Ritemed Propranolol may be available in the countries listed below.
Propranolol hydrochloride (a derivative of Propranolol) is reported as an ingredient of Ritemed Propranolol in the following countries:
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Docpirace may be available in the countries listed below.
Piracetam is reported as an ingredient of Docpirace in the following countries:
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Drilyna may be available in the countries listed below.
Theophylline is reported as an ingredient of Drilyna in the following countries:
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Drolanin may be available in the countries listed below.
Tromantadine hydrochloride (a derivative of Tromantadine) is reported as an ingredient of Drolanin in the following countries:
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Diovenor may be available in the countries listed below.
Diosmin is reported as an ingredient of Diovenor in the following countries:
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Dioxaflex Parches may be available in the countries listed below.
Diclofenac hydroxyethylpyrrolidine (a derivative of Diclofenac) is reported as an ingredient of Dioxaflex Parches in the following countries:
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Vertex may be available in the countries listed below.
Betahistine dimesilate (a derivative of Betahistine) is reported as an ingredient of Vertex in the following countries:
Ceftriaxone is reported as an ingredient of Vertex in the following countries:
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Dapson PCH may be available in the countries listed below.
Dapsone is reported as an ingredient of Dapson PCH in the following countries:
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Zylet is a brand name of loteprednol/tobramycin ophthalmic, approved by the FDA in the following formulation(s):
No. There is currently no therapeutically equivalent version of Zylet available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Zylet. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
Iovone may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Povidone-Iodine is reported as an ingredient of Iovone in the following countries:
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Generic Name: hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium phosphate (Oral route)
hye-oh-SYE-a-meen SUL-fate, meth-EN-a-meen, METH-i-leen BLOO, FEN-il sal-I-si-late, SOE-dee-um FOS-fate, mono-BAY-sik
In the U.S.
Available Dosage Forms:
Therapeutic Class: Urinary Antispasmodic
Pharmacologic Class: Hyoscyamine
Chemical Class: Salicylate, Non-Aspirin
Urelle® is a combination of five medicines: hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium phosphate. It is used to relieve discomfort, swelling, pain, frequent urge to urinate, and cramps or spasms of the urinary tract caused by an infection or a diagnostic procedure.
Hyoscyamine is an antispasmodic drug, which relieves muscle cramps or spasms. Methenamine and methylene blue are antiseptic drugs, which help clear a urinary tract infection. Phenyl salicylate is a pain reliever. Sodium phosphate makes the urine more acidic, which helps methenamine work better.
This medicine is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Urelle® in children. However, use is not recommended in children 6 years of age and younger.
No information is available on the relationship of age to the effects of Urelle® in geriatric patients.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium phosphate. It may not be specific to Urimar-T. Please read with care.
Take this medicine for the full time of treatment, even if you begin to feel better. Also, keep your appointments with your doctor for check-ups so that your doctor will be better able to tell you when to stop taking this medicine.
Drink extra fluids after you take this medicine so you will pass more urine.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.
If your or your child's symptoms do not improve or if they get worse, call your doctor.
Stop using this medicine and check with your doctor right away if you or your child have blurred vision, dizziness, or rapid pulse.
This medicine will make your urine to be colored blue. This is normal and is nothing to worry about.
This medicine will not cure a serious urinary tract infection and will only work to relieve symptoms as long as you continue to take it.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
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Diosmine Vocate may be available in the countries listed below.
Diosmin is reported as an ingredient of Diosmine Vocate in the following countries:
International Drug Name Search
Doctadryle may be available in the countries listed below.
Calcitonin is reported as an ingredient of Doctadryle in the following countries:
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Docetaxel Sandoz may be available in the countries listed below.
Docetaxel is reported as an ingredient of Docetaxel Sandoz in the following countries:
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Tinidal may be available in the countries listed below.
Tinidazole is reported as an ingredient of Tinidal in the following countries:
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Strinacin may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Sulfadiazine is reported as an ingredient of Strinacin in the following countries:
Trimethoprim is reported as an ingredient of Strinacin in the following countries:
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Dipherelin may be available in the countries listed below.
Triptorelin embonate (a derivative of Triptorelin) is reported as an ingredient of Dipherelin in the following countries:
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Doclormeta may be available in the countries listed below.
Lorazepam is reported as an ingredient of Doclormeta in the following countries:
Lormetazepam is reported as an ingredient of Doclormeta in the following countries:
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In some countries, this medicine may only be approved for veterinary use.
A07BC05
0110070-78-5
Antacid
Intestinal adsorbent
Smectite-group minerals
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| OS | Official Synonym |
Diphantoine may be available in the countries listed below.
Phenytoin sodium salt (a derivative of Phenytoin) is reported as an ingredient of Diphantoine in the following countries:
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Relieving symptoms of pain, sinus congestion, runny nose, and sneezing due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.
Acetaminophen/Doxylamine/Pseudoephedrine is an analgesic, antihistamine, and decongestant combination. The analgesic works in the brain to decrease pain. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Acetaminophen/Doxylamine/Pseudoephedrine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Acetaminophen/Doxylamine/Pseudoephedrine. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Acetaminophen/Doxylamine/Pseudoephedrine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Acetaminophen/Doxylamine/Pseudoephedrine as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Acetaminophen/Doxylamine/Pseudoephedrine.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; trouble sleeping; vision changes; yellowing of skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Acetaminophen/Doxylamine/Pseudoephedrine side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.
Store Acetaminophen/Doxylamine/Pseudoephedrine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acetaminophen/Doxylamine/Pseudoephedrine out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Acetaminophen/Doxylamine/Pseudoephedrine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Diophenyl-T may be available in the countries listed below.
Phenylephrine hydrochloride (a derivative of Phenylephrine) is reported as an ingredient of Diophenyl-T in the following countries:
Tropicamide is reported as an ingredient of Diophenyl-T in the following countries:
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SPASMONAL Forte 120 mg, Hard capsules.
Each capsule contains 120 mg alverine citrate.
An opaque, size 1 capsule with a grey cap and blue body, marked “SP120”.
The relief of smooth muscle spasm in conditions such as irritable bowel syndrome, painful diverticular disease of the colon and primary dysmenorrhoea.
Recommended dose and dosage schedules:
Adults (including the elderly): 1 capsule one to three times daily.
Children below the age of 12 years: Not recommended.
Paralytic ileus or known hypersensitivity to any of the ingredients.
Additional warnings to be included in the Patient Information Leaflet:
If this is the first time you have had these symptoms, consult your doctor before using any treatment.
If any of the following apply do not use SPASMONAL Forte 120 mg, it may not be the right treatment for you. See your doctor as soon as possible if:
- you are aged 40 years or over
- you have passed blood from the bowel
- you are feeling sick or vomiting
- you have lost your appetite or lost weight
- you are looking pale and feeling tired
- you are suffering from severe constipation
- you have a fever
- you have recently travelled abroad
- you are or may be pregnant
- you have abnormal vaginal bleeding or discharge
- you have difficulty or pain passing urine.
Consult your doctor if you have developed new symptoms or if your symptoms worsen, or if they do not improve after 2 weeks treatment.
None stated.
Although no teratogenic effects have been reported, use during pregnancy or lactation is not recommended as evidence of safety in preclinical studies is limited.
None.
Possible side effects may include nausea, headache, dizziness, itching, rash and allergic reactions including anaphylaxis.
There have been isolated reports of jaundice due to hepatitis which have been immune-mediated; but this adverse reaction resolved on cessation of alverine treatment.
Can produce hypotension and atropine-like toxic effects. Management is as for atropine poisoning with supportive therapy for hypotension.
Alverine citrate is a spasmolytic which has a specific action on the smooth muscle of the alimentary tract and uterus without affecting the heart, blood vessels and tracheal muscle at therapeutic doses.
After oral administration, alverine is rapidly converted to its primary active metabolite, which is then further converted to two secondary metabolites. There is a high renal clearance of all metabolites indicating that they are eliminated by active renal secretion. The peak plasma level of the most active metabolite occurs between 1 and 1½ hours after oral dosing. The plasma half-life averages 0.8 hours for alverine and 5.7 hours for the active primary metabolite.
Preclinical studies provide evidence that alverine citrate has no significant systemic toxicity potential at the proposed dosage.
Maize starch
Magnesium stearate
Capsule shell: gelatine, E132, E171, E172
None stated.
3 years.
Store in a dry place. Do not store above 25°C.
A box of aluminium foil/UPVC blister strip packs containing 2, 10, 20, 30, 60 or 90 capsules, in strips of 10 capsules as appropriate.
None.
Norgine Limited
Chaplin House
Widewater Place
Moorhall Road
Harefield
UXBRIDGE
Middlesex, UB9 6NS
United Kingdom
PL 00322/0075
09 October 1997/ 04 April 2003
June 2009
Legal category: P
Kalii Chloridi may be available in the countries listed below.
Potassium Chloride is reported as an ingredient of Kalii Chloridi in the following countries:
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Mirtazapine 15 mg Orodispersible Tablets
Each orodispersible tablet contains 15 mg mirtazapine.
Excipients: aspartame (E951) 3 mg, sulphites 0.000015 mg.
For a full list of excipients, see section 6.1.
Orodispersible tablet.
White to off-white, round, flat tablets with bevelled edges and plain on both sides.
Treatment of episodes of major depression.
Adults
The effective daily dose is usually between 15 and 45 mg; the starting dose is 15 or 30 mg.
Mirtazapine begins to exert its effect in general after 1-2 weeks of treatment. Treatment with an adequate dose should result in a positive response within 2-4 weeks. With an insufficient response, the dose can be increased up to the maximum dose. If there is no response within a further 2-4 weeks, then treatment should be stopped.
Elderly
The recommended dose is the same as that for adults. In elderly patients an increase in dosing should be done under close supervision to elicit a satisfactory and safe response.
Children and adolescents under the age of 18 years
Mirtazapine should not be used in children and adolescents under the age of 18 years as efficacy was not demonstrated in two short-term clinical trials (see section 5.1) and because of safety concerns (see sections 4.4, 4.8 and 5.1).
Renal impairment
The clearance of mirtazapine may be decreased in patients with moderate to severe renal impairment (creatinine clearance <40 ml/min). This should be taken into account when prescribing Mirtazapine to this category of patients (see section 4.4).
Hepatic impairment
The clearance of mirtazapine may be decreased in patients with hepatic impairment. This should be taken into account when prescribing Mirtazapine to this category of patients, particularly with severe hepatic impairment, as patients with severe hepatic impairment have not been investigated (seesection 4.4).
Mirtazapine has an elimination half-life of 20-40 hours and therefore Mirtazapine is suitable for once daily administration. It should be taken preferably as a single night-time dose before going to bed. Mirtazapine may also be given in two divided doses (once in the morning and once at night-time, the higher dose should be taken at night).
The tablets should be taken orally. The tablet will rapidly disintegrate and can be swallowed without water.
Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms. It is recommended to discontinue treatment with mirtazapine gradually to avoid withdrawal symptoms (see section 4.4).
Hypersensitivity to the active substance or to any of the excipients.
Concomitant use of mirtazapine with monoamine oxidase (MAO) inhibitors (see section 4.5).
Use in children and adolescents under 18 years of age
Mirtazapine should not be used in the treatment of children and adolescents under the age of 18 years. Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms. In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Suicide/suicidal thoughts or clinical worsening
Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta-analysis of placebo controlled clinical trials of antidepressants in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old. Close supervision of patients and in particular those at high risk should accompany therapy with antidepressants especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
With regard to the chance of suicide, in particular at the beginning of treatment, only a limited number of Mirtazapine orodispersible tablets should be given to the patient.
Bone marrow depression
Bone marrow depression, usually presenting as granulocytopenia or agranulocytosis, has been reported during treatment with Mirtazapine. Reversible agranulocytosis has been reported as a rare occurrence in clinical studies with Mirtazapine. In the post marketing period with Mirtazapine very rare cases of agranulocytosis have been reported, mostly reversible, but in some cases fatal. Fatal cases mostly concerned patients with an age above 65. The physician should be alert for symptoms like fever, sore throat, stomatitis or other signs of infection; when such symptoms occur, treatment should be stopped and blood counts taken.
Jaundice
Treatment should be discontinued if jaundice occurs.
Conditions which need supervision
Careful dosing as well as regular and close monitoring is necessary in patients with:
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Like with other antidepressants, the following should be taken into account:
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Hyponatraemia
Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported very rarely with the use of mirtazapine. Caution should be exercised in patients at risk, such as elderly patients or patients concomitantly treated with medications known to cause hyponatraemia.
Serotonin syndrome
Interaction with serotonergic active substances: serotonin syndrome may occur when selective serotonin reuptake inhibitors (SSRIs) are used concomitantly with other serotonergic active substances (see section 4.5). Symptoms of serotonin syndrome may be hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes that include confusion, irritability and extreme agitation progressing to delirium and coma. From post marketing experience it appears that serotonin syndrome occurs very rarely in patients treated with Mirtazapine alone (see section 4.8).
Elderly patients
Elderly patients are often more sensitive, especially with regard to the undesirable effects of antidepressants. During clinical research with Mirtazapine, undesirable effects have not been reported more often in elderly patients than in other age groups.
Aspartame
Mirtazapine contains aspartame, a source of phenylalanine. Each tablet with 15 mg, 30 mg and 45 mg mirtazapine corresponds to 2.6 mg, 5.2 mg and 7.8 mg phenylalanine, respectively. It may be harmful for patients with phenylketonuria.
The medicinal product contains as ingredient of the peppermint flavour a very small amount of sulphites. These may rarely cause severe hypersensitivity reactions and bronchospasm.
Pharmacodynamic interactions
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Pharmacokinetic interactions
|
Limited data of the use of mirtazapine in pregnant women do not indicate an increased risk for congenital malformations. Studies in animals have not shown any teratogenic effects of clinical relevance, however developmental toxicity has been observed (see section 5.3). Caution should be exercised when prescribing to pregnant women. If Mirtazapine is used until, or shortly before birth, postnatal monitoring of the newborn is recommended to account for possible discontinuation effects.
Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). Although no studies have investigated the association of PPHN to mirtazapine treatment, this potential risk cannot be ruled out taking into account the related mechanism of action (increase in serotonin concentrations).
Animal studies and limited human data have shown excretion of mirtazapine in breast milk only in very small amounts. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Mirtazapine should be made taking into account the benefit of breast-feeding to the child and the benefit of Mirtazapine therapy to the woman.
Mirtazapine has minor or moderate influence on the ability to drive and use machines. Mirtazapine may impair concentration and alertness (particularly in the initial phase of treatment). Patients should avoid the performance of potentially dangerous tasks, which require alertness and good concentration, such as driving a motor vehicle or operating machinery, at any time when affected.
Depressed patients display a number of symptoms that are associated with the illness itself. It is therefore sometimes difficult to ascertain which symptoms are a result of the illness itself and which are a result of treatment with Mirtazapine.
The most commonly reported adverse reactions, occurring in more than 5 % of patients treated with Mirtazapine in randomized placebo-controlled trials (see below) are somnolence, sedation, dry mouth, weight increased, increase in appetite, dizziness and fatigue.
All randomized placebo-controlled trials in patients (including indications other than major depressive disorder), have been evaluated for adverse reactions of Mirtazapine. The meta-analysis considered 20 trials, with a planned duration of treatment up to 12 weeks, with 1501 patients (134 person years) receiving doses of mirtazapine up to 60 mg and 850 patients (79 person years) receiving placebo. Extension phases of these trials have been excluded to maintain comparability to placebo treatment.
Table 1 shows the categorized incidence of the adverse reactions, which occurred in the clinical trials statistically significantly more frequently during treatment with Mirtazapine than with placebo, added with adverse reactions from spontaneous reporting. The frequencies of the adverse reactions from spontaneous reporting are based on the reporting rate of these events in the clinical trials. The frequency of adverse reactions from spontaneous reporting for which no cases in the randomized placebo-controlled patient trials were observed with mirtazapine has been classified as 'not known'.
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1 In clinical trials these events occurred statistically significantly more frequently during treatment with Mirtazapine than with placebo.
2 In clinical trials these events occurred more frequently during treatment with placebo than with Mirtazapine, however not statistically significantly more frequently.
3 In clinical trials these events occurred statistically significantly more frequently during treatment with placebo than with Mirtazapine.
4N.B. dose reduction generally does not lead to less somnolence/sedation but can jeopardize antidepressant efficacy.
5 Upon treatment with antidepressants in general, anxiety and insomnia (which may be symptoms of depression) can develop or become aggravated. Under mirtazapine treatment, development or aggravation of anxiety and insomnia has been reported.
6 Cases of suicidal ideation and suicidal behaviours have been reported during mirtazapine therapy or early after treatment discontinuation (see section 4.4).
In laboratory evaluations in clinical trials transient increases in transaminases and gammaglutamyltransferase have been observed (however associated adverse events have not been reported statistically significantly more frequently with Mirtazapine than with placebo).
Paediatric population:
The following adverse events were observed commonly in clinical trials in children: weight gain, urticaria and hypertriglyceridaemia (see also section 5.1).
Present experience concerning overdose with Mirtazapine alone indicates that symptoms are usually mild. Depression of the central nervous system with disorientation and prolonged sedation have been reported, together with tachycardia and mild hyper- or hypotension. However, there is a possibility of more serious outcomes (including fatalities) at dosages much higher than the therapeutic dose, especially with mixed overdoses.
Cases of overdose should receive appropriate symptomatic and supportive therapy for vital functions. Activated charcoal or gastric lavage should also be considered.
Pharmacotherapeutic group: other antidepressants, ATC code: NO6AX11
Mirtazapine is a centrally active presynaptic α2-antagonist, which increases central noradrenergic and serotonergic neurotransmission. The enhancement of serotonergic neurotransmission is specifically mediated via 5-HT1 receptors, because 5-HT2 and 5-HT3 receptors are blocked by mirtazapine. Both enantiomers of mirtazapine are presumed to contribute to the antidepressant activity, the S(+) enantiomer by blocking α2 and 5-HT2 receptors and the R(-) enantiomer by blocking 5-HT3 receptors.
The histamine H1-antagonistic activity of mirtazapine is associated with its sedative properties. It has practically no anticholinergic activity and, at therapeutic doses, has practically no effect on the cardiovascular system.
Paediatric population:
Two randomised, double-blind, placebo-controlled trials in children aged between 7 and 18 years with major depressive disorder (n=259) using a flexible dose for the first 4 weeks (15-45mg mirtazapine) followed by a fixed dose (15, 30 or 45 mg mirtazapine) for another 4 weeks failed to demonstrate significant differences between mirtazapine and placebo on the primary and all secondary endpoints. Significant weight gain (
After oral administration of Mirtazapine, the active substance mirtazapine is rapidly and well absorbed (bioavailability ≈ 50 %), reaching peak plasma levels after approx. two hours. Binding of mirtazapine to plasma proteins is approx. 85 %. The mean half-life of elimination is 20-40 hours; longer half-lives, up to 65 hours, have occasionally been recorded and shorter half-lives have been seen in young men.
The half-life of elimination is sufficient to justify once-a-day dosing. Steady state is reached after 3-4 days, after which there is no further accumulation. Mirtazapine displays linear pharmacokinetics within the recommended dose range. Food intake has no influence on the pharmacokinetics of mirtazapine.
Mirtazapine is extensively metabolized and eliminated via the urine and faeces within a few days. Major pathways of biotransformation are demethylation and oxidation, followed by conjugation. In vitro data from human liver microsomes indicate that cytochrome P450 enzymes CYP2D6 and CYP1A2 are involved in the formation of the 8-hydroxy metabolite of mirtazapine, whereas CYP3A4 is considered to be responsible for the formation of the N-demethyl and N-oxide metabolites. The demethyl metabolite is pharmacologically active and appears to have the same pharmacokinetic profile as the parent compound.
The clearance of mirtazapine may be decreased as a result of renal or hepatic impairment.
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, carcinogenicity or genotoxicity.
In reproductive toxicity studies in rats and rabbits no teratogenic effects were observed. At two-fold systemic exposure compared to maximum human therapeutic exposure, there was an increase in postimplantation loss, decrease in the pup birth weights, and reduction in pup survival during the first three days of lactation in rats.
Mirtazapine was not genotoxic in a series of tests for gene mutation and chromosomal and DNA damage. Thyroid gland tumours found in a rat carcinogenicity study and hepatocellular neoplasms found in a mouse carcinogenicity study are considered to be species-specific, non-genotoxic responses associated with long-term treatment with high doses of hepatic enzyme inducers.
Mannitol (E421)
Povidone K30
Crospovidone
Silica colloidal anhydrous
Aspartame (E951)
Calcium stearate
Orange flavour [maltodextrin, natural and artificial flavourings, dl-alpha-tocopherol]
Peppermint flavour [maltodextrin, natural flavourings, dextrin, sulphites]
Not applicable.
3 years
Do not store above 30°C. Store in the original package in order to protect from moisture.
Aluminium/Aluminium blisters containing 6, 10, 14, 18, 20, 28, 30, 30 (unit dose), 48, 50, 56, 60, 84, 90, 96, 100 or 100 (unit dose) orodispersible tablets
Not all pack sizes may be marketed.
No special requirements.
Sandoz Ltd
Frimley Business Park,
Frimley, Camberley, Surrey
GU16 7SR
United Kingdom
PL 04416/0696
13.03.2008 / 11.08.2010
26/10/2010 (to be amended after approval)
Dipeptiven may be available in the countries listed below.
Alanine, ß- is reported as an ingredient of Dipeptiven in the following countries:
Glutamine is reported as an ingredient of Dipeptiven in the following countries:
International Drug Name Search
Cetirizina Aldo Union may be available in the countries listed below.
Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Cetirizina Aldo Union in the following countries:
International Drug Name Search
Diphenidol Hydrochloride may be available in the countries listed below.
Diphenidol Hydrochloride (USAN) is also known as Difenidol (Rec.INN)
International Drug Name Search
Glossary
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
