TIZAGELAN 2 mg Coated Tablet
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Инструкция по применению TITSAJELAN
Содержание инструкции
Tizagelan 2 mg tablets, 4 mg tablets
tizanidine
Generic medicine
Read this leaflet carefully before you start taking this medicine as it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Tizagelan is and what it is used for
- 2. What you need to know before you take Tizagelan
- 3. How to take Tizagelan
- 4. Possible side effects
- 5. How to store Tizagelan
- 6. Contents of the pack and other information
1. What is Tizagelan and what is it used for
Tizagelan belongs to a group of medicines called skeletal muscle relaxants.
Tizagelan may be prescribed by your doctor for muscle cramps caused by certain conditions of the
spine or as a result of surgery on the musculoskeletal system (for
example the vertebrae or the hip joint).
Tizagelan may also be prescribed for muscle cramps as a result of disorders of the nervous system, such as multiple sclerosis and after a stroke.
2. What you need to know before taking Tizagelan
Do not take Tizagelan
- if you are allergic to tizanidine or any of the other ingredients of this medicine (listed in section 6).
- if your liver function is severely impaired.
- if you are taking certain medicines that contain fluvoxamine (to treat depression) or ciprofloxacin (an antibiotic) (see also “Other medicines and Tizagelan”).
Warnings and precautions
Talk to your doctor before taking Tizagelan,
- if you have a severe kidney disease. A lower dose may be necessary.
- if you have heart problems such as coronary artery disease.
- if you have liver problems. Your doctor may check your liver enzymes regularly, especially when taking high doses. Stop taking Tizagelan if your skin or the whites of your eyes become yellow (“jaundice”), or if you develop unexplained nausea, loss of appetite or fatigue, and immediately inform your doctor.
- if you have kidney problems.
Children and adolescents
Tizagelan is not recommended in children and adolescents under 18 years of age because
experience with tizanidine in this patient group is limited.
Other medicines and Tizagelan
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Tizagelan must not be taken at the same time as fluvoxamine (for the treatment of
depression) or ciprofloxacin (an antibiotic) (see “Do not take Tizagelan”).
Tell your doctor or pharmacist especially if you are taking
- any medicine to treat an abnormal heart rhythm, such as amiodarone, mexiletine, propafenone or verapamil.
- cimetidine or famotidine (for indigestion and stomach ulcers).
- certain antibiotics, such as rifampicin, or so-called “fluoroquinolones” (such as enoxacin, pefloxacin, norfloxacin).
- rofecoxib, a painkiller.
- aciclovir, an antiviral medicine.
- the contraceptive pill. You may respond to a lower dose of Tizagelan if you are taking the pill.
- ticlopidine (to prevent blood clots).
- any medicine to treat high blood pressure, including diuretics.
- beta-blockers, for example atenolol, propranolol.
- digoxin (used to treat congestive heart failure and heart rhythm problems).
- any sedative (sleeping pills or medicines for anxiety).
- any other medicine that, if taken with tizanidine, could affect the heart rhythm. Check with your doctor or pharmacist.
Tizagelan with food, drinks and alcohol
Tizagelan can be taken with or without food.
Do not take Tizagelan with alcohol because it may increase the sedative effect of tizanidine.
Tizagelan and cigarette smoking
Cigarette smoking may decrease the effect of tizanidine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor for advice before taking this medicine.
It is not recommended to take Tizagelan if you are pregnant or breastfeeding, as the effects of
Tizagelan on pregnancy, the unborn child, or the newborn infant are unknown. The doctor will decide if you
should take Tizagelan.
Driving and using machines
Tizagelan can cause drowsiness and dizziness. This may impair your ability to drive vehicles or
operate any tools or machinery. Do not drive vehicles or use machines until
you know how this medicine affects you.
Tizagelan contains sucrose and lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicine.
3. How to take Tizagelan
Take this medicine following the instructions of your doctor exactly. If you have any doubts, ask your
doctor or pharmacist.
For skeletal muscle cramps following surgery and spinal disorders
The recommended dose for adults is 2-4 mg 3 times a day.
In more severe cases, an additional dose of 2-4 mg may be necessary. This last dose should be
taken late in the evening.
For muscle cramps due to nervous system disorders
The usual starting dose for adults is 2 mg 3 times a day.
Subsequently, the dosage may be gradually increased up to 12-24 mg, divided into 3-4
equal doses per day.
The maximum daily dose is 36 mg.
Use in children and adolescents up to 18 years of age
Tizagelan should not be taken by children, because its use in children has not been adequately
evaluated.
Elderly (65 years and over)
Experience with the use of Tizagelan in the elderly is limited. In addition, kidney function may be
impaired in the elderly. Therefore, Tizagelan should be used with caution in this group of
patients.
How to take Tizagelan
Tizagelan is for oral use.
The tablets should be swallowed with a glass of water.
Tizagelan can be taken with or without food.
If you feel that Tizagelan is too strong or too weak, contact your doctor or
pharmacist.
The tablet can be divided into equal doses.
If you take more Tizagelan than you should
If you (or someone else) take too many tablets or if you think a child has swallowed one of the
tablets, contact the nearest emergency room or doctor immediately.
Overdose may cause nausea, vomiting, low blood pressure, a slow or abnormal heartbeat, headache, small
pupils, difficulty breathing, coma, restlessness or drowsiness.
If you forget to take Tizagelan
If you forget to take one or more tablets, make sure you only take your usual number of
tablets at the next dose. Do not take a double dose to make up for a missed dose.
If you stop taking Tizagelan
Do not stop taking Tizagelan unless your doctor tells you to. Treatment with
Tizagelan should be discontinued gradually, especially if you have taken a high dose, unless your
doctor has told you otherwise. Suddenly stopping treatment may cause effects
such as an increased heart rate and high blood pressure.
If you have any 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 everyone will experience them.
At low doses, such as those recommended for the relief of painful muscle spasms, side effects are usually mild and transient.
At higher doses, recommended for the treatment of spasticity, side effects appear more frequently and more pronounced, but they are rarely so severe as to require discontinuation of treatment.
The following side effects have been reported:
Very common(may affect more than 1 in 10 people)
- Difficulty sleeping or falling asleep
- Dry mouth, gastrointestinal disorders
- Muscle weakness
Common(may affect up to 1 in 10 people)
- Drowsiness, lethargy, dizziness, fatigue
- Slow or fast heartbeat
- Low or reduced blood pressure
- Nausea
Uncommon(may affect up to 1 in 100 people)
- Increased levels of liver enzymes in the blood
Not known(frequency cannot be estimated from available data)
- Infections, stuffy or runny nose, throat infections
- Allergic reactions: o Urticaria o Serious and life-threatening allergic reaction requiring immediate medical attention. The reaction may include extremely low blood pressure, swelling of the throat, difficulty breathing and loss of consciousness.
- Confusion, nervousness, hallucinations (seeing and/or hearing things that are not real)
- Headache
- Difficulty controlling movements, involuntary muscle movements, difficulty speaking
- Fainting
- Feeling of spinning (vertigo)
- Difficulty focusing vision, blurred vision
- Abnormal heart rhythms
- Vomiting, abdominal pain, constipation
- Liver infection or failure
- Itching, rash, skin infection
- Urinary tract infection
- Unusually frequent passage of relatively small amounts of urine
- Loss of appetite
- Feeling of weakness, withdrawal syndrome, flu-like illness
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Tizagelan
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry date
refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Tizagelan contains
- The active substance is tizanidine. Each tablet contains 2 mg of tizanidine (as 2.29 mg of tizanidine hydrochloride/4 mg of tizanidine (as 2.29 mg of tizanidine hydrochloride)
- The other ingredients are lactose monohydrate, pregelatinized starch (corn), macrogol 4000, stearic acid, sucrose, magnesium stearate.
Description of the appearance of Tizagelan and contents of the pack
Tizagelan 2 mg tablets are round and biconvex tablets, from white to yellowish in color, with
a score line on one side and a diameter of approximately 8 mm.
Tizagelan 4 mg tablets are round and biconvex tablets, from white to yellowish in color, with
a score line on one side and a diameter of approximately 8 mm.
Tizagelan is available in PVC/PVdC/PVC-aluminum blisters containing 10, 30, 60, 90, 100 or 120
tablets.
Not all pack sizes may be marketed.
Marketing authorization holder and manufacturer
G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach Austria
This medicinal product is authorized in the Member States of the European Economic Area and in the United
Kingdom (Northern Ireland) with the following denominations:
Netherlands, United Kingdom (Northern Ireland): Tizagelan 2 mg tablets
Tizagelan 4 mg tablets
Austria: Tizagelan 2 mg Tabletten
Tizagelan 4 mg Tabletten
Finland: Tizagelan 2 mg tabletit
Tizagelan 4 mg tabletit
Hungary; Tizagelan 2 mg tabletta
Tizagelan 4 mg tabletta
Italy, Poland: Tizagelan
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- Страна регистрации
- Форма выпускаCoated tablet, 2 MG
- Код АТХM03BX02
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги TITSAJELANФорма выпуска: Tablet, 4 MGДействующее вещество: тизанидинаПроизводитель: SANDOZ S.P.A.Отпускается по рецептуФорма выпуска: Injectable solution, 10 MG/20 MLДействующее вещество: БаклофенПроизводитель: BIOINDUSTRIA LABORATORIO ITALIANO MEDICINALI S.P.A.Отпускается по рецептуФорма выпуска: Coated tablet, 25 MGДействующее вещество: БаклофенПроизводитель: DOC GENERICI SRLОтпускается по рецепту
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Действующее вещество TITSAJELAN — тизанидина. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
TITSAJELAN производится компанией G.L. PHARMA GMBH. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения TITSAJELAN с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
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Вы можете купить TITSAJELAN в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
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