Hedonin 25 mg. 60 tablets
HEDONIN contains a substance called quetiapine. Kvetiapinat belongs to a group of medicines called antipsychotics which improve the symptoms of certain mental illnesses, such as:
♦ Hallucinations (eg. Hearing unexplained voices), strange and frightening thoughts, changes in your behavior, feeling alone and confused.
♦ Conditions which are superior in "upbeat" mood or arousal. It is possible in such cases to need less sleep, you are more talkative, have racing thoughts or ideas. It is also possible to have unusually irritable.
Contained in hedonists quetiapine is approved for the treatment of other conditions that are not mentioned in this leaflet. If you have further questions, ask your doctor or pharmacist.
It is shown that quetiapine preventing recurrence of manic or depressive episodes.
2. BEFORE YOU TAKE HEDONIN
Do not take hedonists
♦ if you are allergic (hypersensitive) to the active substance or to any of the ingredients of a hedonist,
♦ if you are taking drugs such as:
- HIV protease inhibitors (for HIV)
- Antifungals of azole group (eg. Ketoconazole)
- Medicines erythromycin or clarithromycin (antibiotics makropidni) or
- Nefazodone (an antidepressant). See "Taking other medicines".
Do not take a hedonist if any of the above applies to you. If you're not sure, ask your doctor or pharmacist before taking hedonists.
Take special care with hedonists
Hedonists should not be taken by elderly patients with dementia (loss of brain function). The reason for this is that a group of medicines to which it belongs hedonists can increase the risk of stroke in the elderly or in some cases, the risk of death.
Before you start taking your medicine, tell Vashiyalekar if:
♦ suffer from poor blood circulation to the heart or brain or other disorders that predispose to low blood pressure. Hedonists can cause a drop in blood pressure on standing or in the right position, especially with increasing dose at the start of treatment (see. Section 4 "Possible Side Effects")
♦ You spent stroke, especially if you are elderly.
♦ In the event that you know that you have had low white blood cells (which may or may not be caused by other drugs).
♦ If you have had a seizure (convulsion)
♦ In case you notice the appearance of involuntary movements or after a period of treatment movement disorders, such as unusual movements that are constantly repeated. In these cases, you should tell your doctor.
♦ In case of chills, rapid breathing, excessive sweating, changes in level of consciousness or stiff muscles. In this case, do not continue to take a hedonist, and contact your doctor immediately. This may be dangerous disorder known as "neuroleptic malignant syndrome".
♦ If you suffer from diabetes or are at risk of developing diabetes. In very rare cases during treatment with hedonists, it noted an increase in blood sugar levels. If you have diabetes or a tendency to raise blood sugar levels, it is recommended to regularly measure your blood sugar during treatment with hedonists (see. Section 4 "Possible Side Effects").
♦ In rare cases, especially if you are an older age is possible if you or someone in your family have any heart problems (eg. Heart failure or a tendency to irregular heartbeat) arise changes in the conductivity of the heart muscle. For this reason, care must be taken particularly and should not take other medicines at the same time as hedonists used to treat your illness because they may enhance this effect.
♦ If you have problems with your liver.
♦ If you feel excessive sleeping.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Do not take a hedonist if you are taking any of the following medications:
♦ drugs for the treatment of AIDS (HIV protease inhibitors)
♦ drugs for the treatment of fungal infections which contain active substances from the azole group, e. ketoconazole
♦ certain antibiotics that contain active substances macrolide, for example. erythromycin, clarithromycin
♦ antidepressant nefazodone
Tell your doctor if you are taking any of the following medications:
♦ Medicines to treat epilepsy (such as phenytoin or carbamazepine).
♦ Medicines to treat high blood pressure.
♦ Barbiturates (for difficulty sleeping).
♦ Thioridazine (another antipsychotic medicine).
Before you stop taking any of your medicines, please talk to your doctor first.
Tell your doctor if you take:
♦ Drugs that can influence the levels of electrolytes (salts) in your body
♦ Drugs that can trigger abnormal heart rhythm (drugs that prolong QT interval)
♦ Drugs that act in your brain (centrally acting drugs).
Please talk to your doctor first. He knows which drugs can cause these effects.
Taking hedonists with food and drink
Hedonists can be taken with or without food.
During treatment with hedonists should avoid consuming alcohol as in
hedonists combination with alcohol can cause drowsiness.
Hedonists not take with grapefruit juice, because grapefruit juice inhibits the breakdown of
quetiapine in the liver and enhances its effect.
Pregnancy and lactation
No data is available for use hedonists during pregnancy. Therefore, hedonists should not be used during pregnancy unless clearly necessary. If the mother is taking hedonists during pregnancy, the newborn may develop withdrawal symptoms.
It is unknown to what extent quetiapine is excreted in breast milk. In need of conducting treatment breastfeeding should be avoided.
Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
Your tablets may make you feel sleepy. Do not drive or operate machinery until you consider what impact you have tablets.
Important information about some of the ingredients of hedonists
This medicinal product contains lactose which is a type of sugar. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this product.
3. HOW TO TAKE HEDONIN
Always take hedonists just as you have been told by your doctor because each treatment is tailored to individual patient needs. If you're not sure, ask your doctor or pharmacist.
Your doctor will determine your starting dose and how many tablets hedonists should take each day. This will depend on your illness and needs, but it is usually between 150 and 800 mg daily.
Your doctor may decide to start treatment with the lowest dose and gradually increase it if:
♦ You are the elderly
♦ Have liver problems.
♦ Will you take the tablets twice daily.
♦ Swallow the tablets whole with water.
♦ You can take your tablets with or without food.
♦ While taking hedonists not drink grapefruit juice. It can affect the way your medicine works.
♦ Do not stop taking your tablets even if you feel better, unless your doctor tells you.
Children and adolescents:
Not recommended to hedonists in people under 18 years old.
Please consult your doctor if you feel that the effect of a hedonist is too strong
or too weak.
If you take more dose hedonists
If you take more than prescribed by your doctor quantity hedonists can occur drowsiness, dizziness and abnormal heart rhythm. Contact your doctor or nearest hospital. Keep tablets hedonists with you.
If you forget to take HEDONIN
If you forget to take a dose hedonists, take it as soon as you remember
thereof. Do not take a double dose to make up the missed dose.
If you stop taking hedonists
If you suddenly stop taking hedonist may feel unable to sleep (insomnia)
have nausea, headache, diarrhea, vomiting, dizziness or irritability. Your doctor
can offer a reduction of the dose before discontinuation.
If you have any further questions on the use of this product, ask
Your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, hedonists can cause side effects, although not everybody gets them.
Assessment of adverse reactions used the following frequency grouping:
♦ very common: affects more than 1 in 10 patients
♦ common: affects 1 to 10 in 100 patients
♦ uncommon: affects 1 to 10 out of 1,000
♦ rare: affects 1 to 10 in 10,000 patients
♦ very rare: affects less than 1 in 10,000 patients
♦ Not known: From the data available it can not be estimated.
The most frequently reported adverse reactions associated with the use of hedonists are drowsiness, dizziness, dry mouth, mild fatigue, constipation, increased heart rate, lower blood pressure, especially when standing in the right position and indigestion.
Very common side effects
Drowsiness and dizziness (these symptoms usually disappear after a period of ingestion), headaches, drowsiness and dry mouth.
Symptoms of discontinuation (symptoms which occur when you stop taking hedonists) include inability to sleep (insomnia), nausea, headache, diarrhea, vomiting, dizziness or irritability. These usually disappear after a week from the last administration.
Common side effects
Stuffy nose, upset stomach (indigestion), constipation, weight gain (usually during the first weeks of treatment), swelling of the fingers and toes, fatigue, temporary changes in liver function tests (increased liver enzymes), fast heartbeat, increased levels of blood sugar, blurred vision and weakness. It appears marked lowering of blood pressure, especially at the beginning of treatment, especially when standing or in a standing position (orthostatic hypotension), which can cause palpitations or dizziness. You might faint, then immediately take up a horizontal position until you feel better. Usually these symptoms disappear after a period of ingestion. However, if there is no improvement, consult your doctor.
Uncommon side effects
Hypersensitivity (allergic reactions that can include lumps (wheal) and swelling of the skin, Kakko and swelling around the mouth), fainting or seizures, an uncomfortable feeling in the legs (also known as restless leg syndrome), difficulty swallowing, speech disturbances and speech.
Rare side effects
Yellowing of the skin and eyes (jaundice), persistent and painful erection (priapism). Sometime in rare cases may cause the following side effects: fever, rapid breathing, excessive sweating, altered consciousness and muscle stiffness. Upon occurrence of these side effects at the same time when you can be a dangerous disorder (neuroleptic malignant syndrome). In this case, stop taking hedonists and immediately contact your doctor.
Very rare side effects
Worsening of existing diabetes, inflammatory conditions of the liver (hepatitis), abnormal movements that are constantly resumed after a prolonged course of treatment (mainly of the face and tongue), serious skin diseases accompanied by onset of fever and blistering of the mucous membranes ( Syndrome Stevens - Johnson), a severe allergic reaction (called anaphylaxis) which can cause breathing difficulties and shock.
You should stop taking hedonists and immediately contact your doctor if you notice symptoms of angioedema, such as
♦ swelling of the face, tongue or pharynx
♦ difficulty in swallowing
♦ hives and breathing difficulties
Hedonists belongs to a group of medicines that can cause abnormal heart rhythms that can be serious and in severe cases - fatal:
Some side effects were detected only in blood tests. These include increased levels of certain fats (triglycerides and total cholesterol) or blood sugar levels and lowering the number of certain blood cells. From time to time, your doctor may want you to have blood tests. Furthermore, during treatment with hedonists or shortly after discontinuation, may have thoughts of harming or killing. In the event of such thoughts at any time, contact your doctor or nearest hospital.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE HEDONIN
♦ Keep out of reach of children.
♦ Do not use hedonists after the expiry date stated on the blister and 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 in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
HEDONIN 25 mg film-coated tablets
♦ active substance is quetiapine.
1 tablet contains 25 mg quetiapine (as fumarate kvetiapinov)
♦ The other ingredients are:
Tablet core: calcium hydrogen phosphate, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), povidone K 27-32, magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E171), macrogol 400, red iron oxide (E 172) and iron oxide yellow (E-172).