Medifen 3+ Months 100mg/5ml Oral Suspension
4-
Galpharm Children’s Ibuprofen 100mg/5ml Oral Suspension
Read this leaflet carefully because it contains important information.
This medicine is available without prescription for you to treat a mild illness in your child without a doctors help. Nevertheless you still need to use this medicine carefully to get the best results from it.
[• Keep this leaflet. You may need to read it again, p Ask your pharmacist if you need more information or advice. • You must contact a doctor or pharmacist if your child’s symptoms worsen or do not improve.
il. What this medicine is for |2. Before you give this medicine 3. How to give this medicine Possible side effects . Storing this medicine 6. Further information
Q WHAT THIS MEDICINE IS FOR
Galpharm Children’s Ibuprofen 100mg/5ml Oral Suspension pontains ibuprofen, which belongs to a group of medicines ailed Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). 'hese medicines work by changing how the body responds to pain, swelling and high temperature.
[rhis medicine is used to relieve:
• Fever (high temperature) including post immunisation fever at 2 months
|» Mild to moderate pain including headache, sore throat, teething pain and toothache, cold and flu symptoms and minor aches and sprains.
Q BEFORE YOU GIVE THIS MEDICINE
Do not give Galpharm Children’s Ibuprofen 100mg/5ml Oral Suspension to children who:
• have or have had a stomach ulcer, perforation or bleeding of the stomach
• are allergic to ibuprofen, to any of the ingredients (listed in section 6), or to aspirin or other painkillers (an allergic reaction may be recognised as shortness of breath, runny nose, skin rash or itching)
» have kidney or heart failure or severe liver failure
• are taking more than 75mg of aspirin a day.
Warnings and precautions
Anti-inflammatory / pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
[You should discuss your child's treatment with your poctor or pharmacist before giving Galpharm Children’s Ibuprofen 100mg/5ml Oral Suspension to children who:
,• have or have suffered from asthma or have allergies
• have liver or kidney problems
• have stomach or bowel disorders including Crohn’s disease or a condition known as ulcerative colitis
• have Systemic Lupus Erythematosus (SLE) - an illness which affects your immune system. It causes joint pains, skin changes and problems with other parts of your body.
[• have heart problems including heart failure, angina (chest pain), or if they have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the leas or feet due to narrow or blocked arteries), or any
kind of stroke (including 'mini-stroke' or transient ischaemic attack "TIA").
• have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke.
Children and adolescents:
There is a risk of renal impairment in dehydrated children and adolescents.
Other medicines and Galpharm Children’s Ibuprofen 100mg/5ml Oral Suspension
You must not give this medicine if they are taking certain othei medicines - see section 2 'Do not give Galpharm Children’s Ibuprofen 100mg/5ml Oral Suspension to children who:’. Galpharm Children’s Ibuprofen 100mg/5ml Oral Suspension may affect or may be affected by some other medicines. For example:
• medicines that are anti-coagulants (i.e. thin blood/preventl clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• medicines that reduce high blood pressure (ACE-inhibitorsi such as captopril, beta-blockers such as atenolol medicines,| angiotensin-ll receptor antagonists such as losartan)
• corticosteroids
• methotrexate (a medicine for cancer)
• cardiac glycosides (medicines used to treat heart failure)
• cyclosporin and tacrolimus (immunosuppressant medicines often used following organ transplants)
• mifepristone (a medicine used to terminate pregnancy -NSAIDs should not be used for 12 days after mifepristone)
• lithium (for depression or mental problems)
• zidovudine (a medicine to treat viruses)
• quinolone antibiotics (medicines used to treat bacterial infections).
Some other medicines may also affect or be affected by the treatment of Galpharm Children’s Ibuprofen 100mg/5ml Oral Suspension. You should therefore always seek the advice of your doctor or pharmacist before you give Galpharm Children’s Ibuprofen 100mg/5ml Oral Suspension with other medicines
If you are an adult taking this medicine you should be aware of all the above factors and additionally you should talk to your doctor or pharmacist if you:
• are a smoker
• are elderly, as there may be an increased risk of side effects.
Pregnancy and Breastfeeding
Do not take Galpharm Children’s Ibuprofen 100mg/5ml Oral Suspension if you are in the last 3 months of pregnancy. Talk to your doctor before taking Galpharm Children’s Ibuprofen 100mg/5ml Oral Suspension if you are| in the first 6 months of pregnancy or are breastfeeding. Galpharm Children’s Ibuprofen 100mg/5ml Oral Suspension! belongs to a group of medicines which may affect fertility ini women. Fertility goes back to normal when you stop taking the medicine. It is unlikely that if you only take this Ibuprofen: suspension occasionally it will affect your chances of becoming pregnant. If you have problems becoming pregnant talk to your doctor before taking this medicine.
Important information about some of the ingredients of this medicine.
This product contains liquid maltitol (E965). If you have beeni told by your doctor that your child may have an intolerance! to some sugars, talk to your doctor before your child takes this medicinal product. May have a mild laxative effect.
Each 5ml measure contains 1.375g of liquid maltitol (equivalent to 3.2 kcal per 5ml of the medicine).
This product also contains sodium methylparahydroxybenzoata (E219) and sodium propylparahydroxybenzoate (E217). These ingredients may cause allergic reactions (possibly delayed).
_ _ _ _ _Further information overleaf
Check the seal is not broken or the sachet is intact before first use. Shake thoroughly or massage the sachet to mix the contents. Give this medicine using the measuring spoon provided. For oral use.
Do not give to a child weighing less than 5kg:
|
Age |
Dose |
|
Children over 7 years: |
Two 5ml spoonfuls to be given 3 times a day. |
|
Children 4 to 7 years: |
One 5ml spoonful plus one 2.5ml spoonful (7.5ml) to be given 3 times a day |
|
Children 1 to 4 years: |
One 5ml spoonful to be given 3 times a day. |
|
Infants 6 months to 1 year: |
One 2.5ml spoonful to be given 3-4 times a day. |
|
If your child’s symptoms persist for more than 3 days, or if new symptoms occur, talk to your doctor. | |
|
Babies 3 to 6 months: |
One 2.5ml spoonful to be given 3 times a day. |
|
Do not give to babies aged 3 to 6 months for more than 24 hours. | |
|
Doses should usually be given every 6-8 hours, preferably with or after food. Do not give more often than every 4 hours. Do not exceed 4 doses in any 24 hour period. | |
|
Do not give to children under 3 months except for post-immunisation fever: one 2.5ml spoonful may be given followed by one further 2.5ml spoonful 6 hours later if necessary. No more than 2 doses should be given in 24 hours. If fever is not reduced, talk to your doctor. | |
|
This medicine is for short term use only. DO NOT EXCEED THE STATED DOSE | |
• pains in their stomach (abdomen) or other abnormal stomach problems
• pass blood in their stools or motions
• pass black tarry stools or motions
• vomit any blood or dark particles that look like coffee grounds
• worsening of bowel problems (ulcerative colitis or Crohn’s disease).
Blood disorders which can cause:
• unexplained or unusual bruising or bleeding
• sore throat or mouth ulcers
• fever (high temperature)
• extreme paleness or weakness and exhaustion.
Heart and circulation effects: Medicines such as Galpharm Children’s Ibuprofen 100mg/5ml Oral Suspension may be associated with a small increased risk of heart attack (myocardial infarction), high blood pressure, heart failure, swelling due to fluid build-up (oedema) or stroke. Other side effects that may occur include:
Other stomach and intestine effects including:
• diarrhoea, flatulence, constipation and vomiting.
Liver problems that might be indicated by yellowing of the skin] and eyes (jaundice) and/or pale coloured stools and dark urine Kidney problems that might be indicated by passing less or more urine than normal, cloudy urine, blood in the urine, pain in the back and/or swelling (particularly of the legs) -very rarely kidney failure.
Nervous system problems including headache and aseptic] meningitis (which can have symptoms such as severe headache, stiff neck, disorientation, fever and eye sensitivity to light in those with existing auto-immune disorders such as lupus). Reporting of side effects If your child gets any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects] not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.aov.uk/vellowcard By reporting side effects you can help provide more information on the safety of this medicine.
If your child takes too much medicine: Talk to a doctor straight away or go to your nearest hospital casualty department. Take the carton, this leaflet and any remaining |medicine with you.
] POSSIBLE SIDE EFFECTS
Most people take Galpharm Children’s Ibuprofen 100mg/5ml Oral Suspension without any problems, but it can have side effects, like all medicines. To reduce the phance of side effects, especially in the elderly, use the lowest effective dose for the shortest possible time.
If your child gets any of the following at anytime during the treatment STOP GIVING, and get medical help straight away:
Allergic reactions:
The following reactions may mean they are having an allergic reaction to this medicine:
]• asthma, worsening of asthma, unexplained wheezing or shortness of breath
• swelling of the face, lips, tongue and throat (causing difficulty in swallowing or breathing)
]• rapid heart rate, low blood pressure, collapse
• also, there may be skin reaction (including hives, rash and itching) - very rarely these can be severe with blistering and peeling skin.
Stomach and bowel problems including: p indigestion or heartburn
Do not use after the expiry date shown on the pack.
Do not store above 25°C. Store in the original container. Keep out of the sight and reach of children.
What is in this medicine:
The active ingredient is: Ibuprofen 100mg/5ml The other ingredients are: Sodium Methylparahydroxybenzoate (E219), Sodium Propylparahydroxybenzoate (E217), Citric Acid Anhydrous, Saccharin Sodium, Sodium Benzoate, (E211), Dispersible Cellulose, Juicy Orange Flavour, Polysorbate 80, Liquid Maltitol (E965), Xanthan Gum, Purified Water What this medicine looks like and contents of the pack: Galpharm Children’s Ibuprofen 100mg/5ml Oral Suspension is a white opaque smooth suspension available in a bottle containing 100ml of suspension or in sachets containing a 5ml dose which are packed into cartons containing 10 or 20 sachets. Not all pack sizes may be marketed. Marketing Authorisation Holder: Galpharm Healthcare Ltd., Wrafton, Braunton, Devon, EX33 2DL, United Kingdom. Manufacturer: Galpharm International Ltd., Elmhirst Park, Middle Field Road, Barnsley, South Yorkshire, S75 4LS, United Kingdom.
Text revised: April 2016.
4005569|
t