PANACTIV Baby 125mg x 5 supp
Read all of this leaflet carefully before you or your child start using this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your child's doctor or 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 or you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not described in this leaflet. See point 4.
Talk to your doctor if your condition does not improve or if it gets worse after 3 days.
What this leaflet contains
1. What Panactive Baby is and what it is used for
2. What you should know before using Panaktiv Baby
3. How to use Panactive Baby
4. Possible side effects
5. How to store Panaktiv Baby
6. Contents of the package and additional information
1. What Panactive Baby is and what it is used for
The active ingredient in Panaktiv Baby is ibuprofen, which belongs to a group of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). The drug has an analgesic, antipyretic and anti-inflammatory effect.
The medicine is intended for use in children for the short-term symptomatic treatment of mild to moderate pain and high fever.
Panaktiv Baby 125 mg suppositories is recommended for use when oral administration is not possible.
Panactive Baby 125 mg suppositories is indicated for children aged 2 years (12.5 kg body weight) to 6 years (20.5 kg body weight).
2. What you should know before using Panaktiv Baby
Do not use Panactive Baby or give it to your child:
if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6), or other non-steroidal anti-inflammatory drugs (NSAIDs);
if you have had a stomach and/or duodenal ulcer with perforation or bleeding that occurred as a result of NSAID treatment;
if you have (have had two or more episodes of) a stomach ulcer or bleeding;
if you have severe liver failure, severe kidney failure or severe heart failure;
if you simultaneously take other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (increased risk of side effects);
if you have conditions involving an increased tendency to bleed (eg bleeding disorders, thrombocytopenia);
if you have cerebrovascular or other active bleeding;
if you are severely dehydrated (due to vomiting, diarrhea or insufficient fluid intake);
do not use in children with an average weight of 12.5 kg or less.
Do not use products containing ibuprofen if you are a woman in the third trimester of pregnancy (see section "Pregnancy, breast-feeding and fertility").
Warnings and precautions
Talk to your doctor or pharmacist before using Panaktiv Baby.
Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck (angioedema), chest pain, have been reported with ibuprofen. Stop Panaktiv Baby immediately and contact your doctor or emergency department immediately if you notice any of these signs.
Talk to your doctor or pharmacist if you have an infection - see the "Infections" heading below.
Adverse reactions may be reduced by using the minimum effective dose for the shortest period of time necessary to control symptoms.
Talk to your doctor before using or giving your child Panactive Baby if you have previously been diagnosed with:
lupus erythematosus and mixed connective tissue disease;
anorectal diseases;
gastrointestinal diseases and chronic intestinal diseases (ulcerative colitis, Crohn's disease);
arterial hypertension and/or heart problems;
kidney function disorder;
liver function disorder;
blood clotting problems;
active or bronchial asthma in the past, or symptoms of an allergic reaction (bronchospasm may occur as a result of taking the drug);
chicken pox - 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, or may occur in patients who have had similar warning symptoms. In case of gastrointestinal bleeding or ulcer, the use of the drug should be stopped immediately. Patients with a history of gastrointestinal diseases should notify the drug of any atypical symptoms of the digestive tract (especially bleeding), especially in the initial phase of treatment.
The simultaneous long-term use of various analgesics can lead to kidney damage with the risk of kidney failure (analgesic nephropathy).
Anti-inflammatory/analgesic drugs such as ibuprofen may be associated with a slightly increased risk of myocardial infarction or stroke, especially when used in high doses. Do not exceed the recommended dose or duration of treatment.