Ibuprofen + Phenylephrine hydrochloride
important information for the patient.
This medicine should always be taken exactly as described in the patient information leaflet or as advised by your doctor or pharmacist.
Modafen Grip contains ibuprofen and phenylephrine hydrochloride. Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) and is effective in treating pain (including headache), swelling, and can also reduce fever. Phenylephrine hydrochloride (a medicine that reduces nasal congestion) reduces swelling of the nasal mucosa, relieving nasal congestion and reducing pressure that can cause headache.
Modafen Grip is intended to relieve symptoms of colds and flu associated with nasal congestion, including headache, fever, sore throat, stuffy nose and sinuses, and muscle and joint pain.
Modafen Grip should only be used when a cold or flu is accompanied by nasal congestion.
If the patient does not have symptoms of nasal congestion, the preferred medicine should be one that contains only ibuprofen. Modafen Grip is intended for use in adults and adolescents aged 12 and above.
(at least two or more separate episodes or proven cases of ulceration or bleeding),
If you are unsure whether any of the above conditions apply to you, you should consult your doctor before taking the medicine.
Before taking Modafen Grip, you should discuss treatment with your doctor or pharmacist if:
Taking anti-inflammatory/pain-relieving medicines, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose and duration of treatment.
Certain medicines taken at the same time (i.e., other non-steroidal anti-inflammatory drugs [NSAIDs], corticosteroids, anticoagulant medicines, such as warfarin, selective serotonin reuptake inhibitors [SSRIs], or anti-platelet agents, such as acetylsalicylic acid) may increase the risk of toxic effects on the gastrointestinal tract or bleeding.
In patients at increased risk of toxic effects on the gastrointestinal tract, consideration should be given to concurrent use of protective agents.
Patients who have ever had toxic effects on the gastrointestinal tract, especially the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly during the initial stages of treatment.
Severe skin reactions have been reported with the use of Modafen Grip.
If you experience: any skin rash, changes in mucous membranes, blisters, or other signs of allergy, you should stop taking Modafen Grip and seek medical attention immediately, as these may be the first signs of a severe skin reaction. See section 4.
Infections
Modafen Grip may mask the symptoms of infection, such as fever and pain. Therefore, it is possible that Modafen Grip may delay appropriate treatment of the infection, which may lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine during an infection, and the symptoms of the infection persist or worsen, you should consult your doctor immediately.
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.
You should tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
Also, some other medicines may be affected by or have an effect on Modafen Grip. Therefore, before taking Modafen Grip with other medicines, you should always consult your doctor or pharmacist.
During treatment with Modafen Grip, consumption of alcoholic beverages and smoking are not recommended.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before taking this medicine.
You should not take Modafen Grip if you are in the last 3 months of pregnancy, as it may harm your unborn baby or cause problems during delivery.
It may cause kidney and heart problems in the unborn baby. It may affect your tendency to bleed and your baby's tendency to bleed and may cause delayed or prolonged labor. You should not take Modafen Grip during the first 6 months of pregnancy, unless it is absolutely necessary and advised by your doctor. If you require treatment during this period or while trying to conceive, you should use the lowest dose for the shortest possible time. If Modafen Grip is used for more than a few days from the 20th week of pregnancy, it may cause kidney problems in the unborn baby, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the ductus arteriosus in the baby's heart. If you need treatment for a longer period, your doctor may recommend additional monitoring.
The medicine belongs to a group of medicines (NSAIDs) that may affect female fertility. This effect is reversible after stopping the medicine.
Modafen Grip does not affect the ability to drive or use machines. However, in some patients, this medicine may cause dizziness, which may adversely affect activities that require increased attention. In case of their occurrence, you should not drive vehicles or operate machines.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".
This medicine should always be taken exactly as described in the patient information leaflet or as advised by your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.
Modafen Grip is intended for short-term use only.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.
In case of infection, you should consult your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
The usual dose is 2 tablets every 8 hours. You should maintain at least a 4-hour interval between doses and not take more than 6 tablets in 24 hours.
The medicine should not be used for more than 3-5 days without consulting a doctor. If an adult's symptoms do not improve, worsen, or persist for more than 3-5 days, you should consult a doctor. If an adolescent (aged 12 and above) needs to use the medicine for more than 3 days or if symptoms worsen, you should consult a doctor.
Do not exceed the recommended dose or duration of treatment.
Method of administration
Tablets should be swallowed whole with a sufficient amount of liquid. It is important to drink plenty of fluids during colds and flu.
The tablet can be taken independently of meals. When taken with food or shortly after eating, the onset of action may be delayed. However, taking the medicine with food improves tolerance and reduces the likelihood of gastrointestinal disorders.
In elderly patients, the dosage is the same as in adults, but increased caution is necessary (see above "Warnings and precautions").
Increased caution is necessary in patients with liver and kidney failure (see above "Warnings and precautions").
If you have taken more than the recommended dose of Modafen Grip or if a child has accidentally taken this medicine, you should always consult a doctor or go to the nearest hospital.
Overdose symptoms may include nausea, stomach 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, blood in the urine, feeling cold, and breathing difficulties have occurred.
In case of a missed dose, you should take the next dose as soon as possible, provided that the last dose was taken at least 4 hours earlier. Do not take a double dose to make up for a missed dose.
In case of any further doubts about the use of this medicine, you should consult your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
There is an increased risk of side effects in the elderly, in patients who have had stomach or duodenal ulcers (mainly with bleeding or perforation) or in patients undergoing long-term treatment with products containing acetylsalicylic acid.
severe allergic reactions (including potentially life-threatening anaphylactic shock), which can cause skin rashes, swelling of the face, lips, tongue, or throat, wheezing, or difficulty breathing;frequency of occurrence - very rare,
The following are other possible side effects, listed by frequency of occurrence:
Taking such medicines as Modafen Grip may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.
If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.
The medicine should be stored out of sight and reach of children.
Do not store above 25°C. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
Modafen Grip is a white or almost white, biconvex, coated tablet with a diameter of about 10.6 mm.
Pack size: 12 or 24 coated tablets.
Outer packaging: cardboard box.
Not all pack sizes may be marketed.
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
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