Ibufxal Grippal 200 mg / 30 mg film-coated tablets, 20 pcs

Instructions for use for Ibufxal Grippal 200 mg / 30 mg film-coated tablets, 20 pcs

Important notes (compulsory information):

Ibufxal Grippal 200 mg / 30 mg film-coated tablets. Areas of application: For the symptomatic treatment of nasal mucosal swelling with cold with cold-related pain and / or fever in adults and adolescents from 15 Years.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


Instructions for use: Information for patients

IBÜHEXAL® Grippal 200 mg / 30 mg film-coated tablets
For adults and adolescents from 15 years
Ibuprofen / pseudoephedrinhydrochloride

Read the entire leaflet carefully before you start taking this medicine because it contains important information. Always take this medicine as described in this leaflet or just as your doctor or pharmacist is directed.

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. See section 4.
• If the symptoms deteriorate or the medicine for more than 4 days (adults) m or 3 days (adolescents) Need, contact your doctor.

What is in this leaflet
1. What is Ibufxal Grippal and what is it used for?
2. What should you pay attention to Grippal before taking iBuhxal?
3. How to take ibufxal Grippal?
4. Which side effects are possible?
5. What is iBuhxal grippal to keep?
6. Content of the pack and further information

1. What is Ibufxal Grippal and what is it used for?

IBÜFXAL Grippal contains 2 active ingredients: ibuprofen and pseudoephedrin hydrochloride.
Ibuprofen belongs to a group of medicines called non-steroidal anti-rheumatics (NSAR). Nsar mitigates the complaints by relieving pain and lowering fever.
Pseudoephedrinhydrochloride belongs to a group of active substances referred to as vasoconstrictors. They act vascular and thus lead to the shafts of the nasal mucosa.
IBÜFXAL Grippal is applied to the symptomatic treatment of nasal mucosal throat with cold with cold-related pain and / or fever in adults and adults from 15 Years. You should only take this combination agent if you have a clogged nose and headache or fever. If you only suffer from one of the symptoms, talk to your pharmacist or doctor about using either Ibuprofen or pseudoephedrine alone.
If the symptoms deteriorate or you need the medicine longer than 4 days (adults) or 3 days (adolescents), contact your doctor.

2. What should you pay attention to Grippal before taking iBuhxal?

IBÜFXAL Grippal must not be taken:

• if they are allergic to ibuprofen, pseudoephedrin hydrochloride or one of the other ingredients of this medicine mentioned in section 6
• if you are younger than 15 years
• if you are in the 3. Pregnancy is (7 months or longer pregnant)
• if you breastfeed
• if you have ever occurred after taking acetylsalicylic acid or other NSAR an allergic reaction or respiratory distress, asthma, rash, a itchy, running nose or swelling on the face
• in existing or repeatedly, gastric / twelfth ulcer (peptic ulcer) or bleeding (at least 2 different episodes of proven ulcers or bleeding)
• in gastrointestinal bleeding or breakthrough in the history associated with a previous therapy with NSA
• if you are under a heavyearly or renal impairment suffer
• if you are at a heavy heart failure (heart insuffi ciency) To suffer
• if you are in heavy cardiovascular problems (Heart disease, hypertension, angina, fast heartbeat), a thyroid overfunction, diabetes or a pheochromocytoma (A tumor of the adrenals) suffer
• if you have a heart attack in the past (Myocardial infarction) had
• if you have come to a stroke in the past or you have recently announced that you have a stroke risk
• if convulsions have occurred in the past
• if there is an unexplained blood formation disorder
• if you are at increased intraocular pressure (narrow-angled glaucoma) To suffer
• if you have difficulty infiltration in connection with prostate problems
• if you have systemic lupus erythematoses (SLE) was diagnosed, a disease of the immune system, which causes joint pain, skin changes and other complaints
• if you take / use the following medicines:
  • other drugs for discharging the nasal mucosa (Vasokonstrictors), which are assumed or administered via the nose (eg phenylpropanolamine, phenylephrine, ephedrine, xylometazoline or oxymethaline)
  • Methylphenidate, a medicament for the treatment of ADHS (Attention deficit hyperactivity disorder)
  • Medicines against depression, such as non-selective monoamine oxidase inhibitors (referred to as MAO inhibitor, z. B. Iproniazide) or taken them in the last 14 days.

Warnings and Precautions:
Please talk to your doctor or pharmacist before taking Ibufxal Grippal, if

• They suffer from asthma. The application of this medicine can trigger an asthma attack.
• In the prehistory gastrointestinal disorders (eg Diaphrapse HiatusHernia, gastrointestinal bleeding, stomach or duodenum ulcer) had
• They suffered or suffered to suffer from a gastrointestinal disease (Colitis Ulcerosa or Crohn
• You suffer from hypertension
• They suffer from a liver or kidney function disorder
• They have diabetes, as there is the risk of possible diabetic kidney damage
• They have a thyroid overfunction (hyperthyroidism) or suffer from a psychosis
• They suffer from a blood coagulation disorder.

Side effects can be minimized by applying the lowest effective dose over the shortest period of time. Older people have increased risk for side effects. Simultaneous application with other NSAR, including cyclooxygenase (COX) 2-specific inhibitors, increases the risk of side effects (see section "Taking IBÜFXAL Grippal together with other medicines") and should be avoided.
Anti-inflammatory means / painkillers such as ibuprofen can be accompanied by a slightly increased risk for a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or duration of treatment. You should discuss your treatment before taking iBuhxal Grippal with your doctor or pharmacist if you

• heart disease including heart failure (heart insuffi ciency) and angina (chest pain) have or a heart attack, a bypass operation, a peripheral arterial sealing disease (circulatory disorders in the legs or feet due to narrowed or sealed arteries) or any kind of stroke (including mini stroke or transitorizing ischy attack, "TIA
• Hypertension, diabetes or high cholesterol levels or have heart disease or strokes in their family trial or when they are smokers.

Please keep in mind that the medicine is due to its pseudoephedrine component in the following diseasescht may be applied (see section "IBÜFXAL Grippal must not be taken"): Heavy heart or circulation problems (Heart disease, hypertension, angina, fast heartbeat), Thyroid via function, diabetes, pheochromocytoma (a tumor of the adrenalness), heart attack (myocardial infarction) in the prehistory, stroke in the prehistory or risk factors for stroke.
The longer application of any kind of painkillers against headaches can aggravate these. If this is the case or this is suspected, medical advice should be obtained and treatment can be broken off. The diagnosis of headache in medication Transmission (Medication Overuse Headache, MOH) should be assumed in patients who suffer from frequent or daily headaches, though (or just because) they regularly occupy medicines against headaches.
In conjunction with the use of NSAR, it was very rarely reported on serious skin reactions, some with fatal output, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell syndrome). The highest risk of such reactions seems to be at the beginning of the therapy, as these reactions occurred in the majority of cases in the 1st treatment month. Ibufxal Grippal should be discontinued in the first signs of a rash, mucosal lesions or other characters for a hypothermia.

Impact on the result of blood tests:
Pseudoephedrine can disturb some diagnostic blood tests. Inform your doctor about taking this medicine if a blood test is intended for you.

Children and adolescents:
Ibufxal Grippal may not be used in children and adolescents under 15 years. There is a risk of renal impairment in dehydrated adolescents (adolescents with liquid deficiency).

Athlete:
Pseudoephedrinhydrochloride can lead to positive results for doping controls.

Taking IBÜFXAL Grippal together with other medicines:
Inform your doctor or pharmacist if you take / use other medicines, recently taken / applied / applied or intend to take / use other medicines.

> IBÜFXAL Grippal can affect or impair other medicines. Z. B.:

• Drugs that act at tempering tempering (d. H., prevent blood and prevent blood clotting, e.g. Acetylsalicylic acid, warfarin, ticlopidine)
• Medicines that reduce high blood pressure (ACE inhibitors such as B. Captopril, beta blocker such. As aenolol-containing medicines, angiotensin II receptor antagonists such. B. Losartan)

Some other medicines can also affect treatment with IBÜFXAL grippal or affected by such a self. You should therefore always catch up with the advice of your doctor or pharmacist before using IBÜFXAL Grippal together with other medicines.

> IBuhxal Grippal must not be used together with the following medicines:

• other vascular agents (vasoconstrictors) for draining the nasal mucosa, taking or using the nose (eg phenylpropanolamine, phenylephrine and ephedrine)
• a medicine for the treatment of ADHD (attention defi zit hyperactivity) called methylphenidate
• Medicines against depression (antidepressants) such as non-elective monoamine oxidase inhibitors (Mao inhibitors such as. B. Iproniazide). Do not accept this medicine if you have taken the aforementioned funds over the past 14 days.

> Inspect your doctor or pharmacist, especially if you apply the following means:

• other non-steroidal anti-rheumatics (NSAR) including highly dose acetylsalicylic acid and cyclooxygenase (Cox) 2 inhibitors
• Medicines for the treatment Von cardiac arrhythmia heart glycosides, z. B. Digoxin)
• Medicines for the treatment of epilepsy (eg Phenytoin)
• Glucocorticoids, which in numerous diseases, u. A. Pain, swelling, allergies, asthma, rheumatism and skin problems are applied
• Heparin injections
• some medicines for the treatment of depression (eg Lithium, selective serotonin recording inhibitors SSRI, Monoamine oxidase A-inhibitor Mao inhibitors )
• Medicines that temporarily suppress the immune system, e.g. Methotrexate (for the treatment of arthritis, psoriasis and some cancer forms), Ciclosporin or Tacrolimus (administered after transplant)
• AntiDiabetics (sulfonylureas)
• Medicines for the treatment of infections (eg Quinolon antibiotics, trimethoprim)
• Medicines that promote urination ("Drainage tablets", z. As potassium saving diuretics)
• Medicines for the treatment of gout (eg sampleecide and sulfi npyrazon)
• Medicines against migraine (including mutual grain alkaloids based medicines)
• Medicines for the treatment of HIV / AIDS (Zidovudin)
• Preparations containing Ginkgo Biloba

After taking pseudoephedrine, it can come to a sudden blood pressure increase during surgery. Put the treatment with IBÜFXAL Grippal a few days before a surgical procedure and inform your anesthesiatrist (anesthesiologist) about that.

Taking IBÜFXAL Grippal together with alcohol:
During the treatment you should do without alcohol.

Pregnancy, lactation and reproductive capability:
If you are pregnant or breastfeeding, or if you suspect to be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

> Pregnancy:
Avoid using this medicine in the first 6 Months of pregnancy unless otherwise stated by your doctor. Do not take Ibufxal Grippal during the 3. A pregnancy third.

> Latving:
Do not take this medicine if you breastfeed, as your child could damage.

> Reproductive ability:
Ibuprofen belongs to a group of medicines (NSAR), which can affect fertility in women. This effect is reversible (reversible) after discontinuation of the medicament).

Driving and ability to operate machines:
Ibufxal Grippal can cause dizziness, hallucinations, unusual headaches and visual hearing disorders and thus temporarily restrict their ability to operate a vehicle and operate machines. If one of these symptoms occurs at them, you should avoid guiding a vehicle and operating machines.

3. How to take ibufxal Grippal?

Always take this medicine exactly as described in this leaflet or just according to the consultation made with your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure.

Duration of taking:
This medicine is intended for short-term application only. You should take the lowest dose of the shortest possible period to relieve your symptoms. If the symptoms deteriorate or if they are the medicine longer than 4 Days (adults) or 3 days (teenagers) need, contact your doctor.

Dosage:
The recommended dosage applies to adults and adolescents from 15 Years:
1 film tablet, as needed every 6 hours. With more pronounced symptoms, take 2 film-coated tablets, if necessary, all 6 Hours.
The daily steam dose of a total of 6 film-coated tablets (accordingly 1,200 mg ibuprofen and 180 mg pseudoephedrinhydrochloride) must not be exceeded.

Type of application:
The film-coated tablets are to be taken. Take the film-coated tablets so far with a large glass of water, preferably to meals.

Application in children and adolescents:
Ibufxal Grippal may not be used in children and adolescents under 15 years.

If you take a greater amount of IBU Hexal Grippal than you should:
Break the treatment like thatfort and get medical advice, even if you have no complaints.

If you have further questions about taking this medicine, contact your doctor or pharmacist.

4. Which side effects are possible?

Like all medicines, this medicine can also have side effects, but they do not have to occur each other.

Break the intake of Ibufxal Grippal and get immediate medical advice if you notice the following:

• Signs of stomach or intestinal bleeding like light red chair, black tea chair, vomiting of blood or black particles that look like coffee set
• Signs of a serious allergic reaction such. B. Strong rashes, peeling, dandruff or blistering of the skin, swelling on the face, unclear whistling breathing sound, shortness of breath, inclination to bruise

If you notice the following side effects or worse, contact your doctor. This also applies to side effects that are not indicated in this leaflet.

Often (can concern up to 1 of 10 treated)	Indigestion, abdominal skills or pain, nausea, vomiting, bloating, diarrhea, constipation, minor blood loss in the gastrointestinal tract that leads to anemia (anemia) in rare cases
Occasionally (can concern up to 1 of 100 treated)	– Hypersensitivity reactions with hives, itching and asthma attacks (with blood pressure drop) – Central nervous disturbances such as headache, dizziness, sleep disorders, excitement, irritability or fatigue – visual disturbances – ulcers in the gastrointestinal area, sometimes with bleeding and breakthrough, inflammation of the gastric mucosa (gastritis), inflammation of the oral mucosa with ulcer (ulcerative stomatitis), Sharpening of a colitis and crohn's disease – Different rashes
Rarely (can concern up to 1,000 treated)	– Tinnitus (ear noises) – insomnia, nervousness, anxiety, restlessness, trembling, hallucinations – Worlusion of asthma or hypersensitivity reaction with shortness of breath – kidney taste damage (papilla necrosis), increased urinary acid concentration in the blood
Very rare (can be up to 1 out of 10,000 treated)	– Exhalassment of infectious inflammation (eg Necrotizing fasciitis), aseptic meningitis (neck stiffness, headache, nausea, vomiting, fever or consciousness) in patients with pre-existing autoimmune diseases (systemic lupus erythematodes sle, Mixed collagenosis) – Disorders of blood formation (anemia, leukopenia, thrombocytopenia, tank tops, agranulocytosis); This can be expressed in an increased inclination for bruising or susceptibility to infections – Heavy allergic reactions – Psychotic reactions and depression – Hypertension, palpitations, heart failure (heart-insuffi ciency), Heart attack – Inflammation of the esophagus (esophagitis) or pancreas (pancreatitis), diaphragmatically constrictions (Strictures) in the intestine – liver function, liver damage, especially for long-term treatment, liver failure, acute lifetitis (Hepatitis) – heavy skin reactions including rash with redness and blistering (eg Stevens-Johnson syndrome and toxic epidermal necrolysis / Lyell syndrome), hair loss (alopecia), Heavy skin infections and soft tissue complications in chickenpox (Varicella Zoster infection) – Increased serum creatinine, edema (especially in patients with arterial hypertension or renal impairment), Nephrotic syndrome, interstitial nephritis, acute kidney failure
Unknown (frequency based on the available data not estimate)	– Behavioral disorder – Stroke, convulsive capacity, headache – palpitations, fast heartbeat (tachycardia), chest pain, cardiac arrhythmias (arrhythmia) – Blute – Drying, thirst, nausea, vomiting – Rash, hives, itching, excessive sweating – Difficulties in urination

Pharmaceuticals such as iBuhxal Grippal may be associated with a slightly increased risk of cardiac cases ("myocardial infarction") or strokes.

Message of side effects:
If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. You can also share effects directly
Federal Institute for Pharmaceuticals and Medical Products
Dept. Pharmacovigilance
Kurt-Georg-Kiesinger-Allee 3
D-53175 Bonn
Website: www.bfarm.de
Show. By reporting side effects, you can help to provide more information about the security of this medicine.

5. What is iBuhxal grippal to keep?

Keep this medicine inaccessible to children. You may not use this medicine after the expiration date specified on the carton and blister pack according to "until". The expiration date refers to the last day of the specified month. Do not store over 30 ° C. Do not dispose of medicines in the wastewater. Ask your pharmacist how to dispose of the medicine if you do not use it anymore. You help to protect our environment.

6. Content of the pack and further information

What Ibufxal Grippal
The active ingredients are ibuprofen and pseudoephedrinhydrochloride. Each film tablet contains 200 mg ibuprofen and 30 mg pseudoephedrin hydrochloride.

The other ingredients are:
Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, croscarmello sodium, corn starch, high-dispenser silica, magnesium stearate (pH. EUR.) Plant
Film cover: Hypromellosis, Macrogol 400, Talcum, Titanium dioxide (E 171), iron (III) hydroxide oxide x H2O (E 172)

How iBuhxal looks grippal and content of the pack:
Ibufxal Grippal are round, yellow film-coated tablets.
Pack sizes: 10, 12, 20 or 24 film-coated tablets
Not all pack sizes may be placed on the market.

Pharmaceutic entrepreneur:
Hexal AG
Industriestraße 25
83607 Holzkirchen
Telephone: (08024) 908-0
Fax: (08024) 908-1290
E-mail: [email protected]

Manufacturer:
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Bar life

This leaflet was recently revised in December 2015.

Source: Information of the leaflet
Status: 06/2016