DONAMET 300 mg /5 Ml Порошок И Раствор Для Инъекционного Раствора
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Инструкция по применению DONAMET
Содержание инструкции
DONAMET 300 mg/5ml powder and solvent for injectable solution, 500 mg/5ml powder and solvent for injectable solution, 300 mg gastro-resistant tablets, 500 mg gastro-resistant tablets
Ademetionine
Read this leaflet carefully before you start to use this medicine because 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 DONAMET is and what it is used for
- 2. What you need to know before you use DONAMET
- 3. How to use DONAMET
- 4. Possible side effects
- 5. How to store DONAMET
- 6. Contents of the pack and other information
1. What is DONAMET and what is it used for
This medicine contains an active ingredient called ademetionine. Ademetionine is a compound
naturally present in the body, which intervenes in many processes that occur within the
body.
DONAMET is used in the treatment of cholestasis, a disease due to the obstruction of bile
within the liver, caused by problems with the liver (precirrhotic and cirrhotic states) or pregnancy.
It manifests with itching, yellowish discoloration of the skin and eyes, dark urine and pale stools.
2. What you need to know before using DONAMET
Do not use DONAMET if:
- you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
- you have genetic diseases that cause alterations of some protein components such as methionine or homocysteine (for example: cystathionine beta-synthase deficiency, vitamin B12 metabolism defects).
Warnings and precautions
Talk to your doctor or pharmacist before using DONAMET
Tell your doctor if:
- you have had increased ammonia levels in your blood, after taking ademetionine-containing drugs orally;
- you have liver or kidney diseases;
- you suffer from bipolar disorder, depression or other psychiatric illnesses;
- you have a decrease in red blood cells in your blood (anemia);
- you have a vitamin deficiency due to illness or dietary habits (for example, you are vegan);
- you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”);
IN ALL THESE CASES, YOUR DOCTOR WILL EVALUATE THE NEED TO PERFORM
CHECK-UP EXAMS OR TO MODIFY THE THERAPY.
Talk to your doctor if during treatment with DONAMET:
- you experience a state of anxiety or your anxiety worsens, as it may be necessary to re-evaluate your therapy;
- you experience a high level of homocysteine in your blood, which may be caused by therapy with DONAMET (false positive);
- you experience dizziness.
Children and adolescents
DONAMET is not suitable for children and adolescents.
Other medicines and DONAMET
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular, tell your doctor if you are taking:
- medicines against depression called selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants (example clomipramine);
- medicines and supplements that contain an amino acid (a component of proteins) called tryptophan.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding
ask your doctor for advice before using this medicine.
During the first three months of pregnancy and during breastfeeding, DONAMET should only be used in
cases of actual need and under direct medical supervision.
Driving and using machines
DONAMET can cause dizziness: make sure you do not suffer from this side effect before driving
vehicles or using machinery.
DONAMET powder and solvent for injectable solutioncontains less than 1 mmol of sodium per dose,
i.e. it is practically “sodium-free”.
3. How to use DONAMET
Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
Initial dose
DONAMET powder and solvent for injectable solution: 500 mg per day, for 2 weeks. The doctor
may establish a different dose by calculating it based on your weight: from 5 to 12 mg per day for each kilo
of body weight.
The maximum dose is 800 mg per day.
or
DONAMET tablets: 800 mg per day. The doctor may establish a different dose by calculating it based on
your weight from 10 to 25 mg per day for each kilo of body weight.
The maximum dose is 1600 mg per day.
Dose for maintenance therapy
DONAMET tablets: 800 – 1600 mg per day.
Elderly: the doctor may establish a lower dose than those indicated above.
Patients with renal impairment:
If you suffer from kidney problems, the doctor may decide to exercise particular caution when administering
DONAMET.
Method of administration
DONAMET tablets: must be taken by mouth (orally). Swallow the tablets whole, without
chewing them and away from meals. The tablets must be removed from the blister (aluminum packaging)
immediately before use. Do not take DONAMET if the tablets appear different from the white/yellowish color
(due to the presence of holes in the aluminum packaging).
DONAMET powder and solvent for injectable solution: must be administered by an injection into a
vein (intravenously) or into a muscle (intramuscularly). Intravenous administration must be
performed slowly and exclusively by medical personnel.
The solution to be injected must be prepared immediately before use, dissolving the powder
contained in the vial with the clear liquid (solvent) found in the vial inside the
package.
To prepare the solution for injection:
- on the neck of the vial, there is a small colored dot. Gently tap the top of the vial to remove any liquid residue present in the tip; position the vial as shown in figure 1;
- to open the vial, apply pressure with your thumb above the colored dotas shown in figure 2;
- draw the solvent into a syringe and inject it into the vial containing the powder;
- when the powder has dissolved, draw the solution.
Use each vial only once and discard any remaining solution. Do not mix other
medicines into the solution. This is particularly important for alkaline solutions or those containing ions
of calcium. Do not use the powder if it is a different color than white/yellowish (due to damage to the
vial or exposure to heat).
If you take more DONAMET than you should,contact your doctor immediately as appropriate
measures may be necessary.
If you forget to use DONAMET
Do not take a double dose to make up for a missed dose.
If you stop taking DONAMET
It is important that you take this
medicine until the end of the
treatment prescribed by your doctor.
Do not stop treatment just
because you feel better, because your
symptoms may reappear or
worsen.
If you have any doubts 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.
Stop takingDONAMET immediately and contact your doctor if any of the following conditions occur:
- allergic reactions, even severe ones, manifesting with more or less sudden skin lesions, such as color changes in patches or widespread (rash, erythema), itching, hives, swelling (angioedema) of the face, eyes, lips and difficulty breathing (dyspnea, bronchospasm), back pain or chest tightness, changes in blood pressure or heart rate (tachycardia, bradycardia);
- difficulty breathing due to swelling of the throat (laryngeal edema).
Tell your doctor if you notice any of the following during treatment with DONAMET:
Common side effects(may affect up to 1 in 10 people)
- itching;
- headache;
- abdominal pain, diarrhea, nausea;
- anxiety, sleep disorders (insomnia).
Uncommon side effects(may affect up to 1 in 100 people)
- dry mouth, indigestion (dyspepsia), presence of intestinal gas (flatulence), pain or bleeding or other disorders of the stomach or intestines, vomiting;
- fatigue (asthenia), swelling (edema), fever, chills, reactions at the injection site;
- urinary tract infection;
- joint pain or muscle spasms, excessive sweating;
- dizziness, changes in sensation (paresthesia), agitation, confusion;
- hot flashes, low blood pressure (hypotension), inflammation of the veins (phlebitis).
Rare side effects(may affect up to 1 in 1000 people)
- abdominal swelling, inflammation of the esophagus (esophagitis);
- malaise, suicidal ideation/behavior;
- very intense pain localized in the upper abdomen, radiating to the right flank and back and occurring suddenly after a fatty meal or during the night (biliary colic).
Side effects of unknown frequency(the frequency cannot be estimated on the basis of available data)
- liver problems due to a condition called cirrhosis;
- heart or blood vessel problems (cardiovascular disorders);
- flu-like symptoms. Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at “www.agenziafarmaco.gov.it/it/responsabili”. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store DONAMET
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 packaging. The expiry date
refers to the last day of that month.
DONAMET tablets: no special storage precautions are necessary.
DONAMET powder and solvent for injectable solution: store at a temperature not exceeding 30°C.
Use DONAMET immediately after preparation of the solution.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.
6. Package Contents and Other Information
What DONAMET contains
The active ingredient is: ademetionine.
DONAMET 300 mg/5ml powder and solvent for injectable solution
One vial of powder 300 mg contains: 300 mg of ademetionine.
The other ingredients are:
- solvent vial: water for injections, L-lysine, sodium hydroxide.
DONAMET 500 mg/5ml powder and solvent for injectable solution
One vial of powder 500 mg contains: 500 mg of ademetionine.
The other ingredients are:
- solvent vial: water for injections, L-lysine, sodium hydroxide.
DONAMET 300 mg tablets
One tablet contains: 300 mg of ademetionine.
The other ingredients are: microcrystalline cellulose, magnesium stearate, polyethylene glycol 6000,
polymethacrylates, polysorbates, colloidal silicon dioxide, emulsified silicone, sodium starch glycolate, talc.
DONAMET 500 mg tablets
One tablet contains: 500 mg of ademetionine.
The other ingredients are: microcrystalline cellulose, magnesium stearate, polyethylene glycol 6000,
polymethacrylates, polysorbates, colloidal silicon dioxide, sodium hydroxide, emulsified silicone, sodium starch glycolate,
talc.
Description of the appearance of DONAMET and package contents
DONAMET 300 mg/5ml powder and solvent for injectable solution: is available in a package
containing 5 vials of powder and 5 vials of solvent of 5 ml.
DONAMET 500 mg/5ml powder and solvent for injectable solution: is available in a package
containing 5 vials of powder and 5 vials of solvent of 5 ml.
DONAMET 300 mg tablets: is available in a package of 20 tablets.
DONAMET 500 mg tablets: is available in a package of 10 tablets.
Marketing Authorisation Holder
BGP Products S.r.l.-Viale Giorgio Ribotta 11, 00144 Roma (RM)
Manufacturer
DONAMET 300 mg gastroresistant tablets
Hospira S.p.A. – Via Fosse Ardeatine 2, 20060 Liscate (Milan)
DONAMET 500 mg gastroresistant tablets
AbbVie S.r.l. - S.R. 148 Pontina km 52 s.n.c Campoverde (LT)
DONAMET 300 mg/5ml powder and solvent for injectable solution
Hospira S.p.A. – Via Fosse Ardeatine 2, 20060 Liscate (Milan)
AbbVie S.r.l. – S.R. 148 Pontina km 52 s.n.c -Campoverde (LT)
DONAMET 500 mg/5ml powder and solvent for injectable solution
Hospira S.p.A. – Via Fosse Ardeatine 2, 20060 Liscate (Milan)
AbbVie S.r.l. – S.R. 148 Pontina km 52 s.n.c -Campoverde (LT)
Famar L’Aigle – Rue de l’Isle Usine de S.Remy -28380 S. Remy sur Avre (France)
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- Страна регистрации
- Форма выпускаPowder and solvent for injectable solution, 300 MG/5 ML
- 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 DONAMETФорма выпуска: Coated tablet, <200 mgДействующее вещество: СилимаринПроизводитель: ELLEVA PHARMA SRLОтпускается по рецептуФорма выпуска: Granulate, 200 MGДействующее вещество: СилимаринПроизводитель: PHARMABER S.R.L.Отпускается по рецептуФорма выпуска: Hard capsule, 250 MGДействующее вещество: chenodeoxycholic acidПроизводитель: LEADIANT GMBHОтпускается по рецепту
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DONAMET производится компанией VIATRIS ITALIA S.R.L.. 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 DONAMET с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
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Вы можете купить DONAMET в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
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