a doctor before using this medicine.
Allergic reactions to ibuprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported.
If any of these symptoms occur, Modafen Extra Grip should be stopped immediately and the patient should consult a doctor or go to an emergency department.
Patients with asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polyps have a higher risk of allergic reactions when taking acetylsalicylic acid and/or NSAIDs. Allergic symptoms may manifest as angioedema or Quincke's edema. Administration of Modafen Extra Grip may trigger an acute asthma attack, particularly in patients allergic to acetylsalicylic acid or NSAIDs.
Severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been reported very rarely. At the first signs of hypersensitivity after taking or administering Modafen Extra Grip, treatment should be stopped and immediate medical help sought.
Ibuprofen, the active ingredient in Modafen Extra Grip, may temporarily inhibit platelet function (platelet aggregation). Therefore, patients with platelet disorders should be monitored regularly.
In long-term ibuprofen treatment, liver and kidney function parameters and blood morphology with smear should be monitored regularly.
Long-term use of any type of painkillers for headache treatment may worsen these headaches. If such a situation occurs or is suspected, medical advice should be sought and treatment discontinued. Medication-overuse headache may occur in patients who frequently or daily experience headaches despite (or because of) regular use of painkillers.
Taking painkillers, especially those containing multiple active pain-relieving ingredients, may lead to permanent kidney damage with risk of renal failure (analgesic nephropathy). This risk may increase with physical exertion associated with salt loss and dehydration; therefore, such situations should be avoided.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which may be fatal, and which may occur without warning symptoms or in patients with previous warning signs. If gastrointestinal bleeding or ulceration occurs, the medicine should be stopped immediately and a doctor contacted.
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.
During treatment with Modafen Extra Grip, sudden abdominal pain or rectal bleeding due to inflammatory bowel condition (ischemic colitis) may occur. If such gastrointestinal symptoms occur, Modafen Extra Grip should be discontinued immediately and medical advice sought. See section 4.
Taking anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. The recommended dose and duration of treatment should not be exceeded. If symptoms persist, worsen, or do not resolve within 3 days, or if new symptoms appear, a doctor should be consulted.
Long-term simultaneous use of various painkillers may lead to kidney damage with risk of renal failure.
Very rarely, severe skin reactions, some of which have been fatal, including bullous and exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported in patients treated with NSAIDs. The risk of such reactions appears to be highest at the beginning of treatment, with symptoms occurring mostly within the first month. The medicine should be discontinued if skin rash, mucosal lesions, or any other hypersensitivity symptoms occur.
Pseudoephedrine and its main metabolite norpseudoephedrine are listed as prohibited substances for athletes (doping).
As with other centrally acting stimulant medicines, there is a risk of abuse during pseudoephedrine use. Toxic effects may occur with increased doses. Long-term use may lead to tachyphylaxis with increased risk of overdose. Depression may occur after abrupt discontinuation.
During treatment with Modafen Extra Grip, reduced blood flow in the optic nerve may occur. If sudden vision loss occurs, Modafen Extra Grip should be discontinued immediately and medical help sought. See section 4.
Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after using medicines containing pseudoephedrine. PRES and RCVS are rare conditions that may be associated with reduced cerebral blood flow.
If symptoms suggestive of PRES or RCVS occur, Modafen Extra Grip should be discontinued immediately and immediate medical help sought (symptoms, see section 4 "Possible side effects").
Severe skin reactions
Severe skin reactions have been reported with ibuprofen use, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If any of the symptoms related to these severe skin reactions described in section 4 occur, Modafen Extra Grip should be discontinued immediately and medical help sought.
Infections
Modafen Extra Grip may mask signs of infection such as fever and pain. Therefore, Modafen Extra Grip may delay appropriate treatment of infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If this medicine is taken during an infection and infection symptoms persist or worsen, immediate consultation with a doctor is necessary.
Children and adolescents
This medicine is not intended for use in children under 12 years of age.
There is a risk of impaired kidney function in dehydrated children and adolescents.
Modafen Extra Grip and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for use.
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 clot formation), such as aspirin/acetylsalicylic acid, warfarin, ticlopidine.
blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan).

Modafen Extra Grip should not be used simultaneously with monoamine oxidase inhibitors (MAOIs) or within 14 days after their discontinuation (hypertensive crises may occur).
Due to increased risk of vasoconstriction and elevated blood pressure, simultaneous use of Modafen Extra Grip (due to the presence of pseudoephedrine) with the following medicines is not recommended:
dopamine receptor agonists, ergot alkaloid derivatives – bromocriptine, cabergoline, lisuride, pergolide,
vasoconstrictive dopaminergic medicines – dihydroergotamine, ergotamine, methylergometrine,
linezolid,
nasal decongestants (administered orally or nasally) – phenylephrine, ephedrine, phenylpropanolamine.
Additionally, simultaneous use of pseudoephedrine with the following medicines 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, ergot alkaloids,
guanethidine (pseudoephedrine may reduce their antihypertensive effect),
tricyclic antidepressants (pseudoephedrine may theoretically increase the risk of hypertension and cardiac arrhythmias).
Caution should be exercised when using Modafen Extra Grip with the following medicines:
acetylsalicylic acid, except low-dose acetylsalicylic acid (not more than 75 mg per day) prescribed by a doctor, due to increased risk of adverse effects,
other non-steroidal anti-inflammatory drugs, due to increased risk of adverse effects,
antihypertensive medicines: NSAIDs may reduce the effectiveness of blood pressure-lowering medicines,
diuretics: there is limited evidence of reduced effectiveness of diuretics,
anticoagulants: NSAIDs may enhance the effect of blood-thinning medicines such as warfarin (acenocoumarol),
lithium and methotrexate: NSAIDs have been shown to increase serum concentrations of both lithium and methotrexate; serum lithium levels should be monitored,
zidovudine: evidence exists of prolonged bleeding time in patients treated concomitantly with ibuprofen and zidovudine,
corticosteroids: increased risk of adverse effects in the gastrointestinal tract, including gastrointestinal bleeding and increased risk of peptic ulcer disease.
Phenobarbital accelerates ibuprofen metabolism.
Ibuprofen increases serum digoxin and phenytoin concentrations and increases baclofen toxicity.
Ibuprofen reduces urinary excretion of uric acid induced by 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.
Concomitant use of inhaled general anesthetics with pseudoephedrine may cause acute hypertensive reactions in the perioperative period, similar to concomitant use of these anesthetics with other indirectly acting sympathomimetic medicines.
Therefore, discontinuation of Modafen Extra Grip 24 hours before planned general anesthesia is recommended.
Other medicines may also interact with or be affected by Modafen Extra Grip treatment. Therefore, always consult a doctor or pharmacist before using Modafen Extra Grip with other medicines.
Concomitant use of pseudoephedrine with beta-blockers may reduce the hypotensive effect of these medicines.
Modafen Extra Grip with food, drink, and alcohol
Adverse effects may be intensified when alcohol is consumed simultaneously with Modafen Extra Grip.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Modafen Extra Grip is contraindicated during pregnancy and breastfeeding.
Pregnancy
Modafen Extra Grip should not be used during pregnancy as it may harm the unborn child or cause delivery complications. Modafen Extra Grip may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both the patient and the child and may delay or prolong labor. Modafen Extra Grip taken for longer than a few days starting from the 20th week of pregnancy may cause impaired kidney function in the unborn child, leading to low amniotic fluid levels surrounding the child (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the child's heart.
Breastfeeding
Do not use Modafen Extra Grip during breastfeeding.
Fertility
This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of treatment.
Driving and operating machinery
Caution should be exercised when driving or operating machinery during treatment with this medicine.
Modafen Extra Grip contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.
Modafen Extra Grip contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Modafen Extra Grip

The medicine should be taken orally.
Adults and adolescents aged 12 years and older: the initial dose is 2 tablets, followed, if necessary, by 1 to 2 tablets every 4 to 6 hours. The maximum daily dose is 6 tablets.
This medicine should not be used in children under 12 years of age.
Elderly patients: dosage adjustment is not necessary unless hepatic or renal impairment is present. In these patients, dosage should be individually determined.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
In case of infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
This medicine should not be used for longer than 3 days without medical advice. If longer treatment is required or if symptoms worsen, consult a doctor.
The coated tablets should be swallowed whole, without chewing, and taken with an adequate amount of water.
Accidental overdose of Modafen Extra Grip
If a patient has taken more than the recommended dose of Modafen Extra Grip or if a child has accidentally ingested the medicine, medical advice should always be sought from a doctor or the nearest hospital to assess potential health risks and receive guidance on appropriate actions.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, tinnitus, confusion, and nystagmus. After a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, low blood potassium levels, cold sensation, and respiratory disturbances may occur. Additionally, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Acute renal failure and liver damage may also occur. In asthmatics, asthma exacerbation is possible. Moreover, hypotension and shallow breathing may develop.
After ibuprofen overdose, central nervous system disturbances may occur—headache, dizziness, nystagmus, seizures, which may even lead to loss of consciousness. Abdominal pain, nausea, and vomiting may also occur. In severe cases, hypotension, metabolic acidosis, respiratory arrest, and cyanosis (bluish discoloration of skin and mucous membranes) have been observed. Additionally, after pseudoephedrine overdose, elevated arterial blood pressure (hypertensive crisis) may occur.
In case of overdose or accidental ingestion of multiple tablets, consult a doctor. The doctor will provide symptomatic and supportive treatment. Activated charcoal may be administered within the first hour after ingestion (adults: 50 g; children: 1 g/kg body weight).
In all cases with symptoms of overdose, serum electrolyte levels should be checked and an electrocardiogram (ECG) should be performed.
Missed dose of Modafen Extra Grip
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must immediately stop using Modafen Extra Grip and seek immediate medical help if symptoms indicating posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS) occur. These include:

sudden, severe headache,
nausea,
vomiting,
confusion,
seizures,
visual disturbances.

If any of the following symptoms occur in a patient, Modafen Extra Grip must be discontinued immediately and medical help sought:

Red, flat, target-like or circular skin rashes, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genital organs, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome).
Red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Adverse reactions occurring frequently (in less than 1 in 10 patients, but more often than in 1 in 100 patients):
drowsiness, dizziness, heartburn.

Adverse reactions occurring not frequently (in less than 1 in 100 patients, but more often than in 1 in 1,000 patients):
hypersensitivity reactions such as urticaria and itching; anxiety, insomnia, restlessness, hallucinations, headache; depression; taste disturbances; palpitations; abdominal pain, nausea, and dyspepsia.

Adverse reactions occurring rarely (in less than 1 in 1,000 patients, but more often than in 1 in 10,000 patients):
blurred vision, disturbances in tear secretion; diarrhoea, bloating, constipation, vomiting.

Adverse reactions occurring very rarely (in less than 1 in 10,000 patients and in single cases):
blood test abnormalities – anaemia, leukopenia (reduced number of white blood cells), thrombocytopenia (reduced number of platelets), pancytopenia (reduced number of all types of blood cells: white, red, and platelets), agranulocytosis (marked reduction or absence of granulocytes in the blood) – initial symptoms include fever, sore throat, superficial ulcers in the oral cavity, flu-like symptoms, severe fatigue, nosebleeds, or subcutaneous haemorrhages; in patients with autoimmune diseases (such as systemic lupus erythematosus, mixed connective tissue disease), isolated cases of aseptic meningitis have been reported during ibuprofen treatment, with symptoms such as neck stiffness, headache, nausea, vomiting, fever, and disorientation; severe hypersensitivity reactions – facial swelling, swelling of the tongue and larynx, shortness of breath, rapid heartbeat, hypotension (reduced blood pressure), anaphylactic reaction, angioedema, or severe shock; worsening of asthma and bronchospasm; rapid muscle fatigue; hypertension, tachycardia, vasodilation; tarry stools, vomiting blood, ulcerative stomatitis, exacerbation of colitis and Crohn's disease; peptic ulcer of the stomach and/or duodenum, gastrointestinal perforation or bleeding; liver function disorders (especially during prolonged use); severe forms of skin reactions such as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis; painful or difficult urination; reduced urine output, oedema, acute renal failure, renal papillary necrosis (especially during prolonged use), increased serum urea concentration.

Adverse reactions occurring with unknown frequency (frequency cannot be estimated from available data):
manic symptoms such as insomnia, elevated mood or irritability, inflated self-esteem, increased activity or restlessness, racing thoughts, accelerated speech, difficulty concentrating, tachycardia, urinary retention, increased skin sensitivity to sunlight, colitis due to insufficient blood supply (ischaemic colitis), 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), reduced blood flow in the optic nerve (ischaemic optic neuropathy), chest pain, which may be a symptom of a potentially serious allergic reaction known as Kounis syndrome, severe disorders affecting cerebral blood vessels, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). If such symptoms occur, Modafen Extra Grip must be discontinued and immediate medical help sought. See also section 2.

If any of the above symptoms occur, the use of Modafen Extra Grip must be discontinued and medical advice sought immediately.

Due to the use of NSAIDs, oedema, hypertension, and heart failure have been reported.

Taking medicines such as ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Due to the presence of pseudoephedrine in the medicine, gastrointestinal disorders, dyspepsia, nausea, vomiting, ischaemic colitis, excessive sweating, dizziness, increased thirst, rapid heartbeat, cardiac arrhythmias, anxiety, insomnia, skin redness, and rashes may occur. Rarely: urinary retention, muscle weakness, tremors, anxiety, disorientation, thrombocytopenia. Frequency unknown (frequency cannot be estimated from available data): urinary retention may occur, mainly in men with benign prostatic hyperplasia.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 .

Adverse reactions can also be reported to the marketing authorisation holder.

Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Modafen Extra Grip

Store below 30°C, in the original packaging.
Keep the medicine out of the 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Modafen Extra Grip contains
The active substances are ibuprofen and pseudoephedrine hydrochloride. One coated tablet contains 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride.
Other ingredients: microcrystalline cellulose, monohydrate lactose, maize starch, pregelatinized starch, sodium lauryl sulfate, povidone 25, stearic acid, sodium carboxymethyl starch (type C), colloidal anhydrous silica; coating ingredients: 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 size: 12, 24 coated tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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

For further information about this medicine, please contact the Marketing Authorisation Holder's representative:
Stada Pharm Sp. z o.o.
Krakowiaków Street 44
02-255 Warsaw
Tel. +48 22 737 79 20