Fromilid 250 mg. / 5ml. 60 ml.

What is Fromilid and what is it used for?
Formylide belongs to the group of macrolide antibiotics. Formilid is indicated for the treatment of:

respiratory tract infections (inflammation of the middle ear, sinuses, throat, tonsils, bronchi and lungs),
infections of the skin and subcutaneous tissues,
treating mycobacterial infections and preventing these infections.
It is also used to kill Helicobacter pylori bacteria in patients with duodenal ulcer (duodenal ulcer) or gastric ulcer. For ulcer treatment, your doctor will prescribe other medicines at the same time.
Formilly granules for oral suspension are for the treatment of children from 6 months to 12 years of age.

2. What you need to know before taking Fromilid

Do not give Fromilid to your child:

if it is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)
if there is a low level of potassium in the blood (hypokalaemia)
if there is severe liver failure and kidney problems,
if you are taking high-cholesterol medicines (such as lovastatin or simvastatin)
if you and / or someone in your family have had conditions with heart rhythm abnormalities (ventricular cardiac arrhythmia including Torsade de Pointes) or electrocardiogram changes (ECG) called (QT prolongation syndrome) ,
if you are already taking any of the following medicines:
ergotamine or dihydroergotamine (for migraine),
cisapride (for stomach upsets),
pimozide (for some mental illness),
terfenadine or astemizole (for hay fever or allergy),
other medicines that are known to cause serious heart rhythm disturbances
ticagrelor (blood thinner),
allyllazine (for angina pectoris (chest pain)),
colchicine (for gout).
Warnings and precautions
Talk to your doctor or pharmacist before giving Fromilide to your child:

if there are severe kidney problems if there is liver damage,
if you develop severe or prolonged diarrhea during or after taking Fromidil, you should consult your doctor immediately,
if you already take colchicine, as this may cause serious side effects, continued use of Formilide may lead to overgrowth of resistant bacteria (superinfection)
if there is any heart disease,
if there is a slow heartbeat (bradycardia)
in case there are low levels of magnesium in the blood,
if you have porphyria (an inherited liver disease where the body does not produce enough hemoglobin), it should not take clarithromycin if your child is under 6 months of age or if your child is infected with the Mycobacterium avium complex bacteria and is - less than 20 months of age. No studies were conducted in this age group.
Children and adolescents
For children and adolescents over 12 years of age, it is recommended to use Formilol film-coated tablets.
For children under 12 years of age, Formilid oral granules are usually used for oral suspension.

Other drugs and Formilide
Tell your doctor or pharmacist if your child is taking, has recently taken or is likely to take other medicines.

The effect of treatment may be affected if Formilide is taken together with some other medicines. You may need to change the dose, take other precautions or, in some cases, stop taking one of the medicines. This is especially true for the following medicines:

carbamazepine, phenobarbital, phenytoin, valproate (medicines for the treatment of asthma), warfarin (blood thinner), ergotamine or dihydroergotamine (for migraine), triazolam, midazolam or alprazolam (sedative) or verapamil (for the treatment of heart rhythm disorders),
(for the treatment of high cholesterol), pimozide (for the treatment of schizophrenia or other mental illness), fluconazole or itraconazole (for the treatment of fungal infections), rifabutin, rifampicin (antibiotics acting against some infections), etravirine, efavirenz, zidovudine, ritonavir, atazanavir or saquinavir (medicines for HIV),
cyclosporine, sirolimus or tacrolimus (after organ transplantation), terfenadine or astemizole (for hay fever or allergy), cisapride or omeprazole (for stomach upsets)
aminoglycoside antibiotics - gentamicin, streptomycin (to treat many types of bacterial infections), colchicine (to treat gout), amlodipine, diltiazem (for treatment of high blood pressure), tolterodine (for bladder problems), insulin or oral antidiabetic medicines (for diabetes), St. John's wort (herbal medicine),
cilostrazole (to improve blood circulation in the legs), methylprednisolone (inflammatory diseases), sildenafil, tadalafil or vardenafil (erectile dysfunction), vinblastine (for cancer treatment).
Formilide with food, beverages and alcohol
You can give Fromilid to your child, regardless of food. It is recommended that children accept
Use in children
Children under 12 years of age usually receive an oral suspension of 7.5 mg / kg of oral suspension every 12 hours.
Children are advised to take some liquid after taking the oral suspension. The suspension contains small granules that the child should not chew because they are bitter to taste. A syringe for oral administration is administered for proper dosing. One full syringe contains 5 ml of the suspension containing 250 mg clarithromycin. After each use of the syringe, it should be rinsed with water. Treatment usually lasts for 5 to 10 days.

Patients with kidney problems
If you have severe kidney problems, your doctor may prescribe a different dose.

Preparation of the suspension
For the preparation of 60 ml of your suspension, 42 ml of purified or boiled and cooled water is required. The bottle is shaken in advance to make the granules whiten. Add about 1/2 of the required amount of water. Immediately shake well to mix all the water, then add the rest of the water. The reconstituted suspension should reach the marked bottle level.
If you think the effect of the medicine is too strong or too weak, you should consult your doctor or pharmacist.

If you have given your child more than the appropriate dose of Formilide
If you have given your child an overdose, you should consult your doctor or pharmacist
pharmacist immediately!
Overdose usually causes gastrointestinal disorders (nausea, vomiting, abdominal pain), headache and confusion. Treatment is symptomatic.

If you forget to give Fromilid to your child
Do not give a double dose to make up for the missed dose.
If you have missed the dose at the scheduled time, do so as soon as you remember. If this is near the next dose, give the next dose at the usual time.

If you stop taking Formilid
It is important to give your child medicine for as long as your doctor prescribes. If you stop treatment prematurely, the infection may resume.
If you have any further questions on the use of this medicine, you should check with your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.

Common: may affect up to 1 in 10 people

insomnia, headache, changes in the sense of taste,
diarrhea, nausea or vomiting, indigestion (dyspepsia), stomach pain, impaired liver function test, rash, excessive sweating (hyperhidrosis).
Uncommon: may affect up to 1 in 100 people

infections such as stomach and intestinal infections, thrush, vaginal infections, low levels of white blood cells, anemia and other white blood cell disorders, loss of appetite, nervousness, anxiety,
dizziness, trembling (tremor), tinnitus, dizziness and vertigo, changes in the heart rhythm, palpitations, nasal bleeding,
inflammation of the mouth (stomatitis), inflammation of the tongue (glossitis), inflammation of the stomach (gastritis), severe episodic rectal pain (proctalgia)
constipation, dry mouth, burning, gas, excess gas in the stomach and vomiting, gastric acid return to the esophagus (GERD),
bile duct disorder (cholestasis), liver inflammation (hepatitis), itching, hives, small and red spots on the skin (maculo-papular rash)
muscle cramps (muscle cramps), muscle cramps (muscle cramps), fever, chest pain, feeling of general discomfort (feeling unwell), tiredness (fatigue), weakness (asthenia)
changes in the values ​​of some substances in the blood (observed in blood tests).
Not known: frequency can not be estimated from available data;

severe or prolonged diarrhea in which there may be blood or mucus (pseudomembranous colitis), skin infection (erizipel), severe decrease in the number of certain white blood cells, which increases the likelihood of an infection (agranulocytosis), a decrease in blood platelets (thrombocytopenia),
(anaphylactic reaction, angioedema), abnormal dreams, confusion, disorientation, seeing or hearing things (hallucinations), mental disorder, depression, convulsions , inability to taste, changes in the sense of smell, tingling sensation, prickling or burning of the skin, hearing loss,
irregular heart rhythm, rapid heartbeat, bleeding,
inflammation of the pancreas, tongue and discoloration of the teeth, yellowing of the skin and other liver disorders,
(Stevens-Johnson syndrome), a severe disease accompanied by scaling (toxic epidermal necrolysis), acne, nausea, vomiting,
How Do You Store Formilid?
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Store below 30 ° C.
The prepared suspension can be used for 14 days at a temperature below 25 ° C and stored in a protected area.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information

What Fromilid contains:

The active substance is clarithromycin.
The other ingredients of the 250 mg / 5 ml oral suspension are carbomer, povidone, hydroxypropyl methyl cellulose phthalate, talc, castor oil, xanthan gum, orange juice, citric acid anhydrous, saccharin sodium, monoammonium glycyrrhizinate, neohespiridine dihydrochampone, colloidal anhydrous silicon dioxide, titanium dioxide (E171), sugar, sodium sorbate.
What does Fromilid look like and what does the package contain?
250 mg / 5 ml oral suspension granules are white to off-white, small, unformulated granules.
Fromilid is available in cartons with:
Bottle, plastic stopper, syringe for oral administration, granules for preparation of 60 ml oral suspension of 250 mg / 5 ml, in a box.

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