PANACTIV susp 100mg/ml 120ml

PANACTIV susp 100mg/ml 120ml

Patient information leaflet

PANACTIV 100 mg/5 ml oral suspension

Ibuprofen

PANACTIV 100 mg/5 ml oral suspension

Ibuprofen

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use 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 need further information or advice, ask your pharmacist.

- If your child gets any side effects, tell your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

- You should seek medical attention:

- if your child is 3 to 5 months old and does not feel better or his condition worsens after 24 hours;

- if your child is 6 months or older and does not feel better or gets worse after 3 days.

What this leaflet contains

1. What PANACTIV is and what it is used for

2. What you need to know before you take PANACTIV

3. How to take PANACTIV

4. Possible side effects

5. How to store PANACTIV

6. Contents of the pack and other information

1. What PANACTIV is and what it is used for

The active ingredient of PANACTIV is ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). The medicine has pain-relieving, antipyretic and anti-inflammatory effects.

This medicine is intended for use in infants, toddlers and children for short-term symptomatic treatment in the following cases:

· fever (high temperature) of various origins (also in viral infections);

· pain of various origins from moderate to mild:

- headaches, sore throats and muscle aches due to viral infections;

- muscle, joint and bone pain resulting from injury to the musculoskeletal system (sprains, joint dislocations);

- pain resulting from soft tissue injury;

- postoperative pain;

- toothache, pain after tooth extraction;

- headache (also migraine);

- ear pain due to inflammation of the middle ear (only on the advice of a doctor).

2. What you need to know before you use PANACTIV

Do not give PANACTIV to your child if he/she:

are allergic to ibuprofen, other non-steroidal anti-inflammatory drugs (NSAIDs) or any of the other ingredients of this medicine (listed in section 6);
have had signs of allergy in the past such as runny nose, hives, swelling of the face, tongue, lips or throat, bronchospasm or asthma after taking acetylsalicylic acid (aspirin) or other NSAIDs;
has a perforated gastric and/or duodenal ulcer or bleeding after treatment with NSAIDs;
have (had two or more episodes of) stomach ulcer or bleeding;
has severe liver, kidney or cardiovascular failure;
are taking other non-steroidal anti-inflammatory drugs at the same time, including COX-2 inhibitors (increased risk of adverse drug reactions);
have conditions involving an increased tendency to bleed (e.g. blood clotting disorders, thrombocytopenia);
has cerebrovascular or other active bleeding.
Do not use medicines containing ibuprofen if you are a woman in the third trimester of pregnancy (see section “Pregnancy, breast-feeding and fertility”).

Warnings and precautions

Adverse drug reactions can be minimized by using the lowest effective dose for the shortest possible time necessary to control symptoms.

Elderly patients have an increased incidence of adverse drug reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.

Talk to your doctor or pharmacist if you have an infection - see the heading 'Infections' below.

Talk to your doctor before giving PANACTIV to your child if they have been previously diagnosed with:

- lupus erythematosus and mixed connective tissue disease;

- gastrointestinal disease and chronic disease of the small intestine (ulcerative colitis, Crohn's disease);

- arterial hypertension and/or heart problems;

- impaired renal function;

- liver function disorder;

- blood clotting problems;

- active or past bronchial asthma or signs of an allergic reaction (bronchial constriction may occur after taking this medicine);

- chickenpox - see below under the heading "Infections".

There is a risk of gastrointestinal bleeding, ulceration or perforation, which may be life-threatening and may not necessarily be preceded by warning symptoms, and may occur in patients who already have such symptoms. In the event of gastrointestinal bleeding or ulceration, the use of the drug should be discontinued immediately. Patients with a history of gastrointestinal diseases, especially in the elderly (PANACTIV in the form of oral suspension can also be used by adults), should inform the doctor of any atypical symptoms from the digestive tract (especially bleeding), especially in the initial phase of treatment.

At the same time, long-term use of various painkillers can lead to kidney damage with a risk of kidney failure (analgesic nephropathy).

Anti-inflammatory/painkilling medicines such as ibuprofen may be associated with a slightly increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended doses and duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking PANACTIV if:

- you have heart problems, including heart failure, angina (chest pain), or have had a heart attack, bypass surgery, peripheral arterial disease (poor blood circulation in the legs and feet due to narrowed or blocked arteries) or any stroke (including ministroke or transient ischemic attack).

- you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker).

Skin reactions

Serious skin reactions have been reported in connection with the use of PANACTIV. You should stop taking PANACTIV and seek medical help immediately if you develop a skin rash, lesions on the mucous membranes, blisters or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.

Stop using ibuprofen and contact your doctor immediately if your child develops any of the following symptoms (angioedema):

• swelling of the face, tongue or throat;

• difficulty swallowing;

• hives or difficulty breathing.

Patients with systemic lupus erythematosus and mixed connective tissue disease may be at increased risk of aseptic meningitis.

Infections

PANACTIV may mask the signs of infection, such as fever and pain. Therefore, PANACTIV may delay appropriate treatment of the infection, which may lead to an increased risk of complications. This is seen in pneumonia caused by bacteria and bacterial skin infections associated with chickenpox. If you are taking this medicine while you have an infection and the symptoms of the infection persist or worsen, you should consult a doctor immediately.

Ibuprofen, the active ingredient of PANACTIV, may temporarily suppress platelet function (platelet aggregation). Patients with bleeding disorders should be monitored carefully.

During prolonged use of PANACTIV, regular monitoring of liver enzymes, kidney function and blood cell counts is required.

There is a risk of kidney damage in dehydrated children and adolescents.

Headache that may occur during prolonged administration of analgesics should not be treated by administering higher doses of this product.

Isolated cases of toxic amblyopia (reduced visual acuity) have been reported during ibuprofen use, therefore any visual disturbances should be reported to a doctor.

Some anticoagulants (medicines to prevent blood clotting, e.g. acetylsalicylic acid/aspirin, warfarin, ticlopidine), some medicines for high blood pressure (ACE-receptor inhibitors, e.g. captopril, beta-blockers, angiotensin II antagonists) and some other medicines (see below “Other medicines and PANACTIV”) may affect or be affected by treatment with ibuprofen.

Therefore, always consult a doctor before using ibuprofen with other medications.

Other medicines and PANACTIV

Tell your child's doctor if he or she is taking, has recently taken or might take any other medicines.

PANACTIV may affect or be affected by some other medicines, for example:

· analgesics, acetylsalicylic acid/aspirin or other non-steroidal anti-inflammatory drugs;

· medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan);

· medicines that are anticoagulants (e.g. warfarin) and antiplatelet medicines – medicines that prevent clot formation (e.g. ticlopidine);

· lithium or selective serotonin reuptake inhibitors – used for depression;

· methotrexate – used for some types of cancer;

· corticosteroids – used against inflammation;

· cyclosporine – a drug that suppresses the immune system;

· cardiac glycosides (e.g. digoxin) – medicines for heart problems;

· tacrolimus – a medicine that suppresses the immune system;

· mifepristone – used for medical termination of pregnancy;

· zidovudine or ritonavir – used for HIV or AIDS;

· quinolone antibiotics or aminoglycosides – antibiotics to treat infections;

· voriconazole or fluconazole – used for fungal infections;

· probenecid or sulfinpyrazone – medicines to treat gout;

· oral antidiabetic agents – used to treat diabetes mellitus;

· cholestyramine – used to lower cholesterol;

· phenytoin – against epilepsy;

· baclofen – used against skeletal muscle spasms.

Some other medicines may also affect or be affected by treatment with PANACTIV. You should always seek advice from a doctor or pharmacist before using PANACTIV with other medicines.

Pregnancy, breastfeeding and fertility

This section is not applicable to PANACTIV 100 mg/5 ml oral suspension as it is intended for use in children aged 3 months to 12 years. However, the following information refers to the active ingredient ibuprofen.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take PANACTIV 100 mg/5 ml oral suspension 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 your unborn baby. It may affect your and your baby's tendency to bleed and may cause labour to start later or take longer than expected.

You should not take PANACTIV 100 mg/5 ml oral suspension during the first 6 months of pregnancy unless absolutely necessary and on the advice of your doctor. If you need treatment during this period or while you are trying to get pregnant, you should use the lowest dose for the shortest possible time. From the 20th week of pregnancy, ibuprofen can cause kidney problems in your unborn baby if taken for more than a few days, which can lead to a reduced amount of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessels (ductus arteriosus) in the baby's heart. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.

Breastfeeding

Ibuprofen may pass into breast milk in small amounts. There are no known cases of adverse reactions in nursing infants. Breastfeeding does not need to be interrupted during short-term treatment with ibuprofen at doses used to treat pain and fever.

Fertility

This medicine belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) which may have a negative effect on female fertility. The effect is temporary and disappears after the end of treatment.

Driving and using machines

This section is not applicable to PANACTIV 100 mg/5 ml oral suspension, as it is intended for use in children aged 3 months to 12 years. However, the following information refers to the active ingredient ibuprofen.

The medicinal product PANACTIV may cause a feeling of dizziness or vertigo. If this happens, do not drive or use tools or machines. Do not do anything that requires increased attention.

PANACTIV contains sodium benzoate (E211), liquid maltitol (E965), propylene glycol (E1520) and sodium.

This medicine contains:

· 5 mg sodium benzoate in each 5 ml oral suspension

· 2.4 g liquid maltitol in 5 ml. If your doctor has told you that your child has an intolerance to some sugars, contact him/her before using this medicinal product.

· 4.17 mg propylene glycol in each 5 ml of oral suspension.

· 9.67 mg sodium (main ingredient of table salt) in each 5 ml oral suspension. This corresponds to 0.48% of the recommended maximum daily intake of sodium for adults.

3. How to use PANACTIV

Always use this medicine exactly as described in this leaflet or as your child's doctor or pharmacist has told you. You should ask your child's doctor if you are not sure.

The medicine should be taken orally, after meals, with plenty of liquid. Shake the bottle before use.

The package contains a dispenser in the form of a syringe.

The lowest effective dose should be used for the shortest possible time to relieve symptoms. If you have an infection, consult a doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).

The recommended dose should not be exceeded.

Instructions for using the dosing syringe

1. Unscrew the bottle cap (press and turn counterclockwise).

2. The dispenser should be pressed tightly against the neck of the bottle.

3. The bottle should be shaken vigorously.

4. To fill the dispenser, the bottle should be turned upside down and then the desired amount of suspension should be withdrawn by pulling the plunger.

5. Turn the bottle upright, carefully unscrew the dispenser and separate it from the bottle.

6. The end of the dispenser is placed in the mouth and the contents are carefully emptied by slowly pressing the plunger.

7. After application, the bottle should be closed tightly; wash and dry the dispenser.

The commonly used single dose of ibuprofen is 7 to 10 mg/kg up to a maximum daily dose of 20 to 30 mg/kg, according to the following schedule:

Body weight

(Child's age)
Amount of ibuprofen
Frequency per 24 hours (max. daily dose of ibuprofen)
5–7.6 kg (3–6 months)
2.5 ml (1 × 50 mg)
3 times (150 mg)
7.7–9 kg (6–12 months)
2.5 ml (1 × 50 mg)
3 to 4 times (150-200 mg)
10–15 kg (1–3 years)
5 ml (1 × 100 mg)
3 times (300 mg)
16–20 kg (4–6 years)
7.5 ml (1 × 150 mg)
3 times (450 mg)
21–29 kg (7–9 years)
10 ml (1 × 200 mg)
3 times (600 mg)
30-40 kg (10–12 years)
15 ml (1 × 300 mg)
3 times (900 mg)

The dose may be repeated every 6-8 hours, with an interval of at least 4 hours between successive doses.

For short-term use only.

In children 3 to 5 months of age, a doctor should be consulted if symptoms worsen or persist for more than 24 hours.

For children under 6 months of age, the medicinal product can only be administered after consultation with a doctor and on medical advice.

If a child (older than 6 months) or adolescent needs the medicine for more than 3 days, or the symptoms get worse, consult a doctor.

It should not be given to children younger than 3 months.

Once opened, the package should be used within 6 months.

Use of PANACTIV in patients with renal and/or hepatic disorders

If you have mild or moderate kidney and/or liver failure, the dose should be as low as possible. The use of ibuprofen is not recommended in people with severe kidney or liver failure.

If you take more PANACTIV than you should

If you have taken more PANACTIV than you should or if the medicine has been accidentally taken by children, contact a doctor or the nearest hospital immediately to get an opinion on the risk and advice on what action to take.

Cases of overdose are rare.

Most patients may experience:

- nausea, vomiting, upper abdominal pain or diarrhea;

- tinnitus, headache and bleeding from the stomach or intestines.

Severe poisonings can affect the central nervous system and manifest as - dizziness;

- agitation, disorientation or coma (very rare);

- seizures (very rare).

In severe poisonings, it can occur;

- metabolic acidosis - symptoms may include nausea, stomach pain, vomiting (mixed with blood), headache, ringing in the ears, confusion and rapid involuntary eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, feeling cold and breathing problems have been reported;

- increase in prothrombin time/INR (international normalization ratio);

- kidney failure or liver damage;

- in patients with bronchial asthma, asthmatic symptoms may worsen.

There is no specific antidote. Treatment is symptomatic and supportive. The doctor will consider oral administration of activated charcoal within one hour of overdose.

If you forget to take PANACTIV

Do not take a double dose to make up for a missed dose.

4. Possible side effects

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

PANACTIV is generally well tolerated. The following side effects have been observed during short-term use of ibuprofen, at doses available without a prescription.

Common (affects 1 to 10 in 100 people treated):

· heartburn, abdominal pain, malaise, vomiting, gas, diarrhea, constipation, mild gastrointestinal bleeding, in exceptional cases causing anemia.

Uncommon (affects 1 to 10 in 1,000 people treated):

· headache, dizziness, insomnia, drowsiness, agitation, irritability and fatigue.

· ulceration of the digestive tract with possible bleeding and perforation, ulcerative stomatitis, inflammation of the stomach, worsening of ulcerative colitis and Crohn's disease.

· blurred vision.

· hypersensitivity reactions with skin eruptions and pruritus, as well as asthma attacks (with possible lowering of blood pressure), various skin rashes.

Rare (affects 1 to 10 in 10,000 treated):

· vertigo (dizziness).

· fluid retention (edema).

· ringing in the ears (tinnitus).

Very rare (affects less than 1 in 10,000 people treated):

· inflammation of the esophagus or pancreas, intestinal blockage.

· Gastric and/or duodenal ulcers, with or without bleeding and sometimes fatal, especially in the elderly, as well as perforation, may occur.

· kidney disorders, which manifest as passing less or more urine than normal, cloudy urine, blood in the urine, back pain or swelling (especially of the legs). Increased concentration of urea in the serum, renal failure, nephrotic syndrome, interstitial nephritis, possibly accompanied by acute renal failure. In general, the usual use of (various types of) painkillers can lead in rare cases to long-term severe kidney problems.

· liver function disorders, damage and acute inflammation of the liver, especially with long-term use - liver failure.

· Abnormalities observed in blood parameters (anemia, leukopenia - reduction in the number of white blood cells, thrombocytopenia - reduction in the number of platelets, pancytopenia - a blood disorder representing a deficiency of all normal elements of the blood: erythrocytes, leukocytes and platelets, agranulocytosis - reduction in the number of granulocytes). The initial symptoms are: fever, sore throat, superficial ulcerations of the oral mucosa, flu-like symptoms, malaise and bleeding (e.g. bruising, ecchymoses, purpura and nosebleeds).

· erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis, serious skin infections during chickenpox.

· swelling of the face, larynx and tongue, rapid breathing, tachycardia - heart rhythm disturbance, hypotension - decrease in blood pressure, shock.

In patients with pre-existing autoimmune disease (systemic lupus erythematosus, mixed connective tissue disease) isolated cases of symptoms of aseptic meningitis with stiff neck, headache, nausea, vomiting, fever and disorientation have been observed during treatment with ibuprofen.

· edema, hypertension, heart failure associated with the use of high doses of NSAIDs. The occurrence of edema, arterial hypertension and heart failure has been reported during treatment with NSAIDs.

· high blood pressure, palpitations (heart palpitations), heart failure.

· worsening of asthma and bronchospasm.

· psychotic reactions and depression.

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

· A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and an increase in eosinophils (a type of white blood cell).

· Red, scaly, widespread rash with subcutaneous bumps and blisters, mainly localized in the skin folds, torso and upper limbs, accompanied by high fever at the start of treatment (acute generalized exanthematous pustulosis). Stop using PANACTIV if you develop these symptoms and seek medical help immediately. See section 2.

· the skin becomes sensitive to light.

Medicines such as PANACTIV may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke.

Reporting side effects

If you get any side effects, please tell your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the Medicines Executive Agency,

8 Damyan Gruev Street

1303 Sofia

Tel.: +35 928903417

website: www.bda.bg

By reporting side effects, you can help provide more information about the safety of this medicine.

5. How to store PANACTIV

Keep out of the reach of children.

Store below 25°C. Do not refrigerate or freeze.

Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.

The suspension should be used within 6 months of first opening the package. To remind yourself, write the date of opening in a blank space on the box.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect the environment.

6. Contents of the pack and other information

What PANACTIV contains

The active ingredient is ibuprofen. 1 ml of the suspension contains 20 mg ibuprofen. 5 ml of the suspension contains 100 mg ibuprofen.

The excipients are: hypromellose, xanthan gum, glycerol (E422), sodium benzoate (E211), liquid maltitol (E965), sodium citrate, citric acid monohydrate, saccharin sodium (E954), sodium chloride, strawberry flavour (flavourings, propylene glycol (E1520), water), purified water.

What PANACTIV looks like and contents of the pack

PANACTIV is a white or off-white, strawberry-flavoured oral suspension supplied in 100 ml or 120 ml white PET bottles with a child-resistant cap and sealing ring. Each pack contains a 5 ml polystyrene (LDPE) dosing syringe (with 0.1 ml graduations).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Pharmaceutical Works POLPHARMA SA

19, Pelplińska Str.

83-200 Starogard Gdański

Poland

Manufacturer

Zakłady Farmaceutyczne POLPHARMA SA

Medan Branch in Sieradz

street Władysława Łokietka 10, 98-200 Sieradz

Poland

This medicinal product is authorised in the Member States of the EEA under the following names:

Bulgaria: PANACTIV 100 mg/5 ml oral suspension

Latvia: IBUGARD 100 mg/5 ml suspension

Lithuania: IBUGARD 100 mg/5 ml geriamoji suspensija;

Hungary: PANACTIV 100 mg/5 ml belsőleges szuszpenzió;

Date of last revision of the leaflet: