Modafen grip

MODAFEN GRIP
200 mg + 5 mg, coated tablets,
Ibuprofenum + Phenylephrini hydrochloridum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or according
to the instructions of a doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If any adverse reactions occur in the patient, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days in adolescents or after 3–5 days in adults, or if the patient feels worse, consult a doctor.

Contents of the leaflet

1. What Modafen Grip is and what it is used for
2. What you need to know 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 Modafen Grip is and what it is 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 relieving pain (including headache), reducing inflammation, and may also reduce fever. Phenylephrine hydrochloride (a nasal decongestant) reduces swelling of the nasal mucosa, thereby relieving nasal congestion and reducing pressure that may contribute to headache.

Modafen Grip is intended for the relief of cold and flu symptoms associated with nasal mucosal congestion, including headache, fever, sore throat, nasal and sinus congestion, as well as muscle and joint pain.

Modafen Grip should be used only when cold or flu is accompanied by nasal obstruction.
If the patient does not have symptoms of nasal obstruction, a medicine containing ibuprofen alone is preferred.
Modafen Grip is intended for use in adults and adolescents aged 12 years and older.

2. Important information before using Modafen Grip

When not to use Modafen Grip:

• if the patient is allergic to ibuprofen, hydrochloride of phenylephrine, or any of the other ingredients of this medicine (listed in section 6)
• if allergic reactions have ever occurred to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), manifesting as shortness of breath, asthma, or urticaria,
• if the patient has active or recurrent gastric or duodenal ulcer or gastrointestinal bleeding, or if they have previously experienced repeated episodes of bleeding

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

• if the patient has ever had gastrointestinal bleeding or perforation related to previous treatment with NSAIDs,
• if the patient has blood disorders or coagulation disorders,
• if the patient has significantly elevated blood pressure (severe hypertension), severe heart, liver, or kidney failure,
• in women during the third trimester of pregnancy,
• if the patient has diabetes,
• if the patient has hyperactive thyroid gland (hyperthyroidism),
• if the patient has primary closed-angle glaucoma,
• if the patient has urinary retention (inability to pass urine),
• if the patient has a vascular tumor near the kidney (pheochromocytoma),
• when currently using:
• medications used to treat depression (monoamine oxidase inhibitors [MAOIs]) or if the patient has used them within the last two weeks,
• medications used to treat depression (tricyclic antidepressants),
• medications used to treat high blood pressure or heart disease (beta-adrenolytics),
• sympathomimetic drugs (medications used to reduce mucosal congestion), including those administered by various routes such as oral, nasal, ear, or eye preparations.

If the patient is unsure whether any of the above conditions apply, they should consult a doctor before using the medicine.
Warnings and precautions
Before using Modafen Grip, the patient should discuss treatment with a doctor or
pharmacist if:

• the patient has or has ever had intestinal problems,
• the patient has inflammatory bowel disease such as Crohn’s disease or ulcerative colitis,
• the patient has impaired kidney or liver function,
• the patient has bronchial asthma, hay fever, nasal polyps, or chronic obstructive respiratory diseases,
• the patient has recently undergone major surgery,
• the patient has systemic lupus erythematosus (an immune system disorder) or other connective tissue disorders (due to the risk of aseptic meningitis),
• the patient has heart diseases such as heart failure, angina pectoris (chest pain), history of myocardial infarction, coronary bypass surgery, peripheral arterial disease (poor circulation in legs due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischemic attack - TIA).
• the patient has hypertension, diabetes, increased cholesterol levels, family history of heart disease or stroke, or if the patient smokes.
• the patient has benign prostatic hyperplasia (enlarged prostate).
• the patient has infections – see section "Infections" below.

Use of 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 or duration of treatment.
Some concomitantly administered drugs (e.g., other non-steroidal anti-inflammatory drugs [NSAIDs],
corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors [SSRIs], or antiplatelet drugs such as acetylsalicylic acid) may
increase the risk of gastrointestinal toxicity or bleeding.
In patients at increased risk of gastrointestinal toxicity, consider concomitant use of gastroprotective agents.
Patients who have previously experienced gastrointestinal toxicity,
especially elderly individuals, should report any unusual abdominal symptoms (particularly gastrointestinal bleeding) to their doctor, especially in the early
stages of treatment.
Skin reactions
Severe skin reactions associated with the use of Modafen Grip have been reported.
If any skin rash, mucosal lesions, blisters, or other allergic symptoms occur, the use of Modafen Grip should be discontinued immediately and medical help sought without delay, as these may be early signs of a very serious skin reaction. See section 4.
Infections
Modafen Grip may mask signs of infection such as fever and pain. Therefore, Modafen 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 you take this medicine during an infection and symptoms persist or worsen, seek immediate medical advice.
Children and adolescents
This medicine is not intended for use in children under 12 years of age.
There is a risk of kidney dysfunction in dehydrated children and adolescents.
Modafen Grip and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to use.
Do not use Modafen Grip if the patient is taking:

• any other medicines containing acetylsalicylic acid or other NSAIDs,
• cold and flu remedies,
• medicines used to treat nasal mucosal congestion (nasal obstruction),
• or has taken antidepressant medicines within the past two weeks (see above section "When not to use Modafen Grip"),
• sympathomimetic drugs (see above section "When not to use Modafen Grip"),
• medicines used to treat high blood pressure or heart disease (beta-blockers) (see above section "When not to use Modafen Grip").

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

• corticosteroids,
• antihypertensive drugs (ACE inhibitors such as captopril, beta-adrenolytics such as atenolol-containing drugs, angiotensin II receptor antagonists such as losartan) and diuretics,
• anticoagulant drugs (i.e., blood thinners/preventing clot formation, 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 (used in the treatment of bipolar disorder and depression), methotrexate (used in cancer or rheumatic diseases), sulfinpyrazone and probenecid (used in the treatment of gout), cyclosporine and tacrolimus (immunosuppressive drugs), zidovudine (used in the treatment of AIDS), digoxin (used in the treatment of heart failure), phenytoin (used in the treatment of epilepsy), baclofen (used in the treatment of skeletal muscle spasms), ergotamine and methysergide (used in the treatment of migraine attacks), mifepristone (abortion pill).

Some other medicines may also be affected by or influence treatment with Modafen Grip. Therefore,
always consult a doctor or pharmacist before using Modafen Grip with other medicines.
Modafen Grip with food, drink, and alcohol
During treatment with Modafen Grip, consumption of alcoholic beverages and smoking is not recommended.
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.
Do not take Modafen Grip if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause problems during delivery. It may cause kidney and heart problems in the unborn child. It may affect bleeding tendency in both mother and child and may result in delayed or prolonged labor. Do not take Modafen Grip during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is required during this period or when trying to conceive, use the lowest dose for the shortest possible time. If Modafen Grip is used for longer than a few days beyond week 20 of pregnancy, it may cause kidney problems in the unborn child, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.
This medicine belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible after discontinuation of the medicine.
Driving and operating machinery
Modafen Grip does not affect the ability to drive or operate machinery. However,
in some patients, this medicine may cause dizziness, which could adversely affect
activities requiring increased attention. If dizziness occurs, do not drive
or operate machinery.
Modafen 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 Grip

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults and adolescents aged 12 years and older
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, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
The usual dose is 2 tablets every 8 hours. There should be at least a 4-hour interval between doses, and no more than 6 tablets should be taken within 24 hours.
This medicine should not be used for longer than 3–5 days without consulting a doctor. If symptoms in adults do not improve, worsen, or persist for longer than 3–5 days, consult a doctor. If in adolescents (aged 12 years and older) the medicine needs to be used for longer than 3 days or if symptoms worsen, consult a doctor.
Do not exceed the recommended dose or duration of treatment.
Method of administration
Tablets should be swallowed whole with an adequate amount of liquid. It is important to drink plenty of fluids during cold and flu.
The tablet may be taken independently of meals. When taken with food or shortly after eating, onset of action may be delayed. However, taking the medicine with food improves its tolerability and reduces the likelihood of gastrointestinal discomfort.
Elderly patients
Dosage in elderly patients is the same as in adults; however, increased caution is required (see section above “Warnings and precautions”).
Patients with hepatic or renal impairment
Increased caution is necessary in patients with liver or kidney dysfunction (see section above “Warnings and precautions”).
Taking more Modafen Grip than recommended
If a patient has taken more than the recommended dose of Modafen Grip, or if a child has accidentally ingested this medicine, seek medical advice immediately or go to the nearest hospital.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus, disorientation, and nystagmus. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, feeling cold, and breathing difficulties may occur.
Missed dose of Modafen Grip
If a dose is missed, 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.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
There is an increased likelihood of adverse reactions in elderly individuals, in those who have previously had stomach or duodenal ulcers (particularly with bleeding or mucosal perforation), or in individuals 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 any of the following symptoms occur: severe allergic reactions (including potentially life-threatening anaphylactic shock), which may cause skin rash, swelling of the face, lips, mouth, tongue or throat, wheezing or difficulty breathing; frequency: 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: very rare,
• significant decrease in white blood cell count, which increases the risk of infection, high fever, mucosal and skin lesions; frequency: very weak,
• digestive problems such as stomach pain or other unusual gastrointestinal symptoms (common); bloody or black stools, vomiting blood or dark particles resembling coffee grounds (frequency: rare).

The following are other possible adverse reactions listed according to their frequency of occurrence:
Very common (may affect more than 1 in 10 people):

• indigestion, nausea, vomiting, diarrhoea, flatulence, constipation.

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

• headache, dizziness, difficulty sleeping (insomnia).

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

• urticaria, itching, rash,
• tinnitus.

Rare (may affect up to 1 in 1000 people):

• inflammation of the protective membranes covering the brain and spinal cord (meningitis),
• visual disturbances, disturbances in colour vision,
• ulceration or perforation in the stomach, oesophagus 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, increased blood pressure,
• blood disorders (initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, fatigue, unexplained bleeding and bruising),
• mouth ulcers, gastritis, exacerbation of existing bowel disease (colitis or Crohn's disease),
• liver or kidney disorders (including possible kidney failure, kidney inflammation), blood in urine, cystitis.

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

• irregular or rapid heartbeat, slowed heart rate,
• 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 bronchial asthma), worsening of asthma.
• Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling, and increased eosinophil count (a type of white blood cell),
• increased sensitivity of the skin to light,
• 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 generalised exanthematous pustulosis). If such symptoms occur, you should stop taking Modafen Grip and seek immediate medical help. See also section 2.

Taking medicines such as Modafen Grip may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.
Reporting of adverse reactions
If any adverse reactions occur, including any 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 of the 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.
By reporting adverse reactions, additional information regarding the safety of the medicine can be collected.

5. How to store Modafen Grip

Keep this medicine 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 specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Modafen Grip contains

• The active substances are: ibuprofen 200 mg and phenylephrine hydrochloride 5 mg in each coated tablet,
• Other ingredients are: maize starch, pregelatinized maize starch, sodium carboxymethyl starch (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 white or almost white, biconvex coated tablets with a diameter of approximately 10.6 mm.
Pack size: 12 or 24 coated tablets.
Outer packaging: cardboard box.
Not all pack sizes may be marketed.

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