Defrinol® Forte 60 mg+400 mg 10x

The sale of this medicine via the Internet is prohibited by the law of the Republic of Serbia, while advertising it via the Internet is permitted exclusively as a reminder and has the purpose of informing.

Defrinol®
forte (60 mg + 400 mg), film tablets
pseudoephedrine, ibuprofen
Read this leaflet carefully before you start taking this medicine because it contains information
that are important to you.
Always take this medicine exactly as stated in this leaflet or as explained to you by your doctor
or a pharmacist.
- Save the instructions. You may need to read it again.
- If you have additional questions or need advice, contact your pharmacist.
- If you experience any side effects, contact your doctor or pharmacist. This
includes any side effects not listed in this guide. See section 4.
- If you do not feel better or feel worse after 7 days, you must contact your doctor.
In this guide you will read:
1. What is Defrinol forte and what is it for?
2. What you need to know before taking Defrinol forte
3. How to take Defrinol forte
4. Possible side effects
5. How to store Defrinol forte
6. Contents of the package and other information
2 out of 6
1. What is Defrinol forte and what is it for?
Defrinol forte is a drug used to relieve nasal and sinus congestion, headache, pain, inflammation,
fever and other cold and flu symptoms. The tablets contain pseudoephedrine hydrochloride
which is the so-called a decongestant that relieves nasal and sinus congestion and ibuprofen, which belongs to the non-steroidal group
anti-inflammatory drugs and relieves pain and headache, reduces temperature and signs of inflammation.
Defrinol forte is used in adults and children over 12 years of age.
2. What you need to know before taking Defrinol forte
Warn the doctor if you are taking other medications, have a chronic disease, a metabolic disorder,
you are hypersensitive to medicines or have had allergic reactions to some of them.
Defrinol forte should not be taken:
▪ if you have or have previously had a stomach ulcer, perforation (rupture of the stomach wall) or bleeding from
digestive tract;
▪ if you have had perforation or bleeding from the stomach after the use of non-steroidal anti-inflammatory drugs
(NSAIDs) (vomiting of bloody or dark contents that look like black coffee grounds, blood in the stool or
black tar-like stools);
▪ if you are allergic or have had hypersensitivity reactions (e.g. asthma, runny nose, swelling of the face, lips
or throat, skin rash) when taking ibuprofen, aspirin, other non-steroidal anti-inflammatory drugs
medicines (NSAIDs), pseudoephedrine or if you are allergic to any of the auxiliary substances in the composition
medicine;
▪ if you are already taking aspirin (acetylsalicylic acid) in a dose higher than 75 mg per day or another medicine from
NSAID groups;
▪ if you have severe liver or kidney disease;
▪ if you have severe heart or blood vessel disease, including rapid heart rate and angina;
▪ if you have high blood pressure;
▪ if you have an overactive thyroid gland, diabetes or an adrenal gland tumor (so-called pheochromocytoma);
▪ if you have glaucoma (eye disease with increased eye pressure);
▪ if you are taking or have used in the last 14 days medicines for the treatment of depression called inhibitors
monoamine oxidase (MAO inhibitors);
▪ if you have a prostate problem;
▪ if you are pregnant.
Other important information
Risk of heart attack and stroke: Pain relievers such as ibuprofen can lead to
a small increase in the risk of heart attack or stroke, especially if used in large doses.
Follow the recommendations on the dose and length of drug administration.
Warnings and precautions
Before using the medicine, inform your doctor or pharmacist:
▪ if you have or have previously had asthma or other allergic disease, bowel disease or Crohn's disease;
▪ if you have kidney, heart or liver disease;
▪ if you have a systemic connective tissue disease such as systemic lupus;
▪ if you are elderly (because unwanted reactions may occur more often);
▪ if you use or have been prescribed other pain relievers;
▪ if you have heart problems such as heart failure, angina (chest pain), if you have had a heart attack
stroke, if you have a bypass installed, if you have peripheral artery disease (poor circulation in the legs
and feet due to narrowing of the arteries) or you have had any type of stroke (including the so-called
mini-stroke ie. transient ischemic attack) - see section Risk of heart attack and stroke;
▪ if you have high blood pressure, diabetes, elevated cholesterol values, if you have people in your family
with heart disease or stroke, if you are a smoker.
3 out of 6
If you develop generalized erythema with pustules, followed by a fever, stop immediately
with the application of the drug and contact your doctor or the nearest health facility. See section 4. Possible
side effects.
Other drugs and Defrinol forte
Before using the medicine, inform your doctor or pharmacist if you are taking or have recently taken any other medicine,
including those obtained without a prescription:
▪ other drugs for pain relief;
▪ low doses of aspirin, up to 75 mg per day;
▪ anticoagulants (medicines against blood clotting, eg warfarin, ticlopidine);
▪ mifepristone (for termination of pregnancy) - do not take ibuprofen if you have used it in the previous 12 days
mifepristone;
▪ diuretics (drugs for fluid excretion);
▪ antihypertensives (medicines against high blood pressure) (e.g. ACE inhibitors such as captopril,
beta blockers such as atenolol, angiotensin II receptor antagonists such as losartan); medicines for
heart diseases;
▪ corticosteroids (anti-inflammatory drugs used for various diseases and conditions such as pain,
swelling, allergies, asthma, rheumatism and skin diseases);
▪ lithium (for the treatment of mood disorders);
▪ methotrexate (for the treatment of arthritis, cancer, psoriasis);
▪ zidovudine (for the treatment of HIV);
▪ quinolone antibiotics (for the treatment of infections);
▪ antidepressants;
▪ ciclosporin or tacrolimus (medicines to suppress the immune response, e.g. after transplantation, for
psoriasis or rheumatism);
▪ other decongestants or appetite suppressants;
▪ ergot alkaloids (for migraine).
Taking Defrinol forte with food, drinks and alcohol
Taking food does not affect the effect of Defrinol forte. It is not recommended to use the drug with alcohol
increased risk of bleeding from the gastrointestinal tract.
Pregnancy, breastfeeding and fertility
Before you start taking any medicine, consult your doctor or pharmacist.
▪ Ibuprofen, which is part of Defrinol forte, belongs to the group of drugs that can have an adverse effect
on women's fertility. This effect stops when the drug is stopped. Consult your own
doctor before taking this medicine if you have trouble getting pregnant.
▪ During the first 6 months of pregnancy, you can take the medicine only after consulting a doctor.
▪ The medicine must not be used in the last three months of pregnancy because it can cause damage to the fetus.
▪ If you are breastfeeding, consult your doctor before taking this medicine.
▪ If you use this medicine, it may reduce your chances of getting pregnant. This effect ends after
discontinuation of the drug.
Driving vehicles and operating machines
No influence of the drug on psychophysical abilities is expected when driving a motor vehicle and handling
machines if the recommended dose is applied.
The drug Defrinol forte contains the color Ponceau 4R lacquer 22% (E124).
May cause allergic reactions.
3. How to take Defrinol forte
Always take Defrinol forte film-coated tablets exactly as prescribed. Check with your doctor or
pharmacist if you are not sure how to take the medicine.
4 out of 6
For symptom control, the lowest effective dose should be used for the shortest possible period.
The drug is administered orally.
Adults and children over 12 years old:
▪ One film-coated tablet, up to a maximum of 3 tablets per day, as needed, at intervals of at least 8 hours.
▪ Do not take more than 3 tablets in 24 hours.
▪ If the symptoms do not go away or worsen or it takes more than 7 days to alleviate them
days, you should consult a doctor.
Defrinol forte film tablets should not be used in the treatment of children under 12 years of age.
If you take more Defrinol forte than you should
If you have taken a higher dose of Defrinol forte than you should, contact your doctor immediately and take it with you
take these instructions or the medicine package with you.
Taking large doses of Defrinol forte can cause nausea, stomach pain, vomiting (sometimes with
mixed with blood), headache, tinnitus, confusion and nystagmus. Drowsiness, pain in
chest pain, palpitations, loss of consciousness, convulsions (usually in children), weakness, dizziness, blood in the urine, feeling
body chills and breathing problems.
If you forget to take Defrinol forte
Never take a double dose to make up for a missed dose!
If you forgot to take the medicine at the usual time, do not make up the dose scheduled for that day, but
continue with your usual dosing regimen.
If you suddenly stop taking Defrinol forte
If your symptoms stop, you can stop taking the medicine.
If there is no improvement or if your symptoms worsen, stop taking the medicine and contact your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
patients taking this medicine.
Very common side effects (may occur in more than 1 in 10 patients taking the medicine).
Common side effects (may occur in up to 1 in 10 patients taking the medicine).
Occasional side effects (may occur in up to 1 in 100 patients taking the drug).
Rare side effects (may occur in up to 1 in 1000 patients taking the drug).
Very rare side effects (may occur in up to 1 in 10,000 patients taking the drug).
Frequency not known: cannot be estimated from the available data.
Some side effects can be serious. Stop taking the medicine and seek medical attention immediately
seek medical attention if you notice any of the following symptoms:
▪ blood in the regurgitated contents or contents resembling black coffee grounds,
▪ blood in the stool or stool black as tar,
▪ stomach problems including pain, indigestion and heartburn,
▪ hypersensitivity reaction such as skin rash (sometimes severe, followed by skin peeling); facial swelling,
neck or throat; exacerbation of asthma, difficulty breathing,
▪ a serious skin reaction called DRESS syndrome. Symptoms are: rash on the skin, elevated body temperature
temperature, swelling of lymph glands and increased level of eosinophils (type of white blood cells),
▪ sudden appearance of elevated temperature, redness of the skin or the appearance of numerous small pustules (it can be
sign of acute generalized exanthematous pustulosis - AGEP) can occur in the first two days
drug administration. Meningitis (eg neck stiffness, fever, disorientation),
5 out of 6
▪ Kidney problems that can lead to kidney failure (symptoms can be shortness of breath,
pronounced fatigue and weakness, loss of appetite, swelling of the ankles).
Stop taking the medicine and tell your doctor immediately if you notice any of the following
symptoms:
▪ nausea, vomiting;
▪ dizziness, headache, hearing problems;
▪ dry mouth, thirst, sweating, loss of appetite;
▪ chest pain, rapid or irregular heartbeat, increased blood pressure, heart weakness (fatigue, difficulty
breathing, leg swelling);
▪ fluid retention, which leads to leg swelling;
▪ restlessness, insomnia;
▪ rarely, diarrhea, gas, constipation, yellow discoloration of the skin or sclera, pain in the upper part of the abdomen,
exacerbation of colitis or Crohn's disease, difficulty urinating, muscle weakness, tremors, anxiety,
hallucinations (when you see, hear or feel things that are not there) especially in children;
▪ very rarely, fatigue or pronounced exhaustion, changes in the blood count that can cause unusual
bruises or frequent infections, e.g. sore throat, mouth ulcers, flu-like symptoms);
▪ a small increase in the risk of heart attack or stroke if you use high doses of the drug for a long time
period.
If any side effect becomes serious or you notice any side effect not listed in
this instruction, please inform your doctor or pharmacist about it.
Reporting adverse reactions
If you experience any unwanted reaction, you should inform your doctor or pharmacist.
This includes any possible side effects that are not listed in this guide. By signing up
adverse reactions can help evaluate the safety of this medicine. They suspect unwanted reactions
you can report to the Agency for Medicines and Medical Devices of Serbia (ALIMS):
Agency for Medicines and Medical Devices of Serbia
National Center for Pharmacovigilance
Vojvode Stepe 458, 11221 Belgrade
Republic of Serbia
website: www.alims.gov.rs
e-mail: nezeljene.reakcije@alims.gov.rs
5. How to store Defrinol forte
Keep the medicine out of the sight and reach of children.
You must not use the drug Defrinol forte after the expiration date indicated on the outer packaging ("Valid
to the"). The term of use expires on the last day of the specified month.
Store at a temperature of up to 25° C, in the original packaging.
Unusable medicines are handed over to the pharmacy where the notice that they are to be collected is displayed in that pharmacy
unusable medicines from citizens. Unusable medicines must not be thrown into the sewer or together with
communal waste. These measures will help protect the environment.
6 out of 6
6. Contents of the package and other information
What does Defrinol forte contain?
Content of active substances:
1 film tablet contains 60 mg of pseudoephedrine hydrochloride and 400 mg of ibuprofen
Content of auxiliary substances:
Tablet core: calcium phosphate; starch, corn; sodium starch glycolate type A; hypromellose E-5;
magnesium stearate.
Film tablets: hypromellose E-5; macrogol 6000; talcum powder; titanium dioxide; paint Ponceau 4R lacquer 22% (E124).
What the drug Defrinol forte looks like and the contents of the package
Appearance: Round, biconvex, film-coated tablets of dark red color, on the edge of white color.
Packaging:
The inner packaging is an ALU/PVC-PVC blister, which contains 10 film tablets.
The outer packaging is a collapsible cardboard box containing 1 blister (total of 10 film-coated tablets) and
Instructions for the drug.
License holder and manufacturer
Galenika ad Belgrade
Batajnički road bb, Belgrade
This instruction was last approved
July, 2019.
Mode of administration of the drug:
The drug is issued without a doctor's prescription.
License number and date:
515-01-00355-19-001 from July 1, 2019.