MIRTAZAPINE COMBINO PHARM 30 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Mirtazapine Combino Pharm 30 mg tablets EFG

Mirtazapine

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What MIRTAZAPINA COMBINO PHARM 30 mg tablets are and what they are used for
2. Before you take MIRTAZAPINA COMBINO PHARM 30mg tablets
3. How to take MIRTAZAPINA COMBINO PHARM 30 mg tablets
4. Possible side effects
5. Storing MIRTAZAPINA COMBINO PHARM 30 mg tablets
6. Further information

1. What MIRTAZAPINA COMBINO PHARM 30 mg TABLETS are and what they are used for

Mirtazapina Combino Pharm tablets are film-coated tablets of beige color, oblong, biconvex and with a score line on one side.

Mirtazapina Combino Pharm is available in packs of 30 tablets.

Mirtazapine belongs to the group of medicines called antidepressants. Mirtazapine relieves the depressed mood that causes depression. During depression, changes occur in the brain: brain nerve cells communicate with each other through chemical substances, and in depression, the normal amount of these substances is lower. Antidepressants can correct these deficiencies and restore normal brain function.

2. BEFORE TAKING MIRTAZAPINA COMBINO PHARM 30 mg TABLETS

Do not take Mirtazapina Combino Pharm:

• If you are allergic (hypersensitive) to mirtazapine or any of the other ingredients of Mirtazapina Combino Pharm 30 mg tablets.

Be careful with Mirtazapina Combino Pharm:

• If you have or are currently experiencing:

• seizures (epilepsy)
• liver diseases, such as jaundice (yellow color of the skin or mucous membranes). If jaundice occurs, your doctor will discontinue treatment
• kidney diseases
• heart diseases
• low blood pressure
• psychiatric diseases such as schizophrenia and bipolar depression (alternating periods of excitement/hyperactivity and periods of depression)
• diabetes mellitus
• increased intraocular pressure (glaucoma)
• urination difficulties due to an enlarged prostate
• • Rarely, mirtazapine can cause a decrease in white blood cells, which causes a lower resistance of the body to infections. If you experience fever, sore throat, mouth sores, severe gastrointestinal disorders, or other signs of infection, you should contact your doctor immediately and have a blood test. These symptoms usually occur within 4-6 weeks of treatment and are generally reversible when discontinued.
  • Elderly patients are often more sensitive to the adverse effects of antidepressant medications, although clinical studies have not shown more frequent adverse effects with mirtazapine in the elderly than in other ages. However, experience to date is limited.

Consult your doctor, even if any of the above situations have occurred to you in the past.

There are some sporadic cases of patients who develop a tendency to suicide, particularly during the initial phase of treatment. If you think this is happening to you, contact your doctor immediately.

There are some sporadic cases of patients who develop a tendency to suicide, particularly during the initial phase of treatment. If you think this is happening to you, contact your doctor immediately.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may have suicidal thoughts, suicidal behaviors, or self-harm. This can be enhanced when you start taking antidepressants, as these medications require time to take effect, usually two weeks but sometimes more.

You may be more exposed to this:

• If you have previously had suicidal attempts or self-harm.
• If you are a young adult. Clinical studies have shown an increased risk of suicidal behaviors in adults under 25 years of age with psychiatric conditions treated with antidepressants.

If you (or the person you care for) have suicidal thoughts or self-harm at any time, contact your doctor or go immediately to a hospital.

It may be helpful to discuss with a close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. Ask them if your depression or anxiety is worsening or if they are concerned about your changes in behavior.

Use of other medications:

Tell your doctor or pharmacist if you are using or have recently used any other medications, including those obtained without a prescription.

Certain medications may interact with Mirtazapina Combino Pharm, in which case it may be necessary to change the dose or discontinue treatment with one of the medications, such as:

• some medications for the treatment of AIDS (HIV protease inhibitors)
• some antifungals, medications for the treatment of fungal infections (azolic antifungals such as ketoconazole)
• erythromycin (an antibiotic)
• nefazodone (a medication for depression)
• some medications for the treatment of epilepsy (carbamazepine and phenytoin)
• rifampicin (an antibiotic medication for the treatment of tuberculosis)
• cimetidine (a medication for stomach ulcers)
• warfarin (a medication to prevent blood clotting)

Do not take Mirtazapina Combino Pharm if you are already taking other antidepressants called "MAO inhibitors".

You should wait 2 weeks after treatment with these antidepressants before taking Mirtazapina Combino Pharm. Also, be careful if you take Mirtazapina Combino Pharm and benzodiazepines (sedative medications) because mirtazapine can increase the sedative effects of these medications.

Do not take Mirtazapina Combino Pharm if you are already taking other antidepressant medications such as venlafaxine and selective serotonin reuptake inhibitors (SSRIs)

Taking Mirtazapina Combino Pharm with food and beverages:

Mirtazapine can increase the effect of alcohol. Therefore, it is not advisable to drink alcohol during treatment with Mirtazapina Combino Pharm.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medication.

If you are taking Mirtazapina Combino Pharm and become pregnant, your doctor will assess the convenience of continuing treatment. The use of Mirtazapina Combino Pharm is not recommended during the lactation period.

Children

The safety and efficacy of mirtazapine have not been studied in children. Therefore, it is not recommended to treat children with Mirtazapina Combino Pharm.

Driving and using machines:

Mirtazapine can decrease alertness and concentration. Therefore, during treatment with Mirtazapina Combino Pharm, avoid performing potentially hazardous tasks that require continuous attention, such as driving or operating machinery.

Important information about some of the ingredients of Mirtazapina Combino Pharm

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.

3. HOW TO TAKE MIRTAZAPINA COMBINO PHARM 30 mg TABLETS

Follow the administration instructions of Mirtazapina Combino Pharm 30 mg tablets indicated by your doctor.

Consult your doctor or pharmacist if you have any doubts.

Follow these instructions unless your doctor has given you different ones. Remember to take your medication. Your doctor will indicate the duration of your treatment with Mirtazapina Combino Pharm. Do not discontinue treatment before, as your illness may worsen. Inform your doctor how the treatment is going.

Your doctor will indicate how to gradually decrease the dose until you can finish your treatment.

Generally, you will start with 15 mg or 30 mg per day (the highest dose is taken at night), which can be gradually increased as needed by your doctor until the most effective daily dose is reached. For the treatment to be successful, it is very important that you take your tablet(s) every day.

It is desirable that after the first 2-4 weeks of treatment, you talk to your doctor about the effect of the treatment, as it usually takes two to four weeks before an improvement is experienced. If the effect has been insufficient, your doctor may prescribe a higher dose, and after another 2-4 weeks, a new visit to your doctor is recommended.

Take the tablet(s) at the same time every day, preferably once, at night before bedtime.

If your doctor recommends it, Mirtazapina Combino Pharm can be taken in divided doses, half during the day (one in the morning and one at night before bedtime).

If you take more Mirtazapina Combino Pharm than you should:

In case of overdose or accidental ingestion, consult a doctor or pharmacist immediately. You can also contact the Toxicology Information Service. Telephone 91 562 04 20.

Vomiting should be induced as soon as possible. If the medication has not been taken with other medications or alcohol, the symptoms after an overdose are usually relatively mild. Confusion and prolonged sedation, or drowsiness, have been found, along with changes in heart rate and blood pressure.

If you forget to take Mirtazapina Combino Pharm:

Do not take a double dose to make up for forgotten doses, follow these instructions:

If you have to take one dose per day before bedtime and you forget, do not take the forgotten dose the next morning because you may experience drowsiness during the day. Continue treatment the next night with your normal dose.

If you have to take the tablets twice a day (one in the morning after breakfast and one at night, before bedtime) and you have forgotten to take one or both doses, do the following:

If you stop taking Mirtazapina Combino Pharm:

If you carefully follow your doctor's instructions to gradually discontinue treatment, it is not expected that negative effects will appear.

However, if you suddenly stop long-term treatment with Mirtazapina Combino Pharm, nausea, headache, discomfort, anxiety, and agitation may appear.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Mirtazapina Combino Pharm can have side effects.

The following side effects can occur frequently:

• increased appetite and weight gain
• drowsiness, which can affect concentration
• generalized or localized fluid accumulation (swelling in certain parts of the body), with weight gain
• dizziness
• headache

The following side effects can occur infrequently:

• nausea

The following side effects can occur rarely:

• nightmares or intense dreams
• manic attacks
• agitation
• confusion
• seizures (convulsions)
• strange sensation in the skin (burning, pinching, tingling, numbness)
• restless leg movements during sleep, inner restlessness, inability to remain still
• rarely, occasional dizziness or fainting, especially when getting up quickly if you are stretched out or sitting
• dry mouth
• diarrhea
• yellowing of the eyes or skin; may suggest liver function alterations
• urticaria
• joint pain
• muscle pain
• fatigue
• hallucinations
• anxiety*
• insomnia*
• decrease in white blood cells, with decreased resistance of the body to infections, which can manifest as: fever, sore throat, mouth sores, or other signs of infection.

• In general, antidepressant treatment can develop or worsen anxiety and insomnia (which can be symptoms of depression). Under mirtazapine treatment, the development or worsening of anxiety and insomnia has been rarely reported.

If one of these last adverse reactions appears, consult your doctor immediately.

If you consider that any of the side effects you suffer is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storing MIRTAZAPINA COMBINO PHARM 30 mg TABLETS

No special storage conditions are required.

Keep out of the reach and sight of children.

Expiration date

Do not use Mirtazapina Combino Pharm after the expiration date stated on the packaging.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. FURTHER INFORMATION

Composition of Mirtazapina Combino Pharm

• The active ingredient is mirtazapine. Each tablet contains 30 mg of mirtazapine.
• The other ingredients (excipients) are:
• Core: lactose monohydrate, corn starch, hydroxypropyl cellulose, colloidal anhydrous silica, magnesium stearate.
• Coating: hypromellose, macrogol 8000, titanium dioxide (E-171), red iron oxide (E-172), yellow iron oxide (E-172), black iron oxide (E-172).

Appearance of the product and packaging content

Beige, oblong, and biconvex tablets with a score line on one side.

Mirtazapina Combino Pharm 30 mg tablets are available in packs of 30 tablets and 500 tablets.

Marketing authorization holder and manufacturer:

MEDICHEM, S.A.

Fructuós Gelabert, 6-8

08970 Sant Joan Despí, BARCELONA

SPAIN

Manufacturer:

COMBINO PHARM, S.L.

Fructuos Gelabert, 6-8

Sant Joan Despi (Barcelona)

08970, Spain

Or

COMBINO PHARM (MALTA) LTD.

HF 60, Hal Far Industrial Estate

Hal Far, BBG07-Malta

This leaflet was approved in July 2008