ACTISINU 200 mg/30 mg Tabletki Powlekane

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1. ACTISINU 200 mg/30 mg, film-coated tablets
   1. What is ACTISINU and what is it used for
   2. What you need to know before taking ACTISINU
   3. How to take ACTISINU
   4. Possible side effects
   5. How to store ACTISINU
   6. Package Contents and Other Information

ACTISINU 200 mg/30 mg, film-coated tablets

Ibuprofen/Pseudoephedrine hydrochloride
For adults and adolescents aged 15 years and over

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if your symptoms worsen or if the medicine is needed for more than 4 days in adults or 3 days in adolescents.

Contents of this leaflet:

• 1. What ACTISINU is and what it is used for
• 2. What you need to know before you take ACTISINU
• 3. How to take ACTISINU
• 4. Possible side effects
• 5. How to store ACTISINU
• 6. Contents of the pack and other information

1. What is ACTISINU and what is it used for

ACTISINU contains two active ingredients: ibuprofen and pseudoephedrine hydrochloride.
Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs
provide relief by alleviating pain and lowering fever.
Pseudoephedrine hydrochloride belongs to a group of active ingredients called vasoconstrictors that act
on the blood vessels in the nose to relieve nasal congestion.
ACTISINU is used for the symptomatic treatment of nasal congestion in the common cold associated with headache
and/or fever in adults and adolescents aged 15 years and over.
You should only take this combination product if you have a blocked nose with headache or
fever. If you have only one of these symptoms, talk to your pharmacist or doctor about using only ibuprofen or only pseudoephedrine.
Consult your doctor if your symptoms worsen or if the medicine is needed for more than 4 days
in adults or 3 days in adolescents.

2. What you need to know before taking ACTISINU

Do not take ACTISINU if:

• you are allergic to ibuprofen or pseudoephedrine hydrochloride or to any of the other ingredients of this medicine (listed in section 6)
• you are under 15 years of age
• you are in the third trimester of pregnancy (6 months or more)
• you are breastfeeding
• you have previously had an allergic reaction or shortness of breath, asthma, skin rashes, runny nose or itching of the

nose or swelling of the face following taking acetylsalicylic acid or other NSAIDs

• you have active or a history of recurrent gastric/duodenal ulcers (peptic ulcers) or bleeding (at least two distinct episodes of ulcers or bleeding confirmed)
• you have a history of bleeding or perforation of the gastrointestinal tract related to previous use of NSAIDs
• you have severe liver or kidney failure
• you have severe heart failure
• you have serious heart or circulation problems (heart disease, high blood pressure, fast heartbeat), hyperactive thyroid gland, diabetes, pheochromocytoma (a tumor of the adrenal gland)
• you have a history of heart attack (myocardial infarction)
• you have had a stroke or have been told you are at risk of stroke
• you have a history of seizures (epileptic fits)
• you suffer from disorders of blood cell production of unknown origin
• you have an increase in eye pressure (closed-angle glaucoma)
• you have difficulty urinating due to prostate problems
• you have been diagnosed with systemic lupus erythematosus (SLE), a disease that affects the immune system and causes joint pain, skin changes and other problems
• you are taking:
• other nasal decongestants (vasoconstrictor drugs) administered orally or nasally (e.g. phenylpropanolamine, phenylephrine, ephedrine, xylometazoline or oxymetazoline)
• methylphenidate, a medicine for attention deficit hyperactivity disorder (ADHD)
• medicines for depression such as non-selective monoamine oxidase inhibitors (known as MAOIs, e.g. iproniazide) or if you have taken them in the last 14 days

Warnings and precautions
Talk to your doctor or pharmacist before taking ACTISINU if:

• you suffer from asthma; use of this medicine may cause an asthma attack
• you have a history of gastrointestinal problems (such as hiatal hernia, gastrointestinal bleeding, peptic or duodenal ulcer)
• you have or have had a gastrointestinal disease (ulcerative colitis or Crohn's disease)
• you have high blood pressure, diabetes, high cholesterol levels, a family history of heart disease or stroke, or if you are a smoker
• you have liver or kidney problems
• you have diabetes due to potential diabetic nephropathy
• you have an overactive thyroid gland (hyperthyroidism) or psychosis
• you have a blood clotting disorder
• you are pregnant or breastfeeding
• you have had heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrowing or blockage of arteries), or any type of stroke (including "mini-stroke" or transient ischemic attack "TIA").

Sudden abdominal pain or rectal bleeding may occur with ACTISINU, due to
inflammation of the colon (ischemic colitis). If you develop these gastro-intestinal symptoms, stop
taking ACTISINU and contact your doctor or seek immediate medical attention. See section

• 4.

If you develop a widespread feverish rash accompanied by pustules, stop taking ACTISINU and
contact your doctor or seek immediate medical attention. See section 4.
Adverse effects can be minimized by using the lowest effective dose for the shortest
possible period. Elderly people are at greater risk of adverse effects.
Concomitant use with NSAIDs, including selective cyclooxygenase (COX)-2 inhibitors, increases the risk of
adverse reactions (see section "Other medicines and ACTISINU" below) and should be avoided.
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a modest increase
in the risk of heart attack or stroke, especially if used at high doses. Do not exceed the recommended dose or duration of
treatment.
Do not use this medicine for purposes other than its intended use and never take more than the amount
recommended. Do not take for longer than the recommended duration of treatment (4 days in adults or 3
days in adolescents).
Increased doses of pseudoephedrine may be toxic and continued use may lead to taking more
ACTISINU than the recommended dose to achieve the desired effect, increasing the risk of
overdose.
If you suddenly stop treatment, depression may occur.
Prolonged use of any type of painkiller for headache can cause worsening. If this
situation occurs or is suspected, consult a doctor and stop treatment. A diagnosis of
medication overuse headache (MOH) should be suspected in patients who
have frequent or daily headaches despite (or because of) the regular use of headache medicines.
Serious skin reactions have been reported in association with treatment with ACTISINU. Stop
taking ACTISINU and consult your doctor immediately if you experience a rash, mucous membrane lesions, blisters or other signs of allergy, as they may be the first signs of a very serious skin
reaction. See section 4.

Interference with blood test results
Pseudoephedrine may interfere with some diagnostic blood tests. Tell your doctor that you
are taking this medicine if you need to have a blood test.

Children and adolescents
ACTISINU should not be given to children under 15 years of age.
There is a risk of kidney failure in dehydrated adolescents.

Athletes
For those who engage in sports: the use of the drug without therapeutic need constitutes doping and may
still result in a positive doping test.

Other medicines and ACTISINU

Tell your doctor or pharmacist if you are taking, have recently taken or might take any

other medicines.
ACTISINU can influence or be influenced by some other types of medicines. For example:

• anticoagulant medicines (blood thinners/prevent blood clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine)
• medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin-II receptor antagonists such as losartan).

Some other medicines may also influence or be influenced by treatment with ACTISINU. Always consult
a doctor before using ACTISINU together with other medicines.
ACTISINU should not be used in combination with:

• other vasoconstrictor agents used as nasal decongestants, administered both orally and nasally (e.g. phenylpropanolamine, phenylephrine and ephedrine)
• a medicine for attention deficit hyperactivity disorder (ADHD) called methylphenidate
• medicines for depression such as non-selective monoamine oxidase inhibitors (MAOIs, such as iproniazide). Also, do not take this medicine if you have taken such drugs in the last 14 days. In particular, tell your doctor or pharmacist if you are taking:
• other non-steroidal anti-inflammatory drugs (NSAIDs), including high doses of acetylsalicylic acid and selective COX-2 inhibitors
• medicines for the treatment of heart arrhythmias (cardiac glycosides, e.g. digoxin)
• medicines for the treatment of epilepsy (e.g. phenytoin)
• glucocorticoids, which are used for numerous conditions such as pain, swelling, allergy, asthma, rheumatism and skin problems
• injectable heparin
• some medicines for depression (e.g. lithium, selective serotonin reuptake inhibitors [SSRIs] monoamine oxidase inhibitors [MAOIs] A)
• medicines for the temporary suppression of the immune system, e.g. methotrexate (for arthritis, psoriasis and some cancers), cyclosporine or tacrolimus (given after a transplant surgery)
• medicines for diabetes (sulfonylureas)
• medicines used for the treatment of infections (e.g. quinolones, trimethoprim)
• medicines that help you urinate (diuretics, e.g. potassium-sparing diuretics)
• medicines for gout (e.g. probenecid and sulfinpyrazones)
• medicines for migraine (including medicines derived from ergot alkaloids)
• medicines for the treatment of HIV/AIDS (zidovudine)
• preparations containing Ginkgo biloba The administration of pseudoephedrine can cause a sudden increase in blood pressure during surgery. Stop treatment with ACTISINU several days before surgery and inform your anesthesiologist.

ACTISINU with alcohol
You should avoid drinking alcohol during treatment.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding,
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 advised by your
doctor.
Do not take ACTISINU during the third trimester of pregnancy.

Breastfeeding
Do not take this medicine if you are breastfeeding, as it may harm the baby.

Fertility
Ibuprofen belongs to a group of medicines (NSAIDs) that may impair fertility in women.
This effect is reversible upon stopping the medicine.

Driving and using machines
ACTISINU may cause dizziness, hallucinations, unusual headache and disturbances of vision or hearing and therefore
may temporarily affect your ability to drive or use machines. If you experience any of
these symptoms do not drive and do not use machines.

ACTISINU contains Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say essentially ‘sodium-free’.

3. How to take ACTISINU

Take this medicine following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Duration of treatment
This medicine should only be used for short periods of treatment. The minimum effective dose should be used to relieve symptoms for the shortest possible time.
If the use of the medicine is necessary for more than 4 days in adults or 3 days in adolescents, or if symptoms worsen, consult your doctor.

Dosage
The recommended dose for adults and adolescents aged 15 years and over is:
1 tablet every 6 hours, if necessary. For more severe symptoms, take 2 tablets every 6 hours, if necessary.
Do not exceed the maximum daily dose of 6 tablets per day (equivalent to 1200 mg of ibuprofen and 180 mg of pseudoephedrine hydrochloride).

Method of administration
The tablets are for oral use. These should be swallowed whole and not chewed, with plenty of water, preferably during meals.

Use in children and adolescents
ACTISINU should not be given to children and adolescents under the age of 15 years.

If you take more ACTISINU than you should
Stop treatment and consult your doctor immediately, even if you do not feel unwell.
If you have taken more ACTISINU than you should or if your child has taken this medicine by mistake, always contact a doctor or the nearest hospital to obtain advice on the risk and recommendations on what action to take.
Symptoms may include nausea, stomach pain, vomiting (possibly with traces of blood), headache, ringing in the ears, confusion and uncontrolled eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (especially in children), weakness and dizziness, blood in the urine, feeling of coldness in the body and breathing problems have been reported.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking ACTISINU and consult your doctor immediately if you notice:

• signs of intestinal bleedingsuch as: bright red stools, tarry black stools, vomiting blood or dark particles like coffee grounds
• signs of colitis (inflammation of the colon)such as: sudden stomach pain, blood in the stools, rectal bleeding and diarrhoea
• signs of a severe allergic reactionsuch as: severe skin rashes, peeling, blistering or flaking of the skin, swelling of the face, hands, feet or genitals, wheezing breathing of unknown origin, shortness of breath, easy bruising

Contact your doctor if you experience any of the following side effects, notice worsening or any other effects not listed.

Common (may affect up to 1 in 10 people)

• indigestion, stomach discomfort or pain, nausea, vomiting, flatulence, diarrhoea, constipation, mild gastrointestinal bleeding, which rarely leads to anaemia
• insomnia, dry mouth

Uncommon (may affect up to 1 in 100 people)

• hypersensitivity reactions with urticaria, itching and asthma attacks (with a drop in blood pressure)
• central nervous system disorders such as headache, dizziness, difficulty sleeping, agitation, irritability or fatigue
• visual disturbances
• gastrointestinal ulcers, sometimes with bleeding and perforation, gastritis, swelling of the mouth lining with ulceration (ulcerous stomatitis), worsening of colitis and Crohn's disease
• various skin rashes

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

• tinnitus (ringing in the ears)
• restlessness, tremor
• worsening of asthma or hypersensitivity reaction with shortness of breath
• kidney tissue damage (papillary necrosis), increased concentrations of uric acid in the blood

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

• worsening of infectious inflammations (e.g. necrotizing fasciitis), aseptic meningitis (stiff neck, headache, nausea, vomiting, fever or disorientation) in patients with pre-existing autoimmune diseases (systemic lupus erythematosus (SLE), mixed connective tissue disease)
• problems in the production of blood cells (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis), which could lead to easy bruising or increased susceptibility to infections
• severe allergic reactions
• psychotic reactions and depression
• high blood pressure, irregular heartbeat, heart failure, heart attack
• skin rash, itching (pruritus cutaneus)
• inflammation of the oesophagus (oesophagitis) and pancreas (pancreatitis), diaphragm-like intestinal stenosis
• liver dysfunction, liver damage, especially with long-term therapy, liver failure, acute inflammation of the liver (hepatitis)
• severe skin reactions including rashes with redness and blisters (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell's syndrome), hair loss (alopecia), severe skin infections and complications affecting soft tissues in case of chickenpox (varicella zoster virus infection)
• increased serum creatinine, oedema (particularly in patients with hypertension or renal insufficiency), nephrotic syndrome, interstitial nephritis, acute renal failure

Not known (frequency cannot be estimated from the available data)

• abnormal behaviour
• stroke, seizures, headache
• chest pain, fast heartbeat, irregular heartbeat
• thirst, nausea, vomiting
• urticaria, itching, excessive sweating, tingling sensation
• euphoric mood, hallucination, nervousness, anxiety
• drowsiness
• redness of the skin, blisters or rash
• pain, discomfort or difficulty urinating, inability to urinate
• high blood pressure
• angioedema (difficulty breathing, skin rash, swelling of the face, hands or feet)
• inflammation of the colon due to insufficient blood supply (ischaemic colitis)
• it is possible that a serious skin reaction known as DRESS syndrome may occur. The symptoms of DRESS

include: rash, fever, swollen lymph nodes and increased eosinophils (a type of
white blood cells). A widespread, red and scaly rash, with the formation of pustules under the skin and
blisters located mainly on the skin folds, trunk and upper limbs accompanied by
fever (Acute Generalized Exanthematous Pustulosis - AGEP) may occur at the beginning or within the first 2
days of treatment with ACTISINU.
Stop using ACTISINU if you develop these symptoms and contact your doctor or seek immediate
medical assistance. See section 2.
Medicines similar to ACTISINU may be associated with a slight increase in the risk of heart attack
(“myocardial infarction”) or stroke.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store ACTISINU

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the package or blister after (Exp.). The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What ACTISINU contains

• The active ingredients are ibuprofen and pseudoephedrine hydrochloride. Each film-coated tablet contains 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride
• The other ingredients are: Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose, corn starch, anhydrous colloidal silica, magnesium stearate. Tablet coating: hypromellose, macrogol 400, talc, titanium dioxide (E171), yellow iron oxide (E172)

Description of the appearance of ACTISINU and package contents
ACTISINU are round, yellow, film-coated tablets.
Packs: 10, 12, 20 or 24 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Johnson & Johnson S.p.A. via Ardeatina km 23,500 - 00071 Santa Palomba – Pomezia Roma

Manufacturer
Dragenopharm Apotheker Püschl GmbH, Göllstraße 1, 84529 Tittmoning Germany.

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Germany: Olytabs 200mg/30mg Filmtabletten
Belgium: Sinuphene 200mg/30mg Filmomhulde tabletten
Bulgaria: Олитабс 200mg/30mg филмирани таблетки
Croatia: Olytabs 200 mg/30 mg filmom obložene tablete
Ireland: Non-Drowsy Sudapro Head Cold 200mg/30mg film coated tablets
Italy: ACTISINU 200mg/30mg compresse rivestite con film
Luxembourg: Sinuphene 200mg/30mg comprimés pelliculés
Malta: Non-Drowsy Sudapro Head Cold 200 mg/30mg Film-coated Tablets
Portugal: Cegrinaso 200mg/30mg comprimido revestido por película
Romania: Olytabs 200 mg/30mg comprimate filmate
UK: Sudafed Sinus Pressure & Pain 200mg/30mg Tablets
“Detailed and up-to-date information on this medicinal product is available by scanning the QR
code on the outer packaging with a smartphone. The information is also available on the Database