PATIENT INFORMATION LEAFLET
Mirtazapina Almus 15 mg Film-Coated Tablets EFG
Read this leaflet carefully before you start taking this medicine.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same.
- If you think any of the side effects get serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
1. What Mirtazapina Almus is and what it is used for
2. Before taking Mirtazapina Almus
3. How to take Mirtazapina Almus
4. Possible side effects
5. Storage of Mirtazapina Almus
6. Further information
Mirtazapina Almus belongs to a group of medicines calledantidepressants.
Mirtazapina is used to treat depression.
Do not take Mirtazapina Almus
Be especially careful with Mirtazapina Almus
Use in children and adolescents under 18 years
Mirtazapina Almus should not be used in children and adolescents under 18 years because its efficacy has not been demonstrated.At the same time, you should know that in patients under 18 years, there is a higher risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medication. Despite this, your doctor may prescribe Mirtazapina Almus to patients under 18 years when they decide it is the best option for the patient. If your doctor has prescribed Mirtazapina Almus to a patient under 18 years and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed above in patients under 18 years taking Mirtazapina Almus appear or worsen.
Additionally, the long-term safety effects related to growth, maturation, and development of mirtazapina in this age group are not yet known.
Furthermore, significant weight gain has been observed in this age range more frequently than in adults.
Suicidal thoughts and worsening of depression
If you are depressed, you may sometimes have thoughts of harming yourself or committing suicide. This could worsen when you start taking antidepressants for the first time, as these medications usually take two weeks or more to have a normal effect.
You may be more prone to thinking this way if:
?If you have thoughts of harming yourself or committing suicide at any time, consult your doctor or go to the hospital immediately.
It may be helpful to tell a close relative or friendthat you are depressed, and ask them to read this leaflet. You can ask them to tell you if they think your depression is worsening, or if they are concerned about changes in your behavior.
Also, be especially careful with Mirtazapina Almus
?Inform your doctor about these situations before taking Mirtazapina Almus, if you have not already:
?Stop taking Mirtazapina Almus and contact your doctor immediately to perform a blood test.
In rare cases, these symptoms may be signs of bone marrow production disorders. Although rare, these symptoms appear 4-6 weeks after treatment.
A higher risk of bone fractures has been observed in patients treated with this type of medication.
Severe skin reactions, such as Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (NET), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of mirtazapina. Discontinue use and seek medical attention immediately if you notice any of the symptoms described in section 4 related to these severe skin reactions.
If you have ever had severe skin reactions, do not restart treatment with mirtazapina.
Use of other medications
Inform your doctor or pharmacist if you are taking (or will take) any of the medications listed below.
Also, inform your doctor or pharmacist if you are using or have used recently other medications, even those purchased without a prescription.
Do not take Mirtazapina Almuswith:
Examples of MAOIs include moclobemide, tranylcypromine (both are antidepressants), and selegiline (for Parkinson's disease).
Be careful ifyou take Mirtazapina Almus with:
medications for schizophreniasuch as olanzapine.
allergy medicationssuch as cetirizine.
intense pain medicationssuch as morphine.
In combination with these medications, mirtazapina may increase the drowsiness caused by these medications.
Taking Mirtazapina Almus with food and drinks
You may feel drowsy if you drink alcohol while taking mirtazapina.
It is recommended not to drink any alcohol.
You can take mirtazapina with or without food.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before using any medication.
The limited experience of administering Mirtazapina Almus to pregnant women does not indicate an increased risk. However, you should be careful if you use it during pregnancy.
If you are taking mirtazapina and become pregnant or want to become pregnant, consult your doctor if you can continue taking mirtazapina. If you use mirtazapina until or shortly before delivery, your baby will be examined to detect any possible adverse effects.
Consult your doctor if you can breastfeed while taking Mirtazapina Almus.
Make sure your doctor or midwife knows that you are taking Mirtazapina Almus. When taken during pregnancy, especially in the last three months of pregnancy, medications like Mirtazapina Almus may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and appear blue. These symptoms usually start within the first 24 hours after the baby is born. If this happens to your baby, inform your doctor or midwife immediately
Driving and operating machinery
Mirtazapina Almus may affect your concentration or alertness. Make sure your faculties are not impaired before driving or operating machinery.
Important information about some of the components of Mirtazapina Almus coated tablets
This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.
Follow exactly the administration instructions for Mirtazapina Almus as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.
How much to take
The usual initial dose is 15 or 30 mg per day.Your doctor may recommend increasing the dose after a few days to the amount that is best for you (between 15 and 45 mg per day). The usual dose is the same for all ages. However, if you are an older person or if you have a kidney or liver disease, your doctor may change the dose.
When to take it
?Take Mirtazapina Almus at the same time every day.
It is better to take the mirtazapine dose all at once before going to bed. However, your doctor may recommend that you divide your mirtazapine dose into the morning and evening before going to bed. The highest dose should be taken before going to bed.
The tablets are taken orally. Take the prescribed dose of Mirtazapina Almus without chewing, with water or juice.
When to expect to feel better
Normally, Mirtazapina Almus will start to take effect after 1 or 2 weeks and after 2 to 4 weeks you may start to feel better. It is essential that during the first weeks of treatment, you speak with your doctor about the effects of mirtazapine:
?between 2 and 4 weeks after starting to take mirtazapine, speak with your doctor about how this medication has affected you.
If you still do not feel better, your doctor may prescribe a higher dose. In that case, speak with your doctor again after another 2 to 4 weeks.
Normally, you will need to take mirtazapine until the symptoms of depression have disappeared for 4 to 6 months.
If you take more Mirtazapina Almus than you should
?If you or someone takes too much Mirtazapina Almus, consult a doctor immediately. You can also call the Toxicological Information Service. Phone 91 562 04 20.
The most likely symptoms of a mirtazapine overdose (without other medications or alcohol) are drowsiness, disorientation, and palpitations.
If you forget to take Mirtazapina Almus
If you have to take your dose once a day:
If you have to take your dose twice a day:
If you interrupt the treatment with Mirtazapina Almus
?Stop taking mirtazapine only if you consult your doctor.
If you stop taking it too soon, depression may reappear. When you feel better, speak with your doctor. Your doctor will decide when you can stop treatment.
Do not stop taking mirtazapine abruptly, even when depression has disappeared. If you stop taking mirtazapine abruptly, you may feel sick, dizzy, agitated, or anxious and have headaches. These symptoms can be avoided by gradually stopping treatment. Your doctor will indicate how to gradually decrease the dose.
If you have any other doubts about the use of this product, ask your doctor or pharmacist.
Like all medicines, Mirtazapina Almus can cause side effects, although not everyone will experience them.
Some side effects are more likely than others. The possible side effects of mirtazapina are listed below and can be divided into:
Very common:
Common:
In clinical trials with children under 18 years, the following side effects were frequently observed: significant weight gain, urticaria, and increased triglycerides in the blood.
Uncommon:
?Stop taking mirtazapina and consult your doctor immediately.
Rare:
?Stop taking mirtazapina and consult your doctor immediately.
Unknown:
?Stop taking mirtazapina and consult your doctor immediately to have a blood test.
In rare cases, mirtazapina may cause changes in blood cell production (bone marrow depression). Some people become less resistant to infections because mirtazapina may cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, mirtazapina may also cause a decrease in red and white blood cells and platelets (aplastic anemia), a decrease in platelets (thrombocytopenia), or an increase in white blood cells in the blood (eosinophilia).
?Stop taking mirtazapina and consult your doctor immediately.
?Stop taking mirtazapina and consult your doctor immediately.
?Stop taking mirtazapina and consult your doctor immediately.
Reporting of side effects:
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
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Keep out of reach and sight of children.
Do not use Mirtazapina Almus after the expiration date that appears on the packaging and in the blister pack after CAD. The expiration date is the last day of the month indicated.
Store in the original packaging to protect it from light and moisture.
No special storage conditions are required.
Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medicines at the SIGRE collection point of the pharmacy.Ask your pharmacist if you are unsure how to dispose of unused packaging and medicines. This will help protect the environment.
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Composition of Mirtazapina Almus
-The active ingredient is mirtazapine.
Mirtazapina Almus 15 mg film-coated tablets contain 15 mg of mirtazapine
per tablet.
-The other components are:
Tablet core: Lactose monohydrate, maize pregelatinised starch and magnesium stearate.
Film coating: Hydroxypropylmethylcellulose, titanium dioxide (E171),
polyethylene glycol 8000, yellow iron oxide (E172).
Appearance of the product and contents of the package
Mirtazapina Almus are film-coated tablets.
The tablets are yellow, oblong, biconvex, and have a notch on one side. The notch is only for splitting and facilitating swallowing, but not for dividing into equal doses.
Mirtazapina Almus 15 mg film-coated tablets are packaged in blisters.
The following package sizes are available: 30 and 60 film-coated tablets.
Holder of the marketing authorization and responsible for manufacturing
Holder ofthe marketing authorization:
Almus Farmacéutica, S.A.U.
Marie Curie, 54
08840 Viladecans (Barcelona), Spain
Telephone: 93 739 71 80
Email: farmacovigilancia@almusfarmaceutica.es
Responsible for manufacturing:
ATLANTIC PHARMA - Produções Farmacêuticas, S.A.
Rua da Tapada Grande, nº 2, Abrunheira
24710-189, Sintra (Portugal)
Medinfar Manufacturing, S.A.
Parque Industrial Armando Martins Tavares
Rua Outeiro da Armada, 5, Condeixa-a-Nova
3150-194, Sebal (Portugal)
This leaflet has been approved inAugust 2020
The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/
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