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WHAT HEDONIN IS AND WHAT IT IS USED FOR
Hedonin contains a substance called quetiapine. Quetiapine belongs to a group of medicines called antipsychotics that improve the symptoms of some types of mental illness such as:
♦ Hallucinations (eg hearing unexplained voices), strange and frightening thoughts, changes in your behavior, feeling of loneliness and confusion.
♦ Conditions in which you feel in a "raised" mood or excitement In such cases, you may need less sleep, be more talkative, have jump over thoughts or ideas You may also be unusually irritable .
Hedonine-containing quetiapine is also authorized for treatment of other conditions not mentioned in this leaflet. If you have any further questions, ask your doctor or pharmacist.
Quetiapine has not been shown to prevent the recurrence of manic or depressive episodes.
2. BEFORE YOU TAKE HEDONIN
Do not take Heidenin
- if you are allergic (hypersensitive) to the active substance or any of the other ingredients of Hedonin,
♦ if you are taking medicines such as:
- HIV protease inhibitors (for AIDS treatment)
- azole group antifungal medicines (eg ketoconazole)
Medicines called erythromycin or clarithromycin (macropide antibiotics), or
- nefazodone (an antidepressant). See "Taking other medicines".
Do not take Hedonin if any of the above applies to you. If you are not sure, ask your doctor or pharmacist before taking Hedonin.
Take special care with Hedonin
Hedonin should not be taken by elderly patients with dementia (loss of brain function). The reason for this is that the group of medicinal products to which Heidan belongs may increase the risk of stroke in elderly patients or, in some cases, the risk of death.
Before you start taking your medicine, tell your doctor if:
♦ You suffer from poor blood circulation of the heart or brain or other disorders that predispose you to low blood pressure. Hedonin may cause a sudden drop in blood pressure when straightened or in a right position, especially when increasing the dose at the start of treatment (see section 4, Possible side effects)
♦ You have suffered a stroke, especially if you are elderly.
♦ If you are known to have a low white blood cell count in the past (which may or may not be caused by other medicines).
♦ If you have had a seizure (seizure)
♦ In case you notice the occurrence of involuntary movements or after a certain period of treatment motor disorders, such as unusual movements, which are constantly repeated. In these cases, you should tell your doctor.
♦ If chills, rapid breathing, severe sweating, changes in the degree of consciousness or stiffness of the muscles occur. In this case, do not continue to take Hedonin, and tell your doctor immediately. This may be a dangerous disorder, known as "malignant neuroleptic syndrome".
♦ If you suffer from diabetes or are at risk of developing diabetes. In very rare cases, elevations in blood sugar levels have been reported during treatment with Hedonin. If you have diabetes or have a tendency to raise your blood sugar levels, it is recommended that you regularly measure your blood sugar during treatment with Hedonin (see section 4, "Possible Side Effects").
♦ In rare cases, especially if you are older, it is possible that if you or someone in your family has any heart problems (eg heart failure or a tendency to heart failure), changes in the conduction of the heart muscle . Therefore, special care should be taken and you should not take other medicines, such as hedonine, that are used to treat your illness as they may increase this effect.
♦ If you have problems with your liver.
♦ If you feel a feeling of drowsiness.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines
medicines, including medicines obtained without a prescription.
Do not take Hedonin if you are taking any of the following medicines:
♦ medicines to treat AIDS (HIV protease inhibitors)
♦ medicines to treat fungal infections that contain active substances from the azole group, eg. ketoconazole
♦ certain antibiotics containing active substances from the macrolide group, eg. erythromycin, clarithromycin
♦ the antidepressant nefazodone
Tell your doctor if you are taking any of the following medicines:
♦ Medicines to treat epilepsy (such as phenytoin or carbamazepine).
♦ Medicines to treat high blood pressure.
♦ Barbiturates (for difficult to fall asleep).
♦ Thioridazine (another antipsychotic medicine).
Before you stop taking one of your medicines, please tell your doctor first.
Tell your doctor if you are taking:
♦ Medicines that can affect the levels of the electrolytes (salts) in your body
♦ Medicines that can cause abnormal heart rhythm (medicines that prolong the QT interval)
♦ Medicines that work in your brain (centrally acting medicines).
Please tell your doctor first. He knows which drugs can cause these effects.
Take Hedonin with food and drink
Hedonin can be taken with or without food.
Heated alcohol should be avoided as alcohol in the
combination with alcohol Hedonine may cause drowsiness.
Do not take hedonin with grapefruit juice, as grapefruit juice inhibits the degradation of
quetiapine in the liver and thus enhances its effect.
Pregnancy and breastfeeding
No data are available on the use of Hedonin during pregnancy. Hedonin should therefore not be used during pregnancy unless clearly necessary. If the mother takes Hedonin during pregnancy, withdrawal symptoms may develop in the newborn.
It is not known to what extent quetiapine is excreted in breast milk. If treatment is needed, breastfeeding should be avoided.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Your tablets may make you feel drowsy. Do not drive or operate machinery until you determine the effect of the tablets.
Important information about some of the ingredients of Hedonin
This medicinal product contains lactose, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.
3. HOW TO TAKE HEDONIN
Always take Heidenin exactly as your doctor has told you, as each treatment is tailored to the patient's individual needs. If you are not sure, ask your doctor or pharmacist.
Your doctor will determine your starting dose and how many Hedonine tablets you should take each day. This will depend on your illness and needs, but it is usually between 150 and 800 mg per day.
Your doctor may decide to start treatment with the lowest dose and gradually increase it if:
♦ You are elderly
♦ You have liver problems.
♦ You will take the tablets twice a day.
♦ Swallow the tablets whole with water.
♦ You may take your tablets with or without food.
♦ Do not drink grapefruit juice while taking Hedonin. It can affect the way the medicine works.
Do not stop taking your tablets, even if you feel better until your doctor tells you.
Children and adolescents:
Hedonin is not recommended for use in people under 18 years of age.
Please check with your doctor if you feel that the effect of Hedonin is too strong
or too weak.
If you take more Hedonine than you should
If you take more Hedonin than prescribed by your doctor, it may cause drowsiness, dizziness and abnormal heart rhythm. Contact your doctor or your nearest healthcare provider. Keep Hedonin tablets with you.
If you forget to take Hedonin
If you forget to take one dose of Hedonin, take it as soon as you remember
this. Do not take a double dose to make up for the missed dose.
If you stop taking Hedonin
If you suddenly stop taking Hedonin, you may feel unable to fall asleep (insomnia)
have nausea, headache, diarrhea, vomiting, dizziness or irritability. Your doctor
may offer you a dose reduction before discontinuing treatment.
If you have any further questions on the use of this product, please ask
Your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, Hedonin may cause side effects, although not everyone gets them.
The following frequency grouping was used to evaluate the adverse drug reactions:
♦ very common: affects more than 1 in 10 patients
♦ common: affects 1 to 10 users in 100
♦ Uncommon: affects 1 to 10 users in 1,000
♦ rare: affects 1 to 10 users in 10,000
♦ Very rare: affects less than 1 in 10,000 patients
♦ Not known: Can not be estimated from the available data.
The most commonly reported side effects associated with the use of Hedonin are drowsiness, dizziness, dry mouth, mild tiredness, constipation, fast heartbeat, lowering of blood pressure, especially when standing and in the right position and indigestion.
Very common side effects
Drowsiness and dizziness (these symptoms usually resolve after a certain period of drug intake), headache, feeling drowsy and dry mouth.
Symptoms of discontinuation of treatment (symptoms that occur when you stop taking Hedonin) include inability to sleep (insomnia), nausea, headache, diarrhea, vomiting, dizziness or irritability. They usually disappear after a week from the last intake.
Common side effects
Nausea, abdominal discomfort (constipation), constipation, weight gain (usually during the first weeks of treatment), swelling of the toes and fingers, fatigue, temporary changes in liver function (increase in liver enzymes), rapid heartbeat , elevated blood sugar levels, blurred vision and weakness. A marked decrease in blood pressure may occur, especially when starting treatment, especially when standing or standing (orthostatic hypotension), which may cause palpitations or dizziness. It may make you sick, In that case, immediately take a horizontal position until you feel better. These symptoms usually disappear after a certain period of drug intake. However, if there is no improvement, talk to your doctor.
Uncommon side effects
Hypersensitivity (allergic reactions, which may include lumps and swelling of the skin, bloating and swelling around the mouth), fainting or fainting, an uncomfortable feeling in the legs (also known as Restless Legs Syndrome), difficulty in swallowing, speech disorder and speech.
Rare side effects
Yellow skin and eyes (jaundice), prolonged and painful erection (priapism). Sometimes and in rare cases the following side effects may occur: fever, rapid breathing, excessive sweating, consciousness changes, and muscular stiffness. If these side effects occur at the same time, you may experience a dangerous disorder (malignant neuroleptic syndrome). In this case, stop taking Hedonin and contact your doctor immediately.
Very rare side effects
Worsening of existing diabetes, liver inflammation (hepatitis), abnormal movements that are constantly resumed after a long course of treatment (mainly face and tongue), severe skin diseases accompanied by fever and blistering of the mucous membranes Stevens-Johnson syndrome), a severe allergic reaction (called anaphylaxis) that can cause breathing difficulties and shock.
You should stop taking Hedonin and contact your doctor immediately if you notice any angioedema such as
♦ Swelling of the face, tongue or pharynx
♦ difficulty in swallowing
♦ hives and difficulty in breathing
Hedonine belongs to a group of medicinal products that may cause heart rhythm disturbances, which may be serious and, in severe cases, fatal:
Some side effects are only detected during blood tests. These include increasing levels of certain fats (triglycerides and total cholesterol) or blood sugar and decreasing the number of certain blood cells. Occasionally, your doctor may wish to do blood tests. In addition, thoughts of self-harm or suicide may occur during or with Hedonin treatment soon after it is discontinued. If any such thought occurs at any time, contact your doctor or nearest healthcare facility.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
HOW TO STORE HEDONIN
♦ Keep out of the reach and sight of children.
Do not use Hedonin after the expiry date which is stated on the blister or carton. The expiry date refers to the last day of that month.
♦ This medicinal product does not require any special storage conditions.
♦ Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of your unnecessary medicines. These measures will help to protect the environment.
6. ADDITIONAL INFORMATION
What does Hedonin contain:
Hedonin 200 mg film-coated tablets
♦ The active substance is quetiapine
1 film-coated tablet contains 200 mg of quetiapine (such as quetiapine fumarate).
♦ The other ingredients are:
Calcium hydrogen phosphate, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (Type A), povidone K 27-32, magnesium stearate.
Hypromellose, titanium dioxide (E171), macrogol 400, iron oxide, red (E-172) and ferric oxide, yellow (E-172).
What Heidonin looks like and what the package contains
Hedonin 200 mg film-coated tablets: Round, white, double-convex, film-coated tablets.
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