MODAFEN 200 mg + 5 Mg Tablets

Contents of the leaflet

1. Patient Information Leaflet: User Information
2. MODAFEN GRIP
3. 200 mg + 5 mg, coated tablets,
   1. You should carefully read the contents of this leaflet before taking the medicine, as it contains
   2. Table of Contents of the Leaflet
4. What is Modafen Grip and what is it used for
5. Important information before taking Modafen Grip
   1. When not to take Modafen Grip:
   2. Warnings and precautions
   3. Skin reactions
   4. Children and adolescents
   5. Modafen Grip and other medicines
   6. Do not take Modafen Grip if you are taking:
   7. Modafen Grip may affect the action of other medicines or other medicines may affect the action of Modafen Grip. For example:
   8. Modafen Grip with food, drink, and alcohol
   9. Pregnancy, breastfeeding, and fertility
   10. Driving and using machines
   11. Modafen Grip contains sodium
6. How to take Modafen Grip
   1. Adults and adolescents aged 12 and above
   2. Elderly patients
   3. Patients with liver or kidney function disorders
   4. Taking a higher dose of Modafen Grip than recommended
   5. Missing a dose of Modafen Grip
7. Possible side effects
   1. You should stop taking this medicine and contact your doctor or the nearest hospital immediately if you experience any of the following symptoms:
   2. Very common (may affect more than 1 in 10 people):
   3. Common (may affect up to 1 in 10 people):
   4. Uncommon (may affect up to 1 in 100 people):
   5. Rare (may affect up to 1 in 1,000 people):
   6. Very rare (may affect up to 1 in 10,000 people):
   7. Frequency not known (frequency cannot be estimated from the available data):
   8. Reporting side effects
8. How to store Modafen Grip
9. Contents of the pack and other information
   1. What Modafen Grip contains
   2. What Modafen Grip looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet: 11/2022

Patient Information Leaflet: User Information

MODAFEN GRIP

200 mg + 5 mg, coated tablets,

Ibuprofen + Phenylephrine hydrochloride

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

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.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should speak to your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3 days in adolescents or 3-5 days in adults there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

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

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

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.

2. Important information before taking Modafen Grip

When not to take Modafen Grip:

• if you are allergic to ibuprofen, phenylephrine hydrochloride, or any of the other ingredients of this medicine (listed in section 6)
• if you have ever had allergic reactions to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, manifested by shortness of breath, asthma, or hives,
• if you have active or recurrent stomach or duodenal ulcers, or if you have ever had multiple bleeding episodes

(at least two or more separate episodes or proven cases of ulceration or bleeding),

• if you have ever had bleeding or perforation of the gastrointestinal tract associated with previous NSAID treatment,
• if you have bleeding disorders or blood clotting disorders,
• if you have significantly elevated blood pressure (severe hypertension), severe heart failure, liver, or kidney disease,
• in women in the third trimester of pregnancy,
• if you have diabetes,
• if you have an overactive thyroid gland (hyperthyroidism),
• if you have primary angle-closure glaucoma,
• if you have urinary retention (inability to urinate),
• if you have a vascular tumor near the kidney (pheochromocytoma),
• in case of current use:
• medicines used to treat depression (from the group of monoamine oxidase inhibitors [MAOIs]) or if you have taken them in the last two weeks,
• medicines used to treat depression (from the group of tricyclic antidepressants),
• medicines used to treat high blood pressure or heart disease (from the group of beta-adrenergic blockers),
• sympathomimetic medicines (used to reduce nasal congestion) including those administered by different routes, i.e., orally and topically (medicines used for the nose, ear, and eye).

If you are unsure whether any of the above conditions apply to you, you should consult your doctor before taking the medicine.

Warnings and precautions

Before taking Modafen Grip, you should discuss treatment with your doctor or pharmacist if:

• you have or have had intestinal problems,
• you have non-specific, ulcerative colitis, such as Crohn's disease or ulcerative colitis of the colon,
• you have liver or kidney function disorders,
• you have asthma, hay fever, nasal polyps, or chronic obstructive pulmonary disease (COPD),
• you are immediately after major surgery,
• you have systemic lupus erythematosus (an immune system disorder) and other connective tissue disorders (due to the risk of developing aseptic meningitis),
• you have heart diseases, such as heart failure, angina pectoris (chest pain), you have had a heart attack, coronary artery bypass grafting, or you have peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or if you have had any stroke (including mini-stroke or transient ischemic attack - TIA).
• you have high blood pressure, diabetes, high cholesterol levels, there is a history of heart disease or stroke in your family, or if you smoke.
• you have an enlarged prostate gland (prostate enlargement).
• you have infections - see "Infections" below.

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.

Skin reactions

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.

• 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.

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 Grip and other medicines

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.

Do not take Modafen Grip if you are taking:

• any other medicines containing acetylsalicylic acid or other NSAIDs,
• cold and flu medicines,
• medicines used to treat nasal congestion (nasal stuffiness),
• or have taken antidepressant medicines in the last two weeks (see above "When not to take Modafen Grip"),
• sympathomimetic medicines (see above "When not to take Modafen Grip"),
• medicines used to treat high blood pressure or heart disease (from the group of beta-blockers) (see above "When not to take Modafen Grip").

Modafen Grip may affect the action of other medicines or other medicines may affect the action of Modafen Grip. For example:

• corticosteroids,
• blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan), and diuretics,
• anticoagulant medicines (i.e., blood thinners/anti-clotting agents, such as acetylsalicylic acid, warfarin, ticlopidine),
• selective serotonin reuptake inhibitors (SSRIs) (medicines used to treat depression),
• certain antibiotics (quinolones, aminoglycosides),
• sulfonylurea derivatives (medicines used by diabetics)
• lithium (a medicine used to treat manic-depressive illness and depression), methotrexate (a medicine used to treat cancer or rheumatic diseases), sulfinpyrazone, and probenecid (medicines used to treat gout), cyclosporine, and tacrolimus (immunosuppressive medicines), zidovudine (a medicine used to treat AIDS), digoxin (a medicine used to treat heart failure), phenytoin (a medicine used to treat epilepsy), baclofen (a medicine used to treat muscle spasms), ergotamine, and methysergide (medicines used to treat migraine attacks), mifepristone (a morning-after pill).

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.

Modafen Grip with food, drink, and alcohol

During treatment with Modafen Grip, consumption of alcoholic beverages and smoking are not recommended.

Pregnancy, breastfeeding, and fertility

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.

Driving and using machines

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.

Modafen 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 Grip

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.

Adults and adolescents aged 12 and above

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.

Elderly patients

In elderly patients, the dosage is the same as in adults, but increased caution is necessary (see above "Warnings and precautions").

Patients with liver or kidney function disorders

Increased caution is necessary in patients with liver and kidney failure (see above "Warnings and precautions").

Taking a higher dose of Modafen Grip than recommended

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.

Missing a dose of Modafen Grip

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.

4. Possible side effects

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.

You should stop taking this medicine and contact your doctor or the nearest hospital immediately if you experience any of the following symptoms:

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,

• severe skin reactions with purple spots or patches on the skin, blisters, peeling of the skin, (high) fever, joint pain, and (or) eye inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis); frequency of occurrence - very rare,
• significant decrease in white blood cell count, which increases the risk of infection, high fever, changes in mucous membranes and skin; frequency of occurrence - very rare,
• digestive problems such as stomach pain or other unusual stomach symptoms (frequently occurring); bloody or black stools, vomiting blood or dark particles resembling coffee grounds (frequency of occurrence - rare).

The following are other possible side effects, listed by frequency of occurrence:

Very common (may affect more than 1 in 10 people):

• indigestion, nausea, vomiting, diarrhea, gas, constipation.

Common (may affect up to 1 in 10 people):

• headache, dizziness, difficulty sleeping (insomnia).

Uncommon (may affect up to 1 in 100 people):

• hives, itching, rash,
• ringing in the ears.

Rare (may affect up to 1 in 1,000 people):

• meningitis (inflammation of the protective membranes surrounding the brain and spinal cord),
• vision disturbances, color vision disturbances,
• ulceration or perforation of the stomach, esophagus, or intestines, dark or black stools, and vomiting blood,
• nervousness.

Very rare (may affect up to 1 in 10,000 people):

• depression,
• palpitations, heart failure, high blood pressure,
• blood disorders (the first symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, fatigue, unexplained bleeding and bruising),
• mouth ulcers, gastritis, exacerbation of existing intestinal disease (colitis or Crohn's disease),
• liver or kidney disorders (possible kidney failure, nephritis), blood in the urine, cystitis.

Frequency not known (frequency cannot be estimated from the available data):

• irregular or rapid heartbeat, slow heart rhythm,
• eye pain and burning, blurred vision, sensitivity or intolerance to light, acute angle-closure glaucoma (eye pain), difficulty breathing or wheezing (mainly in patients with asthma), worsening of asthma.
• Severe skin reactions known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, fever, swelling of lymph nodes, and an increased number of eosinophils (a type of white blood cell),
• increased sensitivity of the skin to light,
• red scaly rash with thickening under the skin and blisters, mainly located in skin folds, on the torso, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, you should stop taking Modafen Grip and seek medical attention immediately. See also section 2.

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

Reporting side effects

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.

5. How to store Modafen Grip

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.

6. Contents of the pack and other information

What Modafen Grip contains

• the active substances of the medicine are: ibuprofen 200 mg and phenylephrine hydrochloride 5 mg in each coated tablet,
• the other ingredients are: corn starch, pregelatinized corn starch, sodium carboxymethylcellulose (type A), talc, povidone 30, colloidal anhydrous silica, stearic acid 50, hypromellose 2910/5, macrogol 6000, titanium dioxide (E 171).

What Modafen Grip looks like and contents of the pack

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 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

Date of last revision of the leaflet: 11/2022