Siafen Suspension For Children 20 mg/ml (120 ml)

Do not use Siafen:

• if your child is hypersensitive to the active substance ibuprofen or any of the other ingredients of the product;
• in children with asthma attacks, urticaria or hay fever caused by aspirin; • in the presence of peptic ulcer of the stomach and duodenum and / or evidence of gastrointestinal bleeding in the past; • in cases of history of gastrointestinal bleeding in the past caused by other drugs from the group of non-steroidal anti-inflammatory drugs; • in severe heart failure; •  in severe liver, kidney or cardiovascular disease;
• Do not use Siafen in children under 6 months of age.

Take special care with Siafen: 

• Siafen may irritate the stomach and intestines at any time during treatment, with or without warning symptoms. Discontinue treatment and consult your doctor if your child begins to complain of stomach pain, nausea, vomiting, especially if there has been an ulcer or gastrointestinal bleeding in the past.
• Increased risk of gastrointestinal complications tract exists in patients who are taking corticosteroids and anticoagulants concomitantly with ibuprofen.
• Use with caution in all manifestations of hypersensitivity to food and drugs, in chronic allergic rhinitis, chronic sinusitis and / or nasal polyps, bronchial asthma.
• Siafen is used with caution in children with kidney disease, cardiovascular disease, high blood pressure, impaired blood clotting. Discuss treatment with your doctor.
• Siafen can, although rarely, cause serious skin reactions. Treatment should be discontinued at the first sign of skin hypersensitivity.
• Due to its anti-inflammatory action, the medicinal product may mask the signs of acute inflammation, which necessitates the exclusion of a bacterial infection. This medicine can also be used by adults if necessary. The warnings and the above information also apply to them.
• Medicines such as Siafen may be associated with a slightly increased risk of heart attack or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended doses and duration of treatment.
• In case of heart problems, stroke or possible risk of their occurrence, treatment should be discussed with your doctor.

Pregnancy and lactation

Siafen suspension is intended for use in children

Driving and using machines

Siafen suspension is a dosage form for use in children.

Side effects:

Consult a doctor if you experience: indigestion, heartburn, pain or other stomach problems, worsening of asthma, rash, dizziness, headache, hearing loss.

Discontinue treatment with Siafen and consult a doctor immediately if you experience symptoms such as:

• blisters on the skin, mouth, eyes and genitals, vomiting blood, bloody diarrhea, stomach ulcers, heart rhythm problems, toxic hepatitis with or without jaundice / yellowing of the skin and sclera swelling.

Medicines such as Siafen may be associated with a slightly increased risk of heart attack or stroke.

SIAFEN oral suspension 20 mg / ml 120 ml SOPHARMA

Package leaflet: information for the user

Siafen 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 have to read it again.
• If you need further information or advice, ask your pharmacist. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If after 3 days your child does not feel better or his condition worsens, you should seek medical attention.

What is in this leaflet

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

1. What Siafen is and what it is used for

Siafen oral suspension is an anti-inflammatory, painkiller and temperature-lowering drug for use in childhood. It contains the active substance ibuprofen, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).

Siafen oral suspension is used for:

• rapidly and effectively lowering your child’s fever, including after immunisation;
• quickly and effectively relieve mild to moderate pain, for example, with sore throat, teething, toothache, earache, headache, minor injuries and sprains;
• relieve cold and flu symptoms.

2. What you need to know before you use Siafen

Do not use Siafen:

• If your child is allergic to the active substance ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• If your child has ever suffered from shortness of breath, asthma, runny nose, hives, swelling of the face, tongue, lips or throat after taking acetylsalicylic acid (aspirin), or other medicines to relieve pain and fever (NSAIDs).
• If your child suffers or has suffered from an ulcer, perforation, or haemorrhage from the gastrointestinal tract two or more episodes of proven ulcer or haemorrhage.
• If your child has experienced perforation or bleeding in the intestinal tract in the past after taking pain relief and fever (NSAID) medications.
• If your child suffers from severe hepatic, renal or heart failure. In the last three months of pregnancy.

Warnings and precautions

Talk to your doctor or pharmacist before using Siafen.

• If your child suffers from allergic diseases that are at risk of difficulty breathing (hay fever, bronchial asthma, chronic sinusitis and/or polyps in the nose) or hypersensitivity to food and medication.
• If your child is taking other medicines in the NSAIDs group (including COX-2 inhibitors such as celecoxib and etoricoxib), their concomitant use should be avoided.
• If your child suffers from an autoimmune disease such as systemic lupus erythematosus (SLE) or mixed connective disease.
• If your child suffers or has suffered from high blood pressure and/or heart failure. Discuss the treatment with the attending physician. Do not exceed the recommended doses and duration of treatment (24 hours for infants aged 3-6 months weighing more than 5 kg or 3 days for children over 6 months).
• Siafen is used with caution in children with liver disease, kidney disease, cardiovascular disease and impaired blood clotting.
• Siafen is used with caution in severely dehydrated children as there is a risk of renal impairment.
• If your child suffers from chronic bowel disease (Crohn’s disease or ulcerative colitis), as ibuprofen may exacerbate it (see section 4).
• Siafen may irritate your child’s stomach and intestines at any time during treatment, with or without warning symptoms. Stop treatment immediately and see your doctor if your child starts complaining of stomach pain, nausea, vomiting, especially if there has been an ulcer or gastrointestinal hemorrhage in the past.
• If your child is taking Siafen at the same time as corticosteroids (e.g. prednisolone), anti-clotting drugs such as warfarin, anti-depression medicines (SSRIs) or blood-thinning agents such as acetylsalicylic acid, there is a greater risk of gastrointestinal complications.
• Siafen can, although rarely, cause serious skin reactions (exfoliative dermatitis, Stevens Johnson syndrome). You should stop taking Siafen and seek medical attention immediately if you develop a skin rash, mucous membrane lesions, blisters or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.

You have an infection — see section 4.4. section “Infections” below.

This medicinal product can also be used by adults if necessary. In addition to the above information, the following warnings apply to them:

• There is evidence that the use of medicines such as Siafen (ibuprofen), especially in high doses and for a prolonged period of time, may be associated with a slightly increased risk of heart problems (e.g. myocardial infarction or stroke). Do not exceed the recommended doses and duration of treatment.
• For heart problems, stroke or possible risk of heart disease (e.g. high blood pressure, diabetes, elevated cholesterol or smoking), treatment should be discussed with your doctor or pharmacist.
• In elderly patients, adverse reactions are more often observed with the use of high doses of NSAIDs, especially gastrointestinal hemorrhages, ulcers and perforations, sometimes with fatal outcome. Such patients should start treatment at the lowest effective dose possible.

Infections

Siafen can hide the signs of infections, for example, fever and pain. Therefore, it is possible that Siafen may delay the 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.

Other medicines and Siafen

Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines, including medicines obtained without a prescription. Tell your doctor if your child is taking:

• • other medicines to relieve pain and fever that contain ibuprofen, other NSAIDs, or aspirin (>75 mg/day). Siafen should not be taken concomitantly with other medicines of the same group (NSAIDs); corticosteroids (prednisolone); anti-clotting drugs (warfarin); diuretics (drainage);
• medicines to treat high blood pressure (antihypertensives); drugs for the treatment of heart failure — digoxin; antibiotics such as ciprofloxacin and levofloxacin; lithium (a medicine for depression);
• methotrexate (a medicine to treat cancer or rheumatism);
• antiplatelets (aspirin) and selective serotonin reuptake inhibitors (medicines for depression);
• • medicines that suppress the immune system (ciclosporin, tacrolimus); medicine to treat AIDS (zidovudine).

Pregnancy, breast-feeding and fertility

Siafen oral suspension is intended for use in children, but can also be used by adults if necessary. Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

Tell your doctor if you become pregnant while using Siafen oral suspension. Do not take this medicine in the last 3 months of pregnancy as it may harm your unborn child or cause birth problems. It can cause kidney and heart problems in your unborn baby. It can affect your tendency and that of your baby to bleed and may cause labor to start later or be longer than expected. You should not take Siafen oral suspension during the first 6 months of pregnancy unless absolutely necessary and on the recommendation of your doctor. If you need treatment during this period or while trying to become pregnant, the lowest dose should be used for the shortest possible time. From the 20th week of pregnancy, Siafen oral suspension may cause kidney problems in your unborn baby if taken for more than a few days, which may result in a reduced amount of amniotic fluid surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Lactation

Ibuprofen and its metabolites pass in very small amounts into breast milk. Short-term use of Syaphene at recommended doses usually does not require discontinuation of breast-feeding, as it is not known to harm the infant until now.

Fertility

Siafen oral suspension belongs to a group of products (NSAIDs) for which single cases of temporary decrease in the ability to become pregnant in women are known with prolonged use of higher doses. This effect is reversible after stopping the drug.

Driving and using machines

Siafen oral suspension is a dosage form for use in childhood, but can also be used by adults if necessary.

With short-term use at recommended doses, this medicine has no or negligible influence on the ability to drive and use machines.

Siafen oral suspension contains methyl- and propyl parahydroxybenzoate, which may cause allergic reactions (possibly of delayed type).

Siafen oral suspension contains sorbitol. If your child has an intolerance to some sugars, consult a doctor before starting treatment with Siafen.

3. How to use Siafen

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The lowest effective dose should be used for the shortest possible time needed 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).

• For pain, fever and cold and flu symptoms:

The usual daily dose of Siafen oral suspension is 20 to 30 mg/kg body weight, divided into several doses as follows:

Siafen can be given approximately every 6 to 8 hours (or at least 4 hours between doses when necessary). Do not exceed the dose indicated in the instructions.

Siafen oral suspension is not recommended for children under 3 months of age or weighing less than 5 kg unless prescribed by a doctor.

Immunisation induced temperature:

Usually, one dose of 2.5 ml of Siafen is sufficient. If necessary, one more dose can be given 6 hours later, but not more than 2 doses of 2.5 ml in 24 hours. If the temperature does not decrease, do not give a third dose. Consult the attending physician necessarily.

Duration of treatment: Siafen oral suspension is recommended short-term use – no more than 3 days.

• Infants aged 3-5 months (weighing more than 5 kg): should be resolved if symptoms worsen or do not respond within 24 hours. Syaphene oral suspension (three doses).
• Infants and children over 6 months of age: if it is necessary to take this medicinal product for more than 3 days or if the child’s symptoms worsen, the advice of a doctor should be sought. It is recommended to use the lowest effective dose for the shortest possible period of time.

Method of administration:

• Oral. It is recommended that patients with sensitive stomachs take Siafen oral suspension with meals. Shake well before use.

If your child has taken Syaphene more than the required dose or if the medicine has accidentally been taken by children, contact a doctor or the nearest hospital immediately to get an opinion on the risk and advice on action to be taken.

Symptoms may include nausea, vomiting (mixed with blood), headache, ringing in the ears, confusion, and rapid and 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.

If you miss taking Siafen

Do not give or take a double dose to make up for a forgotten dose. If you forget to take or give a dose, take or give that dose as soon as you detect the pass, then continue to take it, or give the next dose according to the dosing intervals indicated above.

If you have any further questions on the use of this medicine, ask your pharmacist.

4. Possible side effects

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

Side effects caused by Siafen are very rare and are characteristic of the majority of NSAIDs.

Discontinue treatment and see a doctor immediately if any of the following symptoms occur:

• swelling of the face, tongue, lips or throat with difficulty swallowing and shortness of breath. Seek medical attention immediately. These may be signs of rare but serious allergic reactions.
• traces of blood in the stool, colored in dark feces, vomiting with traces of blood or dark, the color of coffee particles. Worsening of existing colitis or Crohn’s disease are possible.
• rashes all over the body, flaking or blistering on the skin, mouth, eyes and genitals (Stevens-Johnson syndrome).
• severe skin reaction known as DRESS syndrome. Symptoms of DRESS include: skin rash, fever, swelling of the lymph nodes and an increase in eosinophils (a type of white blood cell).

Uncommon (occurs in less than 1 in 100 users):

Consult a doctor if they appear:

• rashes and itching on the skin;
• headache;
• indigestion, heartburn, pain or other stomach problems.

Rare (occurs in less than 1 in 1,000 users):

Consult a doctor if they last more than a few days or become troublesome diarrhea, bloating, constipation, or vomiting.

Very rare (occurring in less than 1 in every 10,000 users):

Discontinue treatment and consult a doctor if any of the following symptoms occur:

• fever, sore throat, mouth ulcers, flu-like symptoms, severe exhaustion, unusual bleeding and easy bruising (abnormal blood indicators);
• neck stiffness, headache, nausea, vomiting, fever and disorientation (symptoms of aseptic meningitis);
• palpitations, occurrence of chest pain, heart rhythm disturbance. Medicines such as Siafen (ibuprofen) may be associated with a slightly increased risk of a cardiac event (myocardial infarction) or stroke, which are unlikely when used in childhood doses.

Not known:

• red, scaly, covering a large surface rash with bulges under the skin and blisters, localized mainly on the skin folds, body and upper limbs, accompanied by fever at the initiation of treatment (acute generalized eccentmatous pustulosis). Stop using Siafen if you develop these symptoms and seek medical advice immediately. See also section 2;
• The skin becomes sensitive to light.

Elderly patients using this medicine have an increased risk of side effects.

Side effects can be minimised by using the lowest effective dose possible to manage symptoms as soon as possible.

Reporting of adverse reactions

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Siafen

Keep out of the reach of children.

Store in the original package at a temperature below 25°C. Do not freeze.

Use the medicine up to 1 month after opening the bottle.

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

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

6. Contents of the pack and other information

What Siafen contains

• The active substance is ibuprofen 100 mg in 5 ml suspension.
• The other ingredients are: sorbitol (E 420), sodium starch glycolate (type A, xanthan gum, polysorbate 80, glycerol, citric acid monohydrate, sodium citrate dihydrate. propylene glycol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), saccharin sodium, liquid essence “Tuti fruti”, purified water.

What Siafen looks like and contents of the pack

Oral suspension of white, to almost white color, with the smell of fruit.

120 ml each in dark glass bottles with an aluminium or polyethylene cap, or dark PET bottles with a polyethylene cap; 1 bottle in a cardboard box, together with a measuring cup and a leaflet.

Marketing Authorisation Holder and Manufacturer

SOPHARMA AD, Bulgaria