GRIPPOSTAD WITH IBUPROFEN 200 MG/5 MG FILM-COATED TABLETS

2. What you need to know before taking Grippostad with Ibuprofen

Do not take Grippostad with Ibuprofen if:

• you are allergic to ibuprofen, phenylephrine hydrochloride, or any of the other components of this medication (listed in section 6), or to acetylsalicylic acid or other analgesics
• you have ever had an ulcer, perforation, or stomach bleeding
• you have had worsening of asthma, skin rash, nasal secretion with itching, or facial swelling when taking ibuprofen, acetylsalicylic acid, or similar medications
• you have had gastrointestinal bleeding or perforation when taking NSAIDs (non-steroidal anti-inflammatory drugs)
• you are taking other analgesic NSAIDs
• you are taking more than 75 mg of acetylsalicylic acid per day. If you are taking low doses of acetylsalicylic acid (up to 75 mg per day), consult your doctor or pharmacist before taking this medication.
• you have severe liver or kidney problems
• you have severe heart problems (severe heart failure), high blood pressure, or blood coagulation disorder.
• you have breathing difficulties
• you have hyperthyroidism
• you are taking or have taken in the last 14 days a medication called a monoamine oxidase inhibitor (usually used to treat depression)
• you are in the last 3 months of pregnancy (see also section 2 "Pregnancy, breastfeeding, and fertility")
• you are under 12 years of age

Warnings and precautions

Consult your doctor or pharmacist before starting to take Grippostad with Ibuprofen if:

• you have or have had asthma
• you have kidney, heart, liver, or intestinal problems
• you have high cholesterol or have previously had a heart attack or stroke
• you have any gastrointestinal disease (such as ulcerative colitis or Crohn's disease)
• you have systemic lupus erythematosus (an immune system disease that causes joint pain, skin changes, or other organ disorders)
• you are a smoker
• you are in the first 6 months of pregnancy
• you have diabetes
• you have glaucoma
• you have prostate enlargement
• you have an infection; see the "Infections" heading below

Infections

Grippostad with Ibuprofen may mask signs of an infection, such as fever and pain. Consequently, Grippostad with Ibuprofen may delay appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medication while having an infection and the symptoms of the infection persist or worsen, consult your doctor without delay.

Skin reactions

Severe skin reactions have been reported in association with Grippostad with Ibuprofen treatment. Stop taking Grippostad with Ibuprofen and seek medical attention immediately if you experience any skin rash, lesions on the mucous membranes, blisters, or other signs of allergy, as these may be the first signs of a very severe skin reaction. See section 4.

Taking anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increase in the risk of heart attack (myocardial infarction) or stroke, especially when taken in high doses. Do not exceed the recommended dose or treatment duration.

Consult your doctor or pharmacist before taking Grippostad with Ibuprofen if you:

• have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in the legs due to narrow or blocked arteries), or any type of stroke (including "mini-stroke" or transient ischemic attack "TIA").
• Have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Adolescents

There is a risk of renal failure in dehydrated adolescents.

Taking Grippostad with Ibuprofen with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

To reduce the risk of side effects, do not take this medication with other NSAIDs (e.g., acetylsalicylic acid, ibuprofen). If you are taking low doses of acetylsalicylic acid (up to 75 mg per day), consult your doctor or pharmacist before taking this medication.

Grippostad with Ibuprofen may affect or be affected by other medications. For example:

Avoid taking this medication with the following medications:

• used to treat asthma and various inflammatory disorders (corticosteroids, e.g., prednisolone, beclomethasone)
• used to treat bacterial infections (quinolone antibiotics, e.g., ciprofloxacin, norfloxacin, levofloxacin)
• anticoagulant medications (i.e., thin the blood or prevent clotting, e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• heart medications (e.g., glycosides) or blood pressure-lowering medications (e.g., ACE inhibitors like captopril, beta-blockers like atenolol, angiotensin II receptor antagonists like losartan)
• used to help you urinate (diuretics)
• used for temporary suppression of the immune system (e.g., methotrexate, cyclosporine, tacrolimus)
• used to treat mania or depression (e.g., lithium, monoamine oxidase inhibitors, or SSRIs)
• used for abortion (e.g., mifepristone)
• used to treat HIV (e.g., zidovudine)

Other medications may also affect or be affected by Grippostad with Ibuprofen treatment. Therefore, you should always consult your doctor or pharmacist before using Grippostad with Ibuprofen with other medications.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Grippostad with Ibuprofen belongs to a group of medications that may affect female fertility. Fertility returns to normal when you stop taking this medication. It is unlikely that if you only take Grippostad with Ibuprofen occasionally, it will affect your chances of becoming pregnant. If you have problems becoming pregnant, consult your doctor before taking this medication.

Inform your doctor if you become pregnant while taking this medication. DO NOT take this medication if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and delay or prolong labor more than expected.

DO NOT take this medication during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor.

If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From the 20th week of pregnancy, this medication may cause kidney problems in your fetus, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Consult your doctor or pharmacistBEFOREtaking this medication if you are breastfeeding.

Grippostad with Ibuprofen contains sodium

This medication contains 2.92 mg of sodium (less than 1 mmol of sodium (23 mg)) per tablet, which means it is essentially sodium-free.

3. How to take Grippostad with Ibuprofen

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly. In case of doubt, ask your doctor or pharmacist.

Method of administration

The tablets should be swallowed whole with water.

It is important to drink plenty of fluids when you have a cold and flu.

Dose

Adults, elderly, and adolescents over 12 years of age:

Take 2 tablets every 8 hours. Leave at least 4 hours between doses and do not take more than 6 tablets in 24 hours.

Treatment duration

This medication is for short-term use only. The lowest effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult your doctor without delay if the symptoms (such as fever and pain) persist or worsen (see section 2).

Adults:

Do not take Grippostad with Ibuprofen for more than 5 days.

Adolescents over 12 years of age:

Do not take Grippostad with Ibuprofen for more than 3 days.

If you do not improve or worsen, consult your doctor.

Children under 12 years of age must not take this medication

If you take more Grippostad with Ibuprofen than you should:

If you have taken more Grippostad with Ibuprofen than you should or a child has taken this medication accidentally, contact your doctor or go to the nearest hospital for advice on the risk or actions to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may be bloody), gastrointestinal bleeding (see also section 4), diarrhea, headache, ringing in the ears, confusion, and involuntary eye movements. Agitation, drowsiness, disorientation, or coma may also occur. Occasionally, patients develop seizures. At high doses, somnolence, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in urine, low potassium levels in the blood, feeling cold, and breathing difficulties have been reported. Additionally, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma in asthmatics is possible. Additionally, hypotension and decreased breathing may occur.

In case of overdose or accidental ingestion, go to a medical center immediately, even if you feel well, or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medication and the amount ingested.

If you forget to take Grippostad with Ibuprofen

Consult the previous instructions on how to take this medication and do not take more than advised. Do not take a double dose to make up for forgotten tablets.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Side effects can be minimized by taking the lowest effective dose for the shortest time necessary to relieve symptoms. You may experience one of the known side effects of NSAIDs (see below).

If you notice any of the following side effects at any time during treatment, STOP taking this medication and seek medical attention immediately:

• signs of intestinal bleeding,such as:
• red blood in stools, black stools
• vomiting blood or dark particles that look like coffee grounds
• signs of severe allergic reactionsuch as:
• difficulty breathing or unexplained wheezing
• dizziness or rapid heartbeat
• severe skin reactions, such as itching, skin rash with redness, peeling, blisters (e.g., Stevens-Johnson syndrome)
• swelling of the face, tongue, or throat
• signs of kidney problems, such as:
• urinating more or less
• cloudy or bloody urine
• back pain and/or swelling (especially in the legs)
• signs of aseptic meningitissuch as:
• stiff neck
• headache
• feeling unwell, being sick
• fever or disorientation. Patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease) may be more likely to be affected.
• A severe skin reaction known as DRESS syndrome may occur.DRESS syndrome includes skin rash, fever, swelling of lymph nodes, and increased eosinophils (a type of white blood cell).
• Generalized red scaly rash, with bumps under the skin and blistersmainly on the skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Grippostad with Ibuprofen if you experience these symptoms and seek medical attention immediately. See also section 2. Frequency not known (cannot be estimated from available data)

Stop taking this medication and inform your doctor if you experience the following uncommon side effectsthat may affect up to 1 in 100 people:

• indigestion, heartburn, or discomfort
• stomach pain (abdomen) or other abnormal stomach problems

Inform your doctor if you have any of the following side effects, if they worsen, or if you notice any side effect not described:

Uncommon side effectsthat may affect up to 1 in 100 people:

• allergic reactions such as skin rash (hives), itching, peeling
• headache, dizziness, tinnitus (ringing in the ears)

Rare side effectsthat may affect up to 1 in 1,000 people:

• flatulence (gas), diarrhea, constipation, and vomiting

Very rare side effectsthat may affect up to 1 in 10,000 people:

• blood disorder resulting in unexplained bruising or bleeding, fever, sore throat, mouth ulcers, flu-like symptoms, and severe fatigue
• low blood pressure or irregular heartbeat
• liver problems

Side effectsfor which the frequency cannot be estimated from available data:

• worsening of asthma or bronchospasm
• swelling (edema), high blood pressure, heart failure, or stroke
• worsening of colitis and Crohn's disease
• difficulty urinating (in men only)
• skin becomes sensitive to light

Medications like Grippostad with Ibuprofen may be associated with a small increase in the risk of heart attack (myocardial infarction) or stroke. See section 2 "Warnings and precautions".

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Grippostad with ibuprofen

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging. The expiry date is the last day of the month indicated.

Do not store above 30 °C.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE Point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Grippostad with ibuprofen

The active ingredients are:

• ibuprofen
• phenylephrine hydrochloride

Each tablet contains:

• 200 mg of ibuprofen
• 5 mg of phenylephrine hydrochloride

The other ingredients are:

Core:

• microcrystalline cellulose
• sodium starch glycolate (from potato)
• hypromellose 6 mPa.s
• sodium stearyl fumarate

Coating:

• Opadry White 200F280000 (composed of polyvinyl alcohol, talc, macrogol, titanium dioxide, methacrylic acid copolymer, sodium bicarbonate)

Appearance of the product and package contents

Grippostad with ibuprofen is presented in the form of white, round, biconvex film-coated tablets with a score line on one face and a diameter of 10 mm. The score line is not intended for breaking the tablet.

The packages can be of 12, 16, 20, and 24 tablets.

Marketing authorization holder and manufacturer.

Holder:

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Manufacturer:

STADA Arzneimittel AG

Stadastrasse, 2-18

61118 Bad Vilbel

Germany

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

or

IBS-Experts International d.o.o.

Ruševje 15,

10290 Zaprešić,

Croatia

This medicine is authorized in the Member States of the European Economic Area under the following names:

UK: Ibuprofen 200 mg and Phenylephrine hydrochloride 5 mg film-coated tablets

ES: Grippostad with ibuprofen 200 mg/5 mg film-coated tablets

HR: Ibufix 200 mg/5 mg film-coated tablets

IT: Ibuprofene e Fenilefrina EG

PL: FLUSTAD

SK: IBUGRIPP

Date of last revision of the text:November 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products