150 mg, 300 mg film-coated tablets 
moclobemide

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Aurorix is ​​and what it is used for 
2. What you need to know before you use Aurorix 
3. How to use Aurorix 
4. Possible side effects 
5. How to store Aurorix 
6. Contents of the packaging and other information 

1. What Aurorix is ​​and what it is used for

Aurorix is ​​used for various forms of depression and in the treatment of social phobia(fear of situations where one is at the center of others’ attention).

The cause of depression is not completely clear. It is known that in certain types of depression, the amount of nerve messenger substances, the so-called neurotransmitters, is low. This disrupts the transmission of impulses between nerve cells in the brain. By inhibiting a certain egg white substance ( enzyme et MAO-A), Aurorix increases the number of neurotransmitters in the brain and thus improves the disturbed impulse transmission.

2. What you need to know before you use Aurorix

Do not use Aurorix

  • if you are allergic to moclobemide or any of the other ingredients of this medicine (listed in section 6).
  • in pheochromocytoma (a benign tumor of the adrenal gland).
  • in thyrotoxicosis (too high production of thyroid hormone).
  • in case of acute confusion.
  • if you are taking medicines containing selegiline (for Parkinson’s disease ), linezolid (for severe infections ), dextromethorphan (cough suppressants), bupropion (for depression), triptans (for migraines ), or pethidine or tramadol (for severe pain).

Also, do not give Aurorix to children as they lack experience.

Warnings and cautions

Talk to your doctor before using Aurorix.

Those with hepatic impairment should consult a physician before starting treatment with Aurorix.

In some people, Aurorix may cause dry mouth. Careful oral hygiene is then important.

If you experience insomnia, nervousness, or tremors during the first weeks of treatment, contact a doctor immediately.

If you experience mania that involves a state of unusual and rapidly changing thoughts, unmotivated joy, and excessive physical activity, you should contact a doctor immediately.

If you start to feel worse and have thoughts of harming yourself

You who are depressed and/or suffer from worry/anxiety may sometimes have thoughts of harming yourself or committing suicide. These symptoms can get worse when you start using antidepressants because it takes time for drugs of this type to take effect, usually about 2 weeks, sometimes longer.

These thoughts may be common:

– if you have previously had thoughts of harming yourself or committing suicide,

– if you are younger than 25 years. Studies have shown that young adults (younger than 25 years) with mental illness who are treated with antidepressant drugs have an increased risk of suicidal thoughts and thoughts of harming themselves.

Contact a doctor as soon as possible or see the nearest hospital if you have thoughts of injuring yourself or committing suicide.

It may be helpful to tell a relative or close friend that you are depressed and/or suffering from anxiety. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think you are feeling worse or if they think your behavior is changing.

Other medicines and Aurorix

The treatment effect may be affected if Aurorix is ​​taken at the same time as certain other medicines. The treating physician, therefore, needs to be aware of a concomitant medication with drugs containing:

adrenaline-like drugs (including for asthma and low blood pressure ), cimetidine (for stomach ulcers ), linezolid (for severe infections ), omeprazole (for stomach ulcers ), dextromethorphan (cough suppressants), certain antidepressants ( fluoxetine, venlafaxine, citalopram, escalate paroxetine, sertraline, fluvoxamine, trimipramine, maprotiline, and clomipramine), selegiline (for Parkinson’s disease), sibutramine (for obesity), certain migraine medications (eg sumatriptan, zolmitriptan, rizatriptan) and certain painkillers (tramadol, fentanyl), pethidine, dextropropoxyphene, morphine, hydromorphone, and codeine ) may affect or be affected by treatment with Aurorix.

(Traditional) herbal medicines containing St. John’s wort (hypericum) should be used with caution in combination with this medicine.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines, (traditional) herbal medicines, and herbal medicines.

Aurorix with food and drink

With normal eating habits, no special dietary restrictions are required. However, you should avoid eating large amounts of stored cheese (more than 100 g per meal).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Limited experience of use during pregnancy.

Breast-feeding

Transfers to breast milk, but is unlikely to affect breastfed infants.

Driving and using machines

Aurorix may impair the ability to react in some people, which should be borne in mind at times when sharper attention is required, such as when driving a car and precision work.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Aurorix contains lactose

Aurorix contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Aurorix contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to use Aurorix

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Dose one is determined by the doctor, who adjusts it individually for each patient. Never change the prescribed dose yourself without consulting your doctor.

The recommended starting dose is 300 mg daily, usually divided into 2-3 sessions. For more severe depression, the dose can be increased up to 600 mg daily.

After starting treatment, it can take up to a couple of weeks before you feel better. The treatment usually lasts 3-6 months.

Take Aurorix immediately after the meal.

Aurorix is ​​not recommended for use in children.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following occur, do not take more Aurorix. Tell your doctor immediately, or go to the nearest emergency room.

  • Signs and symptoms of serotonergic symptoms such as restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting. (This is rare and may affect up to 1 in 1,000 people)
  • Thoughts of harming oneself or committing suicide. (This is less common and may affect up to 1 in 100 people)

Very common (may affect more than 1 user in 10): Dizziness, headache, difficulty sleeping, dry mouth (careful oral hygiene is important), nausea

Common (may affect up to 1 in 10 people): Vomiting, diarrhea, constipation, agitation, anxiety, and crawling ( paresthesias ), irritability, restlessness, low blood pressure, and rash

Uncommon (may affect up to 1 in 100 people): Visual disturbances, confusion, taste change, redness, fluid retention ( edema ), pruritus, hives, and weakness

Rare (may affect up to 1 in 1,000 people): Low blood sodium levels ( hyponatremia ), increased liver enzymes, delusions, and decreased appetite

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Aurorix

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 carton after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

– The active substance is moclobemide 150 mg and 300 mg per tablet respectively.

The other ingredients in 150 mg film-coated tablets are lactose monohydrate 148 mg, titanium dioxide (dye E 171), yellow iron oxide (dye E 172), magnesium stearate, hypromellose, povidone, ethylcellulose, sodium starch glycollate, talc, maize starch, and starch.

The other ingredients in 300 mg film-coated tablets are lactose monohydrate 26.5 mg, titanium dioxide (dye E 171), magnesium stearate, ethylcellulose, sodium starch glycollate, talc, maize starch, macrogol 6000, hypromellose, and povidone.

What the medicine looks like and the contents of the pack

150 mg film-coated tablets: Light yellow, oval, biconvex film-coated tablet with a scoreline, marked 150. Pack size: 100 pcs.

300 mg film-coated tablets: White, oval, biconvex film-coated tablet with a scoreline, marked 300: Pack size: 60 pcs.

Marketing Authorization Holder and Manufacturer

Meda AB

Box 906

170 09 Solna

Tel: 08 630 1900

Email: info@medasverige.se

Manufacturer

Meda Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Germany

Alternatively

Cenexi SAS

52, rue Marcel and Jacques Gaucher

94120 Fontenay-sous-Bois

France

Muhammad Nadeem

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